VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1691883
Sex: F
Age: 45
State: LA

Vax Date: 03/06/2021
Onset Date: 08/27/2021
Rec V Date: 09/11/2021
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: flu shot; diarrhea; vomiting; sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea) and INFLUENZA (flu shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 029A21A) for COVID-19 vaccination. 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 27-Aug-2021, the patient experienced ILLNESS (sick). On 29-Aug-2021, the patient experienced VOMITING (vomiting). On 30-Aug-2021, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced INFLUENZA (flu shot). At the time of the report, ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea) and INFLUENZA (flu shot) outcome was unknown. This case was linked to MOD-2021-302245 (Patient Link).

Other Meds:

Current Illness:

ID: 1691884
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: Immediate dizziness; Nausea; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Immediate dizziness) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Immediate dizziness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Immediate dizziness) and NAUSEA (Nausea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment medications provided. Pharmacist stated that -according to the information of moderna patient should not get the second dose since this was an immediate reaction. and asked about the second vaccine -should she get the Janssen vaccine as her second dose?

Other Meds:

Current Illness:

ID: 1691885
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: adverse effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse effect). At the time of the report, VACCINATION COMPLICATION (adverse effect) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by reporter. No treatment medications were provided by reporter.

Other Meds:

Current Illness:

ID: 1691886
Sex: M
Age: 57
State: TX

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: COVID-19; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm soreness) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. Concomitant products included TRANYLCYPROMINE SULFATE (PARNATE), CLONAZEPAM (KLONOPIN), LAMOTRIGINE (LAMICTAL) and EZETIMIBE (ZETIA) for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Right arm soreness). The patient was treated with PARACETAMOL (TYLENOL) for Chills, Headache and Fatigue, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Right arm soreness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported the arm soreness lasted for about a day. The patient can be contacted via email or phone. This case was linked to MOD-2021-302232 (Patient Link).

Other Meds: PARNATE; KLONOPIN; LAMICTAL; ZETIA

Current Illness:

ID: 1691887
Sex: F
Age: 20
State: OH

Vax Date: 08/09/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
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: Swelling of that portion of it started immediately; Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it's from the shoulder to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it's from the shoulder to the elbow) and VACCINATION SITE SWELLING (Swelling of that portion of it started immediately) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE SWELLING (Swelling of that portion of it started immediately). In August 2021, the patient experienced VACCINATION SITE PAIN (Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it's from the shoulder to the elbow). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. In August 2021, VACCINATION SITE SWELLING (Swelling of that portion of it started immediately) had resolved. At the time of the report, VACCINATION SITE PAIN (Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it's from the shoulder to the elbow) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. The patient took Tylenol initially for 2 days and then Advil was used when it started hurting again and was put hot prior to work and then iced it. The patient's pain and swelling went away after vaccination but it started again during training that was probably around 17th or 18th of August and was still painful. Patient had no other symptoms.

Other Meds:

Current Illness:

ID: 1691888
Sex: F
Age: 58
State: AL

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 09/11/2021
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: Test Name: Covid test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: couldn't get the second dose as it had an unexpected back to back surgery; Headache; so tired; Nauseated; body aches, hurt all over/sore; pretty sick/got sick; had no energies, had to go to bed; The patient thought it was sinusitis; it was red around, localized; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (pretty sick/got sick), ASTHENIA (had no energies, had to go to bed), SINUSITIS (The patient thought it was sinusitis), ERYTHEMA (it was red around, localized) and PRODUCT DOSE OMISSION ISSUE (couldn't get the second dose as it had an unexpected back to back surgery) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 04-Nov-2020, Cancer and Surgery (2 surgeries after first dose of vaccine). On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced ILLNESS (pretty sick/got sick), ASTHENIA (had no energies, had to go to bed), SINUSITIS (The patient thought it was sinusitis), ERYTHEMA (it was red around, localized), HEADACHE (Headache), FATIGUE (so tired), NAUSEA (Nauseated) and MYALGIA (body aches, hurt all over/sore). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (couldn't get the second dose as it had an unexpected back to back surgery). At the time of the report, ILLNESS (pretty sick/got sick), ASTHENIA (had no energies, had to go to bed), SINUSITIS (The patient thought it was sinusitis), ERYTHEMA (it was red around, localized), PRODUCT DOSE OMISSION ISSUE (couldn't get the second dose as it had an unexpected back to back surgery), HEADACHE (Headache), FATIGUE (so tired), NAUSEA (Nauseated) and MYALGIA (body aches, hurt all over/sore) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. 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: Cancer

ID: 1691889
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: Within 1 hour had a severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Within 1 hour had a severe headache) 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 HEADACHE (Within 1 hour had a severe headache). At the time of the report, HEADACHE (Within 1 hour had a severe headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided.

Other Meds:

Current Illness:

ID: 1691890
Sex: M
Age: 56
State: MA

Vax Date: 04/06/2021
Onset Date: 08/29/2021
Rec V Date: 09/11/2021
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: 20210901; Test Name: Alkaline phosphatase; Result Unstructured Data: Alkaline phosphatase decreased.; Test Date: 20210901; Test Name: Creatinine; Result Unstructured Data: Creatinine increased.; Test Name: Body temperature; Result Unstructured Data: Body temperature increased.; Test Date: 20210829; Test Name: COVID-19; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 20210901; Test Name: Hematocrit; Result Unstructured Data: Hematocrit decreased; Test Date: 20210901; Test Name: Hemoglobin; Result Unstructured Data: Hemoglobin decreased.; Test Date: 20210901; Test Name: Lymphocytes; Result Unstructured Data: Lymphocytes increased; Test Date: 20210901; Test Name: Mean platelet volume; Result Unstructured Data: Mean platelet volume increased.; Test Date: 20210901; Test Name: Monocytes; Result Unstructured Data: Monocytes increased.; Test Date: 20210901; Test Name: Absolute neutrophil count; Result Unstructured Data: Absolute neutrophil count decreased.; Test Date: 20210901; Test Name: Neutrophils; Result Unstructured Data: Neutrophils decreased.; Test Date: 20210901; Test Name: RBC; Result Unstructured Data: RBC decreased; Test Date: 20210901; Test Name: Troponin; Result Unstructured Data: abnormal

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Altered level of consciousness; Lack of drug effect; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (Altered level of consciousness) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CORONAVIRUS TEST POSITIVE (tested positive for Covid-19 he took both the nasal swab test and the PCR). On an unknown date, the patient experienced ALTERED STATE OF CONSCIOUSNESS (Altered level of consciousness) (seriousness criterion medically significant), RHINORRHOEA (Runny nose), HEAD DISCOMFORT (Extreme Head Pressure/Cranial Pressure), DYSPNOEA (Shortness of breath), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (An absolute terrible head throbbing./Headache), PYREXIA (Fever) and MYALGIA (Muscle aches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, ALTERED STATE OF CONSCIOUSNESS (Altered level of consciousness), CORONAVIRUS TEST POSITIVE (tested positive for Covid-19 he took both the nasal swab test and the PCR), RHINORRHOEA (Runny nose), HEAD DISCOMFORT (Extreme Head Pressure/Cranial Pressure), DYSPNOEA (Shortness of breath), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (An absolute terrible head throbbing./Headache), PYREXIA (Fever) and MYALGIA (Muscle aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, COVID-19: positive (Positive) Positive. On an unknown date, Blood alkaline phosphatase: 36 (Low) Alkaline phosphatase decreased.. On an unknown date, Blood creatinine: 1.3 (High) Creatinine increased.. On an unknown date, Body temperature: 101.5 fahrenheit (High) Body temperature increased.. On an unknown date, Haematocrit: 39.3 (Low) Hematocrit decreased. On an unknown date, Haemoglobin: 13.2 (Low) Hemoglobin decreased.. On an unknown date, Lymphocyte count: 46.3 (High) Lymphocytes increased. On an unknown date, Mean platelet volume: 11.5 (High) Mean platelet volume increased.. On an unknown date, Monocyte count: 12.5 (High) Monocytes increased.. On an unknown date, Neutrophil count: 1.77 (Low) Absolute neutrophil count decreased. and 37.1 (Low) Neutrophils decreased.. On an unknown date, Red blood cell count: 4.39 (Low) RBC decreased. On an unknown date, Troponin: abnormal (abnormal) abnormal. Patient reported that he received nebulizer as a treatment. No concomitant medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Significant information received on 3-Sep-2021. Lab data, event details, treatment medication were added.; Sender's Comments: This is a case of drug ineffective. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. Based on the current available information and temporal association between the use of the product and the start date of the event of altered state of consciousness, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1691891
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (swollen arm) and pain in extremity (sore arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced peripheral swelling (swollen arm) and pain in extremity (sore arm). At the time of the report, peripheral swelling (swollen arm) and pain in extremity (sore arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported. This case linked to MOD-2021-302671 (patient link).

Other Meds:

Current Illness:

ID: 1691892
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Diarrhea 3 days after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea 3 days after vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea 3 days after vaccine). At the time of the report, DIARRHOEA (Diarrhea 3 days after vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication provided by reporter. No treatment medication provided by reporter.

Other Meds:

Current Illness:

ID: 1691893
Sex: M
Age: 68
State: OH

Vax Date: 02/11/2021
Onset Date: 03/12/2021
Rec V Date: 09/11/2021
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: sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 013M20A) for COVID-19 vaccination. The patient's past medical history included Heart attack (3 heart attacks) and Stroke. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown. No relevant concomitant medications were reported. Treatment information was unknown. Patient was vegan for 10 yrs now. And use no oils in his diet." This case was linked to MOD-2021-302607 (Patient Link).

Other Meds:

Current Illness:

ID: 1691894
Sex: F
Age:
State: FL

Vax Date: 04/01/2021
Onset Date: 08/30/2021
Rec V Date: 09/11/2021
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: urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown. no concomitant medications are provided. treatment to the events not reported. patient wants to get the booster on 1-sep-2021. This case was linked to MOD-2021-302521 (Patient Link).; Sender's Comments: Based on pathophysiology of the event urinary tract infection, the event is assessed as unlikely related to mRNA-1273.

Other Meds:

Current Illness:

ID: 1691895
Sex: F
Age: 62
State: OH

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 09/11/2021
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: Ache in her injection site arm; Slight fever; Body aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Ache in her injection site arm), PYREXIA (Slight fever), MYALGIA (Body aches) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (Ache in her injection site arm), PYREXIA (Slight fever), MYALGIA (Body aches) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE PAIN (Ache in her injection site arm), PYREXIA (Slight fever), MYALGIA (Body aches) and NAUSEA (Nausea) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications were provided. No treatment medications were reported. This case was linked to MOD-2021-302693 (Patient Link).

Other Meds:

Current Illness:

ID: 1691896
Sex: F
Age:
State:

Vax Date: 08/21/2021
Onset Date: 08/22/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dizziness; Not feeling well; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MALAISE (Not feeling well) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. The patient's past medical history included Surgery on 27-May-2021. Concomitant products included TRAMADOL for an unknown indication. On 21-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced DIZZINESS (Dizziness), MALAISE (Not feeling well) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Dizziness, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache) had not resolved and MALAISE (Not feeling well) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medication: Tylenol 500mg morning and if needed two at bedtime for headache and dizziness, patient said this is not working. The patient woke up not feeling well, had relaxed since then. The patient had been, dizzy since then also headaches, the day after she got her first vaccine. The patient was still experiencing the dizziness and headaches. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: TRAMADOL

Current Illness:

ID: 1691897
Sex: F
Age: 53
State: FL

Vax Date: 07/17/2021
Onset Date:
Rec V Date: 09/11/2021
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: Swollen hands and feet severe pain; Swollen hands and feet severe pain; hurts to walk; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen hands and feet severe pain), PAIN IN EXTREMITY (Swollen hands and feet severe pain) and GAIT DISTURBANCE (hurts to walk) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054cz1a and 006d21a) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-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 PERIPHERAL SWELLING (Swollen hands and feet severe pain), PAIN IN EXTREMITY (Swollen hands and feet severe pain) and GAIT DISTURBANCE (hurts to walk). At the time of the report, PERIPHERAL SWELLING (Swollen hands and feet severe pain) and PAIN IN EXTREMITY (Swollen hands and feet severe pain) had not resolved and GAIT DISTURBANCE (hurts to walk) outcome was unknown. Concomitant medication were not provided. Treatment medication were not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1691898
Sex: M
Age: 34
State: AR

Vax Date: 08/03/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: appendicitis/ appendix removed; This spontaneous case was reported by a pharmacist and describes the occurrence of APPENDICITIS (appendicitis/ appendix removed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced APPENDICITIS (appendicitis/ appendix removed) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (appendix removed) for Appendicitis. At the time of the report, APPENDICITIS (appendicitis/ appendix removed) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1691899
Sex: M
Age: 50
State:

Vax Date: 03/15/2021
Onset Date: 08/20/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210820; Test Name: blood pressure; Result Unstructured Data: increased

Allergies:

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

Symptoms: malaise; Myalgia; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), MYALGIA (Myalgia) and FATIGUE (fatigue) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis, Penicillin allergy, Foot drop, Skin lesion and Sleeplessness. Concomitant products included OCRELIZUMAB (OCREVUS), BUPROPION, FAMPRIDINE (AMPYRA), FISH OIL (OMEGA 3 FISH OILS), BACLOFEN and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication. On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced MALAISE (malaise), MYALGIA (Myalgia) and FATIGUE (fatigue). At the time of the report, MALAISE (malaise), MYALGIA (Myalgia) and FATIGUE (fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Blood pressure measurement: increased (High) increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided.

Other Meds: OCREVUS; BUPROPION; AMPYRA; OMEGA 3 FISH OILS; BACLOFEN; ADDERALL

Current Illness: Foot drop; Multiple sclerosis; Penicillin allergy; Skin lesion; Sleeplessness

ID: 1691900
Sex: M
Age:
State: NY

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 09/11/2021
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: One dose given > 12 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One dose given > 12 hours after puncture) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (One dose given > 12 hours after puncture). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (One dose given > 12 hours after puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant product use was provided by the reporter. No treatment medication was provided. The patient received the expired dose 8 hours passed the 12-hour expiration. The vial was initially stored in the refrigerator on 24 Aug 2021 (one week ago) and was removed from refrigerator, dose drawn up at room temperature, and then administered to the patient. Total amount of time the vial was exposed to room temperature range (46? to 77? F).

Other Meds:

Current Illness:

ID: 1691901
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
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: I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).; I am 7 months pregnant.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).) and MATERNAL EXPOSURE DURING PREGNANCY (I am 7 months pregnant.) 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. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).) and MATERNAL EXPOSURE DURING PREGNANCY (I am 7 months pregnant.). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (I am 7 months pregnant.) outcome was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1691902
Sex: F
Age:
State: NY

Vax Date: 07/16/2021
Onset Date: 07/16/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Greater than 35 days since patient's first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since patient's first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since patient's first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since patient's first dose) had resolved. Concomitant medication was not provided Treatment information was not reported Patient had an appointment for her second dose on 13 Aug 2021, but did not receive the second dose. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1691903
Sex: M
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: pain at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a 35-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) 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 reported No treatment information was provided This case was linked to MOD-2021-303281 (Patient Link).

Other Meds:

Current Illness:

ID: 1691904
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: not to be able to get pregnant; This spontaneous case was reported by an other health care professional and describes the occurrence of INFERTILITY FEMALE (not to be able to get pregnant) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 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 INFERTILITY FEMALE (not to be able to get pregnant). At the time of the report, INFERTILITY FEMALE (not to be able to get pregnant) 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 reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1691905
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: I became infected with Covid about 3 weeks after having had my first Moderna shot.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I became infected with Covid about 3 weeks after having had my first Moderna shot.) 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, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (I became infected with Covid about 3 weeks after having had my first Moderna shot.). At the time of the report, COVID-19 (I became infected with Covid about 3 weeks after having had my first Moderna shot.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1691906
Sex: U
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: agitation; 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 AGITATION (agitation) in an elderly patient of an unknown 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 AGITATION (agitation). At the time of the report, AGITATION (agitation) 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 and Treatment medication were reported.

Other Meds:

Current Illness:

ID: 1691907
Sex: M
Age: 70
State: IN

Vax Date: 08/30/2021
Onset Date: 08/30/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: almost passed out; body is cold; He's having a cold sweat, body is cold; He has a rash underneath both armpits; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (almost passed out), FEELING COLD (body is cold), COLD SWEAT (He's having a cold sweat, body is cold) and RASH (He has a rash underneath both armpits) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) 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) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced DIZZINESS (almost passed out), FEELING COLD (body is cold), COLD SWEAT (He's having a cold sweat, body is cold) and RASH (He has a rash underneath both armpits). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, DIZZINESS (almost passed out) outcome was unknown and FEELING COLD (body is cold), COLD SWEAT (He's having a cold sweat, body is cold) and RASH (He has a rash underneath both armpits) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medications was reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1691908
Sex: F
Age: 75
State: WA

Vax Date: 07/14/2021
Onset Date: 09/01/2021
Rec V Date: 09/11/2021
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: I have a problem with vision a retinal specialist diagnosed me with macular degeneration and retinal ganglion thinning; I have a problem with vision a retinal specialist diagnosed me with macular degeneration and retinal ganglion thinning; I have a general feeling of illness fatigue my breathing is getting worse and dyspnea/violently sick; Add severe fatigue I did not have any energy and I also had a lump on my injection site; I have a general feeling of illness fatigue my breathing is getting worse and dyspnea; Ongoing episodes of chills and shaking and severe diarrhea; I have a mild rash that comes and goes; I have increased joint pain more than I have had before I have joint instability muscle weakness; After relatively constant headache in the front of my head constant nausea but no vomiting trouble eating; Add severe fatigue I did not have any energy and I also had a lump on my injection site; After relatively constant headache in the front of my head constant nausea but no vomiting trouble eating; vomiting; Ongoing episodes of chills and shaking and severe diarrhea; flets; violently sick; Ongoing episodes of chills and shaking and severe diarrhea/severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of MACULAR DEGENERATION (I have a problem with vision a retinal specialist diagnosed me with macular degeneration and retinal ganglion thinning) and RETINAL DEGENERATION (I have a problem with vision a retinal specialist diagnosed me with macular degeneration and retinal ganglion thinning) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included CURCUMIN for Inflammation, ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) for Vision abnormal NOS, LEVOTHYROXINE, LIOTHYRONINE, LISINOPRIL, ESTRADIOL, METHYLPHENIDATE, INSULIN ASPART (NOVOLOG), INSULIN GLARGINE (LANTUS), CLONAZEPAM, CAFFEINE, VITAMIN D NOS, CYANOCOBALAMIN (B12-VITAMIN), CALCIUM MEFOLINATE (L METHYLFOLATE), PYRIDOXINE HYDROCHLORIDE (B6), HYDROCODONE and ALBUTEROL SULFATE for an unknown indication. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced DIARRHEA (Ongoing episodes of chills and shaking and severe diarrhea/severe diarrhea), VACCINATION COMPLICATION (flets), ILLNESS (violently sick), CHILLS (Ongoing episodes of chills and shaking and severe diarrhea) and VOMITING (vomiting). On an unknown date, the patient experienced MACULAR DEGENERATION (I have a problem with vision a retinal specialist diagnosed me with macular degeneration and retinal ganglion thinning) (seriousness criterion medically significant), RETINAL DEGENERATION (I have a problem with vision a retinal specialist diagnosed me with macular degeneration and retinal ganglion thinning) (seriousness criterion medically significant), ILLNESS (I have a general feeling of illness fatigue my breathing is getting worse and dyspnea/violently sick), VACCINATION SITE MASS (Add severe fatigue I did not have any energy and I also had a lump on my injection site), DYSPNOEA (I have a general feeling of illness fatigue my breathing is getting worse and dyspnea), TREMOR (Ongoing episodes of chills and shaking and severe diarrhea), RASH (I have a mild rash that comes and goes), ARTHRALGIA (I have increased joint pain more than I have had before I have joint instability muscle weakness), HEADACHE (After relatively constant headache in the front of my head constant nausea but no vomiting trouble eating), FATIGUE (Add severe fatigue I did not have any energy and I also had a lump on my injection site) and NAUSEA (After relatively constant headache in the front of my head constant nausea but no vomiting trouble eating). At the time of the report, MACULAR DEGENERATION (I have a problem with vision a retinal specialist diagnosed me with macular degeneration and retinal ganglion thinning), RETINAL DEGENERATION (I have a problem with vision a retinal specialist diagnosed me with macular degeneration and retinal ganglion thinning), ILLNESS (I have a general feeling of illness fatigue my breathing is getting worse and dyspnea/violently sick), DIARRHEA (Ongoing episodes of chills and shaking and severe diarrhea/severe diarrhea), VACCINATION SITE MASS (Add severe fatigue I did not have any energy and I also had a lump on my injection site), DYSPNOEA (I have a general feeling of illness fatigue my breathing is getting worse and dyspnea), TREMOR (Ongoing episodes of chills and shaking and severe diarrhea), VACCINATION COMPLICATION (flets), ILLNESS (violently sick), RASH (I have a mild rash that comes and goes), ARTHRALGIA (I have increased joint pain more than I have had before I have joint instability muscle weakness), HEADACHE (After relatively constant headache in the front of my head constant nausea but no vomiting trouble eating), CHILLS (Ongoing episodes of chills and shaking and severe diarrhea), FATIGUE (Add severe fatigue I did not have any energy and I also had a lump on my injection site), NAUSEA (After relatively constant headache in the front of my head constant nausea but no vomiting trouble eating) and VOMITING (vomiting) outcome was unknown. No treatment information was provided by the reporter. Patient had suspended her inflammation medication (curcumin phytosome) so that it would not interfere with the efficacy of the vaccine. Now that she tried to take it again and discovered that she cannot go back to the old medication. Company Comment: Very limited information regarding these events has been provided at this time. Additional information required. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Significant follow up received on 02 SEP 2021 included addition of start date of events and concomitant drugs.; Sender's Comments: Very limited information regarding these events has been provided at this time. Additional information required.

Other Meds: LEVOTHYROXINE; LIOTHYRONINE; LISINOPRIL; ESTRADIOL; METHYLPHENIDATE; NOVOLOG; LANTUS; CLONAZEPAM; CAFFEINE; VITAMIN D NOS; B12-VITAMIN; L METHYLFOLATE; B6; HYDROCODONE; ALBUTEROL SULFATE; LUTEIN +; CURCUMIN

Current Illness:

ID: 1691909
Sex: M
Age: 53
State: OH

Vax Date: 06/08/2021
Onset Date: 06/01/2021
Rec V Date: 09/11/2021
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: discomfort; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (discomfort) and FATIGUE (Tiredness) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced DISCOMFORT (discomfort) and FATIGUE (Tiredness). At the time of the report, DISCOMFORT (discomfort) and FATIGUE (Tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and Treatment was not specified. This case was linked to MOD-2021-303237 (Patient Link).

Other Meds:

Current Illness:

ID: 1691910
Sex: F
Age: 75
State: FL

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Shaking inside; Nauseous; Vomiting; Got really sick at night; Dizzy; Weak/Feeling very weak; Confusion was high; Lot of stomach sore; Felt like being hit by a truck; Couldn't sleep; Her head was all over the place; Arms, legs and feet hurt a lot; Tingling sensation on one of her sides/ this sensation was all over her body/Still has tingling sensation on body; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick at night), NERVOUSNESS (Shaking inside), DIZZINESS (Dizzy), ASTHENIA (Weak/Feeling very weak) and CONFUSIONAL STATE (Confusion was high) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PARAESTHESIA (Tingling sensation on one of her sides/ this sensation was all over her body/Still has tingling sensation on body). On 29-Aug-2021, the patient experienced ILLNESS (Got really sick at night), DIZZINESS (Dizzy), ASTHENIA (Weak/Feeling very weak), CONFUSIONAL STATE (Confusion was high), ABDOMINAL PAIN UPPER (Lot of stomach sore), FEELING ABNORMAL (Felt like being hit by a truck), INSOMNIA (Couldn't sleep), HEAD DISCOMFORT (Her head was all over the place), PAIN IN EXTREMITY (Arms, legs and feet hurt a lot) and VOMITING (Vomiting). On 30-Aug-2021, the patient experienced NAUSEA (Nauseous). On 31-Aug-2021, the patient experienced NERVOUSNESS (Shaking inside). On 24-Aug-2021, PARAESTHESIA (Tingling sensation on one of her sides/ this sensation was all over her body/Still has tingling sensation on body) had resolved. On 30-Aug-2021, DIZZINESS (Dizzy), ASTHENIA (Weak/Feeling very weak), CONFUSIONAL STATE (Confusion was high), ABDOMINAL PAIN UPPER (Lot of stomach sore), FEELING ABNORMAL (Felt like being hit by a truck), INSOMNIA (Couldn't sleep), HEAD DISCOMFORT (Her head was all over the place), PAIN IN EXTREMITY (Arms, legs and feet hurt a lot) and VOMITING (Vomiting) had resolved. At the time of the report, ILLNESS (Got really sick at night), NERVOUSNESS (Shaking inside) and NAUSEA (Nauseous) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1691911
Sex: M
Age: 64
State: OH

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 09/11/2021
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: Missed second shot, about 4 months post first shot; Bad Headache after first vaccine; Chronic Fatigue came back after first vaccine; Joint pain came back after first vaccine; felt like had the flu after first vaccine; had no strength after first vaccine; Brain Fog came back after first vaccine; Chronic Migraine came back after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like had the flu after first vaccine), ASTHENIA (had no strength after first vaccine), FEELING ABNORMAL (Brain Fog came back after first vaccine), MIGRAINE (Chronic Migraine came back after first vaccine) and PRODUCT DOSE OMISSION ISSUE (Missed second shot, about 4 months post first shot) in a 64-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. Concurrent medical conditions included Chronic fatigue syndrome, Foggy feeling in head (Brain fog), Chronic migraine (25 Days a month from a virus since 20 years), Joint pain and Fibromyalgia. Concomitant products included TOPIRAMATE (TOPAMAX) for Migraine. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like had the flu after first vaccine), ASTHENIA (had no strength after first vaccine), FEELING ABNORMAL (Brain Fog came back after first vaccine), MIGRAINE (Chronic Migraine came back after first vaccine), HEADACHE (Bad Headache after first vaccine), FATIGUE (Chronic Fatigue came back after first vaccine) and ARTHRALGIA (Joint pain came back after first vaccine). On 31-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second shot, about 4 months post first shot). At the time of the report, INFLUENZA LIKE ILLNESS (felt like had the flu after first vaccine), ASTHENIA (had no strength after first vaccine), FEELING ABNORMAL (Brain Fog came back after first vaccine), MIGRAINE (Chronic Migraine came back after first vaccine), PRODUCT DOSE OMISSION ISSUE (Missed second shot, about 4 months post first shot), HEADACHE (Bad Headache after first vaccine), FATIGUE (Chronic Fatigue came back after first vaccine) and ARTHRALGIA (Joint pain came back after first vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. He did not take the second dose because of side effects of first dose but as his family have no side effects he is tempted to take the second dose of vaccine. Treatment information was not provided.

Other Meds: TOPAMAX

Current Illness: Chronic fatigue syndrome; Chronic migraine (25 Days a month from a virus since 20 years); Fibromyalgia; Foggy feeling in head (Brain fog); Joint pain

ID: 1691912
Sex: F
Age: 55
State: CA

Vax Date: 12/30/2020
Onset Date: 02/01/2021
Rec V Date: 09/11/2021
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: rash is a little bit itchy every so often; the rash turns very red, like scars shape like rings; little bumps on their chest; horrible rash on the base of the neck/rash all around the neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash is a little bit itchy every so often), RASH ERYTHEMATOUS (the rash turns very red, like scars shape like rings), KERATOSIS PILARIS (little bumps on their chest) and RASH (horrible rash on the base of the neck/rash all around the neck) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-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 RASH PRURITIC (rash is a little bit itchy every so often), RASH ERYTHEMATOUS (the rash turns very red, like scars shape like rings), KERATOSIS PILARIS (little bumps on their chest) and RASH (horrible rash on the base of the neck/rash all around the neck). At the time of the report, RASH PRURITIC (rash is a little bit itchy every so often), RASH ERYTHEMATOUS (the rash turns very red, like scars shape like rings), KERATOSIS PILARIS (little bumps on their chest) and RASH (horrible rash on the base of the neck/rash all around the neck) had not resolved. No relevant concomitant medications were reported. Patient was undergone a Biopsy but results were unavailable. Patient was treating with steroid injections and steroid cream.

Other Meds:

Current Illness:

ID: 1691913
Sex: F
Age: 71
State: CA

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: She could not get warm, she was bone cold; She slept a lot; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (She could not get warm, she was bone cold), HYPERSOMNIA (She slept a lot) and FATIGUE (Exhausted) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 0LGL20A) for COVID-19 vaccination. Concomitant products included OMEPRAZOLE, MIRABEGRON (MYRBETRIQ), ATORVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced FEELING COLD (She could not get warm, she was bone cold), HYPERSOMNIA (She slept a lot) and FATIGUE (Exhausted). At the time of the report, FEELING COLD (She could not get warm, she was bone cold), HYPERSOMNIA (She slept a lot) and FATIGUE (Exhausted) outcome was unknown. Patient reported that she was asthmatic at baseline. She had COVID-19 before first dose. No treatment medications were reported

Other Meds: OMEPRAZOLE; MYRBETRIQ; ATORVASTATIN; SYNTHROID; ALBUTEROL [SALBUTAMOL SULFATE]; TRELEGY

Current Illness:

ID: 1691914
Sex: F
Age: 48
State: TX

Vax Date: 07/25/2021
Onset Date: 08/29/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210829; Test Name: Body temperature; Result Unstructured Data: 100F

Allergies:

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

Symptoms: Blood in the stool; Hives all over her legs/Hives spread to arms and lips; Chills; Body aches; Fever 100F; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in the stool) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever 100F). On 31-Aug-2021, the patient experienced HAEMATOCHEZIA (Blood in the stool) (seriousness criterion medically significant) and URTICARIA (Hives all over her legs/Hives spread to arms and lips). On 30-Aug-2021, PYREXIA (Fever 100F) had resolved. At the time of the report, HAEMATOCHEZIA (Blood in the stool), URTICARIA (Hives all over her legs/Hives spread to arms and lips), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, Body temperature: 100 (High) 100F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient experienced fever, chills and body aches.On 31 Aug 2021,in the morning she noticed hives all over her legs but there were no itching and in the evening the hives were also on her arms and lips.No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1691915
Sex: F
Age: 23
State: IL

Vax Date: 05/16/2021
Onset Date: 05/16/2021
Rec V Date: 09/11/2021
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: she never went to get her 2nd dose after receiving the first.; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL DOSE OMISSION (she never went to get her 2nd dose after receiving the first.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced INTENTIONAL DOSE OMISSION (she never went to get her 2nd dose after receiving the first.). On 16-May-2021, INTENTIONAL DOSE OMISSION (she never went to get her 2nd dose after receiving the first.) had resolved. It was stated that she did not experience any adverse reactions with the 1st dose. She was not taking any concomitant medications at this time. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1691916
Sex: F
Age:
State: GA

Vax Date: 08/30/2021
Onset Date: 08/31/2021
Rec V Date: 09/11/2021
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: extremely cold; weak; achy; This spontaneous case was reported by a nurse and describes the occurrence of FEELING COLD (extremely cold), ASTHENIA (weak) and PAIN (achy) 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 30-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced FEELING COLD (extremely cold), ASTHENIA (weak) and PAIN (achy). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) at an unspecified dose and frequency. At the time of the report, FEELING COLD (extremely cold), ASTHENIA (weak) and PAIN (achy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1691917
Sex: F
Age:
State: CT

Vax Date: 03/05/2021
Onset Date: 08/17/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Eyes started burning (Not sure if vaccine related); Eyes started itching (Not sure if vaccine related); Vision fades sometimes (Not sure if vaccine related); This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes started burning (Not sure if vaccine related)), EYE PRURITUS (Eyes started itching (Not sure if vaccine related)) and VISUAL IMPAIRMENT (Vision fades sometimes (Not sure if vaccine related)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 027A21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced EYE IRRITATION (Eyes started burning (Not sure if vaccine related)), EYE PRURITUS (Eyes started itching (Not sure if vaccine related)) and VISUAL IMPAIRMENT (Vision fades sometimes (Not sure if vaccine related)). At the time of the report, EYE IRRITATION (Eyes started burning (Not sure if vaccine related)), EYE PRURITUS (Eyes started itching (Not sure if vaccine related)) and VISUAL IMPAIRMENT (Vision fades sometimes (Not sure if vaccine related)) outcome was unknown. Patient stated that for the above mentioned events if she blinks, it gets back to normal. Patient didn't saw her doctor since June2021 and in June her vision was healthy. Her blood sugar had been normal after vaccination and it did not fluctuate. No concomitant medications were mentioned. No treatment details were reported.

Other Meds:

Current Illness: Diabetes

ID: 1691918
Sex: F
Age: 45
State: CA

Vax Date: 08/03/2021
Onset Date: 08/13/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: was pregnant and received the vaccine; she is not feeling so strong; Not feeling well; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (was pregnant and received the vaccine), ASTHENIA (she is not feeling so strong) and MALAISE (Not feeling well) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was unspecified date. On 13-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (was pregnant and received the vaccine), ASTHENIA (she is not feeling so strong) and MALAISE (Not feeling well). The cesarean delivery occurred on unspecified date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (was pregnant and received the vaccine) had resolved and ASTHENIA (she is not feeling so strong) and MALAISE (Not feeling well) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported. Treatment history was not reported .; Sender's Comments: This is a case of maternal exposure during pregnancy (vaccine exposure during pregnancy) for this 45-year-old female. The female underwent cesarean section and delivered a live baby10 days after the first dose of mRNA-1273. The patient also reports asthenia and malaise. Based on the available information, the events are confounded by preceding cesarean delivery. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1691919
Sex: F
Age: 75
State: NC

Vax Date: 01/06/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: congestion; legs were very painful; some fever; got infected with covid-19/ breakthrough case; a little bit of malaise; slight fatigue/ extreme fatigue/ they were very tired; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case), MALAISE (a little bit of malaise), NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful) and FATIGUE (slight fatigue/ extreme fatigue/ they were very tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included RABEPRAZOLE SODIUM, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL ALLERGY 24HR), MAGNESIUM, AZELASTINE, COLECALCIFEROL (VITAMIN D3), PARACETAMOL (TYLENOL), IBUPROFEN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MALAISE (a little bit of malaise) and FATIGUE (slight fatigue/ extreme fatigue/ they were very tired). In August 2021, the patient experienced DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case). On an unknown date, the patient experienced NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful) and PYREXIA (some fever). At the time of the report, DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case), MALAISE (a little bit of malaise), NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful), FATIGUE (slight fatigue/ extreme fatigue/ they were very tired) and PYREXIA (some fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient treatment included Over-the-counter stuff. Patient said that she is in her 70s.

Other Meds: RABEPRAZOLE SODIUM; XYZAL ALLERGY 24HR; MAGNESIUM; AZELASTINE; VITAMIN D3; TYLENOL; IBUPROFEN; TRELEGY

Current Illness:

ID: 1691920
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: Sore arm for couple of days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm for couple of days) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm for couple of days). At the time of the report, MYALGIA (Sore arm for couple of days) outcome was unknown. Concomitant medications were not reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1691921
Sex: F
Age:
State: MD

Vax Date: 08/27/2021
Onset Date: 08/30/2021
Rec V Date: 09/11/2021
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: Her arm hurt a little bit; fever; nausea appeared again; Diarrhea appeared again/diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm hurt a little bit), DIARRHOEA (Diarrhea appeared again/diarrhea), NAUSEA (Nausea), PYREXIA (fever) and NAUSEA (nausea appeared again) 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 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced DIARRHOEA (Diarrhea appeared again/diarrhea) and NAUSEA (Nausea). On 31-Aug-2021, the patient experienced PYREXIA (fever) and NAUSEA (nausea appeared again). On an unknown date, the patient experienced PAIN IN EXTREMITY (Her arm hurt a little bit). On 30-Aug-2021, NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Her arm hurt a little bit), DIARRHOEA (Diarrhea appeared again/diarrhea), PYREXIA (fever) and NAUSEA (nausea appeared again) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1691922
Sex: F
Age: 25
State: VT

Vax Date: 08/27/2021
Onset Date: 08/28/2021
Rec V Date: 09/11/2021
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: hot to the touch; itching; very painful; big, red rash around injection site; big, red rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), PRURITUS (itching), PAIN (very painful), VACCINATION SITE ERYTHEMA (big, red rash around injection site) and VACCINATION SITE RASH (big, red rash around injection site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Allergy and Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (esophageal), CETIRIZINE for Allergy, LEVOTHYROXINE, METFORMIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 27-Aug-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 VACCINATION SITE RASH (big, red rash around injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to the touch), PRURITUS (itching), PAIN (very painful) and VACCINATION SITE ERYTHEMA (big, red rash around injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency; IBUPROFEN for Adverse reaction, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to the touch), PRURITUS (itching), PAIN (very painful), VACCINATION SITE ERYTHEMA (big, red rash around injection site) and VACCINATION SITE RASH (big, red rash around injection site) outcome was unknown.

Other Meds: LEVOTHYROXINE; CETIRIZINE; FAMOTIDINE; METFORMIN; LEXAPRO

Current Illness: Acid reflux (esophageal); Allergy

ID: 1691923
Sex: M
Age: 68
State: CT

Vax Date: 05/06/2021
Onset Date:
Rec V Date: 09/11/2021
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: Vertigo; Loosing balance but has not fallen, feels like the room is tilting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and BALANCE DISORDER (Loosing balance but has not fallen, feels like the room is tilting) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 023C21A) for COVID-19 vaccination. No medical history provided by reporter. Concomitant products included FOLIC ACID, METOPROLOL, FUROSEMIDE, AMLODIPINE, OLMESARTAN MEDOXOMIL and ALLOPURINOL (ALOPURINOL) for an unknown indication. On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-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 VERTIGO (Vertigo) and BALANCE DISORDER (Loosing balance but has not fallen, feels like the room is tilting). At the time of the report, VERTIGO (Vertigo) and BALANCE DISORDER (Loosing balance but has not fallen, feels like the room is tilting) outcome was unknown. Concomitant medication also include Tantoprazole. About two weeks after receiving second dose of the vaccine came down with vertigo occurring all throughout the day. Patient stated that he can function but he just can't climb up on a chair or ladder. No treatment information were provided.

Other Meds: FOLIC ACID; METOPROLOL; FUROSEMIDE; AMLODIPINE; OLMESARTAN MEDOXOMIL; ALOPURINOL

Current Illness:

ID: 1691924
Sex: M
Age:
State: WA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 09/11/2021
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: The usual sore arm; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (The usual sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002L20A and 024M20A) 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) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced MYALGIA (The usual sore arm). On 30-Jan-2021, MYALGIA (The usual sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided. This case was linked to MOD-2021-303204, MOD-2021-303300 (Patient Link).

Other Meds:

Current Illness:

ID: 1691925
Sex: M
Age: 72
State: FL

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/11/2021
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: Tingling sensation on both sides of his body; Sweated at night; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation on both sides of his body) and NIGHT SWEATS (Sweated at night) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PARAESTHESIA (Tingling sensation on both sides of his body) and NIGHT SWEATS (Sweated at night). On 25-Aug-2021, PARAESTHESIA (Tingling sensation on both sides of his body) and NIGHT SWEATS (Sweated at night) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product includes High Blood Pressure medication. Treatment information was unknown.

Other Meds:

Current Illness: Blood pressure high

ID: 1691926
Sex: F
Age: 40
State: MD

Vax Date: 07/29/2021
Onset Date: 07/29/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210801; Test Name: DVT; Test Result: Negative ; Result Unstructured Data: tested negative for DVT (Deep vein thrombosis).; Test Date: 20210801; Test Name: Pregnancy Test; Test Result: Positive ; Result Unstructured Data: She was three weeks a long, got pregnant between the two doses.; Test Date: 20210820; Test Name: sonogram; Test Result: Inconclusive ; Result Unstructured Data: confirmed that everything came out

Allergies:

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

Symptoms: crumping (in pain); miscarriage; bleeding/ still bleeding "so heavy"/ still bleeding; felt dizzy; pain in her left calf; feared a blood clot; so much pain she couldn't walk/limping; whole body was sick; Maternal exposure during pregnancy; hand was hurting/hand was sore; This spontaneous retrospective pregnancy case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (miscarriage) and HAEMORRHAGE (bleeding/ still bleeding "so heavy"/ still bleeding) in a 40-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included DVT (History of DVT with her first pregnancy 4 years ago but hasn't been taking blood thinners or presented any symptoms since) and Pregnancy (her first pregnancy 4 years ago). Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 29-Jul-2021, the patient experienced ILLNESS (whole body was sick), PAIN IN EXTREMITY (hand was hurting/hand was sore) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 30-Jul-2021, the patient experienced GAIT DISTURBANCE (so much pain she couldn't walk/limping). On 01-Aug-2021, the patient experienced FEAR (feared a blood clot) and PAIN IN EXTREMITY (pain in her left calf). On 06-Aug-2021, the patient experienced ABORTION SPONTANEOUS (miscarriage) (seriousness criterion medically significant), HAEMORRHAGE (bleeding/ still bleeding "so heavy"/ still bleeding) (seriousness criterion medically significant) and DIZZINESS (felt dizzy). On 20-Aug-2021, the patient experienced PAIN (crumping (in pain)). The delivery occurred on 06-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 29-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (miscarriage), ILLNESS (whole body was sick), FEAR (feared a blood clot), DIZZINESS (felt dizzy), GAIT DISTURBANCE (so much pain she couldn't walk/limping), PAIN (crumping (in pain)), PAIN IN EXTREMITY (hand was hurting/hand was sore) and PAIN IN EXTREMITY (pain in her left calf) outcome was unknown and HAEMORRHAGE (bleeding/ still bleeding "so heavy"/ still bleeding) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Deep vein thrombosis: negative (Negative) tested negative for DVT (Deep vein thrombosis).. On 01-Aug-2021, Pregnancy test: positive (Positive) She was three weeks a long, got pregnant between the two doses.. On 20-Aug-2021, Ultrasound scan: inconclusive (Inconclusive) confirmed that everything came out. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 01-Aug-2021, the patient went to emergency department. On 20-Aug-2021, she had a sonogram and confirmed everything came out. Treatment medication were not reported. Action taken was not applicable. This is a case of maternal exposure during pregnancy with associated AEs of abortion spontaneous, haemorrhage, illness, fear, dizziness, gait disturbance, pain and pain in extremity. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-303234 (Patient Link).; Sender's Comments: This is a case of maternal exposure during pregnancy with associated AEs of abortion spontaneous, haemorrhage, illness, fear, dizziness, gait disturbance, pain and pain in extremity. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS

Current Illness:

ID: 1691927
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: pain in his left hip radiating down the leg; The pain started on Sunday and got worse; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in his left hip radiating down the leg) and CONDITION AGGRAVATED (The pain started on Sunday and got worse) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain in his left hip radiating down the leg) and CONDITION AGGRAVATED (The pain started on Sunday and got worse). At the time of the report, ARTHRALGIA (pain in his left hip radiating down the leg) and CONDITION AGGRAVATED (The pain started on Sunday and got worse) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1691928
Sex: F
Age:
State: GA

Vax Date: 01/11/2021
Onset Date:
Rec V Date: 09/11/2021
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: pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) outcome was unknown. No concomitant product information were provided by the reporter. Patient went into the need for surgery on the pleura 2 months ago. No treatment information was provided by the reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1691929
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: What happens if the second dose is applied for more than a month; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (What happens if the second dose is applied for more than a month) 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 UNEVALUABLE EVENT (What happens if the second dose is applied for more than a month). At the time of the report, UNEVALUABLE EVENT (What happens if the second dose is applied for more than a month) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details were provided. No treatment information was mentioned. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1691930
Sex: F
Age: 39
State: IL

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 09/11/2021
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: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05E21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in December 2020 and the estimated date of delivery was 15-Nov-2021. On 31-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. On 31-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication were not reported Treatment medication were not reported Patient was 29 weeks pregnant. Patient got injection to the shoulder; Sender's Comments: This is a case of maternal exposure during pregnancy with no associated AEs for this 39-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1691931
Sex: M
Age:
State: OH

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (hasn't had a second dose) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. May 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced product dose omission issue (hasn't had a second dose). At the time of the report, product dose omission issue (hasn't had a second dose) resolved. No concomitant medications or treatment information reported.

Other Meds:

Current Illness:

ID: 1691932
Sex: U
Age:
State:

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 09/11/2021
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: >35 days since first dose, My first dose was March 18. How long can I go between doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days since first dose, My first dose was March 18. How long can I go between doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (>35 days since first dose, My first dose was March 18. How long can I go between doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days since first dose, My first dose was March 18. How long can I go between doses) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am