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: 1755757
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/06/2021
Rec V Date: 10/02/2021
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: TASTE THE VACCINE; FACE BECOME NUMB; NUMBNESS WHOLE LEFT SIDE DOWN ARM; This spontaneous report received from a patient concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the patient experienced taste the vaccine. On 06-MAR-2021, the patient experienced face become numb. On 06-MAR-2021, the patient experienced numbness whole left side down arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the face become numb, numbness whole left side down arm and taste the vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1755758
Sex: F
Age:
State: RI

Vax Date:
Onset Date: 09/08/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: 105.0 F; Test Date: 20210911; Test Name: Electrocardiogram; Result Unstructured Data: Normal

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: A TYPICAL YEAST INFECTION; HAIR STARTED TO FALL OUT IN THE SHOWER AND WITH BRUSHING; ECZEMA ON BOTH HANDS AND ARMS; HEADACHES ON/OFF LIKE MIGRAINES; CHEST PAIN; LOST APPETITE COMPLETELY AND READY TO PASS OUT FROM HUNGER/NOT EATING.; LIGHTHEADED; EXTREME CHILLS; FEVER; HOT/COLD SENSATIONS; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 196 pounds, and height was 66 inches. The patient's concurrent conditions included: sesame seeds allergy, and penicillin allergy, and other pre-existing medical conditions included: The patient was very healthy, never had any health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced hot/cold sensations. On 08-SEP-2021, the patient experienced extreme chills. On 08-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 105.0 F. On 09-SEP-2021, the patient experienced lost appetite completely and ready to pass out from hunger/not eating. On 09-SEP-2021, the patient experienced lightheaded. On 10-SEP-2021, the patient experienced chest pain. On 11-SEP-2021, the patient experienced eczema on both hands and arms. On 11-SEP-2021, the patient experienced headaches on/off like migraines. Laboratory data included: Electrocardiogram (NR: not provided) Normal. On 18-SEP-2021, the patient experienced hair started to fall out in the shower and with brushing. On 19-SEP-2021, the patient experienced a typical yeast infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, hot/cold sensations, extreme chills, and fever on SEP-2021, was recovering from eczema on both hands and arms, and a typical yeast infection, had not recovered from hair started to fall out in the shower and with brushing, and the outcome of lost appetite completely and ready to pass out from hunger/not eating., headaches on/off like migraines and lightheaded was not reported. This report was non-serious. This case, from the same reporter is linked to 20211000473.

Other Meds:

Current Illness: Food allergy; Penicillin allergy

ID: 1755759
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 02/01/2021
Rec V Date: 10/02/2021
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: Test Date: 20210507; Test Name: COVID test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: upset stomach; chills; Permitted by caller to collect details of call. Caller referenced this case number: MOD-2021-122758. (Current case now crosslinked with Case # MOD21-089750). Caller compying with request to return call & provide an email address. She does not have an email address. This agent did confirm her mailing address & added minimal update to vaccine information. "I got the shots of the Moderna Covid-19 vaccine in Jan2021 & Feb2021. It was at the end of the month for both of them." 1st dose: Near end of Jan2021 Lot: unknown Exp: unknown inj site: left arm Age: 86yo DOB: 15May1934 Pregnant: No 2nd dose: Near end of Feb2021 Lot: unknown Exp: unknown inj site: left arm Age: 86yo DOB: 15May1934 Pregnant: No Consent given for Safety follow up/contact.

Other Meds:

Current Illness:

ID: 1755760
Sex: M
Age: 30
State: CA

Vax Date: 07/14/2021
Onset Date: 07/14/2021
Rec V Date: 10/02/2021
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: Hearing loss-i can't hear as well in the left ear as the right; Ear popping sensation; numbness in lower right ear; sharp pain in the rear left ear canals; ringing ear; headache; 1st dose 14 jul 2021, 2nd dose 25 aug 2021; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Hearing loss-i can't hear as well in the left ear as the right), EAR DISCOMFORT (Ear popping sensation), HYPOAESTHESIA (numbness in lower right ear), EAR PAIN (sharp pain in the rear left ear canals) and TINNITUS (ringing ear) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-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) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced HYPOACUSIS (Hearing loss-i can't hear as well in the left ear as the right), EAR PAIN (sharp pain in the rear left ear canals), TINNITUS (ringing ear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 14 jul 2021, 2nd dose 25 aug 2021). 14-Jul-2021, the patient experienced EAR DISCOMFORT (Ear popping sensation), HYPOAESTHESIA (numbness in lower right ear) and HEADACHE (headache). At the time of the report, HYPOACUSIS (Hearing loss-i can't hear as well in the left ear as the right), EAR DISCOMFORT (Ear popping sensation), HYPOAESTHESIA (numbness in lower right ear) and HEADACHE (headache) had not resolved and EAR PAIN (sharp pain in the rear left ear canals), TINNITUS (ringing ear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 14 jul 2021, 2nd dose 25 aug 2021) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications reported. No treatment information was provided. About 20 minutes after receiving the Madonna COVID-19 vaccine patient started to experience what one would referred to as hearing loss at ?rst it was a sharp pain in the rear left ear canals. After a couple of weeks the pain has stopped the ringing has stopped but he still can't hear as well in the left ear as the right anymore this has happened since the Moderna vaccine. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow up received and updated Patient demographics, second dose information, and action taken. New events hearing impaired, ear pain and tinnitus, inappropriate schedule of product administered added. Removed event hearing disability

Other Meds:

Current Illness:

ID: 1755761
Sex: M
Age: 72
State: NE

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 202105; Test Name: Antibody test; Test Result: Positive ; Result Unstructured Data: Have the spike protein on antibody testing in May 2021.; Test Date: 20210128; Test Name: Antibody test; Test Result: Positive ; Result Unstructured Data: had antibodies present; Test Date: 20210528; Test Name: Antibody test; Test Result: Positive ; Result Unstructured Data: had antibodies present; Test Date: 202101; Test Name: Nucleic acid test; Test Result: Negative ; Result Unstructured Data: probably did not have the COVID-19 virus in Jan2021

Allergies:

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

Symptoms: never received hissecond Moderna vaccine; Arthritis in his 1st and 2nd digits of the hands, and not his 3rd-5th/reactive arthritis after first Moderna shot; Could not open or close hand or make a fist; This spontaneous case was reported by a physician and describes the occurrence of ARTHRITIS (Arthritis in his 1st and 2nd digits of the hands, and not his 3rd-5th/reactive arthritis after first Moderna shot), MOBILITY DECREASED (Could not open or close hand or make a fist) and PRODUCT DOSE OMISSION ISSUE (never received hissecond Moderna vaccine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, the patient experienced ARTHRITIS (Arthritis in his 1st and 2nd digits of the hands, and not his 3rd-5th/reactive arthritis after first Moderna shot) and MOBILITY DECREASED (Could not open or close hand or make a fist). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never received hissecond Moderna vaccine). The patient was treated with PREDNISONE for Hand arthritis, at a dose of 40 mg for 4 days then tapered for 3 and PREDNISONE for Hand arthritis, at a dose of : 40 mg for 4 days then tapered for 3. At the time of the report, ARTHRITIS (Arthritis in his 1st and 2nd digits of the hands, and not his 3rd-5th/reactive arthritis after first Moderna shot) was resolving, MOBILITY DECREASED (Could not open or close hand or make a fist) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (never received hissecond Moderna vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Nucleic acid test: negative (Negative) probably did not have the COVID-19 virus in Jan2021. On 28-Jan-2021, Antibody test: positive (Positive) had antibodies present. In May 2021, Antibody test: positive (Positive) Have the spike protein on antibody testing in May 2021.. On 28-May-2021, Antibody test: positive (Positive) had antibodies present. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The reactive arthritis had resolved by 95-97 percent. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Patient details updated, new events were added. On 23-Sep-2021: Follow up document received updated event addition and outcome of event for arthritis.; Sender's Comments: This report concerns a 73 year old male patient with no relevant medical history who experienced non-serious and unexpected event of reactive arthritis of 1st and 2nd digits of his hands with decreased mobility (reported as could not open or close or make a fist). The event occurred after an unknown duration following vaccination with first dose of mRNA-1273. The patient reported not taking the 2nd dose of the vaccine in fear of re-occurrence of the event (coded as product dose omission). The re-challenge was assessed as not applicable as the second dose was not administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1755762
Sex: F
Age: 82
State: PA

Vax Date: 05/04/2021
Onset Date:
Rec V Date: 10/02/2021
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: shoulder stiffness/stiff upto ear/Stiff left arm where she received her vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (shoulder stiffness/stiff upto ear/Stiff left arm where she received her vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. No Medical History information was reported. On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (shoulder stiffness/stiff upto ear/Stiff left arm where she received her vaccine). At the time of the report, MUSCULOSKELETAL STIFFNESS (shoulder stiffness/stiff upto ear/Stiff left arm where she received her vaccine) had resolved. No concomitant medications were reported. On 6-AUG-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) in unknown route with batch no.007B21A Patient received compresses and pain relievers as treatment medications but they did not help. Patient went to the ER and they gave her a muscle relaxer and she is fine now. This case was linked to MOD-2021-274267 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Added event and treatment information. On 23-Sep-2021: Follow up document received contains event coding and outcome of event updated

Other Meds:

Current Illness:

ID: 1755763
Sex: F
Age: 63
State: NY

Vax Date: 04/19/2021
Onset Date:
Rec V Date: 10/02/2021
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: Dizziness; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VERTIGO (Vertigo) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizziness) and VERTIGO (Vertigo). The patient was treated with MECLIZINE [MECLOZINE] for Dizziness and Vertigo, at a dose of 12.5 mg. At the time of the report, DIZZINESS (Dizziness) and VERTIGO (Vertigo) outcome was unknown. No concomitant medications were reported. The patient reports the onset of the events occurring some weeks after vaccination. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received contains non-significant information, but initial events onset date captured as 2021 and vaccine facility information added hence processed as significant .; Sender's Comments: This case concerns a 63-year-old female patient with no relevant history reported, who experienced the unexpected non serious events of Dizziness and Vertigo. The events started a few weeks after the second dose of Moderna COVID-19 Vaccine. The stop date and outcome of the events are unknown. Rechallenge is not applicable as no additional dosing will be given. The delayed onset of the events remains as a confounder for the case. The benefit-risk relationship of covid-19 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1755764
Sex: F
Age: 51
State: GA

Vax Date: 05/17/2021
Onset Date:
Rec V Date: 10/02/2021
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: More than 36 days after first dose without receiving the second dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days after first dose without receiving the second dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-May-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 PRODUCT DOSE OMISSION ISSUE (More than 36 days after first dose without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after first dose without receiving the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided. No treatment information provided by the reporter. Most recent FOLLOW-UP information incorporated above included on 24-Sep-2021 Follow up received contained Updated demographics, gender female.

Other Meds:

Current Illness:

ID: 1755765
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/02/2021
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: Patient did not take the second dose of vaccine.; Nausea; Vomiting; Dizziness; Diaphoresis; Near syncope; Spinning room; BPPV; Mild tinnitus; This spontaneous case was reported by a physician and describes the occurrence of Dizziness, Diaphoresis, Near syncope, Vertigo, and BPPV in a 54-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. Concurrent medical conditions included Hypertension (HTN), Foramen ovale patent (PFO), and Adrenal disorder (Overactive adrenal gland). In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced Dizziness, Diaphoresis, Near syncope, Viertigo, BPPV, Tinnitus, Nausea, and Vomiting. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine). The patient was treated with MECLIZINE at a dose of UNK dosage form, ZOFRAN, at a dose of UNK dosage form; Physical therapy (Vertigo exercises (Epley maneuver)) for Vertigo and Physical therapy (Vertigo exercises (Epley maneuver)) for Vertigo positional. In May 2021, Dizziness had not resolved, Diaphoresis, Near syncope, Vertigo, BPPV, Tinnitus, Nausea, and Vomiting had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was taken to Emergency Room and was discharged on the same day. Patient prescribed for vertigo exercises, Epley maneuver. Concomitant product use was not provided. This case was linked to MOD-2021-276754 (Patient Link). Most recent FOLLOW-UP information incorporated above included on 06-Aug-2021: Follow-up received on 06-Aug-2021 and included non-significant information.

Other Meds:

Current Illness: Adrenal disorder (Overactive adrenal gland); Foramen ovale patent (PFO); Hypertension (HTN)

ID: 1755766
Sex: F
Age: 49
State: IL

Vax Date: 08/02/2021
Onset Date: 08/02/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: blood pressure was higher than usual.; Test Date: 20210802; Test Name: blood pressure; Result Unstructured Data: 134/86; Test Date: 20210803; Test Name: blood pressure; Result Unstructured Data: 134/86; Test Date: 20210802; Test Name: Body Temperature; Result Unstructured Data: 97.6; Test Date: 20210803; Test Name: Body Temperature; Result Unstructured Data: 96.7; Test Date: 20210802; Test Name: Heart Rate; Result Unstructured Data: 92 Beats per minutes; Test Date: 20210803; Test Name: Heart Rate; Result Unstructured Data: 83 Beats per minutes; Test Date: 20210802; Test Name: OXYGEN SATURATION; Result Unstructured Data: 99% on R/A; Test Date: 20210802; Test Name: Respiratory Rate; Result Unstructured Data: 99 Beats per minutes; Test Date: 20210803; Test Name: Respiratory Rate; Result Unstructured Data: 99 Beats per minutes

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: memory issues; tired and could not perform my normal activities; has brain fog; tightness and discomfort in chest; voice changed from her throat closing up; blood pressure was higher than usual.; shotness of breath; throat burning then traveled to chest; pain and pressure in her chest and throat; pain and pressure in her chest and throat; pain and pressure in her chest and throat; 5 min after the shot, severe sharp headache; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (memory issues), FEELING ABNORMAL (has brain fog), THROAT IRRITATION (throat burning then traveled to chest), CHEST PAIN (pain and pressure in her chest and throat) and CHEST DISCOMFORT (pain and pressure in her chest and throat) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Gastritis on 05-Sep-2017, Smoker, Hay fever, Hypersensitivity reaction, Ulcer (Duodenal and anastomotic ulcer), Arthritis on 10-Oct-2014, Emergency care (at the ER for six hours), Degenerative bone disease (both knees.) and Gastric bypass on 19-Jul-2021. Concurrent medical conditions included Allergy to chemicals, Drug allergy (Doxycycline, Covid-19 vaccine allergy), Latex allergy (Rash, redness swelling burning pain.) since 17-Jul-2020, Shellfish allergy (Anaphylaxis, Hives, horse voice ,dizziness, throat swelling, panic .) since 15-Jan-2017, Seasonal asthma (SOB), Food allergy (patient experience headache, rash, throat pressure pain brings asthma.) since 10-Feb-2015, GERD and Acid reflux (oesophageal) (aggravated by allergic reaction to vaccine.) since 05-Sep-2017. Concomitant products included MULTIVITAMINS [VITAMINS NOS] from 12-Feb-2017 to an unknown date, IRON from 12-Feb-2017 to an unknown date and CALCIUM from 12-Feb-2017 to an unknown date for Deficiency vitamin, PHENTERMINE HCL from 15-Nov-2020 to an unknown date for Metabolic disorder, PANTOPRAZOLE, CITRIC ACID MONOHYDRATE, POTASSIUM CITRATE MONOHYDRATE (POTASSIUM CITRATE CITRIC ACID), SUCRALFATE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE HFA), OMEPRAZOLE, EPINEPHRINE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication. On 02-Aug-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced THROAT IRRITATION (throat burning then traveled to chest), DYSPHONIA (voice changed from her throat closing up), HYPERTENSION (blood pressure was higher than usual.), DYSPNOEA (shotness of breath) and HEADACHE (5 min after the shot, severe sharp headache). 02-Aug-2021, the patient experienced CHEST PAIN (pain and pressure in her chest and throat), CHEST DISCOMFORT (pain and pressure in her chest and throat) and OROPHARYNGEAL PAIN (pain and pressure in her chest and throat). On 03-Aug-2021, the patient experienced CHEST DISCOMFORT (tightness and discomfort in chest). On 05-Aug-2021, the patient experienced FEELING ABNORMAL (has brain fog). On an unknown date, the patient experienced MEMORY IMPAIRMENT (memory issues) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (tired and could not perform my normal activities). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) 03-Aug-2021 for Adverse event, at a dose of UNK UNK, q3h; PREDNISONE (oral) ongoing since an unknown date at a dose of 20 milligram twice a day; FAMOTIDINE ongoing from 03-Aug-2021 at a dose of 20 milligram and CETIRIZINE ongoing from 03-Aug-2021 at a dose of 10 milligram. On 08-Aug-2021, FEELING ABNORMAL (has brain fog) had resolved. At the time of the report, MEMORY IMPAIRMENT (memory issues), THROAT IRRITATION (throat burning then traveled to chest), CHEST PAIN (pain and pressure in her chest and throat), CHEST DISCOMFORT (pain and pressure in her chest and throat), OROPHARYNGEAL PAIN (pain and pressure in her chest and throat), CHEST DISCOMFORT (tightness and discomfort in chest), DYSPHONIA (voice changed from her throat closing up), HYPERTENSION (blood pressure was higher than usual.), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (tired and could not perform my normal activities) and HEADACHE (5 min after the shot, severe sharp headache) had resolved and DYSPNOEA (shotness of breath) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, Blood pressure measurement: 134/86 (High) 134/86. On 02-Aug-2021, Body temperature: 96.7 (normal) 97.6. On 02-Aug-2021, Heart rate: 92 (normal) 92 Beats per minutes. On 02-Aug-2021, Oxygen saturation: 99% 99% on R/A. On 02-Aug-2021, Respiratory rate: 99 (normal) 99 Beats per minutes. On 03-Aug-2021, Blood pressure measurement: 134/86 (High) 134/86. On 03-Aug-2021, Body temperature: 96.7 (normal) 96.7. On 03-Aug-2021, Heart rate: 83 (normal) 83 Beats per minutes. On 03-Aug-2021, Respiratory rate: 99 (normal) 99 Beats per minutes. On an unknown date, Blood pressure measurement: high (High) blood pressure was higher than usual.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Takes medications for acid reflux and ulcerative. Treatment medication included steroids and Pepcid. Patient had epi pen at the appointment but did not use it. Stopped on her way home from vaccine location to get Benadryl before things got worse and continued to take two more doses that evening, a total of three doses The patient went to the ER on 03-Aug-2021 wasn't getter better, was there for 6 hours as outpatient was given IV therapy. patient received antihistamine and steroid through IV on 2 AUG 2021. Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Significant Follow-up received and AE, Event outcome, Lab data, Concomitant medication, Historical Conditions, Allergies and treatment medications added.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; IRON; CALCIUM; PHENTERMINE HCL; PANTOPRAZOLE; POTASSIUM CITRATE CITRIC ACID; SUCRALFATE; ALBUTEROL SULFATE HFA; OMEPRAZOLE; EPINEPHRINE; VITAMIN D [COLECALCIFEROL]

Current Illness: Acid reflux (oesophageal) (aggravated by allergic reaction to vaccine.); Allergy to chemicals; Drug allergy (Doxycycline, Covid-19 vaccine allergy); Food allergy (patient experience headache, rash, throat pressure pain brings asthma.); GERD; Latex allergy (Rash, redness swelling burning pain.); Seasonal asthma (SOB); Shellfish allergy (Anaphylaxis, Hives, horse voice ,dizziness, throat swelling, panic .)

ID: 1755767
Sex: M
Age: 24
State: VA

Vax Date: 08/08/2021
Onset Date: 08/08/2021
Rec V Date: 10/02/2021
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: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received. patient contact details added. event onset date updated. vaccine start date updated. On 09-Aug-2021: Follow-up information include no new information

Other Meds:

Current Illness:

ID: 1755768
Sex: F
Age: 51
State: MA

Vax Date: 03/25/2021
Onset Date: 05/18/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Test Name: blood pressure; Test Name: blood pressure; Test Name: BLOOD PRESSURE; Test Name: EMG; Result Unstructured Data: normal; Test Name: lost 8 lbs/weight loss now between 15- 18lbs

Allergies:

Symptom List: Rash, Urticaria

Symptoms: really bad nerve pain in her shoulder, arms, wrists that hurt and upper part of legs, back of her thighs; depression; anxiety; chest pain; abdominal pain/slight left abdomen pain; back pain; burning sensation/burning; itching pain; strength has weakned; Stomach burning; no longer fell comfortable; New pains are symmetrical hip/groin pain; ear feels full; urinate frequenlty; burning pain; pain in arms/Feel like my hand strength has weakened and the motor skills in my hands are of; Tingling in spine, shoulders, earlobes, arms, armpits, the skin of my neck,tingles in my scalp, tingling in my calves and heels; burning, tingling, searing pain in top of her spine, in-between her two shoulders, then across of her chest; balance problems, sense of unbalance; cannot walk/cannot walk without stabilizing gait or holding on to something/Cannot sit for long periods of time without balance; dizziness; nausea/a little nausea; burning, tingling, searing pain in right shoulder/in-between her two shoulders/wrist pain; face pain in left sinus and left head; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (burning, tingling, searing pain in top of her spine, in-between her two shoulders, then across of her chest), BALANCE DISORDER (balance problems, sense of unbalance), GAIT DISTURBANCE (cannot walk/cannot walk without stabilizing gait or holding on to something/Cannot sit for long periods of time without balance), DIZZINESS (dizziness) and NEURALGIA (really bad nerve pain in her shoulder, arms, wrists that hurt and upper part of legs, back of her thighs) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B211A and 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension (at onset of reaction pressure was low, taken off most BP meds), Penicillin allergy and High cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE from an unknown date to 15-Jun-2021 for Blood pressure high, ATORVASTATIN from 14-Feb-2021 to 15-May-2021 for Cholesterol high, LOSARTAN from an unknown date to 15-Jun-2021 for Hypertension, NADOLOL from 01-Aug-2020 to an unknown date and MAGNESIUM from 01-Aug-2020 to an unknown date for Prophylaxis, CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), FISH OIL, PROBIOTICS NOS, OMEPRAZOLE and FAMOTIDINE (PEPCID AC) for an unknown indication. On 25-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced FACIAL PAIN (face pain in left sinus and left head). On 18-May-2021 at 10:00 PM, the patient experienced SPINAL PAIN (burning, tingling, searing pain in top of her spine, in-between her two shoulders, then across of her chest), BALANCE DISORDER (balance problems, sense of unbalance), GAIT DISTURBANCE (cannot walk/cannot walk without stabilizing gait or holding on to something/Cannot sit for long periods of time without balance), DIZZINESS (dizziness), NAUSEA (nausea/a little nausea) and ARTHRALGIA (burning, tingling, searing pain in right shoulder/in-between her two shoulders/wrist pain). In July 2021, the patient experienced PARAESTHESIA (Tingling in spine, shoulders, earlobes, arms, armpits, the skin of my neck,tingles in my scalp, tingling in my calves and heels), PAIN (burning pain), PAIN IN EXTREMITY (pain in arms/Feel like my hand strength has weakened and the motor skills in my hands are of), URINARY INCONTINENCE (urinate frequenlty), MALAISE (no longer fell comfortable), GROIN PAIN (New pains are symmetrical hip/groin pain) and EAR DISCOMFORT (ear feels full). On an unknown date, the patient experienced NEURALGIA (really bad nerve pain in her shoulder, arms, wrists that hurt and upper part of legs, back of her thighs), DEPRESSION (depression), ANXIETY (anxiety), BURNING SENSATION (burning sensation/burning), CHEST PAIN (chest pain), ABDOMINAL PAIN (abdominal pain/slight left abdomen pain), BACK PAIN (back pain), PRURITUS (itching pain), ASTHENIA (strength has weakned) and DYSPEPSIA (Stomach burning). The patient was treated with CELECOXIB (CELEXA [CELECOXIB]) ongoing since an unknown date for Anxiety, at an unspecified dose and frequency and LORAZEPAM ongoing since an unknown date for Anxiety, at an unspecified dose and frequency. At the time of the report, SPINAL PAIN (burning, tingling, searing pain in top of her spine, in-between her two shoulders, then across of her chest), BALANCE DISORDER (balance problems, sense of unbalance), GAIT DISTURBANCE (cannot walk/cannot walk without stabilizing gait or holding on to something/Cannot sit for long periods of time without balance), DIZZINESS (dizziness) and NAUSEA (nausea/a little nausea) had not resolved, NEURALGIA (really bad nerve pain in her shoulder, arms, wrists that hurt and upper part of legs, back of her thighs), FACIAL PAIN (face pain in left sinus and left head), DEPRESSION (depression), ANXIETY (anxiety), PARAESTHESIA (Tingling in spine, shoulders, earlobes, arms, armpits, the skin of my neck,tingles in my scalp, tingling in my calves and heels), BURNING SENSATION (burning sensation/burning), PAIN (burning pain), CHEST PAIN (chest pain), ABDOMINAL PAIN (abdominal pain/slight left abdomen pain), BACK PAIN (back pain), PAIN IN EXTREMITY (pain in arms/Feel like my hand strength has weakened and the motor skills in my hands are of), PRURITUS (itching pain), URINARY INCONTINENCE (urinate frequenlty), ASTHENIA (strength has weakned), MALAISE (no longer fell comfortable), GROIN PAIN (New pains are symmetrical hip/groin pain), EAR DISCOMFORT (ear feels full) and DYSPEPSIA (Stomach burning) outcome was unknown and ARTHRALGIA (burning, tingling, searing pain in right shoulder/in-between her two shoulders/wrist pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 96/77 Low, 125/85 High, 110/88 normal and 125/93 abnormal. On an unknown date, Electromyogram: normal (normal) normal. On an unknown date, Weight decreased: unknown abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that the patient went to ER twice from pain. Concomitant medication also included blood pressure and headache preventative, 6 weeks of atorvastatin, but stopped it. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant follow up, Event, Patient details, Suspect and concomitant drug details updated.

Other Meds: HYDROCHLOROTHIAZIDE; LOSARTAN; ATORVASTATIN; VITAMIN B 12 [CYANOCOBALAMIN]; VITAMIN D [COLECALCIFEROL]; FISH OIL; PROBIOTICS NOS; NADOLOL; MAGNESIUM; OMEPRAZOLE; PEPCID AC

Current Illness: High cholesterol; Hypertension (at onset of reaction pressure was low, taken off most BP meds); Penicillin allergy

ID: 1755769
Sex: F
Age:
State: FL

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: after their first and second dose, their injection arm was warm; patient also experienced a little discomfort; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (after their first and second dose, their injection arm was warm), DISCOMFORT (patient also experienced a little discomfort) and MYALGIA (Body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Diabetes. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (after their first and second dose, their injection arm was warm), DISCOMFORT (patient also experienced a little discomfort) and MYALGIA (Body ache). At the time of the report, VACCINATION SITE WARMTH (after their first and second dose, their injection arm was warm), DISCOMFORT (patient also experienced a little discomfort) and MYALGIA (Body ache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported No Treatment medications reported This case was linked to MOD-2021-318331, MOD-2021-318415 (Patient Link).

Other Meds:

Current Illness: Diabetes

ID: 1755770
Sex: F
Age:
State: FL

Vax Date: 01/07/2021
Onset Date: 09/04/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: body ache; discomfort; swelling on their left arm; got the third dose without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING, PAIN, DISCOMFORT, and OFF LABEL USE in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 039K20A and 029K20A) for COVID-19 vaccination. The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Diabetes. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced OFF LABEL USE. On 05-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING. On an unknown date, the patient experienced PAIN, and DISCOMFORT. On 04-Sep-2021, OFF LABEL USE (got the third dose without being immunocompromised) had resolved. At the time of the report, PERIPHERAL SWELLING, PAIN, and DISCOMFORT outcome was unknown. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-318414, MOD-2021-318331 (Patient Link).

Other Meds:

Current Illness: Diabetes

ID: 1755771
Sex: U
Age:
State: TX

Vax Date: 01/19/2021
Onset Date: 02/21/2021
Rec V Date: 10/02/2021
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: arm felt heavy after the second dose; fever of 100.2?F after the second dose; Strong headache after the second dose; Chills; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm felt heavy after the second dose), PYREXIA (fever of 100.2?F after the second dose), HEADACHE (Strong headache after the second dose), CHILLS (Chills) and MIGRAINE (Migraine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. UNKNOWN and UNKNOWN) for COVID-19 vaccination. Concurrent medical conditions included Cancer in remission and Immunosuppression (Immune system is very low). On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced LIMB DISCOMFORT (arm felt heavy after the second dose), PYREXIA (fever of 100.2?F after the second dose), HEADACHE (Strong headache after the second dose), CHILLS (Chills) and MIGRAINE (Migraine). On 22-Feb-2021, PYREXIA (fever of 100.2?F after the second dose), HEADACHE (Strong headache after the second dose), CHILLS (Chills) and MIGRAINE (Migraine) had resolved. On 23-Feb-2021, LIMB DISCOMFORT (arm felt heavy after the second dose) had resolved. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1755772
Sex: M
Age: 71
State: WV

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210819; Test Name: Body temperature; Result Unstructured Data: body temperature elevated (99.9 Fahrenheit).

Allergies:

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

Symptoms: he got sleepy; so drowsy; temperature of 99.9; sick for a month; heart felt like it was going to beat out of chest/he felt bad; could hardly hold head up/could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE, DOWZY, BODY TEMPERATURE ABNORMAL (temperature of 99.9), ILLNESS, and FEELING ABNORMAL (heart felt like it was going to beat out of chest/he felt bad) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included PREDNISONE and METHOTREXATE for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE, DROWSY, BODY TEMPERATURE ABNORMAL (temperature of 99.9), ILLNESS, FEELING ABNORMAL (heart felt like it was going to beat out of chest/he felt bad), and MOBILITY DECREASED (could hardly hold head up/could not get out of bed). At the time of the report, SOMNOLENCE, DROWSY, BODY TEMPERATURE ABNORMAL (temperature of 99.9), ILLNESS (sick for a month), FEELING ABNORMAL (heart felt like it was going to beat out of chest/he felt bad), and MOBILITY DECREASED (could hardly hold head up/could not get out of bed) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 19-Aug-2021, Body temperature 99.9 (High) body temperature elevated. No treatment medications reported. Patient has symptoms for a month after third dose, but now he's feeling fine. Most recent FOLLOW-UP information incorporated above includes on 24-Sep-2021: Significant follow up received on 24 Sep 2021, first and second dosage information added in product tab, outcome of event updated to recovered.

Other Meds: PREDNISONE; METHOTREXATE

Current Illness:

ID: 1755773
Sex: M
Age: 49
State: CT

Vax Date: 03/27/2021
Onset Date: 09/15/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Name: BP; Result Unstructured Data: Elevated; Test Date: 20210916; Test Name: Blood work; Result Unstructured Data: normal; Test Name: Heartrate; Result Unstructured Data: 80 beats per minute, heartbeat felt like it was pounding through the chest; Test Name: Covid test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: Felt a rapid heart beat/ Heartbeat felt like he it was pounding through his chest/ he could not get his heartbeat to calm down/ heart palpitation; Aches; Low grade fever; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Felt a rapid heart beat/ Heartbeat felt like he it was pounding through his chest/ he could not get his heartbeat to calm down/ heart palpitation), PAIN (Aches), PYREXIA (Low grade fever) and HEADACHE (Slight headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017(B or 8)21A, 045B21A and 039A21A) for COVID-19 vaccination. Concurrent medical conditions included Muscular dystrophy (MD). On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced PALPITATIONS (Felt a rapid heart beat/ Heartbeat felt like he it was pounding through his chest/ he could not get his heartbeat to calm down/ heart palpitation), PAIN (Aches), PYREXIA (Low grade fever) and HEADACHE (Slight headache). At the time of the report, PALPITATIONS (Felt a rapid heart beat/ Heartbeat felt like he it was pounding through his chest/ he could not get his heartbeat to calm down/ heart palpitation) had not resolved and PAIN (Aches), PYREXIA (Low grade fever) and HEADACHE (Slight headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, Blood test: normal (normal) normal. On an unknown date, Blood pressure measurement: 160/95 (High) Elevated. On an unknown date, Heart rate: 80 (High) 80 beats per minute, heartbeat felt like it was pounding through the chest. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. No concomitant medications were provided. No treatment medications were reported. On 15-Sep-2021, the heart beat felt like pounding through the chest and could not take the deep breath. The patient went to the urgent care. The patient had elevated heart beat and blood pressure with no chest pain. Due to the increased heart beat, the patient called EMS and they gave oxygen which calmed and so patient declined to admit in ER. The patient mentioned in the follow up document that patient had taken 3 doses in which there was no issues with 1st and 2nd doses only problem with 3rd dose and stated that patient had fever for 2nd dose. This case was linked to MOD-2021-334108 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up document received on 27-Sep-2021 contained significant information that Patient enquired regarding filling the form and had no issues with 1st and 2nd doses of moderna.

Other Meds:

Current Illness: Muscular dystrophy (MD)

ID: 1755774
Sex: F
Age:
State:

Vax Date: 08/21/2021
Onset Date: 09/18/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: strong pressure in the chest/ but feels like some pressure there; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (strong pressure in the chest/ but feels like some pressure there) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced CHEST DISCOMFORT (strong pressure in the chest/ but feels like some pressure there). At the time of the report, CHEST DISCOMFORT (strong pressure in the chest/ but feels like some pressure there) outcome was unknown. Concomitant medications was not provided by the reporter Treatment information was not provided Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1755775
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: Got the first dose of the vaccine "on the butt"; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Got the first dose of the vaccine "on the butt") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Amputation (double amputee (no arms)). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Got the first dose of the vaccine "on the butt"). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Got the first dose of the vaccine "on the butt") 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 medications were reported. The patient was a double amputee and had no arms. It was reported that patient got the first dose of the vaccine on the butt. Patient had administered a 3rd dose of the vaccine in the anterolateral thigh. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received contains significant information of third dose administration. which is in the I-narrative

Other Meds:

Current Illness:

ID: 1755776
Sex: F
Age: 38
State: CO

Vax Date: 02/09/2021
Onset Date: 09/15/2021
Rec V Date: 10/02/2021
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: I was feeling unwell; Patient was scheduled for a FLU vaccine last September 15, 2021 Pharmacist mistakenly administered; Patient was scheduled for a FLU vaccine last September 15, 2021 Pharmacist mistakenly administered; Muscle aches; Joint pain; Chills; Low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 025A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included FLUVOXAMINE for Anxiety, MONTELUKAST SODIUM (SINGULAIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy, PROBIOTICS NOS for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Low grade fever), HEADACHE (Headache), EXTRA DOSE ADMINISTERED (Patient was scheduled for a FLU vaccine last September 15, 2021 CVS Pharmacist mistakenly administered) and PRODUCT ADMINISTRATION ERROR (Patient was scheduled for a FLU vaccine last September 15, 2021 Pharmacist mistakenly administered). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Headache, at an unspecified dose and frequency. On 15-Sep-2021, EXTRA DOSE ADMINISTERED (Patient was scheduled for a FLU vaccine last September 15, 2021 Pharmacist mistakenly administered) and PRODUCT ADMINISTRATION ERROR (Patient was scheduled for a FLU vaccine last September 15, 2021 Pharmacist mistakenly administered) had resolved. On 20-Sep-2021, MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache) had resolved. Patient was scheduled for a FLU vaccine last September 15, 2021. Pharmacist mistakenly administered.Moderna COVID vaccine. Case is currently under the Regional Director. Shot act as a booster but official paper works are still unavailable.

Other Meds: PROBIOTICS NOS; SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLUVOXAMINE

Current Illness:

ID: 1755777
Sex: F
Age: 68
State: OH

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Asthenia; Dysstasia; Dyskinesia; Chills; Headache; Gait Disturbance; Limb discomfort; Sore arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Sep-2021. The most recent information was received on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Asthenia), DYSSTASIA (Dysstasia), GAIT DISTURBANCE (Gait Disturbance), LIMB DISCOMFORT (Limb discomfort) and DYSKINESIA (Dyskinesia) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LISINOPRIL, ATENOLOL, ATORVASTATIN, FISH OIL and CALCIUM for an unknown indication. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced MYALGIA (Sore arm). On 14-May-2021, the patient experienced GAIT DISTURBANCE (Gait Disturbance), LIMB DISCOMFORT (Limb discomfort), CHILLS (Chills) and HEADACHE (Headache). On 15-May-2021, the patient experienced DYSKINESIA (Dyskinesia). On an unknown date, the patient experienced ASTHENIA (Asthenia) and DYSSTASIA (Dysstasia). On 15-May-2021, DYSKINESIA (Dyskinesia), CHILLS (Chills) and HEADACHE (Headache) had resolved. On 16-May-2021, GAIT DISTURBANCE (Gait Disturbance) and LIMB DISCOMFORT (Limb discomfort) had resolved. At the time of the report, ASTHENIA (Asthenia), DYSSTASIA (Dysstasia) and MYALGIA (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. treatment medications were not provided This case was linked to MOD-2021-325844 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant follow up

Other Meds: LISINOPRIL; ATENOLOL; ATORVASTATIN; FISH OIL; CALCIUM

Current Illness:

ID: 1755778
Sex: F
Age:
State: MA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 10/02/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: COVID-19 antibody test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Unevaluable event

Symptoms: renal infarct; a blood clot that killed the upper left quadrant of left kidney; anaphylaxis; This spontaneous case was reported by an other health care professional and describes the occurrence of RENAL INFARCT (renal infarct), RENAL VEIN THROMBOSIS (a blood clot that killed the upper left quadrant of left kidney) and ANAPHYLACTIC REACTION (anaphylaxis) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20) for COVID-19 vaccination. The patient's past medical history included COVID-19 (patient had bad COVID, Recoverd), Anaphylaxis, Hypersensitivity reaction, Urticaria and Hay fever. Previously administered products included for Product used for unknown indication: Flu vaccine (3 days of flu symptoms) in 2012. Past adverse reactions to the above products included Flu symptoms with Flu vaccine. Concurrent medical conditions included Adhesive tape allergy (Adhesive from bandaids allergy -patient had Eczema and red postules), Latex allergy (Patient had rash, red postules), Drug allergy (Patient had migraine, light sensitivity, stomach aches, severe diarrhea), Environmental allergy (Patient had Congestion, sinus infection, sneezing, bronchitis) since 1975, Hypothyroidism since 1993 and Hypercholesteremia since 1998. Concomitant products included MONTELUKAST SODIUM and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism. On 28-Jan-2021 at 5:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021 at 5:00 PM, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criterion medically significant). On an unknown date, the patient experienced RENAL INFARCT (renal infarct) (seriousness criteria hospitalization and medically significant) and RENAL VEIN THROMBOSIS (a blood clot that killed the upper left quadrant of left kidney) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in September 2021 due to RENAL INFARCT. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 28-Jan-2021 at an unspecified dose and frequency. At the time of the report, RENAL INFARCT (renal infarct) and RENAL VEIN THROMBOSIS (a blood clot that killed the upper left quadrant of left kidney) outcome was unknown and ANAPHYLACTIC REACTION (anaphylaxis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RENAL INFARCT (renal infarct), RENAL VEIN THROMBOSIS (a blood clot that killed the upper left quadrant of left kidney) and ANAPHYLACTIC REACTION (anaphylaxis) to be possibly related. This case concerns a 52 year old female patient, with medical history of hypersensitivity to Flu vaccine, drug, latex and environmental allergies, COVID-19 disease and hypercholesterolemia, who experienced serious unexpected events of renal infarct and renal vein thrombosis and also experienced expected event of anaphylactic reaction after the first dose of mRNA-1273. The event anaphylactic reaction occurred the same day after vaccination and renal infarct and renal vein thrombosis occurred 8 months after first dose of mRNA-1273. The rechallange is unknown. Patient?s history of allergies could be considered contributing factor for the event anaphylactic reaction. Patient?s medical history of COVID-19 disease remains a confounder for the event renal vein thrombosis. Anaphylactic reaction is consistent with the current understanding of the mechanism of action of the vaccine. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Added additional serious events anaphylaxis,renal infarct, Renal vein thrombosis. On 23-Sep-2021: Vaccine facility, vaccine information, patient demographics, medical history, concomitant and treatment medications added, new event( urticaria, feeling hot) added, hospitalisation added for event renal infarct, event start date and outcome updated for anaphylaxis, pruritus and urticaria.; Sender's Comments: This case concers a 52 year old female patient, with medical history of hypersensitivity to Flu vaccine, drug, latex and environmental allergies, COVID-19 disease and hypercholesterolemia, who experienced serious unexpected events of renal infarct and renal vein thrombosis and also experienced expected event of anaphylactic reaction after the first dose of mRNA-1273. The event anaphylactic reaction occurred the same day after vaccination and renal infarct and renal vein thrombosis occurred 8 months after first dose of mRNA-1273. The rechallange is unknown. Patient?s history of allergies could be considered contributing factor for the event anaphylactic reaction. Patient?s medical history of COVID-19 disease remains a confounder for the event renal vein thrombosis. Anaphylactic reaction is consistent with the current understanding of the mechanism of action of the vaccine. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds: CRESTOR; SYNTHROID; MONTELUKAST SODIUM; XYZAL

Current Illness: Adhesive tape allergy (Adhesive from bandaids allergy -patient had Eczema and red postules); Drug allergy (Patient had migraine, light sensitivity, stomach aches, severe diarrhea); Environmental allergy (Patient had Congestion, sinus infection, sneezing, bronchitis); Hypercholesteremia; Hypothyroidism; Latex allergy (Patient had rash, red postules)

ID: 1755779
Sex: M
Age:
State: GA

Vax Date: 05/17/2021
Onset Date: 09/21/2021
Rec V Date: 10/02/2021
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: received 2nd dose almost 4 months later; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose almost 4 months later) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose almost 4 months later). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose almost 4 months later) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. patient have not experienced any known symptoms and not received any treatments. no concomitant medications are provided, treatment to the events not reported.

Other Meds:

Current Illness:

ID: 1755780
Sex: M
Age: 20
State: DE

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 10/02/2021
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: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1755781
Sex: F
Age: 42
State: KY

Vax Date: 09/20/2021
Onset Date: 09/20/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Feeling weird; Tightness in her chest; Like when you smoke a pack of cigarettes and that kind of soreness.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feeling weird), CHEST DISCOMFORT (Tightness in her chest) and MYALGIA (Like when you smoke a pack of cigarettes and that kind of soreness.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced FEELING ABNORMAL (Feeling weird), CHEST DISCOMFORT (Tightness in her chest) and MYALGIA (Like when you smoke a pack of cigarettes and that kind of soreness.). At the time of the report, FEELING ABNORMAL (Feeling weird), CHEST DISCOMFORT (Tightness in her chest) and MYALGIA (Like when you smoke a pack of cigarettes and that kind of soreness.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant use were reported No Treatment were reported

Other Meds:

Current Illness:

ID: 1755782
Sex: F
Age: 36
State: TX

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210816; Test Name: Heart rate; Result Unstructured Data: fast

Allergies:

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

Symptoms: Numb Tongue/Tip of the tongue still numb; Jittery; Numb Face with tingling; Flushing; Chest pain; Heart was fast; Shortness of breath/Hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb Tongue/Tip of the tongue still numb), FEELING JITTERY (Jittery), HYPOAESTHESIA (Numb Face with tingling), FLUSHING (Flushing) and CHEST PAIN (Chest pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced HYPOAESTHESIA ORAL (Numb Tongue/Tip of the tongue still numb), FEELING JITTERY (Jittery), HYPOAESTHESIA (Numb Face with tingling), FLUSHING (Flushing), CHEST PAIN (Chest pain), HEART RATE INCREASED (Heart was fast) and DYSPNOEA (Shortness of breath/Hard time breathing). At the time of the report, HYPOAESTHESIA ORAL (Numb Tongue/Tip of the tongue still numb), FEELING JITTERY (Jittery), HYPOAESTHESIA (Numb Face with tingling), FLUSHING (Flushing), CHEST PAIN (Chest pain), HEART RATE INCREASED (Heart was fast) and DYSPNOEA (Shortness of breath/Hard time breathing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Heart rate: fast fast. 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. After the shot the patient waited more than 15 minutes and within 30 minutes felt a numb tongue, jittery, numb face with tingling, flushing, chest pain, her heart was fast, shortness of breath/hard time breathing for about 6 hours. But the tip of tongue was still numb since then. No Concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1755783
Sex: M
Age: 54
State: DE

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 10/02/2021
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: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) 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 relevant concomitant medication was reported. Treatment information were not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1755784
Sex: M
Age: 46
State: DE

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 10/02/2021
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: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Expired product has been administered to consumer with storage error. No concomitant and treatment information provided.

Other Meds:

Current Illness:

ID: 1755785
Sex: F
Age:
State: TN

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: after first vaccine sick for 4-5 days; flu like symptoms; left hand tingling in finger tips/feels like pins and needles; sometimes numb; fingers swell; hand is sensitive to the touch; pain in left hand; This case was received via an unknown source, no reference has been entered for a health authority, on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, INFLUENZA LIKE ILLNESS, PARAESTHESIA, HYPOAESTHESIA, and PERIPHERAL SWELLING in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VALSARTAN HCL, OMEPRAZOLE, ASPIRIN, DILTIAZEM, TERAZOSIN, DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE TIMOLOL, HUMALAND, and VITAMIN C for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (after first vaccine sick for 4-5 days), INFLUENZA LIKE ILLNESS, PARAESTHESIA, HYPOAESTHESIA, PERIPHERAL SWELLING, SENSITIVE SKIN, and PAIN IN EXTREMITY. At the time of the report, ILLNESS, INFLUENZA LIKE ILLNESS, PARAESTHESIA, HYPOAESTHESIA, PERIPHERAL SWELLING, SENSITIVE SKIN, and PAIN IN EXTREMITY outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-326687 (Patient Link).

Other Meds: VALSARTAN HCL; OMEPRAZOLE; ASPIRIN; DILTIAZEM; TERAZOSIN; DORZOLAMIDE TIMOLOL; HUMALAND; VITAMIN C

Current Illness:

ID: 1755786
Sex: F
Age:
State:

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 10/02/2021
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: become pregnant since receiving both doses; the common side effects, the day after vaccine and that it is not ongoing and self resolved within a day of receiving the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (the common side effects, the day after vaccine and that it is not ongoing and self resolved within a day of receiving the vaccine) and MATERNAL EXPOSURE BEFORE PREGNANCY (become pregnant since receiving both doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-May-2022. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (become pregnant since receiving both doses). On an unknown date, the patient experienced VACCINATION COMPLICATION (the common side effects, the day after vaccine and that it is not ongoing and self resolved within a day of receiving the vaccine). On 16-Jan-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (become pregnant since receiving both doses) had resolved. At the time of the report, VACCINATION COMPLICATION (the common side effects, the day after vaccine and that it is not ongoing and self resolved within a day of receiving the vaccine) had resolved. No relevant concomitant medication were provided. No treatment information was provided. This case concerns a female patient, unknown age with no relevant medical history, who experienced the unexpected events of maternal exposure before pregnancy and vaccine complication. The event vaccine complication was said to occur one day after the vaccine. The rechallenge is unknown since details of vaccine complication was not disclosed. The benefit-risk relationship of is not affected by this report. This case was linked to MOD-2021-326826 (Patient Link). Reporter did not allow further contact; Sender's Comments: This case concerns a female patient, unknown age with no relevant medical history, who experienced the unexpected events of maternal exposure before pregnancy and vaccine complication. The event vaccine complication was said to occur one day after the vaccine. The rechallenge is unknown since details of vaccine complication was not disclosed. The benefit-risk relationship of is not affected by this report.

Other Meds:

Current Illness:

ID: 1755787
Sex: F
Age: 41
State: TX

Vax Date: 12/26/2020
Onset Date: 01/21/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Name: Body temperarture; Result Unstructured Data: 103 F; Test Name: Body temperarture; Result Unstructured Data: 102.2F; Test Name: Body temperarture; Result Unstructured Data: high; Test Date: 20210121; Test Name: Body temperarture; Result Unstructured Data: 99 F; Test Name: Covid-19 antibody test; Test Result: Negative ; Result Unstructured Data: negative; Test Name: Covid-19 Test; Test Result: Negative ; Result Unstructured Data: negative

Allergies:

Symptom List: Injection site pain

Symptoms: her arm began to ache (within 15minutes); started to feel bad, not feel too good; achy, aches began by the 3rd-5th day/severe pain; stomach was upset/stomach-ache; irritable; She felt foggy, felt like brain fog; she did not feel too good/she did not feel good at all; groin nodes (all on right side) swelled like a golf ball/lymph nodes started swelling all on the right side/supraclavicular nodes lymph swelling/axillary nodes swelling; Condition agrravated; headache/coming down with something; lots of joint pain; things felt weird/felt very drained; fever for the next 3 days/pretty high fever 2 weeks (over 100F); This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (her arm began to ache (within 15minutes)), FEELING ABNORMAL (started to feel bad, not feel too good), PAIN (achy, aches began by the 3rd-5th day/severe pain), ABDOMINAL PAIN UPPER (stomach was upset/stomach-ache) and IRRITABILITY (irritable) in a 42-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 Meningitis in 2014 and Traumatic brain injury. Concurrent medical conditions included Pain, Attention deficit hyperactivity disorder, Osteophyte formation, Neck pain and Joint pain (at baseline). Concomitant products included OMEPRAZOLE, LISDEXAMFETAMINE MESILATE (VYVANSE), BUPROPION, MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS, TRAMADOL and PARACETAMOL (TYLENOL) for an unknown indication. On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (her arm began to ache (within 15minutes)), FEELING ABNORMAL (started to feel bad, not feel too good), PAIN (achy, aches began by the 3rd-5th day/severe pain), ABDOMINAL PAIN UPPER (stomach was upset/stomach-ache), IRRITABILITY (irritable), FEELING ABNORMAL (She felt foggy, felt like brain fog), MALAISE (she did not feel too good/she did not feel good at all), LYMPHADENOPATHY (groin nodes (all on right side) swelled like a golf ball/lymph nodes started swelling all on the right side/supraclavicular nodes lymph swelling/axillary nodes swelling), HEADACHE (headache/coming down with something), ARTHRALGIA (lots of joint pain), FATIGUE (things felt weird/felt very drained) and PYREXIA (fever for the next 3 days/pretty high fever 2 weeks (over 100F)). 21-Jan-2021, the patient experienced CONDITION AGGRAVATED (Condition agrravated). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her arm began to ache (within 15minutes)), FEELING ABNORMAL (started to feel bad, not feel too good), PAIN (achy, aches began by the 3rd-5th day/severe pain), ABDOMINAL PAIN UPPER (stomach was upset/stomach-ache), IRRITABILITY (irritable), FEELING ABNORMAL (She felt foggy, felt like brain fog), MALAISE (she did not feel too good/she did not feel good at all), LYMPHADENOPATHY (groin nodes (all on right side) swelled like a golf ball/lymph nodes started swelling all on the right side/supraclavicular nodes lymph swelling/axillary nodes swelling), CONDITION AGGRAVATED (Condition agrravated), HEADACHE (headache/coming down with something), ARTHRALGIA (lots of joint pain), FATIGUE (things felt weird/felt very drained) and PYREXIA (fever for the next 3 days/pretty high fever 2 weeks (over 100F)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 99 (High) 99 F. On an unknown date, Body temperature: 103 (High) 103 F, 102.2 (High) 102.2F and 101 (High) high. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) negative. On an unknown date, SARS-CoV-2 test: negative (Negative) negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. patient had medical history of bone spurs in her back, neck and joint pain at baseline and she has neurological memory issues. patient had reported her lumbar puncture was negative and labs came back normal. Company comment: This case concerns a 42 year old female with a history of pain, bone spurs in back, neck and joint pain, meningitis, neurologic memory loss and traumatic brain injury who experienced the non-serious unlisted events of Pain in extremity, Abdominal pain upper, Feeling abnormal and non-serious listed events of Fatigue, Arthralgia, Headache and Pyrexia. The events began the day of Moderna COVID-19 vaccine and for days after with occasional relapse over the next couple of months. Re-challenge is positive for pain, pyrexia and fatigue as these occurred with the first dose also. The medical history of pain, bone spurs, neck and joint pain, meningitis and traumatic brain remain confounders as these could contribute to the events. Benefit-risk relationship of Modera COVID-19 vaccine is not affected by this report. This case was linked to MOD-2021-326770 (Patient Link).; Sender's Comments: This case concerns a 42 year old female with a history of pain, bone spurs in back, neck and joint pain, meningitis, neurologic memory loss and traumatic brain injury who experienced the non-serious unlisted events of Pain in extremity, Abdominal pain upper, Feeling abnormal and non-serious listed events of Fatigue, Arthralgia, Headache and Pyrexia. The events began the day of Moderna COVID-19 vaccine and for days after with occasional relapse over the next couple of months. Re-challenge is positive for pain, pyrexia and fatigue as these occurred with the first dose also. The medical history of pain, bone spurs, neck and joint pain, meningitis and traumatic brain remain confounders as these could contribute to the events. Benefit-risk relationship of Modera COVID-19 vaccine is not affected by this report.

Other Meds: OMEPRAZOLE; VYVANSE; BUPROPION; MULTIVITAMIN [VITAMINS NOS]; VITAMIN D NOS; TRAMADOL; TYLENOL

Current Illness: Attention deficit hyperactivity disorder; Joint pain (at baseline); Neck pain; Osteophyte formation

ID: 1755788
Sex: F
Age:
State: CA

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/02/2021
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: Inappropriate schedule of vaccine administered; Gum infection; a really bad one; Vertigo; Was not able to walk for about four hours after the shot; Feeling so weak; The second dose hit her hard; Dizzy; Swollen lymph nodes on the right side by the upper neck under her chin; Body ache all over; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVITIS (Gum infection; a really bad one), VERTIGO (Vertigo), GAIT INABILITY (Was not able to walk for about four hours after the shot), ASTHENIA (Feeling so weak) and VACCINATION COMPLICATION (The second dose hit her hard) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included CALCIUM, FISH OIL and MAGNESIUM for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced GINGIVITIS (Gum infection; a really bad one), VERTIGO (Vertigo), ASTHENIA (Feeling so weak), VACCINATION COMPLICATION (The second dose hit her hard), DIZZINESS (Dizzy), LYMPHADENOPATHY (Swollen lymph nodes on the right side by the upper neck under her chin) and MYALGIA (Body ache all over). April 2021, the patient experienced GAIT INABILITY (Was not able to walk for about four hours after the shot). On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PENICILLIN NOS for Gum infection, at a dose of 500 milligram. On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, GINGIVITIS (Gum infection; a really bad one), VERTIGO (Vertigo), GAIT INABILITY (Was not able to walk for about four hours after the shot), ASTHENIA (Feeling so weak), VACCINATION COMPLICATION (The second dose hit her hard), DIZZINESS (Dizzy), LYMPHADENOPATHY (Swollen lymph nodes on the right side by the upper neck under her chin) and MYALGIA (Body ache all over) outcome was unknown. After receiving second dose vaccine, patient also experienced high temperature for 2 days and light temperature for 3 to 4 days at least. This case was linked to MOD-2021-325583, MOD-2021-326895 (Patient Link).

Other Meds: CALCIUM; FISH OIL; MAGNESIUM

Current Illness:

ID: 1755789
Sex: F
Age: 58
State:

Vax Date: 09/19/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: a degree and a half of temperature

Allergies:

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

Symptoms: not in the mood, I'm in pain right now; wouldn't have called if it wasn't so bad; pain is sore; it was horrible last night; fever; injection site pain; little bit of chills; feeling specific pectoral muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not in the mood, I'm in pain right now), FEELING ABNORMAL (wouldn't have called if it wasn't so bad), PAIN (pain is sore), PAIN (it was horrible last night) and PYREXIA (fever) in a 59-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. No Medical History information was reported. On 19-Sep-2021 at 4:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (not in the mood, I'm in pain right now), FEELING ABNORMAL (wouldn't have called if it wasn't so bad), PAIN (pain is sore), PAIN (it was horrible last night), PYREXIA (fever), VACCINATION SITE PAIN (injection site pain), CHILLS (little bit of chills) and MYALGIA (feeling specific pectoral muscle pain). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (not in the mood, I'm in pain right now), FEELING ABNORMAL (wouldn't have called if it wasn't so bad), PAIN (pain is sore), PAIN (it was horrible last night), PYREXIA (fever), VACCINATION SITE PAIN (injection site pain), CHILLS (little bit of chills) and MYALGIA (feeling specific pectoral muscle pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) a degree and a half of temperature. Concomitant medications was not provided by the reporter Treatment Ice The patient was rude and said it was not in the mood, I'm in pain right now, pain is sore, in the past a little bit of chills, fever but now I'm feeling specific pectoral muscle pain. The patient received the doses in the left arm. On Sunday it felt injection site pain and on Monday started to feel the pectoral. The patient said it was horrible last night it was terrible and that wouldn't have called if it wasn't so bad.

Other Meds:

Current Illness:

Date Died: 08/28/2021

ID: 1755790
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
Hospital: Y

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

Lab Data: Test Name: ALT; Result Unstructured Data: elevated; Test Name: BNP; Result Unstructured Data: elevated; Test Name: D-Dimer; Result Unstructured Data: elevated; Test Name: Liver Enzymes; Result Unstructured Data: elevated

Allergies:

Symptom List: Tremor

Symptoms: congestive heart failure; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (congestive heart failure) and DYSPNOEA (short of breath) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criteria death, hospitalization and medically significant) and DYSPNOEA (short of breath) (seriousness criteria death, hospitalization and medically significant). The patient died on 28-Aug-2021. The reported cause of death was Congestive heart failure and Short of breath. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: elevated (High) elevated. On an unknown date, Brain natriuretic peptide: elevated (High) elevated. On an unknown date, Fibrin D dimer: elevated (High) elevated. On an unknown date, Hepatic enzyme: elevated (High) elevated. No concomitant medication details was provided. No treatment medication details was provided. Company comment: This case concerns a male patient of an unknown age with no previous relevant medical reported, who experienced the unexpected events of cardiac failure congestive and dyspnoea. The events occurred on an unknown number of days after the second dose of mRNA-1273 and had fatal outcome after on an unknown number of days with date 28-Aug-2021. No autopsy report was provided. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a male patient of an unknown age with no previous relevant medical reported, who experienced the unexpected events of cardiac failure congestive and dyspnoea. The events occurred on an unknown number of days after the second dose of mRNA-1273 and had fatal outcome after on an unknown number of days with date 28-Aug-2021. No autopsy report was provided. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Reported Cause(s) of Death: congestive heart failure; short of breath

Other Meds:

Current Illness:

ID: 1755791
Sex: M
Age: 53
State: IN

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/02/2021
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: ecg; Result Unstructured Data: normal; Test Name: grip strength; Result Unstructured Data: decreased

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: doctor think his heart has gotten bigger; Don't have his sense of taste; Had a very bad reaction to the vaccine; Product dose omission; the first day he felt just kind of tired; He had heart inflammation; He lost 10 pounds right away; He's got swelling in his arm and legs; lost the feeling at the end of the fingers/the very tip of his fingers don't have any feeling/His fingertips are weird; Couldn't figure out how to keep playing, his sticks won't work; and his heart wasn't feeling right/it was like a heavy weight, or a ball in your heart/it is not a heart pain, it is like he had a bowling ball in his heart; Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (He had heart inflammation) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart attack (had 2 heart attacks in the last year and a half), COVID-19 in December 2019 and Angioplasty (had 3 heart stent in the last year and a half.). Concomitant products included ATENOLOL, LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced CARDITIS (He had heart inflammation) (seriousness criterion medically significant), WEIGHT DECREASED (He lost 10 pounds right away), PERIPHERAL SWELLING (He's got swelling in his arm and legs), HYPOAESTHESIA (lost the feeling at the end of the fingers/the very tip of his fingers don't have any feeling/His fingertips are weird), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't figure out how to keep playing, his sticks won't work), CARDIAC DISCOMFORT (and his heart wasn't feeling right/it was like a heavy weight, or a ball in your heart/it is not a heart pain, it is like he had a bowling ball in his heart), FEELING ABNORMAL (Feeling bad) and FATIGUE (the first day he felt just kind of tired). On an unknown date, the patient experienced CARDIOMEGALY (doctor think his heart has gotten bigger), AGEUSIA (Don't have his sense of taste), IMMUNISATION REACTION (Had a very bad reaction to the vaccine) and PRODUCT DOSE OMISSION ISSUE (Product dose omission). At the time of the report, CARDITIS (He had heart inflammation), WEIGHT DECREASED (He lost 10 pounds right away), PERIPHERAL SWELLING (He's got swelling in his arm and legs), HYPOAESTHESIA (lost the feeling at the end of the fingers/the very tip of his fingers don't have any feeling/His fingertips are weird), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't figure out how to keep playing, his sticks won't work), CARDIAC DISCOMFORT (and his heart wasn't feeling right/it was like a heavy weight, or a ball in your heart/it is not a heart pain, it is like he had a bowling ball in his heart), FEELING ABNORMAL (Feeling bad), CARDIOMEGALY (doctor think his heart has gotten bigger), AGEUSIA (Don't have his sense of taste), IMMUNISATION REACTION (Had a very bad reaction to the vaccine) and FATIGUE (the first day he felt just kind of tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Product dose omission) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Grip strength: decreased (abnormal) decreased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient had COVID in Dec-2019 for which he never got a test but he confirmed as COVID because he lost sense of smell and taste and had a pretty bad fever for about 2 days and upper respiratory symptoms for which he did not take any treatment. Lab Data includes chest x-ray with awaiting results. Other concomitant medications include blood thinners and diuretics. Treatment information was not provided. Company Comment - This case concerns a 53 year-old, male subject with a history of COVID-19, Heart attack (had 2 heart attacks in the last year and a half), COVID-19 in December 2019 and Angioplasty who experienced the expected event of FATIGUE and the unexpected events of IMMUNIZATION REACTION, CARDITIS, WEIGHT DECREASED, PERIPHERAL SWELLING, HYPOAESTHESIA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, CARDIAC DISCOMFORT, FEELING ABNORMAL, CARDIOMEGALY, PRODUCT DOSE OMISSION ISSUE and AGEUSIA. The events occurred in the same month when he received the first dose of [Spikevax]. The rechallenge was not applicable (he did not take second dose). The events were considered related to the study drug per the reporter's assessment. The medical history of HEART DISEASE, use of concomitant medication ATENOLOLremains as confounders. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 53 year-old, male subject with a history of COVID-19, Heart attack (had 2 heart attacks in the last year and a half), COVID-19 in December 2019 and Angioplasty who experienced the expected event of FATIGUE and the unexpected events of IMMUNIZATION REACTION, CARDITIS, WEIGHT DECREASED, PERIPHERAL SWELLING, HYPOAESTHESIA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, CARDIAC DISCOMFORT, FEELING ABNORMAL, CARDIOMEGALY, PRODUCT DOSE OMISSION ISSUE and AGEUSIA. The events occurred in the same month when he received the first dose of [Spikevax] The rechallenge was not applicable (he did not take second dose) The events were considered related to the study drug per the reporter's assessment The medical history of HEART DISEASE, use of concomitant medication ATENOLOLremains as confounders The benefit-risk relationship of the vaccine is not affected by this report

Other Meds: ATENOLOL; LISINOPRIL; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1755792
Sex: F
Age: 68
State: CA

Vax Date: 02/15/2021
Onset Date: 03/15/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Funny chemical taste in the mouth; Felt groggy like someone had given the patient a sedative; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Funny chemical taste in the mouth) and SOMNOLENCE (Felt groggy like someone had given the patient a sedative) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 002B2119) for COVID-19 vaccination. The patient's past medical history included Total knee replacement on 21-Jun-2021. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DYSGEUSIA (Funny chemical taste in the mouth). 15-Mar-2021, the patient experienced SOMNOLENCE (Felt groggy like someone had given the patient a sedative). On 15-Mar-2021, DYSGEUSIA (Funny chemical taste in the mouth) and SOMNOLENCE (Felt groggy like someone had given the patient a sedative) had resolved. Concomitant product use was not provided. It was reported that the knee surgery was scheduled on December last year in 2020, but due to COVID surge it was cancelled and re-scheduled. The reporter was unsure about the lot number of the second dose. Treatment information was not provided. The patient was glad that the patient did not have a reaction like those women who got the J and J vaccination and died from a bad, weird sinus reaction. The patient knows a social worker who received the Pfizer vaccine and has had no problems with the first dose, but reacted to the second dose. The knee replacement was a major surgery and the patient was at the three month mark now. This case concerns a 69-year-old female patient with no relevant medical history, who experienced the unexpected events of Dysgeusia and Somnolence. These events occurred one day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 69-year-old female patient with no relevant medical history, who experienced the unexpected events of Dysgeusia and Somnolence. These events occurred one day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness:

ID: 1755793
Sex: U
Age:
State:

Vax Date: 09/21/2021
Onset Date: 09/01/2021
Rec V Date: 10/02/2021
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: I feel horrible; feeling so hot/my body is so hot inside; tingling in my body; hurting a lot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I feel horrible), FEELING HOT (feeling so hot/my body is so hot inside), PARAESTHESIA (tingling in my body) and PAIN (hurting a lot) 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 21-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PARAESTHESIA (tingling in my body) and PAIN (hurting a lot). On 22-Sep-2021, the patient experienced FEELING ABNORMAL (I feel horrible) and FEELING HOT (feeling so hot/my body is so hot inside). At the time of the report, FEELING ABNORMAL (I feel horrible), FEELING HOT (feeling so hot/my body is so hot inside), PARAESTHESIA (tingling in my body) and PAIN (hurting a lot) outcome was unknown. No concomitant medication provided. no treatment medication was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1755794
Sex: F
Age: 62
State: CA

Vax Date: 05/19/2021
Onset Date: 09/01/2021
Rec V Date: 10/02/2021
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: "lightheadedness but I do not know if this can be due to dehydration because I am in the mountains"; laying in bed she cups her ear and can hear whooshing and crunching sounds, compared to tinnitus; taste seems different; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS ("lightheadedness but I do not know if this can be due to dehydration because I am in the mountains"), TINNITUS (laying in bed she cups her ear and can hear whooshing and crunching sounds, compared to tinnitus) and TASTE DISORDER (taste seems different) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019E21A and 019E21A) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder NOS and Anxiety. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced DIZZINESS ("lightheadedness but I do not know if this can be due to dehydration because I am in the mountains"), TINNITUS (laying in bed she cups her ear and can hear whooshing and crunching sounds, compared to tinnitus) and TASTE DISORDER (taste seems different). At the time of the report, DIZZINESS ("lightheadedness but I do not know if this can be due to dehydration because I am in the mountains"), TINNITUS (laying in bed she cups her ear and can hear whooshing and crunching sounds, compared to tinnitus) and TASTE DISORDER (taste seems different) had not resolved. Concomitant medications include medications for Thyroid and Anxiety. Treatment medications were not provided. Patient stated that she never had symptoms after the vaccine doses until about 1-2 weeks ago. Patient stated when laying in bed she cups her ear and can hear whooshing and crunching sounds, compared to tinnitus. Per reporter, lightheadedness but she was not sure due to dehydration because she was in the mountains and her tasted seems different.

Other Meds: MULTIVITAMINS [VITAMINS NOS]

Current Illness: Anxiety; Thyroid disorder NOS

ID: 1755795
Sex: M
Age: 84
State: CA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 10/02/2021
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: My left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (left arm). At the time of the report, PAIN IN EXTREMITY (left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant products were reported. No treatment information was reported by the reporter. Patient reported that after receiving first dose his left arm was sore. This case was linked to MOD-2021-327934, MOD-2021-327671 (Patient Link).

Other Meds:

Current Illness:

ID: 1755796
Sex: F
Age: 68
State: TX

Vax Date: 01/15/2021
Onset Date: 09/21/2021
Rec V Date: 10/02/2021
Hospital: Y

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: Tight throat after booster 3rd shot; Swelling on the left side of neck (throat) after booster 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Tight throat after booster 3rd shot) and SWELLING (Swelling on the left side of neck (throat) after booster 3rd shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 030M20A and 041L20A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Lisinopril (5 years ago). Past adverse reactions to the above products included Angioedema with Lisinopril. 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 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced THROAT TIGHTNESS (Tight throat after booster 3rd shot) (seriousness criterion hospitalization) and SWELLING (Swelling on the left side of neck (throat) after booster 3rd shot) (seriousness criterion hospitalization). The patient was hospitalized on 21-Sep-2021 due to SWELLING and THROAT TIGHTNESS. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 21-Sep-2021 for Throat tightness and Neck swelling, at a dose of 1 UNK and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 21-Sep-2021 for Throat tightness and Neck swelling, at a dose of 120 mg. On 21-Sep-2021, THROAT TIGHTNESS (Tight throat after booster 3rd shot) and SWELLING (Swelling on the left side of neck (throat) after booster 3rd shot) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient did not had any reactions after the first two shots. Five minutes after the booster shot, her throat was tight and started to swell on the left side of the neck. She was given some Benadryl shot and steroid shot and transported to the emergency room where she received additional Benadryl and Steroid shot (120 mg). Company comment: A 69-year-old female was hospitalized with serious unexpected events of throat tightness and swelling. Latency 249 days after first dose, 221 days after second dose, and 5 minutes after third dose mRNA-1273. Events resolved with diphenhydramine and steroids. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: A 69-year-old female was hospitalized with serious unexpected events of throat tightness and swelling. Latency 249 days after first dose, 221 days after second dose, and 5 minutes after third dose mRNA-1273. Events resolved with diphenhydramine and steroids. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1755797
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: Red; Lump; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), VACCINATION SITE MASS (Lump) and VACCINATION SITE PAIN (arm pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red), VACCINATION SITE MASS (Lump) and VACCINATION SITE PAIN (arm pain). At the time of the report, ERYTHEMA (Red), VACCINATION SITE MASS (Lump) and VACCINATION SITE PAIN (arm pain) outcome was unknown. No concomitant medication reported. No treatment medication reported. This case was linked to MOD-2021-328266, MOD-2021-328332 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1755798
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: last one had her experiencing really bad arm pain, red, and lump; last one had her experiencing really bad arm pain, red, and lump; last one had her experiencing really bad arm pain, red, and lump; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (last one had her experiencing really bad arm pain, red, and lump), VACCINATION SITE MASS (last one had her experiencing really bad arm pain, red, and lump) and VACCINATION SITE PAIN (last one had her experiencing really bad arm pain, red, and lump) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 ERYTHEMA (last one had her experiencing really bad arm pain, red, and lump), VACCINATION SITE MASS (last one had her experiencing really bad arm pain, red, and lump) and VACCINATION SITE PAIN (last one had her experiencing really bad arm pain, red, and lump). At the time of the report, ERYTHEMA (last one had her experiencing really bad arm pain, red, and lump), VACCINATION SITE MASS (last one had her experiencing really bad arm pain, red, and lump) and VACCINATION SITE PAIN (last one had her experiencing really bad arm pain, red, and lump) outcome was unknown. No concomitant medication reported. No treatment medication reported. This case was linked to MOD-2021-328266, MOD-2021-328331 (Patient Link).

Other Meds:

Current Illness:

ID: 1755799
Sex: F
Age: 67
State: CA

Vax Date: 09/18/2021
Onset Date:
Rec V Date: 10/02/2021
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: Her arm was sore; had no energy; felt extremely tired for several days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm was sore), ASTHENIA (had no energy) and FATIGUE (felt extremely tired for several days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No medical history information was reported. Concomitant products included PANTOPRAZOLE for an unknown indication. On 18-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Her arm was sore), ASTHENIA (had no energy) and FATIGUE (felt extremely tired for several days). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Her arm was sore), ASTHENIA (had no energy) and FATIGUE (felt extremely tired for several days) 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-2021-328467, MOD-2021-328498 (Patient Link).

Other Meds: PANTOPRAZOLE

Current Illness:

ID: 1755800
Sex: U
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: magnet sticking/He can stick a magnet to arm and it sticks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (magnet sticking/He can stick a magnet to arm and it sticks) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (magnet sticking/He can stick a magnet to arm and it sticks). At the time of the report, UNEVALUABLE EVENT (magnet sticking/He can stick a magnet to arm and it sticks) outcome was unknown. No concomitant medication information was provided. Reporter stated that, he had 2 family members who got the vaccine. Reporter stated that 100 plus days later, which he had been tracking. He could stick a magnet to arm and it sticks. He had seen many videos online showing similar situation. No treatment medication information was provided.

Other Meds:

Current Illness:

ID: 1755801
Sex: F
Age: 70
State: ID

Vax Date: 01/29/2021
Onset Date: 02/24/2021
Rec V Date: 10/02/2021
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: chills for 4 hours (12 hours after flu shot); sore arm for 24 hours after the second dose; chills for 24 hours after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for 24 hours after the second dose), CHILLS (chills for 24 hours after the second dose) and CHILLS (chills for 4 hours (12 hours after flu shot)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination. No medical history was reported. The patient's past medical history included Thyroidectomy on 15-Aug-2011. Concomitant products included LEVOTHYROXINE from 16-Aug-2011 to an unknown date for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm for 24 hours after the second dose) and CHILLS (chills for 24 hours after the second dose). On 21-Sep-2021, the patient experienced CHILLS (chills for 4 hours (12 hours after flu shot)). On 25-Feb-2021, PAIN IN EXTREMITY (sore arm for 24 hours after the second dose) and CHILLS (chills for 24 hours after the second dose) had resolved. On 22-Sep-2021, CHILLS (chills for 4 hours (12 hours after flu shot)) had resolved. No treatment medication was reported by the reporter. The patient received the high dose flu shot of the Fluzone HD QUAD 2021-22 PFS shot and they experienced chills for 4 hours (9 pm 21-Sep-2021-1 am 22-Sep-2021), the onset was 12 hours after shot. They have never in the past had chills after the flu shot (right arm), and they think this might have to do with the COVID vaccine. Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up information received: Added patient demographics, race and ethnicity. Added medical history. Added concomitant product information.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1755802
Sex: F
Age: 42
State: TN

Vax Date: 08/12/2021
Onset Date: 09/18/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210918; Test Name: Body temperature; Result Unstructured Data: 103.3 fever

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: She also experienced Covid-19 arm with that injection but it was much more severe. She state that it has still not gone away completely as of today 23Sep2021; area above and below injection site cold to the touch; She had swelling on her arm the size of a softball, intense itching; had swelling on her arm the size of a softball, intense itching; chills; body aches; experience sever flu like symptoms; fever 103.3; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She also experienced Covid-19 arm with that injection but it was much more severe. She state that it has still not gone away completely as of today 23Sep2021), VACCINATION SITE COLDNESS (area above and below injection site cold to the touch), INFLUENZA LIKE ILLNESS (experience sever flu like symptoms), PYREXIA (fever 103.3) and VACCINATION SITE PRURITUS (She had swelling on her arm the size of a softball, intense itching) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (experience sever flu like symptoms), PYREXIA (fever 103.3), CHILLS (chills) and MYALGIA (body aches). On an unknown date, the patient experienced VACCINATION COMPLICATION (She also experienced Covid-19 arm with that injection but it was much more severe. She state that it has still not gone away completely as of today 23Sep2021), VACCINATION SITE COLDNESS (area above and below injection site cold to the touch), VACCINATION SITE PRURITUS (She had swelling on her arm the size of a softball, intense itching) and VACCINATION SITE SWELLING (had swelling on her arm the size of a softball, intense itching). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 20-Sep-2021, INFLUENZA LIKE ILLNESS (experience sever flu like symptoms), CHILLS (chills) and MYALGIA (body aches) had resolved. At the time of the report, VACCINATION COMPLICATION (She also experienced Covid-19 arm with that injection but it was much more severe. She state that it has still not gone away completely as of today 23Sep2021) and PYREXIA (fever 103.3) had not resolved and VACCINATION SITE COLDNESS (area above and below injection site cold to the touch), VACCINATION SITE PRURITUS (She had swelling on her arm the size of a softball, intense itching) and VACCINATION SITE SWELLING (had swelling on her arm the size of a softball, intense itching) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, Body temperature: 103.3 (High) 103.3 fever. Concomitant drug was not reported. This case was linked to MOD-2021-328812 (Patient Link).

Other Meds:

Current Illness:

ID: 1755803
Sex: U
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: four patients received expired Moderna COVID-19 doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (four patients received expired Moderna COVID-19 doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (four patients received expired Moderna COVID-19 doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (four patients received expired Moderna COVID-19 doses) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1755804
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Name: Balance test; Result Unstructured Data: abnormal

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: I am still not myself; Cannot walk by myself; hard of hearing; water behind ear and an infection left ear; Fell yesterday; vertigo/13 weeks I had the dizziness and vertigo (horrible); dizzy/13 weeks I had the dizziness and vertigo (horrible); Couldn't hear right after the shot/hard of hearing,No hearing in the left ear after shot; I've been sick since I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I am still not myself), ILLNESS (I've been sick since I got the shot), GAIT DISTURBANCE (Cannot walk by myself), FALL (Fell yesterday) and DEAFNESS (Couldn't hear right after the shot/hard of hearing,No hearing in the left ear after shot) in an 83-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. No Medical History information was reported. On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ILLNESS (I've been sick since I got the shot) and DEAFNESS (Couldn't hear right after the shot/hard of hearing,No hearing in the left ear after shot). On 26-Mar-2021, the patient experienced VERTIGO (vertigo/13 weeks I had the dizziness and vertigo (horrible)). 26-Mar-2021, the patient experienced DIZZINESS (dizzy/13 weeks I had the dizziness and vertigo (horrible)). On 21-Sep-2021, the patient experienced FALL (Fell yesterday). On an unknown date, the patient experienced VACCINATION COMPLICATION (I am still not myself), GAIT DISTURBANCE (Cannot walk by myself), HYPOACUSIS (hard of hearing) and MIDDLE EAR EFFUSION (water behind ear and an infection left ear). The patient was treated with PREDNISONE for Ear infection, at an unspecified dose and frequency. In 2021, VERTIGO (vertigo/13 weeks I had the dizziness and vertigo (horrible)) and DIZZINESS (dizzy/13 weeks I had the dizziness and vertigo (horrible)) had resolved. At the time of the report, VACCINATION COMPLICATION (I am still not myself) and ILLNESS (I've been sick since I got the shot) had not resolved, GAIT DISTURBANCE (Cannot walk by myself) and FALL (Fell yesterday) outcome was unknown, DEAFNESS (Couldn't hear right after the shot/hard of hearing,No hearing in the left ear after shot) and HYPOACUSIS (hard of hearing) was resolving and MIDDLE EAR EFFUSION (water behind ear and an infection left ear) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Balance test: abnormal (abnormal) abnormal. No concomitant medication details was provided. Patient stated that about a month before she had the first dose but does not have exact date. For dizziness and vertigo patient called doctor and doctor gave medicine that did not work. Patient reports that prior to calling her doctor she experienced 24 hours dizziness. On the morning of the 26-March-2021 patient was very vertigo and dizzy. She called doctor and she gave me medicine that did not work. Patient reported that prior to calling her doctor she experienced 24 hours dizziness. Patient reported she went to ENT doctors who diagnosed water behind ear and an infection left ear which has resolved. She was prescribed prednisone for 14 days. Caller reports she had balance testing and that she ended up going to a provider (for help). Doctor gave her exercises (that helped). She had two sessions and no longer dizzy. She cannot walk by herself and fell on 21-Sep-2021. She was on a walker now. The ENT specialist doesn't know what was wrong. Patient stated she had an appointment with a neurologist (never been to one before). Thirteen weeks she had the dizziness and vertigo (horrible). Could not hear right after the shot which was coming back a little at the time of reporting. Also, she had no hearing in the left ear after shot and was coming back a little now. She been sick since she got the shot. She was still not herself. Patient reported she had been to the hospital three times in 6 weeks. Patient reported she stayed two nights once and 1 night the other times. Patient reported she had MRI and CAT scan, but result was not reported.; Sender's Comments: This case concerns a 83-year-old female patient with no reported medical history, who experienced the unexpected events hearing loss, vertigo and dizziness. The events occurred approximately one month after the first dose and 1 to 3 days after the second dose of mRNA-1273 Moderna vaccine. Event Hearing loss was automatically upgraded as a Serious event as per IME list. However, based on information available (is resolving) and as per medical criteria was classified as Non-serious.The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1755805
Sex: F
Age: 59
State: NY

Vax Date: 08/30/2021
Onset Date: 09/04/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she still feels having shortness of breath; tachycardia; Her medical condition of Herpetic Whitlow that she has for over 20 years seems to have triggered after 1st dose; The same thing happened next night exactly same way; The same thing happened next night exactly same way; and chest pain.; 4 days later (04Sep2021), she woke up with gasping the breath; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (she still feels having shortness of breath), TACHYCARDIA (tachycardia), CONDITION AGGRAVATED (Her medical condition of Herpetic Whitlow that she has for over 20 years seems to have triggered after 1st dose), DYSPNOEA (The same thing happened next night exactly same way) and CHEST PAIN (The same thing happened next night exactly same way) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included West Nile virus meningoencephalitis in May 2021. Concurrent medical conditions included Herpetic whitlow (she has for over 20 years seems to have triggered after 1st dose). On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Sep-2021, the patient experienced CHEST PAIN (and chest pain.) and DYSPNOEA (4 days later (04Sep2021), she woke up with gasping the breath). On 05-Sep-2021, the patient experienced DYSPNOEA (The same thing happened next night exactly same way) and CHEST PAIN (The same thing happened next night exactly same way). On an unknown date, the patient experienced DYSPNOEA (she still feels having shortness of breath), TACHYCARDIA (tachycardia) and CONDITION AGGRAVATED (Her medical condition of Herpetic Whitlow that she has for over 20 years seems to have triggered after 1st dose). At the time of the report, DYSPNOEA (she still feels having shortness of breath) and TACHYCARDIA (tachycardia) had not resolved, CONDITION AGGRAVATED (Her medical condition of Herpetic Whitlow that she has for over 20 years seems to have triggered after 1st dose), DYSPNOEA (The same thing happened next night exactly same way) and CHEST PAIN (The same thing happened next night exactly same way) outcome was unknown and CHEST PAIN (and chest pain.) and DYSPNOEA (4 days later (04Sep2021), she woke up with gasping the breath) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment information was reported. It was reported that first episode of chest and gasping was resolved within 10 minutes after patient sat up on her bed.

Other Meds:

Current Illness: Herpetic whitlow (she has for over 20 years seems to have triggered after 1st dose)

ID: 1755806
Sex: M
Age: 13
State: TN

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210830; Test Name: C-reactive protein; Result Unstructured Data: should be under 8.; Test Date: 202011; Test Name: Covid-19 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: sneezing; runny nose; developed an extreme sore throat that lasted 30 hours/sore throat came back; too tired; EKG borderline QT prolongation; heartburn after eating a biscuit; chest hurt; felt very cold; lightheaded; sore right knee; did not feel good; slight fever; Give Moderna vaccine at 13 years of agee; This spontaneous case was reported by a consumer and describes the occurrence of ELECTROCARDIOGRAM QT PROLONGED (EKG borderline QT prolongation) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Asthma. On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Give Moderna vaccine at 13 years of agee). On 28-Aug-2021, the patient experienced FEELING ABNORMAL (did not feel good), ARTHRALGIA (sore right knee) and PYREXIA (slight fever). On 30-Aug-2021, the patient experienced ELECTROCARDIOGRAM QT PROLONGED (EKG borderline QT prolongation) (seriousness criterion medically significant), BURNING SENSATION (heartburn after eating a biscuit), CHEST PAIN (chest hurt), FEELING COLD (felt very cold), DIZZINESS (lightheaded) and FATIGUE (too tired). On 01-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (developed an extreme sore throat that lasted 30 hours/sore throat came back). On 09-Sep-2021, the patient experienced SNEEZING (sneezing) and RHINORRHOEA (runny nose). On 30-Aug-2021, FEELING ABNORMAL (did not feel good), ARTHRALGIA (sore right knee) and PYREXIA (slight fever) had resolved. On 13-Sep-2021, OROPHARYNGEAL PAIN (developed an extreme sore throat that lasted 30 hours/sore throat came back), SNEEZING (sneezing) and RHINORRHOEA (runny nose) had resolved. At the time of the report, ELECTROCARDIOGRAM QT PROLONGED (EKG borderline QT prolongation) outcome was unknown, BURNING SENSATION (heartburn after eating a biscuit), CHEST PAIN (chest hurt), FEELING COLD (felt very cold), DIZZINESS (lightheaded) and FATIGUE (too tired) was resolving and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Give Moderna vaccine at 13 years of agee) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive. On 30-Aug-2021, C-reactive protein: 20.2 (High) should be under 8.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications were not reported. The reporter stated that patient was given Moderna vaccine instead of the Pfizer vaccine and noticed it after injection when they handed their vaccination card It was on 27August 2021 in right arm and patient had been exposed to Covid-19 in November of 2020 and was positive for it. On 28Aug2021 patient woke up and said right knee was hurting and patient did not feel good all weekend and had a small fever. On 30August 2021 patient had heartburn after eating a biscuit at school and said chest hurt, patient used asthma inhaler twice instead of once and became lightheaded and felt very cold. Patient was too tired to go in the house when they got home and took him to the doctor that afternoon and they did bloodwork and then went to a hospital for an EKG. The results of the bloodwork were a CRP of 20.2 which should be under 8 and they wanted to repeat the bloodwork on 1 September 2021 and patient developed an extreme sore throat that lasted 30 hours and then his asthma started acting up. On 9 September 2021 the sore throat came back, sneezing, and very runny nose these lasted until 13 September 2021, Patient is now started feeling better. Company Comment: This is a case of 'Product administered to patient of inappropriate age' for this 13-year-old, male with a medical history of asthma, who experienced the unexpected serious event of ECG QT prolonged; unexpected non-serious events of feeling abnormal, chest pain, feeling cold, oropharyngeal pain, sneezing, rhinorrhea and dizziness; expected non-serious events of pyrexia arthralgia and fatigue. The events occurred 3 days after receiving Moderna mRNA-1273 Vaccine (dose number unknown). The rechallenge is not applicable as the events were reported after a single dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a case of 'Product administered to patient of inappropriate age' for this 13-year-old, male with a medical history of asthma, who experienced the unexpected serious event of ECG QT prolonged; unexpected non-serious events of feeling abnormal, chest pain, feeling cold, oropharyngeal pain, sneezing, rhinorrhea and dizziness; expected non-serious events of pyrexia arthralgia and fatigue. The events occurred 3 days after receiving Moderna mRNA-1273 Vaccine (dose number unknown). The rechallenge is not applicable as the events were reported after a single dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report. (Further information is requested).

Other Meds:

Current Illness: Asthma

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am