VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1823377
Sex: F
Age:
State:

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 10/28/2021
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: COVID VIRUS; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for covid-19 vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported. On 2021, the patient experienced abdominal pain. On SEP-2021, the patient experienced covid virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from abdominal pain, and was recovering from covid virus. This report was non-serious.

Other Meds:

Current Illness:

ID: 1823378
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: FOOT EXOSTOSIS; ACHILLES TENDONITIS; This spontaneous report received from a consumer via a company representative concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported. On an unspecified date, the patient experienced foot exostosis, and achilles tendonitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from foot exostosis, and achilles tendonitis. This report was non-serious.

Other Meds: Humira

Current Illness: Crohn's disease

ID: 1823379
Sex: F
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: FEELING TIRED; ARM HURT; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included leflunomide. On JUL-2021, the patient experienced arm hurt. On an unspecified date, the patient experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, and was recovering from feeling tired. This report was non-serious.

Other Meds: ARAVA

Current Illness:

ID: 1823380
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
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: ACUTE ABDUCENS NERVE PALSY OF SIXTH CRANIAL NERVE; This spontaneous report received from a parent concerned a 24 year old male of unspecified race and ethnicity. The patient's weight was 175 pounds, and height was 72 inches. The patient's past medical history included: covid-19 positive (In March 2021), and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 19-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-OCT-2021, the patient experienced double vision in his left eye. Consumer reported that, patient complained of double vision in his left eye for about 6 weeks, so patient went to see an optometrist. On 26-OCT-2021, patient was diagnosed with acute abducens nerve palsy of sixth cranial nerve. Consumer reported that, on 27-OCT-2021 patient was referred to ophthalmologist and scheduled for an Magnetic resonance imaging (MRI). Consumer reported that, patient had a Covid-19 in MAR-2021, so was unsure about diagnosis was due to vaccine or tumor, stroke (aneurysm) or increased cranial pressure. Patient had no other adverse effects after the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of acute abducens nerve palsy of sixth cranial nerve was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211051676.; Sender's Comments: V0: 20211051664- Covid-19 vaccine ad26.cov2.s- acute abducens nerve palsy of sixth cranial nerve. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1823381
Sex: F
Age:
State: VA

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

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

Lab Data:

Allergies:

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

Symptoms: SIXTH CRANIAL NERVE PALSY; This spontaneous report received from a consumer via social media (article in the Journal of Ophthalmology) concerned a 24 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter stated that on unspecified date diagnosis of sixth cranial nerve palsy was a side effect of the Janssen COVID19 vaccine and that a case was seen at an eye center, with a 24 year old female also reporting double vision and getting a similar diagnosis as her son, of sixth cranial nerve palsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sixth cranial nerve palsy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211051664.; Sender's Comments: V0: 20211051676- Covid-19 vaccine ad26.cov2.s- sixth cranial nerve palsy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1823382
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: SWOLLEN TEMPLE VEINS; DIZZINESS; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced swollen temple veins, dizziness, low grade fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen temple veins, dizziness, low grade fever, and headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1823383
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain. This report was non-serious.

Other Meds:

Current Illness:

ID: 1823384
Sex: F
Age:
State: MI

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

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

Lab Data: Test Name: Biopsy; Result Unstructured Data: Nothing came up; Comments: 3 separate biopsies performed, and nothing came up

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: BLISTERS THAT COMES AND GO; INSIDE OF MOUTH, NOSE AND CHEEK WAS RED; MOUTH IRRITATION; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blisters that comes and go, inside of mouth, nose and cheek was red, and mouth irritation. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) Nothing came up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blisters that comes and go, inside of mouth, nose and cheek was red and mouth irritation was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1823385
Sex: M
Age:
State: NV

Vax Date:
Onset Date: 10/26/2021
Rec V Date: 10/28/2021
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: VACCINE WAS ADMINISTERED PAST THE RECOMMENDED STORAGE TIME (VACCINE WAS REFRIGERATED OVER NIGHT BEFORE BEING ADMINISTERED); This spontaneous report received from a health care professional concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 26-OCT-2021 10:40 for prophylactic vaccination. No concomitant medications were reported. On 26-OCT-2021, the patient experienced vaccine was administered past the recommended storage time (vaccine was refrigerated over night before being administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was administered past the recommended storage time (vaccine was refrigerated over night before being administered) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211052091.

Other Meds:

Current Illness:

ID: 1823386
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: SIDE EFFECT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effect was not reported. This report was non-serious. This case, from the same reporter is linked to 20211052831 and 20211052814.

Other Meds:

Current Illness:

ID: 1823387
Sex: U
Age:
State:

Vax Date:
Onset Date: 10/14/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 202110; Test Name: MRI; Result Unstructured Data: Negative; Test Date: 202110; Test Name: MRI; Result Unstructured Data: Negative

Allergies:

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

Symptoms: LEFT ARM STARTED LOSING FEELING AND STRENGTH/LOST AROUND EIGHTY PERCENTAGE OF STRENGTH IN FINGERS; LEFT WRIST FOREARM FEELS NUMB ALONG WITH REAR DELTOID MIDDLE DELTOID/RIGHT PINKY FEELING A BIT NUMB; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, Laboratory data included: MRI (NR: not provided) Negative, Negative. On 14-OCT-2021, the patient experienced left arm started losing feeling and strength/lost around eighty percentage of strength in fingers. On 14-OCT-2021, the patient experienced left wrist forearm feels numb along with rear deltoid middle deltoid/right pinky feeling a bit numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left wrist forearm feels numb along with rear deltoid middle deltoid/right pinky feeling a bit numb, and left arm started losing feeling and strength/lost around eighty percentage of strength in fingers. This report was non-serious.

Other Meds:

Current Illness:

ID: 1823388
Sex: F
Age:
State: NV

Vax Date:
Onset Date: 10/26/2021
Rec V Date: 10/28/2021
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: VACCINE REFRIGERATED OVER NIGHT BEFORE BEING ADMINISTERED; INCORRECTLY STORED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: 20-MAR-2022) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-OCT-2021, the patient experienced vaccine refrigerated over night before being administered. On 26-OCT-2021, the patient experienced incorrectly stored vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine refrigerated over night before being administered and incorrectly stored vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211051934.

Other Meds:

Current Illness:

ID: 1823389
Sex: U
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: BRAIN FOG; VERY HEAVY FEELING; FEELING GRUMPY; LOTS OF ACHES AND PAINS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced brain fog, very heavy feeling, feeling grumpy, lots of aches and pains, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the brain fog, lots of aches and pains, fever, very heavy feeling and feeling grumpy was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1823390
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 202103; Test Name: Blood test; Result Unstructured Data: no significant findings; Test Date: 202103; Test Name: Laboratory test; Result Unstructured Data: no significant findings

Allergies:

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

Symptoms: TIRED; FLARE OF CONGESTION, SINUS, RED EYES; FEVER; RED EYES; CONGESTION IN HEAD AND EARS/ SINUS ISSUES; CHEST PAIN/TWINGE OF PAIN IN UPPER CHEST; RACING HEART; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included: no thyriod gland, and concurrent conditions included: high cholesterol, non alcoholic, non smoker, trees allergy, grass allergy, ragweed allergy, pollen allergy, and latex allergy, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. Concomitant medications included levocetirizine dihydrochloride for allergy, montelukast sodium for allergy, rosuvastatin calcium for high cholesterol, and levothyroxine sodium for thyroidectomy. On MAR-2021, the patient experienced red eyes. On MAR-2021, the patient experienced congestion in head and ears/ sinus issues. On MAR-2021, the patient experienced chest pain/twinge of pain in upper chest. On MAR-2021, the patient experienced racing heart. Laboratory data included: Blood test (NR: not provided) no significant findings, and Laboratory test (NR: not provided) no significant findings. On 05-MAR-2021, the patient experienced fever. On AUG-2021, the patient experienced flare of congestion, sinus, red eyes. On an unspecified date, the patient experienced tired. Treatment medications (dates unspecified) included: paracetamol, methylprednisolone, and azithromycin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red eyes, and congestion in head and ears/ sinus issues on JUN-2021, chest pain/twinge of pain in upper chest, flare of congestion, sinus, red eyes on OCT-2021, and fever on 09-MAR-2021, and the outcome of tired and racing heart was not reported. This report was non-serious.

Other Meds: SYNTHROID; XYZAL; SINGULAIR; CRESTOR

Current Illness: Abstains from alcohol; Grass allergy; High cholesterol; Latex allergy; Non-smoker; Pollen allergy; Ragweed allergy; Seasonal allergy

ID: 1823391
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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 report received from a patient via a company representative concerned a patient of unspecified age and gender. The patient's concomitant medications, height and weight not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number not reported) dose, start therapy date not reported for immunization. The patient never had the flu, never got a cold. The batch/lot number not reported. The company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced stiff muscles 24/7, pain all the time, felt a difference in their body, constantly cold, and muscles always sore. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered from muscles always sore, stiff muscles 24/7, pain all the time, and constantly cold. The outcome of felt a difference in their body not reported.

Other Meds:

Current Illness:

ID: 1823392
Sex: F
Age:
State: ME

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 10/28/2021
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: FLU-LIKE SYMPTOMS; FEELING SICK; FATIGUE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol drinker, and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy (anaphylactic reaction) when treated with macrogol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 23-AUG-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the patient experienced flu-like symptoms. On 12-MAR-2021, the patient experienced feeling sick. On 12-MAR-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, feeling sick, and fatigue on 15-MAR-2021. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1823393
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 10/26/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 20211026; Test Name: Heart rate; Result Unstructured Data: 138 beats per minute while resting; Comments: 138 beats per minute while resting.; Test Date: 20211026; Test Name: Heart rate; Result Unstructured Data: 100 beats per minute (elevated); Comments: The elevated heart rate was noted on 26-OCT-2021 at 12:41 pm

Allergies:

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

Symptoms: HAVING ELEVATED HEART RATE (100 BEATS PER MINUTE AND UP TO 138 BEATS PER MINUTE WHILE RESTING); TROUBLE BREATHING; SICK TO WORK MID DAY; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-OCT-2021, the patient experienced having elevated heart rate (100 beats per minute and up to 138 beats per minute while resting). On 26-OCT-2021, the patient experienced trouble breathing. On 26-OCT-2021, the patient experienced sick to work mid day. Laboratory data included: Heart rate (NR: not provided) 100 beats per minute (elevated), 138 beats per minute while resting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from having elevated heart rate (100 beats per minute and up to 138 beats per minute while resting), and trouble breathing, and the outcome of sick to work mid day was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1823394
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: MILD BUT PERSISTENT HEADACHE; LOW-GRADE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced mild but persistent headache, and low-grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild but persistent headache, and low-grade fever. This report was non-serious.

Other Meds:

Current Illness:

ID: 1823395
Sex: U
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: RECEIVED A MODERNA BOOSTER SHOT; CHILLS; FATIGUE; PAIN AT INJECTION SITE; ARM MUSCLE PAIN; DIARRHEA; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had covid-19 three times (uncertain regarding if before or after vaccine). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mrna 1273 for prophylactic vaccination. On an unspecified date, the patient experienced received a moderna booster shot, chills, fatigue, pain at injection site, arm muscle pain, diarrhea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, pain at injection site, arm muscle pain, chills, diarrhea, headache and received a moderna booster shot was not reported. This report was non-serious.

Other Meds: MRNA 1273

Current Illness:

ID: 1823396
Sex: M
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced polymyalgia rheumatica (pmr) when treated with varicella zoster vaccine live (oka/merck) for shingles. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills. This report was non-serious.

Other Meds:

Current Illness:

ID: 1823397
Sex: M
Age:
State: IN

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
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: FELT ACHEY; INTERMITTENT SHARP PAINS IN CHEST; DULL AND HEAVY FEELING IN CHEST; PULLED A MUSCLE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 23-OCT-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced felt achey. On OCT-2021, the patient experienced intermittent sharp pains in chest. On OCT-2021, the patient experienced dull and heavy feeling in chest. On OCT-2021, the patient experienced pulled a muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt achey, intermittent sharp pains in chest, and dull and heavy feeling in chest, and the outcome of pulled a muscle was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1823398
Sex: U
Age:
State:

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

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

Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: diagnosed with COVID-19; Comments: when the patient was under quarantine; Test Name: Laboratory test; Result Unstructured Data: Negative; Comments: within three days before boarding

Allergies:

Symptom List: Unevaluable event

Symptoms: VACCINE BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via social media (news article) via company representative concerned an adult of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: unknown, expiry: unknown) dose was not reported, 1 total administered, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Three days (unspecified date) before boarding the patient had negative test results. On an unspecified date during quarantine period, the patient was diagnosed with covid-19 (suspected vaccination failure, and vaccine breakthrough infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and vaccine breakthrough infection was not reported. This report was associated with product quality complaint: 90000199306. This report was serious (Other Medically Important Condition). This case is a duplicate of 20211037697. It was determined that nullification and deletion was required for Manufacturer Report Number (20211037697) as it was duplicate of Manufacturer Case Number (20211052628). All relevant information regarding Manufacturer Report Number (20211037697) will be submitted under Manufacturer Case Number (20211052628).; Sender's Comments: V0: 20211052628-covid-19 vaccine ad26.cov2.s-Vaccine breakthrough infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211052628-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1823399
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 09/04/2021
Rec V Date: 10/28/2021
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: ADMINISTERED TWO DOSES OF VACCINE (FIRST DOSE ON MAR-2021 AND SECOND TWO DOSE ON 04-SEP-2021); OFF LABEL USE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021, and dose was not reported, administered on 04-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-SEP-2021, the patient experienced administered two doses of vaccine (first dose on mar-2021 and second two dose on 04-sep-2021). On 04-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and administered two doses of vaccine (first dose on mar-2021 and second two dose on 04-sep-2021) was not reported. This report was non-serious.

Other Meds:

Current Illness: Immunocompromised

ID: 1823400
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: HAD BEEN INJURED BY VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced had been injured by vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had been injured by vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211052831 and 20211051962.

Other Meds:

Current Illness:

ID: 1823401
Sex: M
Age:
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: HAD BEEN INJURED BY VACCINE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced had been injured by vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had been injured by vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211051962 and 20211052814.

Other Meds:

Current Illness:

ID: 1823402
Sex: M
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: TINNITUS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tinnitus was not reported. This report was non-serious. This case, from the same reporter is linked to 20211051846 and 20211053779.

Other Meds:

Current Illness:

ID: 1823403
Sex: U
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: This spontaneous report received from a consumer concerned a patient of unspecified age and gender. No medical history, concurrent conditions, height or weight reported for the patient. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number not reported) dose, start therapy date not reported for immunization. The batch/lot number not reported, but requested. No concomitant medications reported. On an unspecified date, patient experienced tinnitus. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of tinnitus: not reported. This case, from the same reporter linked to 20211051846 and 20211053453.

Other Meds:

Current Illness:

ID: 1823404
Sex: F
Age: 51
State: FL

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 10/28/2021
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: twitching in the eye; tingling in the feet, legs and left side of face; Swelling on the left side of the face; Pain in feet and legs; felt like was going to fall; dizziness; off balance; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), BALANCE DISORDER (off balance), BLEPHAROSPASM (twitching in the eye), PARAESTHESIA (tingling in the feet, legs and left side of face) and SWELLING FACE (Swelling on the left side of the face) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension (Improvement) since 01-Jan-1993, Allergy to animals (Allergy to cats), Pollen allergy, Dust allergy and Food allergy (Allergy to Shrimp). Concomitant products included LOSARTAN from 01-Jan-2013 to an unknown date, TRIAMTERENE from 01-Jan-1993 to an unknown date, LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) from 01-Jan-2020 to an unknown date and VITAMIN D3 from 01-Jan-2020 to an unknown date for an unknown indication. On 16-Aug-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021 at 10:45 AM, the patient experienced DIZZINESS (dizziness), BALANCE DISORDER (off balance) and FEELING ABNORMAL (felt like was going to fall). On 08-Oct-2021, the patient experienced PAIN IN EXTREMITY (Pain in feet and legs). On 11-Oct-2021, the patient experienced PARAESTHESIA (tingling in the feet, legs and left side of face) and SWELLING FACE (Swelling on the left side of the face). On 11-Oct-2021 at 5:30 AM, the patient experienced BLEPHAROSPASM (twitching in the eye). On 17-Aug-2021, DIZZINESS (dizziness), BALANCE DISORDER (off balance) and FEELING ABNORMAL (felt like was going to fall) had resolved. At the time of the report, BLEPHAROSPASM (twitching in the eye), PARAESTHESIA (tingling in the feet, legs and left side of face) and SWELLING FACE (Swelling on the left side of the face) had not resolved and PAIN IN EXTREMITY (Pain in feet and legs) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DIZZINESS (dizziness), BALANCE DISORDER (off balance), BLEPHAROSPASM (twitching in the eye), PARAESTHESIA (tingling in the feet, legs and left side of face), SWELLING FACE (Swelling on the left side of the face) and PAIN IN EXTREMITY (Pain in feet and legs) to be possibly related. No further causality assessment was provided for FEELING ABNORMAL (felt like was going to fall). Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant follow up received, contains patient demographics, event swelling in face and pain in leg, medical history and concomitant medications added.

Other Meds: LOSARTAN; TRIAMTERENE; FLAXSEED OIL [LINUM USITATISSIMUM OIL]; VITAMIN D3

Current Illness: Allergy to animals (Allergy to cats); Dust allergy; Food allergy (Allergy to Shrimp); Hypertension (Improvement); Pollen allergy

ID: 1823405
Sex: M
Age: 50
State: NC

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/28/2021
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: Expired vaccine administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in 2021. On 15-Oct-2021 at 8:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant product reported by reporter. No treatment medication reported by reporter. The vial did not undergo any temperature excursions. This case was linked to MOD-2021-354542 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant Follow up- Medical history updated

Other Meds:

Current Illness:

ID: 1823406
Sex: F
Age:
State: OH

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Biopsy; Result Unstructured Data: She was diagnosed by biopsy with telogen effluvium

Allergies:

Symptom List: Nausea

Symptoms: Patient has been losing at least the 60% hair in the past 6 months. She was diagnosed by biopsy with "telogenic efluvian"; Diagnosed by biopsy with telogenic efluvian, same in the past after a surgery, but not so intense like now; This spontaneous case was reported by a nurse and describes the occurrence of ALOPECIA (Patient has been losing at least the 60% hair in the past 6 months. She was diagnosed by biopsy with "telogenic efluvian") and DIFFUSE ALOPECIA (Diagnosed by biopsy with telogenic efluvian, same in the past after a surgery, but not so intense like now) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 037D21A) for COVID-19 vaccination. The patient's past medical history included Telogen effluvium. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-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 ALOPECIA (Patient has been losing at least the 60% hair in the past 6 months. She was diagnosed by biopsy with "telogenic efluvian") and DIFFUSE ALOPECIA (Diagnosed by biopsy with telogenic efluvian, same in the past after a surgery, but not so intense like now). At the time of the report, ALOPECIA (Patient has been losing at least the 60% hair in the past 6 months. She was diagnosed by biopsy with "telogenic efluvian") and DIFFUSE ALOPECIA (Diagnosed by biopsy with telogenic efluvian, same in the past after a surgery, but not so intense like now) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: telogen effluvium (abnormal) She was diagnosed by biopsy with telogen effluvium. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment medication provided. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Reporter address and patient age updated

Other Meds:

Current Illness:

ID: 1823407
Sex: F
Age:
State: SC

Vax Date: 09/17/2021
Onset Date: 09/01/2021
Rec V Date: 10/28/2021
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: Rash in the injection site; itch in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash in the injection site) and VACCINATION SITE PRURITUS (itch in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE RASH (Rash in the injection site) and VACCINATION SITE PRURITUS (itch in the injection site). At the time of the report, VACCINATION SITE RASH (Rash in the injection site) and VACCINATION SITE PRURITUS (itch in the injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient stated 1st dose on 9-17-21 .Some itch and rash in the injection site. It last for 48hs then goes away by itself. No concomitant medications provided. No treatment medications provided. This case was linked to MOD-2021-355778 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: follow up document received on 20-Oct-2021 contains Non significant Follow up information.; Reporter's Comments: Per SO, please obtain email address for SO follow up Agent made outbound call 20Oct2021 at 2:19 PM ET and spoke to patient who states she never gave follow up consent for Safety initially although consent was granted as per original case and does not want to be followed up with regarding original adverse event case.

Other Meds:

Current Illness:

ID: 1823408
Sex: F
Age:
State: SC

Vax Date: 09/17/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rash in the injection site; itch in the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash in the injection site) and PRURITUS (itch in the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE RASH (Rash in the injection site) and PRURITUS (itch in the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in October 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash in the injection site) had not resolved and PRURITUS (itch in the injection site) outcome was unknown. No concomitant medications were reported. Patient reports that she's experiencing Rash at the time of the report, i.e.,18-Oct-2021 and its not resolved. She took Benadryl and it helped her with the symptoms. This case was linked to MOD-2021-355776 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received contains non-significant information.

Other Meds:

Current Illness:

ID: 1823409
Sex: M
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: Baby who was breastfed, stool is more than normal, it is not like a solid but also not like diarrhea; Vaccine exposure via breastmilk; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL FAECES (Baby who was breastfed, stool is more than normal, it is not like a solid but also not like diarrhea) and EXPOSURE VIA BREAST MILK (Vaccine exposure via breastmilk) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding. No Medical History information was reported. On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with ABNORMAL FAECES (Baby who was breastfed, stool is more than normal, it is not like a solid but also not like diarrhea) and EXPOSURE VIA BREAST MILK (Vaccine exposure via breastmilk). The delivery occurred on an unknown date, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, ABNORMAL FAECES (Baby who was breastfed, stool is more than normal, it is not like a solid but also not like diarrhea) outcome was unknown and EXPOSURE VIA BREAST MILK (Vaccine exposure via breastmilk) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown. Concomitant medication was not provided. Treatment information was not provided. CC: This case concerns a male patient, unknown age, with breastfeeding mother who had maternal exposure during breastfeeding and no other medical history, who experienced the non-serious, unexpected events of exposure via breastmilk and abnormal faeces. The events occurred on unknown day after mother received unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report. This case was linked to MOD-2021-356031 (Parent-Child Link). See case MOD-2021-356031 for details regarding the Parent case.; Sender's Comments: This case concerns a male patient, unknown age, with breastfeeding mother who had maternal exposure during breastfeeding and no other medical history, who experienced the non-serious, unexpected events of exposure via breastmilk and abnormal faeces. The events occurred on unknown day after mother received unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1823410
Sex: U
Age:
State: CA

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Dose administered to 4 patients past 30 days in refrigerator.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 4 patients past 30 days in refrigerator.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 4 patients past 30 days in refrigerator.). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered to 4 patients past 30 days in refrigerator.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was mentioned. No treatment medication was mentioned. This case was linked to MOD-2021-355911, MOD-2021-355908 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow up received on 21-Oct-2021 contains non significant information.

Other Meds:

Current Illness:

ID: 1823411
Sex: F
Age:
State: GA

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: 15 patients received an expired Moderna dose/gave Moderna vaccines from a vial with an expiration date of 10/15/21; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (15 patients received an expired Moderna dose/gave Moderna vaccines from a vial with an expiration date of 10/15/21) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (15 patients received an expired Moderna dose/gave Moderna vaccines from a vial with an expiration date of 10/15/21). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (15 patients received an expired Moderna dose/gave Moderna vaccines from a vial with an expiration date of 10/15/21) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided No treatment medication provided The Moderna vial (10 dose, 0.5ml) was removed from the freezer to the refrigerator on 10-11-2021 without any temperature variations in the transfer from the freezer. The solution was off white in color. No variation in color from all the other previously used vials. 16 patients received 0.25 ml booster dose. 3 patients received 0.5 ml full dose. Event onset time was given 01:18pm Vaccination facility information is reported as Doctors office, and the address is 4360 Chamblee-Dunwoody Rd, Suite 370 with clinical name Arbor / Haven OBGYN. This case was linked to US-MODERNATX, INC.-MOD-2021-362642, US-MODERNATX, INC.-MOD-2021-362750 (E2B Linked Report). This case was linked to MOD-2021-362017, MOD-2021-362031, MOD-2021-361987, MOD-2021-362064 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow-up received on 18-oct-2021 and contains NNI. On 24-Oct-2021: Patient initials ,narrative updated; Sender's Comments: US-MODERNATX, INC.-MOD-2021-362750:cluster master file MOD-2021-355973 US-MODERNATX, INC.-MOD-2021-362642:

Other Meds:

Current Illness:

ID: 1823412
Sex: F
Age: 25
State: NC

Vax Date: 10/17/2021
Onset Date: 10/17/2021
Rec V Date: 10/28/2021
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: Test Date: 20211017; Test Name: Body temperature; Result Unstructured Data: fever that was 101.8F

Allergies:

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

Symptoms: been breastfeeding; arm is sore again; fever that was 101.8F; headache; muscle aches; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is sore again), PYREXIA (fever that was 101.8F), HEADACHE (headache), MYALGIA (muscle aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Oct-2021, the patient experienced VACCINATION SITE PAIN (arm is sore again), PYREXIA (fever that was 101.8F), HEADACHE (headache), MYALGIA (muscle aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (been breastfeeding). On 17-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION SITE PAIN (arm is sore again), PYREXIA (fever that was 101.8F), HEADACHE (headache), MYALGIA (muscle aches) and MATERNAL EXPOSURE DURING BREAST FEEDING (been breastfeeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Oct-2021, Body temperature: 101.8f (High) fever that was 101.8F. Concomitant product use was not provided by the reporter. ? No treatment information was provided. CC: This case of maternal exposure during breast feeding and inappropriate schedule of product administration concerns a 25-year-old female patient with no relevant medical history who experienced non-serious expected events of headache, myalgia and vaccination site pain. The events occurred within 24 hours from the second dose of Spikevax, whereas the event of vaccination site pain occurred after both doses. Rechallenge was positive for the event of vaccination site pain since the event reoccurred after both doses whereas rechallenge for the remaining events was not applicable as the events occurred after the second dose so no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report This case was linked to MOD-2021-355915 (Parent-Child Link). This case was linked to MOD-2021-356031 (Patient Link). See case MOD-2021-355915 for details regarding the child case. Reporter did not allow further contact; Sender's Comments: This case of maternal exposure during breast feeding and inappropriate schedule of product administration concerns a 25-year-old female patient with no relevant medical history who experienced non-serious expected events of headache, myalgia and vaccination site pain. The events occurred within 24 hours from the second dose of Spikevax, whereas the event of vaccination site pain occurred after both doses. Rechallenge was positive for the event of vaccination site pain since the event reoccurred after both doses whereas rechallenge for the remaining events was not applicable as the events occurred after the second dose so no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report

Other Meds:

Current Illness:

ID: 1823413
Sex: F
Age: 48
State: NC

Vax Date: 09/17/2021
Onset Date: 10/16/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 20211016; Test Name: body temperature; Result Unstructured Data: probably 100?F or 101?F (couldn't check it)

Allergies:

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

Symptoms: Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine; started having temperature; pain under the arm pit; burning under the arm pit like if it was administered there/burning; appeared like a ball; pain in my legs; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning under the arm pit like if it was administered there/burning), SWELLING (appeared like a ball), PAIN IN EXTREMITY (pain in my legs), FEELING ABNORMAL (Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine) and PYREXIA (started having temperature) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Oct-2021, the patient experienced BURNING SENSATION (burning under the arm pit like if it was administered there/burning), SWELLING (appeared like a ball), PAIN IN EXTREMITY (pain in my legs), PYREXIA (started having temperature) and AXILLARY PAIN (pain under the arm pit). On an unknown date, the patient experienced FEELING ABNORMAL (Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 Tylenol. At the time of the report, BURNING SENSATION (burning under the arm pit like if it was administered there/burning) had not resolved and SWELLING (appeared like a ball), PAIN IN EXTREMITY (pain in my legs), FEELING ABNORMAL (Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine), PYREXIA (started having temperature) and AXILLARY PAIN (pain under the arm pit) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2021, Body temperature: high (High) probably 100?F or 101?F (couldn't check it). Concomitant medication of the patient was not reported. After the first dose, the patient did not experience any adverse events. The patient received the second dose at 6 o clock. The burning started between Saturday and Sunday and started to get worried. On 18-Oct-2021, the patient went to urgent care where it was told it was a side effect to the Moderna Vaccine and on Friday the patient had an ultrasound.

Other Meds:

Current Illness:

ID: 1823414
Sex: F
Age: 52
State: DE

Vax Date: 09/08/2021
Onset Date:
Rec V Date: 10/28/2021
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: Numbness; Tingling in hand, feet, and legs and arms./like little pins and needs like nerve problems/needle pain; keep going to the bathroom, urinating; Extreme itching under arms and all the crevice areas on body; >than 35 days since first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling in hand, feet, and legs and arms./like little pins and needs like nerve problems/needle pain), POLLAKIURIA (keep going to the bathroom, urinating), PRURITUS (Extreme itching under arms and all the crevice areas on body) and PRODUCT DOSE OMISSION ISSUE (>than 35 days since first dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling in hand, feet, and legs and arms./like little pins and needs like nerve problems/needle pain), POLLAKIURIA (keep going to the bathroom, urinating), PRURITUS (Extreme itching under arms and all the crevice areas on body) and PRODUCT DOSE OMISSION ISSUE (>than 35 days since first dose). At the time of the report, HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling in hand, feet, and legs and arms./like little pins and needs like nerve problems/needle pain) had not resolved, POLLAKIURIA (keep going to the bathroom, urinating) outcome was unknown and PRURITUS (Extreme itching under arms and all the crevice areas on body) and PRODUCT DOSE OMISSION ISSUE (>than 35 days since first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Laboratory information included test for sugar and the results were normal. Patient states that she was doing research to find out whether she was having Guillen-Barre disease.

Other Meds:

Current Illness:

ID: 1823415
Sex: U
Age: 67
State: PA

Vax Date: 03/09/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
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: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication provided by reporter. No treatment medication provided by reporter.

Other Meds:

Current Illness:

ID: 1823416
Sex: F
Age: 74
State: NC

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Name: triglycerides; Result Unstructured Data: about 150 (unspecified units); Test Name: GGT; Result Unstructured Data: 460 (unspecified units); Test Name: L-LDL; Result Unstructured Data: little high

Allergies:

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

Symptoms: GGT is off the charts,GGT is 460; triglycerides was also high, about 150; L-LDL was also a little high; This spontaneous case was reported by a consumer and describes the occurrence of GAMMA-GLUTAMYLTRANSFERASE INCREASED (GGT is off the charts,GGT is 460), BLOOD TRIGLYCERIDES INCREASED (triglycerides was also high, about 150) and LOW DENSITY LIPOPROTEIN INCREASED (L-LDL was also a little high) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 GAMMA-GLUTAMYLTRANSFERASE INCREASED (GGT is off the charts,GGT is 460), BLOOD TRIGLYCERIDES INCREASED (triglycerides was also high, about 150) and LOW DENSITY LIPOPROTEIN INCREASED (L-LDL was also a little high). At the time of the report, GAMMA-GLUTAMYLTRANSFERASE INCREASED (GGT is off the charts,GGT is 460), BLOOD TRIGLYCERIDES INCREASED (triglycerides was also high, about 150) and LOW DENSITY LIPOPROTEIN INCREASED (L-LDL was also a little high) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood triglycerides: about 150 (High) about 150 (unspecified units). On an unknown date, Gamma-glutamyltransferase: 460 (High) 460 (unspecified units). On an unknown date, Low density lipoprotein: little high (High) little high. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication were reported. No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1823417
Sex: F
Age: 49
State: FL

Vax Date: 09/20/2021
Onset Date: 10/19/2021
Rec V Date: 10/28/2021
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: really bad stomach pain; extreme flu symptoms; really bad headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (really bad stomach pain), INFLUENZA (extreme flu symptoms), HEADACHE (really bad headache) and NAUSEA (Nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A and 49EZ1A) for COVID-19 vaccination. No medical history was provided by the reporter. On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, the patient experienced ABDOMINAL PAIN UPPER (really bad stomach pain), INFLUENZA (extreme flu symptoms), HEADACHE (really bad headache) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN UPPER (really bad stomach pain), INFLUENZA (extreme flu symptoms), HEADACHE (really bad headache) and NAUSEA (Nausea) outcome was unknown. No concomitant medication listed. No treatment information provided.

Other Meds:

Current Illness:

ID: 1823418
Sex: F
Age: 44
State: AL

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

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

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

Allergies:

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

Symptoms: tested positive for COVID-19; They both missed their second dose due to quarantine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (They both missed their second dose due to quarantine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (They both missed their second dose due to quarantine). At the time of the report, COVID-19 (tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (They both missed their second dose due to quarantine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication listed. No treatment information provided. The patient missed their second dose due to quarantine and are now going to get vaccinated past the 42 day window. This case concerns Product dose omission in a 44 year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. It was reported that the second dose had not been administered due to quarantine and that it was outside of the 42 day window at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns Product dose omission in a 44 year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. It was reported that the second dose had not been administered due to quarantine and that it was outside of the 42 day window at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1823419
Sex: F
Age: 78
State: IA

Vax Date: 02/26/2021
Onset Date: 03/27/2021
Rec V Date: 10/28/2021
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: 202109; Test Name: Lab work; Result Unstructured Data: inflammation level is elevated.; Test Date: 202109; Test Name: x-ray; Result Unstructured Data: No results were reported.

Allergies:

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

Symptoms: I had muscle spasms in both thighs, I couldn't even move.; terrible pain all over my body; My blood work showed that my inflammation level is elevated.; I have a little arthritis.; terrible pain in my neck; muscle pain in my thighs/in my hips/upper arms; I couldn't clinch my fists, because it was very painful; chills; muscle pain in my thighs,hips/muscle pain in my upper arms; I couldn't clinch my fists, because it was very painful/terrible pain all over my body; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (muscle pain in my thighs,hips/muscle pain in my upper arms), PAIN (I couldn't clinch my fists, because it was very painful/terrible pain all over my body), MYALGIA (muscle pain in my thighs/in my hips/upper arms), PAIN (I couldn't clinch my fists, because it was very painful), NECK PAIN (terrible pain in my neck), PAIN (terrible pain all over my body), MUSCLE SPASMS (I had muscle spasms in both thighs, I couldn't even move.), INFLAMMATION (My blood work showed that my inflammation level is elevated.) and ARTHRITIS (I have a little arthritis.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 003B21A) for COVID-19 vaccination. Concomitant products included ROSUVASTATIN from an unknown date to 21-Jun-2021 for Cholesterol. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced CHILLS (chills) (seriousness criterion medically significant), MYALGIA (muscle pain in my thighs,hips/muscle pain in my upper arms) (seriousness criterion medically significant) and PAIN (I couldn't clinch my fists, because it was very painful/terrible pain all over my body) (seriousness criterion medically significant). On 02-Apr-2021, the patient experienced MYALGIA (muscle pain in my thighs/in my hips/upper arms) (seriousness criterion medically significant) and PAIN (I couldn't clinch my fists, because it was very painful) (seriousness criterion medically significant). On 19-Jul-2021, the patient experienced NECK PAIN (terrible pain in my neck) (seriousness criterion medically significant). On 15-Sep-2021, the patient experienced INFLAMMATION (My blood work showed that my inflammation level is elevated.) (seriousness criterion medically significant) and ARTHRITIS (I have a little arthritis.) (seriousness criterion medically significant). On 08-Oct-2021, the patient experienced PAIN (terrible pain all over my body) (seriousness criterion medically significant). On 16-Oct-2021, the patient experienced MUSCLE SPASMS (I had muscle spasms in both thighs, I couldn't even move.) (seriousness criterion medically significant). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, CHILLS (chills), MYALGIA (muscle pain in my thighs,hips/muscle pain in my upper arms), PAIN (I couldn't clinch my fists, because it was very painful/terrible pain all over my body), MYALGIA (muscle pain in my thighs/in my hips/upper arms), PAIN (I couldn't clinch my fists, because it was very painful), NECK PAIN (terrible pain in my neck), PAIN (terrible pain all over my body), MUSCLE SPASMS (I had muscle spasms in both thighs, I couldn't even move.), INFLAMMATION (My blood work showed that my inflammation level is elevated.) and ARTHRITIS (I have a little arthritis.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Full blood count: inflammation level is elevated.. In September 2021, X-ray: . No results were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Company Comment: This RA case concerns a 78 year old female with no reported history who experienced the serious unlisted events of Arthritis, Myalgia, Pain and inflammation beginning a week after the second dose of mRNA-1273. Re-challenge is not applicable as no events occurred with dose and this is dose 2. Benefit-risk relationship of mRNA-1273 is not affected by this report. The events are all assessed as serious by the RA; however, no information in the source documents supports serious criteria being met.; Sender's Comments: This RA case concerns a 78 year old female with no reported history who experienced the serious unlisted events of Arthritis, Myalgia, Pain and inflammation beginning a week after the second dose of mRNA-1273. Re-challenge is not applicable as no events occurred with dose and this is dose 2. Benefit-risk relationship of mRNA-1273 is not affected by this report. The events are all assessed as serious by the RA; however, no information in the source documents supports serious criteria being met.

Other Meds: ROSUVASTATIN

Current Illness:

ID: 1823420
Sex: U
Age: 75
State: PA

Vax Date: 03/14/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
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: Administered vaccine after 33 days in the refrigerator; Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1823421
Sex: U
Age: 49
State: PA

Vax Date: 09/07/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
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: Administered vaccine after 33 days in the refrigerator; Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2021-356818, MOD-2021-357274.

Other Meds:

Current Illness:

ID: 1823422
Sex: F
Age: 34
State: NJ

Vax Date: 01/20/2021
Onset Date: 10/12/2021
Rec V Date: 10/28/2021
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: Urticaria; Allergic reaction; Rash in my body, stomach, over the chest, over the back; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Urticaria), RASH (Rash in my body, stomach, over the chest, over the back) and HYPERSENSITIVITY (Allergic reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012M20A) for COVID-19 vaccination. No medical history was reported by the reporter. Concomitant products included FEXOFENADINE for Allergy. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-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, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced RASH (Rash in my body, stomach, over the chest, over the back). On an unknown date, the patient experienced URTICARIA (Urticaria) and HYPERSENSITIVITY (Allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Urticaria) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown and RASH (Rash in my body, stomach, over the chest, over the back) had not resolved. Treatment Benadryl (didn't help), a cream from the dermatologist. Patient who is not immunocompromised got the third shot. Patient didn't remember in which arm she got the shots

Other Meds: FEXOFENADINE

Current Illness:

ID: 1823423
Sex: F
Age: 65
State: IA

Vax Date: 03/18/2021
Onset Date: 04/01/2021
Rec V Date: 10/28/2021
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: then slow but surely cramping came back/then went off and started coming back again/Since a week ago&even in the middle of the night last night/he almost got the full muscle from his leg cramping/specially the left leg/started having problems again; gave patient a little bit of diarrhea; has been having some rather adverse side effects; started having severe leg crampings, went off and started coming back again; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (has been having some rather adverse side effects), MUSCLE SPASMS (started having severe leg crampings, went off and started coming back again), MUSCLE SPASMS (then slow but surely cramping came back/then went off and started coming back again/Since a week ago&even in the middle of the night last night/he almost got the full muscle from his leg cramping/specially the left leg/started having problems again) and DIARRHOEA (gave patient a little bit of diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Neuropathy peripheral (neuropathy on his feet). Concomitant products included GABAPENTIN for Neuropathy peripheral, LEVOTHYROXINE, FOLIC ACID and OMEPRAZOLE for an unknown indication. On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (has been having some rather adverse side effects), MUSCLE SPASMS (started having severe leg crampings, went off and started coming back again) and DIARRHOEA (gave patient a little bit of diarrhea). On an unknown date, the patient experienced MUSCLE SPASMS (then slow but surely cramping came back/then went off and started coming back again/Since a week ago&even in the middle of the night last night/he almost got the full muscle from his leg cramping/specially the left leg/started having problems again). The patient was treated with MAGNESIUM for Leg cramps, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (has been having some rather adverse side effects), MUSCLE SPASMS (started having severe leg crampings, went off and started coming back again) and MUSCLE SPASMS (then slow but surely cramping came back/then went off and started coming back again/Since a week ago&even in the middle of the night last night/he almost got the full muscle from his leg cramping/specially the left leg/started having problems again) had not resolved and DIARRHOEA (gave patient a little bit of diarrhea) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 16April2021 patient first messaged his doctor, who told him to drink more water and take magnesium. That treatment did help the patient, it kind of got off it, gave patient a little bit of diarrhea.

Other Meds: LEVOTHYROXINE; FOLIC ACID; OMEPRAZOLE; GABAPENTIN

Current Illness: Neuropathy peripheral

ID: 1823424
Sex: F
Age: 43
State: TN

Vax Date: 08/13/2021
Onset Date: 08/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: More than 35 days for 2nd dose; kidneys were bleeding; there is a sore at injection site; Had hives; feet were swollen; lost voice; started having vision problems in left eye/left eye has been shut for no reason; dental problems that she never had; muscle cramps; severe pain; blood pressure has not been controlled; can't run anymore; Have all these new allergies/Can't eat peanut butter anymore/Can't eat eggs anymore; Cannot work; This spontaneous case was reported by a consumer and describes the occurrence of RENAL HAEMORRHAGE (kidneys were bleeding) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concurrent medical conditions included Egg allergy (Can't eat eggs), Food allergy (Can't eat peanut butter), Penicillin allergy, Drug allergy (Norco) and Drug allergy (cephalosporins). Concomitant products included EPINEPHRINE (EPIPEN) for Allergy. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced RENAL HAEMORRHAGE (kidneys were bleeding) (seriousness criterion medically significant), URTICARIA (Had hives), PERIPHERAL SWELLING (feet were swollen), APHONIA (lost voice), VISUAL IMPAIRMENT (started having vision problems in left eye/left eye has been shut for no reason), DENTAL DISCOMFORT (dental problems that she never had), MUSCLE SPASMS (muscle cramps), PAIN (severe pain), BLOOD PRESSURE INADEQUATELY CONTROLLED (blood pressure has not been controlled) and VACCINATION SITE PAIN (there is a sore at injection site). In August 2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot work), MOBILITY DECREASED (can't run anymore) and ALLERGY TO VACCINE (Have all these new allergies/Can't eat peanut butter anymore/Can't eat eggs anymore). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days for 2nd dose). On 20-Aug-2021, RENAL HAEMORRHAGE (kidneys were bleeding) had resolved. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot work), URTICARIA (Had hives), PERIPHERAL SWELLING (feet were swollen), APHONIA (lost voice), VISUAL IMPAIRMENT (started having vision problems in left eye/left eye has been shut for no reason), DENTAL DISCOMFORT (dental problems that she never had), MUSCLE SPASMS (muscle cramps), PAIN (severe pain), BLOOD PRESSURE INADEQUATELY CONTROLLED (blood pressure has not been controlled), MOBILITY DECREASED (can't run anymore), VACCINATION SITE PAIN (there is a sore at injection site) and ALLERGY TO VACCINE (Have all these new allergies/Can't eat peanut butter anymore/Can't eat eggs anymore) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days for 2nd dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication information was mentioned by reporter Patient had not been vaccinated with 2nd dose. It was stated that, she had not treated her or prescribed her any medications. They keep on saying she had antibodies of 2500. She states because of these new allergies she had to carry an EpiPen with her all the time. Company Comment This case concerns a 43-year-old, female patient with no relevant medical history, who experienced the unexpected event of Renal hemorrhage (Kidney bleeding). The event occurred approximately 1 day after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 43-year-old, female patient with no relevant medical history, who experienced the unexpected event of Renal hemorrhage (Kidney bleeding). The event occurred approximately 1 day after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.

Other Meds: EPIPEN

Current Illness: Drug allergy (Norco); Drug allergy (cephalosporins); Egg allergy (Can't eat eggs); Food allergy (Can't eat peanut butter); Penicillin allergy

ID: 1823425
Sex: F
Age: 55
State: NM

Vax Date: 02/27/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1823433
Sex: F
Age: 86
State: OH

Vax Date: 09/12/2021
Onset Date: 09/01/2021
Rec V Date: 10/28/2021
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: Stomach pain; Dizzy; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Dizzy) and NAUSEA (Nauseous) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05UE211A) for COVID-19 vaccination. The patient's past medical history included Hypothyroidism. Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic and Drug allergy. Concomitant products included LEVOTHYROXINE for an unknown indication. On 12-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Dizzy) and NAUSEA (Nauseous). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Dizzy) and NAUSEA (Nauseous) had resolved. No Treatment medication information was provided.

Other Meds: LEVOTHYROXINE

Current Illness: Allergy to antibiotic; Drug allergy; Penicillin allergy

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am