VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1691381
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 07/12/2021
Rec V Date: 09/11/2021
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: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE EXPIRED DUE TO TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 50 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUL-2021, the patient experienced administration of vaccine expired due to temperature excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine expired due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915661, 20210916910, 20210915719, 20210916300, 20210916697, 20210916959, 20210916965, 20210917160, 20210916808, 20210915646, 20210915623, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210915852, 20210916658, 20210917500, 20210915731, 20210916228, 20210916312, 20210916455, 20210916520, 20210916129, 20210916415, 20210916498, 20210916465, 20210916849, 20210916811, 20210915748, 20210917603, 20210913164, 20210915852, 20210917074 and 20210916401.

Other Meds:

Current Illness:

ID: 1691382
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 07/28/2021
Rec V Date: 09/11/2021
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: EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED DUE TO TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 19 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: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the patient experienced expired vaccine administered from the vial affected due to temperature excursion. On 28-JUL-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered from the vial affected due to temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916520, 20210916300, 20210916228, 20210913164, 20210916129, 20210916415, 20210915623, 20210915661, 20210913164, 20210915748, 20210915852, 20210916228, 20210916910, 20210916959, 20210915719, 20210916697, 20210917160, 20210915646, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210916312, 20210916401, 20210916455, 20210916465, 20210916498, 20210916584, 20210916715, 20210916808, 20210916811, 20210917603, 20210916849, 20210916965 and 20210917074.

Other Meds:

Current Illness:

ID: 1691383
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 07/07/2021
Rec V Date: 09/11/2021
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: EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 54 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, and batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 07-JUL-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered from the vial affected from temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916300, 20210916228, 20210916520, 20210915646, 20210915852, 20210916312, 20210916401, 20210916415, 20210915731, 20210916553, 20210915661, 20210915623, 20210916455, 20210916910, 20210915719, 20210916129, 20210916465, 20210915748, 20210916584, 20210916658, 20210916768, 20210916811, 20210916849, 20210916959, 20210916498, 20210913164, 20210916715, 20210916808, 20210917160, 20210917163, 20210916965, 20210917226, 20210916907, 20210917515, 20210917603, 20210917074 and 20210917500.

Other Meds:

Current Illness:

ID: 1691384
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 05/24/2021
Rec V Date: 09/11/2021
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: ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 37 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: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 24-MAY-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915661, 20210916910, 20210915719, 20210916300, 20210916697, 20210916959, 20210917160, 20210916965, 20210915646, 20210916808, 20210915623, 20210917163, 20210916907, 20210916553, 20210913164, 20210916520, 20210915731, 20210915748, 20210915852, 20210916129, 20210916228, 20210916312, 20210916401, 20210916415, 20210916455, 20210916465, 20210916498, 20210916584, 20210916658, 20210916715, 20210916811, 20210916849, 20210917074, 20210917226, 20210917500, 20210917515, 20210917603 and 20210918425.

Other Meds:

Current Illness:

ID: 1691385
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: VACCINE PROVIDED MAJOR CHANGES IN BODY WHICH WERE POSITIVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine provided major changes in body which were positive. The action taken with covid-19 vaccine was not applicable. The outcome of vaccine provided major changes in body which were positive was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1691386
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 06/07/2021
Rec V Date: 09/11/2021
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: ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 22 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: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 07-JUN-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210916300, 20210916959, 20210916965, 20210917160, 20210915661, 20210915646, 20210915623, 20210916808, 20210916715, 20210917163, 20210916520, 20210915731, 20210915748, 20210915852, 20210916129, 20210916228, 20210916312, 20210916401, 20210916415, 20210916455, 20210916465, 20210916498, 20210916553, 20210916584, 20210916658, 20210916697, 20210916768, 20210916808, 20210916811, 20210916849, 20210916910, 20210917074, 20210917226, 20210917500, 20210917515 and 20210917603.

Other Meds:

Current Illness:

ID: 1691387
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 06/07/2021
Rec V Date: 09/11/2021
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: This spontaneous report received from a pharmacist concerned a 73 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 (suspension for injection, route of admin not reported, batch number: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 07-JUN-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the expired vaccine administered from the vial affected from temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915731, 20210915748, 20210916312, 20210915852, 20210916129, 20210916228, 20210916300, 20210916415, 20210916455, 20210916498, 20210916584, 20210916658, 20210916715, 20210916768, 20210916811, 20210916697, 20210916553, 20210916520, 20210916465, 20210916401, 20210913164, 20210915719, 20210916965, 20210915646, 20210917160, 20210915623, 20210916808, 20210917163, 20210916907, 20210917515, 20210917226, 20210915661, 20210916849, 20210916959, 20210917074, 20210917500 and 20210917603.

Other Meds:

Current Illness:

ID: 1691388
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: Lab test; Result Unstructured Data: Diagnosed with Multiple Sclerosis

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: MULTIPLE SCLEROSIS(BLURRY VISION IN EYES); CHILLS; NOT FEELING GOOD; FEVER; This spontaneous report received from a parent concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, non smoker, and patient had no known drug allergies and is healthy. Patient did not had a family history of multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 21-SEP-2021) dose was not reported, frequency 1 total, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the patient experienced chills. not feeling good, fever and then he felt better after couple of days. On 16-JUN-2021, developed blurred vision in his eyes. Patient went to different doctors had different tests done and was diagnosed with multiple sclerosis in July. Patient was perfectly health before getting the vaccine and reporter stated that it might had been a poison or something wrong with the vaccine that patient received. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, not feeling good, and fever on MAY-2021, and had not recovered from multiple sclerosis(blurry vision in eyes). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210916940-Covid-19 vaccine ad26.cov2.s-Multiple sclerosis. 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).

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1691389
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: Weight; Result Unstructured Data: 30 lbs overweight

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: SOMEDAYS CHEST FEELS TIGHT; NERVOUS; OVERWEIGHT; HEADACHE ALMOST EVERY DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight was 30 pounds, and height was not reported. The patient's past medical history included: headache, and concurrent conditions included: autoimmune disease, overweight, and smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced somedays chest feels tight, nervous, overweight, and headache almost every day. Laboratory data (dates unspecified) included: Weight (NR: not provided) 30 lbs. overweight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the somedays chest feels tight, headache almost every day, nervous and overweight was not reported. This report was non-serious.

Other Meds:

Current Illness: Autoimmune disorder; Overweight (30 LBS.); Smoker

ID: 1691390
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 06/07/2021
Rec V Date: 09/11/2021
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: ADMINISTRATION OF EXPIRED VACCINE FROM THE AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 20 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: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the patient experienced administration of expired vaccine from the affected vials due to temperature excursion. On 07-JUN-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine from the affected vials due to temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916808, 20210916401, 20210916553, 20210915719, 20210915731, 20210915852, 20210916228, 20210915623, 20210915646, 20210915661, 20210915748, 20210916300, 20210916312, 20210916415, 20210916455, 20210916520, 20210916584, 20210916658, 20210916715, 20210916768, 20210916811, 20210916849, 20210916910, 20210916959, 20210916129, 20210916907, 20210917163, 20210917515, 20210917226, 20210913164, 20210916465, 20210916498, 20210916697, 20210917074, 20210917160, 20210917603 and 20210917500.

Other Meds:

Current Illness:

ID: 1691391
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 07/12/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ADMINISTRATION OF JANSSEN COVID 19 VACCINE TEMPERATURE EXCURSION; ADMINISTRATION OF JANSSEN COVID 19 VACCINE TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 70 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, and batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUL-2021, the patient experienced administration of janssen covid 19 vaccine temperature excursion. On 12-JUL-2021, the patient experienced administration of janssen covid 19 vaccine temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of janssen covid 19 vaccine temperature excursion and administration of janssen covid 19 vaccine temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210915646, 20210916808, 20210915661, 20210915748, 20210915623, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210916697, 20210916910, 20210915852, 20210916965 and 20210916959.

Other Meds:

Current Illness:

ID: 1691392
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/27/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210830; Test Name: COVID-19 virus test; Result Unstructured Data: Positive

Allergies:

Symptom List: Rash, Urticaria

Symptoms: SUSPECTED COVID-19 INFECTION; Runny nose; This spontaneous report received from a patient via a company representative concerned a 30 year old male. 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 was 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 and lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 2 weeks, from 12-APR-2021 for moderate to severe adult crohn's disease. No concomitant medications were reported. On 27-AUG-2021, the patient experienced runny nose. On 30-AUG-2021, the patient experienced suspected covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from runny nose, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.

Other Meds:

Current Illness: Crohn's disease

ID: 1691393
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: ACHES ALL OVER/PAIN; COULD NOT SLEEP; COULD NOT WALK; BEDRIDDEN THE WHOLE NEXT DAY; CHILLS PULSING THROUGHOUT BODY; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced aches all over/pain, could not sleep, could not walk, bedridden the whole next day, and chills pulsing throughout body. The action taken with covid-19 vaccine was not applicable. The patient was recovering from chills pulsing throughout body, aches all over/pain, could not sleep, could not walk, and bedridden the whole next day. This report was non-serious.

Other Meds:

Current Illness:

ID: 1691394
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 06/23/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 23 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: 1808986, and expiry: 21-SEP-2021) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUN-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 23-JUN-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915731, 20210915852, 20210916228, 20210916312, 20210916455, 20210916553, 20210915623, 20210915661, 20210915748, 20210916312, 20210916401, 20210916455, 20210916553, 20210916715, 20210916768, 20210916808, 20210916811, 20210916849, 20210916849, 20210913164, 20210916520, 20210916129, 20210916415, 20210916520, 20210916584, 20210916658, 20210916959, 20210916907 and 20210916910.

Other Meds:

Current Illness:

ID: 1691395
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 08/04/2021
Rec V Date: 09/11/2021
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: EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 20 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: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 04-AUG-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered from the vial affected from temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210916697, 20210915646, 20210916808, 20210915661, 20210915623, 20210915748, 20210916228, 20210916300, 20210916312, 20210916401, 20210916415, 20210916455, 20210916465, 20210916498, 20210916520, 20210916553, 20210916584, 20210916658, 20210916768, 20210916811, 20210916849, 20210916907, 20210916910, 20210916959, 20210916965, 20210917074, 20210917160, 20210917226, 20210917500, 20210917515, 20210913164, 20210916715, 20210915731, 20210916129, 20210915852 and 20210917603.

Other Meds:

Current Illness:

ID: 1691396
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 05/24/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ADMINISTRATION OF EXPIRED VACCINE; TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 19 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: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the patient experienced administration of expired vaccine. On 24-MAY-2021, the patient experienced temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210913164, 20210916129, 20210916498, 20210916465, 20210916415, 20210916401, 20210916697, 20210915646, 20210915719, 20210916715, 20210915661, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210915623, 20210915731, 20210915748, 20210915852, 20210916228, 20210916300, 20210916312, 20210916455, 20210916520, 20210916584, 20210916658, 20210916808, 20210916811, 20210916849, 20210916910, 20210916959, 20210916965, 20210917074, 20210917160, 20210917500 and 20210917603.

Other Meds:

Current Illness:

ID: 1691397
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 06/21/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 71 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: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the patient experienced expired vaccine administered from the vial affected due to temperature excursion. On 21-JUN-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered from the vial affected due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210915661, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210916697, 20210916910, 20210915852, 20210915646, 20210916965, 20210915623, 20210915731, 20210916228, 20210916312, 20210916697, 20210915748, 20210916415, 20210916455, 20210916520, 20210916584, 20210916658, 20210916808, 20210916811, 20210916849, 20210916959, 20210916465 and 20210916300.

Other Meds:

Current Illness:

ID: 1691398
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 06/21/2021
Rec V Date: 09/11/2021
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: ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist 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, route of admin not reported, batch number: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 21-JUN-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210915661, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210913164, 20210915623, 20210916520, 20210915646, 20210915731, 20210915748, 20210915852, 20210916129, 20210916228, 20210916300, 20210916312, 20210916401, 20210916415, 20210916455, 20210916465, 20210916498, 20210916584, 20210916658, 20210916697, 20210916808, 20210916811, 20210916849, 20210916910, 20210916959, 20210916965, 20210917074, 20210917160, 20210917226, 20210917500 and 20210917603.

Other Meds:

Current Illness:

ID: 1691399
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 09/09/2021
Rec V Date: 09/11/2021
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: EXPIRED VACCINE WAS GIVEN; This spontaneous report received from a health care professional 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: 1808609, and expiry: 07-SEP-2021) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-SEP-2021, the patient experienced expired vaccine was given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine was given was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1691400
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210909; Test Name: Body temperature; Result Unstructured Data: Low grade fever 99.2 was the highest

Allergies:

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

Symptoms: LOW GRADE FEVER; EARLOBE AND EAR RED ON LEFT SIDE (RIGHT WHERE THE JAWBONE ENDS); EARLOBE AND EAR SWOLLEN ON LEFT SIDE (RIGHT WHERE THE JAWBONE ENDS); PAIN FROM EAR TO JAWBONE/EAR TO JAWBONE SORE/PAIN IN JAWBONE BELOW EAR/TIP OF THE JAW HAD LITTLE PAIN; HAD SOMETHING ON EAR AND SCRATCHED IT AND MAYBE THAT IS WHAT STARTED THE INFECTION; RASH ON LEG NEAR KNEE-ITCHY, A LITTLE REDNESS; This spontaneous report received from a patient concerned a 76 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: lymphedema, diverticulitis, osteoarthritis knee, and allergy to penicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On SEP-2021, the patient experienced had something on ear and scratched it and maybe that is what started the infection. On SEP-2021, the patient experienced rash on leg near knee-itchy, a little redness. On 08-SEP-2021, the patient experienced pain from ear to jawbone/ear to jawbone sore/pain in jawbone below ear/tip of the jaw had little pain. On 08-SEP-2021, the patient experienced earlobe and ear red on left side (right where the jawbone ends). On 08-SEP-2021, the patient experienced earlobe and ear swollen on left side (right where the jawbone ends). On 09-SEP-2021, the patient experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) Low grade fever 99.2 was the highest. Treatment medications (dates unspecified) included: sulfamethoxazole/trimethoprim. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on leg near knee-itchy, a little redness, was recovering from low grade fever, and pain from ear to jawbone/ear to jawbone sore/pain in jawbone below ear/tip of the jaw had little pain, had not recovered from earlobe and ear red on left side (right where the jawbone ends), and earlobe and ear swollen on left side (right where the jawbone ends), and the outcome of had something on ear and scratched it and maybe that is what started the infection was not reported. This report was non-serious.

Other Meds: ASPRIN

Current Illness: Diverticulitis; Lymphedema; Osteoarthritis knee; Penicillin allergy

ID: 1691401
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: Test Name: Brain scan NOS; Result Unstructured Data: no problem detected; Comments: 3 different type of brain scan performed and nothing showed up.

Allergies:

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

Symptoms: FORGETFULNESS; MILD PRESSURE ON THE RIGHT SIDE OF SKULL; NERVOUSNESS; TINGLING SENSATION ON RIGHT SIDE OF SKULL AT CROWN TO NECK NEAR LYMPH NODES; NUMBNESS ON RIGHT SIDE OF SKULL AT CROWN TO NECK NEAR LYMPH NODES; This spontaneous report received from a patient concerned a 69 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, Expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced forgetfulness, mild pressure on the right side of skull, nervousness, tingling sensation on right side of skull at crown to neck near lymph nodes, and numbness on right side of skull at crown to neck near lymph nodes. Laboratory data (dates unspecified) included: Brain scan NOS (NR: not provided) no problem detected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from forgetfulness, mild pressure on the right side of skull, and nervousness, and the outcome of numbness on right side of skull at crown to neck near lymph nodes and tingling sensation on right side of skull at crown to neck near lymph nodes was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1691402
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: SICKNESS WITHIN 4 HOUR; OTHER SYMPTOMS; FLU; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sickness within 4 hour, other symptoms, flu, and fever. Treatment medications (dates unspecified) included: ascorbic acid/calcium carbonate/calcium pantothenate/calcium phosphate/chromium/cyanocobalamin/folic acid/magnesium carbonate/magnesium hydroxide/manganese gluconate/nicotinic acid/potassium bicarbonate/potassium carbonate/potassium phosphate dibasic/pyridoxine hydrochloride/quercetin/riboflavin sodium phosphate/sodium bicarbonate/sodium phosphate/thiamine hydrochloride/thioctic acid/zinc ascorbate, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sickness within 4 hour, fever, other symptoms and flu was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1691403
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 05/17/2021
Rec V Date: 09/11/2021
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: ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 22 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: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 17-MAY-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210913164, 20210915623, 20210915646, 20210915661, 20210915731, 20210915748, 20210915852, 20210916129, 20210916129, 20210916228, 20210916300, 20210916312, 20210916401, 20210916415, 20210916455, 20210916465, 20210916498, 20210916520, 20210916553, 20210916584, 20210916650, 20210916697, 20210916715, 20210916768, 20210916808, 20210916811, 20210916849, 20210916907, 20210916910, 20210916959, 20210916965, 20210917074, 20210917160, 20210917163, 20210917226, 20210917500, 20210917515, 20210917603 and 20210917603.

Other Meds:

Current Illness:

ID: 1691404
Sex: U
Age:
State: WA

Vax Date:
Onset Date: 09/09/2021
Rec V Date: 09/11/2021
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: RECEIVED THE JANSSEN VACCINE TODAY AFTER HAVING THE MODERNA (POTENTIAL MEDICATION ERROR); This spontaneous report received from a health care professional concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had everything normal after getting vaccine. 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: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-SEP-2021, the patient experienced received the janssen vaccine today after having the moderna (potential medication error). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received the janssen vaccine today after having the moderna (potential medication error) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1691405
Sex: F
Age:
State: NM

Vax Date:
Onset Date: 09/05/2021
Rec V Date: 09/11/2021
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: FEELS HORRIBLE; CANNOT USE ARM; UNABLE TO SLEEP; MUSCLE FATIGUE; SHOOTING NERVE PAIN IN THE INJECTION SITE, INTO THE BACK, UP TO THE NECK AND DOWN THE ARM; MUSCLE WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 120 pounds, and height was 68 inches. The patient's concurrent conditions included: cholesterol, cigarette smoker 10 cigarettes/day, and non alcohol user, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced did not wear off for 2 weeks after receiving it at the dentist's office when treated with articaine hydrochloride/epinephrine bitartrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 26-AUG-2021 13:15 for prophylactic vaccination. Concomitant medications included rosuvastatin for cholesterol. On 05-SEP-2021, the patient experienced shooting nerve pain in the injection site, into the back, up to the neck and down the arm. On 05-SEP-2021, the patient experienced muscle fatigue. On 05-SEP-2021, the patient experienced muscle weakness. On 06-SEP-2021, the patient experienced unable to sleep. On 09-SEP-2021, the patient experienced cannot use arm. On an unspecified date, the patient experienced feels horrible. Treatment medications (dates unspecified) included: ibuprofen, diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shooting nerve pain in the injection site, into the back, up to the neck and down the arm, muscle weakness, unable to sleep, muscle fatigue, and cannot use arm, and the outcome of feels horrible was not reported. This report was non-serious.

Other Meds: ROSUVASTATIN

Current Illness: Abstains from alcohol; Cholesterol; Cigarette smoker (10 cigarettes/day)

ID: 1691406
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: AT 4 AM PATIENT WAS AWOKEN WITH AN AMBULANCE IN HEAD. 27,500HZ. HIGHEST "C" ON THE GRAND PIANO VERY LOUD SCREAMING SOUND IN HEAD AFTER THE SHOT,; FEVER NEXT DAY; HEADACHE; This spontaneous report received from a patient 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced at 4 am patient was awoken with an ambulance in head. 27, 500hz. highest "c" on the grand piano very loud screaming sound in head after the shot, fever next day, and headache. Treatment medications (dates unspecified) included: prednisone, and ascorbic acid/bioflavonoids nos/choline bitartrate/dl-methionine/hydroxocobalamin/inositol/nicotinamide/panthenol/pyridoxine/riboflavin/thiamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever next day, and headache, and the outcome of at 4 am patient was awoken with an ambulance in head. 27,500hz. highest "c" on the grand piano very loud screaming sound in head after the shot, was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1691407
Sex: F
Age: 57
State: CA

Vax Date: 07/21/2021
Onset Date: 08/11/2021
Rec V Date: 09/11/2021
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: None done to date - getting EKG next week and stress test

Allergies: Penecillin

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: 3 weeks after the vaccine I started to have an irregular heart beat. At first it was not constant but over a few more weeks it has gotten worse. Sometimes it settles but it is irregular most of the time

Other Meds: None

Current Illness: None

ID: 1691408
Sex: F
Age: 58
State: CA

Vax Date: 08/24/2021
Onset Date: 08/28/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Covid test rapid on 9/4/21; strep test negative on 9/4/21; Biopsy of lesion under tongue - results received 9/10/21. Biopsy diagnosis - Submucosal Inclusion Cyst, Benign

Allergies: Plaquenil; Arava; soy; strawberries; wheat; grass, dust

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Not sure if related or an adverse reaction to COVID-19 vaccine: Taking Rinvoq - immunosuppressant for Rheumatoid Arthritis: dentist found lesion under tongue on 8/28/21; saw oral surgeon on 8/31/21 - removed lesion and sent to lab for biopsy; 9/4/21 - Urgent care Visit - diagnosis throat infection and otitis media infection: antibiotic prescribed for 10 days. Covid test: negative; strep test: negative. Biopsy of lesion under tongue - results received 9/10/21 at oral surgeon's office. Biopsy diagnosis - Submucosal Inclusion Cyst, Benign.

Other Meds: Rinvoq; Flonase; Hormone patch; Claritin-D

Current Illness: chronic sinusitis

ID: 1691409
Sex: F
Age: 76
State: MD

Vax Date: 05/11/2021
Onset Date: 06/25/2021
Rec V Date: 09/11/2021
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: 2nd dose given 25June2021 (more than 36 days from the 1st dose); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 25June2021 (more than 36 days from the 1st dose)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676 and 022C21A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis, Fibrositis, Heartburn and Dry eyes. Concomitant products included FISH OIL for Dry eye, OMEPRAZOLE for Heartburn, MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 25June2021 (more than 36 days from the 1st dose)). On 25-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 25June2021 (more than 36 days from the 1st dose)) had resolved. No treatment medications were provided by the reporter. This case was linked to MOD-2021-154239 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-significant follow-up appended On 31-Aug-2021: Patient details, Medical history and concomitant products updated

Other Meds: OMEPRAZOLE; FISH OIL; MULTIVITAMINS [VITAMINS NOS]

Current Illness: Arthritis; Dry eyes; Fibrositis; Heartburn

ID: 1691410
Sex: F
Age:
State:

Vax Date: 03/24/2021
Onset Date: 04/05/2021
Rec V Date: 09/11/2021
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: 202003; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive for Covid 19

Allergies:

Symptom List: Nausea

Symptoms: Small bruises on different part of body; There is pain and the experience of being remote from my surroundings-fog lke.; pain; lethargy; graying of vision; I also have had headaches unlike any experienced before.; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Small bruises on different part of body), FEELING ABNORMAL (There is pain and the experience of being remote from my surroundings-fog lke.), PAIN (pain), LETHARGY (lethargy) and VISUAL IMPAIRMENT (graying of vision) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Iodine allergy, Environmental allergy (Numerous Environmental Allergies), Asthma since 15-Dec-1947 and Hypothyroidism. Concomitant products included CALCIUM CITRATE from 15-Jun-2019 to an unknown date for Bone disorder, THYROID (ARMOUR THYROID) for Hypothyroidism, DOCUSATE SODIUM (COLACE) from 30-Nov-2017 to an unknown date for Stools hard, MAGNESIUM CITRATE from 30-Nov-2017 to an unknown date and VITAMIN D NOS from 15-Jun-2019 to an unknown date for Supplementation therapy. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HEADACHE (I also have had headaches unlike any experienced before.). On an unknown date, the patient experienced CONTUSION (Small bruises on different part of body), FEELING ABNORMAL (There is pain and the experience of being remote from my surroundings-fog lke.), PAIN (pain), LETHARGY (lethargy) and VISUAL IMPAIRMENT (graying of vision). At the time of the report, CONTUSION (Small bruises on different part of body), FEELING ABNORMAL (There is pain and the experience of being remote from my surroundings-fog lke.), PAIN (pain) and HEADACHE (I also have had headaches unlike any experienced before.) had not resolved and LETHARGY (lethargy) and VISUAL IMPAIRMENT (graying of vision) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: positive (Positive) Positive for Covid 19. Patient says she has Headache behind eyes and nose, graying of vision, sensation of being remote from surroundings and lethargy. Treatment information was not provided Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Significant FU : Patient details, product details, concomitant medication , event outcome updated

Other Meds: ARMOUR THYROID; CALCIUM CITRATE; MAGNESIUM CITRATE; VITAMIN D NOS; COLACE

Current Illness: Asthma; Environmental allergy (Numerous Environmental Allergies); Hypothyroidism; Iodine allergy

ID: 1691411
Sex: F
Age: 87
State: OH

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 09/11/2021
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: Greater than 35 days between doses of the Moderna Covid-19 vaccine; Greater than 35 days between doses of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of the Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of the Moderna Covid-19 vaccine) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009DZ1A and 035C21A) for COVID-19 vaccination. Concurrent medical conditions included Latex allergy. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of the Moderna Covid-19 vaccine). On 05-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of the Moderna Covid-19 vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of the Moderna Covid-19 vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications information was not reported. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-302041 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow-up received: Patient demoghraphics, medical history and dose two details were added; Sender's Comments: US-MODERNATX, INC.-MOD-2021-302041:Same reporter

Other Meds:

Current Illness: Latex allergy

ID: 1691412
Sex: F
Age: 74
State: AZ

Vax Date: 02/12/2021
Onset Date: 03/27/2021
Rec V Date: 09/11/2021
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: Constant headahe right above her eyebrows; Always tired; Continuous nose bleed every day/runny nose bloody; Small red dot in her back of leg they are itchy/Small red dot in her back of leg they are itchy; Small red dot in her back of leg they are itchy/Small red dot in her back of leg they are itchy; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Continuous nose bleed every day/runny nose bloody), PRURITUS (Small red dot in her back of leg they are itchy/Small red dot in her back of leg they are itchy), MACULE (Small red dot in her back of leg they are itchy/Small red dot in her back of leg they are itchy), HEADACHE (Constant headahe right above her eyebrows) and FATIGUE (Always tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination. Concomitant products included MELOXICAM for Arthritis, LOSARTAN for Blood pressure high, PRAVASTATIN for Cholesterol, DULOXETINE for Fibromyalgia, OXYBUTYNIN for Urinary incontinence, MUPIROCIN, PREDNISONE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced EPISTAXIS (Continuous nose bleed every day/runny nose bloody), PRURITUS (Small red dot in her back of leg they are itchy/Small red dot in her back of leg they are itchy) and MACULE (Small red dot in her back of leg they are itchy/Small red dot in her back of leg they are itchy). On an unknown date, the patient experienced HEADACHE (Constant headahe right above her eyebrows) and FATIGUE (Always tired). At the time of the report, EPISTAXIS (Continuous nose bleed every day/runny nose bloody), PRURITUS (Small red dot in her back of leg they are itchy/Small red dot in her back of leg they are itchy), MACULE (Small red dot in her back of leg they are itchy/Small red dot in her back of leg they are itchy), HEADACHE (Constant headahe right above her eyebrows) and FATIGUE (Always tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Nose bleed started about 3 weeks after the second shot. Lab details reported include blood work, whose results are not provided. Treatment information reported as, itching stops with medication, came back once she stops taking medication. Patient had three appointments at doctor's office on 28 May 2021, 09 June 2021, 12 July at 3:45 Pm Patient had one appointment at ENT on 14 July at 2:00 Pm Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Added patient demographic details, vaccine facility information, new concomitants, events start date and additional captured I narrative

Other Meds: MUPIROCIN; PREDNISONE; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; LOSARTAN; PRAVASTATIN; OXYBUTYNIN; DULOXETINE; MELOXICAM

Current Illness:

ID: 1691413
Sex: F
Age:
State: MI

Vax Date: 06/10/2021
Onset Date: 07/09/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210309; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

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

Symptoms: Really dry mouth; chills; bodyaches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Really dry mouth), CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (low grade fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 007B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 09-Mar-2021. Concurrent medical conditions included Thyroid disorder NOS (1990's) and High cholesterol (1990's). Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFEXOR XL) for Anxiety, LOVASTATIN for Cholesterol, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for Routine health maintenance, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS. On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2021 at 8:00 AM, the patient experienced CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (low grade fever). On an unknown date, the patient experienced DRY MOUTH (Really dry mouth). On 10-Jul-2021, CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (low grade fever) had resolved. At the time of the report, DRY MOUTH (Really dry mouth) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. Treatment information not reported. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow-up information included updating patient information, medical history, dose detail, and newevents.

Other Meds: EFEXOR XL; LOVASTATIN; SYNTHROID; CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS

Current Illness: High cholesterol (1990's); Thyroid disorder NOS (1990's)

ID: 1691414
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: Got COVID-19 after getting the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Got COVID-19 after getting the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID-19 after getting the vaccine). At the time of the report, COVID-19 (Got COVID-19 after getting the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant product use was provided by the reporter. No treatment medication was provided. This case was linked to MOD-2021-253201 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Updated reporter information, causality for COVID-19 event and added a new event infection.

Other Meds:

Current Illness:

ID: 1691415
Sex: F
Age:
State: IL

Vax Date: 06/16/2021
Onset Date: 06/16/2021
Rec V Date: 09/11/2021
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 year old received first and second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received first and second dose) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 009C21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received first and second dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received first and second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Patient had no problem with both doses Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received on 27-JUL-2021 it contained second dose information, patient demographics were added. On 04-Sep-2021: Non significant follow up-patient initials added

Other Meds:

Current Illness:

ID: 1691416
Sex: M
Age: 35
State: NY

Vax Date: 02/09/2021
Onset Date:
Rec V Date: 09/11/2021
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: 20210709; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: positive for COVID-19

Allergies:

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

Symptoms: started to feel unwell; I also experienced lethargy; I experienced arm soreness that increased throughout the next day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started to feel unwell), LETHARGY (I also experienced lethargy) and MYALGIA (I experienced arm soreness that increased throughout the next day) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy, Allergy to molds (Mold and mildew) and Dust allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRETIC), SODIUM CHLORIDE (SALINASE [SODIUM CHLORIDE]), EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA), ASCORBIC ACID (VIT C), VIT D [VITAMIN D NOS] and ZINC for an unknown indication. On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (started to feel unwell), LETHARGY (I also experienced lethargy) and MYALGIA (I experienced arm soreness that increased throughout the next day). At the time of the report, MALAISE (started to feel unwell), LETHARGY (I also experienced lethargy) and MYALGIA (I experienced arm soreness that increased throughout the next day) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2021, SARS-CoV-2 test: positive (Positive) positive for COVID-19. Other Concomitant medication include Truevita and Barley green for an unknown indication.. No treatment medications were provided. This case was linked to MOD-2021-253075 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up report contains Patient demographics ,concomitant medication, facility information and new event were added .

Other Meds: ZYRETIC; SALINASE [SODIUM CHLORIDE]; TRUVADA; VIT C; VIT D [VITAMIN D NOS]; ZINC

Current Illness: Allergy to molds (Mold and mildew); Dust allergy; Seasonal allergy

ID: 1691417
Sex: F
Age: 36
State: NE

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Felt drunk; Muscle spasms in right top part of right elbow/ Muscle spasms in left area and thigh area; Had problems with talking; Wasn't thinking that well; Felt extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING DRUNK (Felt drunk), MUSCLE SPASMS (Muscle spasms in right top part of right elbow/ Muscle spasms in left area and thigh area), SPEECH DISORDER (Had problems with talking), THINKING ABNORMAL (Wasn't thinking that well) and FATIGUE (Felt extreme tiredness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) 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-Mar-2021, the patient experienced FEELING DRUNK (Felt drunk), MUSCLE SPASMS (Muscle spasms in right top part of right elbow/ Muscle spasms in left area and thigh area), SPEECH DISORDER (Had problems with talking), THINKING ABNORMAL (Wasn't thinking that well) and FATIGUE (Felt extreme tiredness). The patient was treated with BACLOFEN at a dose of 5 milligram three times a day. At the time of the report, FEELING DRUNK (Felt drunk), MUSCLE SPASMS (Muscle spasms in right top part of right elbow/ Muscle spasms in left area and thigh area), SPEECH DISORDER (Had problems with talking), THINKING ABNORMAL (Wasn't thinking that well) and FATIGUE (Felt extreme tiredness) 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 by reporter. This case was linked to MOD-2021-256655 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Added treatment medication Baclofen, Updated events outcome as Resolved. Rechallenge date and results were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1691418
Sex: F
Age: 22
State: SC

Vax Date: 03/10/2021
Onset Date:
Rec V Date: 09/11/2021
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: Past Vaccine window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past Vaccine window) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20a) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past Vaccine window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past Vaccine window) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were provided by the reporter No treatment medication were provided by the reporter. She has not received her second dose, and it has been five months now. Patient's mother wanted to know whether she can get her second dose now, or if she needs to start the series all over again. (There was no expiration date on the vaccination card). Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Patient indentifiers, and event information updated

Other Meds:

Current Illness:

ID: 1691419
Sex: F
Age: 41
State: CA

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 09/11/2021
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: problems with joints in elbows, knee and ankles they are horribly stiff; can barely move, can't move knees and arm; does not feel active as before; completely knocked off after 2nd dos; Right arm red to the touch; Right arm itches; 102.9 fever; Right arm bruised; Right arm has bumps all over; Right arm completely swollen; She can't work with her arm like this; This spontaneous case was reported by a nurse and describes the occurrence of CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this) and JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 17-Jul-2021, the patient experienced CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this), ERYTHEMA (Right arm red to the touch), PRURITUS (Right arm itches) and PYREXIA (102.9 fever). On an unknown date, the patient experienced JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff), HYPOKINESIA (can barely move, can't move knees and arm), ASTHENIA (does not feel active as before) and VACCINATION COMPLICATION (completely knocked off after 2nd dos). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this), JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff), HYPOKINESIA (can barely move, can't move knees and arm), ASTHENIA (does not feel active as before), VACCINATION COMPLICATION (completely knocked off after 2nd dos), ERYTHEMA (Right arm red to the touch), PRURITUS (Right arm itches) and PYREXIA (102.9 fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Significant follow-up : New event added

Other Meds:

Current Illness:

ID: 1691420
Sex: F
Age: 71
State:

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: vertigo/still has vertigo when lays down; dizziness/became dizzy when stand up/became dizzy when bend down/became dizzy when lay down/dizziness would last approximately 10 seconds and then resolve/; felt "wobbly", "like after drinking 3 glasses of champagne"; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo/still has vertigo when lays down), DIZZINESS (dizziness/became dizzy when stand up/became dizzy when bend down/became dizzy when lay down/dizziness would last approximately 10 seconds and then resolve/) and BALANCE DISORDER (felt "wobbly", "like after drinking 3 glasses of champagne") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo/still has vertigo when lays down), DIZZINESS (dizziness/became dizzy when stand up/became dizzy when bend down/became dizzy when lay down/dizziness would last approximately 10 seconds and then resolve/) and BALANCE DISORDER (felt "wobbly", "like after drinking 3 glasses of champagne"). At the time of the report, VERTIGO (vertigo/still has vertigo when lays down), DIZZINESS (dizziness/became dizzy when stand up/became dizzy when bend down/became dizzy when lay down/dizziness would last approximately 10 seconds and then resolve/) and BALANCE DISORDER (felt "wobbly", "like after drinking 3 glasses of champagne") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: TCR : e-mail address updated.

Other Meds: BABY ASPIRIN

Current Illness: Drug allergy (Codeine)

ID: 1691421
Sex: M
Age: 22
State: NE

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 09/11/2021
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: No Adverse event; Greater than 35 days since the patient's first Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient's first Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No Adverse event) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 033B21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient's first Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient's first Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No Adverse event) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant follow-up received on 03-Sept-2021. 2nd Dose details updated, race and ethinicity also updated.

Other Meds:

Current Illness:

ID: 1691422
Sex: M
Age: 73
State: MA

Vax Date: 07/29/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country; Interchange of vaccine product; Chills/got some shivering; Body aches; Tiredness; Low grade fever/fever; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), CHILLS (Chills/got some shivering), MYALGIA (Body aches) and FATIGUE (Tiredness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: COVID-19 VACCINE ASTRAZENECA. Concomitant products included ATENOLOL, GABAPENTIN, CELECOXIB, IBUPROFEN and OXYBUTYNIN for an unknown indication. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), CHILLS (Chills/got some shivering), MYALGIA (Body aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever/fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), CHILLS (Chills/got some shivering), MYALGIA (Body aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever/fever) 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. Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2021: New events added (lower grade fever, chills, tiredness, body aches). On 24-Aug-2021: Reporter details and new events shivering and fever were added.

Other Meds: ATENOLOL; GABAPENTIN; CELECOXIB; IBUPROFEN; OXYBUTYNIN

Current Illness:

ID: 1691423
Sex: F
Age: 70
State: CA

Vax Date: 06/26/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Warmness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warmness) and PRURITUS (Itchiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 041C21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-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 FEELING HOT (Warmness) and PRURITUS (Itchiness). At the time of the report, FEELING HOT (Warmness) and PRURITUS (Itchiness) had resolved. Concomitant medications included: Blood pressure medications Treatment information was not reported Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Includes no new information.

Other Meds:

Current Illness: Hypertension

ID: 1691424
Sex: F
Age: 75
State: AR

Vax Date: 06/25/2021
Onset Date: 07/27/2021
Rec V Date: 09/11/2021
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: sting; Tingling in back of neck, aching, couldn't rest; Burning up then feeling so cold, really cold; Afraid to take a bath ,afraid to fall/Every time I tried to get up I staggered, almost fell several times trying to find winter clothes; Felt very concerned, almost called 911; injection arm was real bad, swollen; Saturday morning felt the muscle was just twisted; itch; I have felt sick 2 more times after I reported to you/too sick/madly sick; Event description: 8 hours after the second dose felt very bad at night, so sick I couldn't sleep that night/ 14 hours no sleep; 48 hours after the second shot a cone of redness came up/red; feel something where needle was injected It's interfering with me; Itching and hurting at injection site; Hurting at injection site/painful; Headache; fever,have had fever some more since I talk to them/fever; muscle still hurts; Chills; Neck ache; sore arm/Arm is hurting ever since I got the shot/arm is still hurting and it has been over a month/does not hurt the same all the time/without doing anything it start hurting; loss of appetite/Didn't feel like eating anything; Second shot made me very sick; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck ache), PAIN IN EXTREMITY (sore arm/Arm is hurting ever since I got the shot/arm is still hurting and it has been over a month/does not hurt the same all the time/without doing anything it start hurting), DECREASED APPETITE (loss of appetite/Didn't feel like eating anything), MALAISE (Second shot made me very sick) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009021A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Syndrome Sjogren's. Concomitant products included LEVOTHYROXINE, ALENDRONATE SODIUM (ALENDRONATE), LORAZEPAM, ESTRADIOL, AMLODIPINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced NECK PAIN (Neck ache), PAIN IN EXTREMITY (sore arm/Arm is hurting ever since I got the shot/arm is still hurting and it has been over a month/does not hurt the same all the time/without doing anything it start hurting), DECREASED APPETITE (loss of appetite/Didn't feel like eating anything), MALAISE (Second shot made me very sick), ARTHROPOD STING (sting), PARAESTHESIA (Tingling in back of neck, aching, couldn't rest), FEELING COLD (Burning up then feeling so cold, really cold), FEAR OF FALLING (Afraid to take a bath ,afraid to fall/Every time I tried to get up I staggered, almost fell several times trying to find winter clothes), FEELING ABNORMAL (Felt very concerned, almost called 911), PERIPHERAL SWELLING (injection arm was real bad, swollen), MUSCLE TWITCHING (Saturday morning felt the muscle was just twisted), PRURITUS (itch), ILLNESS (I have felt sick 2 more times after I reported to you/too sick/madly sick), INSOMNIA (Event description: 8 hours after the second dose felt very bad at night, so sick I couldn't sleep that night/ 14 hours no sleep), ERYTHEMA (48 hours after the second shot a cone of redness came up/red), VACCINATION SITE REACTION (feel something where needle was injected It's interfering with me), VACCINATION SITE PRURITUS (Itching and hurting at injection site), VACCINATION SITE PAIN (Hurting at injection site/painful), HEADACHE (Headache), PYREXIA (fever,have had fever some more since I talk to them/fever), MYALGIA (muscle still hurts) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ALKA SELTZER PLUS [ACETYLSALICYLIC ACID]) for Adverse event, at an unspecified dose and frequency; BENZOCAINE (DERMOPLAST [BENZOCAINE]) for Adverse event, at an unspecified dose and frequency and GLUCOSE OXIDASE, LACTOPEROXIDASE (BIOTENE [GLUCOSE OXIDASE;LACTOPEROXIDASE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck ache), DECREASED APPETITE (loss of appetite/Didn't feel like eating anything), MALAISE (Second shot made me very sick), INFLUENZA LIKE ILLNESS (Flu like symptoms), ARTHROPOD STING (sting), PARAESTHESIA (Tingling in back of neck, aching, couldn't rest), FEELING COLD (Burning up then feeling so cold, really cold), FEAR OF FALLING (Afraid to take a bath ,afraid to fall/Every time I tried to get up I staggered, almost fell several times trying to find winter clothes), FEELING ABNORMAL (Felt very concerned, almost called 911), PERIPHERAL SWELLING (injection arm was real bad, swollen), MUSCLE TWITCHING (Saturday morning felt the muscle was just twisted), PRURITUS (itch), ILLNESS (I have felt sick 2 more times after I reported to you/too sick/madly sick), INSOMNIA (Event description: 8 hours after the second dose felt very bad at night, so sick I couldn't sleep that night/ 14 hours no sleep), ERYTHEMA (48 hours after the second shot a cone of redness came up/red), VACCINATION SITE REACTION (feel something where needle was injected It's interfering with me), VACCINATION SITE PRURITUS (Itching and hurting at injection site), VACCINATION SITE PAIN (Hurting at injection site/painful), HEADACHE (Headache), PYREXIA (fever,have had fever some more since I talk to them/fever), MYALGIA (muscle still hurts) and CHILLS (Chills) outcome was unknown and PAIN IN EXTREMITY (sore arm/Arm is hurting ever since I got the shot/arm is still hurting and it has been over a month/does not hurt the same all the time/without doing anything it start hurting) had not resolved. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received and New Events (Illness, Muscle twitching) added. Corresponding fields and narrative were updated. On 27-Aug-2021: Added New events and the outcome of the event- Pain in extremity updated.

Other Meds: LEVOTHYROXINE; ALENDRONATE; LORAZEPAM; ESTRADIOL; AMLODIPINE; MULTIVITAMINS [VITAMINS NOS]

Current Illness: Syndrome Sjogren's

ID: 1691425
Sex: F
Age: 39
State: FL

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: Heart rate; Result Unstructured Data: increased

Allergies:

Symptom List: Vomiting

Symptoms: Stress/anxiety; Stress/anxiety; heart issues; get the 2nd dose so late after the first one, I asked him if I was able to get the second dose now that its 8 months later / second dose 8 months later; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (Stress/anxiety), ANXIETY (Stress/anxiety), CARDIAC DISORDER (heart issues) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (get the 2nd dose so late after the first one, I asked him if I was able to get the second dose now that its 8 months later / second dose 8 months later) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STRESS (Stress/anxiety), ANXIETY (Stress/anxiety), CARDIAC DISORDER (heart issues) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (get the 2nd dose so late after the first one, I asked him if I was able to get the second dose now that its 8 months later / second dose 8 months later). At the time of the report, STRESS (Stress/anxiety), ANXIETY (Stress/anxiety) and CARDIAC DISORDER (heart issues) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (get the 2nd dose so late after the first one, I asked him if I was able to get the second dose now that its 8 months later / second dose 8 months later) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient went to the cardiologist for tests. No concomitant medications were reported. No treatment information was reported Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Significant follow up appended: event addition On 30-Aug-2021: Non-Significant Follow up document received contains no new information. On 30-Aug-2021: Non-Significant Follow up document received contains no new information.

Other Meds:

Current Illness:

ID: 1691426
Sex: F
Age: 62
State: OK

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 09/11/2021
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: a little puny; heart racing like an adrenaline rush, heart racing; out of breath or become winded, Today she has felt more difficulty with breathing; dizzier; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (a little puny), PALPITATIONS (heart racing like an adrenaline rush, heart racing), DYSPNOEA (out of breath or become winded, Today she has felt more difficulty with breathing) and DIZZINESS (dizzier) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044A21A) for COVID-19 vaccination. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 12-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced ASTHENIA (a little puny), PALPITATIONS (heart racing like an adrenaline rush, heart racing), DYSPNOEA (out of breath or become winded, Today she has felt more difficulty with breathing) and DIZZINESS (dizzier). At the time of the report, ASTHENIA (a little puny) and DIZZINESS (dizzier) outcome was unknown, PALPITATIONS (heart racing like an adrenaline rush, heart racing) had not resolved and DYSPNOEA (out of breath or become winded, Today she has felt more difficulty with breathing) was resolving. No treatment medication were reported Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Reporter information- Occupation updated and Report Sent to Regulatory Authority by Reporter from the initial case.Significant Follow-up received on 31-AUG-2021 contains: Updated Patient demographics, Dose details, Concomitant medications and outcome of the event -'out of breath or become winded, Today she has felt more difficulty with breathing'.

Other Meds: OMEPRAZOLE; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1691427
Sex: F
Age:
State: OK

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 09/11/2021
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: feverish; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (feverish). At the time of the report, PYREXIA (feverish) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medication were provided. No treatment details were provided This case was linked to MOD-2021-275750 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received: Reporter's additional Contact information updated.

Other Meds:

Current Illness:

ID: 1691428
Sex: F
Age:
State: FL

Vax Date: 04/23/2021
Onset Date:
Rec V Date: 09/11/2021
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: vacine site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vacine site pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (vacine site pain). At the time of the report, VACCINATION SITE PAIN (vacine site pain) outcome was unknown. No concomitant product information was provided by the reporter. No treatment information was provided by the reporter. This case was linked to MOD-2021-085605 (Patient Link). Based on current available information and the temporal association between product sue and the start of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-085605 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received and contains no new information.; Sender's Comments: Based on current available information and the temporal association between product sue and the start of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1691429
Sex: F
Age: 88
State: CA

Vax Date: 01/31/2021
Onset Date:
Rec V Date: 09/11/2021
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: Chills; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (slight fever) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001821A and 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (slight fever). At the time of the report, CHILLS (Chills) and PYREXIA (slight fever) outcome was unknown. Concomitant medications were not reported. Treatment details not provided. The patient had queried about information about the contamination of Moderna COVID-19 vaccine vials, about the third dose and comparisons with a booster of the Pfizer COVID-19 vaccine and why the Moderna COVID-19 vaccine has not been approved yet in the country. Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: significant Follow up: updated narrative

Other Meds:

Current Illness:

ID: 1691430
Sex: F
Age: 53
State: GA

Vax Date: 07/27/2021
Onset Date: 08/02/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: not got the second shot; HCP feels having neorological event due to vaccine; Numbness and sharp pain has spread into my knees and lower back.; Numbness and sharp pain has spread into my knees and lower back.; says she cannot walk barefoot due to pain; accidentally hit hand on something and shooting pain went up her arm; numbness and tingling is occurring in both arms, both legs and both feet which started this past Monday 2Aug; tingling and numbness in hands and feet/toes; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (HCP feels having neorological event due to vaccine), GAIT DISTURBANCE (says she cannot walk barefoot due to pain), PARAESTHESIA (tingling and numbness in hands and feet/toes), PAIN IN EXTREMITY (accidentally hit hand on something and shooting pain went up her arm) and HYPOAESTHESIA (numbness and tingling is occurring in both arms, both legs and both feet which started this past Monday 2Aug) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D2119) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Migraine and Allergy. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ALLERGY) for Allergy, ASCORBIC ACID (VITAMINE C), ZINC and CYANOCOBALAMIN (COBALAMIN) for Immune system disorder, CAFFEINE, PHENAZONE (MIGRAENE [CAFFEINE;PHENAZONE]) and NAPROXEN SODIUM, SUMATRIPTAN SUCCINATE (TREXIMET) for Migraine, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation, HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]) for an unknown indication. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced PARAESTHESIA (tingling and numbness in hands and feet/toes). On 06-Aug-2021, the patient experienced GAIT DISTURBANCE (says she cannot walk barefoot due to pain), PAIN IN EXTREMITY (accidentally hit hand on something and shooting pain went up her arm) and HYPOAESTHESIA (numbness and tingling is occurring in both arms, both legs and both feet which started this past Monday 2Aug). On 23-Aug-2021, the patient experienced BACK PAIN (Numbness and sharp pain has spread into my knees and lower back.) and ARTHRALGIA (Numbness and sharp pain has spread into my knees and lower back.). On 30-Aug-2021, the patient experienced NEUROLOGICAL SYMPTOM (HCP feels having neorological event due to vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not got the second shot). The patient was treated with PARACETAMOL (TYLENOL ARTHRITIS) at a dose of 1 dosage form. At the time of the report, NEUROLOGICAL SYMPTOM (HCP feels having neorological event due to vaccine), GAIT DISTURBANCE (says she cannot walk barefoot due to pain), PAIN IN EXTREMITY (accidentally hit hand on something and shooting pain went up her arm), BACK PAIN (Numbness and sharp pain has spread into my knees and lower back.) and ARTHRALGIA (Numbness and sharp pain has spread into my knees and lower back.) outcome was unknown, PARAESTHESIA (tingling and numbness in hands and feet/toes) and HYPOAESTHESIA (numbness and tingling is occurring in both arms, both legs and both feet which started this past Monday 2Aug) had not resolved and PRODUCT DOSE OMISSION ISSUE (not got the second shot) 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. Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow-up document received on 30-AUG-2021 contains Reporter address, Patient demographics- race and ethnicity , medical history, new concomitant medications, new events and event outcome were updated.

Other Meds: SINGULAIR; MULTIVITAMINS [VITAMINS NOS]; DIURETIC [HYDROCHLOROTHIAZIDE]; MIGRAENE [CAFFEINE;PHENAZONE]; VITAMINE C; CETIRIZINE HYDROCHLORIDE ALLERGY; TREXIMET; ZINC; COBALAMIN

Current Illness: Allergy; Migraine

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am