VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1827390
Sex: U
Age:
State: KS

Vax Date: 10/12/2021
Onset Date: 10/12/2021
Rec V Date: 10/29/2021
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: Vaccine was used for doses after expired date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was used for doses after expired date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was used for doses after expired date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was used for doses after expired date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitants and Treatment medication were reported. This case was linked to MOD-2021-359475 (Patient Link).

Other Meds:

Current Illness:

ID: 1827391
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: hundred patients received a dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (hundred patients received a dose from expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 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 (hundred patients received a dose from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (hundred patients received a dose from expired vial) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1827392
Sex: M
Age: 76
State: WA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03T20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications were provided. No treatment medications were provided. This case was linked to MOD-2021-360193 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1827393
Sex: F
Age:
State: IL

Vax Date: 09/22/2021
Onset Date:
Rec V Date: 10/29/2021
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: Ringing in her ears; received the Pfizer vaccine/first dose of the Moderna Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in her ears) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Pfizer vaccine/first dose of the Moderna Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. No Medical History information was reported. On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TINNITUS (Ringing in her ears) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Pfizer vaccine/first dose of the Moderna Covid-19). At the time of the report, TINNITUS (Ringing in her ears) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Pfizer vaccine/first dose of the Moderna Covid-19) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1827394
Sex: F
Age: 54
State: AZ

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Name: Hearing test; Result Unstructured Data: supposed to be at 20 and patient was at 40; Test Name: MRI of the brain; Result Unstructured Data: nnormal

Allergies:

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

Symptoms: equilibrium went off,imbalance; eyes were bloodshot red; ringing in the ear, tinnitus , ringing is very loud and disruptive; decline in the activity of the hearing , couldn't hear ringing at high pitch; Left side of head is clogged feels like it had weight, feels heavy.; Killing my mood and production; No sleep, cant sleep with ringing in the ear.; Interfering with job, sleep and daily activity.; extremely large headache, which lasted over a month, could not get rid of it/Never experienced headache until the Moderna shot.; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (equilibrium went off,imbalance), OCULAR HYPERAEMIA (eyes were bloodshot red), TINNITUS (ringing in the ear, tinnitus , ringing is very loud and disruptive), HYPOACUSIS (decline in the activity of the hearing , couldn't hear ringing at high pitch) and HEAD DISCOMFORT (Left side of head is clogged feels like it had weight, feels heavy.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LAMOTRIGINE and ALPRAZOLAM for an unknown indication. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (extremely large headache, which lasted over a month, could not get rid of it/Never experienced headache until the Moderna shot.). On an unknown date, the patient experienced BALANCE DISORDER (equilibrium went off,imbalance), OCULAR HYPERAEMIA (eyes were bloodshot red), TINNITUS (ringing in the ear, tinnitus , ringing is very loud and disruptive), HYPOACUSIS (decline in the activity of the hearing , couldn't hear ringing at high pitch), HEAD DISCOMFORT (Left side of head is clogged feels like it had weight, feels heavy.), MOOD ALTERED (Killing my mood and production), INSOMNIA (No sleep, cant sleep with ringing in the ear.) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfering with job, sleep and daily activity.). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency and GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, BALANCE DISORDER (equilibrium went off,imbalance), OCULAR HYPERAEMIA (eyes were bloodshot red), TINNITUS (ringing in the ear, tinnitus , ringing is very loud and disruptive), HYPOACUSIS (decline in the activity of the hearing , couldn't hear ringing at high pitch), HEAD DISCOMFORT (Left side of head is clogged feels like it had weight, feels heavy.), MOOD ALTERED (Killing my mood and production), INSOMNIA (No sleep, cant sleep with ringing in the ear.), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfering with job, sleep and daily activity.) and HEADACHE (extremely large headache, which lasted over a month, could not get rid of it/Never experienced headache until the Moderna shot.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: abnormal (abnormal) supposed to be at 20 and patient was at 40. On an unknown date, Magnetic resonance imaging head: normal (normal) nnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient went to ER and gave pain medication and left her in dark room. Left the ER because she did not like drugs in her body. Patient reports that her headache was so bad her eyes were bloodshot red. Patient went to neurologist and got inner ear test - which noticed that there was a decline in the activity of the hearing and there was some imbalance. Left side of head was clogged feels like it had weight, feels heavy. Patient reported neurology also performed an MRI of the brain MRI (normal). Patient stated neurologist referred her an ENT.Went to ENT and had hearing test. Patient stated her test results showed that she couldn't hear ringing at high pitch supposed to be at 20 and patient was at 40. The results was looking at hearing and going to see about a hearing aid. We have to go through the steps. Patient never experienced headache until the Moderna shot. No sleep, can't sleep with ringing in the ear. Never experienced that in whole life. This case was linked to MOD-2021-359515 (Patient Link).

Other Meds: LAMOTRIGINE; ALPRAZOLAM

Current Illness:

ID: 1827395
Sex: F
Age: 71
State: OR

Vax Date: 03/15/2021
Onset Date:
Rec V Date: 10/29/2021
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: After 1st dose of the vaccine she had a sore arm; 1st dose of the vaccine she had a sore arm that was a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After 1st dose of the vaccine she had a sore arm) and VACCINATION SITE SWELLING (1st dose of the vaccine she had a sore arm that was a little swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (After 1st dose of the vaccine she had a sore arm) and VACCINATION SITE SWELLING (1st dose of the vaccine she had a sore arm that was a little swollen). At the time of the report, VACCINATION SITE PAIN (After 1st dose of the vaccine she had a sore arm) and VACCINATION SITE SWELLING (1st dose of the vaccine she had a sore arm that was a little swollen) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was taking blood thinners concomitantly. This case was linked to MOD-2021-359999, MOD-2021-359939 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received and contains no new information.

Other Meds:

Current Illness:

ID: 1827396
Sex: U
Age:
State: SC

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/29/2021
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: administered past the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the expiration date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered past the expiration date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-359738 (Patient Link).

Other Meds:

Current Illness:

ID: 1827397
Sex: U
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
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: Doses administered out of vial that went through excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Doses administered out of vial that went through excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses administered out of vial that went through excursion). At the time of the report, PRODUCT STORAGE ERROR (Doses administered out of vial that went through excursion) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1827398
Sex: F
Age: 44
State: PR

Vax Date: 10/09/2021
Onset Date: 10/01/2021
Rec V Date: 10/29/2021
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: injection site is still pretty red; injection site is still swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site is still pretty red) and VACCINATION SITE SWELLING (injection site is still swollen) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Pulmonary hypertension. Concomitant products included INSULIN for an unknown indication. On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site is still pretty red) and VACCINATION SITE SWELLING (injection site is still swollen). At the time of the report, VACCINATION SITE ERYTHEMA (injection site is still pretty red) and VACCINATION SITE SWELLING (injection site is still swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient also takes other unspecified concomitant medications. Treatment information was not reported.

Other Meds: INSULIN

Current Illness: Pulmonary hypertension

ID: 1827399
Sex: M
Age: 54
State: FL

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Achilles tendon hurts like hell; tingling in chest & left arm; Achilles tendon locked up. bottom 2 inches inches; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in chest & left arm), TENDON INJURY (Achilles tendon locked up. bottom 2 inches inches) and TENDON PAIN (Achilles tendon hurts like hell) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Hypercholesteraemia (10 years ago) in 2011 and Achilles tendon injury (due to statins intake). In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PARAESTHESIA (tingling in chest & left arm) and TENDON INJURY (Achilles tendon locked up. bottom 2 inches inches). On 21-Oct-2021, the patient experienced TENDON PAIN (Achilles tendon hurts like hell). At the time of the report, PARAESTHESIA (tingling in chest & left arm), TENDON INJURY (Achilles tendon locked up. bottom 2 inches inches) and TENDON PAIN (Achilles tendon hurts like hell) outcome was unknown. Patient had taken unspecified statins 10 yrs ago for cholesterol. Concomitant information was not reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1827400
Sex: F
Age: 89
State:

Vax Date: 10/06/2021
Onset Date: 10/01/2021
Rec V Date: 10/29/2021
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: feeling lousy; increased shortness of breath for 2 days, higher than the baseline; occasional diarrhea; Hypotension; weakness; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling lousy), DYSPNOEA (increased shortness of breath for 2 days, higher than the baseline), DIARRHOEA (occasional diarrhea), HYPOTENSION (Hypotension) and ASTHENIA (weakness) in an 89-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. Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) inhalation gas for Primary pulmonary hypertension. Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TADALAFIL and RIVAROXABAN (XARELTO) for an unknown indication. On 06-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) at an unspecified dose. In October 2021, the patient experienced VACCINATION COMPLICATION (feeling lousy), DYSPNOEA (increased shortness of breath for 2 days, higher than the baseline), DIARRHOEA (occasional diarrhea), HYPOTENSION (Hypotension), ASTHENIA (weakness), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, VACCINATION COMPLICATION (feeling lousy), DYSPNOEA (increased shortness of breath for 2 days, higher than the baseline), DIARRHOEA (occasional diarrhea), HYPOTENSION (Hypotension), ASTHENIA (weakness), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown. No Treatment medications reported

Other Meds: TADALAFIL; XARELTO

Current Illness: Pulmonary arterial hypertension

ID: 1827401
Sex: F
Age:
State: CA

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Muscle soreness all over body after first shot / Achy all over the body after first shot; Tired after first shot; Cold sweats after first shot; Hot sweat after first shot; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Cold sweats after first shot), HYPERHIDROSIS (Hot sweat after first shot), MYALGIA (Muscle soreness all over body after first shot / Achy all over the body after first shot) and FATIGUE (Tired after first shot) 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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced COLD SWEAT (Cold sweats after first shot) and HYPERHIDROSIS (Hot sweat after first shot). On 24-Apr-2021, the patient experienced MYALGIA (Muscle soreness all over body after first shot / Achy all over the body after first shot) and FATIGUE (Tired after first shot). On 01-Oct-2021, COLD SWEAT (Cold sweats after first shot) and HYPERHIDROSIS (Hot sweat after first shot) had resolved. At the time of the report, MYALGIA (Muscle soreness all over body after first shot / Achy all over the body after first shot) and FATIGUE (Tired after first shot) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. It was reported that the patient took steroids shot as a treatment which helped tremendously to the patient. Patient took second dose of Moderna COVID-19 vaccine on 23MAY2021 and batch no is 033B21A.

Other Meds:

Current Illness:

ID: 1827402
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
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: Breakthrough COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakthrough COVID 19) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (Breakthrough COVID 19). At the time of the report, COVID-19 (Breakthrough COVID 19) outcome was unknown. No treatment medication was reported. No Concomitant medication was reported. This is a spontaneous case concerning a 75-year-old male patient with no relevant medical history reported, who experienced AESI, non-serious, unexpected event of COVID-19. The event occurred on an unknown date after receiving two doses of mRNA-1273. Rechallenge is not applicable since it cannot be assessed. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-360264 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 75-year-old male patient with no relevant medical history reported, who experienced AESI, non-serious, unexpected event of COVID-19. The event occurred on an unknown date after receiving two doses of mRNA-1273. Rechallenge is not applicable since it cannot be assessed. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1827403
Sex: F
Age: 79
State: CA

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/29/2021
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: Patient received third dose without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Patient received third dose without being immunocompromised) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. In January 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced OFF LABEL USE (Patient received third dose without being immunocompromised). At the time of the report, OFF LABEL USE (Patient received third dose without being immunocompromised) had resolved. No Concomitant product use was reported. No treatment information was provided It was reported that the patient received their first dose of the Moderna vaccine in Jan-2021 and second dose in Feb-2021 and received the third dose without consulting their healthcare provider on whether the patient was immunocompromised or not. Reportedly, the patient had diabetes.

Other Meds:

Current Illness: Diabetes (Patient has Diabetes.)

ID: 1827404
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
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: Temperature excursion/Vaccines administered to patients after temperature excursion; Expired vaccines/Vaccines administered to patients after being expired; 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion/Vaccines administered to patients after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccines/Vaccines administered to patients after being expired) 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 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion/Vaccines administered to patients after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccines/Vaccines administered to patients after being expired). In 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion/Vaccines administered to patients after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccines/Vaccines administered to patients after being expired) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. no concomitant and treatment medications are provided by the reporter. Some time ago the super cold freezer where the vaccines were stored in frozen condition, failed. The freezer went up to (+)21 degrees Fahrenheit so the vaccines were moved to a kitchen refrigerator freezer that kept the vaccines around (+) 18 degrees Fahrenheit. The vaccines were in that environment for 2-3 days because they were thawing out the original freezer per manufacturer's instructions. The vaccines in meantime were then placed in refrigerator because they were past the (+) 5 degrees Fahrenheit mark. The vaccines were maintained in the refrigerator between 36-46 degrees Fahrenheit. maximum 21 degrees Fahrenheit in frozen storage condition,Excursion duration is of 2-3 days,Number of vials impacted 150 vials.

Other Meds:

Current Illness:

ID: 1827405
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: couldn't really sleep on it's side; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (couldn't really sleep on it's side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Small fiber neuropathy. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SLEEP DISORDER (couldn't really sleep on it's side). At the time of the report, SLEEP DISORDER (couldn't really sleep on it's side) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported No treatment medications were reported. This case was linked to MOD-2021-360203 (Patient Link).

Other Meds:

Current Illness:

ID: 1827406
Sex: F
Age: 62
State: CA

Vax Date: 02/27/2021
Onset Date: 10/18/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Date: 20211018; Test Name: Blood glucose; Result Unstructured Data: High blood pressure after meals; Test Date: 20211019; Test Name: Blood glucose; Result Unstructured Data: High blood pressure after meals; Test Date: 20211020; Test Name: Blood glucose; Result Unstructured Data: High blood pressure after meals

Allergies:

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

Symptoms: Period of better breathing, that last a few hours in each occasion/a positive side effect; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Period of better breathing, that last a few hours in each occasion/a positive side effect) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037f21a, 028a21a and 025a21a) for COVID-19 vaccination. The patient's past medical history included Cancer (Patient is a cancer survivor.). Concurrent medical conditions included Asthma, Type 1 diabetes mellitus and Breathing difficult. Concomitant products included INSULIN (INSULIN, REGULAR) for Type 1 diabetes mellitus. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Period of better breathing, that last a few hours in each occasion/a positive side effect). On 20-Oct-2021, THERAPEUTIC RESPONSE UNEXPECTED (Period of better breathing, that last a few hours in each occasion/a positive side effect) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, Blood glucose: high (High) High blood pressure after meals. On 19-Oct-2021, Blood glucose: high (High) High blood pressure after meals. On 20-Oct-2021, Blood glucose: high (High) High blood pressure after meals. Concomitant medication include hormone replacement, thyroid medication and asthma medication. This case was linked to MOD-2021-063657 (Patient Link).

Other Meds: INSULIN, REGULAR

Current Illness: Asthma; Breathing difficult; Type 1 diabetes mellitus

ID: 1827407
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
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: Breakthrough COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakthrough COVID 19) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (Breakthrough COVID 19). At the time of the report, COVID-19 (Breakthrough COVID 19) outcome was unknown. The concomitant medications on use were not provided. No treatment information was provided. The patient was qualified for the monoclonal antibodies. This case was linked to MOD-2021-360105 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 73-year-old, female patient with unknown medical history, who experienced the unexpected non serious (AESI) event of COVID 19. The event occurred on unknown latency after the second dose of Spikevax. No information regarding start dates of the first or second dose either latency were reported, so lack of efficacy is not captured. The rechallenge is not applicable. The Benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1827408
Sex: F
Age: 71
State: CA

Vax Date: 02/02/2021
Onset Date: 03/02/2021
Rec V Date: 10/29/2021
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: My arm was achy; I was tired for day, or so; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was achy) and FATIGUE (I was tired for day, or so) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (My arm was achy) and FATIGUE (I was tired for day, or so). At the time of the report, PAIN IN EXTREMITY (My arm was achy) and FATIGUE (I was tired for day, or so) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-360509 (Patient Link).

Other Meds:

Current Illness:

ID: 1827409
Sex: F
Age: 62
State: WI

Vax Date: 02/12/2021
Onset Date: 03/13/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Date: 20210313; Test Name: Heart Rate; Result Unstructured Data: Heart rate increased and lasted for about a couple of hours

Allergies:

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

Symptoms: Fast heart rate; General aches; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate) and MYALGIA (General aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced HEART RATE INCREASED (Fast heart rate) and MYALGIA (General aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date for Myalgia, at an unspecified dose and frequency. On 13-Mar-2021, HEART RATE INCREASED (Fast heart rate) had resolved. At the time of the report, MYALGIA (General aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Heart rate: increased (High) Heart rate increased and lasted for about a couple of hours. Concomitant medications details were not reported by the reporter. The patient did not experienced any symptoms like this before Moderna COVID-19 vaccine. Patient did not have any medical history of myocarditis/pericarditis.

Other Meds:

Current Illness:

ID: 1827410
Sex: M
Age: 71
State: WI

Vax Date: 09/18/2021
Onset Date: 10/21/2021
Rec V Date: 10/29/2021
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: patient received dose from expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 062E21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vaccine). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication details was reported. No treatment medication details was reported. This case was linked to MOD-2021-360687 (Patient Link).

Other Meds:

Current Illness:

ID: 1827411
Sex: M
Age: 36
State: WI

Vax Date: 10/21/2021
Onset Date: 10/21/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Patient received dose from expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from expired vaccine) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from expired vaccine). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose from expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were mentioned. No treatment details were reported. Regarding dose it was reported as follows: The vial was initially stored in the refrigerator on 18Oct2021. The vial didn't undergo any temperature excursions. This case was linked to MOD-2021-360642, MOD-2021-360723 (Patient Link).

Other Meds:

Current Illness:

ID: 1827412
Sex: M
Age: 39
State: AK

Vax Date: 09/29/2021
Onset Date: 10/20/2021
Rec V Date: 10/29/2021
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: 1st dose on 29 Sep 2021 and 2nd dose on 20 Oct 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 29 Sep 2021 and 2nd dose on 20 Oct 2021) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 026D21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 20-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 29 Sep 2021 and 2nd dose on 20 Oct 2021). On 20-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 29 Sep 2021 and 2nd dose on 20 Oct 2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1827413
Sex: F
Age: 34
State: CT

Vax Date: 12/28/2020
Onset Date: 10/21/2021
Rec V Date: 10/29/2021
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: patient got a booster dose from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got a booster dose from an expired vial) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A, 028L20A and 011J20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got a booster dose from an expired vial). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient got a booster dose from an expired vial) 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. Reporter mentioned 1 vial, carrying 10 doses, originally, only 3 doses were administered from it. Vial was left to thaw straight from the freezer right before being used.

Other Meds:

Current Illness:

ID: 1827414
Sex: F
Age: 55
State: DC

Vax Date: 09/28/2021
Onset Date:
Rec V Date: 10/29/2021
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: Joint pain on both legs which is also swollen and can not get up in the morning; Lower back pain; Left hand numbness; Joint pain on both legs which is also swollen and can not get up in the morning; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Joint pain on both legs which is also swollen and can not get up in the morning), BACK PAIN (Lower back pain), HYPOAESTHESIA (Left hand numbness) and ARTHRALGIA (Joint pain on both legs which is also swollen and can not get up in the morning) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The patient's past medical history included Knee injury (she had injury back in 2009 on in her knees and fell down.) in 2009. On 28-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Joint pain on both legs which is also swollen and can not get up in the morning), BACK PAIN (Lower back pain), HYPOAESTHESIA (Left hand numbness) and ARTHRALGIA (Joint pain on both legs which is also swollen and can not get up in the morning). At the time of the report, JOINT SWELLING (Joint pain on both legs which is also swollen and can not get up in the morning), BACK PAIN (Lower back pain), HYPOAESTHESIA (Left hand numbness) and ARTHRALGIA (Joint pain on both legs which is also swollen and can not get up in the morning) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had her last physical exam in August of 2021. No Concomitant and Treatment medication were reported.

Other Meds:

Current Illness:

ID: 1827415
Sex: F
Age: 53
State: SC

Vax Date: 08/16/2021
Onset Date:
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fever after 1st dose; soreness after 1st dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after 1st dose) and MYALGIA (soreness after 1st dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever after 1st dose) and MYALGIA (soreness after 1st dose). The patient was treated with HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE [HYDROXYZINE HYDROCHLORIDE]) at a dose of 50 mg four times per day; FAMOTIDINE (FAMOTIDINE TEVA) at a dose of 40 mg once a day; PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) at a dose of 10 mg and ONDANSETRON at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever after 1st dose) and MYALGIA (soreness after 1st dose) had not 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. Lab data reported blood tests and EKG with inconclusive results. No Concomitant Medication was provided. This case was linked to MOD-2021-339162 (Patient Link).

Other Meds:

Current Illness: Allergy

ID: 1827416
Sex: F
Age: 26
State: TN

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/29/2021
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: arm tight, arm hard; arm sore; she woke up with her arm 3x its size; arm itchy; arm red; headache; arm where she got the injection became swollen; arm where she got the injection became sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (arm tight, arm hard), VACCINATION SITE PAIN (arm sore), VACCINATION SITE SWELLING (she woke up with her arm 3x its size), VACCINATION SITE PRURITUS (arm itchy) and VACCINATION SITE ERYTHEMA (arm red) in a 26-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 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced VACCINATION SITE SWELLING (arm where she got the injection became swollen) and VACCINATION SITE PAIN (arm where she got the injection became sore). On 16-Oct-2021, the patient experienced HEADACHE (headache). On 21-Oct-2021, the patient experienced VACCINATION SITE INDURATION (arm tight, arm hard), VACCINATION SITE PAIN (arm sore), VACCINATION SITE SWELLING (she woke up with her arm 3x its size), VACCINATION SITE PRURITUS (arm itchy) and VACCINATION SITE ERYTHEMA (arm red). At the time of the report, VACCINATION SITE INDURATION (arm tight, arm hard), VACCINATION SITE PAIN (arm sore), VACCINATION SITE SWELLING (she woke up with her arm 3x its size), VACCINATION SITE PRURITUS (arm itchy), VACCINATION SITE ERYTHEMA (arm red), VACCINATION SITE SWELLING (arm where she got the injection became swollen), VACCINATION SITE PAIN (arm where she got the injection became sore) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1827417
Sex: M
Age: 68
State: TX

Vax Date: 12/30/2020
Onset Date: 06/26/2021
Rec V Date: 10/29/2021
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: pneumonia; bruises on the chest, back, then all over the body; itchy; burning; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K206A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced CONTUSION (bruises on the chest, back, then all over the body), PRURITUS (itchy) and BURNING SENSATION (burning). In October 2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia), CONTUSION (bruises on the chest, back, then all over the body), PRURITUS (itchy) and BURNING SENSATION (burning) outcome was unknown. No concomitant medications were reported. Patient has been treated with steroid shots, oral steroids, & steroid cream. The patient also got pneumonia last week. Company Comment: This case concerns a 69-year-old male patient with no medical history reported, who experienced the unexpected serious event of pneumonia. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event occured after the second dose and no additional dosing will be given. The benefit-risk relationship of the vaccine in not affected by this report.; Sender's Comments: This case concerns a 69-year-old male patient with no medical history reported, who experienced the unexpected serious event of pneumonia. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event occured after the second dose and no additional dosing will be given. The benefit-risk relationship of the vaccine in not affected by this report.

Other Meds:

Current Illness:

ID: 1827418
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
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: neurological syptoms; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (neurological syptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (neurological syptoms). At the time of the report, NEUROLOGICAL SYMPTOM (neurological syptoms) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow up attached on 21-Oct-2021 contains no new information

Other Meds:

Current Illness:

ID: 1827419
Sex: M
Age: 70
State: TX

Vax Date: 10/20/2021
Onset Date: 10/01/2021
Rec V Date: 10/29/2021
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: Chest kinda hearting when tries to breath; Had the same symptoms but worst; Flu like symptoms; Terminating back pain; Feels the arm like if it's dragging it; Shivering in the inside; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest kind of hurting when tries to breath), CONDITION AGGRAVATED (Had the same symptoms but worst), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Terminating back pain) and MOBILITY DECREASED (Feels the arm like if it's dragging it) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced CHEST PAIN (Chest kinda hearting when tries to breath), CONDITION AGGRAVATED (Had the same symptoms but worst), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Terminating back pain), MOBILITY DECREASED (Feels the arm like if it's dragging it) and CHILLS (Shivering in the inside). At the time of the report, CHEST PAIN (Chest kinda hearting when tries to breath), CONDITION AGGRAVATED (Had the same symptoms but worst), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Terminating back pain), MOBILITY DECREASED (Feels the arm like if it's dragging it) and CHILLS (Shivering in the inside) outcome was unknown. No concomitant medications were provided. No treatment medications were reported. This case was linked to MOD-2021-361221 (Patient Link).

Other Meds:

Current Illness:

ID: 1827420
Sex: U
Age:
State: WV

Vax Date: 10/21/2021
Onset Date: 10/21/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: An expired dose (expiration date of 8Oct2021) of the Moderna Covid-19 Vaccine was given to a patient on 21Oct2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired dose (expiration date of 8Oct2021) of the Moderna Covid-19 Vaccine was given to a patient on 21Oct2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired dose (expiration date of 8Oct2021) of the Moderna Covid-19 Vaccine was given to a patient on 21Oct2021). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired dose (expiration date of 8Oct2021) of the Moderna Covid-19 Vaccine was given to a patient on 21Oct2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment drug details was reported.

Other Meds:

Current Illness:

ID: 1827421
Sex: M
Age: 35
State: IL

Vax Date: 10/21/2021
Onset Date: 10/21/2021
Rec V Date: 10/29/2021
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: patient was mistakenly given a dose of vaccine from a vial that was punctured yesterday morning, A patient was mistakenly given a dose of vaccine that was punctured more than 12 hours ago; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was mistakenly given a dose of vaccine from a vial that was punctured yesterday morning, A patient was mistakenly given a dose of vaccine that was punctured more than 12 hours ago) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for an unreported indication: INFLUENZA VACCINE (Body site- left deltoid lot number- E9R44) on 24-Sep-2021. Concurrent medical conditions included Anemia, Gout, Anxiety and Substance use disorder. Concomitant products included LORATADINE for Allergy, BUSPIRONE, QUETIAPINE and PAROXETINE for Anxiety, ALLOPURINOL for Gout, FERROUS SULFATE for Iron deficiency anemia, BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for Substance use disorder, GABAPENTIN for an unknown indication. On 21-Oct-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was mistakenly given a dose of vaccine from a vial that was punctured yesterday morning, A patient was mistakenly given a dose of vaccine that was punctured more than 12 hours ago). On 21-Oct-2021 at 11:00 AM, EXPIRED PRODUCT ADMINISTERED (patient was mistakenly given a dose of vaccine from a vial that was punctured yesterday morning, A patient was mistakenly given a dose of vaccine that was punctured more than 12 hours ago) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Other medications include Vitamins (B12, folate, B1, MVI) 2500 mcg, 1 mg, 100 mg, 1 tab; all qd used for unknown indication taken orally. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow-up information included no new information. On 25-Oct-2021: significant follow up received and contains patients medical history and medications

Other Meds: LORATADINE; FERROUS SULFATE; SUBOXONE; BUSPIRONE; QUETIAPINE; ALLOPURINOL; GABAPENTIN; PAROXETINE

Current Illness: Anemia; Anxiety; Gout; Substance use disorder

ID: 1827422
Sex: F
Age:
State: CA

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: more than 42 days for administration of second dose; patient younger than 18 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose). In June 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment drug details was reported.

Other Meds:

Current Illness:

ID: 1827423
Sex: U
Age:
State: RI

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: patient received half the dose of a Moderna vaccine in error; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received half the dose of a Moderna vaccine in error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (patient received half the dose of a Moderna vaccine in error). At the time of the report, ACCIDENTAL UNDERDOSE (patient received half the dose of a Moderna vaccine in error) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1827424
Sex: F
Age: 30
State: CO

Vax Date: 09/24/2021
Onset Date: 10/22/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Dose administered from punctured Moderna Covid-19 vaccine vial > 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from punctured Moderna Covid-19 vaccine vial > 12 hours post puncture) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035221A and 035221A) for COVID-19 vaccination. No Medical History information was reported. On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from punctured Moderna Covid-19 vaccine vial > 12 hours post puncture). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from punctured Moderna Covid-19 vaccine vial > 12 hours post puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1827425
Sex: M
Age:
State: OK

Vax Date: 09/01/2021
Onset Date:
Rec V Date: 10/29/2021
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: Still down for a day; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Still down for a day) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DEPRESSED MOOD (Still down for a day). At the time of the report, DEPRESSED MOOD (Still down for a day) had resolved. No concomitant products were reported. No treatment information was reported by the reporter. This case was linked to MOD-2021-307765 (Patient Link).

Other Meds:

Current Illness:

ID: 1827426
Sex: F
Age:
State: SC

Vax Date: 08/30/2021
Onset Date: 08/30/2021
Rec V Date: 10/29/2021
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: Chills; Believes the vaccine exacerbated Fibromyalgia possibly; Arm has a knot in it; Muscle ache; Arm red, swollen, and itching; Arm red, swollen, and itching; Arm red, swollen, and itching; Arm sore; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3180) via an unspecified route of administration, administered Left deltoid on 30Aug2021 at 18:00 as dose 1, single for COVID-19 immunization (age at vaccination 61 years). The patients medical history included ongoing fibromyalgia Diagnosed 40 years ago believes the vaccine exacerbated this possibly. Concomitant medications were not reported. No vaccination was administered 4 weeks Prior Vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect was none. On 30Aug2021, the patient experienced arm sore. On 01Sep2021, had muscle ache, arm has a knot. On 31Aug2021, arm red, swollen, and itching. On an unspecified date, had chills, believes the vaccine exacerbated fibromyalgia possibly. It was reported that on Monday evening she had the vaccine and her arm is still sore, red, swollen, and she has a knot in it. She also had chills after the vaccine, muscle aches, and all that stuff which has gotten better. Arm Sore, she noticed the night she went to bed. It also did not help this was the same side she sleeps on. Arm swollen, red, and itching: She started to notice this the following day when woke up. Arm has a knot in it, confirmed it is not as prominent, it is better now. She mentioned she had to leave work yesterday early because she was hurting so bad. The adverse event did not require a visit to emergency room visit or physician office visit. Treatment/Intervention was she took Tylenol, Gabapentin, and used ice pack on arm. She later clarified the Tylenol is technically Acetaminophen, Mipap, Lot: 544785CS7 Exp: Aug2021. Treatment received for the events as Tylenol, Gabapentin, and used ice pack on arm. She later clarified the Tylenol is technically Acetaminophen, Mipap. The outcome of the events was reported as recovering for arm sore, muscle ache, arm has a knot in it and the outcome as not recovered for arm red, swollen, and itching and the outcome as unknown for chills and believes the vaccine exacerbated fibromyalgia. The patient provided information regarding the reported adverse event with the use of the product and consider the Pfizer product had a casual effect to the adverse event. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Fibromyalgia (Verbatim: Fibromyalgia Diagnosed 40 years ago Believes the vaccine exacerbated this possibly)

ID: 1827427
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 09/10/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Name: Cholesterol; Result Unstructured Data: Test Result:Normal; Comments: cholesterol level are normal; Test Name: Blood work; Result Unstructured Data: Test Result:Perfect

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: headache; chills; This is a Spontaneous report based on the information received by Pfizer f(Manufacturer Notification to Pfizer/ Report No: -4797-8196). A contactable consumer reported for a female patient (reporter's colleague) that: A 56-year-old female patient received (Pfizer COVID-19 Vaccine, solution for injection, Batch/ Lot Number was not reported) via unspecified route of administration as dose number unknown, single for covid 19 immunization. The patient medical history included insomnia, restless legs, fatigue, tired, cholesterol from unknown date if unknown ongoing. Patient is fit do exercises and has happy life. Family medical history includes mother's cholesterol is fine as well and her father did not die of a heart attack. she is concerned that the cholesterol medication can cause hallucinations, which she reports her "father was a victim" of (AE Capture US-#-10Sep2021). Past drug history included generic for Synthroid (Levothyroxine) for unknown indication started in 40s and therapy ended. The patient's concomitant medication included CombiPatch 50/140 two patches a week via transdermal route from 2 years ago, 2019 still ongoing . that since starting she has had no side effects and she feels great and new treatment for hormone replacement for hormone replacement and medication for my Kidneys from unknown date. Patient cardiologists want her to get off of the CombiPatch and wants her to take cholesterol medication. On 10Sep2021 patient experienced headache and chills after Pfizer COVID-19 vaccine. Patient still had headaches. Patient received Moderna Covid vaccine from mid-day approximately 5 months ago, Apr2021 by 23:00 and she almost died after the second dose. She received the second dose and had symptoms. She passed out three times after receiving the second dose. Caller reports that she fell two times after the second dose. She reports that she did not pass out due to "unhealth" and reports that she was "normal" prior to receiving the 2nd dose. She also experienced a "very strong headache" and vomiting. It was "hell night" for her following her 2nd dose. She did not go to the hospital because she was afraid of contracting COVID-19 but did speak to her provider about the reaction. Her headache had not gotten better she would have gone to the hospital. She had to take the vaccine due to her kidney issues. The patient underwent kidney study with result(s): 39%, heart study with no calcification on her heart, blood work with result was perfect, cholesterol level are normal. Caller reports that she has no calcification in her arteries. Caller reported patient would take a third dose after eight months. The outcome of events were unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1827428
Sex: F
Age:
State: FL

Vax Date: 08/30/2021
Onset Date: 08/30/2021
Rec V Date: 10/29/2021
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: exclusively breast feeding; exclusively breast feeding; Started vaginally bleeding; Started vaginally bleeding on the day of my second vaccine very heavily.; This is a spontaneous report from a contactable 29-year-old female consumer reported for herself. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown) via unspecified route of administration, on 30Aug2021 (at the age of 29-year-old) as a single dose for COVID-19 immunization. Patient had no medical history. The patient concomitant medication was not reported. Patient had not taken any other vaccine in four weeks. Patient had not COVID prior to the vaccination and was not tested post COVID vaccination. Patient had no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0202), via an unspecified route of administration, in right arm on 09Aug2021 at 15:00 (at the age of 29-year-old) as a single dose for COVID-19 immunization. Other vaccine administered on the 09Aug2021 was Pfizer (unknown manufacturer, Lot number: FC3184) administered in the right arm. On 30Aug2021 at 15:00, patient started vaginally bleeding on the day of her second vaccine very heavily. She was only 2.5 weeks postpartum and exclusively breast feeding. The patient has not received any treatment for the reported events. The clinical outcome for started vaginally bleeding on the day of her second vaccine very heavily was recovering and other events unknown. Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101218839 Maternal case

Other Meds:

Current Illness:

ID: 1827429
Sex: F
Age:
State: FL

Vax Date: 08/12/2021
Onset Date:
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she was in bed "for 4 days" after booster; This is a spontaneous report from Regulatory Authority via pharmacy. A contactable nurse and consumer (patient) reported that a 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation; tofacitinib citrate (XELJANZ, Expiration date: 30Jun2023), oral from 12Aug2021 to an unspecified date, at 5 mg, twice a day (60/BTL) for an unspecified indication. Medical history included allergy to penicillin, allergy to animal, allergy to horse Products. Concomitant medication(s) included temazepam (capsule, strength: 15 mg) at 15 mg; methotrexate (tablet, strength: 2.5 mg) at 2.5 mg; tramadol HCL (tablet, strength: 50 mg) at 50 mg; vitamin B complex tablet; vitamin D3 (capsule, strength: 10 ug) at ug; estrogens conjugated (PREMARIN, tablet, strength: 0.3 mg) at 0.3 mg; leucovorin calcium (Tablet) at 5 mg. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unknown route on an unknown date as dose 1, single for Covid-19 immunization, received second dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unknown route on an unknown date as dose 2, single for Covid-19 immunization. Patient states that doctor stopped Xeljanz for 2 weeks due to Pfizer Covid booster shot, Patient was scheduled for vacation and did not miss work but states she was in Bed "for 4 days" after booster. The action taken in response to the event for tofacitinib citrate was temporarily withdrawn on an unknown date. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: Temazepam; Methotrexate; Tramadol HCL; Vitamin B Complex; Vitamin D3; Premarin; Leucovorin Calcium; Xeljanz

Current Illness:

ID: 1827430
Sex: F
Age:
State: MI

Vax Date: 09/16/2021
Onset Date: 09/16/2021
Rec V Date: 10/29/2021
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: Two minutes after getting it I got a major heat wave; Pressure in my chest; difficult to breath; Really bad chill; Pfizer vaccine and Influenza vaccine administered on 16Sep2021; Pfizer vaccine and Influenza vaccine administered on 16Sep2021; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3183) via an unspecified route of administration, administered in left arm on 16Sep2021 at 4'O clock(at the age of 22-year-old) as dose 1, single for covid-19 immunisation and Influenza vaccine via an unspecified route of administration on 16Sep2021 4'O clock (Batch/Lot number was not reported) as dose number unknown for immunization. No relevant medical history reported. There were no concomitant medications. Patient reported, on 16Sep2021, two minutes after getting her first shot she got a major heat wave and like pressure in her chest like it was kind of difficult to breath and then right after that it was really bad chill and she just have not a heard of anybody that she know that has had a reaction so quickly after getting it. So, she was kind of concern and scared her. Patient took Influenza vaccine at the same time of Pfizer vaccine on 16Sep2021. Outcome of the events was unknown at the time of reporting. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1827431
Sex: F
Age:
State: OR

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 10/29/2021
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: headache; low fever; muscle aches; fatigue; Not able to function as normal for 1 day; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EL1283 and expiry date was not reported), via intramuscular route of administration in right upper arm, on 04Feb2021, approximately 09:30 am (age at vaccination: 79 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes angioedema (date: Started many years ago- ongoing), hypothyroidism (date: many years ago, 1985- ongoing), macular degeneration (date: Many years- ongoing). Reportedly in the past the patient tested positive for COVID-19 (21Dec2020 to Mid Jan2021). The patient concomitant medications include levothyroxine for thyroid (start date unspecified to ongoing), ascorbic acid, fish oil, vitamin e nos, xantofyl, zeaxanthin, zinc (Ocuvite) for macular degeneration, VITAMIN C [ASCORBIC ACID] and Vitamin D3 (Vitamin C+D3), Probiotic, Stamets 7 for immune booster. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EK5730 and expiry date was not reported), via intramuscular route of administration in left upper arm, on 14Jan2021, approximately 10:30 am, as a dose 1, single for COVID-19 immunization and experienced headache, low fever, muscle aches, fatigue, GI tract Symptoms, not able to function as normal for 1 day. On 04Feb2021, within 08-10 hours of vaccine shots the patient experienced all the same symptoms she had during 3 weeks of COVID symptoms. The patient COVID had from late Dec2020 to Mid Jan2021 the exception of GI tract symptoms. Reportedly for the 24 hours the patient had headache, low fever, muscle aches, fatigue. It was reported that the patient was not able to function as normal for 1 day. The events assessed as non-serious. After second vaccine patient took Narco 5-325 mg few hours after the shot because the patient was miserable for 24 hours after first vaccine. The patient did not received treatment for the events. On 05Feb2021, after 24 hours outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: LEVOTHYROXINE; OCUVITE COMPLETE; PROBIOTICS; VITAMIN C [ASCORBIC ACID]; VITAMIN D3

Current Illness: Angioedema (Started many years go); Hypothyroidism; Macular degeneration

ID: 1827432
Sex: F
Age:
State:

Vax Date: 09/20/2021
Onset Date:
Rec V Date: 10/29/2021
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: big lump on the bottom of her armpit; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) dose 3 via an unspecified route of administration on 20Sep2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced big lump on the bottom of her armpit on an unspecified date. Caller received a booster dose of the Pfizer COVID-19 vaccine on September 20, 2021. She noticed a big lump on the bottom of her armpit on the side where she got the vaccine. Caller wanted to know if this is a normal side effect or has anybody reported such side effect post vaccination. She got the injection and was wondering if anybody had the same issue and what could she do to get it to ease out or anything; caller aware Pfizer unable to offer treatment recommendations or medical advice. Dates and seriousness for has a big lump on the bottom of her armpit on the side she got the injection was reported as unspecified. The clinical outcome of the event was unknown. No follow-up attempts are possible. No further information expected.

Other Meds:

Current Illness:

ID: 1827433
Sex: F
Age:
State: WI

Vax Date: 03/03/2021
Onset Date: 03/11/2021
Rec V Date: 10/29/2021
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: like a mass that was just like a few mass break; really bad hives; she can't do her job and it's ruining her; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration administered in right arm on 03Mar2021 (at the age of 38 years old) as DOSE 2, SINGLE for COVID-19 immunisation; patient received dose 1 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration administered in right arm on 10Feb2021 (at the age of 38 years old) as DOSE 1,SINGLE for COVID-19 immunisation. Medical history included ongoing thyroid disorder. Concomitant medication included levothyroxine sodium for thyroid disorder. The patient experienced really bad hives on 11Mar2021, she can't do her job and it's ruining her on 2021, like a mass that was just like a few mass break on 28Mar2021. The patient reported that she developed really bad hives since in 11Mar2021 had gone through 6 different doctors was on antihistamines, Pepcid, lupus meads, was already took thyroid medication. They were telling her that probably Chronic Urticaria and people are getting this from the vaccine and that was how it's going to be from now on. The patient also reported that she is a teacher, and she could not do her job and it's ruining her, she thought it would go away in a few months, but she was still dealing with it. The patient had broken out in massive hives; she never had anything like this before and that had been her reaction since she got the vaccine. She had dislocated her ability to do pretty everything much that she could easily do. She reported that on her 'cab' and they were just like bug bite or something and they had migrated up all over her body little by little. They created themselves anywhere and everywhere they wanted to at least three weeks out of four weeks months and it had like 'face to face' and dislocated her ability to do pretty everything much that she could easily do. So, she did not know what to do at that point she never had anything like this before and that had been her reaction since she got the vaccine, so she guess she was looking for advice and next step where she was supposed to go. It like a mass that was just like a few mass break on 28Mar2021. The patient received Antihistamines, Prednisone, Xolair, Zyrtec, Allegra, Claritin, Pregamet, Pepcid combination and mucous medication for treatment of hives. Outcome of events were unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: LEVOTHYROXINE SODIUM

Current Illness: Thyroid disorder

ID: 1827434
Sex: F
Age:
State: WI

Vax Date: 09/01/2021
Onset Date: 09/23/2021
Rec V Date: 10/29/2021
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: weakness; fatigue; swollen and painful lumps and rash in armpit; swollen and painful lumps and rash in armpit; swollen and painful lumps and rash in armpit; loss of appetite; gastritis; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FE3592 and expiry date was not reported) via an unspecified route of administration in arm left, on an unspecified date in Sep2021 at 03:30 PM (age at the time of vaccination: 45 years), as a dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient's medical history includes auto immune disorder. The patient concomitant medications received within 2 weeks of vaccination was reported as 1. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3180 and expiry date was not reported), via an unspecified route of administration in arm left, on 01Sep2021 at 07:00 PM, as a dose 1, single for COVID-19 immunization. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. On 23Sep2021 the patient experience swollen and painful lumps and rash in armpit, loss of appetite, gastritis, weakness, fatigue. It was reported that the patient received treatment for the adverse event. Outcome of the events were unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1827435
Sex: M
Age:
State: TX

Vax Date: 09/25/2021
Onset Date: 09/25/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Persistent fatigability; Myalgia; This is a spontaneous report from a contactable physician, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Sep2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Sep2021 at 16:30, the patient experienced persistent fatigability and myalgia. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (MANUFACTURER UNKNOWN) and naproxen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events persistent fatigability and myalgia was resolved with sequelae on an unknown date in Sep2021. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1827436
Sex: F
Age:
State:

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 10/29/2021
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: Light headedness; This is a spontaneous report from a non-contactable pharmacist. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via intramuscular route of administration in the right arm on 25Feb2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Feb2021, the patient experienced light headedness. The patient drank 2 cups of water and light headedness went away. The event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were taken as a result of the event and included drinking two cups of water. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event light headedness was resolved on an unknown date in Feb2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1827437
Sex: F
Age:
State: NY

Vax Date: 05/28/2021
Onset Date: 05/31/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Date: 202105; Test Name: Mammogram; Result Unstructured Data: Test Result:Normal; Comments: luckily it looks normal for now-not cancer; Test Date: 202105; Test Name: Ultrasound; Result Unstructured Data: Test Result:Normal; Comments: luckily it looks normal for now-not cancer

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Inflammation swelling, sensibility of breasts (both); swelling, sensibility of breasts (both); sensibility of breasts (both); found lumps; Psychological fear; This is a spontaneous report from a contactable consumer(patient). A 36-years-old non pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number:EWO161), via an unspecified route of administration, administered in right arm on 28May2021 13:00 (at the age of 36 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included resin allergy and covid-19. Concomitant medications included spirulina [spirulina spp.] (SPIRULINA), camellia sinensis extract (GREEN TEA). The patient previously took cefadroxil and experienced drug hypersensitivity. The patient was not pregnant at time of vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had covid prior vaccination and has not been covid tested post vaccination. On 31May2021, patient experienced inflammation, swelling, sensibility of breasts (both). patient was checked by obstetrician-gynecologist, who found lumps, then patient got a mammogram and ultrasound and it looks normal for now not cancer. After the vaccine patient had to go into all these check ups and costly procedures and the psychological fear that accompanied them is also a cause of huge concern for patient. Patient has received treatment for the adverse event. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: SPIRULINA; GREEN TEA

Current Illness:

ID: 1827438
Sex: F
Age:
State: CA

Vax Date: 05/05/2021
Onset Date:
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Name: Height; Result Unstructured Data: Test Result:165; Comments: cm; Test Name: MRI; Result Unstructured Data: Test Result:unknown results; Comments: couldn't finish the test because she felt like she was in a casket; Test Name: Weight; Test Result: 115.21 kg

Allergies:

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

Symptoms: Her left arm is still hurting; She could not even raise her left arm up without it hurting her; her shoulder swell up like a big knot in it/ got a big knot at the injection site; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that, A 62-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) (at the age of 62 years old), dose 2 via an unspecified route of administration, administered in arm left on 05May2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EW0162), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient received her second dose of the Pfizer Covid-19 Vaccine on 05May2021 in her left arm. Her left arm was still hurting. It felt like she was getting a shot into it all over again. She needed to take Tylenol and Ibuprofen to stop the pain, but she did not want to do that forever. It was her second vaccine, and it made her shoulder swell up like a big knot in it. That took six weeks to go away. She could not even raise her left arm up without it hurting her. Her doctor did a Magnetic Resonance Imaging (MRI) on her arm, but she could not finish the test because she felt like she was in a casket. The outcome of the events Her left arm is still hurting was not recovered, her shoulder swell up like a big knot in it/ got a big knot at the injection site was recovered on an unknown date and She could not even raise her left arm up without it hurting her was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1827439
Sex: M
Age:
State: AR

Vax Date: 09/14/2021
Onset Date: 09/01/2021
Rec V Date: 10/29/2021
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: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:160s/90s; Comments: It was in the 160s/90s all three times; Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:160s/90s; Comments: It was in the 160s/90s all three times; Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:160s/90s; Comments: It was in the 160s/90s all three times; Test Date: 20210914; Test Name: Heart cath; Result Unstructured Data: Test Result:No blockages; Comments: No blockages; Test Date: 2021; Test Name: TEE procedure; Result Unstructured Data: Test Result:Ultra value; Comments: Not severe. surgery later this your 2021 Nov-Dec

Allergies:

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

Symptoms: The rash began on his back last night and was itchy/rash is "really itchy; a little painful; broke out in a rash/rash spreading to the front of his chest and covering his arms.; received his Pfizer booster dose on 14Sep2021; received his Pfizer booster dose on 14Sep2021; his blood pressure was up.; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 22Oct2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (COMIRNATY, COVID 19 Vaccine, mRNA), dose 3 intramuscularly, administered in left arm on 14Sep2021 08:00 (Lot Number: FC3181) as dose 3 (booster), single at the age of 76 years old for COVID-19 immunisation. Medical history included ongoing MS (multiple sclerosis) has had since 60 years old; ongoing mitral valve leaking and he needs it repaired or replaced, It has been checked for 8 years and slowly over 8 year period slowly getting worse; detached right macular in right eye from Mar2016 or Apr2016 and ongoing. Weight: 190-192. There were concomitant medications which included blood pressure medication and cholesterol medication. No additional details provided. . Historic vaccine was bnt162b2 dose 1 received intramuscularly administered in left arm on 22Jan2021 07:00 (Lot: EL3302); and dose 2 received intramuscularly administered in left arm on 12Feb2021 07:30 (Lot: EL9264), both as a single dose at the age of 76 years old for COVID-19 immunisation and no reaction on exposure to vaccination. The patient experienced total severe body rash on 26Sep2021. The seriousness of rash was Important medical event. Event rash resulted in physician office visit. On 27Sep2021, broke out in a rash. The rash began on his back last night and was itchy. By this am, the caller reports him waking up scratching the top of his shoulders and the rash had spread up the top of his back. He did go to his general practitioner for evaluation due to the rash spreading to the front of his chest and covering his arms. On 27Sep2021 he began breaking out in a rash covering 2/3 of his body where it looks like measles, it's a rash, and painful. On 14Sep2021 he had a heart cath. The heart cath and covid booster are the only two things that have changed. He had the heart cath as clarified to see if he had any blockages of vessels (no). The rash started small, and it went up her back, core, arms, chest. It started 27Sep2021 afternoon about 4 in the afternoon and it was itching. It was itching back there. When he woke up this morning he was scratching on top of his shoulders and now the rash is covering chest and arms. He stated he can send pictures. He looked online and saw other people had side effects and had a rash. When he went to the doctor his blood pressure was up. They checked it three times and all three times it was up. It was in the 160s/90s all three times. Treatment: Prednisone, he will take like 4 a day, 3 a day, then 2, then 1. Treatment received which included prednisone 7 day pack cleared in about 5 days. The provider was unsure what the rash may be but did prescribe a steroid dose where the patient will take a tapering dose, 4 tonight, then 3, then 2, then 1. The caller denies any change in food or drinks as well as no medication changes. His HCP does plan to follow up on him tomorrow to see how he is doing and if by the end of the treatment regimen prescribed today, if the rash is not improved/resolved they do plan to do lab work. The caller states the rash was really itchy, like you want to rip your skin off and was a little painful, not all but some. Caller describes the rash as looking like measles. Caller does also state that on 22Sep2021, he did have a heart catheterization performed on the left and ride sides of his heart due to a mitral valve leak. The caller will have to go to the Clinic for repair but notes that he does not want to go with this rash. The caller remains very pleasant and states he just wanted to call for information, he was not complaining. He states that he had no trouble with the 1st and 2nd shot. No reaction, no soreness. However with the booster dose, the patient does not having had mild soreness at the shoulder and after that was okay until the rash. Caller stated he does not know if the rash is related to the COVID Booster or not. Investigations: None yet due to rash, will wait to see if Prednisone works and helps. If not will go back for lab work. No prior Vaccinations (within 4 weeks); he has not have the flu shot yet. Test: TEE procedure in 2021 Result: ultra value Not severe, comments: surgery later this your Nov2021 -Dec2021. No specific relevant test for thromboembolic events with thrombocytopenia. The outcome of rash was recovered on 01Oct2021. The outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Eye abnormality (Mar or Apr2016); Mitral valve disease (It has been checked for 8 years and slowly over 8 year period slowly getting worse.); MS (Has had since 60 years old)

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am