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: 1797345
Sex: F
Age:
State: PA

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 10/19/2021
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: Sore at injection site; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 23Feb2021 at 14:45 (Lot Number: EL3247, unknown expiration) as dose 1, single at the age of 47 years old for COVID-19 immunisation. Medical history included allergies to gluten and dairy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) and ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). No other vaccine in four weeks. No history of COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient experienced sore at injection site on 23Feb2021 at 16:30. The patient did not receive treatment for the event. The patient has not yet recovered from the event. No follow-up attempts are possible; information about batch number was already obtained.

Other Meds: ALLEGRA; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYR

Current Illness:

ID: 1797346
Sex: M
Age:
State:

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 10/19/2021
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: This is a spontaneous report from a contactable other healthcare professional. A 71-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Feb 26, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient previously took the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. Reportedly, she and her husband both had a sore arm for 2 days after the vaccine was administered. She stated she also had a sore arm after her flu shot. She took B12 injections every 30 days. She wondered if it would be safe for her to take the B12 injections before the vaccine or if should she wait. She wanted to know if it was ok to take pain/fever reducing medication after receiving the Pfizer vaccine. The outcome of the event: unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1797347
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: felt like he had a terrible cold; This is a spontaneous report from a Pfizer-sponsored program, received from an other-HCP (parent). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 2, single for Covid-19 immunization. The patients medical history and concomitant were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization and experienced sleepy. On an unspecified date the patient experienced terrible cold. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1797348
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: feeling a little ill; irritated; This is a spontaneous report from a contactable consumer (patient) from a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feeling a little ill and irritated. The reporter got the first dose and she called for two concerns. First she was feeling a little ill or irritated after the first shot but now she was better. Second she was asking if she can go out and meet her family. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1797349
Sex: F
Age:
State: KS

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 10/19/2021
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: inflamed lymph nodes left armpit; headache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 22Feb2021 at 14:15 (Lot Number: EN5318, unknown expiration) as dose 2, single at the age of 49 years old for COVID-19 immunisation. Medical history reported as none. No known allergies. No history of COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318) on 29Jan2021 at 14:00 in left arm at the age of 49 years old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced inflamed lymph nodes left armpit and headache on 23Feb2021. The patient did not receive treatment for the events. The patient has not yet recovered from the events. No follow-up attempts are possible; information about batch number was already obtained.

Other Meds:

Current Illness:

ID: 1797350
Sex: M
Age:
State: FL

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 10/19/2021
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: sore arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Feb2021 at 11:00 (Lot Number: EN6201, unknown expiration) as dose 2, single at the age of 75 years old (as reported) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9263) on 22Jan2021 at 14:30 in left arm at the age of 75 years old (as reported) for COVID-19 immunization. The patient called because he was concerned that his second COVID shot seemed extremely quick in a matter of few seconds. The patient wanted reassurance that the shot could be administered that fast. The patient experienced sore arm on unspecified date. Outcome of the event was unknown. No follow-up attempts are possible; information about batch number was already obtained.

Other Meds:

Current Illness:

ID: 1797351
Sex: F
Age:
State: MA

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 10/19/2021
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: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot Number: EL3247), via an unspecified route of administration, administered in left arm on 23Feb2021 at 09:30, (at the age of 42-years-old) as dose number unknown, single dose for covid-19 immunization. Patient was non pregnant at the time of vaccination. The patient's medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID) (daily prescribed medicine) taken for an unspecified indication from an unspecified start date and ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with covid 19 prior to vaccination and patient not tested for covid 19 since the vaccination. On 23Feb2021 at 09:30, the patient experienced sore arm. No treatment received for adverse event. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: SYNTHROID

Current Illness:

ID: 1797352
Sex: F
Age:
State:

Vax Date: 02/19/2021
Onset Date: 02/01/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: arm was sore; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer or other non-HCP. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiry date was not reported), dose 1 via an unspecified route of administration on 19Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patients arm was sore. The patient was wondering when she would need to go back for second dose. Relayed 21 days between doses and said everything went well after vaccine just arm was sore. The patient was advised to contact facility of 1st dose to make 2nd dose appointment. The clinical outcome for the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1797353
Sex: F
Age:
State: PA

Vax Date: 02/14/2021
Onset Date: 02/01/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: diarrhea; nausea; lightheaded; acid reflux; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included COVID virus in Nov2020. The patient's concomitant medications were not reported. The patient experienced diarrhea, nausea, lightheaded and acid reflux on an unspecified date in Feb2021 since getting the first vaccine and is still experiencing side effects. She was asking if she should get the second dose. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1797354
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: hurt to raise her arm the day after the shot.; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 70-years-old female patient received bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hurt to raise her arm the day after the shot on an unspecified date. The outcome of the event was unknown. Information about lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1797355
Sex: F
Age:
State:

Vax Date: 02/11/2021
Onset Date: 02/01/2021
Rec V Date: 10/19/2021
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: Sore arm; vaccination site pain; This is a spontaneous report from a contactable consumer based on the information received by Pfizer. (Mfr Report #: UNT-2021-003071). A contactable 58-year old female consumer reported. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 11Feb2021 (at the age of 58-years-old) as a single dose for covid-19 immunization; treprostinil sodium (REMODULIN, Lot Number: 2101713; Expiration Date: 31Mar2022; concentration of 1.0 mg/ml), intravenous drip on 20Dec2019, at unknown dose,0.02 ?g/kg for primary pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medication(s) included ambrisentan; sildenafil citrate. The patient experienced the event of sore arm from COVID vaccine (vaccination site pain) on Feb2021. Action taken with IV Remodulin was dose not changed due to the event of vaccination site pain. At the time of reporting, the outcome of events was resolved on an unspecified date in 2021. The reporter assessed the causal relationship between IV Remodulin, and the event of vaccination site pain as not related. No follow-up attempts are possible. No further information is expected.

Other Meds: AMBRISENTAN; SILDENAFIL CITRATE

Current Illness: Pulmonary arterial hypertension

ID: 1797356
Sex: M
Age:
State: KY

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Mind fog; Head ache; Body ache; night sweating; inability to concentrate; sense of balance; loss of appetite; general feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198), administered in the left arm, on 08Mar2021 at 13:15 (at the age of 69-years-old) at dose 1, single for COVID-19 immunisation. Medical history included COVID prior vaccination; Kienbock's disease; chronic lymphocytic leukemia; rheumatoid arthritis. No COVID tested post vaccination. The patient had not known allergies. No other vaccine received in four weeks. Concomitant medications included allopurinol, pravastatin, fluoxetine, meloxicam; reported as other medications in two weeks. The patient experienced headache, body ache, night sweating, inability to concentrate, sense of balance, mind fog, loss of appetite and general feeling of exhaustion on 09Mar2021 at 01:00. No treatment administered for the events. The patient was recovering from the events.

Other Meds: ALLOPURINOL; PRAVASTATIN; FLUOXETINE; MELOXICAM

Current Illness:

ID: 1797357
Sex: F
Age:
State: IN

Vax Date: 03/14/2021
Onset Date: 03/15/2021
Rec V Date: 10/19/2021
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: BLOOD WORK; Result Unstructured Data: Test Result:Fine; Comments: they did all the bloodwork and all sorts of stuff and clarified that everything was fine

Allergies:

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

Symptoms: Headache; she feels dizzy/woke up feeling really really dizzy; Caller stated her ears and head feel full- it felt like a migraine after 1st and 2nd dose of Covid vaccine; Sensitive to sound and light; Sensitive to sound and light; described as a weird feeling; very stuffy in her sinuses; stiffness kind of headache probably from sleeping weird; slept pretty much all day on and off; Her eye still hurts; This is a spontaneous report received from a female contactable healthcare professional (Registered nurse) reported for herself that. A 42-year-old female patient received second bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6208) second dose via an unspecified route of administration, administered in deltoid right muscle on 14Mar2021 at 08:30 AM (at the age of 42-year-old) at single dose for COVID-19 immunization. The patient previously received first dose bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, administered in deltoid right muscle on 20Feb2021 (she thinks she received it on this date) (at the age of 41-year-old) at single dose for COVID-19 immunisation. The patient reported that after her first Pfizer vaccine dose she experienced some brain fog, headache, her ears and head feel full, it felt like a migraine, felt sensitive to sound and light and couldn't watch TV and very stuffy in her sinuses. The patient's Medical History (including any illness at time of vaccination) was reported as none. Family Medical History relevant to adverse events was reported as sister got the Moderna vaccine and had a really tough time with both doses. Concomitant medications were not reported. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as COVID dose 1 vaccine. Additional vaccines administered on same date of the Pfizer suspect was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received COVID vaccine so that she can work safely. The patient slept pretty much all day on and off after she received the vaccine and woke up really really dizzy and had a really bad headache. On 15Mar2021, when she got up at around 7:38 AM in the morning, she woke up feeling really dizzy and it made her worry. The patient thought her blood sugar might be low or this might be anxiety so she tried to eat something. The patient felt little bit better, after she did eat something, but it was still not a normal feeling for her. The patient reported that her ears and head feel full and it felt like a migraine after 1st and 2nd dose of COVID vaccine. The patient reported that she had a stiffness kind of headache probably from sleeping weird. The patient felt sensitive to sound and light and described this as a weird feeling and it was otherwise explained as a migraine. The patient clarified that with the first dose, this feeling started on the second day after the vaccine. The patient clarified she was also very stuffy in her sinuses and it could be related to that too, but she does not know. The patient had still fullness in her sinuses and her eye still hurts, but she does not have a cold. The patient received treatment with Acetaminophen extra strength 500 mg, 2 caplets twice about 6 or 7 hours after the vaccine and took another dose again at 11 or 12pm (the patient thought it was closer to 11). The patient explained that we hear about nausea, swelling, pain at the injection site and do not typically see dizziness listed as the typical side effect- thats why she called. The patient underwent all the bloodwork and all sorts of stuff of testing done before the vaccine and clarified that everything was fine. Adverse events did not require a visit to emergency room or Physician Office. Investigation assessment was not done. The patient was feeling dizzy on the day of report. The patient was calling to make sure that the dizziness was normal after the second dose. The patient reported that she could not find information that is credible that lists dizziness as a side effect from the COVID vaccine unless, time to seek medical attention. Dizziness made her to ask questions because it was not something typically seen. The clinical outcome of events headache, she feels dizzy/woke up feeling really really dizzy, her ears and head feel full, it felt like a migraine sensitive to sound and light, could not watch television (TV) described as a weird feeling and eye still hurts as not recovered and the events very stuffy in her sinuses, stiffness kind of headache probably from sleeping weird and slept pretty much all day on and off was unknown. Verbatim event relatedness to Covid vaccine: woke up feeling really really dizzy, really bad headache- ears and head feel full; felt like a migraine after 1st and 2nd dose. Sensitive to sound and light, couldn't watch TV, described as a weird feeling was related. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1797358
Sex: F
Age:
State: OH

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: sore upper arm for 24-36 hours after injection; pregnant at 35 weeks at the time of vaccination; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, in the right arm, on 09Mar2021 09:15 (Lot number: EL9264), at age 32 years old, as dose 1, single, for COVID-19 immunisation, at a school/student health clinic. Relevant medical history and concomitant medications were not reported. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for immunisaiton on 24Feb2021; sertraline, loratadine (CLARITIN) and an unspecified prenatal vitamin all for unknown indications, start and stop dates not reported. The patient was pregnant at 35 weeks at the time of vaccination. The pregnancy due date was reported as 12Apr2021. On 09Mar2021 at 12:00, the patient had sore upper arm for 24-36 hours after injection. No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19 via nasal swab in 2021 with negative result. The patient recovered from sore upper arm for 24-36 hours after injection in Mar2021.

Other Meds: SERTRALINE; CLARITIN [LORATADINE]

Current Illness:

ID: 1797420
Sex: F
Age: 39
State: CA

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 10/19/2021
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: sensation of throat closing, prolonged wheezing, shortness of breath and chest pain; sensation of throat closing, prolonged wheezing, shortness of breath and chest pain; sensation of throat closing, prolonged wheezing, shortness of breath and chest pain; sensation of throat closing, prolonged wheezing, shortness of breath and chest pain; This spontaneous case was reported by a physician and describes the occurrence of WHEEZING (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain), DYSPNOEA (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain), CHEST PAIN (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain) and OROPHARYNGEAL DISCOMFORT (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma and Sulfonamide allergy (allergic to sulfa medications). On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WHEEZING (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain) (seriousness criterion medically significant), DYSPNOEA (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain) (seriousness criterion medically significant), CHEST PAIN (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain) (seriousness criterion medically significant) and OROPHARYNGEAL DISCOMFORT (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE (EPIPEN) for Throat discomfort, at an unspecified dose and frequency. At the time of the report, WHEEZING (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain), DYSPNOEA (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain), CHEST PAIN (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain) and OROPHARYNGEAL DISCOMFORT (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered WHEEZING (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain), DYSPNOEA (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain), CHEST PAIN (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain) and OROPHARYNGEAL DISCOMFORT (sensation of throat closing, prolonged wheezing, shortness of breath and chest pain) to be related. No concomitant medication details was reported. After her vaccine dose, she felt like throat was closing and used her epipen. There was no relief so she was treated at the ER. She also experienced wheezing, shortness of breath and chest pain. She is allergic to sulfa medications. She continues to have these symptoms almost 8 months later. She has seen multiple specialists including pulmonologist, cardiologist, allergist. She is not improved with asthma treatment. Further testing was unrevealing. This case concerns a 40-year-old, female patient with previous relevant medical history of asthma and sulfonamide allergy, who experienced the unexpected events of wheezing, dyspnoea, chest pain and oropharyngeal discomfort. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of asthma and sulfonamide allergy remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 40-year-old, female patient with previous relevant medical history of asthma and sulfonamide allergy, who experienced the unexpected events of wheezing, dyspnoea, chest pain and oropharyngeal discomfort. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of asthma and sulfonamide allergy remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. t.

Other Meds:

Current Illness: Asthma; Sulfonamide allergy (allergic to sulfa medications)

ID: 1797425
Sex: M
Age: 76
State: CA

Vax Date: 03/06/2021
Onset Date:
Rec V Date: 10/19/2021
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: He did not get the 2nd dose; His doctor's said he was allergic to the shot; bled profusely through the donor site; broke out in hives from head to feethives lasted 6 weeks; This spontaneous case was reported by a consumer and describes the occurrence of POST PROCEDURAL HAEMORRHAGE (bled profusely through the donor site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Burn (Spent 3 weeks at a burn center for burns to both hands & his donor site was on his leg.). On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST PROCEDURAL HAEMORRHAGE (bled profusely through the donor site) (seriousness criterion medically significant), URTICARIA (broke out in hives from head to feethives lasted 6 weeks), ALLERGY TO VACCINE (His doctor's said he was allergic to the shot) and PRODUCT DOSE OMISSION ISSUE (He did not get the 2nd dose). At the time of the report, POST PROCEDURAL HAEMORRHAGE (bled profusely through the donor site) and ALLERGY TO VACCINE (His doctor's said he was allergic to the shot) outcome was unknown and URTICARIA (broke out in hives from head to feethives lasted 6 weeks) and PRODUCT DOSE OMISSION ISSUE (He did not get the 2nd dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was provided. No treatment medication details was provided. Prior to getting the dose patient spent 3 weeks at a burn center for burns to both hands & his donor site was on his leg. About 10 days later patient received his 1st dose & broke out in hives from head to feet & bled profusely through the donor site. Company Comment: This case concerns a 76-year-old, male patient with relevant medical history included burns to both hands, who experienced, serious unlisted event of post procedural haemorrhage, among other non-serious events. The event occurred after an unspecified duration from 1st dose of Moderna COVID-19 Vaccine. The rechallenge was unknown as the date just for first dose was provided. However, it is reported that subject never received 2nd dose of vaccine. The medical history of burns to both hands remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 76-year-old, male patient with relevant medical history included burns to both hands, who experienced, serious unlisted event of post procedural haemorrhage, among other non-serious events. The event occurred after an unspecified duration from 1st dose of Moderna COVID-19 Vaccine. The rechallenge was unknown as the date just for first dose was provided. However, it is reported that subject never received 2nd dose of vaccine. The medical history of burns to both hands remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1797426
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 10/11/2021
Rec V Date: 10/19/2021
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: LIGHT HEADEDNESS; PULSING SENSATION AT BACK OF HEAD; RIGHT LEG FEELS LIKE WEIRD CIRCULATION; CHILLS; CHEST PAIN (LOCATED IN THE CENTRE-LEFT SIDE OF CHEST); This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not had any drug abuse or illicit drug use, no prior medical history, did not take any other medications regularly and had not sought medical advice yet. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 11-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-OCT-2021, the patient experienced chest pain (located in the centre-left side of chest). On 12-OCT-2021, the patient experienced right leg feels like weird circulation. On 12-OCT-2021, the patient experienced chills. On 13-OCT-2021, the patient experienced light headedness. On 13-OCT-2021, the patient experienced pulsing sensation at back of head. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 12-OCT-2021, and had not recovered from light headedness, pulsing sensation at back of head, chest pain (located in the centre-left side of chest), and right leg feels like weird circulation. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (Consume 2 cups a week); Non-smoker; Seasonal allergy

ID: 1797427
Sex: U
Age:
State:

Vax Date:
Onset Date: 10/12/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Date: 20211012; Test Name: Body temperature; Result Unstructured Data: Fever 102

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: 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: Unk) dose was not reported, administered on 12-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-OCT-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) Fever 102. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

Date Died:

ID: 1797428
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: DEATH; This spontaneous report received from a consumer (social media) via a company representative concerned a male of unspecified age, race and ethnic origin. 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 administration not reported, batch number: unknown expiry: unknown) dose, start therapy date were not reported, frequency time 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the reporter stated that, "vaccine killed my brother". The patient died from an unknown cause of death. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from unknown cause of death This report was serious (Death).; Sender's Comments: V0 20211031250-COVID-19 VACCINE AD26.COV2.S-death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1797429
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SKIN ON FIRE; LOST TASTE; VERTIGO; SPINE BACK PAIN; CHILLS; NUMBNESS IN EXTREMITIES; DEEP MUSCLE PAIN; NAUSEA; FATIGUE; WEAKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced skin on fire. On AUG-2021, the patient experienced lost taste. On AUG-2021, the patient experienced vertigo. On AUG-2021, the patient experienced spine back pain. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced numbness in extremities. On AUG-2021, the patient experienced deep muscle pain. On AUG-2021, the patient experienced nausea. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep muscle pain, skin on fire, lost taste, numbness in extremities, vertigo, chills, nausea, fatigue, weakness, and spine back pain. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797430
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: LARGE LUMP ON THE BACK OF NECK; SEVERE PAIN; DIFFICULTY WALKING AND STANDING; This spontaneous report received from a parent concerned a male of unspecified age, race and ethnicity via social media. 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) once total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced large lump on the back of neck, severe pain, and difficulty walking and standing, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the large lump on the back of neck, severe pain and difficulty walking and standing was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211031631-COVID-19 VACCINE AD26.COV2.S-Large lump on the back of neck, Severe pain , Difficulty walking and standing 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:

ID: 1797431
Sex: U
Age:
State:

Vax Date:
Onset Date: 02/01/2021
Rec V Date: 10/19/2021
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: BODY ACHES; FATIGUE; FEVER; RECEIVED 2ND DOSE AFTER 57 DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on FEB-2021, and dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On FEB-2021, the patient experienced received 2nd dose after 57 days. On FEB-2021, the patient experienced fatigue. On FEB-2021, the patient experienced fever. On APR-2021, the patient experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fatigue, and fever, and the outcome of received 2nd dose after 57 days was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797432
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 10/19/2021
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: falling sleep in the parking lot/sleeping for 14-15hours; palpitations; shortness of breath; Edema; swelling in her ankles -both legs; I have pain in my hand, in the digit of my fingers; pain in the small joints in the hands; feeling extremely fatigued for 4-5 weeks/persisting fatigue; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (falling sleep in the parking lot/sleeping for 14-15hours), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath), OEDEMA (Edema) and JOINT SWELLING (swelling in her ankles -both legs) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Open heart surgery (Patient had two open heart surgeries and had a pacemaker) and Artificial cardiac pacemaker user. Concomitant products included LOSARTAN, METOPROLOL, POTASSIUM and CALCIUM for an unknown indication. In April 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 HYPERSOMNIA (falling sleep in the parking lot/sleeping for 14-15hours), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath), OEDEMA (Edema), JOINT SWELLING (swelling in her ankles -both legs), PAIN IN EXTREMITY (I have pain in my hand, in the digit of my fingers), ARTHRALGIA (pain in the small joints in the hands), FATIGUE (feeling extremely fatigued for 4-5 weeks/persisting fatigue) and VACCINATION SITE PAIN (pain in the injection site). At the time of the report, HYPERSOMNIA (falling sleep in the parking lot/sleeping for 14-15hours), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath), OEDEMA (Edema), JOINT SWELLING (swelling in her ankles -both legs), FATIGUE (feeling extremely fatigued for 4-5 weeks/persisting fatigue) and VACCINATION SITE PAIN (pain in the injection site) had resolved, PAIN IN EXTREMITY (I have pain in my hand, in the digit of my fingers) outcome was unknown and ARTHRALGIA (pain in the small joints in the hands) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. As per the document patient also reported Concomitant medication such as blood pressure pills, over the counter multivitamins and bunch of meds. No treatment medications was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow-up received 08-OCT-2021 event like pain in hand added.; Sender's Comments: This case concerns a 69 year-old, female with a history of heart surgeries and who is a pacemaker user , who experienced the unexpected non-serious events of HYPERSOMNIA, PALPITATIONS, DYSPNOEA, OEDEMA, JOINT SWELLING, PAIN IN EXTREMITY, FATIGUE, ARTHRALGIA and VACCINATION SITE PAIN. The events occurred approximately 2-3 days after the first dose of mRNA-1273 Moderna vaccine. The rechallenge is N/A (no information about 2nd dose was provided). using a pacemaker could be a confounder for cardiac rhythm disturbance. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.

Other Meds: LOSARTAN; METOPROLOL; POTASSIUM; CALCIUM

Current Illness:

ID: 1797433
Sex: F
Age: 20
State: FL

Vax Date: 10/03/2021
Onset Date: 10/03/2021
Rec V Date: 10/19/2021
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: The needle got block and didn't went all inside the muscle maybe half a needle stay outside; The vaccine didn't went all into the muscle and some went subcutaneous; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The needle got block and didn't went all inside the muscle maybe half a needle stay outside) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The vaccine didn't went all into the muscle and some went subcutaneous) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The needle got block and didn't went all inside the muscle maybe half a needle stay outside) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The vaccine didn't went all into the muscle and some went subcutaneous). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The needle got block and didn't went all inside the muscle maybe half a needle stay outside) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The vaccine didn't went all into the muscle and some went subcutaneous) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided.; Sender's Comments: This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected events of incorrect route of product administration and wrong technique in device usage process. The events incorrect route of product administration and wrong technique in device usage process occurred right after the unknown dose number of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1797434
Sex: M
Age: 61
State: OH

Vax Date: 01/15/2021
Onset Date: 09/30/2021
Rec V Date: 10/19/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: 3 blood clots in the leg; 2 boold clot in the lungs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (3 blood clots in the leg) and PULMONARY EMBOLISM (2 boold clot in the lungs) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced THROMBOSIS (3 blood clots in the leg) (seriousness criteria hospitalization and medically significant) and PULMONARY EMBOLISM (2 boold clot in the lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 30-Sep-2021 to 02-Oct-2021 due to PULMONARY EMBOLISM and THROMBOSIS. On 02-Oct-2021, THROMBOSIS (3 blood clots in the leg) and PULMONARY EMBOLISM (2 boold clot in the lungs) had resolved. No concomitant medication were provided. Patient mentioned that he did not had any cardiovascular issues before. Patient was discharged on blood thinners. Company Comment This case concerns a 62-year-old, male patient, with no disclosed medical history, who experienced the serious, unexpected, AESI events of pulmonary embolism and thrombosis. The events occurred 7 months after second dose of Moderna vaccine. The rechallenge is not applicable as a third dose is not expected. The long onset latency of 7 months remain as confounder to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 62-year-old, male patient, with no disclosed medical history, who experienced the serious, unexpected, AESI events of pulmonary embolism and thrombosis. The events occurred 7 months after second dose of Moderna vaccine. The rechallenge is not applicable as a third dose is not expected. The long onset latency of 7 months remain as confounder to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1797435
Sex: M
Age: 62
State: LA

Vax Date: 09/11/2021
Onset Date: 10/09/2021
Rec V Date: 10/19/2021
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: Hyperactive; Could not sit still; Was really hungry; Start sweating; Arms hurting; Body aches / severe body aches; Headache; Low grade temperature; Chills / bad chills; So weak / really weak; Low appetite; Really cold with terrible chills then really hot and sweating; Been really sick for 2 and half days; Really hot/felt like sun burned; Felt like sun burned; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still), ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite) and FEELING COLD (Really cold with terrible chills then really hot and sweating) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A and 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN/HCTZ) and AMLODIPINE for an unknown indication. On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite), FEELING COLD (Really cold with terrible chills then really hot and sweating), ILLNESS (Been really sick for 2 and half days), FEELING HOT (Really hot/felt like sun burned), BURNING SENSATION (Felt like sun burned), HYPERHIDROSIS (Start sweating), PAIN IN EXTREMITY (Arms hurting), MYALGIA (Body aches / severe body aches), HEADACHE (Headache), PYREXIA (Low grade temperature) and CHILLS (Chills / bad chills). On an unknown date, the patient experienced PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still) and HUNGER (Was really hungry). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram, every 6 hrs. At the time of the report, PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still), ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite), FEELING COLD (Really cold with terrible chills then really hot and sweating), ILLNESS (Been really sick for 2 and half days), FEELING HOT (Really hot/felt like sun burned), BURNING SENSATION (Felt like sun burned), HUNGER (Was really hungry), HYPERHIDROSIS (Start sweating), PAIN IN EXTREMITY (Arms hurting), MYALGIA (Body aches / severe body aches), HEADACHE (Headache), PYREXIA (Low grade temperature) and CHILLS (Chills / bad chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-348139 (Patient Link).

Other Meds: CLARITIN [CLARITHROMYCIN]; MULTIVITAMIN [VITAMINS NOS]; VITAMIN C [ASCORBIC ACID]; TELMISARTAN/HCTZ; AMLODIPINE.

Current Illness:

ID: 1797436
Sex: F
Age:
State: MI

Vax Date: 10/10/2021
Onset Date: 10/10/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Administered expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 10-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved. Concomitant medication use was unknown Treatment information was unknown This case was linked to MOD-2021-347953 (Patient Link).

Other Meds:

Current Illness:

ID: 1797437
Sex: F
Age:
State: NV

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: mentally out of it for 5 days; did not recognize anyone; This spontaneous case was reported by a pharmacist and describes the occurrence of MENTAL DISORDER (mentally out of it for 5 days) and MEMORY IMPAIRMENT (did not recognize anyone) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Psychiatric disorder NOS (has been stabilized for 40 years). Concomitant products included CLOZAPINE, VALPROATE SEMISODIUM (DIVALPROEX), ZIPRASIDONE HYDROCHLORIDE (GEODON [ZIPRASIDONE HYDROCHLORIDE]), LAMOTRIGINE (LAMICTAL), BENZATROPINE MESILATE (COGENTIN), L-METHYLFOLATE, LEVOTHYROXINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), CROMOGLICATE SODIUM (NASALCROM), ALBUTEROL [SALBUTAMOL], CALCIUM, MULTIVITAMIN [VITAMINS NOS] and FISH OIL for an unknown indication. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL DISORDER (mentally out of it for 5 days) and MEMORY IMPAIRMENT (did not recognize anyone). At the time of the report, MENTAL DISORDER (mentally out of it for 5 days) and MEMORY IMPAIRMENT (did not recognize anyone) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient visited an orthopedic surgeon regarding an unspecified procedure and during the consultation she got up from the chair and started walking around like she did not recognize anyone. After 5 days she was back to normal like a switch was turned. No treatment details were reported.

Other Meds: CLOZAPINE; DIVALPROEX; GEODON [ZIPRASIDONE HYDROCHLORIDE]; LAMICTAL; COGENTIN; L-METHYLFOLATE; LEVOTHYROXINE; FLONASE [FLUTICASONE PROPIONATE]; NASALCROM; ALBUTEROL [SALBUTAMOL]; CALCIUM; MULTIVITAMIN [VITAMINS NOS]; FISH OIL

Current Illness: Psychiatric disorder NOS (has been stabilized for 40 years)

ID: 1797438
Sex: F
Age: 62
State: CA

Vax Date: 07/28/2021
Onset Date: 08/29/2021
Rec V Date: 10/19/2021
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: Test Date: 20210829; Test Name: Xray; Result Unstructured Data: X-ray showed no fracture

Allergies:

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

Symptoms: Tingling in fingertips; Numbness in fingertips; Burning in fingertips; Neck and shoulder pain / feels like my neck can't support my head; Pain in pelvic area; Trouble getting out of my car; Prevented from sleeping; headaches off and on; Pain in left hip/shoulder pain/hip pain was so bad that she had trouble getting out of car and sat there for 30 minutes for the pain to dull; Left hand had bruising and swelling on palm about the size of a 1/2 dollar then started to spread to the rest of hand; Swelling on palm about the size of a 1/2 dollar then started to spread to the rest of hand; Cramping in left ankle and left big toe/could not move ankle or big toe; This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA (Tingling in fingertips), HYPOAESTHESIA (Numbness in fingertips), BURNING SENSATION (Burning in fingertips), NECK PAIN (Neck and shoulder pain / feels like my neck can't support my head) and PELVIC PAIN (Pain in pelvic area) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced MUSCLE SPASMS (Cramping in left ankle and left big toe/could not move ankle or big toe). On 05-Oct-2021, the patient experienced PERIPHERAL SWELLING (Swelling on palm about the size of a 1/2 dollar then started to spread to the rest of hand) and CONTUSION (Left hand had bruising and swelling on palm about the size of a 1/2 dollar then started to spread to the rest of hand). On an unknown date, the patient experienced PARAESTHESIA (Tingling in fingertips), HYPOAESTHESIA (Numbness in fingertips), BURNING SENSATION (Burning in fingertips), NECK PAIN (Neck and shoulder pain / feels like my neck can't support my head), PELVIC PAIN (Pain in pelvic area), HYPOKINESIA (Trouble getting out of my car), INSOMNIA (Prevented from sleeping), HEADACHE (headaches off and on) and ARTHRALGIA (Pain in left hip/shoulder pain/hip pain was so bad that she had trouble getting out of car and sat there for 30 minutes for the pain to dull). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling in fingertips), HYPOAESTHESIA (Numbness in fingertips) and BURNING SENSATION (Burning in fingertips) had not resolved and NECK PAIN (Neck and shoulder pain / feels like my neck can't support my head), PELVIC PAIN (Pain in pelvic area), MUSCLE SPASMS (Cramping in left ankle and left big toe/could not move ankle or big toe), HYPOKINESIA (Trouble getting out of my car), PERIPHERAL SWELLING (Swelling on palm about the size of a 1/2 dollar then started to spread to the rest of hand), INSOMNIA (Prevented from sleeping), CONTUSION (Left hand had bruising and swelling on palm about the size of a 1/2 dollar then started to spread to the rest of hand), HEADACHE (headaches off and on) and ARTHRALGIA (Pain in left hip/shoulder pain/hip pain was so bad that she had trouble getting out of car and sat there for 30 minutes for the pain to dull) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, X-ray: normal (normal) X-ray showed no fracture. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient put the coldness of a Frappuccino on hand for bruising and swelling on palm and shake hands to help with the numbness and tingling. No concomitant medications were provided. This case was linked to MOD-2021-348357 (Patient Link).

Other Meds:

Current Illness:

ID: 1797439
Sex: F
Age: 55
State: TX

Vax Date: 09/20/2021
Onset Date:
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Contracted a cold; Sinus infection; Sinus drainage in throat; Tenderness around the shot area; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Contracted a cold), SINUSITIS (Sinus infection), UPPER-AIRWAY COUGH SYNDROME (Sinus drainage in throat) and VACCINATION SITE PAIN (Tenderness around the shot area) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included FLUCONAZOLE for Yeast infection, METFORMIN and GABAPENTIN for an unknown indication. On 20-Sep-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 NASOPHARYNGITIS (Contracted a cold), SINUSITIS (Sinus infection), UPPER-AIRWAY COUGH SYNDROME (Sinus drainage in throat) and VACCINATION SITE PAIN (Tenderness around the shot area). The patient was treated with PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (EQUATE SINUS DAY TIME) for Sinusitis, at an unspecified dose and frequency and DOXYLAMINE SUCCINATE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (EQUATE SINUS NIGHT TIME) for Sinusitis, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Contracted a cold), SINUSITIS (Sinus infection), UPPER-AIRWAY COUGH SYNDROME (Sinus drainage in throat) and VACCINATION SITE PAIN (Tenderness around the shot area) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient was scheduled for her second dose on 18-Oct-2021.

Other Meds: METFORMIN; GABAPENTIN; FLUCONAZOLE

Current Illness:

ID: 1797440
Sex: U
Age:
State: AL

Vax Date: 10/11/2021
Onset Date: 10/11/2021
Rec V Date: 10/19/2021
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: 3 patients were given doses that expired on Saturday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1797441
Sex: U
Age:
State: NY

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 10/19/2021
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: Received the vaccine beyond the use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the vaccine beyond the use date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the vaccine beyond the use date). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received the vaccine beyond the use date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was unknown. The reporter asked if the patients may need another vaccine booster. This case was linked to MOD-2021-348962 (Patient Link).

Other Meds:

Current Illness:

ID: 1797442
Sex: F
Age: 42
State: FL

Vax Date: 08/13/2021
Onset Date: 08/01/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Tender arm; Menstrual bleeding for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tender arm) and OLIGOMENORRHOEA (Menstrual bleeding for 3 weeks) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Tender arm) and OLIGOMENORRHOEA (Menstrual bleeding for 3 weeks). In September 2021, OLIGOMENORRHOEA (Menstrual bleeding for 3 weeks) had resolved. At the time of the report, PAIN IN EXTREMITY (Tender arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant details was not provided. No treatment information was provided. This case was linked to MOD-2021-348591 (Patient Link).

Other Meds:

Current Illness:

ID: 1797443
Sex: M
Age: 23
State: MA

Vax Date: 05/20/2021
Onset Date: 10/11/2021
Rec V Date: 10/19/2021
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: Did not get 2nd dose 1 month after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get 2nd dose 1 month after the 1st dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. No Medical History information was reported. On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 11-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get 2nd dose 1 month after the 1st dose). On 11-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get 2nd dose 1 month after the 1st dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1797444
Sex: F
Age: 69
State: SC

Vax Date: 02/18/2021
Onset Date:
Rec V Date: 10/19/2021
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: Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included AMLODIPINE for Blood pressure, FLUTICASONE for Breathing difficult, OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) for COPD, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and EMPAGLIFLOZIN (JARDIANCE) for Diabetes, PANCREATIN (CREON) for Pancreatic atrophy, GABAPENTIN, PRAVASTATIN, VENLAFAXINE, VALSARTAN and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore). At the time of the report, PAIN IN EXTREMITY (Arm sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication was reported. This case was linked to MOD-2021-348449 (Patient Link).

Other Meds: GABAPENTIN; FARXIGA; AMLODIPINE; PRAVASTATIN; CREON; STIOLTO RESPIMAT; FLUTICASONE; JARDIANCE; VENLAFAXINE; VALSARTAN; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1797445
Sex: F
Age: 57
State: AR

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 10/19/2021
Hospital: Y

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: 202011; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: she had a heart attack; She was not scheduled for the second dose and missed it/ Missed second dose > 5 months; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (she had a heart attack) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She was not scheduled for the second dose and missed it/ Missed second dose > 5 months). On 22-May-2021, the patient experienced MYOCARDIAL INFARCTION (she had a heart attack) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-May-2021 to 25-May-2021 due to MYOCARDIAL INFARCTION. The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Anticoagulant therapy, at an unspecified dose and frequency; PRASUGREL for Anticoagulant therapy, at an unspecified dose and frequency and Surgery (2 stents had put in) for Myocardial infarction. On 20-Mar-2021, PRODUCT DOSE OMISSION ISSUE (She was not scheduled for the second dose and missed it/ Missed second dose > 5 months) had resolved. At the time of the report, MYOCARDIAL INFARCTION (she had a heart attack) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Patient reported that she had no history of heart problem. Company comment: This is a case of Product dose omission of this 58-year-old, female patient, with no known medical history, who experienced the serious, unexpected, AESI event of Myocardial infarction. The event occurred 2 months after first dose of Moderna vaccine. The rechallenge is not applicable as patient only received first dose. The long onset latency of 2 months remain as confounder to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report. This case was linked to MOD-2021-349207, MOD-2021-006363 (Patient Link).; Sender's Comments: This is a case of Product dose omission of this 58-year-old, female patient, with no known medical history, who experienced the serious, unexpected, AESI event of Myocardial infarction. The event occurred 2 months after first dose of Moderna vaccine. The rechallenge is not applicable as patient only received first dose. The long onset latency of 2 months remain as confounder to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1797446
Sex: U
Age:
State:

Vax Date: 10/10/2021
Onset Date: 10/10/2021
Rec V Date: 10/19/2021
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: My partner has had double Astra Zeneca, yesterday we both received a half dose booster of your Moderna.; Recieved half dose booster of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (My partner has had double Astra Zeneca, yesterday we both received a half dose booster of your Moderna.) and UNDERDOSE (Recieved half dose booster of Moderna) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for an unreported indication: ASTRA ZENECA COMPOUND 677 (Patient had double Astra Zeneca). On 10-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (My partner has had double Astra Zeneca, yesterday we both received a half dose booster of your Moderna.) and UNDERDOSE (Recieved half dose booster of Moderna). On 10-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (My partner has had double Astra Zeneca, yesterday we both received a half dose booster of your Moderna.) and UNDERDOSE (Recieved half dose booster of Moderna) had resolved. No concomitant medications were provided. No treatment medications were provided. This case was linked to MOD-2021-349089 (Patient Link).

Other Meds:

Current Illness:

ID: 1797447
Sex: F
Age: 61
State: FL

Vax Date: 05/14/2021
Onset Date: 05/01/2021
Rec V Date: 10/19/2021
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: arm pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Oct-2021 and was forwarded to Moderna on 11-Oct-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. Concurrent medical conditions included Fibromyalgia, Neuropathy, Sciatica and Acid reflux (esophageal). Concomitant products included GABAPENTIN, VALACYCLOVIR [VALACICLOVIR] and OMEPRAZOLE (ZEGERID [OMEPRAZOLE]) for Acid reflux (esophageal), ALPRAZOLAM, PRAVASTATIN, METOPROLOL, NALTREXONE, ALPRAZOLAM (XANAX) and VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for an unknown indication. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (arm pain). In June 2021, PAIN IN EXTREMITY (arm pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked to MOD-2021-349041 (Patient Link).

Other Meds: GABAPENTIN; VALACYCLOVIR [VALACICLOVIR]; ZEGERID [OMEPRAZOLE]; ALPRAZOLAM; PRAVASTATIN; METOPROLOL; NALTREXONE; XANAX; TRINTELLIX

Current Illness: Acid reflux (esophageal); Fibromyalgia; Neuropathy; Sciatica

ID: 1797448
Sex: F
Age: 70
State: TX

Vax Date: 12/31/2020
Onset Date:
Rec V Date: 10/19/2021
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: Cough that "goes with the condition" / being tested for lung disease; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough that "goes with the condition" / being tested for lung disease) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 09762A and 025020A) for COVID-19 vaccination. No Medical History information was reported. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Cough that "goes with the condition" / being tested for lung disease). At the time of the report, COUGH (Cough that "goes with the condition" / being tested for lung disease) outcome was unknown. Patient was being tested for lung disease. No concomitant products were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1797449
Sex: M
Age:
State: LA

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/19/2021
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: slight pain in left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight pain in left injection site arm) in a 75-year-old male 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 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (slight pain in left injection site arm). At the time of the report, VACCINATION SITE PAIN (slight pain in left injection site arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication details were not provided. Treatment details were not provided. The patient reports no Adverse Reactions after his second Moderna Covid-19 vaccine.

Other Meds:

Current Illness:

ID: 1797450
Sex: M
Age:
State: AR

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Severe reaction to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe reaction to vaccine) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Severe reaction to vaccine). At the time of the report, VACCINATION COMPLICATION (Severe reaction to vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-348714 (Patient Link).

Other Meds:

Current Illness:

ID: 1797451
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: Warm to the touch Injection Site after 3rd shot; Itching from Head to toe after 3rd shot; Histamine reaction after 3rd shot; Swollen Injection Site for 3-4 days after 3rd shot; Itchy Injection Site after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), ALLERGY TO VACCINE (Histamine reaction after 3rd shot), VACCINATION SITE SWELLING (Swollen Injection Site for 3-4 days after 3rd shot) and VACCINATION SITE PRURITUS (Itchy Injection Site after 3rd shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Sulfonamide allergy (Caller stated allergic to sulfa.). On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), ALLERGY TO VACCINE (Histamine reaction after 3rd shot), VACCINATION SITE SWELLING (Swollen Injection Site for 3-4 days after 3rd shot) and VACCINATION SITE PRURITUS (Itchy Injection Site after 3rd shot). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), ALLERGY TO VACCINE (Histamine reaction after 3rd shot), VACCINATION SITE SWELLING (Swollen Injection Site for 3-4 days after 3rd shot) and VACCINATION SITE PRURITUS (Itchy Injection Site after 3rd shot) outcome was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness: Sulfonamide allergy (Caller stated allergic to sulfa.)

ID: 1797452
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: Have been keeping track of my body and symptoms/Is there someone I can send some details to?; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Have been keeping track of my body and symptoms/Is there someone I can send some details to?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Have been keeping track of my body and symptoms/Is there someone I can send some details to?). At the time of the report, VACCINATION COMPLICATION (Have been keeping track of my body and symptoms/Is there someone I can send some details to?) outcome was unknown. No concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1797453
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Name: Slitlamp; Result Unstructured Data: Slitlamp examination showed mild conjunctival hyperemia and injection, mild corneal edema, anterior chamber flare and cell, as well as numerous mixed KPs; Test Name: Slitlamp; Result Unstructured Data: Slitlamp examination demonstrated reduced KPs and complete resolution of corneal edema as well as the anterior chamber cells and flare.; Test Name: Best Corrected Visual Acuity; Result Unstructured Data: BCVA was found to have declined to 20/60; Test Name: Best Corrected Visual Acuity; Result Unstructured Data: BCVA improved to 20/40

Allergies:

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

Symptoms: Acute Corneal Transplant Rejection; photophobia; Brow ache and decreased vision in the left eye; brow ache; This literature-non-study case was reported in a literature article and describes the occurrence of TRANSPLANT REJECTION (Acute Corneal Transplant Rejection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Acute corneal transplant rejection after COVID-19 vaccination. Cornea. 2021;00(00) The patient's past medical history included Keratoplasty (Received PKP with cataract extraction in the left eye 22 years previously for corneal edema secondary to amantadine usage for mild relapsing-remitting multiple sclerosis). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 1. On an unknown date, the patient experienced TRANSPLANT REJECTION (Acute Corneal Transplant Rejection) (seriousness criterion medically significant), PHOTOPHOBIA (photophobia), VISUAL IMPAIRMENT (Brow ache and decreased vision in the left eye) and PAIN (brow ache). The patient was treated with PREDNISOLONE ACETATE at a dose of 1 percent, 5 times daily. At the time of the report, TRANSPLANT REJECTION (Acute Corneal Transplant Rejection), PHOTOPHOBIA (photophobia) and VISUAL IMPAIRMENT (Brow ache and decreased vision in the left eye) was resolving and PAIN (brow ache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Slit-lamp examination: slitlamp examination showed mild conjunctival Slitlamp examination showed mild conjunctival hyperemia and injection, mild corneal edema, anterior chamber flare and cell, as well as numerous mixed KPs and decreased Slitlamp examination demonstrated reduced KPs and complete resolution of corneal edema as well as the anterior chamber cells and flare.. On an unknown date, Visual acuity tests: decreased BCVA was found to have declined to 20/60 and increased BCVA improved to 20/40. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TRANSPLANT REJECTION (Acute Corneal Transplant Rejection), PHOTOPHOBIA (photophobia), VISUAL IMPAIRMENT (Brow ache and decreased vision in the left eye) and PAIN (brow ache) to be possibly related. This case concern 4 out of 4 patients with prior keratoplasty developed presumed immunologic rejection after the mRNA-1273 vaccination for coronavirus 2 (SARS-CoV-2). Patient presented with endothelial rejection of the penetrating keratoplasty graft 2 weeks after the second vaccine dose. No previous graft rejection episodes occurred despite inconsistent use of topical corticosteroids. There was no history of COVID-19?related illness or known exposure. Patient experienced initial improvement with steroid treatment as well. These cases suggest acute corneal endothelial rejection may occur soon after either dose of the COVID-19 mRNA vaccine. Prompt initiation of aggressive topical steroid therapy may result in complete resolution of clinical signs and symptoms. Further studies are needed to elucidate the causal mechanism of corneal graft rejection after COVID-19 vaccination. These cases suggest acute corneal endothelial rejection may occur soon after either dose of the COVID-19 mRNA vaccine. Prompt initiation of aggressive topical steroid therapy may result in complete resolution of clinical signs and symptoms. Further studies are needed to elucidate the causal mechanism of corneal graft rejection after COVID-19 vaccination. Company Comment: This case concerns a 77 year-old, male subject with clinical history of CORNEAL TRANSPLANT who experienced the unexpected event of TRANSPLANT REJECTION and other non-serious events. The event occurred one week after the second dose of [Spikevax] The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of the vaccine is not affected by this report This case was linked to MOD-2021-349123, MOD-2021-353544, MOD-2021-353543 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received 14-Oct-2021. Received from team and contain new information about patient identifiers.; Sender's Comments: This case concerns a 77 year-old, male subject with clinical history of CORNEAL TRANSPLANT who experienced the unexpected event of TRANSPLANT REJECTION and other non-serious events. The event occurred one week after the second dose of [Spikevax] The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of the vaccine is not affected by this report

Other Meds:

Current Illness:

ID: 1797454
Sex: U
Age:
State: MD

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: 2 patients received expired moderna covid-19 vaccine/Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received expired moderna covid-19 vaccine/Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received expired moderna covid-19 vaccine/Expired vaccine used). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2 patients received expired moderna covid-19 vaccine/Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. Treatment medications was not provided. Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: follow-up document Includes no new information

Other Meds:

Current Illness:

ID: 1797455
Sex: F
Age:
State: NE

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: missed her 2nd dose due to migraine; This is a spontaneous case received from a contactable female consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history included migraine from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. It was reported that she missed her second dose due to migraine, she wants to reschedule her second dose. She mentioned that her migraine was not related to vaccine. She already have this and it is on and off. The patient experienced missed her 2nd dose due to migraine and missed her 2nd dose due to migraine those from on an unspecified date. The clinical outcome of the events was unknown. Follow up (15Mar2021): This is a Non Significant Follow-up spontaneous report received from a contactable consumer. No new information in source. Follow-up (14May2021): Follow-up attempts completed. No further information expected. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1797456
Sex: F
Age:
State: PA

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: then the second dose, the sore arm started in the evening/ severe pain on Left arm; mild headache; smelling smoke happened after the second vaccine; metallic taste; Pain, tingling, numbness in left arm - radiated down into her left leg; Pain, tingling, numbness in left arm - radiated down into her left leg/tingle on left side of the body; Pain, tingling, numbness in left arm - radiated down into her left leg; experienced multiple GI issues; Most intense pain in her breasts, especially left side/ severe pain on Left arm and Left breast/severe intense pain in her left breast; Indigestion; diarrhea; ear clogged on one side of the head; had tingling, numbness, mostly in her breast area; mild to moderate symptoms upon 1st dose - intensified upon 2nd dose; Second shot, her vaccine was given 18 days later which she called the hospital when they said it was okay to give the 17th-21 days; Second shot, her vaccine was given 18 days later which she called the hospital when they said it was okay to give the 17th-21 days; This is a spontaneous report from a contactable consumer or other non hcp (patient) reporting for his wife. A 72-year-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscular route of administration in arm left on 23Feb2021 (lot number: EL9266, expiry date: 31May2021, at the age of 72-year-old) as single dose for COVID-19 immunization. Medical history included asthma diagnosed 8-10 year ago, has always had seasonal allergies, heart valve calcification diagnosed 12 years ago. Concomitant medication(s) included losartan taken for blood pressure measurement, simvastatin (ZOCOR) taken for blood cholesterol, omeprazole (PROTONIX [OMEPRAZOLE]) and budesonide (PULMICORT) taken for asthma. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscular route of administration in arm left on 05Feb2021 at 14:30 (lot number: EN9581, expiry date: unknown, at the age of 72-year-old) as single dose for COVID-19 immunization at vaccine hospital and experienced heavy and sore arm, mild headache, wide awake, left sided pain, persisting smell smoke, metallic taste, ulcers in her mouth, ocular migraine, abdominal pain, indigestion, heartburn, anxious, diarrhea and no appetite. On 05Feb2021, after receiving her first dose of the vaccine the patient didn't feel the needled at all. It felt very heavy, the patient had a sore arm, that was in the afternoon. In the evening the patient had a mild headache. The patient was up the entire night, wide awake. In the morning, the patient had a very bad pain running down the whole side of her body from the left arm, left breast, left hip, it lasted the entire day. The patient still had the pain in her left breast. That day, the patient had abdominal pain, heartburn, indigestion, she felt very anxious and edgy, no appetite, then she started with gurgling from her throat to her stomach. This was all for several days. Then the patient started with some diarrhea. The patient then started smelling smoke, every day for about 5 days she smelled smoke in different rooms in her house, but her husband could not smell it. Then the patient developed 3 ulcers inside of her mouth. Then the patient developed an ocular migraine. The patient had a metallic taste every afternoon around 4:00 and then she would try to eat something then it would come back in the evening that lasted for 5. Second shot, her vaccine was given 18 days later which she called the hospital when they said it was okay to give the 17th-21 days. The patient wanted to know if it was okay that she got her vaccines 18 days apart. The sore arm only happened with the first dose, the patient had a sore arm with the second one but nothing like the first one. The patient mentioned it to the nurse when she was receiving the second dose of the vaccine and the nurse administered the vaccine slowly. The patient's arm hurt for 3 days with the first dose, then the second dose, the sore arm started in the evening. The patient hasn't recovered completely from her mild headache. The patient's diarrhea went away after 5 days because she took Imodium. The gurgling, cramping pain is still there. The gastrointestinal stuff the patient has almost completely recovered from. After the second shot it, the left side pain went up into the neck and chest, not in the armpit but near the breast on the left. The smelling smoke happened after the second vaccine, same with the metallic taste. Reporter stated that patient had mild to moderate symptoms upon 1st dose - intensified upon 2nd dose. Pain, tingling, numbness in left arm - radiated down into her left leg. Most intense pain in her breasts, especially left side. Additionally, experienced multiple GI issues. She said she experienced side effects which are the following: sore arm, severe pain on Left arm and Left breast, tingle on left side of the body, indigestion, diarrhea, metallic taste on mouth, smell smoke for several days and ear clogged on one side of the head. It was reported that she had severe pain in her right arm which was the site of administration in her left deltoid and it radiated down to her arm and to her leg. She had severe intense pain in her left breast. She had tingling, numbness, mostly in her breast area. Additionally, she had experienced gastro-intestinal issues. The outcome of the events Pain, tingling, numbness in left arm, breast pain and multiple GI issues was recovering, and rest of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: LOSARTAN; ZOCOR; PROTONIX [OMEPRAZOLE]; PULMICORT

Current Illness:

ID: 1797457
Sex: F
Age: 39
State: TN

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/19/2021
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: None

Allergies: NKDA or other allergies

Symptom List: Injection site swelling, Limb discomfort

Symptoms: I experienced mild symptoms such as soreness at injection site, slight headache and fatigue about 3 hours after receiving injection. I think these may be normal reactions to the vaccine. I took Tylenol to ease symptoms. I was advised by my manager to report anyway.

Other Meds: Omeprazole and daily multivitamin

Current Illness: None

ID: 1797458
Sex: F
Age: 23
State:

Vax Date: 09/24/2021
Onset Date: 09/26/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies: none

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

Symptoms: developed itchy nummular eczema like rash across body and extremities.

Other Meds: none

Current Illness: none

ID: 1797459
Sex: M
Age: 60
State: MA

Vax Date: 04/15/2021
Onset Date: 05/01/2021
Rec V Date: 10/19/2021
Hospital: Y

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

Lab Data: Using a fitness Watch, I checked heart rate and ECG after every near-syncope. Also checked blood glucose levels (and found I was not hypoglycemic). EKGs on 9/16/2021 and 9/25/2021. Echo cardiogram on 9/26/2021. Various lab tests 9/16, 9/25-9/29.

Allergies: aspirin, ibuprofen, clindamycin

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

Symptoms: Mid-May (one month after 2nd dose), experienced racing heart (suspected tachycardia) while walking (for fitness), above 130bpm. 9/1/2021 -- experienced first near-syncope around 5pm while standing; resolved itself after several minutes. 9/16/2021 -- experienced second near-syncope around 9:30am while sitting at desk; went to Emergency Center at Hospital. EKG performed, no treatment. No further events. 9/25/2021 -- experienced third near-syncope around 7:30am, while standing (and collapsed to floor this time). Opted not to head to EC at hospital again, at the time. 9/25/2021 -- experienced fourth and fifth near-syncopes around 2pm, while seated. Opted to head to EC at hospital, had sixth near-syncope while riding to EC. Kept in EC while waiting to be admitted to hospital. 9/26/2021 -- diagnosed with right bundle branch block. 9/29/2021 -- cardiac pacemaker implanted (hospital, MD)

Other Meds: Metformin, Atorvastatin, Lisinopril, Humalog, Tuojeo, multivitamin, methylated B-complex, vitamin D3 tumeric/cinnamon/ginger/berberine, CoQ10, esomeprazole, androgel, anastrozole.

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am