VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1790156
Sex: F
Age:
State: OH

Vax Date: 02/01/2021
Onset Date: 06/01/2021
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: Received 2nd shot 3 months after the first shot,They did not have the vaccine available so received the second dose as soon as it became available; Received 2nd shot 3 months after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Received 2nd shot 3 months after the first shot) and PRODUCT AVAILABILITY ISSUE (Received 2nd shot 3 months after the first shot,They did not have the vaccine available so received the second dose as soon as it became available) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Received 2nd shot 3 months after the first shot). On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (Received 2nd shot 3 months after the first shot,They did not have the vaccine available so received the second dose as soon as it became available). In June 2021, PRODUCT ADMINISTRATION INTERRUPTED (Received 2nd shot 3 months after the first shot) and PRODUCT AVAILABILITY ISSUE (Received 2nd shot 3 months after the first shot,They did not have the vaccine available so received the second dose as soon as it became available) had resolved. No concomitant medication were reported. No treatment information was provided by the reporter. This case was linked to MOD-2021-339758 (Patient Link).

Other Meds:

Current Illness:

ID: 1790157
Sex: M
Age:
State: NJ

Vax Date: 09/14/2021
Onset Date: 09/14/2021
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: Moderna vaccine given to patient who had J&J; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine given to patient who had J&J) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine given to patient who had J&J). On 14-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine given to patient who had J&J) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. Patient received Johnson and Johnson vaccine on 27-May-2021. Then returned on 14-Sep-2021 and was asked if patient was vaccinated, patient said no and was given a dose of the Moderna vaccine. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1790158
Sex: M
Age: 62
State: AL

Vax Date: 10/02/2021
Onset Date: 10/02/2021
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: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired dose). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1790159
Sex: M
Age: 34
State: PA

Vax Date: 09/30/2021
Onset Date: 09/30/2021
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: dizziness; patient states being constantly Ill every sense; soreness in arm; Diarrhea; Nausea; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (dizziness), ILLNESS (patient states being constantly Ill every sense), NAUSEA (Nausea) and CHILLS (chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (and had to be hospitalized and received the same medication took) in October 2020 and Hospitalization. Concurrent medical conditions included Chest pain. On 30-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced DIZZINESS (dizziness), ILLNESS (patient states being constantly Ill every sense) and MYALGIA (soreness in arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (dizziness), ILLNESS (patient states being constantly Ill every sense), NAUSEA (Nausea), CHILLS (chills), HEADACHE (headache) and MYALGIA (soreness in arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. Tylenol was taken for extra strength. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow up received: Added events, patient details

Other Meds:

Current Illness: Chest pain

ID: 1790160
Sex: M
Age:
State: AL

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

Symptoms: administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) 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.

Other Meds:

Current Illness:

ID: 1790161
Sex: F
Age:
State: NM

Vax Date: 09/24/2021
Onset Date:
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: being hot/cold; anxiety symptoms; Heart palitation; feeling bad; Pressure headache; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (being hot/cold), ANXIETY (anxiety symptoms), PALPITATIONS (Heart palitation), FEELING ABNORMAL (feeling bad) and TENSION HEADACHE (Pressure headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (being hot/cold), ANXIETY (anxiety symptoms), PALPITATIONS (Heart palitation), FEELING ABNORMAL (feeling bad), TENSION HEADACHE (Pressure headache), MYALGIA (body aches) and CHILLS (chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (being hot/cold), ANXIETY (anxiety symptoms), PALPITATIONS (Heart palitation), FEELING ABNORMAL (feeling bad), TENSION HEADACHE (Pressure headache), MYALGIA (body aches) and CHILLS (chills) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-053194, MOD-2021-053183 (Patient Link).

Other Meds:

Current Illness:

ID: 1790162
Sex: U
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: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Moderna arm; people are getting urticaria on injection site and it spreads; 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 VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE URTICARIA (people are getting urticaria on injection site and it spreads) 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 VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE URTICARIA (people are getting urticaria on injection site and it spreads). At the time of the report, VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE URTICARIA (people are getting urticaria on injection site and it spreads) 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. Reporter stated that she read about the Moderna arm, where people were getting urticaria on injection site and it spreads. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1790163
Sex: F
Age: 56
State: TX

Vax Date: 08/30/2021
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: Pharyngeal swelling

Symptoms: Right injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Right injection site arm was sore) in a 56-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 30-Aug-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 (Right injection site arm was sore). At the time of the report, VACCINATION SITE PAIN (Right injection site arm was sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1790164
Sex: F
Age: 46
State: FL

Vax Date: 01/02/2021
Onset Date: 09/09/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: bleeding; started having hives/has had hives since 19September2021/it's been over 2 weeks, and it is generalized/all over the body/are very intense hives/it comes and goes/urticaria/hives (urticaria) all over her body; itching; received the 3rd Moderna shot booster and is not immunocompromised; This spontaneous case was reported by an other health care professional and describes the occurrence of HAEMORRHAGE (bleeding) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K80A, 028L20A and 039K80A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced OFF LABEL USE (received the 3rd Moderna shot booster and is not immunocompromised). On 19-Sep-2021, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant), URTICARIA (started having hives/has had hives since 19September2021/it's been over 2 weeks, and it is generalized/all over the body/are very intense hives/it comes and goes/urticaria/hives (urticaria) all over her body) and PRURITUS (itching). On 09-Sep-2021, OFF LABEL USE (received the 3rd Moderna shot booster and is not immunocompromised) had resolved. At the time of the report, HAEMORRHAGE (bleeding), URTICARIA (started having hives/has had hives since 19September2021/it's been over 2 weeks, and it is generalized/all over the body/are very intense hives/it comes and goes/urticaria/hives (urticaria) all over her body) and PRURITUS (itching) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medications included unspecified topical corticosteroids and unspecified antihistamines. Company comment: This is a case of Off label use of vaccine for this 47-year-old, female patient with no relevant medical history, who experienced the unexpected events of Haemorrhage, Urticaria, and Pruritus. The events occurred approximately 10 days after the third dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the second dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. The case is assessed as serious as Haemorrhage is an IME and the Urticaria and Pruritus remain unresolved. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow-up received on 04-Oct-2021, contains additional events bleeding, itching and case upgraded to serious.; Sender's Comments: This is a case of Off label use of vaccine for this 47-year-old, female patient with no relevant medical history, who experienced the unexpected events of Haemorrhage, Urticaria, and Pruritus. The events occurred approximately 10 days after the third dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the second dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. The case is assessed as serious as Haemorrhage is an IME and the Urticaria and Pruritus remain unresolved.

Other Meds:

Current Illness:

ID: 1790165
Sex: M
Age: 21
State: PA

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Name: Bloodwork; Result Unstructured Data: Normal; Test Name: EEG; Result Unstructured Data: Normal; Test Name: Spinal tap; Result Unstructured Data: Normal; Test Name: MRI; Result Unstructured Data: Normal; Test Name: Sleep study; Result Unstructured Data: Normal.

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: fatigue; they have experienced brain fog; he experienced splitting headache; Adverse Effect/obscure reaction; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE, FEELING ABNORMAL, HEADACHE, and VACCINATION COMPLICATION in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 041B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-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 FATIGUE (seriousness criterion hospitalization), FEELING ABNORMAL (seriousness criterion hospitalization), HEADACHE (seriousness criterion hospitalization), and VACCINATION COMPLICATION (seriousness criterion hospitalization). The patient was hospitalized from 09-Sep-2021 to sometime in September 2021 due to FATIGUE, FEELING ABNORMAL, HEADACHE, and VACCINATION COMPLICATION. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency; REGLAN for Adverse event, at an unspecified dose and frequency; MAGNESIUM for Adverse event, at an unspecified dose and frequency; AJOVY for Adverse event, at an unspecified dose and frequency; FIORICET for Adverse event, at an unspecified dose and frequency; NARATRIPTAN for Adverse event, at an unspecified dose and frequency; ZONISAMIDE for Adverse event, at an unspecified dose and frequency; NURTEC for Adverse event, at an unspecified dose and frequency and AMOXICILLIN for Adverse event, at a dose of 15 day course. At the time of the report, FATIGUE, FEELING ABNORMAL, HEADACHE, and VACCINATION COMPLICATION had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test Normal. On an unknown date, Electroencephalogram Normal. On an unknown date, Lumbar puncture Normal. On an unknown date, Magnetic resonance imaging Normal. On an unknown date, Sleep study Normal. No concomitant medications were reported. In treatment details, two steroid packs was also prescribed by the HCP's. Patient reported that he had been experiencing splitting headaches since five months. Patient reported that he was fine after first dose. Patient reported that he had been to a ton of doctors including 3 neurologists, 1 PCP, and 1 ENT. He had been to emergency room three times. His first visit to ER was in the month of August as his symptoms got progressively worse. On 09-Sep-2021, patient visited ER for the third time and the stay was for 36 hours. Patient's neurologist think that they are not migraines, in there opinion they are obscure reaction to second dose. This case concerns a 22-year-old, male with unknown medical history, who experienced the unexpected serious (hospitalization criteria) events of headache, fatigue, feeling abnormal and vaccine adverse reaction. The event occurred after the second dose of mRNA-1273 Moderna vaccine (Spikevax) with no exact latency known. The rechallenge was not applicable since this events happened after the second dose and no further dose is expected. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.

Other Meds:

Current Illness:

ID: 1790166
Sex: F
Age: 0
State: MA

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: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Passed out; Sore Throat; Sores in the inside of the mouth; Sores in the inside of the gum; Could not eat or drink; Rash started to appear in her lower left abdomen, back, upper legs and upper arms.; The site of the injection was painful; Shivers/Chills; Fever; This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse drug reaction. On 28-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), STOMATITIS (Sores in the inside of the mouth), GINGIVAL PAIN (Sores in the inside of the gum), FEEDING DISORDER (Could not eat or drink), RASH (Rash started to appear in her lower left abdomen, back, upper legs and upper arms.), VACCINATION SITE PAIN (The site of the injection was painful), CHILLS (Shivers/Chills) and PYREXIA (Fever). On 01-Oct-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). The patient was treated with DEXAMETHASONE (DECADRON [DEXAMETHASONE]) for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), OROPHARYNGEAL PAIN (Sore Throat), STOMATITIS (Sores in the inside of the mouth), GINGIVAL PAIN (Sores in the inside of the gum), FEEDING DISORDER (Could not eat or drink), RASH (Rash started to appear in her lower left abdomen, back, upper legs and upper arms.), VACCINATION SITE PAIN (The site of the injection was painful), CHILLS (Shivers/Chills) and PYREXIA (Fever) 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 concomitant medications were provided. The patient was also prescribed Benadryl for when the effect of the previous long lasting steroid effect wore off . The 28-Sep-2021, at 5PM she started to have fever, shivers, chills, sore throat, sores in the inside of the mouth and swelling of the throat. Also the site of the injection was painful and a rash started to appear in her lower left abdomen, back, upper legs and upper arms. On 01-Oct-2021 she passed out in the floor and was taken to the emergency room where she was diagnosed whit dehydration (the sore throat prevented her from eating and drinking). Company comment: This case concerns a 34-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of loss of consciousness. The event occurred 3 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.; Sender's Comments: This case concerns a 34-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of loss of consciousness. The event occurred 3 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: BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness:

ID: 1790167
Sex: F
Age:
State: GA

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Possibly received an expired dose of the vaccine/ she received they said it was from an expired lot.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Possibly received an expired dose of the vaccine/ she received they said it was from an expired lot.) 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 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Possibly received an expired dose of the vaccine/ she received they said it was from an expired lot.). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Possibly received an expired dose of the vaccine/ she received they said it was from an expired lot.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported

Other Meds:

Current Illness:

ID: 1790168
Sex: F
Age:
State: NY

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: Neuropathy after vaccine; This spontaneous case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy after vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder NOS. 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 NEUROPATHY PERIPHERAL (Neuropathy after vaccine) (seriousness criteria disability and medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy after vaccine) 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 considered NEUROPATHY PERIPHERAL (Neuropathy after vaccine) to be possibly related. No concomitant medication was reported. No treatment medication use was reported. Company comment: This case concerns a female subject of unknown age with a history of autoimmune disorder, who experienced the unexpected event of neuropathy peripheral. The event occurred on an unknown date, patient also received the Moderna Covid-19 vaccine on an unknown date. The rechallenge is not applicable since no other data is provided. The event was considered possibly related to the study drug per the reporter's assessment. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a female subject of unknown age with a history of autoimmune disorder, who experienced the unexpected event of neuropathy peripheral. The event occurred on an unknown date, patient also received the Moderna Covid-19 vaccine on an unknown date. The rechallenge is not applicable since no other data is provided. The event was considered possibly related to the study drug per the reporter's assessment.The benefit-risk relationship of the vaccine is not affected by this report.

Other Meds:

Current Illness: Autoimmune disorder NOS

ID: 1790169
Sex: M
Age:
State: MI

Vax Date: 01/01/2021
Onset Date: 02/01/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Name: Anticonvulsant drug level; Result Unstructured Data: Valproate and carbamazepine normal; Test Name: creatine kinase; Result Unstructured Data: elevated creatine kinase of 1025 U/L; Test Name: electrolytes; Result Unstructured Data: normal; Test Name: Blood glucose; Result Unstructured Data: normal; Test Name: blood pressure; Result Unstructured Data: 145/71 mmHg; Test Name: Thyroid Stimulating Hormone; Result Unstructured Data: 4.81 ?/mL; Test Name: Body Temperature; Result Unstructured Data: 103?F; Test Name: Body Temperature; Result Unstructured Data: The patient had a maximum documented temperature of 104.8?F axillary during his inpatient stay and fever lasted for approximately up to 30 hours after vaccination.; Test Name: Chest X-ray; Result Unstructured Data: Normal; Test Name: CT Scan; Result Unstructured Data: showed no acute changes to suggest infarct or hemorrhage. Postsurgical changes involving right frontoparietal calvarium, encephalomalacia right frontoparietal temporal region and to a lesser extent left parietal region similar when compared with prior CT examinations.; Test Name: C reactive protien; Result Unstructured Data: elevated C reactive protein of 157.4; Test Name: ECG; Result Unstructured Data: showed normal sinus rhythm with no other acute changes.; Test Name: haemoglobin; Result Unstructured Data: 109 g/L; Test Name: tachycardiac; Result Unstructured Data: 114/min; Test Name: International Normalized Ratio; Result Unstructured Data: International Normalized Ratio (INR) of 3.4 (patient taking warfarin).; Test Name: Neurological examination; Result Unstructured Data: residual left-sided weakness and cognitive deficit from his traumatic brain injury; Test Name: oxygen saturation; Result Unstructured Data: normal oxygen saturation on room air; Test Name: Platelet count; Result Unstructured Data: normal; Test Name: Procalcitonin levels; Result Unstructured Data: normal; Test Name: Prothrombin Time (PT); Result Unstructured Data: 37.7 Sec; Test Name: erythrocyte; Result Unstructured Data: 48 mm/hour; Test Name: COVID-19 nasopharyngeal PCR; Test Result: Positive ; Result Unstructured Data: Four months prior to this admission, the patient had a positive-COVID- 19 PCR during a preprocedure screen before ablation of atrial flutter.; Test Name: Urine analysis; Result Unstructured Data: Normal; Test Name: white cell count; Result Unstructured Data: 12.1?10?/L

Allergies:

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

Symptoms: Encephalopathy; abdominal tenderness; post ictal state; COVID-19; significant lethargy; Headache; Fever; Altered mental status; This literature-non-study case was reported in a literature article and describes the occurrence of MENTAL STATUS CHANGES (Altered mental status), LETHARGY (significant lethargy), HEADACHE (Headache), PYREXIA (Fever), ENCEPHALOPATHY (Encephalopathy), ABDOMINAL TENDERNESS (abdominal tenderness), POSTICTAL STATE (post ictal state) and COVID-19 (COVID-19) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Atrial flutter, Hypothyroidism, COVID-19 in October 2020 and Cardiac ablation. Concurrent medical conditions included Type 2 diabetes mellitus, Seizures and Traumatic brain injury. Concomitant products included VALPROATE SODIUM (VALPROATE) and CARBAMAZEPINE for Seizure. 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. In February 2021, the patient experienced MENTAL STATUS CHANGES (Altered mental status) (seriousness criterion hospitalization), LETHARGY (significant lethargy) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization) and PYREXIA (Fever) (seriousness criterion hospitalization). On an unknown date, the patient experienced ENCEPHALOPATHY (Encephalopathy) (seriousness criteria hospitalization and medically significant), ABDOMINAL TENDERNESS (abdominal tenderness) (seriousness criterion hospitalization), POSTICTAL STATE (post ictal state) (seriousness criterion hospitalization) and COVID-19 (COVID-19) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to MENTAL STATUS CHANGES. The patient was treated with CEFTRIAXONE (intravenous) for Meningoencephalitis, at an unspecified dose and frequency; VANCOMYCIN (intravenous) for Meningoencephalitis, at an unspecified dose and frequency; ACYCLOVIR [ACICLOVIR] (intravenous) for Meningoencephalitis, at an unspecified dose and frequency; DEXAMETHASONE (intravenous) for Meningoencephalitis, at an unspecified dose and frequency and WARFARIN at an unspecified dose and frequency. At the time of the report, MENTAL STATUS CHANGES (Altered mental status), LETHARGY (significant lethargy), HEADACHE (Headache), PYREXIA (Fever), ENCEPHALOPATHY (Encephalopathy) and POSTICTAL STATE (post ictal state) had resolved and ABDOMINAL TENDERNESS (abdominal tenderness) and COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anticonvulsant drug level: normal (normal) Valproate and carbamazepine normal. On an unknown date, Blood creatine phosphokinase: 1025 u/l (High) elevated creatine kinase of 1025 U/L. On an unknown date, Blood electrolytes: normal (normal) normal. On an unknown date, Blood glucose: normal (normal) normal. On an unknown date, Blood pressure measurement: 145/71 mmhg 145/71 mmHg. On an unknown date, Blood thyroid stimulating hormone (0.27-4.2): 4.81 ?/ml 4.81 ?/mL. On an unknown date, Body temperature: 103?f 103?F and 104.8?f The patient had a maximum documented temperature of 104.8?F axillary during his inpatient stay and fever lasted for approximately up to 30 hours after vaccination.. On an unknown date, C-reactive protein: 157.4 mg/l (High) elevated C reactive protein of 157.4. On an unknown date, Chest X-ray: normal (normal) Normal. On an unknown date, Computerised tomogram head: no acute changes showed no acute changes to suggest infarct or hemorrhage. Postsurgical changes involving right frontoparietal calvarium, encephalomalacia right frontoparietal temporal region and to a lesser extent left parietal region similar when compared with prior CT examinations.. On an unknown date, Electrocardiogram: normal showed normal sinus rhythm with no other acute changes.. On an unknown date, Haemoglobin: 109 g/l 109 g/L. On an unknown date, Heart rate: 114/min 114/min. On an unknown date, International normalised ratio: 3.4 International Normalized Ratio (INR) of 3.4 (patient taking warfarin).. On an unknown date, Neurological examination: abnormal (abnormal) residual left-sided weakness and cognitive deficit from his traumatic brain injury. On an unknown date, Oxygen saturation: normal (normal) normal oxygen saturation on room air. On an unknown date, Platelet count: normal (normal) normal. On an unknown date, Procalcitonin: normal (normal) normal. On an unknown date, Prothrombin time (10.5-13): 37.7 sec 37.7 Sec. On an unknown date, Red blood cell sedimentation rate: 48 mm/hour 48 mm/hour. On an unknown date, SARS-CoV-2 test: positive (Positive) Four months prior to this admission, the patient had a positive-COVID- 19 PCR during a preprocedure screen before ablation of atrial flutter.. On an unknown date, Urine analysis: normal (normal) Normal. On an unknown date, White blood cell count: 12.1?10?/l 12.1?10?/L. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MENTAL STATUS CHANGES (Altered mental status), LETHARGY (significant lethargy), HEADACHE (Headache), PYREXIA (Fever), ENCEPHALOPATHY (Encephalopathy), ABDOMINAL TENDERNESS (abdominal tenderness), POSTICTAL STATE (post ictal state) and COVID-19 (COVID-19) to be possibly related. The patient received his first dose of mRNA-1273 COVID-19 vaccine in January 2021 which was 3 months after his minimally symptomatic COVID-19 infection. His second dose of vaccine was given in February 2021. He complained of headache a few hours following his second dose but was otherwise at baseline. The next morning his caretaker found him difficult to arouse and feverish. There were postsurgical changes involving right frontoparietal calvarium, encephalomalacia right frontoparietal temporal region and to a lesser extent left parietal region similar when compared with prior CT examinations. Patient had an unwitnessed seizure and postictal confusion secondary to fever. Absence of new focal neurological deficits and the CT findings rule out cerebrovascular accident. Meningoencephalitis was considered but lumbar puncture could not be done due to supratherapeutic INR secondary to warfarin. With the improvement in mental status and resolution of fever, infectious aetiology was deemed unlikely The patient received supportive treatment with intravenous fluids and antipyretics. He was therefore started on empiric treatment for meningoencephalitis with intravenous ceftriaxone, vancomycin, acyclovir and dexamethasone but these were discontinued after patient's mental status markedly improved overnight. He was discharged after his mental status returned to baseline. Meningoencephalitis was initially suspected but treatment was discontinued after mental status changes improvement overnight and was discharges 2 days after admission.; Sender's Comments: This case concerns a 54-year-old, male with a history of assisted care living, seizures under treatment with valproic and carbamazepine, traumatic brain injury as well as postsurgical changes on computerized tomography of the head, atrial flutter, type 2 diabetes and hypothyroidism, who experienced the unexpected serious (as per hospitalization) events of mental status changes, lethargy, headache, pyrexia and abdominal tenderness. The differential diagnosis captured as events were encephalopathy and postictal state. Patient?s COVID 19 PCR test was positive with no clear interpretation. However, this happened less than 15 days after the second dose administration (no LoE). The event occurred approximately 1 days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge not applicable because no other dose is expected. The medical history of Traumatic Brain injury and previous structural lesions to frontoparietal lobes, seizures under treatment with Valproic and Carbamazepin, with no EEG or ammonium level reported, are strong confounders and co suspect drugs. The benefit-risk rel

Other Meds: VALPROATE; CARBAMAZEPINE

Current Illness: Seizures; Traumatic brain injury; Type 2 diabetes mellitus

ID: 1790170
Sex: F
Age:
State: PA

Vax Date:
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: I got sick after the 2nd shot; it was one day of feeling uncomfortable; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (I got sick after the 2nd shot) and FEELING ABNORMAL (it was one day of feeling uncomfortable) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included CELECOXIB (CELEBREX) and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) for Rheumatoid arthritis. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got sick after the 2nd shot) and FEELING ABNORMAL (it was one day of feeling uncomfortable). At the time of the report, ILLNESS (I got sick after the 2nd shot) and FEELING ABNORMAL (it was one day of feeling uncomfortable) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Patient was an ophthalmologist. She was now at the 8 month point since her 2nd Moderna dose. She was in the high risk category and says that it is scary to go back to work and not have a booster dose yet. She said that her colleagues who received the Pfizer are being protected by the booster shot, but not the Moderna consumers.

Other Meds: CELEBREX; PLAQUENIL S

Current Illness: Rheumatoid arthritis

ID: 1790171
Sex: F
Age: 77
State: NJ

Vax Date: 01/29/2021
Onset Date: 01/29/2021
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: My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site) 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. This case was linked to MOD-2021-340460 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

Date Died: 09/08/2021

ID: 1790172
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 08/28/2021
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:

Allergies:

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

Symptoms: hemorrhaging stroke/ brain bleed; in a coma for nine days; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGIC STROKE (hemorrhaging stroke/ brain bleed) and COMA (in a coma for nine days) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high and Heart disorder (Heart problems). Concomitant products included LISINOPRIL for an unknown indication. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced HAEMORRHAGIC STROKE (hemorrhaging stroke/ brain bleed) (seriousness criteria death, hospitalization prolonged and medically significant) and COMA (in a coma for nine days) (seriousness criteria death, hospitalization prolonged and medically significant). The patient was hospitalized on 28-Aug-2021 due to COMA and HAEMORRHAGIC STROKE. The patient died on 08-Sep-2021. The reported cause of death was hemorrhaging stroke. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient found her husband lying on the floor. Reporter was unsure that whether patient was taking concomitant drug daily. No treatment information were provided. Company Comment: This case concerns a 66-year-old, male patient with relevant medical history of Blood pressure high and Heart disorder, who experienced, serious unlisted AESI of hemorrhagic stroke and serious unlisted event of coma, both had a fatal oucome. The event occurred after unspecified duration from second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after second dose of Moderna COVID-19 Vaccine. The exact cause of death was not provided. However, the medical history of Blood pressure high and Heart disorder remains as confounders. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 66-year-old, male patient with relevant medical history of Blood pressure high and Heart disorder, who experienced, serious unlisted AESI of hemorrhagic stroke and serious unlisted event of coma, both had a fatal oucome. The event occurred after unspecified duration from second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after second dose of Moderna COVID-19 Vaccine. The exact cause of death was not provided. However, the medical history of Blood pressure high and Heart disorder remains as confounders. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Reported Cause(s) of Death: Hemorrhaging stroke

Other Meds: LISINOPRIL

Current Illness: Blood pressure high; Heart disorder (Heart problems)

ID: 1790173
Sex: F
Age: 92
State: GA

Vax Date: 05/13/2021
Onset Date: 06/25/2021
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: Rash observed on her left arm/02Oct2021: Same rash observed on her left leg; Vaccinated observed a rash on her right arm, it was blotchy with dry patches; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Vaccinated observed a rash on her right arm, it was blotchy with dry patches) and RASH (Rash observed on her left arm/02Oct2021: Same rash observed on her left leg) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 031C21A) for COVID-19 vaccination. No Medical History information was reported. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced RASH MACULAR (Vaccinated observed a rash on her right arm, it was blotchy with dry patches). On an unknown date, the patient experienced RASH (Rash observed on her left arm/02Oct2021: Same rash observed on her left leg). At the time of the report, RASH MACULAR (Vaccinated observed a rash on her right arm, it was blotchy with dry patches) and RASH (Rash observed on her left arm/02Oct2021: Same rash observed on her left leg) outcome was unknown. On 25-Jun-2021, Vaccinated observed a rash on her right arm, it was blotchy with dry patches. On unknown dat,: Rash observed on her left arm. On 02-Oct-2021, Same rash observed on her left leg. No concomitant medications reported. No treatment medications reported.

Other Meds:

Current Illness:

ID: 1790174
Sex: F
Age: 65
State: NJ

Vax Date: 03/02/2021
Onset Date: 10/01/2021
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: no use of her right hand; slept all day; Caller stated that his wife received the third dose at home, nurse from facility came to their home to administer the vaccine; They decided she needed third dose because she was about begin physical therapy for broken femur; had seizures Fri evening/was worse and unusual; Several seizures; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (had seizures Fri. evening/was worse and unusual), SEIZURE CLUSTER (Several seizures) and MONOPLEGIA (no use of her right hand) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A, 007B21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Femur fracture (She broke her femur in Aug 2021. She had surgery, rehab and rehabilitation for the broken femur) and Surgery in August 2021. Concurrent medical conditions included Complex partial seizures. Concomitant products included ZONISAMIDE (ZONISAMIDE 1 A FARMA), CLOBAZAM, BRIVARACETAM and ESCITALOPRAM for Seizure, FOLIC ACID for an unknown indication, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID; ERGOCALCIFEROL; NICOTINAMIDE; RETINOL; RIBOFLAVIN; THIAMINE HYDROCHLORIDE]). On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced CONDITION AGGRAVATED (had seizures Fri evening/was worse and unusual) (seriousness criterion medically significant) and SEIZURE CLUSTER (Several seizures) (seriousness criterion medically significant). 01-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Caller stated that his wife received the third dose at home, nurse from facility came to their home to administer the vaccine) and OFF LABEL USE (They decided she needed third dose because she was about begin physical therapy for broken femur). On 02-Oct-2021, the patient experienced MONOPLEGIA (no use of her right hand) (seriousness criterion medically significant) and SOMNOLENCE (slept all day). The patient was treated with MIDAZOLAM for Adverse event, at an unspecified dose and frequency. On 01-Oct-2021, PRODUCT ADMINISTRATION ERROR (Caller stated that his wife received the third dose at home, nurse from facility came to their home to administer the vaccine) had resolved. On 02-Oct-2021, CONDITION AGGRAVATED (had seizures Fri evening/was worse and unusual) and SEIZURE CLUSTER (Several seizures) had resolved. On 03-Oct-2021, MONOPLEGIA (no use of her right hand) had resolved. At the time of the report, SOMNOLENCE (slept all day) and OFF LABEL USE (They decided she needed third dose because she was about begin physical therapy for broken femur) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications included iron supplements. Reporter was reporting adverse event for his wife. He stated that his wife has a history of seizure disorder, Complex partial seizure. She received the 3rd dose of the Moderna COVID-19 vaccine on 01-Oct-2021 and had seizures Friday evening 01-Oct-2021 and Saturday 02-Oct-2021. He stated the seizure on Friday was worse and unusual. She had several seizures on the evening of Friday 01-Oct-2021. Caller stated his wife did not lose consciousness but had several seizures 5-10 min apart. The seizure on Saturday 02-Oct-2021 was fairly brief. She slept all day Saturday. He stated he had to give her medication, Midazolam nasal spray. He noted that the midazolam had expired on 18-May-2021. At its worst, she had no use of her right hand. They decided she needed the third dose because she is about to begin physical therapy for a broken femur. He stated she broke her femur in August 2021. She had surgery, rehab and rehabilitation for the broken femur. The event is considered medically significant as per this MSA medical assessment because of the worsening of a chronic condition. Company comment: This case concerns a 65-year-old, female with a history of Complex partial seizure under treatment with Brivaracetam, escitalopram, zonisamide, folic acid, iron supplements, vitamins and clobazam; who experienced the serious unexpected events of Seizure Cluster (AESI) and Monoplegia, approximately 24 hours after a 3rd booster off-label dose of Moderna COVID-19 vaccine. The event Seizure cluster required treatment with Midazolam nasal spray which was expired. The booster dose was considered off-label use, as per the patient was not immunosuppressed. Additionally, the event of misadministration was captured, as per the booster was administered at patient?s home. The primary scheduled administration of Moderna COVID-19 Vaccine was proper, with a timeframe of 28 days between first and second dose. The rechallenge is assessed as not applicable for the 3rd dose, since Seizure cluster event occurred after the 3rd dose and further doses are not expected. As per the information provided, the rechallenge for first and second dose are assessed as unknown (no information regarding adverse events for first and second doses are provided). The medical history of Complex partial seizure and the use of Escitalopram remain a confounder for Seizure cluster event. Further information has been requested. The benefit-risk relationship of drug X in not affected by this report.; Sender's Comments: This case concerns a 65-year-old, female with a history of Complex partial seizure under treatment with Brivaracetam, escitalopram, zonisamide, folic acid, iron supplements, vitamins and clobazam; who experienced the serious unexpected events of Seizure Cluster (AESI) and Monoplegia, approximately 24 hours after a 3rd booster off-label dose of Moderna COVID-19 vaccine. The event Seizure cluster required treatment with Midazolam nasal spray which was expired. The booster dose was considered off-label use, as per the patient was not immunosuppressed. Additionally, the event of misadministration was captured, as per the booster was administered at patient?s home. The primary scheduled administration of Moderna COVID-19 Vaccine was proper, with a timeframe of 28 days between first and second dose. The rechallenge is assessed as not applicable for the 3rd dose, since Seizure cluster event occurred after the 3rd dose and further doses are not expected. As per the information provided, the rechallenge for first and second dose are assessed as unknown (no information regarding adverse events for first and second doses are provided). The medical history of Complex partial seizure and the use of Escitalopram remain a confounder for Seizure cluster event. Further information has been requested. The benefit-risk relationship of drug x in not affected by this report.

Other Meds: Zonisamide 1 A Farma; Clobazam; Brivaracetam; Folic Acid; Escitalopram; Vitamins [Ascorbic Acid; Ergocalciferol; Nicotinamide; Retinol; Riboflavin; Thiamine Hydrochloride]

Current Illness: Complex partial seizures.

ID: 1790175
Sex: F
Age: 77
State: NJ

Vax Date: 01/29/2021
Onset Date: 02/26/2021
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: Test Date: 2021; Test Name: SARS-CoV-2 test; Test Result: Positive; Result Unstructured Data: Positive.

Allergies:

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

Symptoms: I found out that I had COVID-19 when I got the 2nd shot/I'd been having trouble taking deep breaths.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (I found out that I had COVID-19 when I got the 2nd shot/I'd been having trouble taking deep breaths.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced COVID-19 (I found out that I had COVID-19 when I got the 2nd shot/I'd been having trouble taking deep breaths.) (seriousness criterion medically significant). At the time of the report, COVID-19 (I found out that I had COVID-19 when I got the 2nd shot/I'd been having trouble taking deep breaths.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test Positive. No concomitant medication was mentioned. Patient found out that she had Covid-19 when she got the 2nd shot. She had been going back and forth to the Doctor just before she got the shot. She had been having trouble taking deep breaths. No treatment medication was mentioned. Company Comment: This case concerns a 77-year-old female patient with no relevant medical history, who experienced the unexpected serious event of COVID-19 . The event occurred approximately 1 day after the second dose of Spikevax. The rechallenge is not applicable since the event occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to MOD-2021-340415 (Patient Link).

Other Meds:

Current Illness:

ID: 1790176
Sex: U
Age:
State: GA

Vax Date: 10/04/2021
Onset Date: 10/04/2021
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: Expired dose administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment information were reported by the reporter.

Other Meds:

Current Illness:

ID: 1790177
Sex: F
Age: 33
State: TX

Vax Date: 03/09/2021
Onset Date: 10/02/2021
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 Name: Body temperature; Result Unstructured Data: low fever last night about 99.2

Allergies:

Symptom List: Unevaluable event

Symptoms: lump at the site; felt like I couldn't breath; low fever last night about 99.2; Her back hurts; had no energy/Her energy is not 100% yet.; She had tight chest/felt like someone was sitting on my chest; Next day, she was feeling really tired/She was feeling fatigued.; She was nauseated.; She had headache.; She started with sore left arm on same day after receiving 3rd dose.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She started with sore left arm on same day after receiving 3rd dose.), VACCINATION SITE MASS (lump at the site), DYSPNOEA (felt like I couldn't breath), BACK PAIN (Her back hurts) and ASTHENIA (had no energy/Her energy is not 100% yet.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 037A21B and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical history reported. Concomitant products included METFORMIN, GLIMEPIRIDE, CALCIUM, MONTELUKAST SODIUM (SINGULAIR) and SEMAGLUTIDE (OZEMPIC) for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced PAIN IN EXTREMITY (She started with sore left arm on same day after receiving 3rd dose.). On 03-Oct-2021, the patient experienced CHEST DISCOMFORT (She had tight chest/felt like someone was sitting on my chest), FATIGUE (Next day, she was feeling really tired/She was feeling fatigued.), NAUSEA (She was nauseated.) and HEADACHE (She had headache.). On 04-Oct-2021, the patient experienced BACK PAIN (Her back hurts) and ASTHENIA (had no energy/Her energy is not 100% yet.). On an unknown date, the patient experienced VACCINATION SITE MASS (lump at the site), DYSPNOEA (felt like I couldn't breath) and PYREXIA (low fever last night about 99.2). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (She started with sore left arm on same day after receiving 3rd dose.), VACCINATION SITE MASS (lump at the site), DYSPNOEA (felt like I couldn't breath), BACK PAIN (Her back hurts), ASTHENIA (had no energy/Her energy is not 100% yet.), CHEST DISCOMFORT (She had tight chest/felt like someone was sitting on my chest), FATIGUE (Next day, she was feeling really tired/She was feeling fatigued.), NAUSEA (She was nauseated.), HEADACHE (She had headache.) and PYREXIA (low fever last night about 99.2) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 (High) low fever last night about 99.2. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Other concomitant medications include Allergy medicine Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received on 05-OCT-2021 Updated Additional events.

Other Meds: METFORMIN; GLIMEPIRIDE; CALCIUM; SINGULAIR; OZEMPIC

Current Illness:

ID: 1790178
Sex: F
Age: 45
State: OR

Vax Date: 09/02/2021
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: Diarrhea; vomiting after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VOMITING (vomiting after the first shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Hospitalized and intubated). Concurrent medical conditions included Immunocompromised. Concomitant products included TOPIRAMATE, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), PREDNISONE, HYOSCYAMINE, PILOCARPINE, TRAMADOL, QUETIAPINE, GABAPENTIN and URSODEOXYCHOLIC ACID (URSODIOL) for an unknown indication. On 02-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 an unknown date, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (vomiting after the first shot). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (vomiting after the first shot) outcome was unknown. No treatment was provided. This case was linked to MOD-2021-340684 (Patient Link).

Other Meds: TOPIRAMATE; PRILOSEC [OMEPRAZOLE MAGNESIUM]; PREDNISONE; HYOSCYAMINE; PILOCARPINE; TRAMADOL; QUETIAPINE; GABAPENTIN; URSODIOL

Current Illness: Immunocompromised

ID: 1790179
Sex: F
Age: 79
State: AL

Vax Date: 03/06/2021
Onset Date: 04/07/2021
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:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Greater acid reflux than before; Heartburn is awful, I cannot eat or swallow; Heartburn is awful, I cannot eat or swallow; I feel incapacitated; I felt a pain across my back, shoulder blade, arms wrist and neck; I felt a pain across my back, shoulder blade, arms wrist and neck; I felt a pain across my back, shoulder blade, arms wrist and neck/arm began to ache; After the second dose, by the next day injection site was hurting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (I felt a pain across my back, shoulder blade, arms wrist and neck), NECK PAIN (I felt a pain across my back, shoulder blade, arms wrist and neck), PAIN IN EXTREMITY (I felt a pain across my back, shoulder blade, arms wrist and neck/arm began to ache), GASTROOESOPHAGEAL REFLUX DISEASE (Greater acid reflux than before) and DYSPEPSIA (Heartburn is awful, I cannot eat or swallow) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21D and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (After the second dose, by the next day injection site was hurting). On 08-Apr-2021, the patient experienced BACK PAIN (I felt a pain across my back, shoulder blade, arms wrist and neck), NECK PAIN (I felt a pain across my back, shoulder blade, arms wrist and neck) and PAIN IN EXTREMITY (I felt a pain across my back, shoulder blade, arms wrist and neck/arm began to ache). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Greater acid reflux than before), DYSPEPSIA (Heartburn is awful, I cannot eat or swallow), DYSPHAGIA (Heartburn is awful, I cannot eat or swallow) and IMPAIRED WORK ABILITY (I feel incapacitated). The patient was treated with ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Adverse event, at a dose of UNK dosage form. At the time of the report, BACK PAIN (I felt a pain across my back, shoulder blade, arms wrist and neck), NECK PAIN (I felt a pain across my back, shoulder blade, arms wrist and neck), PAIN IN EXTREMITY (I felt a pain across my back, shoulder blade, arms wrist and neck/arm began to ache), GASTROOESOPHAGEAL REFLUX DISEASE (Greater acid reflux than before), DYSPEPSIA (Heartburn is awful, I cannot eat or swallow), DYSPHAGIA (Heartburn is awful, I cannot eat or swallow), IMPAIRED WORK ABILITY (I feel incapacitated) and VACCINATION SITE PAIN (After the second dose, by the next day injection site was hurting) had not resolved. No relevant concomitant medications were reported. Patient had a cardiac workup done at hospital. Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Followup received on 06-OCT-2021 ,Added reporter's address and updated route of administration for dose 1.

Other Meds:

Current Illness:

ID: 1790180
Sex: F
Age: 45
State: OR

Vax Date: 10/01/2021
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: SYR
Vax Site: LA

Lab Data: Test Name: Heart rate; Result Unstructured Data: fast heart rate.

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: hallucinating; difficulty breathing/shortness of breath; swelling around ankles; arm hurts; loss of appetite; coughing; Heart was pounding hard/Heart was beating fast, felt like it was going to come out of my chest.; difficulty speaking; hard to walk on feet; throat hurts; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (hospitalized and intubated). Concurrent medical conditions included Immunocompromised. Concomitant products included TOPIRAMATE, PRILOSEC, PREDNISONE, HYOSCYAMINE, PILOCARPINE, TRAMADOL, QUETIAPINE, GABAPENTIN, and URSODIOL for an unknown indication. On 01-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (seriousness criterion medically significant), DYSPNOEA, JOINT SWELLING, PAIN IN EXTREMITY, DECREASED APPETITE, COUGH, PALPITATIONS, SPEECH DISORDER, GAIT DISTURBANCE, and OROPHARYNGEAL PAIN. At the time of the report, HALLUCINATION, DYSPNOEA, JOINT SWELLING, PAIN IN EXTREMITY, DECREASED APPETITE, COUGH, SPEECH DISORDER, GAIT DISTURBANCE, and OROPHARYNGEAL PAIN was resolving and PALPITATIONS had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, fast heart rate. Other concomitant medication included Mucus relief tablets. Treatment medication was not provided. This case concerns a 45-year-old, female patient with relevant medical history of Immunocompromised, who experienced, serious unlisted event of hallucination, among other non-serious events. The event occurred on an unspecified duration after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after second dose of Moderna COVID-19 Vaccine. The patient's is on quetiapine probably for some psychiatric condition, which may remain a confounder, and patient should be followed-up to confirm. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. This case was linked to MOD-2021-340634 (Patient Link).

Other Meds: TOPIRAMATE; PRILOSEC; PREDNISONE; HYOSCYAMINE; PILOCARPINE; TRAMADOL; QUETIAPINE; GABAPENTIN; URSODIOL

Current Illness: Immunocompromised

ID: 1790181
Sex: F
Age:
State: FL

Vax Date: 01/16/2021
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: tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 039K20A and 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug details were reported. No treatment details were reported. This case was linked to MOD-2021-340745 (Patient Link).

Other Meds:

Current Illness:

ID: 1790182
Sex: M
Age:
State: CA

Vax Date:
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: Skin rash (blotchy red on thighs and torso); Swelling of hands, feet and knees; Swelling of hands, feet and knees; Mild generalized pruritis; Sensation of facial "tightness; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Skin rash (blotchy red on thighs and torso)), PERIPHERAL SWELLING (Swelling of hands, feet and knees), JOINT SWELLING (Swelling of hands, feet and knees), PRURITUS (Mild generalized pruritis) and FACIAL DISCOMFORT (Sensation of facial "tightness) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Surgery (Spinal surgery for Kyphosis a number of years ago) since an unknown date. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Skin rash (blotchy red on thighs and torso)), PERIPHERAL SWELLING (Swelling of hands, feet and knees), JOINT SWELLING (Swelling of hands, feet and knees), PRURITUS (Mild generalized pruritis) and FACIAL DISCOMFORT (Sensation of facial "tightness). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Skin rash (blotchy red on thighs and torso)), PERIPHERAL SWELLING (Swelling of hands, feet and knees) and JOINT SWELLING (Swelling of hands, feet and knees) was resolving and PRURITUS (Mild generalized pruritis) and FACIAL DISCOMFORT (Sensation of facial "tightness) had not resolved. No concomitant medication was provided. The patient was seen at a urgent care center on two occasions last week and was administered some kind of steroid injection on 29 Sep 2021 with mild improvement in his sympotms. Further evaluation(lab tests) were pending.

Other Meds:

Current Illness: Surgery (Spinal surgery for Kyphosis a number of years ago)

ID: 1790183
Sex: F
Age: 62
State: NY

Vax Date: 08/08/2021
Onset Date: 10/02/2021
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: Test Name: sars covid; Test Result: Positive ; Result Unstructured Data: Her second injection was scheduled but she had a positive Covid-19 test 4 days before her shot was scheduled 4Sep2021.

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: felt warm; headache; body aches; nausea; Vaccines 52 days apart; felt so sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt so sick), FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Aug-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-1021, the patient experienced MALAISE (felt so sick). On 02-Oct-2021, the patient experienced FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccines 52 days apart). On 04-Oct-2021, FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccines 52 days apart) had resolved. At the time of the report, MALAISE (felt so sick) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: positiive (Positive) Her second injection was scheduled but she had a positive Covid-19 test 4 days before her shot was scheduled 4Sep2021.. Concomitant medication was not reported. Treatment information was not reported. Patient called to report that she had her first Moderna injection on 8Aug2021. Her second injection was scheduled but she had a positive Covid-19 test 4 days before her shot was scheduled 4Sep2021. She had her second injection 1Oct2021 Lot# 048B21A 52 days after first injection. This case was linked to MOD-2021-340751 (Patient Link).

Other Meds:

Current Illness:

ID: 1790184
Sex: F
Age:
State: FL

Vax Date: 01/16/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: body aches; bloody nose/ nose still hurts; chills; body aches; headches/ head is still hurting; joint pain; fatigued for a month; She received the 3rd dose despite not being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), EPISTAXIS (bloody nose/ nose still hurts), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headches/ head is still hurting) in a 7-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F221A, 039K20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), EPISTAXIS (bloody nose/ nose still hurts), CHILLS (chills), MYALGIA (body aches), HEADACHE (headches/ head is still hurting), ARTHRALGIA (joint pain), FATIGUE (fatigued for a month) and OFF LABEL USE (She received the 3rd dose despite not being immunocompromised). The patient was treated with ERYTHROMYCIN at an unspecified dose and frequency. At the time of the report, PAIN (body aches), CHILLS (chills) and MYALGIA (body aches) outcome was unknown, EPISTAXIS (bloody nose/ nose still hurts), HEADACHE (headches/ head is still hurting) and ARTHRALGIA (joint pain) had not resolved and FATIGUE (fatigued for a month) and OFF LABEL USE (She received the 3rd dose despite not being immunocompromised) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant informations were reported. This case was linked to MOD-2021-340725 (Patient Link).

Other Meds:

Current Illness:

ID: 1790185
Sex: F
Age:
State:

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:

Allergies:

Symptom List: Nausea

Symptoms: She had to press hard to feel a little tenderness on the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She had to press hard to feel a little tenderness on the area of the injection) 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. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (She had to press hard to feel a little tenderness on the area of the injection). At the time of the report, VACCINATION SITE PAIN (She had to press hard to feel a little tenderness on the area of the injection) was resolving. Patient was concerned whether she got the right dose as she barely did not feel any pain at all. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1790186
Sex: F
Age: 62
State: NY

Vax Date: 08/08/2021
Onset Date: 09/04/2021
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 Date: 20210904; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Injection site pain

Symptoms: She had her second injection 1Oct2021 Lot# 048B21A 52 days after first injection; felt warm; headache; body aches; nausea; Positive Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Covid-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had her second injection 1Oct2021 Lot# 048B21A 52 days after first injection), FEELING HOT (felt warm), HEADACHE (headache) and MYALGIA (body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced COVID-19 (Positive Covid-19). On 02-Oct-2021, the patient experienced FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had her second injection 1Oct2021 Lot# 048B21A 52 days after first injection). On 04-Oct-2021, FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea) had resolved. At the time of the report, COVID-19 (Positive Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had her second injection 1Oct2021 Lot# 048B21A 52 days after first injection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No relevant concomitant medications were reported. Treatment information was unknown. This case was linked to MOD-2021-340740 (Patient Link).; Sender's Comments: This case concerns a 62-year-old, female subject with no relevant medical history reported, who experienced the unexpected event of COVID-19. The event occurred twenty-seven after the first dose of Spikevax. The rechallenge was negative. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1790187
Sex: M
Age:
State: NJ

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: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: sore arm for short period of time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for short period of time) in a 71-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 PAIN IN EXTREMITY (sore arm for short period of time). At the time of the report, PAIN IN EXTREMITY (sore arm for short period of time) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were provided by the reporter. No Treatment information was reported. It was reported that patient experienced same kind of sore arm with any other vaccine.

Other Meds:

Current Illness:

ID: 1790188
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: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication and treatment information was reported. This case was linked to MOD-2021-340870 (Patient Link).

Other Meds:

Current Illness:

ID: 1790189
Sex: U
Age:
State:

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: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: dizziness; no appetite; could not work; chills; fever; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DECREASED APPETITE (no appetite), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not work), CHILLS (chills) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 DIZZINESS (dizziness), DECREASED APPETITE (no appetite), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not work), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) on 02-Oct-2021 at a dose of 4 Tylenols. On 03-Oct-2021, CHILLS (chills) had resolved. On 04-Oct-2021, DIZZINESS (dizziness) and NAUSEA (nausea) had not resolved, DECREASED APPETITE (no appetite), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not work) and HEADACHE (headache) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. This case was linked to MOD-2021-340861 (Patient Link).

Other Meds:

Current Illness:

ID: 1790190
Sex: M
Age: 29
State: CA

Vax Date: 12/30/2020
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
Hospital: Y

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: He got COVID positive and hospitalized at the end of JAN2021or beginning of FEB2021; The patient has not received the second dose yet; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication MONOCLONAL ANTIBODY 17-1A (He had Monoclonal antibody treatment > 90 days ago and after having COVID disease). On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE. On an unknown date, the patient experienced COVID-19 (seriousness criterion hospitalization). On 04-Oct-2021, PRODUCT DOSE OMISSION ISSUE had resolved. At the time of the report, COVID-19 outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information was not reported. Per reporter, the patient became COVID positive and hospitalized at the end of Jan-2021 or beginning of Feb-2021. Treatment included monoclonal antibody received more than 90 days ago, after developing COVID disease. A 30-year-old male hospitalized with a serious unexpected event of COVID-19, and product dose omission issue. Latency 1-2 months after first dose mRNA-1273. Events resolved with monoclonal antibody treatment. Rechallenge not applicable due to product dose omission. Reporter causality not provided. No confounders were reported. Causality possible from temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1790191
Sex: M
Age:
State:

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Got covid; more than 42 days for administration of second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Got covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got covid) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose). At the time of the report, COVID-19 (Got covid) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. Treatment medication mention treatment for COVID NOS. Company Comment: This is a case of inappropriate schedule of product administra tion and concerns an unknown age male patient with no relevant medical history, who experienced the unexpected serious event of COVID-19 and was hospitalized. The event of COVID-19 occured unknown number of days after the first dose of Spivax vaccine. The event of inappropriate schedule of product administration was more than 42 days for administration of second dose. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report. Reporter did not allow further contact; Sender's Comments: This is a case of inappropriate schedule of product administra tion and concerns an unknown age male patient with no relevant medical history, who experienced the unexpected serious event of COVID-19 and was hospitalized. The event of COVID-19 occured unknown number of days after the first dose of Spivax vaccine. The event of inappropriate schedule of product administration was more than 42 days for administration of second dose. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report.

Other Meds:

Current Illness:

ID: 1790192
Sex: F
Age: 49
State: VA

Vax Date: 05/14/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Date: 20210528; Test Name: Cholesterol; Result Unstructured Data: Recovered on 28-Sep-2021; Test Name: Blood pressure; Result Unstructured Data: High; Test Name: Blood pressure; Result Unstructured Data: High; Test Name: EKG; Result Unstructured Data: sign of heart attack.

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Patient stated they were itching; Diagnosed with diabetes; blood pressure of 192/93; breaking out that she describe it as chicken pox.The chicken pox break out were in the warm area like under arm and on the stomach.break out did not stop and spread through out the body except for face and feet; diagnosis with dermatitis; biopsy and it was done from the bump that was on the arm; pain in the chest,experienced the chest pain again; left arm went numb and tingling; left arm went numb and tingling; weird feeling; diagnosed with a heart attack; throat was closing up; patient felt nauseated,patient experienced nausea; This spontaneous case was reported by a consumer and describes the occurrence of VARICELLA, DERMATITIS, PERIPHERAL SWELLING, CHEST PAIN, HYPOAESTHESIA, PARAESTHESIA, FEELING ABNORMAL, MYOCARDIAL INFARCTION, OROPHARYNGEAL DISCOMFORT, NAUSEA, PRURITUS, DIABETES MELLITUS, and HYPERTENSION (blood pressure of 192/93) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The patient's past medical history included Chickenpox and Stent placement (Patient was discharged from the hospital on 30Sep2021) on 28-Sep-2021. Concurrent medical conditions included Migraine. Concomitant products included CLONAZEPAM for Anxiety, PAXIL for Depression, FIORICET for Migraine, ASPIRIN, LIPITOR, LISINOPRIL, METOPROLOL, BRILINTA, and WELLBUTRIN XL for an unknown indication. On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced CHEST PAIN (seriousness criteria hospitalization prolonged and medically significant). 28-Sep-2021, the patient experienced HYPOAESTHESIA (seriousness criteria hospitalization prolonged and medically significant), PARAESTHESIA (seriousness criteria hospitalization prolonged and medically significant), FEELING ABNORMAL (seriousness criteria hospitalization prolonged and medically significant), MYOCARDIAL INFARCTION (seriousness criteria hospitalization prolonged and medically significant), OROPHARYNGEAL DISCOMFORT (seriousness criteria hospitalization prolonged and medically significant), NAUSEA (seriousness criteria hospitalization prolonged and medically significant) and HYPERTENSION (blood pressure of 192/93) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced VARICELLA (seriousness criterion medically significant), DERMATITIS (seriousness criterion medically significant), PERIPHERAL SWELLING (seriousness criterion medically significant), PRURITUS (seriousness criterion hospitalization), and DIABETES MELLITUS (seriousness criteria hospitalization and medically significant). The patient was treated with PREDNISONE for Dermatitis, at a dose of 10 milligram, 4 milligram dose pak for 6 days; HYDROXYZINE for Itching, at a dose of 25 milligram; CEFALEXIN for Adverse event, at a dose of 25 milligram; TRIAMCINOLONE for Adverse event, at a dose of 0.1% (450 grams); VALTREX for Adverse event, at an unspecified dose and frequency; NURTEC for Migraine, at an unspecified dose and frequency; ASPIRIN for Adverse event, at an unspecified dose and frequency and NITRO for Adverse event, at an unspecified dose and frequency. On 30-Sep-2021, CHEST PAIN, HYPOAESTHESIA, PARAESTHESIA, FEELING ABNORMAL, MYOCARDIAL INFARCTION, OROPHARYNGEAL DISCOMFORT, NAUSEA, and HYPERTENSION (blood pressure of 192/93) had resolved. At the time of the report, VARICELLA had not resolved and DERMATITIS, PERIPHERAL SWELLING, PRURITUS, and DIABETES MELLITUS outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 28-May-2021, Blood cholesterol 202 (High), Recovered on 28-Sep-2021. On an unknown date, Blood pressure measurement 192/93 (High) and 188/84 (High). On an unknown date, Electrocardiogram (abnormal), sign of heart attack. Post vaccination, It was reported that biopsy was done from the bump that was on the arm and leg and the result from biopsy showed that those bumps are related to medicine. Patient had a cold patch on the back due to the intense pain. Company Comment: This case concerns a 49-year-old, female patient with medical history of Chickenpox, concomitant use of NURTEC, CLONAZEPAM, WELLBUTRIN, FIORICET, LIPITOR, METOPROLOL, ASPIRIN, BRILINTA, and PAXIL who experienced the unexpected serious events of varicella, dermatitis, peripheral swelling, chest pain, hypoaesthesia, paraesthesia, feeling abnormal, myocardial infarction, oropharyngeal discomfort, nausea, pruritus, diabetes mellitus, and hypertension. The events occurred unknown number of days after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the events occurred after the second dose and no additional dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds: ASPIRIN; LIPITOR; LISINOPRIL; METOPROLOL; BRILINTA; PAXIL; CLONAZEPAM; WELLBUTRIN XL; FIORICET

Current Illness: Migraine

ID: 1790193
Sex: F
Age: 65
State: CA

Vax Date: 02/12/2021
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: Tingling sensations; Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensations), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling sensations), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PARAESTHESIA (Tingling sensations) had not resolved, CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown and HEADACHE (Headache) had resolved. No concomitant medication was reported. No treatment medication use was reported. Patient reported after her 3hrd shot, her headache felt like she had 5 heads and when the headache subsided, she felt tingling above her right eye which hasn't gone away. This case was linked to MOD-2021-340950, MOD-2021-340951 (Patient Link).

Other Meds:

Current Illness:

ID: 1790194
Sex: F
Age:
State:

Vax Date:
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: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: got very violently sick; side effects; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very violently sick) and VACCINATION COMPLICATION (side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got very violently sick) and VACCINATION COMPLICATION (side effects). At the time of the report, ILLNESS (got very violently sick) and VACCINATION COMPLICATION (side effects) outcome was unknown. No concomitant medications provided. No treatment medications provided.

Other Meds:

Current Illness:

ID: 1790195
Sex: M
Age:
State: MO

Vax Date: 03/02/2021
Onset Date: 03/01/2021
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: Multiple Myeloma/diagnosed INGUS which is one of the indicators for multiple myeloma.; Glaucoma got worst; Mild neuropathy on the legs/it's mild and shouldn't cause the continuous weakness; Difficulty walking; Still has extreme weakness in the legs; Joint pain; Muscle pains; Extreme fatigue; Severe weakness/continuous weakness; Hypoglycemia; Nauseated; Serious side effects; This spontaneous case was reported by a consumer and describes the occurrence of PLASMA CELL MYELOMA, GLAUCOMA, and NEUROPATHY PERIPHERAL in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypoglycemia, High cholesterol, and Glaucoma. Concomitant products included LATANOPROST for Glaucoma, PRAVASTATIN for High cholesterol, ASPIRIN, VITAMIN D, SIMBRINZA, and MULTIPLE VITAMINS for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION COMPLICATION (Serious side effects). On 30-Mar-2021, the patient experienced NAUSEA. On 31-Mar-2021, the patient experienced HYPOGLYCAEMIA, ASTHENIA, and FATIGUE. On an unknown date, the patient experienced PLASMA CELL MYELOMA (seriousness criterion medically significant), GLAUCOMA (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (seriousness criterion medically significant), GAIT DISTURBANCE, MUSCULAR WEAKNESS, ARTHRALGIA, and MYALGIA. In May 2021, FATIGUE and NAUSEA had resolved. At the time of the report, PLASMA CELL MYELOMA, NEUROPATHY PERIPHERAL, HYPOGLYCAEMIA, GAIT DISTURBANCE, VACCINATION COMPLICATION, ASTHENIA, ARTHRALGIA, and MYALGIA outcome was unknown and GLAUCOMA and MUSCULAR WEAKNESS had not resolved. Concomitant medication given as Lovage 2g twice a day. Treatment information was not provided. The patient said that nothing occur after the first dose. The patient reported that he went to several specialist and that a Neurologist diagnosed the patient with a mild neuropathy on the legs. The patient was sent also to an oncology and was diagnosed with multiple Myeloma, have to watch it because it might never occur but sometimes it does. The patient then said it was diagnosed INGUS which is one of the indicators for multiple myeloma. Patient is hesitant to receive the booster dose. Temporary report number 666967 Company Comment: This case concerns a patient with no previous relevant medical history, who experienced the unexpected events of plasma cell myeloma, glaucoma, neuropathy peripheral. The events occurred after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since events occurred after second dose. The medical history of sulfonamide remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds: PRAVASTATIN; ASPIRIN; LATANOPROST; VITAMIN D NOS; SIMBRINZA; MULTIPLE VITAMINS

Current Illness: Glaucoma; High cholesterol; Hypoglycemia

ID: 1790196
Sex: F
Age: 81
State:

Vax Date: 09/24/2021
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: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Lumpy Injection site; Rash on the injection site; Itching Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lumpy Injection site), VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE PRURITUS (Itching Injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced VACCINATION SITE MASS (Lumpy Injection site), VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE PRURITUS (Itching Injection site). At the time of the report, VACCINATION SITE MASS (Lumpy Injection site), VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE PRURITUS (Itching Injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were not reported. No treatment medications were not provided. Patient has not seen a doctor.

Other Meds:

Current Illness:

ID: 1790197
Sex: F
Age: 47
State: TX

Vax Date: 07/07/2021
Onset Date: 07/07/2021
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: Patient feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising; The patient had a discoloration in the arm and back, and on the upper left shoulder blade; Feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising/ The arm became sore, later the patient was in extreme discomfort; Did not feel comfortable with the way the vaccine was administered/ Injection was not at a 90 degrees angle and no more that 80 degrees; The arm became sore, later the patient was in extreme discomfort/ It hurt to move the arm; Mental status has change; Sleep in their car in their driveway with no explanation, doing odd things; This spontaneous case was reported by a nurse and describes the occurrence of SKIN DISCOLORATION (The patient had a discoloration in the arm and back, and on the upper left shoulder blade), VACCINATION SITE DISCOMFORT (Feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising/ The arm became sore, later the patient was in extreme discomfort), MENTAL STATUS CHANGES (Mental status has change), ABNORMAL BEHAVIOR (sleep in their car in their driveway with no explanation, doing odd things) and VACCINATION SITE BRUISING (Patient feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MENTAL STATUS CHANGES (Mental status has change) and ABNORMAL BEHAVIOR (Sleep in their car in their driveway with no explanation, doing odd things). On 07-Jul-2021, the patient experienced VACCINATION SITE DISCOMFORT (Feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising/ The arm became sore, later the patient was in extreme discomfort), VACCINATION SITE PAIN (The arm became sore, later the patient was in extreme discomfort/ It hurt to move the arm) and PRODUCT ADMINISTRATION ERROR (Did not feel comfortable with the way the vaccine was administered/ Injection was not at a 90 degrees angle and no more that 80 degrees). On 08-Jul-2021, the patient experienced SKIN DISCOLORATION (The patient had a discoloration in the arm and back, and on the upper left shoulder blade). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Patient feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising). On 07-Jul-2021, PRODUCT ADMINISTRATION ERROR (Did not feel comfortable with the way the vaccine was administered/ Injection was not at a 90 degrees angle and no more that 80 degrees) had resolved. At the time of the report, SKIN DISCOLORATION (The patient had a discoloration in the arm and back, and on the upper left shoulder blade) had not resolved and VACCINATION SITE DISCOMFORT (Feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising/ The arm became sore, later the patient was in extreme discomfort), MENTAL STATUS CHANGES (Mental status has change), ABNORMAL BEHAVIOR (Sleep in their car in their driveway with no explanation, doing odd things), VACCINATION SITE BRUISING (Patient feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising) and VACCINATION SITE PAIN (The arm became sore, later the patient was in extreme discomfort/ It hurt to move the arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. On 07-Jul-2021, the patient did not felt comfortable with the way the vaccine was administered, the administrator was nervous and pinching the arm of the patient and the patient saw that the injection was not at a 90 degrees angle and no more that 80 degrees. After getting the shot, the arm became sore, later the patient was in extreme discomfort and it hurt to move the arm. The next day, the patient had a discoloration in the arm and back, and on the upper left shoulder blade. It was getting worse and was much worse that the COVID arm. The patient felt very heavy, it hurt in that area like having an infection because it was thickening and bruising. On an unknown date, a few days ago of reporting, reporter noticed that the patient's mental status had changed, the patient had been doing odd things and was found sleeping in the car in their driveway on three different occasions with no explanation.; Sender's Comments: This case concerns a 47 year old female with no reported medical history , who experienced the unexpected events of vaccination site discomfort, product administration issue, this was accomapanied by expected event of vaccination site pain .which all occurred on the same day after vaccination with the 1st dose of mRNA-1273 (Moderna) . The day after the vaccination with the 1st dose unexpected events of vaccination site bruising and skin discoloration was noted. On an unknown time of onset unexpected events of mental status changes, Abnormal behavior occurred after the 1st dose of the vaccine. The rechallenge is not applicable for this case. The benefit - risk relationship of mRNA-1273 (Moderna ) is not affected by this report.

Other Meds:

Current Illness:

ID: 1790198
Sex: F
Age: 36
State: NY

Vax Date: 04/08/2021
Onset Date: 04/08/2021
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: swelling in my left injection site arm; very tired for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling in my left injection site arm) and FATIGUE (very tired for 2 days) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031BZIA) for COVID-19 vaccination. Concomitant products included SPIRONOLACTONE (SPIRONOLACTON) and VITAMINS NOS for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling in my left injection site arm) and FATIGUE (very tired for 2 days). In April 2021, FATIGUE (very tired for 2 days) had resolved. At the time of the report, VACCINATION SITE SWELLING (swelling in my left injection site arm) 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. Lab data was not provided Treatment product was not provided by the reporter This case refers only to the events of the first dose of the Moderna COVID-19 Vaccine. This case was linked to MOD-2021-341010 (Patient Link).; Sender's Comments: This case concerns a 36-year-old, female patient with no relevant medical history, who experienced the unexpected events of Vaccination site swelling and Fatigue. The events occurred on the day of the first dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. This case is downgraded to Non-serious because the events have resolved within 2 days and did not cause hospitalization, permanent disability or incapacity.

Other Meds: SPIRONOLACTON; VITAMINS NOS

Current Illness:

ID: 1790199
Sex: F
Age: 65
State: CA

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: Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 66-year-old female 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment reported. This case was linked to MOD-2021-340922, MOD-2021-340951 (Patient Link).

Other Meds:

Current Illness:

ID: 1790200
Sex: F
Age: 65
State: CA

Vax Date: 02/12/2021
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:

Allergies:

Symptom List: Vomiting

Symptoms: Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. No concomitant medication was reported by the reporter. No treatment was reported by the reporter. This case was linked to MOD-2021-340950, MOD-2021-340922 (Patient Link).

Other Meds:

Current Illness:

ID: 1790201
Sex: F
Age:
State:

Vax Date:
Onset Date:
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: excess sweating; under left arm she has pain; swollen lymph nodes on her left side where she got vaccine/lymph nodes are swollen; pain is in lymph nodes,really hurts; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (excess sweating), PAIN IN EXTREMITY (under left arm she has pain), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on her left side where she got vaccine/lymph nodes are swollen) and LYMPH NODE PAIN (pain is in lymph nodes,really hurts) 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 Hormone replacement therapy since an unknown date. Concurrent medical conditions included Immunocompromised and Gene mutation. 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 HYPERHIDROSIS (excess sweating), PAIN IN EXTREMITY (under left arm she has pain), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on her left side where she got vaccine/lymph nodes are swollen) and LYMPH NODE PAIN (pain is in lymph nodes,really hurts). At the time of the report, HYPERHIDROSIS (excess sweating), PAIN IN EXTREMITY (under left arm she has pain), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on her left side where she got vaccine/lymph nodes are swollen) and LYMPH NODE PAIN (pain is in lymph nodes,really hurts) outcome was unknown. Treatment information was not provided

Other Meds:

Current Illness: Gene mutation; Hormone replacement therapy; Immunocompromised

ID: 1790202
Sex: F
Age: 42
State: OR

Vax Date: 07/23/2021
Onset Date: 08/22/2021
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: Felt really bad/felt worse for about 24 hours; fever for about 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt really bad/felt worse for about 24 hours) and PYREXIA (fever for about 24 hours) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced FEELING ABNORMAL (Felt really bad/felt worse for about 24 hours) and PYREXIA (fever for about 24 hours). On 23-Aug-2021, FEELING ABNORMAL (Felt really bad/felt worse for about 24 hours) and PYREXIA (fever for about 24 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information include ibuprofen. This case was linked to MOD-2021-341011 (Patient Link).

Other Meds:

Current Illness:

ID: 1790203
Sex: U
Age:
State: TX

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: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: strokes; brain bleed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (strokes) and CEREBRAL HAEMORRHAGE (brain bleed) 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 CEREBROVASCULAR ACCIDENT (strokes) (seriousness criterion medically significant) and CEREBRAL HAEMORRHAGE (brain bleed) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (strokes) and CEREBRAL HAEMORRHAGE (brain bleed) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided. Reporter spoke to reported some people that have received Moderna's COVID-19 vaccine experience strokes and brain bleeds. Also stated that other people reported they had a lot lately and at a "much higher quota than normal", brain bleeds also happened in nursing homes. Company Comment: This case concerns a patient without identifiers and no relevant medical history reported, who experienced the unexpected events of cerebral vascular accident and cerebral haemorrhage. The event occurred after a dose of mRNA-1273 Moderna vaccine (SD doesn?t clarify if it was 1st or 2nd dose, vaccination date was not provided, onset of events was not provided) . The rechallenge is N/A (no information regarding other dose was provided) The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: This case concerns a patient without identifiers and no relevant medical history reported, who experienced the unexpected events of cerebral vascular accident and cerebral haemorrhage. The event occurred after a dose of mRNA-1273 Moderna vaccine (SD doesn?t clarify if it was 1st or 2nd dose, vaccination date was not provided, onset of events was not provided) . The rechallenge is N/A (no information regarding other dose was provided) The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Very limited information regarding this events has been provided at this time. Further information has been requested

Other Meds:

Current Illness:

ID: 1790204
Sex: F
Age: 78
State: MS

Vax Date: 02/08/2021
Onset Date: 03/09/2021
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: Since then her right arm has been bothering her; Since then her right arm has been bothering her and the pain seems to be moving around her upper shoulder where she got her injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Since then her right arm has been bothering her and the pain seems to be moving around her upper shoulder where she got her injection) and PAIN IN EXTREMITY (Since then her right arm has been bothering her) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) 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 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (Since then her right arm has been bothering her and the pain seems to be moving around her upper shoulder where she got her injection). On an unknown date, the patient experienced PAIN IN EXTREMITY (Since then her right arm has been bothering her). At the time of the report, VACCINATION SITE DISCOMFORT (Since then her right arm has been bothering her and the pain seems to be moving around her upper shoulder where she got her injection) and PAIN IN EXTREMITY (Since then her right arm has been bothering her) outcome was unknown. No concomitant product was provided by the reporter. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1790205
Sex: M
Age:
State: FL

Vax Date: 09/29/2021
Onset Date: 09/29/2021
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: This spontaneous case reported by a consumer, describes the occurrence of sluggishness (dopey), abdominal discomfort (upset stomach), pain in extremity (pain in legs), cough (still have a cough) and inappropriate schedule of vaccine administered in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Aug 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 29, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 29, 2021, patient experienced sluggishness (dopey), abdominal discomfort (upset stomach), pain in extremity (pain in legs), cough (still have a cough), inappropriate schedule of product administration (inappropriate schedule of vaccine administered), chills, fatigue (tired) and pyrexia (on that night had fever). Patient treated with Tylenol (paracetamol) for fever, at an unspecified dose and frequency. On Sep 29, 2021, inappropriate schedule of product administration (inappropriate schedule of vaccine administered): resolved. At the time of the report, sluggishness (dopey), abdominal discomfort (upset stomach), pain in extremity (pain in legs), chills, fatigue (tired) and pyrexia (on that night had fever) outcome: unknown and cough (still have a cough): not resolved. No concomitant medication reported. This case linked to MOD-2021-307264 (patient link).

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am