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: 1766984
Sex: F
Age: 55
State: NC

Vax Date: 02/08/2021
Onset Date: 09/14/2021
Rec V Date: 10/07/2021
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: She received and the third gave her energy.; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (She received and the third gave her energy.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 013L20A and 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetic, Blood pressure high and Thyroid disorder. Concomitant products included OLMESARTAN MEDOXOMIL for Blood pressure high, METFORMIN for Diabetes, LEVOTHYROXINE for Thyroid disorder. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She received and the third gave her energy.). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (She received and the third gave her energy.) outcome was unknown. No treatment medication was reported. This case was linked to MOD-2021-335075 (Patient Link).

Other Meds: METFORMIN; LEVOTHYROXINE; OLMESARTAN MEDOXOMIL

Current Illness: Blood pressure high; Diabetic; Thyroid disorder

ID: 1766985
Sex: F
Age: 67
State: FL

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: slight soreness in the left arm; tired; really strong chemical state in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (really strong chemical state in the mouth), PAIN IN EXTREMITY (slight soreness in the left arm) and FATIGUE (tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (really strong chemical state in the mouth). On an unknown date, the patient experienced PAIN IN EXTREMITY (slight soreness in the left arm) and FATIGUE (tired). The patient was treated with MACROGOL 3350 (MIRALAX) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (really strong chemical state in the mouth), PAIN IN EXTREMITY (slight soreness in the left arm) and FATIGUE (tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was taking other unknown medication. 2 to 3 minutes after receiving the first dose, the patient had the reaction. MiraLax made her nauseous because of the polyethylene glycol.

Other Meds:

Current Illness:

ID: 1766986
Sex: F
Age:
State: CT

Vax Date: 09/24/2021
Onset Date: 09/25/2021
Rec V Date: 10/07/2021
Hospital: Y

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: severe allergic reaction; Sunday morning she got hives / hives broke out on hands / went to face / went to lips/ Reaction got worse; muscle aches// Reaction got worse; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (severe allergic reaction), URTICARIA (Sunday morning she got hives / hives broke out on hands / went to face / went to lips/ Reaction got worse) and MYALGIA (muscle aches// Reaction got worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F2114) for COVID-19 vaccination. The patient's past medical history included Asthma. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), PREDNISONE and EPINEPHRINE (EPIPEN) for an unknown indication. On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced ALLERGY TO VACCINE (severe allergic reaction) (seriousness criterion hospitalization), URTICARIA (Sunday morning she got hives / hives broke out on hands / went to face / went to lips/ Reaction got worse) (seriousness criterion hospitalization) and MYALGIA (muscle aches// Reaction got worse) (seriousness criterion hospitalization). The patient was hospitalized on 26-Sep-2021 due to ALLERGY TO VACCINE, MYALGIA and URTICARIA. The patient was treated with EPINEPHRINE (EPIPEN) on 26-Sep-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (severe allergic reaction), URTICARIA (Sunday morning she got hives / hives broke out on hands / went to face / went to lips/ Reaction got worse) and MYALGIA (muscle aches// Reaction got worse) 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 called and stated that she had the first vaccine this past Friday, she states that she had a severe allergic reaction. She stated that she was in the hospital on Sunday since the reaction got worse and was given the EpiPen on Sunday. Reaction started Saturday. She said this happened right after the first vaccine. Saturday morning she got hives, then the hives broke out on her hands and went to her face and lips she had muscle aches. Since the onset she still has these adverse events. The hospital thought that this could have been an allergy to nuts but it was not. She states the hospital thinks it is from the vaccination. Company comment: This case concerns a female patient of unknown age with history of asthma, who experienced the unexpected serious events of Allergy to vaccine, Urticaria, and Myalgia. The events occurred one day after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Hospitalization based on reference to being in the hospital, although not specifically stated that hospital admission occurred.; Sender's Comments: This case concerns a female patient of unknown age with history of asthma, who experienced the unexpected serious events of Allergy to vaccine, Urticaria, and Myalgia. The events occurred one day after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Hospitalization based on reference to being in the hospital, although not specifically stated that hospital admission occurred.

Other Meds: BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; PREDNISONE; EPIPEN

Current Illness:

ID: 1766987
Sex: F
Age: 62
State: MI

Vax Date: 06/25/2021
Onset Date: 06/25/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: No recollection of what had happened during the past 12 hours; 2nd dose 6 weeks after the first dose; Fever; Fatigue; Achy symptoms; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (No recollection of what had happened during the past 12 hours), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 6 weeks after the first dose), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Achy symptoms) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in October 2020, Clot blood (Patient was hospitalized for 7 days (discharged on 02Nov2021) because of a blood clot in the lung.) from October 2020 to November 2020 and Weight loss. Concurrent medical conditions included Neurological disorder NOS (neurological ones, as she said COVID affected her spine and has problems with coordination.). On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced MEMORY IMPAIRMENT (No recollection of what had happened during the past 12 hours), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 6 weeks after the first dose), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Achy symptoms). On 25-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 6 weeks after the first dose) had resolved. At the time of the report, MEMORY IMPAIRMENT (No recollection of what had happened during the past 12 hours) had resolved and PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Achy symptoms) outcome was unknown. No concomitant medication was reported. No treatment medication was reported. The patient had no recollection of what had happened during the past 12 hours what day it was and had to call her daughter. It took a couple days to clear it all out. This case was linked to MOD-2021-335144 (Patient Link).

Other Meds:

Current Illness:

ID: 1766988
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Test Name: stimulation test; Result Unstructured Data: Stimulation test was performed. The adrenal response was markedly abnormal.; Test Name: adrenocorticotropic hormone (ACTH); Result Unstructured Data: Baseline adrenocorticotropic hormone (ACTH) was also low at 1.9 pg/mL (reference range, 7.2-63.3 pg/mL) which confirmed secondary adrenal insufficiency.; Test Name: cortisol; Result Unstructured Data: Both random and morning cortisol levels were below detectable limits (<1.0 ug/dL).; Test Name: cortisol; Result Unstructured Data: The baseline cortisol level of <1.0 ug/dL increased to 2.4 ug/dL at 30 minutes and to 3.0 ug/dL at 60 minutes (normal response is > 18 ug/dL at either time point).; Test Name: hormonal workup; Result Unstructured Data: follicle-stimulating hormone(FSH) of 3.3 mIU/mL (reference range, 1.5-12.4 mIU/mL); Test Name: luteinising hormone; Result Unstructured Data: luteinizing hormone (LH) of 1.9 mIU/mL (reference range, 1.7-8.6 mIU/mL),; Test Name: blood pressure; Result Unstructured Data: The blood pressure 114/78 mm/Hg; Test Name: prolactin level; Result Unstructured Data: hormonal workup revealed a prolactin level of 12.9 ng/mL (reference range, 4.0-15.2 ng/mL); Test Name: Laboratory evaluation; Result Unstructured Data: Serum sodium level of 116 mmol/L (reference range, 135-145 mmol/L).; Test Name: Testosterone; Result Unstructured Data: 8 a.m. testosterone level of 108 ng/dL (reference range, 193-740 ng/dL); Test Name: Testosterone; Result Unstructured Data: Plasma testosterone level normalized without testosterone replacement therapy; Test Name: Thyroid function tests; Result Unstructured Data: The thyroid-stimulating hormone (TSH) was 0.13 uIU/mL (reference range, 0.40-4.50 uIU/mL) and free thyroxine (free T4) level was 0.4 ng/dL (reference range, 0.8-1.8 ng/dL), consistent with central hypothyroidism; Test Name: thyroid stimulating hormone; Result Unstructured Data: The thyroid-stimulating hormone (TSH) was 0.13 uIU/mL (reference range, 0.40- 4.50 uIU/mL); Test Name: computed tomography; Result Unstructured Data: As hormonal workup was consistent with secondary adrenal insufficiency, central hypothyroidism, and central hypogonadism, computed tomography (CT) of the brain was obtained. This showed eccentric 10 x 15 x 9 mm enlargement of the pituitary gland which was new compared with previous images from 2011.; Test Name: Free thyroxine index; Result Unstructured Data: free thyroxine (free T4) level was 0.4 ng/dL (reference range, 0.8-1.8 ng/dL), consistent with central hypothyroidism; Test Name: Complete blood count; Result Unstructured Data: normal; Test Name: the pulse; Result Unstructured Data: The pulse was 68 beats per minute; Test Name: Liver function; Result Unstructured Data: normal; Test Name: magnetic resonance imaging; Result Unstructured Data: Dedicated pituitary protocol magnetic resonance imaging (MRI) showed asymmetric enlargement of the pituitary gland with a larger more globular component on the right. The total gland measured 1.2 cm AP by 1.8 cm transverse by 0.8 c

Allergies:

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

Symptoms: hypophysitis; worsening nausea; vomiting; Headache; Malaise; Arthralgia; acute pan hypopituitarism; abdominal pain; This literature-non-study case was reported in a literature article and describes the occurrence of HYPOPHYSITIS (hypophysitis), NAUSEA (worsening nausea), VOMITING (vomiting), HEADACHE (Headache), MALAISE (Malaise), ARTHRALGIA (Arthralgia), HYPOPITUITARISM (acute pan hypopituitarism) and ABDOMINAL PAIN (abdominal pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOPHYSITIS (hypophysitis) (seriousness criterion hospitalization), NAUSEA (worsening nausea) (seriousness criterion hospitalization), VOMITING (vomiting) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), MALAISE (Malaise) (seriousness criterion hospitalization), ARTHRALGIA (Arthralgia) (seriousness criterion hospitalization), HYPOPITUITARISM (acute pan hypopituitarism) (seriousness criterion hospitalization) and ABDOMINAL PAIN (abdominal pain) (seriousness criterion hospitalization). The patient was treated with DEXAMETHASONE (intravenous) for Adverse event, at a dose of 4 milligram; COSYNTROPIN for Adverse event, at a dose of 250 microgram; PREDNISONE for Adverse event, at an unspecified dose and frequency and LEVOTHYROXINE for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOPHYSITIS (hypophysitis), NAUSEA (worsening nausea), VOMITING (vomiting), HEADACHE (Headache), MALAISE (Malaise), ARTHRALGIA (Arthralgia), HYPOPITUITARISM (acute pan hypopituitarism) and ABDOMINAL PAIN (abdominal pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, ACTH stimulation test: abnormal (abnormal) Stimulation test was performed. The adrenal response was markedly abnormal.. On an unknown date, Blood corticotrophin (7.2 pg/ml-63.3 pg/ml): 1.9 pg/ml (Low) Baseline adrenocorticotropic hormone (ACTH) was also low at 1.9 pg/mL (reference range, 7.2-63.3 pg/mL) which confirmed secondary adrenal insufficiency.. On an unknown date, Blood cortisol: <1.0 ug/dl Both random and morning cortisol levels were below detectable limits (<1.0 ug/dL). and abnormal (abnormal) The baseline cortisol level of <1.0 ug/dL increased to 2.4 ug/dL at 30 minutes and to 3.0 ug/dL at 60 minutes (normal response is > 18 ug/dL at either time point).. On an unknown date, Blood follicle stimulating hormone (1.5 miu/ml-12.4 miu/ml): 3.3 miu/ml (normal) follicle-stimulating hormone(FSH) of 3.3 mIU/mL (reference range, 1.5-12.4 mIU/mL). On an unknown date, Blood luteinising hormone (1.7 miu/ml-8.6 miu/ml): 1.9 miu/ml (normal) luteinizing hormone (LH) of 1.9 mIU/mL (reference range, 1.7-8.6 mIU/mL). On an unknown date, Blood pressure measurement: 114/78 mm/hg The blood pressure 114/78 mm/Hg. On an unknown date, Blood prolactin (4.0 ng/ml-15.2 ng/ml): 12.9 ng/ml (normal) hormonal workup revealed a prolactin level of 12.9 ng/mL (reference range, 4.0-15.2 ng/mL). On an unknown date, Blood sodium (135 mmol/l-145 mmol/l): 116 mmol/l (Low) Serum sodium level of 116 mmol/L (reference range, 135-145 mmol/L).. On an unknown date, Blood testosterone (193 ng/dl-740 ng/dl): 108 ng/dl (Low) 8 a.m. testosterone level of 108 ng/dL (reference range, 193-740 ng/dL) and normalized (normal) Plasma testosterone level normalized without testosterone replacement therapy. On an unknown date, Blood thyroid stimulating hormone (0.40 uiu/ml-4.50 uiu/ml): 0.13 uiu/ml (Low) The thyroid-stimulating hormone (TSH) was 0.13 uIU/mL (reference range, 0.40-4.50 uIU/mL) and free thyroxine (free T4) level was 0.4 ng/dL (reference range, 0.8-1.8 ng/dL), consistent with central hypothyroidism and 0.13 uiu/ml (Low) The thyroid-stimulating hormone (TSH) was 0.13 uIU/mL (reference range, 0.40- 4.50 uIU/mL). On an unknown date, Computerised tomogram head: abnormal As hormonal workup was consistent with secondary adrenal insufficiency, central hypothyroidism, and central hypogonadism, computed tomography (CT) of the brain was obtained. This showed eccentric 10 x 15 x 9 mm enlargement of the pituitary gland which was new compared with previous images from 2011.. On an unknown date, Free thyroxine index (0.8 ng/dl-1.8 ng/dl): 0.4 ng/dl (Low) free thyroxine (free T4) level was 0.4 ng/dL (reference range, 0.8-1.8 ng/dL), consistent with central hypothyroidism. On an unknown date, Full blood count: normal (normal) normal. On an unknown date, Heart rate: 68 beats per minute The pulse was 68 beats per minute. On an unknown date, Liver function test: normal (normal) normal. On an unknown date, Magnetic resonance imaging: abnormal Dedicated pituitary protocol magnetic resonance imaging (MRI) showed asymmetric enlargement of the pituitary gland with a larger more globular component on the right. The total gland measured 1.2 cm AP by 1.8 cm transverse by 0.8 cm craniocaudal, and there was thickening of the pituitary stalk, findings seen with hypophysitis. and diminished enlargement and empty sella After 1 month, follow-up magnetic resonance imaging (MRI) of the pituitary revealed markedly diminished enlargement of the gland with a mostly empty sella.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPOPHYSITIS (hypophysitis), NAUSEA (worsening nausea), VOMITING (vomiting), HEADACHE (Headache), MALAISE (Malaise), ARTHRALGIA (Arthralgia), HYPOPITUITARISM (acute pan hypopituitarism) and ABDOMINAL PAIN (abdominal pain) to be possibly related. Patient received his first dose of the Moderna Covid-19 vaccine. Three days later, he noted the onset of nausea, malaise, and arthralgias. He used nonprescription non-steroidal anti-inflammatory drugs with minimal relief. Despite this, patient received his second dose of Moderna vaccine 28 days later. Two days following this, he began having worsening nausea, vomiting, and mid-epigastric abdominal pain prompting him to present to the emergency department.. Treatment was initiated with high-dose steroids and thyroid hormone replacement. Over the next 2 days, his blood sodium level normalized and symptoms resolved. He was discharged on prednisone and levothyroxine. This case concerns a 51-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of hypophysitis, acute pan hypopituitarism, abdominal pain, nausea, vomiting, headache, malaise and arthralgia. The events occurred 2 days after receiving the second dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the events reported were only after the second dose. The reporter assessed the event as related to the product. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. This case was linked to MOD-2021-334910 (Patient Link).; Sender's Comments: This case concerns a 51-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of hypophysitis, acute pan hypopituitarism, abdominal pain, nausea, vomiting, headache, malaise and arthralgia. The events occurred 2 days after receiving the second dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the events reported were only after the second dose. The reporter assessed the event as related to the product. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.

Other Meds:

Current Illness:

ID: 1766989
Sex: F
Age: 82
State: PA

Vax Date: 02/13/2021
Onset Date:
Rec V Date: 10/07/2021
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: Upset stomach; Cannot lift her arms/cannot bend fingers; Difficulty walking; Severe sweating; Diarrhea; Greatest pain on right side; Excruciating pain in shoulder/excruciating pain in hands, through knees/pain in all joints, fingers; All joints in pain; Chills; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), MOBILITY DECREASED (Cannot lift her arms/cannot bend fingers), GAIT DISTURBANCE (Difficulty walking), HYPERHIDROSIS (Severe sweating) and DIARRHOEA (Diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0173NA, 040A21A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Colectomy. Concurrent medical conditions included Immunocompromised. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), MOBILITY DECREASED (Cannot lift her arms/cannot bend fingers), GAIT DISTURBANCE (Difficulty walking), HYPERHIDROSIS (Severe sweating), DIARRHOEA (Diarrhea), PAIN (Greatest pain on right side), MYALGIA (Excruciating pain in shoulder/excruciating pain in hands, through knees/pain in all joints, fingers), ARTHRALGIA (All joints in pain) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MAGNESIUM SALICYLATE at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), MOBILITY DECREASED (Cannot lift her arms/cannot bend fingers), GAIT DISTURBANCE (Difficulty walking), HYPERHIDROSIS (Severe sweating), DIARRHOEA (Diarrhea), PAIN (Greatest pain on right side), MYALGIA (Excruciating pain in shoulder/excruciating pain in hands, through knees/pain in all joints, fingers), ARTHRALGIA (All joints in pain) and CHILLS (Chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient is on no concomitant medications, but she takes a lot of vitamins.

Other Meds:

Current Illness: Immunocompromised

ID: 1766990
Sex: U
Age: 74
State: CO

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 10/07/2021
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: Felt a little achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt a little achy) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. Concurrent medical conditions included Allergic to cats. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Felt a little achy). At the time of the report, PAIN (Felt a little achy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. This case was linked to MOD-2021-335365.

Other Meds:

Current Illness: Allergic to cats

ID: 1766991
Sex: F
Age: 59
State: WA

Vax Date: 02/04/2021
Onset Date: 07/27/2021
Rec V Date: 10/07/2021
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: 20210727; Test Name: potassium; Result Unstructured Data: low; Test Date: 202104; Test Name: blood test; Test Result: Positive ; Result Unstructured Data: positive for anti-double strand DNA antibodies; Test Name: M Spike; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: immunocompromised; remember things can't remember much of next 2 weeks; it affects ability to concentrate and remember things; Potassium low; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (immunocompromised), MEMORY IMPAIRMENT (remember things can't remember much of next 2 weeks), DISTURBANCE IN ATTENTION (it affects ability to concentrate and remember things) and BLOOD POTASSIUM DECREASED (Potassium low) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 032M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced BLOOD POTASSIUM DECREASED (Potassium low). On an unknown date, the patient experienced IMMUNODEFICIENCY (immunocompromised), MEMORY IMPAIRMENT (remember things can't remember much of next 2 weeks) and DISTURBANCE IN ATTENTION (it affects ability to concentrate and remember things). At the time of the report, IMMUNODEFICIENCY (immunocompromised), MEMORY IMPAIRMENT (remember things can't remember much of next 2 weeks), DISTURBANCE IN ATTENTION (it affects ability to concentrate and remember things) and BLOOD POTASSIUM DECREASED (Potassium low) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: positive for anti-double strand dna antibodies (Positive) positive for anti-double strand DNA antibodies. On 27-Jul-2021, Blood potassium: low (Low) low. On an unknown date, Monoclonal immunoglobulin present: positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications information was not reported. Treatment information was not provided. The patient did many blood tests, the first one after a month of getting second dose, it showed that patient had anti-nuclear antibodies. The second test was positive for anti-double strand DNA antibodies, while the third test was positive for M Spike. Patient went to the ER on 27Jul2021 for low potassium levels. Patient stated to be immunocompromised; Sender's Comments: This case concerns a 59 year-old female patient with no reported medical history, who experienced the unexpected non-serious event of Immunodeficiency. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Manual override done to remove seriousness criteria of Medically significant from event Immunodeficiency based on medical judgement and review of source document that did not include information supporting seriousness criteria.

Other Meds:

Current Illness:

ID: 1766992
Sex: U
Age:
State: MN

Vax Date: 09/24/2021
Onset Date: 09/24/2021
Rec V Date: 10/07/2021
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: three doses were administered to three patients after manufacturer date of expiry; 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 (three doses were administered to three patients after manufacturer date of expiry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (three doses were administered to three patients after manufacturer date of expiry). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (three doses were administered to three patients after manufacturer date of expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant drug was not reported. Treatment medication was not reported. On 08-Sep-2021, The vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions. Three patients were administered expired Moderna covid-19 vaccine (Manufacturer Expiration Date: 18-Sep-2021)

Other Meds:

Current Illness:

ID: 1766993
Sex: M
Age: 20
State: IN

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 10/07/2021
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: sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right arm) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. Concomitant products included HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HCL), CETIRIZINE, FENOFIBRATE, ARIPIPRAZOLE (ABILIFY) and MONTELUKAST for an unknown indication. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore right arm). At the time of the report, VACCINATION SITE PAIN (sore right arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No treatment medication was provided. This case was linked to MOD-2021-335251.

Other Meds: HYDROXYZINE HCL; CETIRIZINE; FENOFIBRATE; ABILIFY; MONTELUKAST

Current Illness:

ID: 1766994
Sex: F
Age: 36
State: TX

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/07/2021
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: Patient is pregnant and got the first dose of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Apr-2022. On 27-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. On 27-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. ? No treatment information was provided.; Sender's Comments: This report concerns a 36 year old female subject with no relevant medical history, who experienced the unexpected event of vaccine exposure during pregnancy. The patient received the first dose of vaccine at unknown weeks of gestation. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1766995
Sex: F
Age: 42
State: MO

Vax Date: 09/23/2021
Onset Date: 09/23/2021
Rec V Date: 10/07/2021
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: Expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided by the reporter. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1766996
Sex: U
Age: 20
State: IN

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 10/07/2021
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: cough; sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and VACCINATION SITE PAIN (sore right injection site arm) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history of patient was reported by the reporter. Concomitant products included HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HCL), CETIRIZINE, FENOFIBRATE, ARIPIPRAZOLE (ABILIFY) and MONTELUKAST for an unknown indication. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (cough) and VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, COUGH (cough) and VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown. No treatment drugs were reported . This case was linked to MOD-2021-335227 (Patient Link).

Other Meds: Hydroxyzine HCL; Cetirizine; Fenofibrate; Abilify; Montelukast

Current Illness:

ID: 1766997
Sex: M
Age: 64
State: PA

Vax Date: 12/25/2020
Onset Date: 08/01/2021
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Test Date: 202108; Test Name: cat scan; Result Unstructured Data: saw A-Fib.

Allergies:

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

Symptoms: Diverticulitis; A-Fib/ heart rhythm problem; This spontaneous case was reported by a nurse and describes the occurrence of DIVERTICULITIS (Diverticulitis) and ATRIAL FIBRILLATION (A-Fib/ heart rhythm problem) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised (not severely). On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criteria hospitalization and medically significant) and ATRIAL FIBRILLATION (A-Fib/ heart rhythm problem) (seriousness criteria hospitalization and medically significant). The patient was treated with DILTIAZEM (CARDIZEM [DILTIAZEM]) for Atrial fibrillation, at an unspecified dose and frequency; APIXABAN (ELIQUIS) for Atrial fibrillation, at an unspecified dose and frequency; METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) (intravenous) for Diverticulitis, at an unspecified dose and frequency; CEFTRIAXONE SODIUM (ROCEPHIN) (intravenous) for Diverticulitis, at an unspecified dose and frequency and AMOXICILLIN SODIUM, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANIC ACID]) (intravenous) for Diverticulitis, at an unspecified dose and frequency. At the time of the report, DIVERTICULITIS (Diverticulitis) and ATRIAL FIBRILLATION (A-Fib/ heart rhythm problem) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Computerised tomogram: abnormal (abnormal) saw A-Fib. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. Patient had some more tests done at hospital and the results were not provided. Company Comment: This case concerns a 64-year-old male patient with medical history of immunocompromise, who experienced the unexpected and serious events of diverticulitis and atrial fibrillation. Time to onset from vaccination was not reported. The rechallenge was unknown, as the patient reports that he might get a third dose. The medical history of immunocompromise remains as a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 64-year-old male patient with medical history of immunocompromise, who experienced the unexpected and serious events of diverticulitis and atrial fibrillation. Time to onset from vaccination was not reported. The rechallenge was unknown, as the patient reports that he might get a third dose. The medical history of immunocompromise remains as a confounder. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness: Immunocompromised (not severely)

ID: 1766998
Sex: M
Age: 82
State: AZ

Vax Date: 09/03/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of lip swelling (swollen lips) and chapped lips (thought it was just chapped lips but it keeps getting worse and worse) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Sep 3, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In September 2021, patient experienced lip swelling (swollen lips) and chapped lips (thought it was just chapped lips but it keeps getting worse and worse). At the time of the report, lip swelling (swollen lips) and chapped lips (thought it was just chapped lips but it keeps getting worse and worse): not resolved. Concomitant medications not provided by reporter. Patient received an antibiotic, which was not helping yet.

Other Meds:

Current Illness:

ID: 1766999
Sex: M
Age: 59
State: WA

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/07/2021
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: chronic hives/full of hives; some aches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (chronic hives/full of hives) and MYALGIA (some aches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. Concurrent medical conditions included Egg allergy (because he ate a lot of eggs). On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced MYALGIA (some aches). On an unknown date, the patient experienced URTICARIA (chronic hives/full of hives). At the time of the report, URTICARIA (chronic hives/full of hives) and MYALGIA (some aches) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. This case was linked to MOD-2021-335299 (Patient Link).

Other Meds:

Current Illness: Egg allergy (because he ate a lot of eggs)

ID: 1767000
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Did not get good response to 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not get good response to 2 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Did not get good response to 2 doses). At the time of the report, VACCINATION COMPLICATION (Did not get good response to 2 doses) 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 provided. This case was linked to MOD-2021-335300 (Patient Link).

Other Meds:

Current Illness:

ID: 1767001
Sex: F
Age: 62
State: CA

Vax Date: 09/25/2021
Onset Date: 09/27/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: dizzy / light dizziness / light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy / light dizziness / light headed) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A1) for COVID-19 vaccination. Concomitant products included LISINOPRIL for Blood pressure high. On 25-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced DIZZINESS (dizzy / light dizziness / light headed). At the time of the report, DIZZINESS (dizzy / light dizziness / light headed) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication was provided.

Other Meds: LISINOPRIL

Current Illness:

ID: 1767002
Sex: M
Age: 59
State: WA

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 10/07/2021
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: chronic hives/ he is still full of hives; some aches (second dose); little loopy for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (chronic hives/ he is still full of hives), MYALGIA (some aches (second dose)) and FATIGUE (little loopy for 12 hours) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 026B21A) for COVID-19 vaccination. Concurrent medical conditions included Egg allergy and Hives. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (chronic hives/ he is still full of hives), MYALGIA (some aches (second dose)) and FATIGUE (little loopy for 12 hours). At the time of the report, URTICARIA (chronic hives/ he is still full of hives), MYALGIA (some aches (second dose)) and FATIGUE (little loopy for 12 hours) outcome was unknown. No Concomitant medications were provided. No treatment medications were provided. It was reported that consumer called to report a chronic hives situation. Consumer works in the forest, so he was subjected to nettles. He thought the hives had to do with nettles, because he runs every day in the forest, and it looked like mosquito bites. Now, he said the nettle season was over, and he was still full of hives. He also thought he might have an egg allergy because he eats a lot of eggs. This case was linked to MOD-2021-335282 (Patient Link).

Other Meds:

Current Illness: Egg allergy; Hives

ID: 1767003
Sex: U
Age:
State: CA

Vax Date: 08/20/2021
Onset Date:
Rec V Date: 10/07/2021
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: Did not get good response to 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not get good response to 2 doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised and Rheumatoid arthritis. On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 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 VACCINATION COMPLICATION (Did not get good response to 2 doses). At the time of the report, VACCINATION COMPLICATION (Did not get good response to 2 doses) outcome was unknown. Patient was on a medication for rheumatoid arthritis. No treatment information was provided. This case was linked to MOD-2021-335290 (Patient Link).

Other Meds:

Current Illness: Immunocompromised; Rheumatoid arthritis

ID: 1767004
Sex: M
Age:
State: FL

Vax Date: 09/24/2021
Onset Date: 09/24/2021
Rec V Date: 10/07/2021
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: 3rd dose MODERNA, 1st and 2nd dose PFIZER; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose MODERNA, 1st and 2nd dose PFIZER) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) Dose 1 and dose 2. On 24-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose MODERNA, 1st and 2nd dose PFIZER). On 24-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose MODERNA, 1st and 2nd dose PFIZER) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness: Immunocompromised

ID: 1767005
Sex: M
Age: 58
State: MO

Vax Date: 08/01/2021
Onset Date: 09/26/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Bell's Palsy on the right side of his face; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy on the right side of his face) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced BELL'S PALSY (Bell's Palsy on the right side of his face) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy on the right side of his face) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Wife is calling to report that her 58-year-old husband received the first dose of Moderna COVID-19 vaccine on 01AUG2021 in the Right arm (Lot# 091D21A & Exp. Date: Unknown). He had the second Moderna COVID-19 vaccine on 29AUG2021, in the left arm (Lot# 058E21A & Exp. Date: Unknown ). Wife states that on 26SEP2021, He developed Bell's Palsy on the right side of his face (Not confirmed by HCP). Wife states that they have not informed his doctor yet and have not called VAERS. Company comment: This case concerns a 58 year old male with no relevant medical history who experienced Serious expected event of Bell''s palsy approximately a less than a month after receiving the second dose of Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a 58 year old male with no relevant medical history who experienced Serious expected event of Bell''s palsy approximately a less than a month after receiving the second dose of Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.

Other Meds:

Current Illness:

ID: 1767006
Sex: M
Age: 73
State: FL

Vax Date: 08/30/2021
Onset Date: 09/27/2021
Rec V Date: 10/07/2021
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: Expired Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 046A21A) 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) (unknown route) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Dose). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired Dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided Concomitant medication were not provided.

Other Meds:

Current Illness:

ID: 1767007
Sex: M
Age: 33
State: WY

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 10/07/2021
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: Administration of expired dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired 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. No concomitant medication were provided No treatment information was reported Patient is not on any concomitant medication that the HCP is aware of. Patient had no known allergies. Patient was observed for 30 minutes after vaccination and was doing okay.

Other Meds:

Current Illness:

ID: 1767008
Sex: F
Age: 83
State: CO

Vax Date: 08/08/2021
Onset Date: 09/16/2021
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Test Date: 20210916; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Sinuses were running after 2nd shot; Throat was burning after 2nd shot; Sores in the mouth after 2nd shot; White dots in the mouth after 2nd shot; Burning in the mouth 2nd shot/More burning sensation in the mouth upon using Magic Mouthwash after 2nd shot; Tired; Thinks she has Oral Candida Yeast Infection after 2nd dose; GERD; Burning in stomach after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinuses were running after 2nd shot), THROAT IRRITATION (Throat was burning after 2nd shot), STOMATITIS (Sores in the mouth after 2nd shot), COATING IN MOUTH (White dots in the mouth after 2nd shot), ORAL DISCOMFORT (Burning in the mouth 2nd shot/More burning sensation in the mouth upon using Magic Mouthwash after 2nd shot), FATIGUE (Tired), ORAL CANDIDIASIS (Thinks she has Oral Candida Yeast Infection after 2nd dose), GASTROOESOPHAGEAL REFLUX DISEASE (GERD) and DYSPEPSIA (Burning in stomach after 2nd shot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The patient's past medical history included GERD. Concurrent medical conditions included Allergy (Another Doctor (ENT-2) did allergy test in MAY2021 and She has a history of allergies). On 08-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced SINUSITIS (Sinuses were running after 2nd shot) (seriousness criterion hospitalization), THROAT IRRITATION (Throat was burning after 2nd shot) (seriousness criterion hospitalization), STOMATITIS (Sores in the mouth after 2nd shot) (seriousness criterion hospitalization), COATING IN MOUTH (White dots in the mouth after 2nd shot) (seriousness criterion hospitalization), ORAL DISCOMFORT (Burning in the mouth 2nd shot/More burning sensation in the mouth upon using Magic Mouthwash after 2nd shot) (seriousness criterion hospitalization), FATIGUE (Tired) (seriousness criterion hospitalization), ORAL CANDIDIASIS (Thinks she has Oral Candida Yeast Infection after 2nd dose) (seriousness criterion hospitalization), GASTROOESOPHAGEAL REFLUX DISEASE (GERD) (seriousness criterion hospitalization) and DYSPEPSIA (Burning in stomach after 2nd shot) (seriousness criterion hospitalization). The patient was treated with FLUTICASONE at a dose of UNK dosage form, qd; IPRATROPIUM at a dose of UNK dosage form, qd; AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at a dose of 865 Tab; AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at a dose of 125 Tab and PANTOPRAZOLE at a dose of UNK dosage form. At the time of the report, SINUSITIS (Sinuses were running after 2nd shot), THROAT IRRITATION (Throat was burning after 2nd shot), STOMATITIS (Sores in the mouth after 2nd shot), COATING IN MOUTH (White dots in the mouth after 2nd shot), ORAL DISCOMFORT (Burning in the mouth 2nd shot/More burning sensation in the mouth upon using Magic Mouthwash after 2nd shot), FATIGUE (Tired), ORAL CANDIDIASIS (Thinks she has Oral Candida Yeast Infection after 2nd dose), GASTROOESOPHAGEAL REFLUX DISEASE (GERD) and DYSPEPSIA (Burning in stomach after 2nd shot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided Other treatment medication included Magic Mouth wash (Diphenhydramine, Lidocaine, Nystatin) and Sweet Potato on the mouth sores Company comment -This case concerns a 83-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of Sinusitis, throat irritation, stomatitis, coating in mouth, oral discomfort, Fatigue, oral Candidiasis, gastroesophageal reflux disease , and dyspepsia. The events occurred 38 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. elderly age remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. This case was linked to MOD-2021-335425 (Patient Link).; Sender's Comments: This case concerns a 83-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of Sinusitis, throat irritation, stomatitis, coating in mouth, oral discomfort, Fatigue, oral Candidiasis, gastroesophageal reflux disease , and dyspepsia. The events occurred 38 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. elderly age remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness: Allergy (Another Doctor (ENT-2) did allergy test in MAY2021 and She has a history of allergies)

ID: 1767009
Sex: M
Age:
State:

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 10/07/2021
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: Pain in joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in joints) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in joints). At the time of the report, ARTHRALGIA (Pain in joints) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant product use was not provided by the reporter. Treatment information was not provided. It was reported that patient thought it could be occurred due to work out. This case was linked to MOD-2021-337202 (Patient Link).

Other Meds:

Current Illness:

ID: 1767010
Sex: F
Age: 20
State: NY

Vax Date: 09/24/2021
Onset Date: 09/27/2021
Rec V Date: 10/07/2021
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: back pain; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) and PAIN IN EXTREMITY (sore arm) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039d21a) for COVID-19 vaccination. Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN LISPRO (HUMALOG) for an unknown indication, LEVOTHYROXINE. On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced BACK PAIN (back pain) and PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK PAIN (back pain) and PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment heating pad was taken.

Other Meds: HUMALOG; LEVOTHYROXINE

Current Illness: Type 1 diabetes mellitus

ID: 1767011
Sex: M
Age: 66
State: HI

Vax Date: 02/13/2021
Onset Date: 03/12/2021
Rec V Date: 10/07/2021
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: sore left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT PAIN (sore left shoulder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination. Concurrent medical conditions included Cancer. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE JOINT PAIN (sore left shoulder). At the time of the report, VACCINATION SITE JOINT PAIN (sore left shoulder) outcome was unknown. No concomitant drugs are provided and treatment drugs are also not provided by the reporter.; Sender's Comments: This case concerns a 66-year-old male patient with current cancer, who experienced a non-serious unexpected event of vaccination site joint pain. The event occurred on the same day of the second dose of mRNA-1273. The rechallenge is not applicable as patient experienced AEs after second dose and no information about the first dose is available and no additional dosing will be given. The benefit-risk relationship of mRNA-1273, is not affected by this report.

Other Meds:

Current Illness: Cancer

ID: 1767012
Sex: U
Age:
State: CA

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: unknown number of patients had been given doses of an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (unknown number of patients had been given doses of an expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. No Medical History information was reported. In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (unknown number of patients had been given doses of an expired vaccine). In September 2021, EXPIRED PRODUCT ADMINISTERED (unknown number of patients had been given doses of an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up document received contain Email updated

Other Meds:

Current Illness:

ID: 1767013
Sex: F
Age: 28
State: MI

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Moderna COVID-19 vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion). On 01-Sep-2021, PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. It was reported that there was a temperature fluctuation that last for 15 hours (approximate 4:05pm through 6:50am the next morning). The lowest temperature was 32.7 with fluctuations until it was restored to 35 degrees and above at 6:50am). It was also mentioned that when the vial was used, it was in a normal liquid state. The vial was moved from freezer to fridge on 31-Aug-2021 and was only in fridge for a day prior to administration. Because the vaccine did not get down to freezing, reporter did not send the excursion for evaluation. Vaccine was administered intramuscularly in the upper deltoid and reporter was not sure which arm. It was stated that patients did not experience any adverse reactions following administration. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow-up received and does not contain any new information.

Other Meds:

Current Illness:

ID: 1767014
Sex: F
Age: 83
State: CO

Vax Date: 07/11/2021
Onset Date: 07/25/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Sinuses were running after 1st shot; Throat was burning after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinuses were running after 1st shot) and THROAT IRRITATION (Throat was burning after 1st shot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The patient's past medical history included GERD. Concurrent medical conditions included Allergy (Another Doctor (ENT-2) did allergy test in MAY2021 and She has a history of allergies.). On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced SINUSITIS (Sinuses were running after 1st shot) and THROAT IRRITATION (Throat was burning after 1st shot). At the time of the report, SINUSITIS (Sinuses were running after 1st shot) and THROAT IRRITATION (Throat was burning after 1st shot) 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 considered SINUSITIS (Sinuses were running after 1st shot) and THROAT IRRITATION (Throat was burning after 1st shot) to be possibly related. Concomitant medication was not provided. The patient received the first dose of Moderna COVID-19 vaccine on 11Jul2021 (Lot# 048C21A & Exp. Date: unknown) in her right arm. Two weeks later, her sinuses were running and her throat was burning. She visited a doctor, but they did not do any COVID test. Company Comment: This case concerns an 83-year-old, female patient with a medical history of Gastroesophageal reflux disease (GERD), who experienced the unexpected non-serious events of sinusitis and throat irritation. The events occurred 2 weeks after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was positive as the events recurred after admininstration of the second dose of the Moderna COVID-19 Vaccine. The medical history of GERD, which may cause throat irritation, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. This case was linked to MOD-2021-335341 (Patient Link).; Sender's Comments: This case concerns an 83-year-old, female patient with a medical history of Gastroesophageal reflux disease (GERD), who experienced the unexpected non-serious events of sinusitis and throat irritation. The events occurred 2 weeks after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was positive as the events recurred after admininstration of the second dose of the Moderna COVID-19 Vaccine. The medical history of GERD, which may cause throat irritation, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness: Allergy (Another Doctor (ENT-2) did allergy test in MAY2021 and She has a history of allergies.)

ID: 1767015
Sex: F
Age: 70
State: FL

Vax Date: 12/30/2020
Onset Date: 01/28/2021
Rec V Date: 10/07/2021
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: Patch was the size of a softball; Red Patch on right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patch was the size of a softball) and VACCINATION SITE ERYTHEMA (Red Patch on right injection site arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ATORVASTATIN, LEVOTHYROXINE, CALCIUM, VITAMIN B12 [VITAMIN B12 NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced RASH (Patch was the size of a softball) and VACCINATION SITE ERYTHEMA (Red Patch on right injection site arm). At the time of the report, RASH (Patch was the size of a softball) and VACCINATION SITE ERYTHEMA (Red Patch on right injection site arm) outcome was unknown. No treatment information was provided. Patient had no adverse reactions after the first vaccination.; Sender's Comments: This case concerns a 71 years old female patient, with no reported relevant medical history, who experienced the non-serious unexpected event of Rash and the non-serious expected event of Vaccination site erythema. The events occurred the same day after the second dose of Spikevax. The rechallenge was not applicable for the events as no additional dosing will be given. Use of concomitant Atorvastatin remains a confouder to the event of Rash. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report

Other Meds: ATORVASTATIN; LEVOTHYROXINE; CALCIUM; VITAMIN B12 [VITAMIN B12 NOS]; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1767016
Sex: M
Age: 61
State: CA

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 10/07/2021
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: progressively gotten worse; tingling in the same arm; throbbing, painful feeling, it's interrupted by pain, it's a dull pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the same arm), PAIN (throbbing, painful feeling, it's interrupted by pain, it's a dull pain) and CONDITION AGGRAVATED (progressively gotten worse) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. Concurrent medical conditions included HIV disease. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV disease, ATORVASTATIN for an unknown indication. On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PARAESTHESIA (tingling in the same arm) and PAIN (throbbing, painful feeling, it's interrupted by pain, it's a dull pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (progressively gotten worse). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling in the same arm), PAIN (throbbing, painful feeling, it's interrupted by pain, it's a dull pain) and CONDITION AGGRAVATED (progressively gotten worse) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient said that pain had progressively gotten worse. The last week or two he could not find a comfortable position to sleep due to the pain he has been experiencing. His sleep has been getting interrupted by the pain. He says that he is normally a healthy person and he does not participate in any activities that would cause a throbbing pain like this. He says that not having been able to sleep the last couple of weeks is most distressing. The patient was qualified to take third dose of Moderna vaccine. The patient could only point towards the Moderna vaccine for causing this. This case was linked to MOD-2021-335659 (Patient Link).

Other Meds: BIKTARVY; ATORVASTATIN

Current Illness: HIV disease

ID: 1767017
Sex: M
Age: 53
State: TX

Vax Date: 09/25/2021
Onset Date: 09/25/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210926; Test Name: Body temperature; Result Unstructured Data: 100 degree Fahrenheit.

Allergies:

Symptom List: Tremor

Symptoms: Diarrhea; Nauseas; fever over 100?F; Dizziness; No appetite; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), HEADACHE (Headache) and PYREXIA (fever over 100?F) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication. On 25-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced HEADACHE (Headache). On 26-Sep-2021, the patient experienced DIZZINESS (Dizziness), DECREASED APPETITE (No appetite) and PYREXIA (fever over 100?F). On 27-Sep-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nauseas). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 27-Sep-2021, PYREXIA (fever over 100?F) had resolved. At the time of the report, DIZZINESS (Dizziness), DECREASED APPETITE (No appetite) and HEADACHE (Headache) had not resolved and DIARRHOEA (Diarrhea) and NAUSEA (Nauseas) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, Body temperature: 100 (High) 100 degree Fahrenheit.. This case was linked to MOD-2021-335510, MOD-2021-335520 (Patient Link).

Other Meds: LIPITOR; METOPROLOL

Current Illness:

ID: 1767018
Sex: F
Age: 68
State: NY

Vax Date: 01/12/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210619; Test Name: SARS-COV-2 AB IgG; Test Result: Positive ; Result Unstructured Data: Reactive positive for Anti-SARS-COV-2 IgG antibodies; Test Date: 20210909; Test Name: SARS-COV-2 AB IgG; Test Result: Positive ; Result Unstructured Data: Reactive positive for Anti-SARS-COV-2 IgG antibodies; Test Date: 20210619; Test Name: COVID SARS test; Test Result: Negative ; Result Unstructured Data: DDF SARS-COV-2 AB IgG was 8.52 reactive and under normal range it's an arrow going to -1.41 and under units index and sore dry blood spots.; Test Date: 20210909; Test Name: COVID SARS test; Result Unstructured Data: DDF SARSCOV-2 AB IgG was 2.93 reactive and under normal range again it's an arrow going to -1.41 and under units it's index and sore dry blood spots.

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Arm hurt; Couldn't lifted up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and LIMB DISCOMFORT (Couldn't lifted up) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt) and LIMB DISCOMFORT (Couldn't lifted up). At the time of the report, PAIN IN EXTREMITY (Arm hurt) and LIMB DISCOMFORT (Couldn't lifted up) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, SARS-CoV-2 antibody test: positive (Positive) Reactive positive for Anti-SARS-COV-2 IgG antibodies. On 19-Jun-2021, SARS-CoV-2 test: negative (Negative) DDF SARS-COV-2 AB IgG was 8.52 reactive and under normal range it's an arrow going to -1.41 and under units index and sore dry blood spots.. On 09-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) Reactive positive for Anti-SARS-COV-2 IgG antibodies. On 09-Sep-2021, SARS-CoV-2 test: DDF SARSCOV-2 AB IgG was 2.93 reactive and under normal range again it's an arrow going to -1.41 and under units it's index and sore dry blood spots.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were mentioned. No treatment details were reported. This case was linked to MOD-2021-335697 (Patient Link).

Other Meds:

Current Illness:

ID: 1767019
Sex: M
Age: 52
State: TX

Vax Date: 02/27/2021
Onset Date:
Rec V Date: 10/07/2021
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: pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication. On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) had not resolved. Treatment was not specified. This case was linked to MOD-2021-335494, MOD-2021-335494 (Patient Link).

Other Meds: LIPITOR; METOPROLOL

Current Illness:

ID: 1767020
Sex: M
Age: 29
State: MO

Vax Date: 07/20/2021
Onset Date: 09/27/2021
Rec V Date: 10/07/2021
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: Expired dose/Had vaccine that expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant and Treatment medication were reported.

Other Meds:

Current Illness:

ID: 1767021
Sex: F
Age: 74
State: FL

Vax Date: 09/24/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication was reported. No Treatment medication was reported.

Other Meds:

Current Illness:

ID: 1767022
Sex: F
Age: 52
State: MO

Vax Date: 09/23/2021
Onset Date: 09/23/2021
Rec V Date: 10/07/2021
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: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 23-Sep-2021, 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 and treatment medications were reported.

Other Meds:

Current Illness:

ID: 1767023
Sex: F
Age: 30
State: NV

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of emotional distress (started feeling an emotional choked-up feeling that lasted for an hour) and anxiety (she has very bad anxiety) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 039D21A and 93990Y) for COVID-19 immunization. No medical history reported. On Aug 31, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 28, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 28, 2021, patient experienced emotional distress (started feeling an emotional choked-up feeling that lasted for an hour). On an unknown date, patient experienced anxiety (she has very bad anxiety). At the time of the report, emotional distress (started feeling an emotional choked-up feeling that lasted for an hour) and anxiety (she has very bad anxiety) outcome: unknown. Concomitant product use and treatment information not provided.

Other Meds:

Current Illness:

ID: 1767024
Sex: F
Age: 34
State: NC

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: Severe stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe stomach pain) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Severe stomach pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment using Pepto Bismuth was reported and it did nothing. No concomitant medication were provided.; Sender's Comments: This case concerns a 34-year-old female patient with no medical history, who experienced the unexpected event of Abdominal pain upper. The event of Abdominal pain upper occurred on the same day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown. The information regarding the second dose was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1767025
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: vaccinated with a 2 dose series of Pfizer and reported he received an accidental 3rd dose of Moderna COVID-19; accidental, inadvertent administration of a dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (vaccinated with a 2 dose series of Pfizer and reported he received an accidental 3rd dose of Moderna COVID-19) and EXTRA DOSE ADMINISTERED (accidental, inadvertent administration of a dose of Moderna COVID-19 vaccine) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for Flu vaccination. Previously administered products included for COVID-19 vaccination: Pfizer vaccine (Second dose) and Pfizer vaccine (First dose). On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (vaccinated with a 2 dose series of Pfizer and reported he received an accidental 3rd dose of Moderna COVID-19) and EXTRA DOSE ADMINISTERED (accidental, inadvertent administration of a dose of Moderna COVID-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (vaccinated with a 2 dose series of Pfizer and reported he received an accidental 3rd dose of Moderna COVID-19) and EXTRA DOSE ADMINISTERED (accidental, inadvertent administration of a dose of Moderna COVID-19 vaccine) had resolved. Not Provided Patient received an accidental third dose of Moderna COVID-19 vaccine when he was to receive Flu shot from his pharmacy.he pharmacist realized the mistake aer administering the dose and proceeded to administer the Flu vaccine. No concomitant medications were reported. No treatment medications were mentioned.

Other Meds:

Current Illness:

ID: 1767026
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: Chest pain after the 2nd dose of the Moderna Covid Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain after the 2nd dose of the Moderna Covid Vaccine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain after the 2nd dose of the Moderna Covid Vaccine). At the time of the report, CHEST PAIN (Chest pain after the 2nd dose of the Moderna Covid Vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter. This case was linked to (E2B Linked Report).; Sender's Comments: This case concerns a 46-year-old female, with no medical history, who experienced the unexpected event of Chest pain. The event of Chest pain occurred on an unknown day after receiving the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable. No more doses are expected for this patient. The benefit-risk relationship is not affected by this report. Case ID:AE-2021-14813

Other Meds:

Current Illness:

ID: 1767027
Sex: M
Age: 52
State: MO

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/07/2021
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: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 52-year-old male patient who received mRNA-1273 (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved. For mRNA-1273 (Unknown), the reporter did not provide any causality assessments. No Treatment medications were provided No Concomitant medications were provided No prior temperature excursions for the patient

Other Meds:

Current Illness:

ID: 1767028
Sex: F
Age: 69
State: CA

Vax Date: 09/22/2021
Onset Date:
Rec V Date: 10/07/2021
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: received a third dose although she was not immunocompromised; normal side effects; diarrhea; fatigued; nauseas; vomiting; fever; muscle ache; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (fatigued), NAUSEA (nauseas), VOMITING (vomiting) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cancer. Concomitant products included LOSARTAN, Lexopril, bisoprolol/HCTZ and vitamin D. On 22-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), FATIGUE (fatigued), NAUSEA (nauseas), VOMITING (vomiting), PYREXIA (fever), MYALGIA (muscle ache), OFF LABEL USE (received a third dose although she was not immunocompromised) and VACCINATION COMPLICATION (normal side effects). At the time of the report, DIARRHOEA (diarrhea), FATIGUE (fatigued), NAUSEA (nauseas), VOMITING (vomiting), PYREXIA (fever) and MYALGIA (muscle ache) outcome was unknown, OFF LABEL USE (received a third dose although she was not immunocompromised) had resolved and VACCINATION COMPLICATION (normal side effects) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Treatment medications were reported. This case was linked to MOD-2021-335664, MOD-2021-335665 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Significant follow up received at 1-OCT-2021 :Narrative concomitant medications, event updated.

Other Meds: Losartan; Lexopril; Bisoprolol/HCTZ; Vitamin D

Current Illness:

ID: 1767029
Sex: U
Age:
State: MI

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 10/07/2021
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: Encephalitis; Meningitis; This spontaneous case was reported by a consumer and describes the occurrence of ENCEPHALITIS (Encephalitis) and MENINGITIS (Meningitis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication. No Medical History information was reported. In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient received first dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ENCEPHALITIS (Encephalitis) (seriousness criterion medically significant) and MENINGITIS (Meningitis) (seriousness criterion medically significant). At the time of the report, ENCEPHALITIS (Encephalitis) and MENINGITIS (Meningitis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. It was reported that consumer was to confused and could not answer more questions. Company Comment : This case concerns a patient with gender and age unknown with no relevant history reported in this case, who experienced the serious unexpected events of Encephalitis and Meningitis. The events occurred on an unknow date, there is no information reported related the latency with the dose of the Moderna COVID-19 Vaccine. The rechallenge is unknown for the events since no information about the dose sequence is provided. Concomitant medication reported as SHINGRIX (VARICELLA ZOSTER VACCINE RGE (CHO)) reminds as a confounder/co-suspects for the events. The events were considered related to the study drug as per the reporter's assessment with the presence of confounding mentioned factors. The benefit-risk relationship of drug x in not affected by this report.; Sender's Comments: This case concerns a patient with gender and age unknown with no relevant history reported in this case, who experienced the serious unexpected events of Encephalitis and Meningitis. The events occurred on an unknow date, there is no information reported related the latency with the dose of the Moderna COVID-19 Vaccine. The rechallenge is unknown for the events since no information about the dose sequence is provided. Concomitant medication reported as SHINGRIX (VARICELLA ZOSTER VACCINE RGE (CHO)) reminds as a confounder/co-suspects for the events. The events were considered related to the study drug as per the reporter's assessment with the presence of confounding mentioned factors. The benefit-risk relationship of drug x in not affected by this report.

Other Meds:

Current Illness:

ID: 1767030
Sex: F
Age: 86
State: NC

Vax Date: 01/22/2021
Onset Date: 07/01/2021
Rec V Date: 10/07/2021
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: Black, hairy tongue; Nausea; Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), TRICHOGLOSSIA (Black, hairy tongue) and NAUSEA (Nausea) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Stomach discomfort. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced AGEUSIA (Loss of taste). On an unknown date, the patient experienced TRICHOGLOSSIA (Black, hairy tongue) and NAUSEA (Nausea). On 28-Sep-2021, AGEUSIA (Loss of taste) had resolved. At the time of the report, TRICHOGLOSSIA (Black, hairy tongue) had resolved and NAUSEA (Nausea) had not resolved. This case concerns a 86-year-old female patient with no relevant medical history, who experienced the unexpected non-serious events of ageusia and trichoglossia and expected non-serious event of nausea. The events occurred on the 5 months after receiving second dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the event Covid-19 occurred only after second dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. No concomitant medications were reported. Treatment medications included compounded mouth wash which cleared up the hairy tongue and nausea pills.; Sender's Comments: This case concerns a 86-year-old female patient with no relevant medical history, who experienced the unexpected non-serious events of ageusia and trichoglossia and expected non-serious event of nausea. The events occurred on the 5 months after receiving second dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the event Covid-19 occurred only after second dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness: Stomach discomfort

ID: 1767031
Sex: M
Age: 58
State: TX

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 10/07/2021
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 Date: 20210106; Test Name: SARS-CoV-2 test; Test Result: Positive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: body aches; chills; tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19), MYALGIA (body aches) and CHILLS (chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (tested positive for Covid-19). On 04-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (body aches) and CHILLS (chills). On 05-Feb-2021, MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: positive Positive. No concomitant medication information was provided. No treatment medication information was provided. This case was linked to MOD-2021-012786 (Patient Link).; Sender's Comments: This case concerns a 58-year-old male patient with no medical history, who experienced expected events of Myalgia, Chills and unexpected evet of COVID-19. The events of Myalgia and Chills occurred on the second day after receiving the second dose of mRNA-1273, Moderna COVID-19 Vaccine. The event of COVID-19 occurred on the second day after receiving the first dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge is Not applicable. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1767032
Sex: M
Age: 62
State: CA

Vax Date: 03/24/2021
Onset Date: 05/01/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: 177/111; Test Name: EKG; Result Unstructured Data: Atrial Fibrillation; Test Name: EKG; Result Unstructured Data: Atrial Fibrillation

Allergies:

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

Symptoms: A-fib (atrial fibrillation); Goosebumps; Feeling dizzy; Shortness of breath; Heart palpitations; arm and muscle twitching; Chest is twitching; Weakness; Anxiety; High blood pressure 177/111; Nausea; Chills; Fever; Fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of ATRIAL FIBRILLATION (A-fib (atrial fibrillation)) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced ATRIAL FIBRILLATION (A-fib (atrial fibrillation)) (seriousness criterion medically significant), PILOERECTION (Goosebumps), DIZZINESS (Feeling dizzy), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), MUSCLE TWITCHING (arm and muscle twitching), CHEST DISCOMFORT (Chest is twitching), ASTHENIA (Weakness), ANXIETY (Anxiety), HYPERTENSION (High blood pressure 177/111), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with METOPROLOL at an unspecified dose and frequency; BISOPROLOL at an unspecified dose and frequency and LOSARTAN at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (A-fib (atrial fibrillation)), PILOERECTION (Goosebumps), DIZZINESS (Feeling dizzy), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), MUSCLE TWITCHING (arm and muscle twitching), CHEST DISCOMFORT (Chest is twitching), ASTHENIA (Weakness), ANXIETY (Anxiety), HYPERTENSION (High blood pressure 177/111), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 177/111 (High) 177/111. On an unknown date, Electrocardiogram: atrial fibrillation (abnormal) Atrial Fibrillation and atrial fibrillation (abnormal) Atrial Fibrillation. Concomitant medications were reported unknown. Patient reported developing the reactions after second dose. The symptoms started 4 months ago and are ongoing and getting worse. It was reported that patient never had A-fib (atrial fibrillation) before. The patient stated that the symptoms are getting worse and had to go to ER 3 times but was not hospitalized. An EKG showed that the patient had atrial fibrillation. EKG done both times he went to ER and showed Atrial fibrillation. Patient is wearing heart monitor right now. The Patient stated that he was initially put on metoprolol (beta blocker) then switched to bisoprolol that caused nightmares and it was also stopped and was advised to start losartan today. Company comment This case concerns a 63 year old male with no relevant medical history who experienced serious unexpected event of atrial fibrillation after the second dose of Modern Covid 19 vaccine. Rechallenge was unknown. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a 63 year old male with no relevant medical history who experienced serious unexpected event of atrial fibrillation after the second dose of Modern Covid 19 vaccine. Rechallenge was unknown. The benefit-risk relationship is not affected by this report.

Other Meds:

Current Illness:

ID: 1767033
Sex: F
Age: 16
State: NY

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 10/07/2021
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: Not receiving 2nd dose on time; 16 year old receiving a dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving a dose of the Moderna COVID19 vaccine) and INTENTIONAL DOSE OMISSION (Not receiving 2nd dose on time) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027d21a) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving a dose of the Moderna COVID19 vaccine). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Not receiving 2nd dose on time). On 17-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving a dose of the Moderna COVID19 vaccine) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (Not receiving 2nd dose on time) had resolved. No concomitant medication was provided. No treatment medication was provided.; Sender's Comments: This case concerns a 16 year old female patient with no relevant medical history reported, who experienced the non serious unexpected events of product administered to patient of inappropriate age and intentional dose omission. The event occurred on an unknown date after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown, since no information about second dose is provided and the event is resolved. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am