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: 1639724
Sex: M
Age: 67
State:

Vax Date: 06/16/2021
Onset Date: 06/16/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Received both dose of Pfizer vaccine and also received the Moderna Vaccine; off label use( first 2 pfizer vaccine and 3rd one Moderna vaccine); chills; ore arm/pain but not extremely sore and couldn't sleep on it; Slight throbbing behind the forehead and eyes but it is not a migraine; nausea; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received both dose of Pfizer vaccine and also received the Moderna Vaccine), OFF LABEL USE (off label use( first 2 pfizer vaccine and 3rd one Moderna vaccine)), CHILLS (chills), MYALGIA (ore arm/pain but not extremely sore and couldn't sleep on it) and HEADACHE (Slight throbbing behind the forehead and eyes but it is not a migraine) in a 67-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. Previously administered products included for COVID-19 immunisation: Pfizer (Receive both doses of Pfizer vaccine in 2021.). On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received both dose of Pfizer vaccine and also received the Moderna Vaccine), OFF LABEL USE (off label use( first 2 pfizer vaccine and 3rd one Moderna vaccine)), CHILLS (chills), MYALGIA (ore arm/pain but not extremely sore and couldn't sleep on it), HEADACHE (Slight throbbing behind the forehead and eyes but it is not a migraine) and NAUSEA (nausea). On 17-Jun-2021, NAUSEA (nausea) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Received both dose of Pfizer vaccine and also received the Moderna Vaccine), OFF LABEL USE (off label use( first 2 pfizer vaccine and 3rd one Moderna vaccine)), CHILLS (chills), MYALGIA (ore arm/pain but not extremely sore and couldn't sleep on it) and HEADACHE (Slight throbbing behind the forehead and eyes but it is not a migraine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient administered both doses of Pfizer vaccine in the year 2021 (was not sure of the exact month). The patient then administered Moderna vaccine as a booster shot. No concomitant medication were reported. No treatment information was reported

Other Meds:

Current Illness:

ID: 1639725
Sex: U
Age: 42
State: PA

Vax Date: 02/05/2021
Onset Date: 03/06/2021
Rec V Date: 08/27/2021
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: fever; Breathing problems; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing problems) and PYREXIA (fever) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma, Allergy, Smell loss (two years) and Taste loss (two years). Concomitant products included ALBUTEROL SULFATE and FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) 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 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Breathing problems). On 08-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, DYSPNOEA (Breathing problems) and PYREXIA (fever) outcome was unknown. Treatment medication included inhalers Action taken with mRNA-1273 Moderna vaccine was Not Applicable This case was linked to MOD-2021-038166 (Patient Link).

Other Meds: ALBUTEROL SULFATE; DULERA

Current Illness: Allergy; Asthma; Smell loss (two years); Taste loss (two years)

ID: 1639726
Sex: U
Age:
State:

Vax Date: 04/18/2021
Onset Date:
Rec V Date: 08/27/2021
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 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse reaction. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. It was not reported if the patient was received any corrective treatment for the event.

Other Meds:

Current Illness:

ID: 1639727
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: trouble breathing; rash; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing) and RASH (rash) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product CODEINE for an unknown indication. Concurrent medical conditions included Blood pressure high, Nose bleeds, Venous insufficiency (in both legs), Disorder ear (an ears disease that cause her to feel vertigo) and Allergy to chemicals (13 allergies to medicines (no further details provided)). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and CODEINE (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (trouble breathing) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Rash, at a dose of 1 dosage form. At the time of the report, DYSPNOEA (trouble breathing) and RASH (rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Reporter mentioned during call that patient was in the hospital (when she received the first dose of the vaccine) that her trouble breathing was from Codeine not that she had an anaphylactic shock.

Other Meds:

Current Illness: Allergy to chemicals (13 allergies to medicines (no further details provided)); Blood pressure high; Disorder ear (an ears disease that cause her to feel vertigo); Nose bleeds; Venous insufficiency (in both legs)

ID: 1639728
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: broke out; rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out) and RASH (rash) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (broke out) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (broke out) and RASH (rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No details provided regarding Concomitant Medications.

Other Meds:

Current Illness:

ID: 1639729
Sex: M
Age: 70
State: NJ

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 08/27/2021
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: Patient about to receive second vaccine 84day after first vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient about to receive second vaccine 84day after first vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient about to receive second vaccine 84day after first vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient about to receive second vaccine 84day after first vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications were not reported. The treatment information was not provided. The patient consulted pharmacist for second dose of Moderna COVID-19 Vaccine .Pharmacist wanted to confirm if it was possible to give second dose as it was beyond the window period.

Other Meds:

Current Illness:

ID: 1639730
Sex: U
Age:
State: IL

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 08/27/2021
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: symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (symptoms). At the time of the report, VACCINATION COMPLICATION (symptoms) outcome was unknown. No treatment information was reported

Other Meds:

Current Illness:

ID: 1639731
Sex: F
Age: 58
State: TX

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Sore arm; Upset stomach; Diarrhea; Red burning eyes; Red painful swollen eye lid; Painful swollen eye lid; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), OCULAR HYPERAEMIA (Red burning eyes) and SWELLING OF EYELID (Red painful swollen eye lid) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products TASIMELTEON (HETLIOZ) capsule for Circadian rhythm sleep disorder and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma. The patient's past medical history included Victim of child abuse and Developmental disturbance (Patient missed social steps). Previously administered products included for Product used for unknown indication: Depakote, Biaxin, Dynapen, Codeine, Erythromycin, Abilify and Keflex. Past adverse reactions to the above products included Drug allergy with Abilify, Biaxin, Codeine, Depakote, Dynapen, Erythromycin and Keflex. Concurrent medical conditions included Attention deficit hyperactivity disorder (Patient stated the condition as predominantly inattentive type), Major depressive disorder (Patient stated the condition as recurrent, moderate), Post-traumatic stress disorder, Anxiety and Asthma. Concomitant products included RANITIDINE HYDROCHLORIDE (ZANTAC), BECLOMETASONE DIPROPIONATE (QNASL), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ALPRAZOLAM (XANAX), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and ESZOPICLONE (LUNESTA) for an unknown indication. In 2015, the patient started TASIMELTEON (HETLIOZ) (Oral) 20 milligram once a day. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) (unknown route) at an unspecified dose. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). 14-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), OCULAR HYPERAEMIA (Red burning eyes), SWELLING OF EYELID (Red painful swollen eye lid) and EYELID PAIN (Painful swollen eye lid). At the time of the report, PAIN IN EXTREMITY (Sore arm), ABDOMINAL DISCOMFORT (Upset stomach), OCULAR HYPERAEMIA (Red burning eyes), SWELLING OF EYELID (Red painful swollen eye lid) and EYELID PAIN (Painful swollen eye lid) had not resolved and DIARRHOEA (Diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported that she took treatment medication along with Hetlioz. Patient also reported that episodes of not sleeping well after taking Hetlioz resulted in waking with burning eyes.

Other Meds: ZANTAC; QNASL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; XANAX; ADDERALL; LUNESTA

Current Illness: Anxiety; Asthma; Attention deficit hyperactivity disorder (Patient stated the condition as predominantly inattentive type); Major depressive disorder (Patient stated the condition as recurrent, moderate); Post-traumatic stress disorder

ID: 1639732
Sex: M
Age:
State: MA

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/27/2021
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: Feels like weeping under patch; Itchy looks like sun burn; The skin at application is red; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WEEPING (Feels like weeping under patch), VACCINATION SITE PRURITUS (Itchy looks like sun burn) and VACCINATION SITE ERYTHEMA (The skin at application is red) 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. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN WEEPING (Feels like weeping under patch), VACCINATION SITE PRURITUS (Itchy looks like sun burn) and VACCINATION SITE ERYTHEMA (The skin at application is red). At the time of the report, SKIN WEEPING (Feels like weeping under patch), VACCINATION SITE PRURITUS (Itchy looks like sun burn) and VACCINATION SITE ERYTHEMA (The skin at application is red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included "Rhodes Bup", and pain patch. Per report, the patient used a pain patch without complaints prior to receiving his vaccination and the subsequent skin reactions. Treatment information was not provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Significant FU - Patient Initials was updated.

Other Meds:

Current Illness:

ID: 1639733
Sex: F
Age: 35
State: MI

Vax Date: 06/02/2021
Onset Date: 06/18/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Blistering rash; One hell of a rash / irritating rash; Injection site has become dark purplish spot; Itching so bad all around the rash area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Injection site has become dark purplish spot), RASH PRURITIC (Itching so bad all around the rash area), BLISTER (Blistering rash) and RASH (One hell of a rash / irritating rash) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Allergic to Aspirin.). On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Injection site has become dark purplish spot), RASH PRURITIC (Itching so bad all around the rash area) and RASH (One hell of a rash / irritating rash). On an unknown date, the patient experienced BLISTER (Blistering rash). At the time of the report, VACCINATION SITE DISCOLOURATION (Injection site has become dark purplish spot), RASH PRURITIC (Itching so bad all around the rash area), BLISTER (Blistering rash) and RASH (One hell of a rash / irritating rash) 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 and treatment medications were reported. No treatment medications were reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-Jun-2021 contains no new information (NNI)

Other Meds:

Current Illness: Drug allergy (Allergic to Aspirin.)

ID: 1639734
Sex: M
Age:
State: NY

Vax Date: 03/04/2021
Onset Date: 04/08/2021
Rec V Date: 08/27/2021
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: 20210420; Test Name: DOPPLER; Test Result: Inconclusive ; Result Unstructured Data: unknown

Allergies:

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

Symptoms: Entire leg turning black and blue; Tender to touch and cannot put pressure on it or bend the leg/Hip to ankle tenderness; Right leg swells Hard as a rock. Tender to touch and cannot put pressure on it or bend the leg.; Right leg swells Hard as a rock; Right leg tight; Right leg tight and ache getting worse and pain intensifies; Trouble walking; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Right leg tight), PAIN (Right leg tight and ache getting worse and pain intensifies), PERIPHERAL SWELLING (Right leg swells Hard as a rock. Tender to touch and cannot put pressure on it or bend the leg.), INDURATION (Right leg swells Hard as a rock) and CONTUSION (Entire leg turning black and blue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031BZ1A and 036AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Lipitor), Latex allergy and Stroke since 27-Jun-2017. Concomitant products included WARFARIN SODIUM (COUMADIN) from 29-Jun-2017 to an unknown date and ROSUVASTATIN from 29-Jun-2017 to an unknown date for Stroke. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MUSCLE TIGHTNESS (Right leg tight), PAIN (Right leg tight and ache getting worse and pain intensifies) and GAIT DISTURBANCE (Trouble walking). On 16-Apr-2021, the patient experienced PERIPHERAL SWELLING (Right leg swells Hard as a rock. Tender to touch and cannot put pressure on it or bend the leg.) and INDURATION (Right leg swells Hard as a rock). On 22-Apr-2021, the patient experienced CONTUSION (Entire leg turning black and blue) and TENDERNESS (Tender to touch and cannot put pressure on it or bend the leg/Hip to ankle tenderness). At the time of the report, MUSCLE TIGHTNESS (Right leg tight), INDURATION (Right leg swells Hard as a rock), TENDERNESS (Tender to touch and cannot put pressure on it or bend the leg/Hip to ankle tenderness) and GAIT DISTURBANCE (Trouble walking) had not resolved and PAIN (Right leg tight and ache getting worse and pain intensifies), PERIPHERAL SWELLING (Right leg swells Hard as a rock. Tender to touch and cannot put pressure on it or bend the leg.) and CONTUSION (Entire leg turning black and blue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Ultrasound Doppler: unknown (Inconclusive) unknown. Patient reports that he continued Ice elevation and rest as treatment. He reported that he visited Orthopaedic specialist twice. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-090461 (Patient Link).

Other Meds: COUMADIN; ROSUVASTATIN

Current Illness: Drug allergy (Lipitor); Latex allergy; Stroke

ID: 1639735
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Problems with remembering now; Lethargy; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Problems with remembering now) and LETHARGY (Lethargy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Meningitis and Infection (Had an infection before 1st dose and took medicine.). 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 MEMORY IMPAIRMENT (Problems with remembering now) and LETHARGY (Lethargy). At the time of the report, MEMORY IMPAIRMENT (Problems with remembering now) and LETHARGY (Lethargy) 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. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-072608, MOD-2021-226822 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-072608:Same reporter (wife case) MOD-2021-226822:Dose 2 case

Other Meds:

Current Illness:

ID: 1639736
Sex: F
Age: 61
State: NJ

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 08/27/2021
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: Felt like I was having an asthma attack.; Left cheek from left ear to inner left side of nose swelled and felt numb.; Tightness in chest; Post nasal drip started from left side of nose; Clogged feeling and soreness in left ear; Clogged feeling and soreness in left ear; Left cheek from left ear to inner left side of nose swelled and felt numb.; Minutes after vaccination her left ear and cheeks, her left side of her face became swollen "on the inside" and numb, and she started feeling numb and tightness on her chest (at the moment the patient used her asthma inhaler and that got better, it o; Minutes after vaccination her left ear and cheeks, her left side of her face became swollen "on the inside" and numb, and she started feeling numb and tightness on her chest (at the moment the patient used her asthma inhaler and that got better, it o; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Felt like I was having an asthma attack.), SWELLING FACE (Left cheek from left ear to inner left side of nose swelled and felt numb.), CHEST DISCOMFORT (Tightness in chest), UPPER-AIRWAY COUGH SYNDROME (Post nasal drip started from left side of nose) and EAR PAIN (Clogged feeling and soreness in left ear) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0092C21A and 030a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic (Patient had Facial swelling, lip swelling, eye lid swelling.), Small intestinal bacterial overgrowth and Asthma. Concomitant products included MELATONIN for Sleepy, COLECALCIFEROL (VITAMIN D 3) for an unknown indication. On 10-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ASTHMA (Felt like I was having an asthma attack.), SWELLING FACE (Left cheek from left ear to inner left side of nose swelled and felt numb.), CHEST DISCOMFORT (Tightness in chest), UPPER-AIRWAY COUGH SYNDROME (Post nasal drip started from left side of nose), EAR PAIN (Clogged feeling and soreness in left ear), EAR CONGESTION (Clogged feeling and soreness in left ear), HYPOAESTHESIA (Left cheek from left ear to inner left side of nose swelled and felt numb.), HEADACHE (Minutes after vaccination her left ear and cheeks, her left side of her face became swollen "on the inside" and numb, and she started feeling numb and tightness on her chest (at the moment the patient used her asthma inhaler and that got better, it o) and FATIGUE (Minutes after vaccination her left ear and cheeks, her left side of her face became swollen "on the inside" and numb, and she started feeling numb and tightness on her chest (at the moment the patient used her asthma inhaler and that got better, it o). The patient was treated with SALBUTAMOL at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE on 10-Mar-2021 at an unspecified dose and frequency. At the time of the report, ASTHMA (Felt like I was having an asthma attack.), SWELLING FACE (Left cheek from left ear to inner left side of nose swelled and felt numb.), CHEST DISCOMFORT (Tightness in chest), UPPER-AIRWAY COUGH SYNDROME (Post nasal drip started from left side of nose), EAR PAIN (Clogged feeling and soreness in left ear), EAR CONGESTION (Clogged feeling and soreness in left ear), HYPOAESTHESIA (Left cheek from left ear to inner left side of nose swelled and felt numb.), HEADACHE (Minutes after vaccination her left ear and cheeks, her left side of her face became swollen "on the inside" and numb, and she started feeling numb and tightness on her chest (at the moment the patient used her asthma inhaler and that got better, it o) and FATIGUE (Minutes after vaccination her left ear and cheeks, her left side of her face became swollen "on the inside" and numb, and she started feeling numb and tightness on her chest (at the moment the patient used her asthma inhaler and that got better, it o) had resolved. No treatment information was reported. Reporter did not allow further contact

Other Meds: MELATONIN; VITAMIN D 3

Current Illness: Allergy to antibiotic (Patient had Facial swelling, lip swelling, eye lid swelling.); Asthma; Small intestinal bacterial overgrowth

ID: 1639737
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: urinary side effects; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT DISORDER (urinary 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT DISORDER (urinary side effects). At the time of the report, URINARY TRACT DISORDER (urinary side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1639738
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 02/26/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included INSULIN, LISINOPRIL, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), AZELASTINE and FAMOTIDINE (PEPCID AC) for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-256801 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: follow up received on 13-JUL-2021 contains concomitant medications

Other Meds: INSULIN; LISINOPRIL; XYZAL; AZELASTINE; PEPCID AC

Current Illness:

ID: 1639739
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Past 42 days since fisrt dose of vaccine/missed second dose/Inappropriate schedule of vaccine administered; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Past 42 days since fisrt dose of vaccine/missed second dose/Inappropriate schedule of vaccine administered) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Past 42 days since fisrt dose of vaccine/missed second dose/Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Past 42 days since fisrt dose of vaccine/missed second dose/Inappropriate schedule of vaccine administered) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1639740
Sex: F
Age: 66
State: MA

Vax Date: 05/01/2021
Onset Date: 05/03/2021
Rec V Date: 08/27/2021
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: floaters in right eye; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (floaters in right eye) and VOMITING (Threw up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003021A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced VITREOUS FLOATERS (floaters in right eye) and VOMITING (Threw up). At the time of the report, VITREOUS FLOATERS (floaters in right eye) and VOMITING (Threw up) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No treatment information was provided.

Other Meds: METFORMIN

Current Illness: Diabetes

ID: 1639741
Sex: M
Age:
State: TX

Vax Date: 05/14/2021
Onset Date:
Rec V Date: 08/27/2021
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: Not able to make their appointment for the second dose of the Moderna COVID-19 vaccine.; Suffered broken ribs after he was kicked in the ribs by a cow on their farm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not able to make their appointment for the second dose of the Moderna COVID-19 vaccine.) and RIB FRACTURE (Suffered broken ribs after he was kicked in the ribs by a cow on their farm) 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 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not able to make their appointment for the second dose of the Moderna COVID-19 vaccine.) and RIB FRACTURE (Suffered broken ribs after he was kicked in the ribs by a cow on their farm). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not able to make their appointment for the second dose of the Moderna COVID-19 vaccine.) had resolved and RIB FRACTURE (Suffered broken ribs after he was kicked in the ribs by a cow on their farm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1639742
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: trying to find an appointment for my 2nd vaccine that is past due; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (trying to find an appointment for my 2nd vaccine that is past due) and PRODUCT AVAILABILITY ISSUE (trying to find an appointment for my 2nd vaccine that is past due) 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 PRODUCT ADMINISTRATION INTERRUPTED (trying to find an appointment for my 2nd vaccine that is past due) and PRODUCT AVAILABILITY ISSUE (trying to find an appointment for my 2nd vaccine that is past due). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (trying to find an appointment for my 2nd vaccine that is past due) and PRODUCT AVAILABILITY ISSUE (trying to find an appointment for my 2nd vaccine that is past due) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided.

Other Meds:

Current Illness:

ID: 1639743
Sex: F
Age: 54
State:

Vax Date: 01/21/2021
Onset Date: 02/20/2021
Rec V Date: 08/27/2021
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: Weakness generalised; Dizziness aggravated; tiredness; fever; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHENIA (Weakness generalised), DIZZINESS (Dizziness aggravated), FATIGUE (tiredness) and PYREXIA ( fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 030L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced FATIGUE (tiredness) and PYREXIA ( fever). On 24-Feb-2021, the patient experienced ASTHENIA (Weakness generalised) and DIZZINESS (Dizziness aggravated). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 21-Feb-2021, FATIGUE (tiredness) and PYREXIA ( fever) had resolved. At the time of the report, ASTHENIA (Weakness generalised) and DIZZINESS (Dizziness aggravated) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient went to emergency visit. Patient was not taking any other concomitant medications. Action taken for Moderna COVID-19 Vaccine was not applicable. This case was linked to MOD-2021-039630 (Patient Link).

Other Meds:

Current Illness:

ID: 1639744
Sex: F
Age: 66
State: MI

Vax Date: 06/14/2021
Onset Date: 06/15/2021
Rec V Date: 08/27/2021
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: itchy throat; allergic reaction; Heart began pounding; Could see it in her eyes, like when you know you have the flu because you can see it in your; immediately felt it in her glands; was tired; Rash on both jaws that went down both sides of neck; Lips started swelling on the way to the doctor; Face was swelling; she developed itchy blotches almost like hives; Face was on fire; Runny nose; Itching at the injection site,itchy; chills; she had everything like she had COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she had everything like she had COVID), LIP SWELLING (Lips started swelling on the way to the doctor), SWELLING FACE (Face was swelling), THROAT IRRITATION (itchy throat) and ALLERGY TO VACCINE (allergic reaction) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced COVID-19 (she had everything like she had COVID), FEELING HOT (Face was on fire), RHINORRHOEA (Runny nose), VACCINATION SITE PRURITUS (Itching at the injection site,itchy) and CHILLS (chills). On 16-Jun-2021, the patient experienced URTICARIA (she developed itchy blotches almost like hives). On 17-Jun-2021, the patient experienced LIP SWELLING (Lips started swelling on the way to the doctor), SWELLING FACE (Face was swelling) and RASH (Rash on both jaws that went down both sides of neck). On an unknown date, the patient experienced THROAT IRRITATION (itchy throat), ALLERGY TO VACCINE (allergic reaction), PALPITATIONS (Heart began pounding), INFLUENZA (Could see it in her eyes, like when you know you have the flu because you can see it in your), FEELING ABNORMAL (immediately felt it in her glands) and FATIGUE (was tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, COVID-19 (she had everything like she had COVID), LIP SWELLING (Lips started swelling on the way to the doctor), THROAT IRRITATION (itchy throat), ALLERGY TO VACCINE (allergic reaction), PALPITATIONS (Heart began pounding), FEELING HOT (Face was on fire), RHINORRHOEA (Runny nose), INFLUENZA (Could see it in her eyes, like when you know you have the flu because you can see it in your), URTICARIA (she developed itchy blotches almost like hives), FEELING ABNORMAL (immediately felt it in her glands), RASH (Rash on both jaws that went down both sides of neck), VACCINATION SITE PRURITUS (Itching at the injection site,itchy), CHILLS (chills) and FATIGUE (was tired) outcome was unknown and SWELLING FACE (Face was swelling) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator

Other Meds:

Current Illness:

ID: 1639745
Sex: M
Age: 62
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/27/2021
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: Rash on back , buttocks, legs/Itchy and red rash; Itchy and red rash; Rash every 72 hours; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash on back , buttocks, legs/Itchy and red rash), RASH ERYTHEMATOUS (Itchy and red rash) and RASH (Rash every 72 hours) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Rash on back , buttocks, legs/Itchy and red rash), RASH ERYTHEMATOUS (Itchy and red rash) and RASH (Rash every 72 hours). At the time of the report, RASH PRURITIC (Rash on back , buttocks, legs/Itchy and red rash), RASH ERYTHEMATOUS (Itchy and red rash) and RASH (Rash every 72 hours) outcome was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1639746
Sex: F
Age: 71
State: MN

Vax Date: 03/03/2021
Onset Date:
Rec V Date: 08/27/2021
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: Sore arm; Falls asleep, sleeps 4 to 5 hours; Falls asleep; Tiredness/ feeling exhausted/ fatigue that is immense and overtakes her body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Falls asleep, sleeps 4 to 5 hours), INSOMNIA (Falls asleep) and FATIGUE (Tiredness/ feeling exhausted/ fatigue that is immense and overtakes her body) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 036A21A) for COVID-19 vaccination. The patient's past medical history included Lymph node excision (Ten lymph nodes were taken out due to cancer.). Concurrent medical conditions included Cancer. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Falls asleep, sleeps 4 to 5 hours), INSOMNIA (Falls asleep) and FATIGUE (Tiredness/ feeling exhausted/ fatigue that is immense and overtakes her body). At the time of the report, PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Falls asleep, sleeps 4 to 5 hours) and FATIGUE (Tiredness/ feeling exhausted/ fatigue that is immense and overtakes her body) had resolved and INSOMNIA (Falls asleep) outcome was unknown. Not Provided Concomitant product use was not provided by the reporter. Patient experienced sore arm felt like having a flu shot. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information received on 12-Jul-2021 updated events outcome to resolved.; Sender's Comments:

Other Meds:

Current Illness: Cancer

ID: 1639747
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Horrible headache) 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 HEADACHE (Horrible headache). At the time of the report, HEADACHE (Horrible headache) 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. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1639748
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Face is swollen after getting my second shot; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face is swollen after getting my second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Face is swollen after getting my second shot). At the time of the report, SWELLING FACE (Face is swollen after getting my second shot) outcome was unknown. No concomitant medications was provided by the reporter. No treatment drug details was provided.

Other Meds:

Current Illness:

ID: 1639749
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: patient reported an incorrect DOB, which lead us to believe that they were 18 or over, therefore given their first dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient reported an incorrect DOB, which lead us to believe that they were 18 or over, therefore given their first dose.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient reported an incorrect DOB, which lead us to believe that they were 18 or over, therefore given their first dose.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient reported an incorrect DOB, which lead us to believe that they were 18 or over, therefore given their first dose.) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided by the reporter Treatment information was not provided by the reporter. No lab data was provided by the reporter.

Other Meds:

Current Illness:

ID: 1639750
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: The swollen part on my arm keeps getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (The swollen part on my arm keeps getting bigger) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (The swollen part on my arm keeps getting bigger). At the time of the report, VACCINATION SITE SWELLING (The swollen part on my arm keeps getting bigger) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications and No Treatment medications were reported.

Other Meds:

Current Illness:

ID: 1639751
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Vertigo; Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Dizziness) and NAUSEA (Nausea) 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 VERTIGO (Vertigo), DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, VERTIGO (Vertigo), DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1639752
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication were reported. No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1639753
Sex: F
Age:
State: CO

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 08/27/2021
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: sore arm; breathing off a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and DYSPNOEA (breathing off a little) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. Concomitant products included VITAMIN D NOS for an unknown indication. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and DYSPNOEA (breathing off a little). At the time of the report, PAIN IN EXTREMITY (sore arm) and DYSPNOEA (breathing off a little) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient history was not provided. Concomitant medication also contain Antacid. Treatment medication not provided. This case was linked to MOD-2021-038179 (Patient Link).

Other Meds: VITAMIN D NOS

Current Illness:

ID: 1639754
Sex: M
Age: 67
State: CA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 08/27/2021
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: Cough; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and RHINORRHOEA (Runny nose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The patient's past medical history included Sneezing. Concurrent medical conditions included Chronic cough. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced COUGH (Cough) and RHINORRHOEA (Runny nose). The patient was treated with CODEINE PHOSPHATE, GUAIFENESIN, PHENIRAMINE MALEATE (ROBITUSSIN WITH CODEINE) at an unspecified dose and frequency and CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE WITH CODEINE) at an unspecified dose and frequency. At the time of the report, COUGH (Cough) and RHINORRHOEA (Runny nose) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2021-226183 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-226183:Dose 1 case

Other Meds:

Current Illness: Chronic cough

ID: 1639755
Sex: M
Age:
State: TX

Vax Date: 05/03/2021
Onset Date:
Rec V Date: 08/27/2021
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: Patient missed his second dose, and now its more than 42 days and will possibly come on 21JUN2021; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose, and now its more than 42 days and will possibly come on 21JUN2021) 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 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose, and now its more than 42 days and will possibly come on 21JUN2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose, and now its more than 42 days and will possibly come on 21JUN2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1639756
Sex: F
Age: 120
State: CA

Vax Date: 01/08/2021
Onset Date: 02/05/2021
Rec V Date: 08/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Little pain on shoulder; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Little pain on shoulder) and FATIGUE (Tired) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ARTHRALGIA (Little pain on shoulder) and FATIGUE (Tired). On 06-Feb-2021, ARTHRALGIA (Little pain on shoulder) and FATIGUE (Tired) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine) was not applicable. No concomitant medication was mentioned. No treatment medication was mentioned. This case was linked to MOD-2021-014536 (Patient Link).

Other Meds:

Current Illness:

ID: 1639757
Sex: U
Age:
State:

Vax Date:
Onset Date: 06/17/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Date: 20210617; Test Name: Body Temperature; Result Unstructured Data: 101.5

Allergies:

Symptom List: Tremor

Symptoms: Fever of 101.5; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.5) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced PYREXIA (Fever of 101.5). At the time of the report, PYREXIA (Fever of 101.5) outcome was unknown. Unknown DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jun-2021, Body temperature: 101.5 (High) 101.5. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1639758
Sex: M
Age:
State: MO

Vax Date: 06/16/2021
Onset Date:
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: felt like something foreign put in my body; hard to describe, felt like a steroid shot; severe flu like symptoms; sweats; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SENSATION OF FOREIGN BODY (felt like something foreign put in my body), FEELING ABNORMAL (hard to describe, felt like a steroid shot), INFLUENZA LIKE ILLNESS (severe flu like symptoms), HYPERHIDROSIS (sweats) and CHILLS (chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SENSATION OF FOREIGN BODY (felt like something foreign put in my body), FEELING ABNORMAL (hard to describe, felt like a steroid shot), INFLUENZA LIKE ILLNESS (severe flu like symptoms), HYPERHIDROSIS (sweats), CHILLS (chills) and NAUSEA (nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, SENSATION OF FOREIGN BODY (felt like something foreign put in my body), FEELING ABNORMAL (hard to describe, felt like a steroid shot), INFLUENZA LIKE ILLNESS (severe flu like symptoms), HYPERHIDROSIS (sweats), CHILLS (chills) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant information was reported. The patient took Ibuprofen which didn't help.

Other Meds:

Current Illness:

ID: 1639759
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Magnet stick to my erect penis but not when it's flaccid after my second injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Magnet stick to my erect penis but not when it's flaccid after my second injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Magnet stick to my erect penis but not when it's flaccid after my second injection). At the time of the report, VACCINATION COMPLICATION (Magnet stick to my erect penis but not when it's flaccid after my second injection) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1639760
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Injection site numb; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPOESTHESIA (Injection site numb) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HYPOESTHESIA (Injection site numb). At the time of the report, INJECTION SITE HYPOESTHESIA (Injection site numb) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were provided by the reporter. No Treatment medications were provided by the reporter. For mRNA-1273 (COVID 19 Vaccine Moderna) (unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1639761
Sex: F
Age: 62
State: WA

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 08/27/2021
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: arm hurt for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt for 24 hours) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high, DILTIAZEM and PANTOPRAZOLE SODIUM for an unknown indication. On 24-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 (arm hurt for 24 hours). At the time of the report, PAIN IN EXTREMITY (arm hurt for 24 hours) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided by the reporter. This case was linked to MOD-2021-054585 (Patient Link).

Other Meds: LISINOPRIL; DILTIAZEM; PANTOPRAZOLE SODIUM

Current Illness: Blood pressure high

ID: 1639762
Sex: F
Age: 62
State: VT

Vax Date: 04/03/2021
Onset Date:
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Date: 202105; Test Name: heart rate; Test Result: Inconclusive ; Result Unstructured Data: irregular; Test Date: 202105; Test Name: X-RAY; Test Result: Inconclusive ; Result Unstructured Data: inconclusive

Allergies:

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

Symptoms: heart started beating fast and it felt really off / Her heart is racing again; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart started beating fast and it felt really off / Her heart is racing again) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A and 009C21N) for COVID-19 vaccination. The patient's past medical history included Cancer, Heart disorder (UNKNOWN CARDIAC ISSUES REPORTED .) and Emergency care (on Tuesday, 04May2021,patient went to her personal doctor and once the HCP listened to her heart he sent her to the ER.). Concurrent medical conditions included Type 2 diabetes mellitus and Asthma. On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (heart started beating fast and it felt really off / Her heart is racing again). At the time of the report, HEART RATE INCREASED (heart started beating fast and it felt really off / Her heart is racing again) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Heart rate irregular:. In May 2021, X-ray:. No concomitant medications were provided. No treatment details were provided.

Other Meds:

Current Illness: Asthma; Type 2 diabetes mellitus

ID: 1639763
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: fatigue; 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 FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included TOFACITINIB CITRATE (XELJANZ) for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown. No treatment information was provided Reporter did not allow further contact

Other Meds: XELJANZ

Current Illness:

ID: 1639764
Sex: M
Age: 56
State: MD

Vax Date: 04/28/2021
Onset Date:
Rec V Date: 08/27/2021
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: persistent cough, like a coughing spam that was persistent and it was; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (persistent cough, like a coughing spam that was persistent and it was) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product DUPILUMAB for Asthma. Concurrent medical conditions included Asthma. On 28-Apr-2021, the patient started DUPILUMAB (Subcutaneous) 300 milligram every two weeks. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (persistent cough, like a coughing spam that was persistent and it was). The patient was treated with BUDESONIDE for Cough, at a dose of 1 UNK. At the time of the report, COUGH (persistent cough, like a coughing spam that was persistent and it was) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient had two doses of dupilumab, then he received his first Moderna shot (date unknown) and two weeks later, On 26-May-2021, Patient took third shot of dupilumab.

Other Meds: DUPILUMAB

Current Illness: Asthma

ID: 1639765
Sex: F
Age:
State:

Vax Date: 05/28/2021
Onset Date: 06/05/2021
Rec V Date: 08/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data: Test Date: 20210605; Test Name: PCR test; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: mild symptoms due to Covid-19 after having first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (mild symptoms due to Covid-19 after having first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced COVID-19 (mild symptoms due to Covid-19 after having first dose). On 16-Jun-2021, COVID-19 (mild symptoms due to Covid-19 after having first dose) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications information was reported. On 25-Jun-2021, the patient's second dose was scheduled. No treatment medications were provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Event outcome updated, event stop date added

Other Meds:

Current Illness:

ID: 1639766
Sex: M
Age: 49
State: MD

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 08/27/2021
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: Trauma in left knee; Groin Pain; joint tenderness/Elbow Pain/ both shoulder /Hip Pain started to become sore/painful (3 - 5 out of 10); This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (Trauma in left knee), GROIN PAIN (Groin Pain) and ARTHRALGIA (joint tenderness/Elbow Pain/ both shoulder /Hip Pain started to become sore/painful (3 - 5 out of 10)) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The patient's past medical history included Back pain. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, CANNABIS for Chronic back pain, ATORVASTATIN and METFORMIN for Type 2 diabetes mellitus. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced JOINT INJURY (Trauma in left knee), GROIN PAIN (Groin Pain) and ARTHRALGIA (joint tenderness/Elbow Pain/ both shoulder /Hip Pain started to become sore/painful (3 - 5 out of 10)). On 23-Apr-2021, ARTHRALGIA (joint tenderness/Elbow Pain/ both shoulder /Hip Pain started to become sore/painful (3 - 5 out of 10)) had resolved. At the time of the report, JOINT INJURY (Trauma in left knee) outcome was unknown and GROIN PAIN (Groin Pain) was resolving. No treatment information were provided. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-227257 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Patient demographics, medical history , concomitant medications and new events were added.

Other Meds: LEXAPRO; ATORVASTATIN; METFORMIN; CANNABIS

Current Illness:

ID: 1639767
Sex: F
Age: 47
State: NY

Vax Date: 06/09/2021
Onset Date: 06/17/2021
Rec V Date: 08/27/2021
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: Vaccination site inflammation; Hives; itch left arm; left arm red; inflammed left arm; Rash; Injection site itching; Injection site redness; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Vaccination site inflammation), URTICARIA (Hives), PRURITUS (itch left arm), ERYTHEMA (left arm red) and INFLAMMATION (inflammed left arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Thyroid cancer on 07-Jun-2015. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 07-Jun-2015 to an unknown date and LIOTHYRONINE for Hormone replacement therapy, CALCITRIOL and CALCIUM CITRATE for Hypoparathyroidism. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced VACCINATION SITE INFLAMMATION (Vaccination site inflammation), URTICARIA (Hives), PRURITUS (itch left arm), ERYTHEMA (left arm red), INFLAMMATION (inflammed left arm), RASH (Rash), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) (oral) on 17-Jun-2021 for Symptomatic treatment, at a dose of 1 dosage form; NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at a dose of 1 dosage form; HYDROCORTISONE on 17-Jun-2021 for Symptomatic treatment, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) on 17-Jun-2021 for Symptomatic treatment, at a dose of 1 dosage form. On 17-Jun-2021, VACCINATION SITE INFLAMMATION (Vaccination site inflammation), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 18-Jun-2021, URTICARIA (Hives), PRURITUS (itch left arm), ERYTHEMA (left arm red) and RASH (Rash) had resolved. At the time of the report, INFLAMMATION (inflammed left arm) outcome was unknown. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant follow up On 09-Aug-2021: Follow up received and contains No new information.

Other Meds: SYNTHROID; LIOTHYRONINE; CALCITRIOL; CALCIUM CITRATE

Current Illness:

ID: 1639768
Sex: F
Age:
State: GA

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 08/27/2021
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: diarrhea; did not have a voice at all / whispering; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and APHONIA (did not have a voice at all / whispering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced DIARRHOEA (diarrhea) and APHONIA (did not have a voice at all / whispering). On 17-Jun-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, APHONIA (did not have a voice at all / whispering) outcome was unknown. Not Provided 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: 1639769
Sex: F
Age: 19
State: FL

Vax Date: 06/10/2021
Onset Date: 06/12/2021
Rec V Date: 08/27/2021
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: Heart pain / chest pain; muscle pain; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Heart pain / chest pain), MYALGIA (muscle pain) and FATIGUE (tiredness) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced CHEST PAIN (Heart pain / chest pain), MYALGIA (muscle pain) and FATIGUE (tiredness). On 12-Jun-2021, CHEST PAIN (Heart pain / chest pain) had resolved. On 13-Jun-2021, MYALGIA (muscle pain) and FATIGUE (tiredness) had resolved. Not Provided No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter. Does not have any information regarding the first dose Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-significant follow up appended - New Reporter (Consumer) added

Other Meds:

Current Illness:

ID: 1639770
Sex: F
Age: 54
State: AZ

Vax Date: 04/20/2021
Onset Date:
Rec V Date: 08/27/2021
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: little arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little arm pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (little arm pain). At the time of the report, VACCINATION SITE PAIN (little arm pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No treatment medication was reported . This case was linked to MOD-2021-187569 (Patient Link).

Other Meds: ZOFRAN [ONDANSETRON]

Current Illness:

ID: 1639771
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: MISS TO TAKE SECOND DOSE IN 6 WEEKS; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (MISS TO TAKE SECOND DOSE IN 6 WEEKS) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (MISS TO TAKE SECOND DOSE IN 6 WEEKS). At the time of the report, PRODUCT DOSE OMISSION ISSUE (MISS TO TAKE SECOND DOSE IN 6 WEEKS) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1639772
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: got 0.7 ml not 0.5 ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (got 0.7 ml not 0.5 ml) 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) .7 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (got 0.7 ml not 0.5 ml). At the time of the report, ACCIDENTAL OVERDOSE (got 0.7 ml not 0.5 ml) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No information about concomitant medications was provided.

Other Meds:

Current Illness:

ID: 1639773
Sex: F
Age: 67
State: IA

Vax Date: 03/02/2021
Onset Date: 05/28/2021
Rec V Date: 08/27/2021
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: Fibromyalgia; extremely tired; Slept almost all day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FIBROMYALGIA (Fibromyalgia), HYPERSOMNIA (Slept almost all day) and FATIGUE (extremely tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma. Concomitant products included DUPILUMAB from 04-Mar-2021 to an unknown date for Asthma. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSOMNIA (Slept almost all day). On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia) and FATIGUE (extremely tired). At the time of the report, FIBROMYALGIA (Fibromyalgia), HYPERSOMNIA (Slept almost all day) and FATIGUE (extremely tired) had not resolved. Concomitant medications also included unspecified steroids. Patient reported that she experiences fatigue and hypersomnia every time she gets her dupilumab dose. No treatment medications were reported.

Other Meds: DUPILUMAB

Current Illness: Asthma

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am