VAERS 2021 Database www.vaers.hhs.gov

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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: 1743486
Sex: F
Age:
State: NV

Vax Date:
Onset Date: 09/17/2021
Rec V Date: 09/29/2021
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: 20210925; Test Name: Body temperature; Result Unstructured Data: 105 F

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: SHOOTING PAIN FROM KNEE TO INSIDE OF THIGH; SLIGHT FEVER ON 1ST 2 DAYS, HIGH FEVER SPIKES ON 9TH AND 10TH DAY; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: osteoarthritis in left knee. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-SEP-2021, the patient experienced shooting pain from knee to inside of thigh. On 17-SEP-2021, the patient experienced slight fever on 1st 2 days, high fever spikes on 9th and 10th day. On 25-SEP-2021, Laboratory data included: Body temperature (NR: not provided) 105 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight fever on 1st 2 days, high fever spikes on 9th and 10th day, and the outcome of shooting pain from knee to inside of thigh was not reported. This report was non-serious.

Other Meds:

Current Illness: Knee osteoarthritis

ID: 1743487
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
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: PAIN IN THE LEGS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced pain in the legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the legs. This report was non-serious.

Other Meds:

Current Illness:

ID: 1743488
Sex: F
Age:
State:

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 09/29/2021
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: COLD SYMPTOMS (SORE THROAT, NASAL CONGESTION AND SNEEZING); This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 150 pounds, and height was 57 inches. The patient's concurrent conditions included: high blood pressure, and post partum preeclampsia, and other pre-existing medical conditions included: The patient and her son had not done covid-19 test. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included metoprolol tartrate for post partum preeclampsia. On 24-SEP-2021, the patient experienced cold symptoms (sore throat, nasal congestion and sneezing). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cold symptoms (sore throat, nasal congestion and sneezing) was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000194835.

Other Meds: METOPROLOL TARTRATE

Current Illness: Blood pressure high; Pre-eclampsia

ID: 1743489
Sex: M
Age:
State: OR

Vax Date:
Onset Date: 09/17/2021
Rec V Date: 09/29/2021
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: OFF LABEL USE; VACCINE ADMINISTERED TO A MINOR; This spontaneous report received from a pharmacist concerned a 12 year old male. The patient's weight was 280 pounds, and height was 74 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-SEP-2021, the patient experienced off label use. On 17-SEP-2021, the patient experienced vaccine administered to a minor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to a minor was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1743490
Sex: U
Age:
State:

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

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

Lab Data: Test Date: 20210924; Test Name: Body temperature; Result Unstructured Data: 101

Allergies:

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

Symptoms: WORST POSSIBLE CHILLS; FEVER OF 101; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 24-SEP-2021, the patient experienced worst possible chills. On 24-SEP-2021, the patient experienced fever of 101. Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 101 and worst possible chills was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1743491
Sex: M
Age:
State: NE

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 09/29/2021
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: POTENTIAL ADMINISTRATION ERROR - EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced potential administration error - expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential administration error - expired janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210953327, 20210953012, 20210952662.

Other Meds:

Current Illness:

ID: 1743492
Sex: U
Age:
State: TX

Vax Date:
Onset Date: 09/27/2021
Rec V Date: 09/29/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 74 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210952718.

Other Meds:

Current Illness:

ID: 1743493
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 09/22/2021
Rec V Date: 09/29/2021
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: ADMINISTRATION OF EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned a 64 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired janssen covid-19 vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1743494
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: positive

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: COVID-19 TEST POSITIVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1743495
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
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: BODY ACHES; FEVER; HEADACHE; COMPLICATIONS; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not pregnant at the time of vaccination The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced complications. On 23-SEP-2021, the patient experienced body aches. On 23-SEP-2021, the patient experienced fever. On 23-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and headache on 26-SEP-2021, and the outcome of complications was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1743496
Sex: M
Age:
State: LA

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

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

Lab Data:

Allergies:

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

Symptoms: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210953241.

Other Meds:

Current Illness:

ID: 1743497
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
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: PEA SIZED NODULE AT INJECTION SITE; TENDER WHEN TOUCHED; This spontaneous report received from a patient concerned a 53 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced pea sized nodule at injection site. On SEP-2021, the patient experienced tender when touched. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pea sized nodule at injection site and tender when touched was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1743498
Sex: M
Age:
State: NE

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 09/29/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a consumer concerned a 50 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210952662.

Other Meds:

Current Illness:

ID: 1743499
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 04/02/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 202106; Test Name: Electrocardiogram; Result Unstructured Data: Normal; Test Date: 202106; Test Name: Blood test; Result Unstructured Data: Normal

Allergies:

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

Symptoms: FELT LIKE BEING FORCED TO MOVE; FELT SEVERE FATIGUE; SLEPT FOR THE DAY/ SLEEPS FOR 13-15 HOURS.; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 265 pounds, and height was 69 inches. The patient's past medical history included: shingles, and concurrent conditions included: sleep apnea, alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient was previously treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid; and experienced drug allergy when treated with phenobarbital. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced slept for the day/ sleeps for 13-15 hours. On JUN-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. On an unspecified date, the patient experienced felt like being forced to move, and felt severe fatigue. Treatment medications (dates unspecified) included: solriamfetol hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt severe fatigue, and slept for the day/ sleeps for 13-15 hours., and the outcome of felt like being forced to move was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (1 small glass a week); Non-smoker; Sleep apnea (uses continuous positive airway pressure (CPAP).)

ID: 1743500
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
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: CHILLS; HEADACHE; SWOLLEN LYMPH NODE UNDER ARMPIT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced chills. On SEP-2021, the patient experienced headache. On SEP-2021, the patient experienced swollen lymph node under armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache and swollen lymph node under armpit was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1743501
Sex: F
Age:
State: MA

Vax Date:
Onset Date: 05/14/2021
Rec V Date: 09/29/2021
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: ADMINISTRATION OF JANSSEN COVID 19 VACCINE AFTER RECEIVING AND HAVING AN ALLERGIC REACTION TO THE PFIZER COVID VACCINE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic reaction to the pfizer covid vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 14-MAY-2021, the patient experienced administration of janssen covid 19 vaccine after receiving and having an allergic reaction to the pfizer covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of janssen covid 19 vaccine after receiving and having an allergic reaction to the pfizer covid vaccine was not reported. This report was non-serious.

Other Meds: BNT 162

Current Illness: Allergy to vaccine

ID: 1743502
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: VACCINE HIT LIKE A SACK OF BRICKS; MIGRAINE; JOINTS DID NOT SUPPORT HAD TO WAIT 30 MINUTES BEFORE STAND AFTER WOKE UP BECAUSE OF KNEES AND FEET; JOINT PAIN FELT LIKE 40 YEARS OLDER FOR A DAY; EXTREMELY TIRED; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine hit like a sack of bricks, migraine, joints did not support had to wait 30 minutes before stand after woke up because of knees and feet, joint pain felt like 40 years older for a day, extremely tired, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine hit like a sack of bricks, fever, migraine, extremely tired, joint pain felt like 40 years older for a day and joints did not support had to wait 30 minutes before stand after woke up because of knees and feet was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1743503
Sex: U
Age:
State: TX

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 09/29/2021
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: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from administered expired vaccine. This report was non-serious.

Other Meds:

Current Illness:

ID: 1743504
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: CHEST PAIN; VERTIGO; SEVERE SIDE EFFECTS; This spontaneous report received from a parent via a company representative concerned a 26 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chest pain, vertigo, and severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, vertigo and severe side effects was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1743505
Sex: M
Age:
State: LA

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 09/29/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210952956.

Other Meds:

Current Illness:

ID: 1743506
Sex: U
Age:
State: NE

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 09/29/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210952662, 20210953012 and 20210952909.

Other Meds:

Current Illness:

ID: 1743507
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme fatigue. This report was non-serious.

Other Meds:

Current Illness:

ID: 1743508
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 03/06/2021
Rec V Date: 09/29/2021
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: PAINFUL BIG LUMP STICKING OUT AT THE INJECTION SITE IN LEFT ARM; This spontaneous report received from a consumer concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis, sulfa allergy, non alcohol user, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 23-AUG-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced painful big lump sticking out at the injection site in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful big lump sticking out at the injection site in left arm. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker; Psoriasis; Sulfonamide allergy

ID: 1743509
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 202109; Test Name: Blood pressure; Result Unstructured Data: 120/80 or 128/81 (units unspecified); Test Name: Blood pressure; Result Unstructured Data: 110/70 (units unspecified)

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: FEELING/SENSATION IN ARM GOING DOWN INTO HER HAND; PAIN GOING DOWN TO HAND WHEN VACCINE WAS ADMINISTERED; FEELS TIRED; BLOOD PRESSURE INCREASED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced blood pressure increased. On SEP-2021, the patient experienced pain going down to hand when vaccine was administered. On SEP-2021, the patient experienced feels tired. Laboratory data included: Blood pressure (NR: not provided) 120/80 or 128/81 (units unspecified). On 22-SEP-2021, the patient experienced feeling/sensation in arm going down into her hand. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 110/70 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling/sensation in arm going down into her hand, and the outcome of feels tired, pain going down to hand when vaccine was administered and blood pressure increased was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1743510
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: Flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) had resolved. No Concomitant medication was provided. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1743511
Sex: F
Age: 70
State: NM

Vax Date: 02/13/2021
Onset Date:
Rec V Date: 09/29/2021
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: sore arm; stomach ache; itchy rash on body; Dizzy all day; muscle aches; headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), RASH PRURITIC (itchy rash on body), DIZZINESS (Dizzy all day) and MYALGIA (muscle aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dizziness and Rash. Concurrent medical conditions included Drug allergy (Cipro allergy and Vicodin) and Contrast media allergy (Iodine based contrast dye). Concomitant products included BUDESONIDE (PULMICORT FLEXHALER) for Asthma, LIFITEGRAST (XIIDRA) for Dry eye, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis, OXYGEN supplementation (OXYGEN), MULTIVITAMIN [VITAMINS NOS], MAGNESIUM CITRATE, VITAMIN D3, VITAMIN B2 [RIBOFLAVIN], PROBIOTICS NOS, FISH OIL, DOCOSAHEXAENOIC ACID (DHA) and CURCUMIN for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-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), RASH PRURITIC (itchy rash on body), DIZZINESS (Dizzy all day), MYALGIA (muscle aches), HEADACHE (headache) and FATIGUE (Fatigue). an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), RASH PRURITIC (itchy rash on body), DIZZINESS (Dizzy all day), MYALGIA (muscle aches), HEADACHE (headache) and FATIGUE (Fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information were not provided. This case was linked to MOD-2021-021976 (Patient Link).

Other Meds: SYNTHROID; PULMICORT FLEXHALER; OXYGEN; XIIDRA; PROLIA; MULTIVITAMIN [VITAMINS NOS]; MAGNESIUM CITRATE; VITAMIN D3; VITAMIN B2 [RIBOFLAVIN]; PROBIOTICS NOS; FISH OIL; DHA; CURCUMIN

Current Illness: Contrast media allergy (Iodine based contrast dye)

ID: 1743512
Sex: M
Age: 74
State: AK

Vax Date: 05/02/2021
Onset Date: 06/03/2021
Rec V Date: 09/29/2021
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: Test Name: Blood test; Result Unstructured Data: showed high inflammation (inflammatory markers increased)

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Neck, legs,and shoulders were painful; Neck, legs,and shoulders were painful; problems in turning over in bed/going up and down stairs and getting in and out of my truck; problems in turning over in walking; Neck, legs,and shoulders were painful; patient don't have a lot of energy which is not normal for the patient; memory doesn't seem as sharp as it was; Did not have the strength in arms and legs that the patient had before the patient took the vaccine; Still has the pain; extreme muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (extreme muscle pain), PAIN (Still has the pain), NECK PAIN (Neck, legs,and shoulders were painful), PAIN IN EXTREMITY (Neck, legs,and shoulders were painful) and HYPOKINESIA (problems in turning over in bed/going up and down stairs and getting in and out of my truck) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-May-2021 at 11:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021 at 11:35 AM, 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 MYALGIA (extreme muscle pain). On 16-Jul-2021, the patient experienced PAIN (Still has the pain). In August 2021, the patient experienced ASTHENIA (patient don't have a lot of energy which is not normal for the patient), MEMORY IMPAIRMENT (memory doesn't seem as sharp as it was) and MUSCULAR WEAKNESS (Did not have the strength in arms and legs that the patient had before the patient took the vaccine). On an unknown date, the patient experienced NECK PAIN (Neck, legs,and shoulders were painful), PAIN IN EXTREMITY (Neck, legs,and shoulders were painful), HYPOKINESIA (problems in turning over in bed/going up and down stairs and getting in and out of my truck), GAIT DISTURBANCE (problems in turning over in walking) and ARTHRALGIA (Neck, legs,and shoulders were painful). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in August 2021 for Adverse event, at a dose of 600 mg three times a day; PREDNISONE for Adverse event, at a dose of 20 mg twice a day; PREDNISONE for Adverse event, at a dose of 20 mg, 1.5 tabs; PREDNISONE for Adverse event, at a dose of 20 mg once a day; PREDNISONE in August 2021 for Adverse event, at a dose of 20 mg, 0.5 tabs and PARACETAMOL (TYLENOL) in August 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (extreme muscle pain), PAIN (Still has the pain), NECK PAIN (Neck, legs,and shoulders were painful), PAIN IN EXTREMITY (Neck, legs,and shoulders were painful), HYPOKINESIA (problems in turning over in bed/going up and down stairs and getting in and out of my truck), GAIT DISTURBANCE (problems in turning over in walking), ASTHENIA (patient don't have a lot of energy which is not normal for the patient), MEMORY IMPAIRMENT (memory doesn't seem as sharp as it was), MUSCULAR WEAKNESS (Did not have the strength in arms and legs that the patient had before the patient took the vaccine) and ARTHRALGIA (Neck, legs,and shoulders were painful) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high inflammation (High) showed high inflammation (inflammatory markers increased). The patient had never been diagnosed or tested positive for COVID-19. The patient had none acute illnesses at the time of vaccination and up to one month before. After the second dose the muscle pain returned and was much more severe. The pain caused problems in turning over in bed, walking, going up and down stairs and getting in and out of my truck. After the patient was out of bed and got moving around, the patient could function a little better but pain did not go away. The treatment with ibuprofen seemed to help a little. The worst pain was when the patient tried to bend over to pick something up off the floor. The patient had to get down on knees and hopefully had something available to aid getting back up. The physician suggested to take higher doses of Ibuprofen or Advil at least 3 times a day. It did help with sleeping but still did not alleviate the pain. Then the physician put the patient on 20 mg Prednisone with Tylenol but it took about 6 hours to start working and lasted 12 hours. Then the patient was put on 40 mg of Prednisone for 3 days then tapered off to 20 mg until all 15 pills were gone. It was better but the patient still had issues with pain. The patient was doing good and had no indication of pain, after taking the tapering doses of prednisone in early Aug-2021. No concomitant medication details was provided. This case was linked to MOD-2021-259078 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Significant followup appended - Events added, treatment details updated, added lab data

Other Meds:

Current Illness:

ID: 1743513
Sex: F
Age: 31
State: CO

Vax Date: 03/26/2021
Onset Date: 04/25/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: Blood test; Result Unstructured Data: Diabetes, thyroids, nutrients deficiency, markers of inflammation. All results came back normal.; Test Name: Electromyography; Result Unstructured Data: received an EMG test, to test nerve conduction in patient's legs, and there was no issue.

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Vaccine exposure before pregnancy; Have the sensation in feet, in head, in back, in buttock area, consistently in leg, occasionally in arm; It was very painful; Tingly feeling became back very strongly: In both legs, inside of mouth, in neck, in whole body; Face felt like I was breaking out in a rash; Felt like I was coming with hives; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingly feeling became back very strongly: In both legs, inside of mouth, in neck, in whole body), MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy), URTICARIA (Felt like I was coming with hives), FEELING ABNORMAL (Have the sensation in feet, in head, in back, in buttock area, consistently in leg, occasionally in arm) and RASH (Face felt like I was breaking out in a rash) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Previously administered products included for Product used for unknown indication: TDAP and FLU vaccine. Past adverse reactions to the above products included No adverse event with FLU vaccine and TDAP. Concomitant products included MACROGOL 3350 (MIRALAX) from an unknown date to June 2021 and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-May-2022. On 25-Apr-2021, the patient experienced PARAESTHESIA (Tingly feeling became back very strongly: In both legs, inside of mouth, in neck, in whole body) and RASH (Face felt like I was breaking out in a rash). 25-Apr-2021, the patient experienced URTICARIA (Felt like I was coming with hives). On an unknown date, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy), FEELING ABNORMAL (Have the sensation in feet, in head, in back, in buttock area, consistently in leg, occasionally in arm) and MYALGIA (It was very painful). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingly feeling became back very strongly: In both legs, inside of mouth, in neck, in whole body), URTICARIA (Felt like I was coming with hives), FEELING ABNORMAL (Have the sensation in feet, in head, in back, in buttock area, consistently in leg, occasionally in arm) and RASH (Face felt like I was breaking out in a rash) had not resolved, MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) had resolved and MYALGIA (It was very painful) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Diabetes, thyroids, nutrients deficiency, markers of inflammation. All results came back normal.. On an unknown date, Electromyogram: normal (normal) received an EMG test, to test nerve conduction in patient's legs, and there was no issue.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product used included Miralax which was stopped in mid June. Treatment medication included Tylenol for a day and did not notice any change. So did not continue. Then took Benadryl but her symptoms became worse. When she had caffeine, it also seemed to worsen symptoms. So stopped caffeine and alcohol. After 2 days of second dose, the tingly feeling became back very strongly: In both legs, inside of mouth, in neck, in whole body. It was very painful. Face felt like she was breaking out in a rash, but there was nothing visible and felt like was coming with hives, but there was nothing to see. That lasted for a day or two. But the symptoms were continuing. She had it in feet, in head, in back, in buttock area. Every day feels a little bit different, but it never completely goes away. It was consistently in leg, occasionally in arm. It had not resolved at all. This case concerns a 31-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure before pregnancy, paresthesia, hives, feeling abnormal and expected events of rash and myalgia. Events paresthesia and rash occurred approximately 2 days after the second dose of Spikevax. The events rash and myalgia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax in not affected by this report. This case was linked to MOD-2021-272239 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow up received, contains updated information on patient demographics, medical history, lab data, outcome of the event paresthesia updated from unknown to not recovered and added new event: Maternal exposure after vaccination.; Sender's Comments: This case concerns a 31-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure before pregnancy, paresthesia, hives, feeling abnormal and expected events of rash and myalgia. Events paresthesia and rash occurred approximately 2 days after the second dose of Spikevax. The events rash and myalgia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax in not affected by this report.

Other Meds: MIRALAX; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1743514
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: cardiac troponin levels; Result Unstructured Data: significantly elevated

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related. No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms. 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. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis. This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-245527, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated for clinic so Incorrect E2B Company Number was removed. Hence new reports generated. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1743516
Sex: M
Age: 51
State: FL

Vax Date: 08/25/2021
Onset Date: 08/26/2021
Rec V Date: 09/29/2021
Hospital: Y

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

Lab Data: Test Date: 20210830; Test Name: blood pressure; Result Unstructured Data: High; Test Date: 20210906; Test Name: blood pressure; Result Unstructured Data: High; Test Date: 20210830; Test Name: CT Scan; Result Unstructured Data: Cat Scan were splotches showing on the white matter of his brain they released him

Allergies:

Symptom List: Nausea

Symptoms: sweating profusely from his palms and feet; dizziness; could not breathe; severe headache; Confusion; Sleep deprivation; High BP; chills; sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), CONFUSIONAL STATE (Confusion), SLEEP DEFICIT (Sleep deprivation), BLOOD PRESSURE INCREASED (High BP), HYPERHIDROSIS (sweating profusely from his palms and feet), DIZZINESS (dizziness) and DYSPNOEA (could not breathe) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced CHILLS (chills), VACCINATION SITE PAIN (sore arm) and PYREXIA (Fever). On 29-Aug-2021, the patient experienced HEADACHE (severe headache) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confusion) (seriousness criterion hospitalization), SLEEP DEFICIT (Sleep deprivation) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (High BP) (seriousness criterion hospitalization), DIZZINESS (dizziness) (seriousness criterion hospitalization) and DYSPNOEA (could not breathe) (seriousness criterion hospitalization). On 06-Sep-2021, the patient experienced HYPERHIDROSIS (sweating profusely from his palms and feet) (seriousness criterion hospitalization). The patient was hospitalized on 06-Sep-2021 due to BLOOD PRESSURE INCREASED, CONFUSIONAL STATE, DIZZINESS, DYSPNOEA, HEADACHE, HYPERHIDROSIS and SLEEP DEFICIT. At the time of the report, HEADACHE (severe headache), CONFUSIONAL STATE (Confusion), SLEEP DEFICIT (Sleep deprivation), BLOOD PRESSURE INCREASED (High BP), DIZZINESS (dizziness) and DYSPNOEA (could not breathe) outcome was unknown, HYPERHIDROSIS (sweating profusely from his palms and feet) and VACCINATION SITE PAIN (sore arm) had not resolved and CHILLS (chills) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, Blood pressure measurement (97-166): 166/97 (High) High. On 30-Aug-2021, Computerised tomogram: abnormal (abnormal) Cat Scan were splotches showing on the white matter of his brain they released him. On 06-Sep-2021, Blood pressure measurement (97-166): 178/110 (High) High. Concomitant medication was not provided Treatment medication was not provided Company Comment: This case concerns a 51 year-old male patient, with no medical history reported, who experienced the unexpected adverse events of HEADACHE, DIZZINESS, DYSPNOEA, CONFUSIONAL STATE, SLEEP DEPRIVATION, BLOOD PRESSURE INCREASED and HYPERHIDROSIS. Events of headache, dizziness, dyspnoea, confusional state, sleep deprivation and blood pressure increased occurred 4 days after the second dose of Spikevax. Event of hyperhidrosis occurred approximately 12 days after the second dose of Spikevax. Negative rechallenge remains a confounder. The benefit-risk relation of Spikevax is not affected by this report. Further information is expected for assessment. This case was linked to MOD-2021-321038 (Patient Link).; Sender's Comments: This case concerns a 51 year-old male patient, with no medical history reported, who experienced the unexpected adverse events of HEADACHE, DIZZINESS, DYSPNOEA, CONFUSIONAL STATE, SLEEP DEPRIVATION, BLOOD PRESSURE INCREASED and HYPERHIDROSIS. Events of headache, dizziness, dyspnoea, confusional state, sleep deprivation and blood pressure increased occurred 4 days after the second dose of Spikevax. Event of hyperhidrosis occurred approximately 12 days after the second dose of Spikevax. Negative rechallenge remains a confounder. The benefit-risk relation of Spikevax is not affected by this report. Further information is expected for assessment.

Other Meds:

Current Illness:

ID: 1743517
Sex: F
Age: 52
State: CA

Vax Date: 03/20/2021
Onset Date:
Rec V Date: 09/29/2021
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: adverse reaction; area in the groin; a cyst that kept getting bigger in the perineal area; fever/I had all of it, everything; chills; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction), MUSCULOSKELETAL DISCOMFORT (area in the groin), PERINEAL CYST (a cyst that kept getting bigger in the perineal area), PYREXIA (fever/I had all of it, everything) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination. Concurrent medical conditions included Hidradenitis suppurativa. Concomitant products included DOXYCYCLINE for Hidradenitis suppurativa. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction), MUSCULOSKELETAL DISCOMFORT (area in the groin), PERINEAL CYST (a cyst that kept getting bigger in the perineal area), PYREXIA (fever/I had all of it, everything) and CHILLS (chills). The patient was treated with CORTISONE at a dose of 1 dosage form and Surgery for Perineal cyst. At the time of the report, ADVERSE REACTION (adverse reaction), MUSCULOSKELETAL DISCOMFORT (area in the groin), PERINEAL CYST (a cyst that kept getting bigger in the perineal area), PYREXIA (fever/I had all of it, everything) and CHILLS (chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-320951 (Patient Link).

Other Meds: DOXYCYCLINE

Current Illness: Hidradenitis suppurativa

ID: 1743518
Sex: M
Age: 67
State: FL

Vax Date: 05/10/2021
Onset Date: 06/11/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: Sometimes when patient wakes up in AM vision becomes blurred; Sometimes when patient wakes up in the morning his walking becomes wobbly; Headache pain goes from my head to my neck; Headache pain on my ears; My injection site arm became red and had a circle the size of a 50 cent piece; Constant headache/headache pain on my temple temple, ears, and forehead.; Joint pain, joint pain becomes worse at night; Fever; Chils; Pain in his left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Sometimes when patient wakes up in AM vision becomes blurred) and GAIT DISTURBANCE (Sometimes when patient wakes up in the morning his walking becomes wobbly) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), AMOXICILLIN, TRAMADOL, DEXAMETHASONE and LEVOFLOXACIN for an unknown indication. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE PAIN (Pain in his left injection site arm). On an unknown date, the patient experienced VISION BLURRED (Sometimes when patient wakes up in AM vision becomes blurred) (seriousness criterion medically significant), GAIT DISTURBANCE (Sometimes when patient wakes up in the morning his walking becomes wobbly) (seriousness criterion medically significant), NECK PAIN (Headache pain goes from my head to my neck), EAR PAIN (Headache pain on my ears), VACCINATION SITE ERYTHEMA (My injection site arm became red and had a circle the size of a 50 cent piece), HEADACHE (Constant headache/headache pain on my temple temple, ears, and forehead.), ARTHRALGIA (Joint pain, joint pain becomes worse at night), PYREXIA (Fever) and CHILLS (Chils). At the time of the report, VISION BLURRED (Sometimes when patient wakes up in AM vision becomes blurred), GAIT DISTURBANCE (Sometimes when patient wakes up in the morning his walking becomes wobbly), NECK PAIN (Headache pain goes from my head to my neck), EAR PAIN (Headache pain on my ears), VACCINATION SITE ERYTHEMA (My injection site arm became red and had a circle the size of a 50 cent piece), HEADACHE (Constant headache/headache pain on my temple temple, ears, and forehead.), ARTHRALGIA (Joint pain, joint pain becomes worse at night), PYREXIA (Fever), CHILLS (Chils) and VACCINATION SITE PAIN (Pain in his left injection site arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative and negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was on antibiotics and steroids. Patient had injection site arm which became red and had a circle the size of a 50 cent piece. Sometimes when the patient wakes up in the morning his vision was blurred and his walking becomes wobbly. It was reported that the headache pain goes from head to neck. Patient felt the headache pain on temple, ears, and forehead. Company Comment : This case concerns a 67-year-old, male patient with previous relevant medical history of use of concomitant medication amlodipine, acetylsalicylic acid and tramadol, who experienced the expected events of vision blurred and gait disturbance. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was positive only for vaccination site pain. The benefit-risk relationship of mRNA-1273 is not affected by this report. The only events medically significant are vision blurred and gait disturbance because the patient sought medical attention for only these events, the rest of the events were downgrade to non-serious due to no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant. This case was linked to MOD-2021-321124 (Patient Link).; Sender's Comments: This case concerns a 67-year-old, male patient with previous relevant medical history of use of concomitant medication amlodipine, acetylsalicylic acid and tramadol, who experienced the expected events of vision blurred and gait disturbance. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was positive only for vaccination site pain. The benefit-risk relationship of mRNA-1273 is not affected by this report. The only events medically significant are vision blurred and gait disturbance because the patient sought medical attention for only these events, the rest of the events were downgrade to non-serious due to no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.

Other Meds: AMLODIPINE; ASPIRIN (E.C.); AMOXICILLIN; TRAMADOL; DEXAMETHASONE; LEVOFLOXACIN

Current Illness:

ID: 1743519
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: TIA after her first shot; Incapacitated for over an hour,lost the whole right side of the body; Fell to the ground, this lasted for 2 or 3 hours; This spontaneous case was reported by a nurse and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA after her first shot), DISABILITY (Incapacitated for over an hour,lost the whole right side of the body) and FALL (Fell to the ground, this lasted for 2 or 3 hours) in an elderly 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA after her first shot) (seriousness criteria disability, medically significant and life threatening), DISABILITY (Incapacitated for over an hour,lost the whole right side of the body) (seriousness criteria disability, medically significant and life threatening) and FALL (Fell to the ground, this lasted for 2 or 3 hours) (seriousness criteria disability and medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA after her first shot), DISABILITY (Incapacitated for over an hour,lost the whole right side of the body) and FALL (Fell to the ground, this lasted for 2 or 3 hours) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was provided. Patient was over the age of 60, female who had a TIA after her first shot.TIA was right sided, she was in capitated for over an hour. When she was driving and got to the house, she lost the whole right side of the body. she was tried to get out of the car and fell to the ground, this lasted for 2 or 3 hours. It finally resolved after that. Company Comment: This case concerns an elderly female subject, who experienced the unexpected events of transient ischaemic attack, Disability and Fall. The event occurred after the first dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns an elderly female subject, who experienced the unexpected events of transient ischaemic attack, Disability and Fall. The event occurred after the first dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1743520
Sex: F
Age:
State:

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
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: 3rd and 4th day after receiving 1st dose "felt like small elephant sitting over heart"; Heart felt real restless; Fatigue; Injection site tenderness; Tender lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (3rd and 4th day after receiving 1st dose "felt like small elephant sitting over heart"), CARDIAC DISCOMFORT (Heart felt real restless), FATIGUE (Fatigue), INJECTION SITE PAIN (Injection site tenderness) and LYMPH NODE PAIN (Tender lymph nodes) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The patient's past medical history included Rheumatic fever (when patient was 16 years old), Angina attack, Blood pressure raised (Patient blood pressure raised due to fear of side effects before receiving first dose) and Fear (Patient blood pressure raised due to fear of side effects before receiving first dose). On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced FEELING ABNORMAL (3rd and 4th day after receiving 1st dose "felt like small elephant sitting over heart") and CARDIAC DISCOMFORT (Heart felt real restless). In September 2021, the patient experienced FATIGUE (Fatigue), INJECTION SITE PAIN (Injection site tenderness) and LYMPH NODE PAIN (Tender lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ALPRAZOLAM (XANAX) for Adverse event, at a dose of UNK dosage form. In September 2021, FEELING ABNORMAL (3rd and 4th day after receiving 1st dose "felt like small elephant sitting over heart"), CARDIAC DISCOMFORT (Heart felt real restless), FATIGUE (Fatigue), INJECTION SITE PAIN (Injection site tenderness) and LYMPH NODE PAIN (Tender lymph nodes) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications information was not reported Patient was anxious and her blood pressure raised due to fear of side effects before receiving first dose. Patient worried about myocarditis and pericarditis risk and was unsure if she would get 2nd dose or not. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1743521
Sex: F
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: contracted Covid-19 3 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted Covid-19 3 weeks ago) in a 59-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) (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 COVID-19 (contracted Covid-19 3 weeks ago). At the time of the report, COVID-19 (contracted Covid-19 3 weeks ago) outcome was unknown. No Concomitant medications were reported No treatment medications were reported Patient got quarantined for 10 days.; Sender's Comments: This case concerns a 59-year-old female patient who experienced the non-serious unexpected event COVID-19, after receiving mRNA-1273 Moderna vaccine. No information was provided regarding the event and date doses of the product. Further information has been requested. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report

Other Meds:

Current Illness:

ID: 1743522
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: COVID positive after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID positive after vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID positive after vaccination). At the time of the report, COVID-19 (COVID positive after vaccination) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. The patient had received the Moderna COVID-19 vaccine and was currently experiencing COVID-19. The reporter asked if the patient can be treated with the "defensa antibody treatment, 2 injections in the arm and 2 in the stomach area".; Sender's Comments: This report concerns a male patient with no relevant medical history who experienced an unexpected non-serious event of COVID-19. The event occurred after an unknown duration following vaccination with mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1743523
Sex: M
Age:
State: RI

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital: Y

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

Lab Data: Test Name: bacterial testing; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: body mass index; Result Unstructured Data: Body mass index28 kg/m2; Test Name: serum C-reactive protein; Result Unstructured Data: C-reactive protein was elevated at 96 mg/dl.; Test Name: TTE Global longitudinal strain; Result Unstructured Data: TTE Global longitudinal strain - 21.0%; Test Name: TTE LVEF; Result Unstructured Data: TTE showed an LVEF of 60% and no pericardial effusion.; Test Name: 12-lead ECG; Result Unstructured Data: 12-lead ECG showed diffuse PR segment depression and PR segment elevation in lead aVR, consistent with acute pericarditis.; Test Name: CMR test; Result Unstructured Data: CMR performed 1 week after hospital discharge showed subepicardial LGE and myocardial edema in the lateral LV segments; Test Name: CMR test; Result Unstructured Data: GLS by TTE and CMR was normal (< -18%).; Test Name: CMR test; Result Unstructured Data: CMR LVEF 59%; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Erythrocyte sedimentation rate 24 mm/hr; Test Name: SARS COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: serum cardiac troponin I; Result Unstructured Data: serum cardiac troponin was elevated at 17 pg/ml; Test Name: viral serologies; Test Result: Negative ; Result Unstructured Data: Other Viral Serologies including Adenovirus, Rhinovirus, influenza/ Parainfluenza, Respiratory Syncytial Virus, Mycoplasma pneumoniae, Chlamydia pneumoniae not detected

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Acute Myopericarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute Myopericarditis) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received 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, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Acute Myopericarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 1 day due to MYOCARDITIS. The patient was treated with COLCHICINE for Myopericarditis, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Acute Myopericarditis) outcome was unknown. Possible DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bacterial test: negative (Negative) Negative. On an unknown date, Body mass index: 28 kg/m2 Body mass index28 kg/m2. On an unknown date, C-reactive protein (0-10mg/dl): 96 mg/dl (abnormal) C-reactive protein was elevated at 96 mg/dl.. On an unknown date, Echocardiogram: - 21.0% TTE Global longitudinal strain - 21.0%. On an unknown date, Ejection fraction: 60% (normal) TTE showed an LVEF of 60% and no pericardial effusion.. On an unknown date, Electrocardiogram: abnormal (abnormal) 12-lead ECG showed diffuse PR segment depression and PR segment elevation in lead aVR, consistent with acute pericarditis.. On an unknown date, Magnetic resonance imaging heart: abnormal (abnormal) CMR performed 1 week after hospital discharge showed subepicardial LGE and myocardial edema in the lateral LV segments, - 19.6% (normal) GLS by TTE and CMR was normal (< -18%). and 59% CMR LVEF 59%. On an unknown date, Red blood cell sedimentation rate (0-15 mm/hr): 24 mm/hr (High) Erythrocyte sedimentation rate 24 mm/hr. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Troponin I (0.006 ng/ml-0.060 ng/ml): 17 pg/ml (abnormal) serum cardiac troponin was elevated at 17 pg/ml. On an unknown date, Viral test: negative (Negative) Other Viral Serologies including Adenovirus, Rhinovirus, influenza/ Parainfluenza, Respiratory Syncytial Virus, Mycoplasma pneumoniae, Chlamydia pneumoniae not detected. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Acute Myopericarditis) to be possibly related. Patient had no coronary artery disease risk factors or cardiac comorbidities. Patient with no known prior health problems presented to the emergency department 3 days after receiving his second dose of the Moderna COVID-19 vaccine with chest pain and dyspnea. Other symptoms included generalized body aches, nausea, headache, chills, and fatigue. No cardiac rub was reported. CMR findings of the patient met updated criteria for acute myocarditis. Patient's length of stay at hospital was reported as 1 day and was discharged home in stable clinical condition. Author stated that longer clinical follow-up may help understand if the CMR abnormalities observed are temporary in the setting of a high inflammatory state or longer-lasting, and whether they help predict any clinically-relevant adverse events or deterioration in cardiac function. Author concluded that in conjunction with other recently published case series and national vaccine safety surveillance data, this case series suggests an association between acute myocarditis and COVID-19 vaccination in young males and highlights a potential pattern in accompanying CMR abnormalities. This case concerns literature review of a 25 year old male who experienced the serious listed event of Myocarditis 3 days after the second dose of Moderna COVID-19 vaccine. Re-challenge is not applicable as it is the second dose and causality is possible in the article. Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report..; Sender's Comments: This case concerns literature review of a 25 year old male who experienced the serious listed event of Myocarditis 3 days after the second dose of Moderna COVID-19 vaccine. Re-challenge is not applicable as it is the second dose and causality is possible in the article. Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1743524
Sex: F
Age: 77
State: IN

Vax Date: 08/26/2021
Onset Date: 08/01/2021
Rec V Date: 09/29/2021
Hospital: Y

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: Lung infection that is either that or pneumonia; The first dose contribute to my issues right now/ I have head to stomach issues now and not before.; Hole in my heart; Made my immune system weak; passed out; Now have brain aneurism (diagnosed while in hospital); tiredness; really lethargic; when I received the vaccine I got a sore arm; feeling weak, not back to 100% with regard to energy or stamina; muscle aches in neck couldn't turn head; nausea; coughing; chills; sweats; headache/severe headache; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Lung infection that is either that or pneumonia), INTRACRANIAL ANEURYSM (Now have brain aneurism (diagnosed while in hospital)), LOSS OF CONSCIOUSNESS (passed out), VACCINATION SITE PAIN (when I received the vaccine I got a sore arm), ASTHENIA (feeling weak, not back to 100% with regard to energy or stamina), LETHARGY (really lethargic), NECK PAIN (muscle aches in neck couldn't turn head), NAUSEA (nausea), COUGH (coughing), CHILLS (chills), HYPERHIDROSIS (sweats), HEADACHE (headache/severe headache), FATIGUE (tiredness), VACCINATION COMPLICATION (The first dose contribute to my issues right now/ I have head to stomach issues now and not before.), CARDIAC DISORDER (Hole in my heart), OROPHARYNGEAL PAIN (Sore throat) and IMMUNE SYSTEM DISORDER (Made my immune system weak) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No medical history was reported by patient. Concurrent medical conditions included Cardiac assistance device user and Headache. Concomitant products included VITAMIN D3 for an unknown indication. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced NECK PAIN (muscle aches in neck couldn't turn head) (seriousness criterion hospitalization), NAUSEA (nausea) (seriousness criterion hospitalization), COUGH (coughing) (seriousness criterion hospitalization), CHILLS (chills) (seriousness criterion hospitalization), HYPERHIDROSIS (sweats) (seriousness criterion hospitalization), HEADACHE (headache/severe headache) (seriousness criterion hospitalization) and OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion hospitalization). On 26-Aug-2021, the patient experienced VACCINATION SITE PAIN (when I received the vaccine I got a sore arm) (seriousness criterion hospitalization) and ASTHENIA (feeling weak, not back to 100% with regard to energy or stamina) (seriousness criterion hospitalization). On 29-Aug-2021, the patient experienced LETHARGY (really lethargic) (seriousness criterion hospitalization). On 04-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criteria hospitalization and medically significant). In September 2021, the patient experienced INTRACRANIAL ANEURYSM (Now have brain aneurism (diagnosed while in hospital)) (seriousness criteria hospitalization and medically significant) and FATIGUE (tiredness) (seriousness criterion hospitalization). On an unknown date, the patient experienced PNEUMONIA (Lung infection that is either that or pneumonia) (seriousness criteria hospitalization and medically significant), VACCINATION COMPLICATION (The first dose contribute to my issues right now/ I have head to stomach issues now and not before.) (seriousness criterion hospitalization), CARDIAC DISORDER (Hole in my heart) (seriousness criterion hospitalization) and IMMUNE SYSTEM DISORDER (Made my immune system weak) (seriousness criterion hospitalization). The patient was hospitalized from 04-Sep-2021 to 06-Sep-2021 due to ASTHENIA, CARDIAC DISORDER, CHILLS, COUGH, FATIGUE, HEADACHE, HYPERHIDROSIS, IMMUNE SYSTEM DISORDER, INTRACRANIAL ANEURYSM, LETHARGY, LOSS OF CONSCIOUSNESS, NAUSEA, NECK PAIN, OROPHARYNGEAL PAIN, PNEUMONIA, VACCINATION COMPLICATION and VACCINATION SITE PAIN. The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at a dose of 1 dosage form; CEFDINIR for Lung infection, at a dose of (5 days after home); METOPROLOL for Adverse event, at a dose of 1 dosage form once a day; PANTOPRAZOLE for Adverse event, at a dose of 1 dosage form once a day; PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form and IBUPROFEN for Headache, at a dose of 1 dosage form. At the time of the report, PNEUMONIA (Lung infection that is either that or pneumonia) had not resolved, INTRACRANIAL ANEURYSM (Now have brain aneurism (diagnosed while in hospital)), LOSS OF CONSCIOUSNESS (passed out), VACCINATION SITE PAIN (when I received the vaccine I got a sore arm), LETHARGY (really lethargic), NECK PAIN (muscle aches in neck couldn't turn head), NAUSEA (nausea), COUGH (coughing), CHILLS (chills), HYPERHIDROSIS (sweats), HEADACHE (headache/severe headache), FATIGUE (tiredness), VACCINATION COMPLICATION (The first dose contribute to my issues right now/ I have head to stomach issues now and not before.), CARDIAC DISORDER (Hole in my heart), OROPHARYNGEAL PAIN (Sore throat) and IMMUNE SYSTEM DISORDER (Made my immune system weak) outcome was unknown and ASTHENIA (feeling weak, not back to 100% with regard to energy or stamina) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported Eye vitamin - oral - preservision as concomitant medication Patient reported that she was not back to 100 percent with regard to energy or stamina after first vaccination, before that she was active, walked two miles a day, rode bicycle, played pickle ball 4 times a week. Patient reported that she was unsure of second vaccine and she saw(in hospital) four different doctors for four different organs (cardiology, pulmonology, GI, Neurologist), all of them that saw me recommend that I get the second one. Patient reported that she had no such problems before that, patient went for CT scan from brain to lower chest and result pending. Treatment included blood thinner that was not specified. This case concerns a 77-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of pneumonia, intracranial aneurism, loss of consciousness, vaccination site pain, asthenia, lethargy, neck pain, nausea, cough, chills, hyperhidrosis, headache, fatigue, abdominal discomfort, cardiac disorder, oropharyngeal pain and immune system disorder. The events occurred approximately 1 to 2 weeks following first dose of Moderna COVID-19 Vaccine and the patient was hospitalized. The patient was diagnosed with brain aneurism while in the hospital and reported to have hole in heart which did not have before, and lung infection. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 77-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of pneumonia, intracranial aneurism, loss of consciousness, vaccination site pain, asthenia, lethargy, neck pain, nausea, cough, chills, hyperhidrosis, headache, fatigue, abdominal discomfort, cardiac disorder, oropharyngeal pain and immune system disorder. The events occurred approximately 1 to 2 weeks following first dose of Moderna COVID-19 Vaccine and the patient was hospitalized. The patient was diagnosed with brain aneurism while in the hospital and reported to have hole in heart which did not have before, and lung infection. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds: VITAMIN D3

Current Illness: Cardiac assistance device user; Headache

ID: 1743525
Sex: M
Age: 54
State: FL

Vax Date: 09/17/2021
Onset Date: 09/17/2021
Rec V Date: 09/29/2021
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: nose bleeds; darkening in the stools; extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EPISTAXIS (nose bleeds), FAECES DISCOLOURED (darkening in the stools) and EXTRA DOSE ADMINISTERED (extra dose administered) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (extra dose administered). On 18-Sep-2021, the patient experienced EPISTAXIS (nose bleeds) and FAECES DISCOLOURED (darkening in the stools). On 17-Sep-2021, EXTRA DOSE ADMINISTERED (extra dose administered) had resolved. At the time of the report, EPISTAXIS (nose bleeds) and FAECES DISCOLOURED (darkening in the stools) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment drug was reported No concomitant product reported It was reported that patient received the 1st dose in 20 Mar 2021 with lot 044a21a, 2nd dose 23 Apr 2021 with lot 037b21a. The symptoms were ongoing but they were getting better. Company Comment : This case concerns a 54-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected events of epistaxis and Faeces discoloured. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness were downgrade due there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender's Comments: This case concerns a 54-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected events of epistaxis and Faeces discoloured. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness were downgrade due there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.

Other Meds:

Current Illness:

ID: 1743526
Sex: M
Age:
State: IL

Vax Date: 09/19/2021
Onset Date: 09/19/2021
Rec V Date: 09/29/2021
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: An expired 2nd dose administered to a patient; An expired 2nd dose administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose administered to a patient) and PRODUCT STORAGE ERROR (An expired 2nd dose administered to a patient) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose administered to a patient) and PRODUCT STORAGE ERROR (An expired 2nd dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose administered to a patient) and PRODUCT STORAGE ERROR (An expired 2nd dose administered to a patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Vial was opened and punctured on 18 Sep 2021 at 10 AM. The vial was at room temperature for 26 hours. A dose was administered on 19 Sep 2021 at around 11 AM. Patient had received 2nd dose. Pharmacist wants to know if the dose needs to be repeated. No Treatment medications were provided No Concomitant medications were provided

Other Meds:

Current Illness:

ID: 1743527
Sex: M
Age: 79
State: NJ

Vax Date: 02/06/2021
Onset Date: 05/01/2021
Rec V Date: 09/29/2021
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: Pemphigoid Bullous; Itchy skin; Red skin; Broke out in blisters, the location of the reaction was torso, towards the back, legs, and arms; bilateral; Delayed reaction; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGOID (Pemphigoid Bullous) in a 79-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 06-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. In May 2021, the patient experienced PRURITUS (Itchy skin), ERYTHEMA (Red skin), BLISTER (Broke out in blisters, the location of the reaction was torso, towards the back, legs, and arms; bilateral) and SKIN REACTION (Delayed reaction). On an unknown date, the patient experienced PEMPHIGOID (Pemphigoid Bullous) (seriousness criterion medically significant). The patient was treated with PREDNISONE (oral) for Pemphigoid, at a dose of 1 dosage form; DOXYCYCLINE ongoing since an unknown date for Pemphigoid, at a dose of 100 milligram twice a day; NIACINAMIDE ongoing since an unknown date for Pemphigoid, at a dose of 1 dosage form twice a day and CORTISONE (topical) ongoing since an unknown date for Pemphigoid, at a dose of 1 dosage form. At the time of the report, PEMPHIGOID (Pemphigoid Bullous), PRURITUS (Itchy skin), ERYTHEMA (Red skin), BLISTER (Broke out in blisters, the location of the reaction was torso, towards the back, legs, and arms; bilateral) and SKIN REACTION (Delayed reaction) had not resolved. No concomitant medication details were provided. The reporter also stated that Consumer was prescribed medications for treatment, which included oral steroid, antibiotics, topical steroid, and vitamin. Also Consumer had discontinued oral steroids. company comment: This case concerns a 79-year-old, male patient with no relevant medical history, who experienced the unexpected event of pemphigoid bullous. The event occurred approximately 3 months after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the event as related to the product. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 79-year-old, male patient with no relevant medical history, who experienced the unexpected event of pemphigoid bullous. The event occurred approximately 3 months after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the event as related to the product. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1743528
Sex: F
Age: 72
State: TX

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 09/29/2021
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: burning in my stomach; may be allergic to the shot; vomit; sweating profusely; hyperventilate; tongue was slightly swollen; blood in my diarrhea; faint; dizzy; weak; sick to my stomach; chemical or metal taste in my mouth; cloudiness in my eyes; diarrhea; too scared to eat; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA HAEMORRHAGIC (blood in my diarrhea) and SYNCOPE (faint) in a 72-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. No Medical History information was reported. On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced DIZZINESS (dizzy), ASTHENIA (weak), ABDOMINAL DISCOMFORT (sick to my stomach), DYSGEUSIA (chemical or metal taste in my mouth), OCULAR DISCOMFORT (cloudiness in my eyes), DIARRHOEA (diarrhea) and FEEDING DISORDER (too scared to eat). On 18-Sep-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (blood in my diarrhea) (seriousness criterion medically significant), SYNCOPE (faint) (seriousness criterion medically significant), HYPERHIDROSIS (sweating profusely), HYPERVENTILATION (hyperventilate), SWOLLEN TONGUE (tongue was slightly swollen), ALLERGY TO VACCINE (may be allergic to the shot) and VOMITING (vomit). On 19-Sep-2021, the patient experienced DYSPEPSIA (burning in my stomach). At the time of the report, DIARRHOEA HAEMORRHAGIC (blood in my diarrhea), SYNCOPE (faint), DIZZINESS (dizzy), ASTHENIA (weak), ABDOMINAL DISCOMFORT (sick to my stomach), DYSGEUSIA (chemical or metal taste in my mouth), OCULAR DISCOMFORT (cloudiness in my eyes), DIARRHOEA (diarrhea), FEEDING DISORDER (too scared to eat), HYPERHIDROSIS (sweating profusely), HYPERVENTILATION (hyperventilate), SWOLLEN TONGUE (tongue was slightly swollen), DYSPEPSIA (burning in my stomach), ALLERGY TO VACCINE (may be allergic to the shot) and VOMITING (vomit) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided No treatment product information was provided company comment: This case concerns a 72-year-old, female patient with no relevant medical history, who experienced the unexpected event of diarrhea hemorrhagic. The event occurred approximately 4 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 72-year-old, female patient with no relevant medical history, who experienced the unexpected event of diarrhea hemorrhagic. The event occurred approximately 4 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1743529
Sex: M
Age: 64
State: GA

Vax Date: 09/17/2021
Onset Date: 09/17/2021
Rec V Date: 09/29/2021
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: we are still sick from that shot; I was nauseous last nigh; we had a real adverse reaction to it; fever, on and off; fatigue; joint pain; muscle pain is too much/muscle pain is terrible and too much; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (we had a real adverse reaction to it), ILLNESS (we are still sick from that shot), PYREXIA (fever, on and off), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History was provided by the reporter. Concomitant products included LISINOPRIL, PAROXETINE and OMEPRAZOLE for an unknown indication. On 17-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced VACCINATION COMPLICATION (we had a real adverse reaction to it), PYREXIA (fever, on and off), FATIGUE (fatigue), ARTHRALGIA (joint pain) and MYALGIA (muscle pain is too much/muscle pain is terrible and too much). On 19-Sep-2021, the patient experienced NAUSEA (I was nauseous last nigh). On 20-Sep-2021, the patient experienced ILLNESS (we are still sick from that shot). At the time of the report, VACCINATION COMPLICATION (we had a real adverse reaction to it), PYREXIA (fever, on and off), FATIGUE (fatigue), ARTHRALGIA (joint pain), MYALGIA (muscle pain is too much/muscle pain is terrible and too much) and NAUSEA (I was nauseous last nigh) outcome was unknown and ILLNESS (we are still sick from that shot) had not resolved. The concomitant medication also included pain medication. No treatment medication were provided.

Other Meds: LISINOPRIL; PAROXETINE; OMEPRAZOLE

Current Illness:

ID: 1743530
Sex: M
Age: 75
State: TX

Vax Date: 08/26/2021
Onset Date: 08/29/2021
Rec V Date: 09/29/2021
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: rash which looked like welts with blisters,size of the fingertip; This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (rash which looked like welts with blisters,size of the fingertip) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E4A) for COVID-19 vaccination. Concurrent medical conditions included COPD. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced RASH VESICULAR (rash which looked like welts with blisters,size of the fingertip). The patient was treated with HYDROCORTISONE ongoing since an unknown date for Blistery rash, at a dose of 1 dosage form and ANTIHISTAMINES ongoing since an unknown date for Blistery rash, at a dose of 1 dosage form. At the time of the report, RASH VESICULAR (rash which looked like welts with blisters,size of the fingertip) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was mentioned by reporter.

Other Meds:

Current Illness: COPD

ID: 1743531
Sex: U
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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; uncontrollable urination; 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 DIARRHEA (Diarrhea) and URINARY INCONTINENCE (uncontrollable urination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 DIARRHEA (Diarrhea) and URINARY INCONTINENCE (uncontrollable urination). At the time of the report, DIARRHEA (Diarrhea) and URINARY INCONTINENCE (uncontrollable urination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not provided by the reporter Treatment information was not provided

Other Meds:

Current Illness:

ID: 1743532
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: I couldn't breath; coughing a lot; I can't do anything; feeling tired with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I couldn't breath), COUGH (coughing a lot), IMPAIRED WORK ABILITY (I can't do anything) and FATIGUE (feeling tired with fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included INSULIN for Diabetes. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DYSPNOEA (I couldn't breath), COUGH (coughing a lot), IMPAIRED WORK ABILITY (I can't do anything) and FATIGUE (feeling tired with fatigue). At the time of the report, DYSPNOEA (I couldn't breath), COUGH (coughing a lot) and IMPAIRED WORK ABILITY (I can't do anything) outcome was unknown and FATIGUE (feeling tired with fatigue) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient reported that the vaccine was administered 3 or 4 months ago. He could not breath and was sitting down for a month. He was coughing a lot. He had been feeling tired for about 4 months already, with fatigue. He cannot do anything. The symptoms started a week after the vaccination was given. No treatment information was reported.

Other Meds: INSULIN

Current Illness: Type II diabetes mellitus

ID: 1743533
Sex: M
Age: 73
State: IL

Vax Date: 08/03/2021
Onset Date: 08/01/2021
Rec V Date: 09/29/2021
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: red patch on arm (1st dose); swollen glands on injection site; continued fever that doesn't go away/elevated body temperature/fever of 100 F at most/fever for 2.5 to 3 weeks (1st dose); COVID arm (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm (1st dose)), ERYTHEMA (red patch on arm (1st dose)), LYMPHADENOPATHY (swollen glands on injection site) and PYREXIA (continued fever that doesn't go away/elevated body temperature/fever of 100 F at most/fever for 2.5 to 3 weeks (1st dose)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. Concomitant products included METOPROLOL TARTRATE (METOPROLOL TARTRATE ACCORD) for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION COMPLICATION (COVID arm (1st dose)). On an unknown date, the patient experienced ERYTHEMA (red patch on arm (1st dose)), LYMPHADENOPATHY (swollen glands on injection site) and PYREXIA (continued fever that doesn't go away/elevated body temperature/fever of 100 F at most/fever for 2.5 to 3 weeks (1st dose)). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication were provided by the reporter. This case was linked to MOD-2021-325347 (Patient Link).

Other Meds: METOPROLOL TARTRATE ACCORD

Current Illness:

ID: 1743534
Sex: F
Age: 49
State: IL

Vax Date: 05/22/2021
Onset Date: 06/19/2021
Rec V Date: 09/29/2021
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: since the shot, her arm is not the same, her arm feels dislocated, she cannot do anything with her left arm; pain where she cannot even put her bra on, have outrageous pain in arm/soreness in the arm; excruciating pain.; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (since the shot, her arm is not the same, her arm feels dislocated, she cannot do anything with her left arm), PAIN IN EXTREMITY (pain where she cannot even put her bra on, have outrageous pain in arm/soreness in the arm) and PAIN (excruciating pain.) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026021F and 024L21A) for COVID-19 vaccination. No Medical History information was reported. On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced LIMB DISCOMFORT (since the shot, her arm is not the same, her arm feels dislocated, she cannot do anything with her left arm), PAIN IN EXTREMITY (pain where she cannot even put her bra on, have outrageous pain in arm/soreness in the arm) and PAIN (excruciating pain.). At the time of the report, LIMB DISCOMFORT (since the shot, her arm is not the same, her arm feels dislocated, she cannot do anything with her left arm), PAIN IN EXTREMITY (pain where she cannot even put her bra on, have outrageous pain in arm/soreness in the arm) and PAIN (excruciating pain.) outcome was unknown. No Concomitant medications were reported. No Treatment medications were reported. This case was linked to MOD-2021-325319 (Patient Link).

Other Meds:

Current Illness:

ID: 1743535
Sex: M
Age: 59
State: IN

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

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

Lab Data: Test Name: Fever; Result Unstructured Data: 103.6 F

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: horrible headache; Charlie horse symptoms; trouble swallowing; chest pain; tightness; incredible pain; Inappropriate scheduling of vaccine; fever 103.6 F; tired/felt extremely tired; did not feel like eating.; started feeling cold; chattering teeth/body chills/shivering; felt sickness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired/felt extremely tired), DECREASED APPETITE (did not feel like eating.), FEELING COLD (started feeling cold), CHILLS (chattering teeth/body chills/shivering) and MALAISE (felt sickness) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C71A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced FATIGUE (tired/felt extremely tired), DECREASED APPETITE (did not feel like eating.), FEELING COLD (started feeling cold), CHILLS (chattering teeth/body chills/shivering), MALAISE (felt sickness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduling of vaccine) and PYREXIA (fever 103.6 F). On an unknown date, the patient experienced HEADACHE (horrible headache), MUSCLE SPASMS (Charlie horse symptoms), DYSPHAGIA (trouble swallowing), CHEST PAIN (chest pain), CHEST DISCOMFORT (tightness) and MYALGIA (incredible pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. On 09-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduling of vaccine) had resolved. At the time of the report, FATIGUE (tired/felt extremely tired), DECREASED APPETITE (did not feel like eating.), FEELING COLD (started feeling cold), CHILLS (chattering teeth/body chills/shivering), MALAISE (felt sickness), HEADACHE (horrible headache), MUSCLE SPASMS (Charlie horse symptoms), DYSPHAGIA (trouble swallowing), CHEST PAIN (chest pain), CHEST DISCOMFORT (tightness), MYALGIA (incredible pain) and PYREXIA (fever 103.6 F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.6 (High) 103.6 F. No concomitant medication were provided. Patient doctor did order test for Lupus and Rheumatoid arthritis, and put him on the 10 lb. weight limit at his work in case he has damaged muscles since patient had incredible pain in his both arms, right flank, shoulder blades and left hip. Patient also referred to Physical therapist twice a week which is helping him a little bit. Company Comment: This case concerns a 59-year-old male patient with no relevant medical history reported who experienced non-serious expected events of fatigue, chills. pyrexia, headache, myalgia and non-serious unexpected events of dysphagia, appetite decreased, chest discomfort, malaise, chest pain and feeling cold. The events occurred within 24 hours after the second dose of Spikevax. Rechallenge was not applicable since the events occurred after the second dose. The events were consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report. This case was linked to MOD-2021-325251 (Patient Link).; Sender's Comments: This case concerns a 59-year-old male patient with no relevant medical history reported who experienced non-serious expected events of fatigue, chills. pyrexia, headache, myalgia and non-serious unexpected events of dysphagia, appetite decreased, chest discomfort, malaise, chest pain and feeling cold. The events occurred within 24 hours after the second dose of Spikevax. Rechallenge was not applicable since the events occurred after the second dose. The events were consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report.

Other Meds:

Current Illness:

ID: 1743536
Sex: F
Age: 43
State: CA

Vax Date: 02/05/2021
Onset Date: 02/01/2021
Rec V Date: 09/29/2021
Hospital: Y

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: Hypothyroidism; Hyperparathyroidism secondary not renal; GERD; Heart burn; Hypertension; Major depression disorder; Hypoxia; Pneumonia; Shortness of breath/having trouble breathing; Organizing pneumonia; Cough; Fever; Chest pain; Edema on their legs; Feel sick/not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORGANISING PNEUMONIA (Organizing pneumonia), PNEUMONIA (Pneumonia), HYPOXIA (Hypoxia), DYSPNOEA (Shortness of breath/having trouble breathing), HYPOTHYROIDISM (Hypothyroidism), HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary not renal), GASTROOESOPHAGEAL REFLUX DISEASE (GERD), DYSPEPSIA (Heart burn), HYPERTENSION (Hypertension) and DEPRESSION (Major depression disorder) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Implantable cardiac monitor insertion since 19-Sep-2021. Concurrent medical conditions included Drug hypersensitivity (Bactrim - hand turning red, developed a rash on the face and back and itching hands.). Concomitant products included LEVOFLOXACIN, OMEPRAZOLE, LEVOTHYROXINE, ESCITALOPRAM OXALATE (LEXAPRO), AMLODIPINE and ZOLEDRONIC ACID (RECLAST) from 22-Apr-2021 to an unknown date for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ORGANISING PNEUMONIA (Organizing pneumonia) (seriousness criteria hospitalization and medically significant). On 23-Feb-2021, the patient experienced MALAISE (Feel sick/not feeling well). On 25-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath/having trouble breathing) (seriousness criterion hospitalization), CHEST PAIN (Chest pain), OEDEMA PERIPHERAL (Edema on their legs), COUGH (Cough) and PYREXIA (Fever). On 28-Feb-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). On 02-Mar-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria hospitalization and medically significant), HYPOTHYROIDISM (Hypothyroidism) (seriousness criteria hospitalization and medically significant), HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary not renal) (seriousness criterion hospitalization), GASTROOESOPHAGEAL REFLUX DISEASE (GERD) (seriousness criterion hospitalization), DYSPEPSIA (Heart burn) (seriousness criterion hospitalization), HYPERTENSION (Hypertension) (seriousness criterion hospitalization) and DEPRESSION (Major depression disorder) (seriousness criterion hospitalization). The patient was hospitalized on 02-Mar-2021 due to DEPRESSION, DYSPEPSIA, DYSPNOEA, GASTROOESOPHAGEAL REFLUX DISEASE, HYPERPARATHYROIDISM SECONDARY, HYPERTENSION, HYPOTHYROIDISM, HYPOXIA, ORGANISING PNEUMONIA and PNEUMONIA. At the time of the report, ORGANISING PNEUMONIA (Organizing pneumonia) and PNEUMONIA (Pneumonia) had not resolved and HYPOXIA (Hypoxia), DYSPNOEA (Shortness of breath/having trouble breathing), HYPOTHYROIDISM (Hypothyroidism), HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary not renal), GASTROOESOPHAGEAL REFLUX DISEASE (GERD), DYSPEPSIA (Heart burn), HYPERTENSION (Hypertension), DEPRESSION (Major depression disorder), CHEST PAIN (Chest pain), OEDEMA PERIPHERAL (Edema on their legs), MALAISE (Feel sick/not feeling well), COUGH (Cough) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was on oxygen while in the hospital and continued to use oxygen after get discharged. Patient stated that was getting better and on 16 Mar 2021, she experienced trouble breathing and it was reported that she had a relapse for pneumonia affecting both lungs, before only the right lung was affected. Patient is still under doctor's care. Company Comment - This case concerns a 77 year-old female patient with a history of drug hypersensitivity who experienced the unexpected events of dyspnea, pneumonia, hypothyroidism, hypoxia, hyperparathyroidism, gastroesophageal reflux, dyspepsia, hypertension, depression, organizing pneumonia. The event of dyspnea occurred approximately 21 days, pneumonia: 24 days, hypothyroidism, hypoxia, hyperparathyroidism, gastroesophageal reflux, dyspepsia, hypertension, and depression: 26 days after the first dose of mRNA-1273. The event of organizing pneumonia occurred at an unknown date after the first dose of mRNA-1273. The rechallenge was not applicable as only information about the first dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-325684 (Patient Link).; Sender's Comments: This case concerns a 77 year-old female patient with a history of drug hypersensitivity who experienced the unexpected events of dyspnea, pneumonia, hypothyroidism, hypoxia, hyperparathyroidism, gastroesophageal reflux, dyspepsia, hypertension, depression, organizing pneumonia. The event of dyspnea occurred approximately 21 days, pneumonia: 24 days, hypothyroidism, hypoxia, hyperparathyroidism, gastroesophageal reflux, dyspepsia, hypertension, and depression: 26 days after the first dose of mRNA-1273. The event of organizing pneumonia occurred at an unknown date after the first dose of mRNA-1273. The rechallenge was not applicable as only information about the first dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds: LEVOFLOXACIN; OMEPRAZOLE; LEVOTHYROXINE; LEXAPRO; AMLODIPINE; RECLAST

Current Illness: Drug hypersensitivity (Bactrim - hand turning red, developed a rash on the face and back and itching hands.); Implantable cardiac monitor insertion

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am