VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.







Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1695329
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: SEVERE REACTION; This spontaneous report received from a patient via a company representative concerned a male 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, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced severe reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1695330
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 09/03/2021
Rec V Date: 09/13/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: FEELING DIZZY/LIGHT HEADED/FEELING GOING TO PASS OUT; SWEATY HANDS; SHORTNESS OF BREATH; NAUSEA THAT COMES AND GOES IN WAVES; HEADACHE THAT COMES AND GOES IN WAVES; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lyme disease, and concurrent conditions included: thyroid, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04321A, expiry: UNKNOWN) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-SEP-2021, the patient experienced nausea that comes and goes in waves. On 03-SEP-2021, the patient experienced headache that comes and goes in waves. On 11-SEP-2021, the patient experienced feeling dizzy/light headed/feeling going to pass out. On 11-SEP-2021, the patient experienced sweaty hands. On 11-SEP-2021, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache that comes and goes in waves, nausea that comes and goes in waves, feeling dizzy/light headed/feeling going to pass out, sweaty hands and shortness of breath was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker; Thyroid disorder

ID: 1695331
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: RASH; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash. This report was non-serious. This case, from the same reporter is linked to 20210921477 and 20210921423.

Other Meds:

Current Illness:

ID: 1695332
Sex: U
Age:
State: IL

Vax Date:
Onset Date: 09/10/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data: Test Date: 20210910; Test Name: Body temperature; Result Unstructured Data: 101 F

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: BODY ACHE; INJECTION SITE LITTLE HARD (ON RIGHT ARM); CHILLS; NAUSEA; 101 F FEVER; FATIGUE; NO ENERGY; This spontaneous report received from a patient concerned a 36 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included: hernia, and concurrent conditions included: irritable bowel syndrome, alcohol user, and non smoker, and other pre-existing medical conditions included: Patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A20A, expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. Concomitant medications included omeprazole for irritable bowel syndrome. On 10-SEP-2021, the patient experienced body ache. On 10-SEP-2021, the patient experienced injection site little hard (on right arm). On 10-SEP-2021, the patient experienced chills. On 10-SEP-2021, the patient experienced nausea. On 10-SEP-2021, the patient experienced 101 f fever. On 10-SEP-2021, the patient experienced fatigue. On 10-SEP-2021, the patient experienced no energy. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, nausea, 101 f fever, chills, fatigue, no energy, and injection site little hard (on right arm). This report was non-serious.

Other Meds: OMEPRAZOLE

Current Illness: Irritable bowel syndrome (Patient is on Omeprazole.); Non-smoker; Social alcohol drinker (Patient consume alcohol sometimes but not today or yesterday.)

ID: 1695333
Sex: F
Age:
State:

Vax Date:
Onset Date: 09/07/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data: Test Date: 202109; Test Name: Blood pressure systolic; Result Unstructured Data: 107 mmHg; Test Date: 202109; Test Name: Pulse rate; Result Unstructured Data: 60; Test Date: 202109; Test Name: Oxygen saturation; Result Unstructured Data: 99-100

Allergies:

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

Symptoms: CHEST PAIN; This spontaneous report received from a consumer 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 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, Laboratory data included: Blood pressure systolic (NR: not provided) 107 mmHg, Oxygen saturation (NR: not provided) 99-100, and Pulse rate (NR: not provided) 60. On 07-SEP-2021, the patient experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain. This report was non-serious.

Other Meds:

Current Illness:

ID: 1695334
Sex: F
Age:
State:

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ANXIETY OVERWHELMING; ARM SORENESS; FATIGUE; MUSCLE PAIN; 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 was not reported, administered on 07-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 SEP-2021, the patient experienced anxiety overwhelming. On SEP-2021, the patient experienced arm soreness. On SEP-2021, the patient experienced fatigue. On SEP-2021, the patient experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, muscle pain, arm soreness, and anxiety overwhelming. This report was non-serious.

Other Meds:

Current Illness:

ID: 1695335
Sex: F
Age: 75
State: TX

Vax Date: 03/13/2021
Onset Date: 03/14/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: problems with her thyroid / her thyroid is all messed up right now; gets nervous usually; Consumer did not receive the second dose of the vaccine, and it has been past 36 days since her first dose.; Arm sore; Arm swollen; Arm red; arm itchy; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PRURITUS (arm itchy) and FEELING HOT (Warm to touch) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Graves' disease, COPD, Anemia and Drug allergy (contrast dye). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), VITAMIN D3, FOLIC ACID and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PRURITUS (arm itchy) and FEELING HOT (Warm to touch). On an unknown date, the patient experienced THYROID DISORDER (problems with her thyroid / her thyroid is all messed up right now), NERVOUSNESS (gets nervous usually) and PRODUCT DOSE OMISSION ISSUE (Consumer did not receive the second dose of the vaccine, and it has been past 36 days since her first dose.). At the time of the report, PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PRURITUS (arm itchy), FEELING HOT (Warm to touch), THYROID DISORDER (problems with her thyroid / her thyroid is all messed up right now) and NERVOUSNESS (gets nervous usually) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Consumer did not receive the second dose of the vaccine, and it has been past 36 days since her first dose.) 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. Other Concomitant medication includes injections for anemia, inhaler (trelogy) for copd, medication for acid reflux added. No Treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant follow up appended-. Reporter contact details and new events -problems with her thyroid / her thyroid is all messed up right now(thyroid disorder),get nervous usually(nervousness) and the event (missed dose) added. On 16-Aug-2021: Significant follow up

Other Meds: BENADRYL A; VITAMIN D3; FOLIC ACID; SYNTHROID

Current Illness: Anemia; COPD; Drug allergy (contrast dye); Graves' disease

ID: 1695336
Sex: F
Age:
State: WA

Vax Date: 04/13/2021
Onset Date: 04/14/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: feeling sick; nausea; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced MALAISE (feeling sick), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 15-Apr-2021, MALAISE (feeling sick), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment also includes fluids like water and juice

Other Meds:

Current Illness:

ID: 1695337
Sex: U
Age:
State: FL

Vax Date: 07/05/2021
Onset Date: 07/05/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Pharmacy received vaccine on 28 May 2021 On 27 Jun 2021 the vaccine was used and was refrigerated. Then the product used by twenty patients and most were of second dose and few were first dose. No relevant concomitant medications were reported. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received in which reporter details were added. Event start date is added. On 26-Aug-2021: The TCR form received in which fax details were provided.

Other Meds:

Current Illness:

ID: 1695338
Sex: M
Age: 49
State: IL

Vax Date: 06/28/2021
Onset Date:
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Headache; Achiness; Tired Feeling; 2nd dose prior to 21 days; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (Headache), PAIN (Achiness), FATIGUE (Tired Feeling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose prior to 21 days) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 038C21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jun-2021 at 4:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021 at 4:20 AM, 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 HEADACHE (Headache), PAIN (Achiness), FATIGUE (Tired Feeling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose prior to 21 days). At the time of the report, HEADACHE (Headache), PAIN (Achiness) and FATIGUE (Tired Feeling) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose prior to 21 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The concomitant history was not reported. The treatment history was not provided. Pharmacist talked to patient after 4 days if second dose and reported events. This case was linked to MOD-2021-303495 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow-up information received on 31-AUG-2021 contains significant information. Reporter information, Patient race, ethnic group, facility information and new events were mentioned.

Other Meds:

Current Illness:

ID: 1695339
Sex: U
Age:
State:

Vax Date: 04/25/2021
Onset Date:
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Have been sick; Wrist has swelling in it/left knee has swollen up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Have been sick) and JOINT SWELLING (Wrist has swelling in it/left knee has swollen up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Have been sick) and JOINT SWELLING (Wrist has swelling in it/left knee has swollen up). At the time of the report, ILLNESS (Have been sick) and JOINT SWELLING (Wrist has swelling in it/left knee has swollen up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications on use were not provided. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow up received on 06 SEP 2021 contains NNI.

Other Meds:

Current Illness:

ID: 1695340
Sex: F
Age: 42
State: GA

Vax Date: 06/02/2021
Onset Date: 06/01/2021
Rec V Date: 09/13/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: feels like it's going to pull against the weight, it's not excruciating, but there; nose bleeds; bumps on my neck; scalp sensitivity to light motion and sound; body aches; Did not receive second dose; deep neurological pain; bone pain; arm heavy; next day, 03Jun 2021, 18-24 hour 03Jun 2021 18-24 hour period after vaccine and increasingly getting worse'; headache; overdosed, given one-half vial; Throbbing; feel much sicker than anyone else in my family; uncontrollable anxiety; Got side effects that were expected but to third degree/ symptoms stop for 4-5 days and then resume, getting increasingly worse; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive second dose), ACCIDENTAL OVERDOSE (overdosed, given one-half vial), NEURALGIA (deep neurological pain), BONE PAIN (bone pain) and LIMB DISCOMFORT (arm heavy) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Depression, PARACETAMOL (TYLENOL) for Neuralgia, NAPROXEN (MOTRIN [NAPROXEN]) for Pain, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), OXYCODONE HYDROCHLORIDE (OXYCODONE [OXYCODONE HYDROCHLORIDE]) and GUAIFENESIN (MUCINEX) for an unknown indication. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced ACCIDENTAL OVERDOSE (overdosed, given one-half vial). On 03-Jun-2021, the patient experienced CONDITION AGGRAVATED (next day, 03Jun 2021, 18-24 hour 03Jun 2021 18-24 hour period after vaccine and increasingly getting worse') and HEADACHE (headache). In June 2021, the patient experienced ANXIETY (uncontrollable anxiety), VACCINATION COMPLICATION (Got side effects that were expected but to third degree/ symptoms stop for 4-5 days and then resume, getting increasingly worse), VACCINATION SITE PAIN (Throbbing) and MALAISE (feel much sicker than anyone else in my family). In July 2021, the patient experienced NEURALGIA (deep neurological pain), BONE PAIN (bone pain) and LIMB DISCOMFORT (arm heavy). On 30-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive second dose). On an unknown date, the patient experienced PAIN OF SKIN (feels like it's going to pull against the weight, it's not excruciating, but there), EPISTAXIS (nose bleeds), NECK MASS (bumps on my neck), SENSITIVE SKIN (scalp sensitivity to light motion and sound) and MYALGIA (body aches). The patient was treated with PARACETAMOL, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (THERAFLU [PARACETAMOL;PHENIRAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) and ACCIDENTAL OVERDOSE (overdosed, given one-half vial) had resolved and NEURALGIA (deep neurological pain), BONE PAIN (bone pain), LIMB DISCOMFORT (arm heavy), CONDITION AGGRAVATED (next day, 03Jun 2021, 18-24 hour 03Jun 2021 18-24 hour period after vaccine and increasingly getting worse'), ANXIETY (uncontrollable anxiety), VACCINATION COMPLICATION (Got side effects that were expected but to third degree/ symptoms stop for 4-5 days and then resume, getting increasingly worse), PAIN OF SKIN (feels like it's going to pull against the weight, it's not excruciating, but there), VACCINATION SITE PAIN (Throbbing), MALAISE (feel much sicker than anyone else in my family), EPISTAXIS (nose bleeds), NECK MASS (bumps on my neck), SENSITIVE SKIN (scalp sensitivity to light motion and sound), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication information include Seroquel nightly, and patient also took liquid form, from a bottle Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow up received on 03-Sep-2021 and includes new events.

Other Meds: DEPO-PROVERA; OXYCODONE [OXYCODONE HYDROCHLORIDE]; ADDERALL; MUCINEX; TYLENOL; MOTRIN [NAPROXEN]

Current Illness:

ID: 1695341
Sex: M
Age: 60
State: OH

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: he couldn't walk for several days.; It took 20 minutes to get to his shower which is 15 feet away, Difficulty walking and standing for prolonged periods; feet (bilateral), hands (lateral) pain; Swelling in joints; Had to shuffle to get to the shower; pain in joints(knees (bilateral), ankles (bilateral), hips (bilateral)); This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (he couldn't walk for several days.), GAIT DISTURBANCE (It took 20 minutes to get to his shower which is 15 feet away, Difficulty walking and standing for prolonged periods), PAIN IN EXTREMITY (feet (bilateral), hands (lateral) pain), JOINT SWELLING (Swelling in joints) and LIMB DISCOMFORT (Had to shuffle to get to the shower) in a 60-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. Concurrent medical conditions included MS, Sulfonamide allergy and Drug allergy (Allergy to Clindamycin.). Concomitant products included METOPROLOL for Atrial fibrillation, EZETIMIBE (ZETIA) and SIMVASTATIN for Cholesterol, LISINOPRIL for Hypertension, OCRELIZUMAB from 15-Aug-2021 to an unknown date for Multiple sclerosis. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-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 GAIT INABILITY (he couldn't walk for several days.), GAIT DISTURBANCE (It took 20 minutes to get to his shower which is 15 feet away, Difficulty walking and standing for prolonged periods), PAIN IN EXTREMITY (feet (bilateral), hands (lateral) pain), JOINT SWELLING (Swelling in joints), LIMB DISCOMFORT (Had to shuffle to get to the shower) and ARTHRALGIA (pain in joints(knees (bilateral), ankles (bilateral), hips (bilateral))). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, GAIT INABILITY (he couldn't walk for several days.), GAIT DISTURBANCE (It took 20 minutes to get to his shower which is 15 feet away, Difficulty walking and standing for prolonged periods), PAIN IN EXTREMITY (feet (bilateral), hands (lateral) pain), JOINT SWELLING (Swelling in joints), LIMB DISCOMFORT (Had to shuffle to get to the shower) and ARTHRALGIA (pain in joints(knees (bilateral), ankles (bilateral), hips (bilateral))) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was prescribed with steroids. Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Significant follow-up received on 13-Aug-2021 included historical condition, concomitant drugs and events added. On 01-Sep-2021: Follow-up contains new event limb discomfort

Other Meds: OCRELIZUMAB; LISINOPRIL; METOPROLOL; ZETIA; SIMVASTATIN

Current Illness: Drug allergy (Allergy to Clindamycin.); MS; Sulfonamide allergy

ID: 1695342
Sex: F
Age: 38
State: NC

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Soreness; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Soreness) in a 38-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. No medical history is provided by reporter. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PROBIOTICS NOS;VITAMINS NOS and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in November 2020 and the estimated date of delivery was 10-Aug-2021. On 20-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the nineteenth week of the pregnancy. The delivery occurred on 10-Aug-2021, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 20-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products include additional vitamin C probiotics This is a case of product exposure during pregnancy with the associated AE of vaccination site pain. And 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. Patient will be contacted to confirm the the pregnancy outcome. Treatment information was not provided. This case was linked to MOD-2021-278102 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up information received includes updated patient initial; Sender's Comments: This is a case of product exposure during pregnancy with the associated AE of vaccination site pain. And 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. Patient will be contacted to confirm the the pregnancy outcome.

Other Meds: SYNTHROID; PROBIOTICS NOS;VITAMINS NOS; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1695343
Sex: F
Age: 47
State: PA

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data: Test Date: 20210830; Test Name: Blood pressure; Result Unstructured Data: 116/70 mmHg; Test Date: 20210830; Test Name: Body temperature; Result Unstructured Data: 98 F; Test Date: 20210830; Test Name: Heart rate; Result Unstructured Data: 87 bpm; Test Date: 20210830; Test Name: respiratory rate; Result Unstructured Data: 12 breaths per minute.

Allergies:

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

Symptoms: broke out in a sweat; chills; cough; wheezing; doing nothing but sleeping; had to call out of work because the fatigue was so bad/extreme fatigue; slight sore throat; arm pain in right arm/painful arm; headache; nose has been running really bad; Local Urticaria; Hypersensitivity reaction; Swollen arn; Local erythema; swelling in the right elbow; diarrhea; pain in the right side; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (doing nothing but sleeping), OROPHARYNGEAL PAIN (slight sore throat), PAIN IN EXTREMITY (arm pain in right arm/painful arm), HYPERHIDROSIS (broke out in a sweat) and JOINT SWELLING (swelling in the right elbow) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09ID21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma (persistent asthma), Seasonal allergy (she usually has seasonal allergy flare-ups in the fall and the spring.), Hypersensitivity, Hay fever, Allergy to antibiotic (Allergic to Augmentin causes upset of GI), Drug allergy (Allergic to Bromfed DM causes sedation), Allergy to antibiotic (Allergic to Doxycycline causes upset of GI), Drug allergy (Allergic to Flonase causes upset of epistaxis), Drug allergy (Allergic to Naproxen causes upset GI), Obesity, Chronic fatigue syndrome, Allergic rhinitis and GERD. Concomitant products included FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D 24 HOUR) for Allergy, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, FAMOTIDINE for GERD, ACETAMINOPHEN for Pain, ALBUTEROL [SALBUTAMOL] for Shortness of breath, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication. On 03-Aug-2021 at 7:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (slight sore throat), PAIN IN EXTREMITY (arm pain in right arm/painful arm), JOINT SWELLING (swelling in the right elbow), DIARRHOEA (diarrhea), PAIN (pain in the right side), RHINORRHOEA (nose has been running really bad), URTICARIA (Local Urticaria), HYPERSENSITIVITY (Hypersensitivity reaction), PERIPHERAL SWELLING (Swollen arn), ERYTHEMA (Local erythema) and HEADACHE (headache). On 05-Aug-2021, the patient experienced SOMNOLENCE (doing nothing but sleeping). 05-Aug-2021, the patient experienced FATIGUE (had to call out of work because the fatigue was so bad/extreme fatigue). On 08-Aug-2021, the patient experienced COUGH (cough) and WHEEZING (wheezing). On 13-Aug-2021, the patient experienced HYPERHIDROSIS (broke out in a sweat) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 03-Aug-2021 at a dose of 500 mg twice a day and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) (oral) from 17-Aug-2021 to 23-Aug-2021 at an unspecified dose and frequency. On 30-Aug-2002, ERYTHEMA (Local erythema) had resolved. On 30-Aug-2021, URTICARIA (Local Urticaria), HYPERSENSITIVITY (Hypersensitivity reaction) and PERIPHERAL SWELLING (Swollen arn) had resolved. At the time of the report, SOMNOLENCE (doing nothing but sleeping), OROPHARYNGEAL PAIN (slight sore throat), HYPERHIDROSIS (broke out in a sweat), JOINT SWELLING (swelling in the right elbow), DIARRHOEA (diarrhea), PAIN (pain in the right side), RHINORRHOEA (nose has been running really bad), FATIGUE (had to call out of work because the fatigue was so bad/extreme fatigue) and CHILLS (chills) outcome was unknown, PAIN IN EXTREMITY (arm pain in right arm/painful arm), COUGH (cough) and WHEEZING (wheezing) had not resolved and HEADACHE (headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, Blood pressure measurement: 116 (normal) 116/70 mmHg. On 30-Aug-2021, Body temperature: 98 (normal) 98 F. On 30-Aug-2021, Heart rate: 87 (normal) 87 bpm. On 30-Aug-2021, Respiratory rate: 12 (normal) 12 breaths per minute.. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERSENSITIVITY (Hypersensitivity reaction) to be possibly related. No further causality assessments were provided for SOMNOLENCE (doing nothing but sleeping), OROPHARYNGEAL PAIN (slight sore throat), PAIN IN EXTREMITY (arm pain in right arm/painful arm), HYPERHIDROSIS (broke out in a sweat), JOINT SWELLING (swelling in the right elbow), DIARRHOEA (diarrhea), PAIN (pain in the right side), COUGH (cough), WHEEZING (wheezing), RHINORRHOEA (nose has been running really bad), URTICARIA (Local Urticaria), PERIPHERAL SWELLING (Swollen arn), ERYTHEMA (Local erythema), FATIGUE (had to call out of work because the fatigue was so bad/extreme fatigue), CHILLS (chills) and HEADACHE (headache). The patient reports she began to have a cough and started wheezing, so she had to take her prescribed inhaler to work. Patient used ice as treatment. Patient seek medical care to doctors office. Patient race mentioned as black in source document. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Added new reporter, patient details, current conditions, lab details, concomitant medication, treatment medication, new events and narrative was updated accordingly.

Other Meds: ALLEGRA D 24 HOUR; ACETAMINOPHEN; ALBUTEROL [SALBUTAMOL]; SYMBICORT; FAMOTIDINE; SINGULAIR

Current Illness: Allergic rhinitis; Allergy to antibiotic (Allergic to Doxycycline causes upset of GI); Allergy to antibiotic (Allergic to Augmentin causes upset of GI); Asthma (persistent asthma); Chronic fatigue syndrome; Drug allergy (Allergic to Naproxen causes upset GI); Drug allergy (Allergic to Flonase causes upset of epistaxis); Drug allergy (Allergic to Bromfed DM causes sedation); GERD; Hay fever; Hypersensitivity; Obesity; Seasonal allergy (she usually has seasonal allergy flare-ups in the fall and the spring.)

ID: 1695344
Sex: F
Age: 22
State:

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: vaccinated a pregnant woman; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccinated a pregnant woman) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3003604) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccinated a pregnant woman). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 09-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccinated a pregnant woman) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. ? No treatment information was provided. ? Second dose of vaccine scheduled for 06-Sep-2021. Very limited information regarding these events has been provided at this time. There is no content in the source document to properly do a medical review. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Translated document received on 7-sep-2021_Translated in language weaver, updated event start date and stop date, outcome.; Sender's Comments: Very limited information regarding these events has been provided at this time. There is no content in the source document to properly do a medical review. Further information has been requested.

Other Meds:

Current Illness:

ID: 1695345
Sex: M
Age: 69
State: AL

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data: Test Date: 20210820; Test Name: fever; Result Unstructured Data: 101.3 degrees F

Allergies:

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

Symptoms: had no energy and laid around; felt like he had the flu; ached; started coughing; fever up to 101.3 degrees F; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (had no energy and laid around), INFLUENZA (felt like he had the flu), PAIN (ached), COUGH (started coughing) and VACCINATION SITE PAIN (vaccination site pain) in a 69-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. Medical history was not provided. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 20-Aug-2021, the patient experienced INFLUENZA (felt like he had the flu), PAIN (ached) and COUGH (started coughing). 20-Aug-2021, the patient experienced PYREXIA (fever up to 101.3 degrees F). On 21-Aug-2021, the patient experienced ASTHENIA (had no energy and laid around). The patient was treated with PARACETAMOL (TYLENOL) on 20-Aug-2021 for Adverse event, at an unspecified dose and frequency. On 20-Aug-2021, COUGH (started coughing) had resolved. On 22-Aug-2021, ASTHENIA (had no energy and laid around), INFLUENZA (felt like he had the flu), PAIN (ached), VACCINATION SITE PAIN (vaccination site pain) and PYREXIA (fever up to 101.3 degrees F) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Body temperature: up to 101.3 (High) 101.3 degrees F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was reported.

Other Meds:

Current Illness:

ID: 1695346
Sex: F
Age: 67
State: WI

Vax Date: 04/20/2021
Onset Date: 08/20/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data: Test Date: 20201228; Test Name: PCR; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: The vaccine vial was opened on 11-Aug-2021. The vial was never removed from the refrigerator after that day and wasted/disposed of. The vial was accidently used for vaccines given on 20-Aug-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine vial was opened on 11-Aug-2021. The vial was never removed from the refrigerator after that day and wasted/disposed of. The vial was accidently used for vaccines given on 20-Aug-2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A, 002C21A and 002C21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 28-Dec-2020 and Kidney transplant on 01-Feb-2013. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine vial was opened on 11-Aug-2021. The vial was never removed from the refrigerator after that day and wasted/disposed of. The vial was accidently used for vaccines given on 20-Aug-2021). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine vial was opened on 11-Aug-2021. The vial was never removed from the refrigerator after that day and wasted/disposed of. The vial was accidently used for vaccines given on 20-Aug-2021) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was administered expired covid vaccine. The vaccine vial was opened on 11-Aug-2021 and one dose was given to a patient. The vial was never removed from the refrigerator after that day and wasted/disposed of. The vial was accidently used for vaccines given on 20-Aug-2021. This was the patient's booster of covid vaccine. No relevant concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Follow-up information included patient details, medical history, lab data and vaccine administration details.

Other Meds:

Current Illness:

ID: 1695347
Sex: M
Age:
State: NY

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

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in shoulder) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. 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 ARTHRALGIA (Pain in shoulder). At the time of the report, ARTHRALGIA (Pain in shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided by the reporter No treatment medication were provided by the reporter

Other Meds:

Current Illness:

ID: 1695348
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: bursitis; hives; inflammation with the joints; This spontaneous case was reported by an other health care professional and describes the occurrence of BURSITIS (bursitis), URTICARIA (hives) and ARTHRITIS (inflammation with the joints) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The patient's past medical history included torn rotator cuff. Concurrent medical conditions included Hives (Hives cleared before recurring again). 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 BURSITIS (bursitis), URTICARIA (hives) and ARTHRITIS (inflammation with the joints). At the time of the report, BURSITIS (bursitis), URTICARIA (hives) and ARTHRITIS (inflammation with the joints) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had a torn rotator cuff years ago. Patient was on steroid treatment for hives and inflammation of joints.

Other Meds:

Current Illness: Hives (Hives cleared before recurring again)

ID: 1695349
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 09/13/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Tremendous pain in both arms for 36-48 hours after second shot; Fever for 36-48 hours after second shot; Chills for 36-48 hours after second shot; Headache for 36-48 hours after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tremendous pain in both arms for 36-48 hours after second shot), PYREXIA (Fever for 36-48 hours after second shot), CHILLS (Chills for 36-48 hours after second shot) and HEADACHE (Headache for 36-48 hours after second shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Pneumonia and Cancer. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Tremendous pain in both arms for 36-48 hours after second shot), PYREXIA (Fever for 36-48 hours after second shot), CHILLS (Chills for 36-48 hours after second shot) and HEADACHE (Headache for 36-48 hours after second shot). In April 2021, PAIN IN EXTREMITY (Tremendous pain in both arms for 36-48 hours after second shot), PYREXIA (Fever for 36-48 hours after second shot), CHILLS (Chills for 36-48 hours after second shot) and HEADACHE (Headache for 36-48 hours after second shot) outcome was unknown. No concomitant medications reported. No treatment information was reported by reporter. This case was linked to MOD-2021-297516, MOD-2021-297591 (Patient Link).

Other Meds:

Current Illness: Cancer; Pneumonia

ID: 1695350
Sex: F
Age: 52
State: IL

Vax Date: 08/24/2021
Onset Date: 08/25/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data: Test Date: 202011; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: The patient had COVID.

Allergies:

Symptom List: Unevaluable event

Symptoms: Vomiting; a 101 F fever; Cold chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (a 101 F fever), CHILLS (Cold chills) and VOMITING (Vomiting) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PYREXIA (a 101 F fever) and CHILLS (Cold chills). On 26-Aug-2021, the patient experienced VOMITING (Vomiting). At the time of the report, PYREXIA (a 101 F fever), CHILLS (Cold chills) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) The patient had COVID.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1695351
Sex: U
Age:
State: VA

Vax Date:
Onset Date: 08/26/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: A full untouched 10 dose Moderna COVID-19 vaccine only having enough for four doses which were administered to four patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PACKAGING QUANTITY ISSUE (A full untouched 10 dose Moderna COVID-19 vaccine only having enough for four doses which were administered to four patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT PACKAGING QUANTITY ISSUE (A full untouched 10 dose Moderna COVID-19 vaccine only having enough for four doses which were administered to four patients). On 26-Aug-2021, PRODUCT PACKAGING QUANTITY ISSUE (A full untouched 10 dose Moderna COVID-19 vaccine only having enough for four doses which were administered to four patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The reporter stated that they were not sure of what exactly occurred as the facility was sent a sealed vial and only 4 doses were contained within it. There were no doses withdrawn from the vial at their pharmacy and therefore she do not believe that the patients received expired product. Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: New event-product packaging issue added.

Other Meds:

Current Illness:

ID: 1695352
Sex: M
Age: 65
State: CA

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 24-Jan-2021, PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was taking Diabetes medication. This case was linked to MOD-2021-297898 (Patient Link).

Other Meds:

Current Illness:

ID: 1695353
Sex: F
Age: 76
State: OR

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Tenderness; Feels sleepy all day; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), SOMNOLENCE (Feels sleepy all day) and VACCINATION SITE PAIN (Pain at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026CZ1A) for COVID-19 vaccination. Concurrent medical conditions included Bee sting (Bee stings) and Drug allergy (Multiple allergies to medications (she don't have a list)). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), SUPER B COMPLEX WITH C, GINKGO BILOBA (GINGKO BILOBA), COLECALCIFEROL, UBIDECARENONE (COQ10 + D3), VITAMIN D3, CENTRUM SILVER +50, GLUCOSAMINE, EMERGEN C, ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +), VITIS VINIFERA EXTRACT (GRAPESEED), METOPROLOL, IRON and LOSARTAN for an unknown indication. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced TENDERNESS (Tenderness), SOMNOLENCE (Feels sleepy all day) and VACCINATION SITE PAIN (Pain at injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram once. At the time of the report, TENDERNESS (Tenderness), SOMNOLENCE (Feels sleepy all day) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient also reported other concomitant medications that include Garlic capsule, Aller-tec 1 tab once daily.

Other Meds: ASPIRIN 81; SUPER B COMPLEX WITH C; GINGKO BILOBA; COQ10 + D3; VITAMIN D3; CENTRUM SILVER +50; GLUCOSAMINE; EMERGEN C; LUTEIN +; GRAPESEED; METOPROLOL; IRON; LOSARTAN

Current Illness: Bee sting (Bee stings); Drug allergy (Multiple allergies to medications (she don't have a list))

ID: 1695354
Sex: F
Age: 86
State: CA

Vax Date: 08/25/2021
Onset Date: 08/26/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Nose dripping; Feeling hot; Feel like they have a bad cold; Feel like they have a bad allergies; Cold chills; Right arm very sore; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Nose dripping), FEELING HOT (Feeling hot), NASOPHARYNGITIS (Feel like they have a bad cold), HYPERSENSITIVITY (Feel like they have a bad allergies) and CHILLS (Cold chills) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in April 2021. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced RHINORRHOEA (Nose dripping), FEELING HOT (Feeling hot), NASOPHARYNGITIS (Feel like they have a bad cold), HYPERSENSITIVITY (Feel like they have a bad allergies), CHILLS (Cold chills) and MYALGIA (Right arm very sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Nose dripping), FEELING HOT (Feeling hot), NASOPHARYNGITIS (Feel like they have a bad cold), HYPERSENSITIVITY (Feel like they have a bad allergies), CHILLS (Cold chills) and MYALGIA (Right arm very sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medication includes blood thinner and the patient was on a lot of daily medications but did not felt like going through them at this time.

Other Meds:

Current Illness:

ID: 1695355
Sex: F
Age: 74
State: FL

Vax Date: 01/27/2021
Onset Date: 02/24/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: low grade fever after second dose; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever after second dose) and HEADACHE (slight headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 030L20A) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol, GERD, Anaemia and Restless leg syndrome. Concomitant products included FERROUS GLUCONATE (POLY-IRON [FERROUS GLUCONATE]) for Anaemia, OMEPRAZOLE for GERD, ATORVASTATIN for High cholesterol, CLONAZEPAM for Restless leg syndrome. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (low grade fever after second dose) and HEADACHE (slight headache). On 25-Feb-2021, PYREXIA (low grade fever after second dose) and HEADACHE (slight headache) had resolved. Treatment information was not provided. This case was linked to MOD-2021-298189 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Reporter contact info, patient demographics updated, medical history, first dose batch no and concomitant were added,

Other Meds: ATORVASTATIN; OMEPRAZOLE; POLY-IRON [FERROUS GLUCONATE]; CLONAZEPAM

Current Illness: Anaemia; GERD; High cholesterol; Restless leg syndrome

ID: 1695356
Sex: U
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/16/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: How can I complete my vaccination; Got COVID-19 two days after receiving Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID-19 two days after receiving Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (How can I complete my vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced COVID-19 (Got COVID-19 two days after receiving Moderna vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (How can I complete my vaccination). At the time of the report, COVID-19 (Got COVID-19 two days after receiving Moderna vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (How can I complete my vaccination) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1695357
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: red; itches terribly; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itches terribly) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itches terribly). At the time of the report, VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itches terribly) outcome was unknown. No concomitant medication was reported. No treatment history was reported. This case was linked to MOD-2021-298586, MOD-2021-298603 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1695358
Sex: M
Age: 69
State: FL

Vax Date: 01/08/2021
Onset Date: 08/27/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data: Test Date: 20210511; Test Name: Surgery; Test Result: Inconclusive ; Result Unstructured Data: thyroid cancer removed

Allergies:

Symptom List: Nausea

Symptoms: 3rd dose 26 of Aug 2021; soreness in his arm; swelling without pain in his ankles on the bottom of his legs / I had severe swelling of both ankles.; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling without pain in his ankles on the bottom of his legs / I had severe swelling of both ankles.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose 26 of Aug 2021) and PAIN IN EXTREMITY (soreness in his arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028l20a, 053e21a and 039k20a) for COVID-19 vaccination. The patient's past medical history included Thyroid cancer in April 2021 and Kidney stones. Concurrent medical conditions included Sarcoidosis and Diabetes. Concomitant products included METHOTREXATE and PREDNISONE for Arthritis, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Breathing difficult, GLIPIZIDE and GEFITINIB (B-D NANO 2ND GEN NEEDLE) for Diabetes, METHYLPHENIDATE for Narcolepsy, TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN [TAMSULOSIN HYDROCHLORIDE]) for Urination pain, AMLODIPINE, ATORVASTATIN, FOLIC ACID, LOSARTAN, OMEPRAZOLE, ZOLEDRONIC ACID from 20-Aug-2021 to an unknown date, LEVOTHYROXINE SODIUM (SYNTHROID), BROMAZEPAM (TENSONIL), TRAZODONE, ESCITALOPRAM OXALATE (LEXAPRO), TRAZODONE HYDROCHLORIDE (TRAZODONE [TRAZODONE HYDROCHLORIDE]), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) and AMLODIPINE for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced JOINT SWELLING (swelling without pain in his ankles on the bottom of his legs / I had severe swelling of both ankles.). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose 26 of Aug 2021) and PAIN IN EXTREMITY (soreness in his arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, JOINT SWELLING (swelling without pain in his ankles on the bottom of his legs / I had severe swelling of both ankles.) and PAIN IN EXTREMITY (soreness in his arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose 26 of Aug 2021) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Surgery: unknown (Inconclusive) thyroid cancer removed. This case was linked to MOD-2021-299975 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Significant follow up appended :Concomitant Drugs

Other Meds: AMLODIPINE; ATORVASTATIN; FOLIC ACID; GLIPIZIDE; LOSARTAN; METHOTREXATE; METHYLPHENIDATE; OMEPRAZOLE; ZOLEDRONIC ACID; B-D NANO 2ND GEN NEEDLE; PREDNISONE; SYNTHROID; TENSONIL; TRAZODONE; LEXAPRO; TAMSULOSIN [TAMSULOSIN HYDROCHLORIDE]; TRAZ

Current Illness: Diabetes; Sarcoidosis

ID: 1695359
Sex: F
Age: 71
State: TX

Vax Date: 07/26/2021
Onset Date: 08/23/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data: Test Date: 20210827; Test Name: blood pressure; Result Unstructured Data: 92/62 low; Test Date: 20210827; Test Name: blood pressure; Result Unstructured Data: 90/57; Test Date: 20210827; Test Name: blood pressure; Result Unstructured Data: 89/52 low; Test Date: 20210827; Test Name: blood pressure; Result Unstructured Data: 92/56 low; Test Date: 20210827; Test Name: blood pressure; Result Unstructured Data: 110/70 low; Test Date: 20210827; Test Name: body temperature; Result Unstructured Data: 101 F High; Test Date: 20210827; Test Name: Heart rate; Result Unstructured Data: 89 high; Test Date: 20210827; Test Name: Heart rate; Result Unstructured Data: 76 high; Test Date: 20210827; Test Name: Heart rate; Result Unstructured Data: 72; Test Date: 20210827; Test Name: Heart rate; Result Unstructured Data: 68 normal; Test Date: 20210827; Test Name: Heart rate; Result Unstructured Data: 76 normal

Allergies:

Symptom List: Injection site pain

Symptoms: Feels sluggish, like I don't want to do anything; lethargic feeling; mental lapse; Systolic blood pressure 90 mmHg; Flushing; chills; low blood pressure for several days/top number 90-96/bottom number in the 50s; lethargic feeling; didn't feel like sleeping; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (low blood pressure for several days/top number 90-96/bottom number in the 50s), SLUGGISHNESS (Feels sluggish, like I don't want to do anything), the second episode of LETHARGY (lethargic feeling), FEELING ABNORMAL (mental lapse) and HYPERTENSION (Systolic blood pressure 90 mmHg) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Food allergy (mushroom-under dr care for 5 days) since 1980 and Contrast media allergy (anaphylaxis) since 1981. Concomitant products included MONTELUKAST for Allergy, SODIUM NITRATE for Chest heaviness, ROSUVASTATIN for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (T3) for Hypothyroidism, REST ZZZ for Sleep disorder NOS. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced the first episode of LETHARGY (lethargic feeling) and FEELING ABNORMAL (didn't feel like sleeping). On 24-Aug-2021, the patient experienced HYPOTENSION (low blood pressure for several days/top number 90-96/bottom number in the 50s). On an unknown date, the patient experienced SLUGGISHNESS (Feels sluggish, like I don't want to do anything), the second episode of LETHARGY (lethargic feeling), FEELING ABNORMAL (mental lapse), HYPERTENSION (Systolic blood pressure 90 mmHg), FLUSHING (Flushing) and CHILLS (chills). On 28-Aug-2021, FEELING ABNORMAL (didn't feel like sleeping) had resolved. At the time of the report, HYPOTENSION (low blood pressure for several days/top number 90-96/bottom number in the 50s), SLUGGISHNESS (Feels sluggish, like I don't want to do anything), the last episode of LETHARGY (lethargic feeling), FEELING ABNORMAL (mental lapse), HYPERTENSION (Systolic blood pressure 90 mmHg), FLUSHING (Flushing) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Blood pressure measurement: 24-aug-2021 (Low) 92/62 low, 25-aug-2021 (Low) 90/57, 26-aug-2021 (Low) 89/52 low, 27-aug-2021 (Low) 92/56 low and 28-aug-2021 (Low) 110/70 low. On 27-Aug-2021, Body temperature: 101 f (High) 101 F High. On 27-Aug-2021, Heart rate: 24-aug-2021 (High) 89 high, 25-08-2021 (High) 76 high, 26-08-2021 (normal) 72, 27-aug-2021 (normal) 68 normal and 28-aug-2021 (normal) 76 normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment was provided by reporter. Take it easy used as treatment on 23-08-2021 and stopped on 28-08-2021. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up with patient information added, concomitants were added and allergic reactions are added

Other Meds: SYNTHROID; T3; SODIUM NITRATE; MONTELUKAST; ROSUVASTATIN; REST ZZZ

Current Illness: Contrast media allergy (anaphylaxis); Food allergy (mushroom-under dr care for 5 days)

ID: 1695360
Sex: M
Age: 28
State: NC

Vax Date: 08/05/2021
Onset Date: 08/28/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 2nd dose less than 28 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose less than 28 days) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose less than 28 days). On 28-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose less than 28 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment drug details was reported. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received on 01-SEP-2021. No new information

Other Meds:

Current Illness:

ID: 1695361
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Took the shot felt a burning itching flowing through veins down into wrist; Felt a fiery itch flowing into and around heart.; Had a sudden onset stabbing headache on right forehead; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Took the shot felt a burning itching flowing through veins down into wrist), PRURITUS (Felt a fiery itch flowing into and around heart.) and HEADACHE (Had a sudden onset stabbing headache on right forehead) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Took the shot felt a burning itching flowing through veins down into wrist), PRURITUS (Felt a fiery itch flowing into and around heart.) and HEADACHE (Had a sudden onset stabbing headache on right forehead). At the time of the report, BURNING SENSATION (Took the shot felt a burning itching flowing through veins down into wrist), PRURITUS (Felt a fiery itch flowing into and around heart.) and HEADACHE (Had a sudden onset stabbing headache on right forehead) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No Treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1695362
Sex: M
Age: 72
State: FL

Vax Date: 08/28/2021
Onset Date: 08/28/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: First two doses administered were Pfizer but today the patient received a Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (First two doses administered were Pfizer but today the patient received a Moderna vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (First two doses.). On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (First two doses administered were Pfizer but today the patient received a Moderna vaccine). On 28-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (First two doses administered were Pfizer but today the patient received a Moderna vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication were provided.

Other Meds:

Current Illness:

ID: 1695363
Sex: U
Age:
State: NC

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Got COVID-19; 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 COVID-19 (Got COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID-19). At the time of the report, COVID-19 (Got COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were provided by the reporter. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1695364
Sex: F
Age: 76
State: TX

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/13/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

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

Symptoms: could not taste the coke/ lost sense of taste; lost sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (could not taste the coke/ lost sense of taste) and ANOSMIA (lost sense of smell) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Norco allergy). On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced AGEUSIA (could not taste the coke/ lost sense of taste) and ANOSMIA (lost sense of smell). At the time of the report, AGEUSIA (could not taste the coke/ lost sense of taste) and ANOSMIA (lost sense of smell) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment was reported.

Other Meds:

Current Illness: Drug allergy (Norco allergy)

ID: 1695365
Sex: F
Age: 31
State: NC

Vax Date: 07/23/2021
Onset Date: 08/27/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: She has a knot on the arm at the injection site; Itches like when you get a cut and it starts to heal; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (She has a knot on the arm at the injection site) and PRURITUS (Itches like when you get a cut and it starts to heal) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 035C21A) for COVID-19 vaccination. Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced VACCINATION SITE MASS (She has a knot on the arm at the injection site) and PRURITUS (Itches like when you get a cut and it starts to heal). At the time of the report, VACCINATION SITE MASS (She has a knot on the arm at the injection site) and PRURITUS (Itches like when you get a cut and it starts to heal) outcome was unknown. No treatment medications were provided. This case was linked to MOD-2021-300288 (Patient Link).

Other Meds: ASPIRINE

Current Illness:

ID: 1695366
Sex: F
Age:
State: FL

Vax Date: 01/21/2021
Onset Date: 02/19/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: no energy; Woke up at 2 am with shivering; aching all over; Burning up; Couldn't move/Barely made it to the bathroom/sat in one position; Could not go back to sleep; Couldn't eat or drink/ Didn't want anything to drink or eat; Couldn't easily walk; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning up), MOBILITY DECREASED (Couldn't move/Barely made it to the bathroom/sat in one position), INSOMNIA (Could not go back to sleep), DECREASED APPETITE (Couldn't eat or drink/ Didn't want anything to drink or eat) and GAIT DISTURBANCE (Couldn't easily walk) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Heart disorder, Constipation and Hypercholesteraemia. Concomitant products included AMLODIPINE for Blood pressure high, MAGNESIUM CITRATE for Constipation, ACETYLSALICYLIC ACID (ASPIRIN 81) for Heart disorder, PITAVASTATIN CALCIUM (PIVASTA) for Hypercholesteraemia, EZETIMIBE for Hypercholesterolaemia. On 21-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced BURNING SENSATION (Burning up), MOBILITY DECREASED (Couldn't move/Barely made it to the bathroom/sat in one position), INSOMNIA (Could not go back to sleep), DECREASED APPETITE (Couldn't eat or drink/ Didn't want anything to drink or eat), GAIT DISTURBANCE (Couldn't easily walk), CHILLS (Woke up at 2 am with shivering) and MYALGIA (aching all over). On 20-Feb-2021, the patient experienced ASTHENIA (no energy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 mg. On 21-Feb-2021, BURNING SENSATION (Burning up), MOBILITY DECREASED (Couldn't move/Barely made it to the bathroom/sat in one position), INSOMNIA (Could not go back to sleep), DECREASED APPETITE (Couldn't eat or drink/ Didn't want anything to drink or eat), GAIT DISTURBANCE (Couldn't easily walk), ASTHENIA (no energy), CHILLS (Woke up at 2 am with shivering) and MYALGIA (aching all over) had resolved. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received contains significant information- Patient's race, ethnicity, concomitant, treatment medications and dosage regimen.

Other Meds: PIVASTA; EZETIMIBE; AMLODIPINE; ASPIRIN 81; MAGNESIUM CITRATE

Current Illness: Blood pressure high; Constipation; Heart disorder; Hypercholesteraemia

ID: 1695367
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Unspecific AE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unspecific AE) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Unspecific AE). At the time of the report, VACCINATION COMPLICATION (Unspecific AE) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1695368
Sex: F
Age: 58
State: PA

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 09/13/2021
Hospital:

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

Lab Data: Test Name: Weight; Result Unstructured Data: 10 lb weight loss

Allergies:

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

Symptoms: Severe pain to the right upper buttocks and hamstring; Bilateral ankle swelling; Shortness of breath; Right leg colour change; Right leg weak from muscle atrophy; Pain with sitting and climbing stairs; Tendinopathy; Hamstring pain severe; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULOSKELETAL PAIN (Severe pain to the right upper buttocks and hamstring), JOINT SWELLING (Bilateral ankle swelling), DYSPNOEA (Shortness of breath), SKIN DISCOLOURATION (Right leg colour change) and MUSCLE ATROPHY (Right leg weak from muscle atrophy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hives, Migraine since 01-Jan-2005, Osteoporosis since 01-Jan-2000 and Anaphylaxis. Concomitant products included VITAMINS NOS (MVI [VITAMINS NOS]) for Supplementation therapy, LORATADINE (CLARITINE) from 02-Mar-2021 to an unknown date and RANITIDINE HYDROCHLORIDE (ZANTAC) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL PAIN (Severe pain to the right upper buttocks and hamstring), JOINT SWELLING (Bilateral ankle swelling), DYSPNOEA (Shortness of breath), SKIN DISCOLOURATION (Right leg colour change), MUSCLE ATROPHY (Right leg weak from muscle atrophy), PAIN (Pain with sitting and climbing stairs), TENDON DISORDER (Tendinopathy) and MYALGIA (Hamstring pain severe). The patient was treated with GABAPENTIN ongoing since an unknown date for Adverse event, at a dose of 100 milligram once a day and PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK UNK, qd. At the time of the report, MUSCULOSKELETAL PAIN (Severe pain to the right upper buttocks and hamstring), JOINT SWELLING (Bilateral ankle swelling), SKIN DISCOLOURATION (Right leg colour change), MUSCLE ATROPHY (Right leg weak from muscle atrophy), TENDON DISORDER (Tendinopathy) and MYALGIA (Hamstring pain severe) outcome was unknown, DYSPNOEA (Shortness of breath) was resolving and PAIN (Pain with sitting and climbing stairs) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: loss (Low) 10 lb weight loss. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 12-Jan-2012, the patient started NSAIDs treatment for hives. The patient went to orthopedic urgent care and was treated for tendinopathy. The patient went for physical therapy for two to three times per week in the past three months. The patient was home care nurse and since past seven months was resting at home. This case was linked to MOD-2021-294480 (Patient Link).

Other Meds: MVI [VITAMINS NOS]; CLARITINE; ZANTAC

Current Illness: Anaphylaxis; Hives; Migraine; Osteoporosis

ID: 1695369
Sex: F
Age: 55
State: GA

Vax Date: 08/18/2021
Onset Date:
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: like hay fever; pressure behind the eyes; congestion feeling across the bridge of the nose; pressure in the teeth; nose was itching; runny nose; headache; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (like hay fever), OCULAR DISCOMFORT (pressure behind the eyes), NASAL CONGESTION (congestion feeling across the bridge of the nose), DENTAL DISCOMFORT (pressure in the teeth) and NASAL PRURITUS (nose was itching) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Urinary tract infection. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEASONAL ALLERGY (like hay fever), OCULAR DISCOMFORT (pressure behind the eyes), NASAL CONGESTION (congestion feeling across the bridge of the nose), DENTAL DISCOMFORT (pressure in the teeth), NASAL PRURITUS (nose was itching), RHINORRHOEA (runny nose) and HEADACHE (headache). The patient was treated with CEFALEXIN (CEPHALEXINE) on 10-Aug-2021 for Urinary tract infection, at a dose of UNK, 7 days; VITAMINS NOS ongoing since an unknown date at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SEASONAL ALLERGY (like hay fever), OCULAR DISCOMFORT (pressure behind the eyes), NASAL CONGESTION (congestion feeling across the bridge of the nose), DENTAL DISCOMFORT (pressure in the teeth), NASAL PRURITUS (nose was itching), RHINORRHOEA (runny nose) and HEADACHE (headache) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medications also included Allergy release medicine.

Other Meds:

Current Illness: Urinary tract infection

ID: 1695370
Sex: M
Age: 31
State: PA

Vax Date: 08/30/2021
Onset Date: 08/30/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (sulfa drugs), Penicillin allergy, Major depression, Anemia, Hiatal hernia and Insomnia. Concomitant products included BUPROPION for Depression, TRAZODONE for Insomnia. On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 30-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not reported. Patient's race is black. Patient's height is 66.14 inches. Patient received the vaccine on 30th Aug 2021 at 08:45 am. This report refers to a case of Product storage error for mRNA-1273, lot # 014C21A with no associated AEs. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received: reporters information , patient's demographic, concurrent condition of the patient and concomitant medication were updated.; Sender's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # 014C21A with no associated AEs.

Other Meds: BUPROPION; TRAZODONE

Current Illness: Anemia; Drug allergy (sulfa drugs); Hiatal hernia; Insomnia; Major depression; Penicillin allergy

ID: 1695371
Sex: F
Age: 77
State: TX

Vax Date: 08/28/2021
Onset Date: 08/29/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Suffered severe incident twice; Dementia; Showing a maniac behavior; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Suffered severe incident twice), DEMENTIA (Dementia) and MANIA (Showing a maniac behavior) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D2LA) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism and Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE and SPIRONOLACTONE for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism. On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced DEMENTIA (Dementia). 29-Aug-2021, the patient experienced MANIA (Showing a maniac behavior). On an unknown date, the patient experienced VACCINATION COMPLICATION (Suffered severe incident twice). On 29-Aug-2021, DEMENTIA (Dementia) and MANIA (Showing a maniac behavior) had resolved. At the time of the report, VACCINATION COMPLICATION (Suffered severe incident twice) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was provided. This case was linked to MOD-2021-301073, MOD-2021-300955 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Adverse event updated to suffered severe incident twice On 03-Sep-2021: Follow-up received on 03-Sep-2021 and No New Information is provided.

Other Meds: SYNTHROID; HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

Current Illness: Blood pressure high; Hypothyroidism

ID: 1695372
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 242 patients were administered expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (242 patients were administered expired doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (242 patients were administered expired doses). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (242 patients were administered expired doses) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication were provided. Lot numbers and their following expiration date: 1. 001C21A (12Oct2021) 2. 011A21A (16Aug2021) 3. 011M202A (16July2021) 4. 027C21A (18Sept2021) 5. 031A21A (28Aug2021) 6. 041B21A (4Oct2021)

Other Meds:

Current Illness:

ID: 1695373
Sex: M
Age: 64
State: OR

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/13/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: lack of energy/their strength in the right hand is gone; The weakness in the right hand is moving up their arm to their elbow now; the patient fatigues real easy now; left arm about 2 to 3 inches from the injection site a sore has opened up and clear liquid is coming out; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (lack of energy/their strength in the right hand is gone), MUSCULAR WEAKNESS (The weakness in the right hand is moving up their arm to their elbow now), FATIGUE (the patient fatigues real easy now) and VACCINATION SITE PAIN (left arm about 2 to 3 inches from the injection site a sore has opened up and clear liquid is coming out) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The patient's past medical history included Stroke. Concurrent medical conditions included Seizures, Pain and Paralyzed (Left side of their body is paralyzed.). Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for Pain, PHENYTOIN for Seizures, PANTOPRAZOLE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ESCITALOPRAM and LOVASTATIN for an unknown indication. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ASTHENIA (lack of energy/their strength in the right hand is gone), MUSCULAR WEAKNESS (The weakness in the right hand is moving up their arm to their elbow now), FATIGUE (the patient fatigues real easy now) and VACCINATION SITE PAIN (left arm about 2 to 3 inches from the injection site a sore has opened up and clear liquid is coming out). At the time of the report, ASTHENIA (lack of energy/their strength in the right hand is gone), MUSCULAR WEAKNESS (The weakness in the right hand is moving up their arm to their elbow now), FATIGUE (the patient fatigues real easy now) and VACCINATION SITE PAIN (left arm about 2 to 3 inches from the injection site a sore has opened up and clear liquid is coming out) had not 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 treatment information was reported. Reporter did not allow further contact

Other Meds: PHENYTOIN; ADVIL 12 HOUR; PANTOPRAZOLE; VITAMIN D 2000; ESCITALOPRAM; LOVASTATIN

Current Illness: Pain; Paralyzed (Left side of their body is paralyzed.); Seizures

ID: 1695374
Sex: F
Age: 28
State: TX

Vax Date: 08/21/2021
Onset Date: 08/21/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Lethargic; Headache; fatigue; Coughing; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), COUGH (Coughing), HEADACHE (Headache), FATIGUE (fatigue) and MYALGIA (sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced MYALGIA (sore arm). On 25-Aug-2021, the patient experienced COUGH (Coughing). On 26-Aug-2021, the patient experienced LETHARGY (Lethargic), HEADACHE (Headache) and FATIGUE (fatigue). In August 2021, MYALGIA (sore arm) had resolved. At the time of the report, LETHARGY (Lethargic), COUGH (Coughing), HEADACHE (Headache) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1695375
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received 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 HEADACHE (Slight headache). At the time of the report, HEADACHE (Slight headache) outcome was unknown. No Concomitant medication information was reported. No treatment medications were provided. This case was linked to MOD-2021-301391, MOD-2021-301391 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1695376
Sex: F
Age: 68
State: GA

Vax Date: 01/22/2021
Onset Date: 04/01/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data: Test Name: Allergy testing; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: Biopsy; Result Unstructured Data: Biopsy which found non specific eczema; Test Name: Blood pressure; Result Unstructured Data: Normal; Test Name: Blood test; Test Result: Negative ; Result Unstructured Data: Negative for blood clots; Test Name: Body temperature; Result Unstructured Data: Normal; Test Name: Heart rate; Result Unstructured Data: Normal; Test Name: Respiratory rate; Result Unstructured Data: normal

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Because of itching symptoms, I was bruised (black & blue)/Black and blue marks because she scratched it; Hypersensitivity reaction; Adverse allergic reaction of a rash on both arms, abdomen, chest and lower back that lasted almost 2 months/Generalized rash; Non specific eczema; Itchy/Constant itching; Hives-like, pink, raw bumps on abdomen, both arms, lower back/ Itchy bumps on both arms, chest, abdomen, lower back/ Itchy/ Constant itching; Redness generalised; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Adverse allergic reaction of a rash on both arms, abdomen, chest and lower back that lasted almost 2 months), SKIN DISCOLOURATION (Black and blue marks because she scratched it), ECZEMA (Non specific eczema), URTICARIA (Hives-like, pink, raw bumps on abdomen, both arms, lower back/ Itchy bumps on both arms, chest, abdomen, lower back/ Itchy/ Constant itching) and ERYTHEMA (Redness generalised) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Factor V Leiden mutation (lowest level of Factor 5 Leiden blood disorder) since 2002, Blood pressure high since 2000 and Anxiety since 2013. Concomitant products included SERTRALINE for Anxiety, HYDROCHLOROTHIAZIDE, VALSARTAN (DIOVAN HCT) from 2000 to an unknown date for Blood pressure high, ACETYLSALICYLIC ACID (ASPRIN) for Factor V Leiden mutation, METFORMIN for Prediabetes. On 22-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced URTICARIA (Hives-like, pink, raw bumps on abdomen, both arms, lower back/ Itchy bumps on both arms, chest, abdomen, lower back/ Itchy/ Constant itching) and ERYTHEMA (Redness generalised). In April 2021, the patient experienced DERMATITIS ALLERGIC (Adverse allergic reaction of a rash on both arms, abdomen, chest and lower back that lasted almost 2 months), SKIN DISCOLOURATION (Black and blue marks because she scratched it) and ECZEMA (Non specific eczema). On an unknown date, the patient experienced CONTUSION (Bruised (balck and blue)). The patient was treated with TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency; CAMPHOR, MENTHOL (SARNA [CAMPHOR;MENTHOL]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (CALADRYL [DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency. On 30-Jun-2021 at 5:00 PM, URTICARIA (Hives-like, pink, raw bumps on abdomen, both arms, lower back/ Itchy bumps on both arms, chest, abdomen, lower back/ Itchy/ Constant itching) and ERYTHEMA (Redness generalised) had resolved. At the time of the report, DERMATITIS ALLERGIC (Adverse allergic reaction of a rash on both arms, abdomen, chest and lower back that lasted almost 2 months), SKIN DISCOLOURATION (Black and blue marks because she scratched it) and ECZEMA (Non specific eczema) had resolved and CONTUSION (Bruised (balck and blue)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: negative (Negative) Negative. On an unknown date, Biopsy: abnormal (abnormal) Biopsy which found non specific eczema. On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Blood test: negative (Negative) Negative for blood clots. On an unknown date, Body temperature: normal (normal) Normal. On an unknown date, Heart rate: normal (normal) Normal. On an unknown date, Respiratory rate: normal (normal) normal. Patient reported treatment medication as different sprays and creams, Oatmeal baths. The patient had 2 weeks of steroids, 2 injections, Equate 1 percent Hydrocortisone spray. The patient scrubbed vinegar to the infected areas and had oatmeal baths and it went away. The patient visited two dermatologists, one allergist, hemotogist for bruising and herbal/ acupuncture specialist for 2 months. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received contains significant information- patient information, history, lab data, concomitant medications and events were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.

Other Meds: ASPRIN; METFORMIN; SERTRALINE; DIOVAN HCT

Current Illness: Anxiety; Blood pressure high; Factor V Leiden mutation (lowest level of Factor 5 Leiden blood disorder)

ID: 1695377
Sex: F
Age: 35
State: PA

Vax Date: 08/30/2021
Onset Date: 08/30/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information was reported by reporter. Crosslinked to MOD21-137073

Other Meds:

Current Illness:

ID: 1695378
Sex: F
Age: 48
State: PA

Vax Date: 08/30/2021
Onset Date: 08/30/2021
Rec V Date: 09/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: received expired doses today 30Aug2021, The use-by date was 27Aug2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses today 30Aug2021, The use-by date was 27Aug2021) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses today 30Aug2021, The use-by date was 27Aug2021). On 30-Aug-2021, EXPIRED PRODUCT ADMINISTERED (received expired doses today 30Aug2021, The use-by date was 27Aug2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am