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: 1790458
Sex: M
Age:
State: TX

Vax Date: 09/30/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
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: He had body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (He had body aches) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced MYALGIA (He had body aches). At the time of the report, MYALGIA (He had body aches) outcome was unknown. No concomitant medications were not reported. No treatment medications were not provided. This case was linked to MOD-2021-344206 (Patient Link).

Other Meds:

Current Illness:

ID: 1790459
Sex: M
Age:
State: WY

Vax Date: 10/01/2021
Onset Date: 10/06/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Numbness on the left side of face; Tongue is numb; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA (Numbness on the left side of face) and HYPOAESTHESIA ORAL (Tongue is numb) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced HYPOAESTHESIA (Numbness on the left side of face) and HYPOAESTHESIA ORAL (Tongue is numb). At the time of the report, HYPOAESTHESIA (Numbness on the left side of face) and HYPOAESTHESIA ORAL (Tongue is numb) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment medications were not provided by reporter. The patient stated that five days after the shot, showed up in clinic complaining that the left side of his face was numb and his tongue was numb. The patient did not have difficulty breathing and performing tests. patient does not have a family history of Bell's Palsy.; Sender's Comments: This case concerns a 51-year-old male patient with no relevant medical history, who experienced the unexpected events of Hypoesthesia and Hypoesthesia Oral. The events occurred 5 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness:

ID: 1790460
Sex: F
Age:
State: IL

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: administered with the vaccine at 15 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered with the vaccine at 15 years old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered with the vaccine at 15 years old). On 28-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered with the vaccine at 15 years old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1790461
Sex: M
Age:
State: FL

Vax Date: 10/05/2021
Onset Date:
Rec V Date: 10/16/2021
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: Migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine headache). At the time of the report, MIGRAINE (Migraine headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medication was reported. No treatment Drug was reported.

Other Meds:

Current Illness:

ID: 1790462
Sex: M
Age:
State: TX

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 10/16/2021
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: Painful left arm for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful left arm for 24 hours) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. Concurrent medical conditions included Herpes simplex type I. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes simplex type I. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful left arm for 24 hours). On 27-Aug-2021, PAIN IN EXTREMITY (Painful left arm for 24 hours) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were reported. This case was linked to MOD-2021-344229 (Patient Link).

Other Meds: VALTREX

Current Illness: Herpes simplex type I

ID: 1790463
Sex: F
Age: 43
State: KS

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/16/2021
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: she woke up with sweats; muscles were weak; arms felt heavy/ Arms felt like led; pressure on the chest continued intermittently/ chest feels a lot of pressure; pain in chest continued intermittently/ chest pain has become less but still come and go; she gets out of breathe; Headache feels like ice pick and stabbed her cranium through the brain/headache lasts for 10 minutes or 5-10second; tired and was mostly in bed; headache; fever; body chills; joint pain; muscle pain; numbness in the arm is now faded/ still has that sensation in the left arm; Tingling/ Left side of face has tingling sensation which she still has now; Stomach pain; inflammation on both side of her body/her body is very inflamed; tiredness; she woke up with weird tingling/ weird sensation in both her arms; pressure on her chest/ /chest feels a lot of pressure; pain in her chest; she developed flu like symptoms; lethargy; heart palpitation/ heart stuff still continuing; immediately she got dizzy in the room/lots of dizziness that continued for the rest of the day; heart began to race/ heart beating fast/ heart beating hard/ heart felt as if it will pop out/ been over a week and a half and has not stopped; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (immediately she got dizzy in the room/lots of dizziness that continued for the rest of the day), PALPITATIONS (heart began to race/ heart beating fast/ heart beating hard/ heart felt as if it will pop out/ been over a week and a half and has not stopped), CHEST DISCOMFORT (pressure on her chest/chest feels a lot of pressure), CHEST PAIN (pain in her chest) and INFLUENZA LIKE ILLNESS (she developed flu like symptoms) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced DIZZINESS (immediately she got dizzy in the room/lots of dizziness that continued for the rest of the day) and PALPITATIONS (heart began to race/ heart beating fast/ heart beating hard/ heart felt as if it will pop out/ been over a week and a half and has not stopped). On 03-Oct-2021, the patient experienced CHEST DISCOMFORT (pressure on her chest/ /chest feels a lot of pressure), CHEST PAIN (pain in her chest), INFLUENZA LIKE ILLNESS (she developed flu like symptoms), LETHARGY (lethargy), PALPITATIONS (heart palpitation/ heart stuff still continuing), PARAESTHESIA (she woke up with weird tingling/ weird sensation in both her arms), HYPOAESTHESIA (numbness in the arm is now faded/ still has that sensation in the left arm), PARAESTHESIA (Tingling/ Left side of face has tingling sensation which she still has now), ABDOMINAL PAIN UPPER (Stomach pain), INFLAMMATION (inflammation on both side of her body/her body is very inflamed), FATIGUE (tiredness), HEADACHE (headache), PYREXIA (fever), CHILLS (body chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 04-Oct-2021, the patient experienced HYPERHIDROSIS (she woke up with sweats), MUSCULAR WEAKNESS (muscles were weak), LIMB DISCOMFORT (arms felt heavy/ Arms felt like led), CHEST DISCOMFORT (pressure on the chest continued intermittently/ chest feels a lot of pressure), CHEST PAIN (pain in chest continued intermittently/ chest pain has become less but still come and go), DYSPNOEA (she gets out of breathe), HEADACHE (Headache feels like ice pick and stabbed her cranium through the brain/headache lasts for 10 minutes or 5-10second) and FATIGUE (tired and was mostly in bed). The patient was treated with NAPROXEN at a dose of 400 mg. On 04-Oct-2021, HYPERHIDROSIS (she woke up with sweats), MUSCULAR WEAKNESS (muscles were weak) and FATIGUE (tired and was mostly in bed) had resolved. At the time of the report, DIZZINESS (immediately she got dizzy in the room/lots of dizziness that continued for the rest of the day), LETHARGY (lethargy), HYPOAESTHESIA (numbness in the arm is now faded/ still has that sensation in the left arm), FATIGUE (tiredness), HEADACHE (headache), PYREXIA (fever), CHILLS (body chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had resolved, PALPITATIONS (heart began to race/ heart beating fast/ heart beating hard/ heart felt as if it will pop out/ been over a week and a half and has not stopped), PALPITATIONS (heart palpitation/ heart stuff still continuing), CHEST DISCOMFORT (pressure on the chest continued intermittently/ chest feels a lot of pressure), CHEST PAIN (pain in chest continued intermittently/ chest pain has become less but still come and go), PARAESTHESIA (Tingling/ Left side of face has tingling sensation which she still has now) and HEADACHE (Headache feels like ice pick and stabbed her cranium through the brain/headache lasts for 10 minutes or 5-10second) had not resolved and CHEST DISCOMFORT (pressure on her chest/ /chest feels a lot of pressure), CHEST PAIN (pain in her chest), INFLUENZA LIKE ILLNESS (she developed flu like symptoms), PARAESTHESIA (she woke up with weird tingling/ weird sensation in both her arms), LIMB DISCOMFORT (arms felt heavy/ Arms felt like led), DYSPNOEA (she gets out of breathe), ABDOMINAL PAIN UPPER (Stomach pain) and INFLAMMATION (inflammation on both side of her body/her body is very inflamed) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reported that her weight was 140. Patient reported that she will not be getting her second dose. Patient reported that fever, body chills, joint pain, muscle pain, lethargy, tiredness, headache lasted for 2.5 days. Patient consulted NP and was prescribed with steroids medication which she has not taken yet. Patient discloses that she had COVID twice before and did not have antibodies when she went to check for them (Before receiving her first shot) No concomitant medications were reported. On 3 Oct 2021,Chest X-ray and Electrocardiogram was normal.

Other Meds:

Current Illness:

ID: 1790464
Sex: F
Age:
State:

Vax Date: 10/06/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Vaccine administered after improper storage & handling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Oct-2021 and was forwarded to Moderna on 06-Oct-2021. This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after improper storage & handling) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after improper storage & handling). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after improper storage & handling) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1790465
Sex: M
Age:
State: TX

Vax Date: 08/26/2021
Onset Date: 09/24/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Fever of 99.1 ranging to 101 degrees F; Test Date: 20210924; Test Name: Body temperature; Result Unstructured Data: 103 degrees F; Test Date: 20211001; Test Name: Body temperature; Result Unstructured Data: 100 degrees F; Test Date: 20211002; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Had a 100 degrees F fever ongoing until today/in the morning he will have a fever of 99.1 ranging to 101 degrees F by evening; Chills when traveling on the plane; Felt achy; Fever of 103 degrees F for about a day and a half total of 24-36 hour; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a 100 degrees F fever ongoing until today/in the morning he will have a fever of 99.1 ranging to 101 degrees F by evening), CHILLS (Chills when traveling on the plane), MYALGIA (Felt achy) and PYREXIA (Fever of 103 degrees F for about a day and a half total of 24-36 hour) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 939902) for COVID-19 vaccination. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for HSV infection. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced MYALGIA (Felt achy) and PYREXIA (Fever of 103 degrees F for about a day and a half total of 24-36 hour). On 01-Oct-2021, the patient experienced PYREXIA (Had a 100 degrees F fever ongoing until today/in the morning he will have a fever of 99.1 ranging to 101 degrees F by evening) and CHILLS (Chills when traveling on the plane). The patient was treated with PARACETAMOL, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (THERAFLU [PARACETAMOL;PHENIRAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE]) for Adverse reaction, at a dose of 1 dosage form. On 25-Sep-2021, MYALGIA (Felt achy) and PYREXIA (Fever of 103 degrees F for about a day and a half total of 24-36 hour) had resolved. At the time of the report, PYREXIA (Had a 100 degrees F fever ongoing until today/in the morning he will have a fever of 99.1 ranging to 101 degrees F by evening) had not resolved and CHILLS (Chills when traveling on the plane) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2021, Body temperature: 103 (High) 103 degrees F. On 01-Oct-2021, Body temperature: 100 (High) 100 degrees F. On 02-Oct-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Body temperature: 99.1 to 101 (High) Fever of 99.1 ranging to 101 degrees F. This case was linked to MOD-2021-344216 (Patient Link).

Other Meds: VALTREX

Current Illness:

ID: 1790466
Sex: F
Age: 60
State: IA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: SWELLING OF INJECTION SITE; received the expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE SWELLING (SWELLING OF INJECTION SITE) and EXPIRED PRODUCT ADMINISTERED (received the expired vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in August 2021. On 28-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the expired vaccine). On 29-Sep-2021, the patient experienced VACCINATION SITE SWELLING (SWELLING OF INJECTION SITE). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received the expired vaccine) had resolved. On 01-Oct-2021, VACCINATION SITE SWELLING (SWELLING OF INJECTION SITE) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant product reported by reporter. No treatment medication reported by reporter. Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Added medical history information. Added lab data information. Added Route and anatomical location of vaccine administration. Added event.

Other Meds:

Current Illness:

ID: 1790467
Sex: F
Age: 71
State: TX

Vax Date: 09/09/2021
Onset Date: 09/09/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: extrapyramidal symptoms; body started jerking; couldn't walk; legs buckled; sick for two days from the second vaccination/woke up and felt so ill; slept the whole day; bad reactions/scary reactions; vomited like mad; This spontaneous case was reported by a consumer and describes the occurrence of EXTRAPYRAMIDAL DISORDER (extrapyramidal symptoms), DYSKINESIA (body started jerking), GAIT INABILITY (couldn't walk), LIMB DISCOMFORT (legs buckled) and ILLNESS (sick for two days from the second vaccination/woke up and felt so ill) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (The patient put off having the vaccination because they felt they had antibodies.) in January 2021 and Hip surgery (bad back). Concomitant products included PARACETAMOL (TYLENOL), GABAPENTIN, TRAMADOL, IRON, OLMESARTAN, ATORVASTATIN, LORATADINE and MONTELUKAST for an unknown indication. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXTRAPYRAMIDAL DISORDER (extrapyramidal symptoms), DYSKINESIA (body started jerking), GAIT INABILITY (couldn't walk), LIMB DISCOMFORT (legs buckled), ILLNESS (sick for two days from the second vaccination/woke up and felt so ill), HYPERSOMNIA (slept the whole day), VACCINATION COMPLICATION (bad reactions/scary reactions) and VOMITING (vomited like mad). The patient was treated with ONDANSETRON for Vomiting, at a dose of 1 dosage form. On 09-Sep-2021, VOMITING (vomited like mad) had resolved. At the time of the report, EXTRAPYRAMIDAL DISORDER (extrapyramidal symptoms), DYSKINESIA (body started jerking), GAIT INABILITY (couldn't walk), LIMB DISCOMFORT (legs buckled), ILLNESS (sick for two days from the second vaccination/woke up and felt so ill), HYPERSOMNIA (slept the whole day) and VACCINATION COMPLICATION (bad reactions/scary reactions) outcome was unknown. The patient was visiting her children at the moment and expresses her concerns about future travel requiring the booster dose. She wanted to know what to do if she wanted to travel but doesn't want to take the third booster dose. She said they wont let her travel without taking it. She asked if she should take the third booster dose. This case was linked to MOD-2021-344049 (Patient Link).; Sender's Comments: This case concerns a 71-year-old female patient with no relevant medical history, who experienced the unexpected event of hypersomnia. The event occurred on the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds: TYLENOL; GABAPENTIN; TRAMADOL; IRON; OLMESARTAN; ATORVASTATIN; LORATADINE; MONTELUKAST

Current Illness:

ID: 1790468
Sex: F
Age:
State: VA

Vax Date: 10/05/2021
Onset Date: 10/05/2021
Rec V Date: 10/16/2021
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: Metallic objects (keys, scissors) that are clinging to body post vaccination/ sticking on shoulder, chest, forhead and cheeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Metallic objects (keys, scissors) that are clinging to body post vaccination/ sticking on shoulder, chest, forhead and cheeks) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016E21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced VACCINATION COMPLICATION (Metallic objects (keys, scissors) that are clinging to body post vaccination/ sticking on shoulder, chest, forhead and cheeks). At the time of the report, VACCINATION COMPLICATION (Metallic objects (keys, scissors) that are clinging to body post vaccination/ sticking on shoulder, chest, forhead and cheeks) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. The reached out to the pharmacist who gave the vaccine and showed them the event.

Other Meds:

Current Illness:

ID: 1790469
Sex: F
Age:
State: UT

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Liver transplant. Concurrent medical conditions included Immunocompromised (immunocompromised patient). 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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. HCP reports patient received Pfizer Covid-19 Vaccine as third dose in her pharmacy on 6 Oct 2021 as patient was immunocompromised. No concomitant medications was reported. No treatment drug details was reported. This case was linked to MOD-2021-344241 (Patient Link).

Other Meds:

Current Illness: Immunocompromised (immunocompromised patient)

ID: 1790470
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Administered expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1790471
Sex: F
Age:
State: UT

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Liver transplant. Concurrent medical conditions included Immunocompromised. 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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient received Pfizer COVID-19 Vaccine as third dose on 6 Oct 2021. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. This case was linked to MOD-2021-344235 (Patient Link).

Other Meds:

Current Illness: Immunocompromised

ID: 1790472
Sex: F
Age:
State: IL

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
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: administered with the vaccine at 13 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered with the vaccine at 13 years old) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered with the vaccine at 13 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered with the vaccine at 13 years old) 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. No treatment medications were reported. No concomitant treatment was reported.

Other Meds:

Current Illness:

ID: 1790473
Sex: M
Age: 65
State: IA

Vax Date: 09/24/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
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: Received the expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the expired vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis. Concomitant products included METOPROLOL SUCCINATE for an unknown indication. On 24-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 (Received the expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received the expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received on 8 Oct 2021 , Medical history, Vaccine facility information added and patient race, ethnicity, patient route of administration and anatomical location updated, current condition added. Concomitant medication added.

Other Meds: METOPROLOL SUCCINATE

Current Illness: Multiple sclerosis

ID: 1790474
Sex: F
Age: 71
State: MI

Vax Date: 03/12/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: blood pressure kept rising; Test Date: 20210928; Test Name: Blood pressure; Result Unstructured Data: BP went up to over 200/100; Test Date: 20210928; Test Name: Chest X-ray; Result Unstructured Data: had a blood clot; Test Date: 20210928; Test Name: CT scan; Result Unstructured Data: had a blood clot; Test Name: Heart rate; Result Unstructured Data: heart rate was going up

Allergies:

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

Symptoms: Blood pressure kept rising/BP went up to over 200/100; Blood clot; Very weak/could not lift anything heavy; Heart rate was going up; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) and HYPERTENSION (Blood pressure kept rising/BP went up to over 200/100) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath). On 28-Sep-2021, the patient experienced THROMBOSIS (Blood clot) (seriousness criteria hospitalization, medically significant and intervention required). On an unknown date, the patient experienced HYPERTENSION (Blood pressure kept rising/BP went up to over 200/100) (seriousness criteria hospitalization and medically significant), ASTHENIA (Very weak/could not lift anything heavy) and HEART RATE INCREASED (Heart rate was going up). The patient was hospitalized from 28-Sep-2021 to 29-Sep-2021 due to HYPERTENSION and THROMBOSIS. The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at a dose of 5 milligram twice a day. At the time of the report, THROMBOSIS (Blood clot), HYPERTENSION (Blood pressure kept rising/BP went up to over 200/100) and HEART RATE INCREASED (Heart rate was going up) outcome was unknown, DYSPNOEA (Shortness of breath) had resolved and ASTHENIA (Very weak/could not lift anything heavy) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2021, Blood pressure measurement: 200/100 (High) BP went up to over 200/100. On 28-Sep-2021, Chest X-ray: abnormal (abnormal) had a blood clot. On 28-Sep-2021, Computerised tomogram: abnormal (abnormal) had a blood clot. On an unknown date, Blood pressure measurement: rising (High) blood pressure kept rising. On an unknown date, Heart rate: high (High) heart rate was going up. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. The shortness of breath went on for few days. She was checking her blood pressure (BP), pulse and temperature. Her blood pressure kept rising, her heart rate was going up with her blood pressure and she was getting very weak. She called her doctor and she was told to go to the emergency room (ER). She went to the ER on 28-Sep-2021, they ran tests; her BP went up to over 200/100. They did chest XRAY and CT scan and found that she had a blood clot. She was not on a long ride neither she had stayed in bed for few days. She was up and actively up till the date (while talking to the doctor). The doctor could not tell her what caused it but the only thing she could think of was the shot. She was healthy and had no problems. She was discharged the next day, in the afternoon. She had an appointment with her healthcare provider on Friday 8-Oct-2021. Her walking got better, but she still could not lift anything heavy. Company comment: This case concerns a 71-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of Thrombosis and hypertension. The events occurred approximately 5 months and 20 days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 71-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of Thrombosis and hypertension. The events occurred approximately 5 months and 20 days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.

Other Meds:

Current Illness:

ID: 1790475
Sex: F
Age: 20
State: IA

Vax Date: 09/24/2021
Onset Date: 09/24/2021
Rec V Date: 10/16/2021
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: Received the expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. Concurrent medical conditions included Immune system disorder (Weakened immune system from premature birth) since 18-Feb-2001. On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes on 08-Oct-2021 Follow up received and contains patient demographics, medical history, and product details, batch number updated.

Other Meds:

Current Illness: Immune system disorder (Weakened immune system from premature birth)

ID: 1790476
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Not immunocompromised received a third dose of the Moderna covid 19 vaccine,; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Not immunocompromised received a third dose of the Moderna covid 19 vaccine,) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 EXTRA DOSE ADMINISTERED (Not immunocompromised received a third dose of the Moderna covid 19 vaccine,). At the time of the report, EXTRA DOSE ADMINISTERED (Not immunocompromised received a third dose of the Moderna covid 19 vaccine,) had resolved. No concomitant medications was reported. No treatment drug details was reported. Patient was not immunocompromised.

Other Meds:

Current Illness:

ID: 1790477
Sex: F
Age: 75
State: PA

Vax Date: 01/22/2021
Onset Date: 10/02/2021
Rec V Date: 10/16/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), NASOPHARYNGITIS (Feels like a cold) and PYREXIA (Had a little temperature) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013L20) for COVID-19 vaccination. Concurrent medical conditions included Breast cancer, Chronic respiratory disease, Wheezy bronchitis and Knee pain. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) from June 2021 to an unknown date for Chronic respiratory disease, ALBUTEROL SULFATE, HYDROCHLOROTHIAZIDE, ROSUVASTATIN, POTASSIUM CHLORIDE, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D [VITAMIN D NOS], DOCUSATE SODIUM (COLACE), LEVOTHYROXINE, MELOXICAM, VARICELLA ZOSTER VACCINE, LORATADINE, OMEPRAZOLE and MACROGOL 3350 (MIRALAX) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced DYSPNOEA (Difficulty breathing) and NASOPHARYNGITIS (Feels like a cold). On an unknown date, the patient experienced PYREXIA (Had a little temperature). At the time of the report, DYSPNOEA (Difficulty breathing), NASOPHARYNGITIS (Feels like a cold) and PYREXIA (Had a little temperature) outcome was unknown. As concomitant medication the patient is using eye drops as needed and water pill. For chronic respiratory condition the patient was taking medicine. The patient mentioned that they were experiencing difficulty breathing after being at a wedding with a lot of people and air conditioning. No treatment information was provided by the reporter.

Other Meds: ALBUTEROL SULFATE; HYDROCHLOROTHIAZIDE; ROSUVASTATIN; POTASSIUM CHLORIDE; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN D [VITAMIN D NOS]; COLACE; LEVOTHYROXINE; MELOXICAM; VARICELLA ZOSTER VACCINE; LORATADINE; OMEPRAZOLE; MIRALAX; WIXELA INHUB

Current Illness: Breast cancer; Chronic respiratory disease; Knee pain; Wheezy bronchitis

ID: 1790478
Sex: F
Age: 74
State: IA

Vax Date: 09/24/2021
Onset Date: 09/24/2021
Rec V Date: 10/16/2021
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: received the expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the expired vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL SUCCINATE and HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE) for Hypertension. On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the expired vaccine). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received the expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. No treatment information was provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Additional information received included route of administration, anatomical location, and concomitant drug.

Other Meds: METOPROLOL SUCCINATE; TRIAMTERENE/HYDROCHLOROTHIAZIDE

Current Illness: Hypertension

ID: 1790479
Sex: F
Age: 61
State: IA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
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: RED AT INJECTION SITE (NO PAIN); SWELLING AT INJECTION SITE (NO PAIN); Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine), VACCINATION SITE ERYTHEMA (RED AT INJECTION SITE (NO PAIN)) and VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE (NO PAIN)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis and Hypertension. 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 (Patient received expired dose of the Moderna vaccine). On 29-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (RED AT INJECTION SITE (NO PAIN)) and VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE (NO PAIN)). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved. On 02-Oct-2021, VACCINATION SITE ERYTHEMA (RED AT INJECTION SITE (NO PAIN)) and VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE (NO PAIN)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received and added medical history of the patient. added new events and batch number updated.

Other Meds:

Current Illness: Arthritis; Hypertension

ID: 1790480
Sex: U
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/16/2021
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: With lots of adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (With lots of adverse reactions) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (With lots of adverse reactions). At the time of the report, VACCINATION COMPLICATION (With lots of adverse reactions) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. The patient was a PSW (Personal Support Workers) at nursing home. The patient was administered with Moderna COVID vaccine last January to February 2 doses. This case was linked to MOD-2021-344288 (Patient Link).

Other Meds:

Current Illness:

ID: 1790481
Sex: F
Age: 51
State: OH

Vax Date: 09/03/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20211002; Test Name: Heart rate; Result Unstructured Data: Abnormal; Test Date: 20211002; Test Name: Heart rate; Result Unstructured Data: abnormal; Test Date: 20211002; Test Name: Heart rate; Result Unstructured Data: abnormal; Test Date: 20211003; Test Name: Heart rate; Result Unstructured Data: abnormal; Test Date: 20211003; Test Name: Heart rate; Result Unstructured Data: After putting on drip to lower heart rate

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of SINUS TACHYCARDIA (sinus tachycardia), DYSPNOEA (short of breath), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (My normal activities have been impacted like gardening, running the vacuum, cooking, putting up groceries or dishes), WEIGHT DECREASED (Burned more calories) and VACCINATION COMPLICATION (Laid on couch) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Sulfa allergy). On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore arm). On 02-Oct-2021, the patient experienced SINUS TACHYCARDIA (sinus tachycardia), VACCINATION COMPLICATION (Laid on couch), DIZZINESS (light headed), MYALGIA (body aches), PYREXIA (fever) and CHILLS (chills). On 03-Oct-2021, the patient experienced RASH (rash that went from under bra to waist line then spread up chest to neck line to bottom part of hair line and shoulders/At the hospital, I noticed that I had developed a rash / red flushing around my midsection). On 12-Oct-2021, the patient experienced DYSPNOEA (short of breath) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (My normal activities have been impacted like gardening, running the vacuum, cooking, putting up groceries or dishes). On an unknown date, the patient experienced WEIGHT DECREASED (Burned more calories). The patient was treated with POTASSIUM for Adverse event, at an unspecified dose and frequency and MAGNESIUM for Adverse event, at an unspecified dose and frequency. At the time of the report, SINUS TACHYCARDIA (sinus tachycardia) had not resolved, DYSPNOEA (short of breath), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (My normal activities have been impacted like gardening, running the vacuum, cooking, putting up groceries or dishes), WEIGHT DECREASED (Burned more calories), VACCINATION COMPLICATION (Laid on couch), DIZZINESS (light headed) and VACCINATION SITE PAIN (sore arm) outcome was unknown, RASH (rash that went from under bra to waist line then spread up chest to neck line to bottom part of hair line and shoulders/At the hospital, I noticed that I had developed a rash / red flushing around my midsection) had resolved and MYALGIA (body aches), PYREXIA (fever) and CHILLS (chills) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2021, Heart rate: 11o (abnormal) Abnormal, 120 (abnormal) abnormal and 135 (abnormal) abnormal. On 03-Oct-2021, Heart rate: 105-108 (abnormal) abnormal and about 77 (normal) After putting on drip to lower heart rate. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SINUS TACHYCARDIA (sinus tachycardia), DYSPNOEA (short of breath), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (My normal activities have been impacted like gardening, running the vacuum, cooking, putting up groceries or dishes), WEIGHT DECREASED (Burned more calories), VACCINATION COMPLICATION (Laid on couch), DIZZINESS (light headed), RASH (rash that went from under bra to waist line then spread up chest to neck line to bottom part of hair line and shoulders/At the hospital, I noticed that I had developed a rash / red flushing around my midsection), VACCINATION SITE PAIN (sore arm), MYALGIA (body aches), PYREXIA (fever) and CHILLS (chills) to be possibly related. Patient went to the Emergency Room on 03-OCT-2021 where tests were conducted and she was released with a diagnosis of sinus tachycardia. They performed an ECG, CT Scan, EKG, Chest X-ray, Basic metabolic panel, Troponin T, D-Dimer, Complete blood count with differential. Patinet took a cold shower, drank cold water, performed deep breathing exercises, and held her breath for a beat before exhaling as attempts to lower my heart rate. These attempts would work just for a very few moments. The patient also stated that just take potassium and magnesium supplement No concomitant medications were reported Patient was given IV drip to lower my heart rate. This case was linked to MOD-2021-344291 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow-up information received on12-OCT-2021, Patient demographic details , Medical history , event outcome and additional events updated.; Sender's Comments: This case concerns a 51-year-old non-pregnant female with a BMI of 29.3, with no previous relevant medical history, who experienced the unexpected non serious AESI event Sinus tachycardia and other expected non serious events after the second dose of a proper schedule of administration (28 days between doses) of Moderna COVID-19 vaccine. The diagnosis of Sinus tachycardia was made in an ER room after performing ECG, CT Scan, EKG, Chest X-ray, Basic metabolic panel, Troponin T, D-Dimer and Complete blood count. Heart rate was between 105 to more than 130 bpm. The patient did not required hospitalization. The events? onset was 1 day after the second dose. At the time of the report the event Sinus tachycardia was ongoing. For the event Sinus tachycardia the rechallenge is not applicable as per it was reported after the second dose and no further doses are expected. The benefit-risk relationship of Covid19 Moderna vaccine is not affected by this report.

Other Meds:

Current Illness: Drug allergy (Sulfa allergy)

ID: 1790482
Sex: F
Age: 76
State: IA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: received the expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the expired vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) 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 (received the expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received the expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. no concomitant medications are provided. treatment to the events not reported. patients received the expired vaccine. 21 patients received expired vaccine. Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Significant Follow up received- ADR form received, patient DOB updating, batch number updating.

Other Meds:

Current Illness:

ID: 1790483
Sex: U
Age:
State:

Vax Date: 09/22/2021
Onset Date:
Rec V Date: 10/16/2021
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: Bloating tummy; Reflux; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Bloating tummy), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISTENSION (Bloating tummy), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux) and NAUSEA (Nausea). The patient was treated with ESOMEPRAZOLE for Adverse reaction, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISTENSION (Bloating tummy), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux) and NAUSEA (Nausea) outcome was unknown. Patient consume only natural sugars (found in fruits etc) and on a low sodium diet. No concomitant medication was provided. This case was linked to MOD-2021-344140 (Patient Link).

Other Meds:

Current Illness:

ID: 1790484
Sex: U
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/16/2021
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: With lots of adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (With lots of adverse reactions) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (With lots of adverse reactions). At the time of the report, VACCINATION COMPLICATION (With lots of adverse reactions) outcome was unknown. No concomitant medications were provided. No treatment medications were reported. This case was linked to MOD-2021-344276 (Patient Link).

Other Meds:

Current Illness:

ID: 1790485
Sex: M
Age:
State:

Vax Date: 10/06/2021
Onset Date: 10/06/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Vaccine administered after improper storage & handling; Vial Frozen got defrost then refrozen twice and then thawed.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR and EXPIRED PRODUCT ADMINISTERED in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced PRODUCT STORAGE ERROR and EXPIRED PRODUCT ADMINISTERED. On 06-Oct-2021, PRODUCT STORAGE ERROR and EXPIRED PRODUCT ADMINISTERED had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications are provided. Patient had given vial Frozen got defrost then refrozen twice and then thawed. After that given to 2 patients, Both are feeling fine. HCP did not provide HCP facility details, neither vaccination site details. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1790486
Sex: F
Age: 32
State:

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 10/16/2021
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: More than 42 days for administration of second dose; Dermatologic reaction/Papulopustular rash; This spontaneous case was reported by a physician and describes the occurrence of RASH PUSTULAR (Dermatologic reaction/Papulopustular rash) and PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. Concomitant products included USTEKINUMAB (STELARA) for Psoriatic arthritis. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced RASH PUSTULAR (Dermatologic reaction/Papulopustular rash). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose). At the time of the report, RASH PUSTULAR (Dermatologic reaction/Papulopustular rash) had not resolved and PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose) 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 concomitants drugs were provided. Treatment drugs were oral and topical steroids.

Other Meds: STELARA

Current Illness:

ID: 1790487
Sex: F
Age:
State: WI

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Ultrasound; Result Unstructured Data: ultrasound was done, and it was confirmed it was tendonitis

Allergies:

Symptom List: Nausea

Symptoms: Diagnosed with tendonitis/it was confirmed it was tendonitis; Cannot do movements with her shoulder; Shoulder pain, shoulder is painful; This spontaneous case was reported by a pharmacist and describes the occurrence of TENDONITIS (Diagnosed with tendonitis/it was confirmed it was tendonitis), VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot do movements with her shoulder) and ARTHRALGIA (Shoulder pain, shoulder is painful) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 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 TENDONITIS (Diagnosed with tendonitis/it was confirmed it was tendonitis), VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot do movements with her shoulder) and ARTHRALGIA (Shoulder pain, shoulder is painful). At the time of the report, TENDONITIS (Diagnosed with tendonitis/it was confirmed it was tendonitis), VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot do movements with her shoulder) and ARTHRALGIA (Shoulder pain, shoulder is painful) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: abnormal (abnormal) ultrasound was done, and it was confirmed it was tendonitis. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. Patient received the first dose 2 months ago and he was hesitant on getting the second dose. No Treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Follow up received contains confirmed tendonitis.

Other Meds:

Current Illness:

ID: 1790488
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Rare cases of young male adults with symptoms of heart inflammation; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Rare cases of young male adults with symptoms of heart inflammation) in an adult 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDITIS (Rare cases of young male adults with symptoms of heart inflammation) (seriousness criterion medically significant). At the time of the report, CARDITIS (Rare cases of young male adults with symptoms of heart inflammation) 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. Company Comment: This case concerns a male patient of unknown age with no previous relevant medical history reported, who experienced the unexpected event of carditis. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age with no previous relevant medical history reported, who experienced the unexpected event of carditis. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1790489
Sex: F
Age: 74
State: MI

Vax Date: 02/27/2021
Onset Date:
Rec V Date: 10/16/2021
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: Soreness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21a) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-336820, MOD-2021-344336 (Patient Link).

Other Meds:

Current Illness:

ID: 1790490
Sex: F
Age: 74
State: MI

Vax Date: 02/27/2021
Onset Date:
Rec V Date: 10/16/2021
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: Soreness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) 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. On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-344335, MOD-2021-336820 (Patient Link).

Other Meds:

Current Illness:

ID: 1790491
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: not feeling well for two days after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling well for two days after receiving vaccine) in a 36-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (not feeling well for two days after receiving vaccine). At the time of the report, VACCINATION COMPLICATION (not feeling well for two days after receiving vaccine) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information provided by the reporter. No treatment information provided.

Other Meds:

Current Illness:

ID: 1790492
Sex: F
Age: 37
State: MA

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 10/16/2021
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: like flu symptoms; feel woozy; whole body was in pain; heavy nose bleeding that lasted for about a minute; had a really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (heavy nose bleeding that lasted for about a minute), INFLUENZA LIKE ILLNESS (like flu symptoms), DIZZINESS (feel woozy), HEADACHE (had a really bad headache) and MYALGIA (whole body was in pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 052E21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included LABETALOL for Hypertension. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced HEADACHE (had a really bad headache). On 30-Sep-2021, the patient experienced EPISTAXIS (heavy nose bleeding that lasted for about a minute). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (like flu symptoms), DIZZINESS (feel woozy) and MYALGIA (whole body was in pain). The patient was treated with TRAMADOL for Headache, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE) for Adverse event, at an unspecified dose and frequency. On 30-Sep-2021, EPISTAXIS (heavy nose bleeding that lasted for about a minute) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (like flu symptoms), DIZZINESS (feel woozy), HEADACHE (had a really bad headache) and MYALGIA (whole body was in pain) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-344147 (Patient Link).

Other Meds: LABETALOL

Current Illness: Hypertension

ID: 1790493
Sex: M
Age: 75
State: MI

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 10/16/2021
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: Injection site soreness; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Allergy to molds, Allergy to antibiotic, Drug allergy, Drug allergy and Drug allergy. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication listed. No treatment information provided. This case was linked to MOD-2021-336776, MOD-2021-344344 (Patient Link).

Other Meds:

Current Illness: Allergy to antibiotic; Allergy to molds; Drug allergy; Penicillin allergy

ID: 1790494
Sex: M
Age: 75
State: MI

Vax Date: 02/26/2021
Onset Date: 03/26/2021
Rec V Date: 10/16/2021
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: Injection site soreness; Vaccine administered by IN route; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered by IN route) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007b21a and 010A21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Food allergy (yeast), Drug allergy (Clindamycin), Drug allergy (Codeine), Drug allergy (Morphine) and Drug allergy (Zofran). On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intranodal) dosage was changed to 1 dosage form. On 26-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered by IN route). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site soreness). On 26-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered by IN route) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site soreness) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intranodal), the reporter did not provide any causality assessments. No concomitant medication listed. No treatment information provided. This case was linked to MOD-2021-344343, MOD-2021-336776 (Patient Link).

Other Meds:

Current Illness: Drug allergy (Zofran); Drug allergy (Morphine); Drug allergy (Codeine); Drug allergy (Clindamycin); Food allergy (yeast); Penicillin allergy

ID: 1790495
Sex: M
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 10/16/2021
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: had some effects after the 2nd dose that lasted a day and a half; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE DRUG REACTION (had some effects after the 2nd dose that lasted a day and a half) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-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 ADVERSE DRUG REACTION (had some effects after the 2nd dose that lasted a day and a half). At the time of the report, ADVERSE DRUG REACTION (had some effects after the 2nd dose that lasted a day and a half) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient had some effects after the second dose that lasted a day and a half. No Treatment informations were reported. This case was linked to MOD-2021-344368 (Patient Link).

Other Meds:

Current Illness:

ID: 1790496
Sex: M
Age: 43
State: IL

Vax Date: 10/06/2021
Onset Date: 10/06/2021
Rec V Date: 10/16/2021
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: Dose administered after use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported. On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment medications provided.

Other Meds:

Current Illness:

ID: 1790497
Sex: F
Age:
State: NY

Vax Date: 10/06/2021
Onset Date: 10/06/2021
Rec V Date: 10/16/2021
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: some discomfort in arm; It was due to the way the pharmacist gave the shot; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (some discomfort in arm) and ADMINISTRATION RELATED REACTION (It was due to the way the pharmacist gave the shot) 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 06-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced LIMB DISCOMFORT (some discomfort in arm) and ADMINISTRATION RELATED REACTION (It was due to the way the pharmacist gave the shot). On 06-Oct-2021, ADMINISTRATION RELATED REACTION (It was due to the way the pharmacist gave the shot) had resolved. At the time of the report, LIMB DISCOMFORT (some discomfort in arm) outcome was unknown. No concomitant medication were reported. No treatment information was provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1790498
Sex: F
Age: 72
State: FL

Vax Date: 02/08/2021
Onset Date: 05/01/2021
Rec V Date: 10/16/2021
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: breast cancer; lymph node cancer on her left breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (breast cancer) and LYMPHOMA (lymph node cancer on her left breast) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031L20A) 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) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced BREAST CANCER (breast cancer) (seriousness criterion medically significant) and LYMPHOMA (lymph node cancer on her left breast) (seriousness criterion medically significant). The patient was treated with Surgery (Lateral Mastectomy) for Breast cancer and Surgery (Lateral Mastectomy) for Lymphoma. At the time of the report, BREAST CANCER (breast cancer) and LYMPHOMA (lymph node cancer on her left breast) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. The patient got her first dose on left deltoid muscle (non dominant arm). The patient had surgery-lateral mastectomy on an unspecified date in Jun-2021. The patient mentioned that the lymph node cancer was on her left breast and that it was very minimal, small. She had cancer only in one but, she did not want to take a chance. The patient did not clarify whether she took the surgery on both breasts. She only mentioned later that her left breast was cut off. Company Comment: This case concerns a 73-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of Breast cancer, and lymphoma. The event occurred after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. Elderly age 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-2021-344364 (Patient Link).; Sender's Comments: This case concerns a 73-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of Breast cancer, and lymphoma. The event occurred after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. Elderly age remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness:

ID: 1790499
Sex: F
Age: 72
State: FL

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 10/16/2021
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: breast inflame, left side affected by the cancer also the side that got inflame, immediately in a couple of days, red and inflame was infected; Got sick; headache; reaction of the Moderna on lymph node; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CELLULITIS (breast inflame, left side affected by the cancer also the side that got inflame, immediately in a couple of days, red and inflame was infected) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 012A21A and 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer (diagnosed in May) in May 2021, Mastectomy (got the surgery "lateral mastectomy" on June) in June 2021, Breast prosthesis removal and Mastectomy. 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) (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 an unknown date, the patient experienced BREAST CELLULITIS (breast inflame, left side affected by the cancer also the side that got inflame, immediately in a couple of days, red and inflame was infected) (seriousness criterion medically significant), ILLNESS (Got sick), HEADACHE (headache) and LYMPHADENOPATHY (reaction of the Moderna on lymph node). At the time of the report, BREAST CELLULITIS (breast inflame, left side affected by the cancer also the side that got inflame, immediately in a couple of days, red and inflame was infected), ILLNESS (Got sick), HEADACHE (headache) and LYMPHADENOPATHY (reaction of the Moderna on lymph node) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. patient got the surgery "lateral mastectomy" on June Company Comment: This case concerns a 73-year-old, female patient with a history of breast cancer diagnosed recently and mastectomy, who experienced the unexpected serious event of breast cellulitis. The event occurred at an unknown day after the third dose of Spikevax. The rechallenge was not applicable as the events happened after the third dose. The medical history of breast cancer diagnosed recently, and mastectomy remain a confounder. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to MOD-2021-344360 (Patient Link).; Sender's Comments: This case concerns a 73-year-old, female patient with a history of breast cancer diagnosed recently and mastectomy, who experienced the unexpected serious event of breast cellulitis. The event occurred at an unknown day after the third dose of Spikevax. The rechallenge was not applicable as the events happened after the third dose. The medical history of breast cancer diagnosed recently, and mastectomy remain a confounder. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1790500
Sex: F
Age: 74
State: CA

Vax Date: 02/02/2021
Onset Date: 03/02/2021
Rec V Date: 10/16/2021
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: Really intense dreams - hallucinatory dreams; chills; Fever; headache; Tired, fatigued, kind of "brohl"; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Really intense dreams - hallucinatory dreams), CHILLS (chills), PYREXIA (Fever), HEADACHE (headache) and FATIGUE (Tired, fatigued, kind of "brohl") in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 029620A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ABNORMAL DREAMS (Really intense dreams - hallucinatory dreams), CHILLS (chills), PYREXIA (Fever) and HEADACHE (headache). 02-Mar-2021, the patient experienced FATIGUE (Tired, fatigued, kind of "brohl"). On 03-Mar-2021, ABNORMAL DREAMS (Really intense dreams - hallucinatory dreams), CHILLS (chills), PYREXIA (Fever) and HEADACHE (headache) had resolved. On 09-Mar-2021, FATIGUE (Tired, fatigued, kind of "brohl") had resolved. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1790501
Sex: M
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: had some effects after the first but they have lasted 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (had some effects after the first but they have lasted 4 days) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (had some effects after the first but they have lasted 4 days). At the time of the report, ADVERSE DRUG REACTION (had some effects after the first but they have lasted 4 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not provided by the reporter. had some effects after the 2nd dose that lasted a day and a half. have since developed the same symptoms as the first but they have lasted 4 days. Treatment information was not provided This case was linked to MOD-2021-344349 (Patient Link).

Other Meds:

Current Illness:

ID: 1790502
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: multiple EKGs; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: Stress test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: echo; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Vomiting

Symptoms: arrythmia under control with medication; after second dose patient went into SVT; bruising from her deltoid to the bottom of her latissimus dorsi; anemic; periodic chest pain for a couple of months; This spontaneous case was reported by a physician and describes the occurrence of ARRHYTHMIA (arrythmia under control with medication) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (arrythmia under control with medication) (seriousness criterion medically significant), SUPRAVENTRICULAR TACHYCARDIA (after second dose patient went into SVT), MUSCLE CONTUSION (bruising from her deltoid to the bottom of her latissimus dorsi), ANAEMIA (anemic) and CHEST PAIN (periodic chest pain for a couple of months). At the time of the report, ARRHYTHMIA (arrythmia under control with medication) was resolving, SUPRAVENTRICULAR TACHYCARDIA (after second dose patient went into SVT), MUSCLE CONTUSION (bruising from her deltoid to the bottom of her latissimus dorsi) and ANAEMIA (anemic) outcome was unknown and CHEST PAIN (periodic chest pain for a couple of months) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: negative (Negative) Negative and negative (Negative) Negative. On an unknown date, Echocardiogram: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. There was no diagnosis of myocarditis or pericarditis and no medical history of arrhythmia. Patient had seen a cardiologist. Company Comment: This case concerns a 38-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of arrhythmia and supraventricular tachycardia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 38-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of arrhythmia and supraventricular tachycardia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1790503
Sex: F
Age:
State: MT

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: whole arm of the injection is hurting really bad/hurting so bad behind arm/The patient was under a lot of pain and it was hard to understand her when she spoke; under armpit there's a big bruise that keeps growing and growing/purple bruising; under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise; under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise/This morning it started to swell; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise/This morning it started to swell), PAIN IN EXTREMITY (whole arm of the injection is hurting really bad/hurting so bad behind arm/The patient was under a lot of pain and it was hard to understand her when she spoke), CONTUSION (under armpit there's a big bruise that keeps growing and growing/purple bruising) and AXILLARY MASS (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise) in a 30-year-old female 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) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced SWELLING (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise/This morning it started to swell). On an unknown date, the patient experienced PAIN IN EXTREMITY (whole arm of the injection is hurting really bad/hurting so bad behind arm/The patient was under a lot of pain and it was hard to understand her when she spoke), CONTUSION (under armpit there's a big bruise that keeps growing and growing/purple bruising) and AXILLARY MASS (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise). At the time of the report, SWELLING (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise/This morning it started to swell), PAIN IN EXTREMITY (whole arm of the injection is hurting really bad/hurting so bad behind arm/The patient was under a lot of pain and it was hard to understand her when she spoke), CONTUSION (under armpit there's a big bruise that keeps growing and growing/purple bruising) and AXILLARY MASS (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1790504
Sex: F
Age: 62
State: MA

Vax Date: 10/06/2021
Onset Date: 10/06/2021
Rec V Date: 10/16/2021
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: butterfly rash on her cheeks and nose; nausea; vomiting; headache; fever; swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BUTTERFLY RASH, NAUSEA, VOMITING, HEADACHE, and PYREXIA in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic. Concomitant products included INSULIN for an unknown indication. On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced BUTTERFLY RASH, NAUSEA, VOMITING, HEADACHE, PYREXIA, and VACCINATION SITE SWELLING. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency. At the time of the report, BUTTERFLY RASH, NAUSEA, VOMITING, HEADACHE, PYREXIA, and VACCINATION SITE SWELLING had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown. Treatment included Ice.

Other Meds: INSULIN

Current Illness: Diabetic

ID: 1790505
Sex: F
Age:
State: OH

Vax Date: 09/03/2021
Onset Date: 10/02/2021
Rec V Date: 10/16/2021
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; rash / red flushing; Chills; Fever; Body aches; shaky when she work up; sinus Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaky when she work up), SINUS TACHYCARDIA (sinus Tachycardia), DYSPNOEA (short of breath), RASH (rash / red flushing) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced TREMOR (shaky when she work up), SINUS TACHYCARDIA (sinus Tachycardia), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches). On 03-Oct-2021, the patient experienced RASH (rash / red flushing). On an unknown date, the patient experienced DYSPNOEA (short of breath). At the time of the report, TREMOR (shaky when she work up), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown, SINUS TACHYCARDIA (sinus Tachycardia) and DYSPNOEA (short of breath) had not resolved and RASH (rash / red flushing) had resolved. Concomitant medication was not reported. Treatment information was not reported. Patient Reported on 2-Oct-2021 symptoms of chills, fever, body aches, heart rate was elevated from 105 to over 138 throughout the day and heart rate did not slow down by 10/3/21, she as go to the hospital to be checked out. She spoke with the nurse hotline for my insurance and she advised that I go to the emergency room as, when at rest, my heart rate was at 105 to 110 bpm and when walking around the house it would rise to over 120. On 12-OCT-2021, she still have issues with heart rate. As an example, normal activities like washing the dishes make her heart race to 130 bpm and get short of breath. Once her heart rate rises, it takes considerable time for it to go below 100 bpm (24 minutes to up to 2 hours). Normal activities have been impacted like gardening, running the vacuum, cooking, putting up groceries or dishes. She got winded and heart rate speeds up considerably more than prior to the 2nd dose of the vaccine. Patient stated that she went to the Atrium Medical Center Emergency Room on 3-OCT-2021 where tests were conducted and she was released with a diagnosis of sinus tachycardia. They performed an ECG, CT Scan, EKG, Chest X-ray, Basic metabolic panel, Troponin T, D-Dimer, Complete blood count with differential. She was given an IV drip to lower her heart rate. At the hospital, she had developed a rash / red flushing around my midsection. The rash/redness has since gone away which took several days (it spread during that time to my neck and into my hairline). Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: significant Follow-Up Included: Patient Detail and event are updated.; Sender's Comments: This case concerns a female patient of unknown age with no previous relevant medical history, who experienced the unexpected non serious event/AESI of Sinus tachycardia and other associated non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 1 day after the second dose of Spikevax and was ongoing 10 days later. The patient consulted to the emergency room. Electrocardiogram, Chest X-ray, basic metabolic panel, Troponin T, D-Dimer and complete blood count with differential showed no other positive findings. The rechallenge is not applicable, since the schedule of vaccination has been completed and a further dose is not expected. The benefit-risk relationship of Spikevax vaccine is not affected by this report

Other Meds:

Current Illness:

ID: 1790506
Sex: F
Age: 52
State: PA

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore right arm on same day after receiving vaccine.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included MELOXICAM for an unknown indication. On 18-Aug-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 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 18-Aug-2021, the patient experienced PAIN IN EXTREMITY (A sore right arm on same day after receiving vaccine.). At the time of the report, PAIN IN EXTREMITY (A sore right arm on same day after receiving vaccine.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. Patient took vaccination at vaccination facility, pharmacy. This case was linked to MOD-2021-288132 (Patient Link).

Other Meds: MELOXICAM

Current Illness:

ID: 1790507
Sex: F
Age: 70
State: FL

Vax Date: 02/07/2021
Onset Date: 03/18/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: More than 35 days between first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 090A21A, 0J8(H or N)20X and 052E21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal and Cholesterol. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 18-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose). On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose) had resolved. Patient had cholesterol blood pressure issues that were managed by medication. Patient was not immunocompromised. Treatment information was not provided.

Other Meds:

Current Illness: Blood pressure abnormal; Cholesterol

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am