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: 1767034
Sex: F
Age: 66
State: MN

Vax Date: 08/11/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: Nutrition is going down; Brain fog; Confused; Disoriented; Dehydrated, cannot got enough fluids in; Severe nausea; Severe vomiting; Renal function was affected; Very slurred speech; Severe muscle spasms; Lots of facial swelling; Inability to walk/ trouble walking; same symptoms/ sick; same symptoms/ fatigue; This spontaneous case was reported by a nurse and describes the occurrence of RENAL IMPAIRMENT (Renal function was affected) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 091021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cancer surgery. Concurrent medical conditions included Cancer (diagnosed with cancer in spring and had surgery) and Nephrectomy (she only has one kidney now). Concomitant products included LEVOTHYROXINE, PEMBROLIZUMAB (KEYTRUDA) and AXITINIB (INLYTA) for an unknown indication. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced RENAL IMPAIRMENT (Renal function was affected) (seriousness criterion medically significant), MUSCLE SPASMS (Severe muscle spasms), SWELLING FACE (Lots of facial swelling), GAIT DISTURBANCE (Inability to walk/ trouble walking), NUTRITIONAL CONDITION ABNORMAL (Nutrition is going down), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (Confused), DISORIENTATION (Disoriented), DEHYDRATION (Dehydrated, cannot got enough fluids in), NAUSEA (Severe nausea) and VOMITING (Severe vomiting). 09-Sep-2021, the patient experienced DYSARTHRIA (Very slurred speech). In September 2021, the patient experienced ILLNESS (same symptoms/ sick) and FATIGUE (same symptoms/ fatigue). At the time of the report, RENAL IMPAIRMENT (Renal function was affected) and NUTRITIONAL CONDITION ABNORMAL (Nutrition is going down) had not resolved and DYSARTHRIA (Very slurred speech), MUSCLE SPASMS (Severe muscle spasms), SWELLING FACE (Lots of facial swelling), GAIT DISTURBANCE (Inability to walk/ trouble walking), ILLNESS (same symptoms/ sick), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (Confused), DISORIENTATION (Disoriented), DEHYDRATION (Dehydrated, cannot got enough fluids in), NAUSEA (Severe nausea), VOMITING (Severe vomiting) and FATIGUE (same symptoms/ fatigue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication included immunotherapy for chemo. It was reported that the patient looked like having Bell's palsy and was never been like this before. She had to go to the ER 3 times to get IV therapy and visited the physician twice. Treatment information included IV therapy at ER 3 times. Company Comment: This case concerns a 66-year-old, female patient with previous relevant medical history of Cancer and Nephrectomy, who experienced the unexpected event of Renal Impairment. The event occurred on the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since the event of renal impairment happened only in the second dose. The rechallenge for the events of illness, nausea, vomiting, fatigue, and gait inability is not applicable since the outcome of the events from the first dose are unknown. The medical history of cancer and nephrectomy remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. This case was linked to MOD-2021-335638 (Patient Link).; Sender's Comments: This case concerns a 66-year-old, female patient with previous relevant medical history of Cancer and Nephrectomy, who experienced the unexpected event of Renal Impairment. The event occurred on the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since the event of renal impairment happened only in the second dose. The rechallenge for the events of illness, nausea, vomiting, fatigue, and gait inability is not applicable since the outcome of the events from the first dose are unknown. The medical history of cancer and nephrectomy remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds: LEVOTHYROXINE; KEYTRUDA; INLYTA

Current Illness: Cancer (diagnosed with cancer in spring and had surgery); Nephrectomy (she only has one kidney now)

ID: 1767035
Sex: U
Age: 67
State: SC

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

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Had temperature; Test Date: 20210909; Test Name: COVID-19 PCR; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210915; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Felt like something in her chest like a bomb after getting 3rd dose; Had a cold; felt like a flu; she had sever reaction after receiving 3rd dose; Could lift her head up off the pillow this time; Patient is still experiencing little fatigue; little bit of a headache that is more toward sinus; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Felt like something in her chest like a bomb after getting 3rd dose), NASOPHARYNGITIS (Had a cold), INFLUENZA (felt like a flu), SINUS HEADACHE (little bit of a headache that is more toward sinus) and VACCINATION COMPLICATION (she had sever reaction after receiving 3rd dose) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Non-smoker and Vaccination adverse reaction. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication. On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced SINUS HEADACHE (little bit of a headache that is more toward sinus). On an unknown date, the patient experienced CHEST DISCOMFORT (Felt like something in her chest like a bomb after getting 3rd dose), NASOPHARYNGITIS (Had a cold), INFLUENZA (felt like a flu), VACCINATION COMPLICATION (she had sever reaction after receiving 3rd dose), HEAD DISCOMFORT (Could lift her head up off the pillow this time) and FATIGUE (Patient is still experiencing little fatigue). The patient was treated with AZITHROMYCIN (Z-PAK) on 19-Sep-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Felt like something in her chest like a bomb after getting 3rd dose) and HEAD DISCOMFORT (Could lift her head up off the pillow this time) outcome was unknown and NASOPHARYNGITIS (Had a cold), INFLUENZA (felt like a flu), SINUS HEADACHE (little bit of a headache that is more toward sinus), VACCINATION COMPLICATION (she had sever reaction after receiving 3rd dose) and FATIGUE (Patient is still experiencing little fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative and. On 15-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: abnormal (abnormal) Had temperature. Patient went on PCR COVID-19 test on 28-Sep-2021. This case was linked to MOD-2021-334391, MOD-2021-335705 (Patient Link).

Other Meds: SYNTHROID; VITAMINS NOS

Current Illness: Non-smoker; Vaccination adverse reaction

ID: 1767036
Sex: F
Age: 56
State: NY

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210114; Test Name: Body temperature; Result Unstructured Data: 102 F; Test Date: 20210114; Test Name: heart rate; Result Unstructured Data: 130; Test Date: 20210114; Test Name: Oxygen saturation; Test Result: 88 %; Result Unstructured Data: 88%.

Allergies:

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

Symptoms: soreness at the injection site; could barely walk/ legs were going to break when I walked on them; stress; felt tired; intense muscle pain/ achy; fever (102 F); felt like having covid all over again; intense bone pain; shortness of breath; tachycardia/ tachycardia got to 130; oxygen dropped to 88%; little bit dizzy; This spontaneous case was reported by a nurse and describes the occurrence of SUSPECTED COVID-19 (felt like having covid all over again), BONE PAIN (intense bone pain), DYSPNOEA (shortness of breath), TACHYCARDIA (tachycardia/ tachycardia got to 130) and OXYGEN SATURATION DECREASED (oxygen dropped to 88%) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer female and COVID-19. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced SUSPECTED COVID-19 (felt like having covid all over again). 14-Jan-2021, the patient experienced BONE PAIN (intense bone pain), DYSPNOEA (shortness of breath), TACHYCARDIA (tachycardia/ tachycardia got to 130), OXYGEN SATURATION DECREASED (oxygen dropped to 88%), DIZZINESS (little bit dizzy), STRESS (stress), FATIGUE (felt tired), MYALGIA (intense muscle pain/ achy) and PYREXIA (fever (102 F)). On 15-Jan-2021, the patient experienced GAIT DISTURBANCE (could barely walk/ legs were going to break when I walked on them) and VACCINATION SITE PAIN (soreness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) on 14-Jan-2021 for Fever, at an unspecified dose and frequency. In January 2021, SUSPECTED COVID-19 (felt like having covid all over again), BONE PAIN (intense bone pain), DYSPNOEA (shortness of breath), TACHYCARDIA (tachycardia/ tachycardia got to 130), OXYGEN SATURATION DECREASED (oxygen dropped to 88%), DIZZINESS (little bit dizzy), GAIT DISTURBANCE (could barely walk/ legs were going to break when I walked on them), STRESS (stress), FATIGUE (felt tired), MYALGIA (intense muscle pain/ achy) and PYREXIA (fever (102 F)) had resolved and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 102 f (High) 102 F. On 14-Jan-2021, Heart rate: 130 (High) 130. On 14-Jan-2021, Oxygen saturation: 88 % (Low) 88%. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. About 3 hours after first shot, nurse felt like having COVID all over again. She felt tired, but she thought it was due to being so stressed. She also had Intense bone pain, intense muscle pain, shortness of breath, tachycardia, fever (102 F). She had Tylenol and the fever went down. Her oxygen dropped to 88 percent and got a little bit dizzy during the night. She drank a lot of fluids while going through that. The tachycardia got 130 at some point. Symptoms lasted for 10 hours or until the morning. The next day, she was so achy, she could barely walk and felt like her legs were going to break when she walked on. Everything went away after 2 days. On the second day, nurse felt amazing like a superhero, like a rebound effect. No concomitant medications were reported. This case was linked to MOD-2021-335717 (Patient Link).; Sender's Comments: This case concerns a 56-year-old female patient with no relevant medical history who experienced non-serious unexpected events of suspected COVID-19, bone pain, dyspnoea, tachycardia, oxygen saturation decreased, dizziness, stress, fatigue, myalgia, pyrexia, gait disturbance and vaccination site pain. The events occurred approximately 1 day after the first dose of mRNA-1273. Rechallenge was positive as adverse events resolved prior to dose 2, and patient reports that she did experience the same adverse events after second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1767037
Sex: F
Age: 56
State: NY

Vax Date: 01/14/2021
Onset Date: 02/01/2021
Rec V Date: 10/07/2021
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: pain wasn't as intense; soreness at the injection site; muscle pain; fatigue; bone pain; got the same symptoms, but they were not as intense; shortness of breath was not as intense; tachycardia was not as intense/ wasn't tachycardic so much; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (got the same symptoms, but they were not as intense), DYSPNOEA (shortness of breath was not as intense), TACHYCARDIA (tachycardia was not as intense/ wasn't tachycardic so much), PAIN (pain wasn't as intense) and BONE PAIN (bone pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 14-Feb-2021, the patient experienced PAIN (pain wasn't as intense). In February 2021, the patient experienced VACCINATION COMPLICATION (got the same symptoms, but they were not as intense), DYSPNOEA (shortness of breath was not as intense), TACHYCARDIA (tachycardia was not as intense/ wasn't tachycardic so much), BONE PAIN (bone pain), MYALGIA (muscle pain) and FATIGUE (fatigue). In February 2021, BONE PAIN (bone pain) had resolved, MYALGIA (muscle pain) outcome was unknown. At the time of the report, VACCINATION COMPLICATION (got the same symptoms, but they were not as intense), DYSPNOEA (shortness of breath was not as intense), TACHYCARDIA (tachycardia was not as intense/ wasn't tachycardic so much), PAIN (pain wasn't as intense), VACCINATION SITE PAIN (soreness at the injection site) and FATIGUE (fatigue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not provided. Patient took Benadryl before taking the second shot. Treatment information was not provided This case was linked to MOD-2021-335716 (Patient Link).

Other Meds:

Current Illness:

ID: 1767038
Sex: F
Age: 52
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: sick with all three doses; lethargic after dose 1; fever not above a 100?F after dose 1; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick with all three doses), LETHARGY (lethargic after dose 1) and PYREXIA (fever not above a 100?F after dose 1) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced LETHARGY (lethargic after dose 1) and PYREXIA (fever not above a 100?F after dose 1). On an unknown date, the patient experienced ILLNESS (sick with all three doses). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) for Fever, at an unspecified dose and frequency. On 10-Jan-2021, LETHARGY (lethargic after dose 1) and PYREXIA (fever not above a 100?F after dose 1) had resolved. At the time of the report, ILLNESS (sick with all three doses) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2021-335764, MOD-2021-335775 (Patient Link).

Other Meds:

Current Illness:

ID: 1767039
Sex: F
Age: 52
State: TX

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 10/07/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick with all three doses), URINARY TRACT INFECTION (A week after dose 2 got UTI), VACCINATION COMPLICATION (second and third dose had an impact on her hormones), VULVOVAGINAL DRYNESS (dry vagina) and PYREXIA (fever not above a 100?F after dose 1) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A, 013M20A and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced PYREXIA (fever not above a 100?F after dose 1). On an unknown date, the patient experienced ILLNESS (sick with all three doses), URINARY TRACT INFECTION (A week after dose 2 got UTI), VACCINATION COMPLICATION (second and third dose had an impact on her hormones), VULVOVAGINAL DRYNESS (dry vagina) and VOMITING (vomited after dose 2). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and ESTRADIOL for Vaginal dryness, at an unspecified dose and frequency. On 10-Jan-2021, PYREXIA (fever not above a 100?F after dose 1) outcome was unknown. At the time of the report, ILLNESS (sick with all three doses), URINARY TRACT INFECTION (A week after dose 2 got UTI), VACCINATION COMPLICATION (second and third dose had an impact on her hormones), VULVOVAGINAL DRYNESS (dry vagina) and VOMITING (vomited after dose 2) outcome was unknown. No concomitant medications were reported. This case was linked to MOD-2021-335745 (Patient Link).

Other Meds:

Current Illness:

ID: 1767040
Sex: M
Age:
State: FL

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

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

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. 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 an unknown date, the patient experienced COVID-19 (Positive for Covid-19). At the time of the report, COVID-19 (Positive for Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not provided by the reporter Treatment information was not provided; Sender's Comments: This case concerns a male patient of unknown age with no relevant medical history reported who experienced non serious unexpected event of special interest COVID-19. The event occurred unknown time after the first dose of Spikevax. Rechallenge was unknown since there is no information regarding the second dose. The benefit-risk relationship of drug is not affected by this report. The patient experienced COVID-19 prior to second dose administration.

Other Meds:

Current Illness:

ID: 1767041
Sex: F
Age: 64
State: FL

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 10/07/2021
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: Mildly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mildly sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (Mildly sore arm). At the time of the report, VACCINATION SITE PAIN (Mildly sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Treatment information was not provided. This case was linked to MOD-2021-335979, MOD-2021-335982 (Patient Link).

Other Meds:

Current Illness:

ID: 1767042
Sex: F
Age:
State: OH

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 10/07/2021
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: vaginal bleeding; lethargic; upper and lower back pain/pain in her upper back; didn't feel good; general aches and pains like she had the flu; a little nauseous; pain around her shoulders; chills; injection site was tender to the touch/injection site pain/tender to the touch; injection site was raised/raised bump at the injection site; injection site bruised/bruising around the injection site; bled a lot after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (injection site was raised/raised bump at the injection site), VACCINATION SITE BRUISING (injection site bruised/bruising around the injection site), VAGINAL HAEMORRHAGE (vaginal bleeding), LETHARGY (lethargic) and BACK PAIN (upper and lower back pain/pain in her upper back) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION SITE MASS (injection site was raised/raised bump at the injection site), VACCINATION SITE BRUISING (injection site bruised/bruising around the injection site), VACCINATION SITE HAEMORRHAGE (bled a lot after the injection) and VACCINATION SITE PAIN (injection site was tender to the touch/injection site pain/tender to the touch). On 04-Aug-2021, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding), LETHARGY (lethargic), BACK PAIN (upper and lower back pain/pain in her upper back), MALAISE (didn't feel good), PAIN (general aches and pains like she had the flu), NAUSEA (a little nauseous), ARTHRALGIA (pain around her shoulders) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 06-Aug-2021, PAIN (general aches and pains like she had the flu) had resolved. In August 2021, BACK PAIN (upper and lower back pain/pain in her upper back) and ARTHRALGIA (pain around her shoulders) had resolved. At the time of the report, VACCINATION SITE MASS (injection site was raised/raised bump at the injection site), VACCINATION SITE BRUISING (injection site bruised/bruising around the injection site), LETHARGY (lethargic), MALAISE (didn't feel good), VACCINATION SITE HAEMORRHAGE (bled a lot after the injection), NAUSEA (a little nauseous), VACCINATION SITE PAIN (injection site was tender to the touch/injection site pain/tender to the touch) and CHILLS (chills) outcome was unknown and VAGINAL HAEMORRHAGE (vaginal bleeding) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment includes Ice and Tea This case was linked to MOD-2021-336033 (Patient Link).

Other Meds:

Current Illness:

ID: 1767043
Sex: F
Age:
State: CA

Vax Date: 09/27/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: fever.

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: swelling in the right arm and leg; swelling in the right arm and leg; Looks and feel terrible; fever of 102.2; This spontaneous case was reported by an other health care professional and describes the occurrence of the first episode of PERIPHERAL SWELLING (swelling in the right arm and leg), the second episode of PERIPHERAL SWELLING (swelling in the right arm and leg), MALAISE (Looks and feel terrible) and PYREXIA (fever of 102.2) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced the first episode of PERIPHERAL SWELLING (swelling in the right arm and leg), the second episode of PERIPHERAL SWELLING (swelling in the right arm and leg), MALAISE (Looks and feel terrible) and PYREXIA (fever of 102.2). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, last episode of PERIPHERAL SWELLING (swelling in the right arm and leg), MALAISE (Looks and feel terrible) and PYREXIA (fever of 102.2) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.2 (High) fever. 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 provided.

Other Meds:

Current Illness:

ID: 1767044
Sex: U
Age:
State: CA

Vax Date: 09/24/2021
Onset Date: 09/24/2021
Rec V Date: 10/07/2021
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: 3 patients received doses punctured past 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received doses punctured past 12 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received doses punctured past 12 hours). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (3 patients received doses punctured past 12 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication listed. No treatment information provided. Vial was punctured 12-16 hours prior while maintained at proper refrigerated temperature and protocol for revaccination.

Other Meds:

Current Illness:

ID: 1767045
Sex: M
Age: 44
State: MA

Vax Date: 09/01/2021
Onset Date:
Rec V Date: 10/07/2021
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: severe numbness in his right arm; tingling sensation that runs down his arm; feels debilitating; a cyst became inflamed; a cyst became inflamed; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (severe numbness in his right arm), PARAESTHESIA (tingling sensation that runs down his arm), FEELING ABNORMAL (feels debilitating), INFLAMMATION (a cyst became inflamed) and CHEST WALL CYST (a cyst became inflamed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Chest wall cyst. On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (severe numbness in his right arm), PARAESTHESIA (tingling sensation that runs down his arm), FEELING ABNORMAL (feels debilitating), INFLAMMATION (a cyst became inflamed) and CHEST WALL CYST (a cyst became inflamed). At the time of the report, HYPOAESTHESIA (severe numbness in his right arm), PARAESTHESIA (tingling sensation that runs down his arm) and FEELING ABNORMAL (feels debilitating) outcome was unknown and INFLAMMATION (a cyst became inflamed) and CHEST WALL CYST (a cyst became inflamed) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication use was reported. The second thing is he has a cyst on his chest that he's had for 4 years, but it became inflamed after the vaccination. It was acting up pretty severely that he went to his doctor who said it was from the vaccine. His doctor had to cut and drain the cyst and it seems fine now.

Other Meds:

Current Illness: Chest wall cyst

ID: 1767046
Sex: M
Age: 51
State: WV

Vax Date: 12/23/2020
Onset Date: 08/21/2021
Rec V Date: 10/07/2021
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: lump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump at the injection site) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A, 029L20A and 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced VACCINATION SITE MASS (lump at the injection site). At the time of the report, VACCINATION SITE MASS (lump at the injection site) outcome was unknown. Concomitant and Treatment was not specified. This case was linked to MOD-2021-336394 (Patient Link).

Other Meds:

Current Illness:

ID: 1767047
Sex: M
Age:
State: IA

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: GI effect - diarrhea; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (GI effect - diarrhea) and MYALGIA (body aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (GI effect - diarrhea) and MYALGIA (body aches). At the time of the report, DIARRHOEA (GI effect - diarrhea) and MYALGIA (body aches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication was reported No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1767048
Sex: M
Age: 67
State: MI

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: 8 patients got expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1767049
Sex: F
Age: 73
State: CA

Vax Date: 02/20/2021
Onset Date: 09/26/2021
Rec V Date: 10/07/2021
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: Knocked her on her back; knot in her shoulder; a little discomfort; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (Knocked her on her back), MUSCULOSKELETAL DISCOMFORT (knot in her shoulder), DISCOMFORT (a little discomfort) and PYREXIA (low grade fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced BACK DISORDER (Knocked her on her back), MUSCULOSKELETAL DISCOMFORT (knot in her shoulder), DISCOMFORT (a little discomfort) and PYREXIA (low grade fever). At the time of the report, BACK DISORDER (Knocked her on her back), MUSCULOSKELETAL DISCOMFORT (knot in her shoulder), DISCOMFORT (a little discomfort) and PYREXIA (low grade fever) outcome was unknown. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1767050
Sex: M
Age:
State: MI

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

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

Lab Data:

Allergies:

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

Symptoms: 8 patients got expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication use was reported.

Other Meds:

Current Illness:

ID: 1767051
Sex: M
Age: 14
State: TX

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: patient under 18 years got a dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years got a dose of the Moderna vaccine) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years got a dose of the Moderna vaccine). On 28-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years got a dose of the Moderna vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. This case was linked to MOD-2021-336648 (Patient Link).

Other Meds:

Current Illness:

ID: 1767052
Sex: M
Age: 69
State: VA

Vax Date: 01/21/2021
Onset Date: 03/01/2021
Rec V Date: 10/07/2021
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: 1st dose received on 21Jan2021 and 2nd dose received on 01Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 21Jan2021 and 2nd dose received on 01Mar2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 022M20A) for COVID-19 vaccination. The patient's past medical history included Heart attack (The patient had a heart attack 11 years ago prior to receiving the 1st dose of the moderna vaccine). Concurrent medical conditions included Heart disease, unspecified (The patient was a high-risk patient as he had a heart condition and heart attack 11 years ago prior to receiving the 1st dose of the moderna vaccine) and Hearing impaired (he had trouble hearing but stated that it was not due the vaccine.). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 21Jan2021 and 2nd dose received on 01Mar2021). On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 21Jan2021 and 2nd dose received on 01Mar2021) had resolved. No concomitant medications reported. No treatment information was provided. The patient seemed upset and stated that he is confused with lack of information and so much confusion surrounding the 3rd dose and booster vaccine.

Other Meds:

Current Illness: Hearing impaired (he had trouble hearing but stated that it was not due the vaccine.); Heart disease, unspecified (The patient was a high-risk patient as he had a heart condition.)

ID: 1767053
Sex: M
Age: 75
State: MI

Vax Date: 09/20/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication listed. No treatment information provided.

Other Meds:

Current Illness:

ID: 1767054
Sex: F
Age: 52
State: MI

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: administered a dose of the Moderna vaccine from the expired lot; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna vaccine from the expired lot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna vaccine from the expired lot). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna vaccine from the expired lot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was unknown.

Other Meds:

Current Illness:

ID: 1767055
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 09/20/2021
Rec V Date: 10/07/2021
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: Was administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) 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. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1767056
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: Flu like symptoms for 12 hours after second Moderna covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms for 12 hours after second Moderna covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for 12 hours after second Moderna covid-19 vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms for 12 hours after second Moderna covid-19 vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. treatment medications were not reported. This case was linked to MOD-2021-336846 (Patient Link).

Other Meds:

Current Illness:

ID: 1767057
Sex: F
Age: 91
State: FL

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 10/07/2021
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: muscle weakness; hand tremors; difficulty getting out of a chair; sleeping up to 14 hours a day; pain in extremities-epecially the left arm; puffiness in her feet; extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness), TREMOR (hand tremors), HYPOKINESIA (difficulty getting out of a chair), HYPERSOMNIA (sleeping up to 14 hours a day) and PAIN IN EXTREMITY (pain in extremities-epecially the left arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dementia since 2013, Hyperlipidemia and Arthritis. Concomitant products included DONEPEZIL for Dementia. On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness), TREMOR (hand tremors), HYPOKINESIA (difficulty getting out of a chair), HYPERSOMNIA (sleeping up to 14 hours a day), PAIN IN EXTREMITY (pain in extremities-epecially the left arm), OEDEMA PERIPHERAL (puffiness in her feet) and FATIGUE (extreme tiredness). At the time of the report, MUSCULAR WEAKNESS (muscle weakness), TREMOR (hand tremors), HYPOKINESIA (difficulty getting out of a chair), HYPERSOMNIA (sleeping up to 14 hours a day), PAIN IN EXTREMITY (pain in extremities-epecially the left arm), OEDEMA PERIPHERAL (puffiness in her feet) and FATIGUE (extreme tiredness) had not resolved. No concomitant medication was provided No treatment received by the patient Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Follow up document received and contains no new information On 28-Sep-2021: ADR received on 28 Sep 2021,mentioned AE outcome On 28-Sep-2021: follow up received no new information; Sender's Comments: This case concerns a 91-year-old female patient with a relevant n medical history of dementia, who experienced the unexpected non-serious events of muscular weakness, tremor, hypokinesia, hypersomnia, pain in extremity, oedema peripheral and expected non-serious event of fatigue. The event covid19 occurred on the 8 months after receiving second dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the event Covid-19 occurred only after second dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds: DONEPEZIL

Current Illness: Arthritis; Dementia; Hyperlipidemia

ID: 1767058
Sex: F
Age: 64
State: PA

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210820; Test Name: fever; Result Unstructured Data: At 8 PM, 100.9 degrees F

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: she got sick; her skin hurt; didn't sleep well; headache; body aches; fever 100.9 degrees F; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (she got sick), PAIN OF SKIN (her skin hurt), INSOMNIA (didn't sleep well), HEADACHE (headache) and MYALGIA (body aches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included HIV infection (which patient contracted from her husband.), Chronic fatigue, Chronic bronchitis, Chronic pneumonia, Degenerative joint disease, Seasonal allergy, Penicillin allergy and Immunocompromised. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Degenerative joint disease, BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV disease, EPINEPHRINE (EPIPEN) for an unknown indication. On 20-Aug-2021 at 12:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021 at 8:00 PM, the patient experienced ILLNESS (she got sick), INSOMNIA (didn't sleep well) and HEADACHE (headache). 20-Aug-2021 at 8:00 PM, the patient experienced PAIN OF SKIN (her skin hurt). 20-Aug-2021 at 8:00 PM, the patient experienced MYALGIA (body aches), PYREXIA (fever 100.9 degrees F) and CHILLS (chills). On 22-Aug-2021, ILLNESS (she got sick), PAIN OF SKIN (her skin hurt), INSOMNIA (didn't sleep well), HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever 100.9 degrees F) and CHILLS (chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Body temperature: 100.9 (High) At 8 PM, 100.9 degrees F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient treatment information include no medication for events. This case was linked to MOD-2021-337213 (Patient Link).

Other Meds: BIKTARVY; VICODIN; FLONASE [FLUTICASONE PROPIONATE]; EPIPEN

Current Illness: Chronic bronchitis; Chronic fatigue; Chronic pneumonia; Degenerative joint disease; HIV infection (which patient contracted from her husband.); Immunocompromised; Penicillin allergy; Seasonal allergy

ID: 1767059
Sex: F
Age: 73
State: NJ

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 10/07/2021
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: inability to eat, clarified as feeling queasy.; inability to eat, clarified as feeling queasy.; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (inability to eat, clarified as feeling queasy.) and NAUSEA (inability to eat, clarified as feeling queasy.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Shingles. Concurrent medical conditions included Bell's palsy. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEEDING DISORDER (inability to eat, clarified as feeling queasy.) and NAUSEA (inability to eat, clarified as feeling queasy.). At the time of the report, FEEDING DISORDER (inability to eat, clarified as feeling queasy.) and NAUSEA (inability to eat, clarified as feeling queasy.) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-337833 (Patient Link).

Other Meds:

Current Illness: Bell's palsy

ID: 1767060
Sex: M
Age: 73
State: NJ

Vax Date: 01/19/2021
Onset Date: 02/16/2021
Rec V Date: 10/07/2021
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: slighty swollen sore arm with both vaccines; slighty swollen sore arm with both vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (slighty swollen sore arm with both vaccines) and VACCINATION SITE PAIN (slighty swollen sore arm with both vaccines) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination. The patient's past medical history included Heart valve disorders (history of heart valves). Concurrent medical conditions included Overweight (slightly overweight). On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE SWELLING (slighty swollen sore arm with both vaccines) and VACCINATION SITE PAIN (slighty swollen sore arm with both vaccines). At the time of the report, VACCINATION SITE SWELLING (slighty swollen sore arm with both vaccines) and VACCINATION SITE PAIN (slighty swollen sore arm with both vaccines) outcome was unknown. No concomitant medication was reported by the reporter. No treatment was reported by the reporter. This case was linked to MOD-2021-337936 (Patient Link).

Other Meds:

Current Illness: Overweight (slightly overweight)

ID: 1767061
Sex: F
Age: 70
State: IL

Vax Date: 01/28/2021
Onset Date: 09/23/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210923; Test Name: COVID-19; Test Result: Positive ; Result Unstructured Data: COVID positive

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Arm pain forever; Bursitis; Sick; injection site pain; Some fatigue; COVID positive / just getting over COVID; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain forever), BURSITIS (Bursitis), ILLNESS (Sick), COVID-19 (COVID positive / just getting over COVID) and DRUG INEFFECTIVE (Lack of drug effect) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Shoulder replacement. Previously administered products included for an unreported indication: FLU. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced COVID-19 (COVID positive / just getting over COVID) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain forever), BURSITIS (Bursitis), ILLNESS (Sick), INJECTION SITE PAIN (injection site pain) and FATIGUE (Some fatigue). At the time of the report, PAIN IN EXTREMITY (Arm pain forever), BURSITIS (Bursitis), ILLNESS (Sick), COVID-19 (COVID positive / just getting over COVID), DRUG INEFFECTIVE (Lack of drug effect), INJECTION SITE PAIN (injection site pain) and FATIGUE (Some fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, SARS-CoV-2 test: positive (Positive) COVID positive. No Treatment were reported. Patient mentioned flu shot caused bursitis and tendonitis. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: follow up received on 29-SEP-2021 includes Event was added On 04-Oct-2021: follow up received contains medical history , events for flu shot; Sender's Comments: This case concerns a 71-year-old, female with reported history of Flu vaccination and shoulder replacement, who experienced the unexpected AESI event of Drug ineffective because of COVID 19 infection more than 15 days after the second dose of the vaccine within a correct interval with the first dose. The event occurred approximately 7 months and 26 days after the first dose and 6 month and 27 days after the most recent dose (second dose) of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was unknown since the patient is planning on getting the booster. Several other non serious or AESI events were reported, such as pain in extremity, tendinitis and bursitis that could be confounded by the history of shoulder replacement and the co suspect of flu vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report

Other Meds: CRESTOR; FOSAMAX

Current Illness:

ID: 1767062
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: administered the first dose of Moderna then contracted COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (administered the first dose of Moderna then contracted COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (administered the first dose of Moderna then contracted COVID). At the time of the report, COVID-19 (administered the first dose of Moderna then contracted COVID) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient wants to know whether safe to take her second dose . Concomitant medication use was unknown Treatment information was unknown; Sender's Comments: This case concerns a female with unknown age with no reported relevant medical history , who experienced the unexpected event of Covid 19. This event occurred on an unknown date after the 1st dose of mRNA-1273 (Moderna) . The rechallenge is not applicable. The benefit-risk relationship of Moderna is not affected by this report.

Other Meds:

Current Illness:

ID: 1767063
Sex: M
Age: 67
State: MS

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 10/07/2021
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: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 015M20A and 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021 at 10:59 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021 at 9:18 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment medication reported.

Other Meds:

Current Illness:

ID: 1767064
Sex: F
Age: 83
State: MS

Vax Date: 01/18/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 031M20A and 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not reported. Treatment medications was not reported.

Other Meds:

Current Illness:

ID: 1767065
Sex: M
Age: 60
State: MS

Vax Date: 09/01/2015
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 016M20A and 023M20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2015, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment information was reported vaccine administered to patient on SEP 01 2021 as a third dose without any adverse effect

Other Meds:

Current Illness:

ID: 1767066
Sex: M
Age: 73
State: MS

Vax Date: 02/08/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 012M20A and 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021 at 1:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021 at 3:09 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021 at 4:21 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. No Treatment medication information was provided

Other Meds:

Current Illness:

ID: 1767067
Sex: F
Age: 73
State: MS

Vax Date: 02/08/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A, 010A21A and 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication details were provided. No Treatment medication details were provided.

Other Meds:

Current Illness:

ID: 1767068
Sex: F
Age: 80
State: MS

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. This case was linked to MOD-2021-306137 (Patient Link).

Other Meds:

Current Illness:

ID: 1767069
Sex: F
Age: 66
State: MS

Vax Date: 01/22/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 029A21A and 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021 at 1:13 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021 at 1:21 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication were reported. No treatment medication were reported. Moderna vaccine 044A21A expired on 31 Aug 2021. Vaccine administered to client on 01 Sep 2021 as a third dose.

Other Meds:

Current Illness:

ID: 1767070
Sex: F
Age: 80
State: MS

Vax Date: 01/16/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 031M20A and 029L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Allergies to medications), Food allergy and Allergy (Other products). On 16-Jan-2021 at 11:42 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021 at 10:03 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that there was no adverse event noted. Concomitant medication information was not reported Treatment information was not reported

Other Meds:

Current Illness: Allergy (Other products); Drug allergy (Allergies to medications); Food allergy

ID: 1767071
Sex: M
Age: 55
State: MS

Vax Date: 12/22/2020
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 030L20A and 011J20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided Treatment medication was not provided by the reporter

Other Meds:

Current Illness:

ID: 1767072
Sex: F
Age:
State: MD

Vax Date: 07/17/2021
Onset Date: 07/21/2021
Rec V Date: 10/07/2021
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: Saturday-Tuesday tight chest; Saturday-Tuesday tight chest, should and pectoral muscle; Wednesday- nausea; stomach cramps; watery diarrhea; This is a spontaneous report from a contactable other hcp. A 27-years-old female (non-pregnant) patient received bnt162b2 (Formulation: Solution for injection in pre-filled syringe, Batch/lot number : unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 17Jul2021 14:00 (age at vaccination: 27 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Hashimotos thyroiditis from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported; zinc (ZINC) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid, caffeine (BC [ACETYLSALICYLIC ACID;CAFFEINE]) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took nickel and experienced allergy to metals. The patient had covid prior vaccination and covid not tested post vaccination.On 21Jul2021, 08:00 AM Patient experienced, Saturday to tuesday tight chest, shoulder and pectoral muscle, Wednesday nausea, stomach cramps, watery diarrhea (as reported). The outcome of all events reported as not recovered. Information about lot/batch number has been requested.

Other Meds: LEVOTHYROXINE; B12 [CYANOCOBALAMIN]; ZINC; LO LOESTRIN FE; BC [ACETYLSALICYLIC ACID;CAFFEINE]; CLARITIN [LORATADINE]

Current Illness:

ID: 1767073
Sex: F
Age:
State:

Vax Date: 07/22/2021
Onset Date: 07/01/2021
Rec V Date: 10/07/2021
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: lightheadedness and stomach pain at night; lightheadedness and stomach pain at night; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 17-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 22Jul2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient experienced light-headedness and stomach pain at night. The patient was asking if these are normal side effects of the vaccine or if she needs to see a doctor. The outcome of the event was unknown. Information about lot/Batch number has been requested. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1767074
Sex: M
Age:
State: AR

Vax Date: 07/23/2021
Onset Date: 07/24/2021
Rec V Date: 10/07/2021
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: Body aches; tired; headaches; Just overall a not feeling well arm sore at injection site; Just overall a not feeling well arm sore at injection site; Some chest pain very minor; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration, administered in Arm Left on 23Jul2021 17:30 as 2nddose, single for covid-19 immunisation (age at vaccination was 52 years). Historical vaccine was A 52-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration, administered in Arm Left on 02Jul2021, 04:30 PM as 1st dose, single for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced body aches, tired, headaches, just overall a not feeling well arm sore at injection site, just overall a not feeling well arm sore at injection site, some chest pain very minor on 24Jul2021 10:00. No treatment was received. No, covid prior vaccination. If covid tested post vaccination was no. The clinical outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1767075
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: thyroiditis subacute; lymphadenopathy; tachycardia; This is a spontaneous report from a contactable consumer. A 41-years-old female patient (Pregnant: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (Age of vaccination: Unknown) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced thyroiditis subacute, lymphadenopathy and tachycardia. The outcome of events was not recovered. The article refers to 29 cases that can be found in table 1 in the article. A safety signal for SAT following COVID-19 vaccination was observed via disproportionality analysis comparing the number of observed reports against the calculated number of expected reports. Disproportionate reporting was observed to be statistically significant for the two mRNA-based vaccines of Pfizer/BioNTech (observed n=18, expected n=3) resulting in a lower 95% limit of the Information Component measure for disproportionality (IC025) of 1.5 and Moderna (observed n=5, expected n=1, IC025 = 0.1). The expected value is based on the total number of reports on the covid-19 vaccines and the proportion of reports that relate to SAT in a regulatory database. Reports in a regulatory database: Up to 08Jun2021, a regulatory database, contained 29 reports of SAT (MedDRA preferred term (PT): thyroiditis subacute) following immunization with the novel COVID-19 vaccines. Furthermore, a regulatory database comprised 50 cases reporting the PT autoimmune thyroiditis and another 50 cases reporting the PT thyroiditis following COVID-19 vaccination up to 08Jun2021. In 30 of the 50 cases reporting the PT autoimmune thyroiditis patients were described to suffer underlying Hashimoto's thyroiditis flaring up after the vaccination. Cases reporting SAT were sent from nine countries. Countries contributing most reports were the (Withheld) (n=9), (Withheld) (n=6), and (Withheld) (n=4). Eighteen (62%) of the 29 reports were for the Pfizer/BioNTech mRNA vaccine, five for the Moderna mRNA vaccine, and six for the AstraZeneca adenovirus vector-based vaccine. Cases were mostly classified as non-serious (62%). In the 11 serious cases, two reported caused or prolonged hospitalization and the other nine medically important conditions as the seriousness criteria. Information on the dose number was available in 19 cases. In 11 cases the SAT occurred after administration of the first dose and in nine cases after the second dose. Time-to-onset (TTO) was observed to be in median three days after the second dose (ranging from 0 to 60 days) compared to a median TTO of six days after the first dose (ranging from 0 to 26 days). Patients experiencing SAT following vaccination were mainly female (n=24; 83%) and five patients were male (17%). Patients's age was reported in 28 cases resulting in a median age of 45 years (range 18 to 67 years). Information about the outcome was available in 22 cases. The outcome was reported as 'not recovered' at the time of reporting in 12 cases (41%), in eight cases it was reported as 'recovered' and in the remaining two cases the outcome was unknown. Treatment: In seven cases (24%) patients reportedly received pharmacotherapy. In six of the cases corticosteroids (prednisone or dexamethasone) were used to treat SAT and in the remaining case the patient was planned to start antibiotic therapy. Furthermore, in the recent scientific literature a series of case reports of patients developing SAT associated with COVID-19 infections was published 14-21. Six of the eight published reports concern female patients 14-16, 19-21. In most of the cases the onset of the SAT's symptoms (such as anterior neck pain) was reported around two weeks to one month after COVID-19 infection and the condition usually responded well to corticosteroid treatment. Though there is not much evidence of SAT following immunization in general, a series of case reports on patients developing SAT in association with COVID-19 infection can be found in the recent scientific literature. Inflammatory response, apoptosis, and local damage, direct viral replication, interaction with thyroidal ACE2 receptors, and a potential central mechanism with low TSH level possibly secondary to hypothalamus-pituitary dysfunction have been discussed as potential mechanisms for COVID-19-induced SAT. Since the vaccines included in the analyzed case series do not contain the virus itself in any form (neither live attenuated nor inactivated), but only its genetic material, the hypotheses related to direct viral or post-viral damage seem rather improbable in the current context. However, one case (case 18) reported a viral thyroiditis without further specification and in another two cases may represent confounders. Another possible mechanism could be related to autoimmune reactions. In association with vaccines the concept of the autoimmune or inflammatory syndrome induced by adjuvants, known as (unlisted country) syndrome comes to mind. A literature review conducted by (name) and colleagues in 2017 investigated the potential correlation between (unlisted country) and thyroidal autoimmune conditions. The authors included a series of case reports of patients developing autoimmune thyroid conditions (SAT, multinuclear giant cell granulomas, and thyrotoxicosis) following immunization with various vaccines (in two cases seasonal influenza vaccine, and H1N1 influenza vaccination in the remaining case) 26. The Pfizer/BioNTech vaccine that was reported as suspected in the majority of the cases in the current case series, does not contain any "classical" adjuvant. However, the nanoparticles used as delivery system of the mRNA were discussed to either code liver or themselves to act as adjuvants. Nevertheless, the role of (unlisted country) as a potential mechanism is undermined by lacking evidence. Another hypothesis could be the induction of autoimmune reactions by molecular mimicry. Even though its relevance for the development of autoimmune thyroid diseases was questioned, results from an in-silico study suggested that it might play a role. Furthermore, limitations of the analyzed data (e.g., underreporting of concomitant medication or underlying conditions due to technical constraints in some reporting systems) must be considered. Summary/Conclusion: Subacute thyroiditis (SAT) is a typically painful inflammatory condition of the thyroid, potentially causing hyperthyroidism-like symptoms such as tachycardia, agitation, tremor, and hyperhidrosis. It is often associated with viral infections, such as mumps, measles, coxsackie, adenovirus, and influenza A and B infection. A safety signal of subacute thyroiditis following vaccination with the novel mRNA- and vector-based COVID-19 vaccines was found during a screening of the regulatory database, and another regulatory database on 21Apr2021. By 08Jun021 there were 29 a regulatory database reporting SAT following the immunization with COVID-19 vaccines entered in a regulatory database. Most of the reports contained Pfizer/BioNTech's and Moderna's mRNA-based vaccines as suspected. Statistically significant disproportionate reporting was observed for these two vaccines. Eleven reports (38%) were classified as serious and in seven cases (24%) pharmacotherapy of SAT symptoms was reported. In five reports cardiac reactions, such as tachycardia and palpitations, and in three reports hyperthyroidism were co-reported. Since SAT's symptomatology can be confused with other painful oropharyngeal conditions (e.g.: odontalgia) but carries the risk of thyrotoxicosis and therefore the possibility of related cardiac, hepatic, and neuromuscular conditions, patients and health care professionals should be sensitized to consider the possibility of SAT following vaccination with the novel COVID-19 vaccines. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1767076
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: thyroiditis subacute; This is a spontaneous report from a non-contactable consumer or other non-health care professional. A 67-year-old female (unknown pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Medical history included thyroid disorder. The patient stopped her thyroid medication and the symptoms resolved. The patient's concomitant medications were not reported.The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization.The patient experienced subacute thyroiditis on an unspecified date.As the case reports described in this signal have been transmitted from the Centers to Database, we kindly request you not to resubmit them to the correspondent Regulatory Authority as this is where they originate from. The article refers to 29 cases that can be found in table 1 in the article. Up to 08Jun2021, Database, the WHO database of individual case safety reports (ICSRs) contained # reports including a vaccine as suspected. Thirty-nine percent (#) of those reports concern the COVID-19 vaccines.A safety signal for SAT following COVID-19 vaccination was observed via disproportionality analysis comparing the number of observed reports against the calculated number of expected reports. Disproportionate reporting was observed to be statistically significant for the two mRNA based vaccines of Pfizer/BioNTech (observed n: 18, expected n: 3) resulting in a lower 95% limit of the Information Component measure for disproportionality (#) of 1.5 and Moderna (observed n: 5, expected n: 1, IC025: 0.1). The expected value is based on the total number of reports on the covid-19 vaccines and the proportion of reports that relate to SAT in Database. Up to 08June2021, Database, the WHO database of individual case safety reports (ICSRs), contained 29 reports of SAT (MedDRA preferred term (PT): thyroiditis subacute) following immunization with the novel COVID-19 vaccines. Furthermore, Databasecomprised 50 cases reporting the PT autoimmune thyroiditis and another 50 cases reporting the PT thyroiditis following COVID-19 vaccination up to 08Jun2021. In 30 of the 50 cases reporting the PT autoimmune thyroiditis patients were described to suffer underlying Hashimotos thyroiditis flaring up after the vaccination. Cases reporting SAT were sent from nine countries. Countries contributing most reports were the United States of America (n: 9), Italy (n: 6), and Spain (n: 4). Eighteen (62%) of the 29 reports were for the Pfizer/BioNTech mRNA vaccine, five for the Moderna mRNA vaccine, and six for the AstraZeneca adenovirus vector-based vaccine.Cases were mostly classified as non-serious (62%). In the 11 serious cases, two reported caused or prolonged hospitalization and the other nine medically important conditions as the seriousness criteria. Information on the dosenumber was available in 19 cases.In 11 cases the SAT occurred after administration of the first dose and in nine cases after the second dose.Time-to-onset (TTO) was observed to be in median three days after the second dose (ranging from 0 to 60 days) compared to a median TTO of six days after the first dose (ranging from 0 to 26 days). In one case (case 8), reporting the SAT onset after the second dose, it was mentioned that the patient experienced SAT already after the first dose and that symptoms recurred with the second (positive rechallenge).Time-to-onset in this case was reported as one day after vaccination with the second dose.Furthermore, this patient seemed to have an underlying thyroid disorder. It was reported that the symptoms of SAT resolved when she stopped her thyroid medication. Since it was not specified what kind of medication the patient was taking, it is not possible to conclude whether it was underlying hyper or hypothyroidism.Patients experiencing SAT following vaccination were mainly female (n: 24 83%) and five patients were male (17%).Patients age was reported in 28 cases resulting in a median age of 45 years (range 18 to 67 years). The most frequently co-reported terms were pyrexia (n: 7), lymphadenopathy and neck pain (each n: 4), and blood TSH decreased, headache, hyperthyroidism, iodine uptake decreased, tachycardia, and thyroxine free decreased (each n: 3).The radioactive iodine uptake (RAIU) test is a reliable test to differentiate between causes of hyperthyroidism. Low uptake suggests thyroiditis and high uptake suggests Graves disease6. In the current case series, RAIU was performed in three cases confirming the diagnosis of SAT (cases 5, 23, and 26). In five reports (17%) cardiac reactions, such as tachycardia and palpitations, and in three cases (10%) hyperthyroidism was coreported. Another eight cases contained non-specific reaction terms, such as pyrexia (n: 7), neck pain (n: 4), headache (n: 3), and arthralgia (n: 2). Information about the outcome was available in 22 cases.The outcome was reported as not recovered at the time of reporting in 12 cases (41%), in eight cases it was reported as recovered and in the remaining two cases the outcome was unknown. In seven cases (24%) patients reportedly received pharmacotherapy.In six of the cases corticosteroids (prednisone or dexamethasone) were used to treat SAT and in the remaining case the patient was planned to start antibiotic therapy. Information about the outcome was available in five of these cases. In two cases the patients were reported to have recovered, in one case the patient was recovering at the time of reporting and in the remaining two cases the outcome was reported as not recovered at the time of reporting, but in one of those cases (case 16) the patient was reported to respond to prednisone treatment. Except for case 8, a second patient (case 2) was reported to have an underlying thyroid disorder (autoimmune thyroiditis).Furthermore, the patient in case 13 was reported to have complained about a swelling at the right side of her neck with pain radiating to the right ear for one month prior to vaccination. She was furthermore reported to have underlying normocytic anemia.However, an SAT was suspected and successfully treated with NSAIDs and corticosteroids. In a third case (case 23) the patient was found to have had a past COVID-19 infection (diagnosed via an antibody test) but an acute infection was excluded via antigen testing. Furthermore, in the recent scientific literature a series of case reports of patients developing SAT associated with COVID-19 infections was published14 21. Six of the eight published reports concern female patients14 16,19 21.In most of the cases the onset of the SATs symptoms (such as anterior neck pain) was reported around two weeks to one month after COVID-19 infection and the condition usually responded well to corticosteroid treatment. In the current case series, three of the 16 authorized COVID-19 vaccines were reported as suspected.The reports included in the analysed case series were sent from nine countries from different geographic regions fulfilling the criterion of consistency.The stages of vaccine rollout in different countries as well as the availability of the vaccines in various geographic regions should be kept in mind when interpreting the presented results. An apparent difference in the TTO between the first and the second dose was observed.However, the variation in TTO was observed to be quite large with 0 26 days following the first dose and even 0-60 days following the second dose.This time span is similar when compared to SAT onset following a natural infection, which was observed to be two to eight weeks. However, when interpreting the presented data, it must be considered that SAT diagnosis requires medical consultation an examination. In the current case series, several cases (e.g. cases 3, 4,

Other Meds:

Current Illness:

ID: 1767077
Sex: M
Age:
State:

Vax Date: 03/17/2021
Onset Date: 04/16/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: Nasal Swab; Result Unstructured Data: Test Result:unknown

Allergies:

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

Symptoms: I developed diagnosed psoriasis after the second dose of my covid vaccine. The symptoms is moderate to severe with plague psoriasis through my entire scalp, face, chest, back, arms, legs and througho; This is a spontaneous report from a non-contactable consumer (patient himself). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: Not reported) via an unspecified route, administered in Right arm on 17Mar2021 (41-year-old at vaccination) as a Dose 2, Single for Covid-19 immunization. Facility type vaccine was reported as Pharmacy or Drug Store. The patient's medical history included elevated sugar level, elevated cholesterol, chronic ear medical condition and known allergies to Ciprofloxin. The patient's family medical history included genetic predisposed with his father and sister having mild psoriasis or eczema. The patient's concomitant medications were not reported. The patient had not received any other vaccine within four weeks prior to vaccination. The patient was not diagnosed for covid prior vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: Not reported) via an unspecified route, administered in Right arm on 24Feb2021 (41-year-old at vaccination) as a Dose 1, Single for Covid-19 immunization. The patient developed diagnosed psoriasis after the second dose of his covid vaccine. The symptoms was moderate to severe with plague psoriasis through his entire scalp, face, chest, back, arms, legs and throughout body. He had never had psoriasis but genetic predisposed with his father and sister having mild psoriasis or eczema. He had been prescribed steroid cream, steroid pills and Tacrolimus but had not healed after 3 months of therapy. Currently he would start systemic injections (Skyrizi, immunosuppressant biologics) due to the fact that it's spreading, and symptoms are not improving. Additionally, he would have to joined a Psoriasis support group on social media and various others have reported psoriasis flare up after their Covid vaccine after being in remission for years. These adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test and procedure which included Sars CoV-2 test (Nasal swab): result unspecified, post vaccination. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1767078
Sex: F
Age:
State: TX

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

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

Lab Data: Test Name: Ultrasound of heart; Result Unstructured Data: Test Result:Unknown; Test Name: ultrasound of lymph node; Result Unstructured Data: Test Result:Unknown

Allergies:

Symptom List: Vomiting

Symptoms: I had a pain from my right arm into my heart; Pain on left side 3 days in chest; I had a pain from my right arm into my heart; Left arm lymph node inflamed; Ache all over; Light headed; The initial safety information received was reporting only non-serious adverse drug reactions, upon receipt of follow-up information on 21Sep2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0198) intramuscularly on 06Jul2021 at 13:00 (at the age of 75-years-old ) as a single dose in the left arm for COVID-19 immunization. Medical history included diabetes, atrial fibrillation, pancreatic cancer, mitral prolapse valves problem, thyroid cancer and heart problems, all from an unspecified date and unspecified if ongoing. The patient stated that next week she was going for a PET scan for another problem because she had pancreatic and thyroid cancer. Family medical history relevant to the adverse events was reported as diabetes, heart- prelaspe value (as reported) and high blood pressure. Concomitant medications included clopidogrel, dapagliflozin propanediol monohydrate (FORXIGA), pantoprazole, metformin, ezetimibe, chlortalidone, doxazosin, calcitriol, rosuvastatin calcium (CRESTOR), krill oil, levothyroxine sodium (SYNTHROID), probiotics, vitamin D3, cyanocobalamin (B12) and cranberry, all taken for unspecified indications on unspecified dates. Prior vaccinations were reported as none. The patient reported that she did not "do vaccines". She did not do the flu or the pneumonia or the chickenpox or any vaccines. That was why she did not want this one. On 07Jul2021, the patient experienced pain on left side 3 days in chest and I had a pain from my right arm into my heart and on an unspecified date in 2021 the patient experienced ache all over, lightheaded and left arm lymph node inflamed. The events ache all over and lightheaded were both serious for medically significant. The events required a visit to the physician office. The patient stated that she received the first dose of the vaccine on 06Jul2021 and after the first shot, for two or three days later, the patient had a pain from her right arm into her heart and then after the third day it went away. The patient stated that she really did not want this shot. She was not going to get this vaccine; however, she was a two-time cancer survivor and when she went to join (redacted), her doctor told her that she needed to get it. After she got the vaccine, she had to prove to him that she received the inoculation. She stated that not only was she a two-time cancer survivor of two different types of cancer, she also had heart a fib and heart problems. She was really distressed, especially after the first shot. She had pain in her heart and also in her left side because that was where the injection was, in her left arm. It stated that it could cause inflammation of the heart muscle and inflammation of the lining outside the heart. She did not think she would have gotten this shot because she was fine up until the time that she got these injections and she really gave the doctor a hard time about it because she did not want it. She had to go to see a heart specialist tomorrow, a routine visit, but she was going to ask him how he would detect any of this information in her heart (as reported). Treatment received was reported as no. The patient underwent ultrasound of heart and ultrasound of lymph node, both on unspecified dates with unknown results. The clinical outcomes of the events pain on left side 3 days in chest and I had a pain from my right arm into my heart were recovered/resolved on unspecified dates, while the clinical outcomes of the events ache all over, light headed and left arm lymph node inflamed were unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100985815 similar report from same reporter

Other Meds: CLOPIDOGREL; FORXIGA; PANTOPRAZOLE; METFORMIN; EZETIMIBE; CHLORTHALIDONE; DOXAZOSIN; CALCITRIOL; CRESTOR; KRILL OIL; SYNTHROID; PROBIOTICS; VITAMIN D3; B12 [CYANOCOBALAMIN]; CRANBERRY

Current Illness:

ID: 1767079
Sex: F
Age:
State: UT

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: Antibody test; Test Result: Negative

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: soreness where they put it in/had soreness in the arm for one day when she got each of the injections; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN6204), dose 2 intramuscular, administered in Arm Right on 05Mar2021 as dose 2, single for covid-19 immunisation (at the age of 78 years). Medical history included Low blood sugar from an unknown date and unknown if ongoing (diagnosed when she was 32). Concomitant medications included benzylpenicillin sodium (PENICILLINE) taken for tooth abscess from Jul2021 to an unspecified stop date; hydrastis canadensis (GOLDEN SEAL ROOT & RHIZOMETINCTURE) taken for infection, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 27Jun2021 for covid-19 immunisation. On an unspecified date patient experienced soreness where they put it in/had soreness in the arm for one day when she got each of the injections. Received call from Reporter forPatient who had the Pfizer COVID vaccine, both doses. They went to check to see if she had antibodies today. She will be 80 next year. Caller later stated age at time of events was 78. She just found out today, she has no immunity and ants to know what she does. Patient then came on the line in the background and stated she wanted to report it in case there may be other people like her. Call recording notification provided. She did not have a complete address, phone or email for primary care provider. She provided patient's name as (Withheld) Patient reported some of the information for report herself and some information was reported by her daughter, who was on the call providing initial report information. She went and got checked to see if she had immunity. Reporter had gotten the Moderna vaccine on the same day and she had positive immunity, whereas patient had the Pfizer ones and had no immunity. At the time, she was having trouble with her teeth. She had two abscesses. She was taking an herb and it is Golden Seal Root. It kills viruses and bacteria. If she is taking something that kills viruses, would that kill antibodies. That is her question. The only problem with the Golden Seal Root is that it gives her diarrhea just like the antibiotics. Penicillin gave her diarrhea too. When she got the teeth out, she stopped taking Golden Seal Root and started taking Penicillin. She could not take both. She does not have a lot or expiration for the Golden Seal Root or the Penicillin. She has been having trouble with teeth and ear for months and was taking the Golden Seal Root for a while and was trying to prevent an infection in her blood. One tooth was bothering her sinuses and 1 tooth was bothering her ear. Now sinus and ear have cleared up once the teeth were pulled. The dentist did an emergency procedure to remove both abscessed teeth. She then wanted to see if she had antibodies. She had no side effect from the shot. She then said it was just like the flu shot. She just had soreness where they put it in and that is usual. She did not have the manufacturer, lot or expiration for the flu shot that she got a sore arm for. She had to go into another area to move her arm to circulate the medication after she got the Pfizer COVID vaccine. She only had soreness in the arm for one day when she got each of the injections and then it was gone. She was hoping she can get a third Pfizer shot. Her doctor and pharmacy say it is not authorized though. The patient underwent lab tests and procedures which included antibody test: negative on an unspecified date. The outcome of the events was recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: PENICILLINE; GOLDEN SEAL ROOT & RHIZOMETINCTURE

Current Illness:

ID: 1767080
Sex: F
Age:
State: GA

Vax Date: 06/30/2021
Onset Date:
Rec V Date: 10/07/2021
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: she got ear infection and she was on antibiotic therapy; This is a spontaneous report from a contactable consumer (patient) via regulatory authority (CEP ID: 159558). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Jun2021, as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient got ear infection. She said that her 2nd dose is scheduled today (05Aug2021). She wants to know if it is safe for her to do air travel after getting the 2nd dose. She added that she got the 1st dose of the Covid-19 vaccine last 30Jun2021 and originally, her 2nd dose schedule was on 30Jul2021, but she got ear infection and she was on antibiotic therapy that is why she did not get the 2nd dose on its scheduled date. Submitted a manual AE form because of ear infection after taking the 1st dose of the Covid-19 vaccine. Therapeutic measures were taken as a result of the event with antibiotic therapy. The outcome of event ear infection was unknown. Follow-up attempts are completed. No further information is expected

Other Meds:

Current Illness:

ID: 1767081
Sex: M
Age:
State: FL

Vax Date: 07/30/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Short of breath; Slightly elevated heart rate if I am at rest like talking to you it is normal but if I get up and do anything slightly elevate heart rate; I am on oxygen; Fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 30Jul2021 (Lot Number: IFA7485, expiration date: Oct2021) as a single dose for COVID-19 immunization. Medical history included diabetes and COVID-19- hospitalized from 06Jul2021 to 19Jul2021. Concomitant medication included metformin taken for diabetes. The patient had COVID-19 and was in the hospital from 06Jul2021 to 19Jul2021. He was not given plasma in hospital. He waited 2 weeks (further not clarified) and then got the first BNT162b2 dose. Within 3 days after he got the shot he started getting really short of breath. He wanted to know if he needed to see a doctor about it or if it would go away. He had slightly elevated heart rate. When at rest, it was normal but if he got up and did anything, slightly elevated heart rate. He feels short of breath. Recently he had fever and that went away. When probed for any treatment for the event, the patient stated, "No, I am on oxygen, oxygen concentrator from hospital not from home, that's the only treatment." The outcome of short of breath, elevated heart rate and fever was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: METFORMIN

Current Illness:

ID: 1767082
Sex: F
Age:
State: OH

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

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

Lab Data: Test Date: 20210202; Test Name: Fever; Result Unstructured Data: Test Result:101.7; Test Name: Pulse; Result Unstructured Data: Test Result:83-153 bpm; Test Name: Pulse; Result Unstructured Data: Test Result:65; Comments: resting pulse normally; Test Date: 20210202; Test Name: Pulse; Result Unstructured Data: Test Result:83-113 bpm

Allergies:

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

Symptoms: abdominal cramps/abdominal pain; body aches; extreme exhaustion; Vomiting; lethargic rest of day; nausea; chest pain; violent chills; shaking; pulse 83-153 bpm/rapid pulse/tachycardia/pulse 83-113 bpm; Fever 101.7; This is a spontaneous report from a contactable other health care professional (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EC3302), via an unspecified route of administration in the right arm on 02Feb2021 at 14:00 (at the age of 57-year-old), dose 2, single for COVID-19 immunisation. Medical history included allergy to vegetable leaves, plants-poison Ivey and allergy to NSAIDS. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) administered via an unspecified route of administration in the left arm on 12Jan2021 at 14:00 (at the age of 57-year-old), dose 1, single for COVID-19 immunisation and experienced fever 101.7, violent chills, nausea, pulse 83 - 113 bpm/rapid pulse, abdominal cramps, body aches, extreme exhaustion, chest pain, shaking, lethargic rest day, localized injection site urticarial, seems to have an autoimmune response, hives wrapped around her entire left ankle, ankle was swollen and not very comfortable. The patient previously took paracetamol (PCM), acetylsalicylic acid (Aspirin) and had allergy to these medications. The patient previously took the antihistamine cetirizine hydrochloride (Zyrtec) daily for allergy; metoprolol; levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. On 02Feb2021 at 20:00, the patient experienced fever of 101.7. On the same day at 21:00, the patient had violent chills, shaking, rapid pulse. On 03Feb2021, the patient had nausea ad chest pain. On 04Feb2021 at 02:00, the patient had fever and was lethargic rest of day. On an unspecified date the patient had abdominal cramps, vomiting, body aches, extreme exhaustion and a pulse rate of 83-153 beats per minute. There was multiorgan involvement of cardiovascular and gastrointestinal. The cardiovascular involvement included tachycardia and chest pain in the evening on 03Feb2021. The patient's resting pulse normally was 65 pulse and after vaccine it was 83-113 beats per minutes. The gastrointestinal involvement included abdominal pain, nausea, vomiting. The patient did not have decreased level of consciousness, no loss of consciousness, no dermatological/mucosal involvement, no generalized urticaria (hives), no generalized erythema, no angioedema (not hereditary), no generalized pruritus with skin rash, no generalized pruritus without skin rash, no generalized prickle sensation, no red and itchy eyes, and had no diarrhea. The patient did not require medical intervention for the events. The events did not require initiation of new medication or other treatment or procedure. The patient did not see in the emergency department, not hospitalized, not admitted to an Intensive Care Unit. The patient did not receive any recent vaccines for any other conditions prior to the events. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 vaccine prior to the events. The outcome of the events was recovered. The reporter considered that the COVID-19 vaccine had a causal effect to the adverse events. No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116136 Same reporter/patient/ product, different dose and events

Other Meds:

Current Illness:

ID: 1767083
Sex: F
Age:
State: PA

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 10/07/2021
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: Hearing test; Result Unstructured Data: Test Result:unknown

Allergies:

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

Symptoms: It was clarified the hearing screening showed a little bit of hearing loss in right ear; buzzing in her ear; UTI; normal pain that went away, this was at the injection site; is interfering with her sleep; This is a spontaneous report from a contactable consumer reported for herself. A 71-years-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in left arm on 26Mar2021 (at around 10-11am) (at the age of 71-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included, lyme disease (had Lyme's disease and was given antibiotics, this was years ago) from an unknown date and unknown if ongoing. Concomitant medication was not reported. Historical vaccination include, PNEUMOCOCCAL VACCINE on Aug2020, patient experienced rash pruritic (With the pneumonia shot patient had a rash on lower back that patient thought was shingles. It was itchy and lasted 3-4 weeks with a little pain but was not like what was normally reported for shingles. Maybe it was not but thought it was. Patient did not have it looked at because patient did not want to go to the doctor at that time due to COVID. The shot was done in Aug2020. Patient had no product name, NDC, Lot, or Expiry for this product, it was given by primary care doctor). History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and additional Vaccines Administered on Same Date of the Pfizer Suspect reported as none. Prior Vaccinations (within 4 weeks) and adverse events following prior vaccinations reported as none. Patient did hot have medical history (including any illness at time of vaccination). Patient take no medication other than supplements. Investigation assessment reported as yes. Vaccine not administered at military facility. On 2021, it was clarified the hearing screening showed a little bit of hearing loss in right ear, buzzing in ear, uti (urinary tract infection) and normal pain that went away, this was at the injection site and it was interfering with sleep. The patient underwent lab tests and procedures which included acoustic stimulation tests: unknown on 2021. Patient did not visited to Emergency Room and Physician Office, patient went for normal check up at the doctor and mentioned this. The outcome of the event Urinary tract infections and vaccination site pain was recovered on 2021, tinnitus was not recovered while other events were unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am