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: 1707459
Sex: F
Age: 75
State: AL

Vax Date: 01/18/2021
Onset Date: 02/23/2021
Rec V Date: 09/17/2021
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: Inappropriate schedule of vaccine administered(18Jan2021/ 23Feb2021); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(18Jan2021/ 23Feb2021)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 042120A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure. Concomitant products included VALSARTAN for Blood pressure, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for Reflux gastritis, VITAMINS NOS, POTASSIUM CHLORIDE, COLECALCIFEROL (D3), CLONIDINE, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL-D) and DILTIAZEM for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(18Jan2021/ 23Feb2021)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(18Jan2021/ 23Feb2021)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was taking a medicine to help digestion and another medicine to help gut be more normal. This case was linked to MOD-2021-311012 (Patient Link).

Other Meds: VALSARTAN; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; VITAMINS NOS; POTASSIUM CHLORIDE; D3; CLONIDINE; CITRACAL-D; DILTIAZEM

Current Illness: Blood pressure

ID: 1707460
Sex: U
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 09/17/2021
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: Did not return for their 2nd dose after 28 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not return for their 2nd dose after 28 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 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 (Did not return for their 2nd dose after 28 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not return for their 2nd dose after 28 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product information was provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1707461
Sex: F
Age: 67
State: CA

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 09/17/2021
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: inflamed head; Sore Left Lymph Node; Headache/Her head hurt; Administered too far away from shoulder bone/may be 2" below; Sore Nose; Gland under Jaw felt like marbled/Gland under Jaw sticking out; Puffy face; Red face; Neuralgia; Delayed Allergic Reaction; Missed the second dose; Pre-existing thing on he said it sounds like Cellulitis/ Cellulitis; Bled a lot after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Pre-existing thing on he said it sounds like Cellulitis/ Cellulitis) and HAEMORRHAGE (Bled a lot after vaccination) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced HAEMORRHAGE (Bled a lot after vaccination) (seriousness criterion medically significant). On 26-May-2021, the patient experienced CELLULITIS (Pre-existing thing on he said it sounds like Cellulitis/ Cellulitis) (seriousness criterion medically significant), NASAL DISCOMFORT (Sore Nose), JAW DISORDER (Gland under Jaw felt like marbled/Gland under Jaw sticking out), SWELLING FACE (Puffy face), ERYTHEMA (Red face), NEURALGIA (Neuralgia), ALLERGY TO VACCINE (Delayed Allergic Reaction), PRODUCT DOSE OMISSION ISSUE (Missed the second dose), LYMPH NODE PAIN (Sore Left Lymph Node), HEADACHE (Headache/Her head hurt) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered too far away from shoulder bone/may be 2" below). On an unknown date, the patient experienced INFLAMMATION (inflamed head). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date for Headache, at an unspecified dose and frequency and CEPHALEXIN [CEFALEXIN] ongoing since an unknown date for Prophylaxis, at a dose of 500 mg twice a day. On 26-May-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered too far away from shoulder bone/may be 2" below) had resolved. In 2021, CELLULITIS (Pre-existing thing on he said it sounds like Cellulitis/ Cellulitis), HAEMORRHAGE (Bled a lot after vaccination), NASAL DISCOMFORT (Sore Nose), JAW DISORDER (Gland under Jaw felt like marbled/Gland under Jaw sticking out), SWELLING FACE (Puffy face), ERYTHEMA (Red face), NEURALGIA (Neuralgia), ALLERGY TO VACCINE (Delayed Allergic Reaction), PRODUCT DOSE OMISSION ISSUE (Missed the second dose), LYMPH NODE PAIN (Sore Left Lymph Node) and HEADACHE (Headache/Her head hurt) had resolved. At the time of the report, INFLAMMATION (inflamed head) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded. Lymph node pain and headache are consistent with the known safety profile of mRNA-1273 vaccine.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded. Lymph node pain and headache are consistent with the known safety profile of mRNA-1273 vaccine.

Other Meds:

Current Illness:

ID: 1707462
Sex: F
Age: 28
State: CA

Vax Date: 04/07/2021
Onset Date: 04/14/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Acid reflux; Having really bad pain at that time; hand got swollen, like under arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hand got swollen, like under arm), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and PAIN IN EXTREMITY (Having really bad pain at that time) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0251321A) for COVID-19 vaccination. Concomitant products included IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PERIPHERAL SWELLING (hand got swollen, like under arm). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and PAIN IN EXTREMITY (Having really bad pain at that time). At the time of the report, PERIPHERAL SWELLING (hand got swollen, like under arm) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) outcome was unknown and PAIN IN EXTREMITY (Having really bad pain at that time) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product information was not provided. This case was linked to MOD-2021-311791 (Patient Link).

Other Meds: MOTRIN [IBUPROFEN]

Current Illness:

ID: 1707463
Sex: F
Age: 28
State: CA

Vax Date: 04/07/2021
Onset Date: 08/17/2021
Rec V Date: 09/17/2021
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: this is happening only on my left arm/something is there in my underarm; side effects; acid reflux; hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow), LIMB DISCOMFORT (this is happening only on my left arm/something is there in my underarm), ADVERSE REACTION (side effects) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0251214 and 0251321A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced PERIPHERAL SWELLING (hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow). On an unknown date, the patient experienced LIMB DISCOMFORT (this is happening only on my left arm/something is there in my underarm), ADVERSE REACTION (side effects) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow) had not resolved, LIMB DISCOMFORT (this is happening only on my left arm/something is there in my underarm) had resolved and ADVERSE REACTION (side effects) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PERIPHERAL SWELLING (hand got swollen, like under arm/left hand is a little bit swollen/feels heavier/left hand is heavier/left biceps is swollen, from the shoulder to the elbow), LIMB DISCOMFORT (this is happening only on my left arm/something is there in my underarm) and ADVERSE REACTION (side effects) to be related. No further causality assessment was provided for GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux). No concomitant medication was reported. No treatment medication was reported however, patient had taken Motrin for 2 days post the first dose at the time. This case was linked to MOD-2021-311729 (Patient Link).

Other Meds:

Current Illness:

ID: 1707464
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: struggled to use it afterward due to soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (struggled to use it afterward due to soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cerebral palsy. 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 MYALGIA (struggled to use it afterward due to soreness). At the time of the report, MYALGIA (struggled to use it afterward due to soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. concomitant medication was not provided. Patient requested to be vaccinated in his good arm and struggled to use it afterward due to soreness. He was wondering if his second dose can be given IM in his gluteal muscle. treatment information was not provided.

Other Meds:

Current Illness: Cerebral palsy

ID: 1707465
Sex: F
Age: 30
State: VA

Vax Date: 07/01/2021
Onset Date: 08/23/2021
Rec V Date: 09/17/2021
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: missed her period after vaccination; her period turned completely different; lower ovarian pain/Her pain didn't go away; she received her 1st dose of Moderna COVID 19 vaccine on 1Jul2021. She believed she got her 2nd dose in July as well, and she thinks she got it 2 weeks after; Maternal exposure during pregnancy; ectopic pregnancy/pregnancy was in her fallopian tube; she was pregnant, but she had complication; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ECTOPIC PREGNANCY (ectopic pregnancy/pregnancy was in her fallopian tube) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Asthma. On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 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. On 23-Aug-2021, the patient experienced ECTOPIC PREGNANCY (ectopic pregnancy/pregnancy was in her fallopian tube) (seriousness criterion medically significant) and COMPLICATION OF PREGNANCY (she was pregnant, but she had complication). On an unknown date, the patient experienced AMENORRHOEA (missed her period after vaccination), MENSTRUAL DISORDER (her period turned completely different), ADNEXA UTERI PAIN (lower ovarian pain/Her pain didn't go away), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she received her 1st dose of Moderna COVID 19 vaccine on 1Jul2021. She believed she got her 2nd dose in July as well, and she thinks she got it 2 weeks after) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Elective Termination. For foetus 1, The outcome was reported as Ectopic pregnancy. induce a miscarriage. At the time of the report, ECTOPIC PREGNANCY (ectopic pregnancy/pregnancy was in her fallopian tube) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she received her 1st dose of Moderna COVID 19 vaccine on 1Jul2021. She believed she got her 2nd dose in July as well, and she thinks she got it 2 weeks after) had resolved and COMPLICATION OF PREGNANCY (she was pregnant, but she had complication), AMENORRHOEA (missed her period after vaccination), MENSTRUAL DISORDER (her period turned completely different), ADNEXA UTERI PAIN (lower ovarian pain/Her pain didn't go away) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. Patient had a Depo shot on18Aug2021 for birth control. No Treatment information 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. Causality for the maternal exposure during pregnancy is not applicable; 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. Causality for the maternal exposure during pregnancy is not applicable.

Other Meds:

Current Illness: Asthma

ID: 1707466
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 09/04/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Chest pain; back pain; left eye numbness; tingling feeling at left side of the jaw; jaw keeps locking up; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), BACK PAIN (back pain), HYPOAESTHESIA EYE (left eye numbness), PARAESTHESIA (tingling feeling at left side of the jaw) and TRISMUS (jaw keeps locking up) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced CHEST PAIN (Chest pain), BACK PAIN (back pain), HYPOAESTHESIA EYE (left eye numbness), PARAESTHESIA (tingling feeling at left side of the jaw) and TRISMUS (jaw keeps locking up). At the time of the report, CHEST PAIN (Chest pain), BACK PAIN (back pain), HYPOAESTHESIA EYE (left eye numbness), PARAESTHESIA (tingling feeling at left side of the jaw) and TRISMUS (jaw keeps locking up) outcome was unknown. Reportedly, Patient was advised to consult the doctor for further assessment. Consent for follow up was affirmative. Patient had not visited Healthcare Professional Concomitant product use was not provided. Treatment product information was not provided.

Other Meds:

Current Illness:

ID: 1707467
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1707468
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: They got something flipped up the heart; This spontaneous case was reported by a consumer and describes the occurrence of EXTRASYSTOLES (They got something flipped up the heart) 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 EXTRASYSTOLES (They got something flipped up the heart). At the time of the report, EXTRASYSTOLES (They got something flipped up the heart) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1707469
Sex: M
Age: 72
State: CO

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 09/17/2021
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: Had an exhausting 24 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Had an exhausting 24 hours) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Had an exhausting 24 hours). On 01-Sep-2021, FATIGUE (Had an exhausting 24 hours) had resolved. Not Provided No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. This case was linked to MOD-2021-304655 (Patient Link).

Other Meds:

Current Illness:

ID: 1707470
Sex: M
Age: 37
State: FL

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 09/17/2021
Hospital: Y

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: Immediately 6 hours after the first dose had symptoms similar to a heart attack; Involuntary muscle spasms; pain head to toe; Brain fog affecting his mental health; Depression; Brain fog affecting his mental health, causing depression; Unable to work; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CARDIAC DISCOMFORT (Immediately 6 hours after the first dose had symptoms similar to a heart attack) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MARIJUANA, DULOXETINE HYDROCHLORIDE (CYMBALTA) and NALTREXONE for an unknown indication. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced CARDIAC DISCOMFORT (Immediately 6 hours after the first dose had symptoms similar to a heart attack) (seriousness criterion hospitalization prolonged), MUSCLE CONTRACTIONS INVOLUNTARY (Involuntary muscle spasms), PAIN (pain head to toe), FEELING ABNORMAL (Brain fog affecting his mental health), DEPRESSION (Depression), EMOTIONAL DISTRESS (Brain fog affecting his mental health, causing depression) and IMPAIRED WORK ABILITY (Unable to work). The patient was hospitalized on 17-May-2021 due to CARDIAC DISCOMFORT. At the time of the report, CARDIAC DISCOMFORT (Immediately 6 hours after the first dose had symptoms similar to a heart attack), MUSCLE CONTRACTIONS INVOLUNTARY (Involuntary muscle spasms), PAIN (pain head to toe), FEELING ABNORMAL (Brain fog affecting his mental health), DEPRESSION (Depression), EMOTIONAL DISTRESS (Brain fog affecting his mental health, causing depression) and IMPAIRED WORK ABILITY (Unable to work) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was hospitalized on 17MAY2021 and again on 19MAY2021. No treatment information mentioned. 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. however, the patient is a marijuana user and the psychiatric disorder in this report could be confounded by the use of this drug as repeated marijuana use can result in worsening depression symptoms , emotional distress and brain fog.; 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. however, the patient is a marijuana user and the psychiatric disorder in this report could be confounded by the use of this drug as repeated marijuana use can result in worsening depression symptoms , emotional distress and brain fog.

Other Meds: MARIJUANA; CYMBALTA; NALTREXONE

Current Illness:

ID: 1707471
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I had mild flu like symptoms), RASH PRURITIC (Itching), BURNING SENSATION (Burning) and RASH (Within 24 hours of the Moderna vaccine I broke out in the most awful body rash with stabbing pain) 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 INFLUENZA LIKE ILLNESS (I had mild flu like symptoms), RASH PRURITIC (Itching), BURNING SENSATION (Burning) and RASH (Within 24 hours of the Moderna vaccine I broke out in the most awful body rash with stabbing pain). At the time of the report, INFLUENZA LIKE ILLNESS (I had mild flu like symptoms), RASH PRURITIC (Itching), BURNING SENSATION (Burning) and RASH (Within 24 hours of the Moderna vaccine I broke out in the most awful body rash with stabbing pain) had resolved.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant medications were provided by reporter. The rash finally stopped after taking an antibiotic.

Other Meds:

Current Illness:

ID: 1707472
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Her breast cancer come back after being cancer free for 11 years; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER RECURRENT (Her breast cancer come back after being cancer free for 11 years) 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 BREAST CANCER RECURRENT (Her breast cancer come back after being cancer free for 11 years) (seriousness criterion medically significant). At the time of the report, BREAST CANCER RECURRENT (Her breast cancer come back after being cancer free for 11 years) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Reporter did not allow further contact; 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: 1707473
Sex: F
Age: 69
State: CA

Vax Date: 05/11/2021
Onset Date: 09/07/2021
Rec V Date: 09/17/2021
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: she lost her balance and fell down; Fell down; More than 35 days after the first dose (11May2021) without receiving the second dose (7-Sep-2021); This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (she lost her balance and fell down), FALL (Fell down) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose (11May2021) without receiving the second dose (7-Sep-2021)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced BALANCE DISORDER (she lost her balance and fell down), FALL (Fell down) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose (11May2021) without receiving the second dose (7-Sep-2021)). On 07-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose (11May2021) without receiving the second dose (7-Sep-2021)) had resolved. At the time of the report, BALANCE DISORDER (she lost her balance and fell down) and FALL (Fell down) outcome was unknown. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1707474
Sex: F
Age: 56
State: CA

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I had diarrhea nausea and vomiting; I was sick for approximately 4 days; I had diarrhea nausea and vomiting; I had diarrhea nausea and vomiting; Fever and major fatigue and tiredness; Fever and major fatigue and tiredness; Arm was red and painful; Arm was red and painful; patient did not receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (I had diarrhea nausea and vomiting), ILLNESS (I was sick for approximately 4 days), NAUSEA (I had diarrhea nausea and vomiting), VOMITING (I had diarrhea nausea and vomiting) and PYREXIA (Fever and major fatigue and tiredness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HYDROCHLOROTHIAZIDE and GLIMEPIRIDE (AMARYL) for an unknown indication. On 22-Apr-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 DIARRHOEA (I had diarrhea nausea and vomiting), ILLNESS (I was sick for approximately 4 days), NAUSEA (I had diarrhea nausea and vomiting), VOMITING (I had diarrhea nausea and vomiting), PYREXIA (Fever and major fatigue and tiredness), FATIGUE (Fever and major fatigue and tiredness), VACCINATION SITE ERYTHEMA (Arm was red and painful), VACCINATION SITE PAIN (Arm was red and painful) and PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (I had diarrhea nausea and vomiting), ILLNESS (I was sick for approximately 4 days), NAUSEA (I had diarrhea nausea and vomiting), VOMITING (I had diarrhea nausea and vomiting), PYREXIA (Fever and major fatigue and tiredness), FATIGUE (Fever and major fatigue and tiredness), VACCINATION SITE ERYTHEMA (Arm was red and painful) and VACCINATION SITE PAIN (Arm was red and painful) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: HYDROCHLOROTHIAZIDE; AMARYL

Current Illness:

ID: 1707475
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: When I went for 2nd dose Medical Facility), my blood pressure was higher than they preferred, so I didn't get it. Now, it's been 6 weeks since 1st shot; my blood pressure was higher than they preferred; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (When I went for 2nd dose ( Medical Facility), my blood pressure was higher than they preferred, so I didn't get it. Now, it's been 6 weeks since 1st shot) and BLOOD PRESSURE INCREASED (my blood pressure was higher than they preferred) 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 PRODUCT DOSE OMISSION ISSUE (When I went for 2nd dose (Medical Facility), my blood pressure was higher than they preferred, so I didn't get it. Now, it's been 6 weeks since 1st shot) and BLOOD PRESSURE INCREASED (my blood pressure was higher than they preferred). At the time of the report, PRODUCT DOSE OMISSION ISSUE (When I went for 2nd dose (Medical Facility), my blood pressure was higher than they preferred, so I didn't get it. Now, it's been 6 weeks since 1st shot) had resolved and BLOOD PRESSURE INCREASED (my blood pressure was higher than they preferred) outcome was unknown.

Other Meds:

Current Illness:

ID: 1707476
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: I started having side effects one week after 3rd dose of Moderna; 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 VACCINATION COMPLICATION (I started having side effects one week after 3rd dose of Moderna) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I started having side effects one week after 3rd dose of Moderna). At the time of the report, VACCINATION COMPLICATION (I started having side effects one week after 3rd dose of Moderna) outcome was unknown. Concomitant medications were not reported. Treatment medications were not reported. Patient took immunosuppressive drugs.

Other Meds:

Current Illness:

ID: 1707477
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Kidneys problem; Heart problem; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Kidneys problem) and CARDIAC DISORDER (Heart problem) 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 RENAL DISORDER (Kidneys problem) and CARDIAC DISORDER (Heart problem). At the time of the report, RENAL DISORDER (Kidneys problem) and CARDIAC DISORDER (Heart problem) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product use was provided by the reporter. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1707478
Sex: U
Age:
State:

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 09/17/2021
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: lost taste; fatigued; 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 AGEUSIA (lost taste) and FATIGUE (fatigued) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (lost taste) and FATIGUE (fatigued). At the time of the report, AGEUSIA (lost taste) and FATIGUE (fatigued) outcome was unknown. No relevant concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1707479
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects ) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects ). At the time of the report, VACCINATION COMPLICATION (Side effects ) outcome was unknown. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1707480
Sex: U
Age:
State:

Vax Date: 07/28/2021
Onset Date:
Rec V Date: 09/17/2021
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: >35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) 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 28-Jul-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). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications was provided. No Treatment medication was provided.

Other Meds:

Current Illness:

ID: 1707481
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) 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 AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided by the reporter No treatment medication were provided by the reporter Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1707482
Sex: F
Age: 58
State: MS

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

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

Lab Data: Test Date: 20210905; Test Name: Covid-19 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: tested positive for covid-19 after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid-19 after first dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced COVID-19 (tested positive for covid-19 after first dose). At the time of the report, COVID-19 (tested positive for covid-19 after first dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported by reporter Treatment information was not provided by reporter

Other Meds:

Current Illness:

ID: 1707483
Sex: F
Age: 23
State: GA

Vax Date: 02/09/2021
Onset Date:
Rec V Date: 09/17/2021
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: hives; trouble breathing; throat swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives), DYSPNOEA (trouble breathing) and PHARYNGEAL SWELLING (throat swelling) in a 24-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 09-Feb-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 URTICARIA (hives), DYSPNOEA (trouble breathing) and PHARYNGEAL SWELLING (throat swelling). At the time of the report, URTICARIA (hives), DYSPNOEA (trouble breathing) and PHARYNGEAL SWELLING (throat swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1707484
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: high

Allergies:

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

Symptoms: periods of high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (periods of high blood pressure) 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 HYPERTENSION (periods of high blood pressure). At the time of the report, HYPERTENSION (periods of high blood pressure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1707485
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital: Y

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

Lab Data: Test Name: Coronary angiography; Result Unstructured Data: showed only mild coronary artery disease; Test Name: antinuclear antibody; Result Unstructured Data: normal; Test Name: blood count; Result Unstructured Data: normal; Test Name: creatinine; Result Unstructured Data: normal; Test Name: lactate dehydrogenase; Result Unstructured Data: normal; Test Name: BUN; Result Unstructured Data: normal; Test Name: Chest x-ray; Result Unstructured Data: did not show any underlying cardiopulmonary process.; Test Name: coxsackievirus antibody; Test Result: Negative ; Result Unstructured Data: negative; Test Name: C-reactive protein; Result Unstructured Data: normal; Test Name: Transthoracic echocardiography; Result Unstructured Data: showed a reduced left ventricular ejection fraction of 35% with hypokinesis of the mid and distal segments and normal contraction of the basal segments with normal right ventricular function; Test Name: Transthoracic echocardiography; Test Result: Inconclusive ; Result Unstructured Data: resolution with EF of 60%?65% with no wall-motion abnormalities (5 week follow up).; Test Name: Electrocardiogram; Result Unstructured Data: showed evolving ST-T changes suggestive of inferolateral ischemia; Test Name: D-dimer; Result Unstructured Data: normal; Test Name: D-Dimer; Result Unstructured Data: normal; Test Name: heart rate; Result Unstructured Data: 40?s, bradycardia; Test Name: Viral studies; Test Result: Negative ; Result Unstructured Data: negative; Test Name: influenza A; Test Result: Negative ; Result Unstructured Data: negative; Test Name: influenza B; Test Result: Negative ; Result Unstructured Data: negative; Test Name: procalcitonin; Result Unstructured Data: normal; Test Name: sedimentation rate; Result Unstructured Data: normal; Test Name: COVID-19 serology; Test Result: Negative ; Result Unstructured Data: negative; Test Name: SARS-CoV-2 RNA PCR tests; Test Result: Negative ; Result Unstructured Data: negative; Test Name: ferritin; Result Unstructured Data: normal; Test Name: Thyroid function; Result Unstructured Data: normal; Test Name: troponin; Result Unstructured Data: was elevated to 0.57 ng/dL (normal , 0.034 ng/dL)

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Takotsubo Cardiomyopathy; coronary artery disease; lightheadedness; myalgia; nausea; fatigue; headache; This literature-non-study case was reported in a literature article and describes the occurrence of STRESS CARDIOMYOPATHY (Takotsubo Cardiomyopathy) and CORONARY ARTERY DISEASE (coronary artery disease) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: COVID-19 Vaccine?Associated Takotsubo Cardiomyopathy. 2021 The patient's past medical history included Nephrectomy in 2000. Concurrent medical conditions included Asthma, Glaucoma, Hyperlipidemia, Renal cell carcinoma and Lightheadedness (Transthoracic echocardiography (TTE) 2 months before because of this, with no findings regarding the ones from the TTE during hospitalization). Concomitant products included MULTIVITAMINS [VITAMINS NOS], LATANOPROST and TIMOLOL for an unknown indication. 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 STRESS CARDIOMYOPATHY (Takotsubo Cardiomyopathy) (seriousness criteria hospitalization and medically significant), CORONARY ARTERY DISEASE (coronary artery disease) (seriousness criterion hospitalization), DIZZINESS (lightheadedness), MYALGIA (myalgia), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at an unspecified dose and frequency; ATORVASTATIN ongoing since an unknown date at an unspecified dose and frequency; LISINOPRIL ongoing since an unknown date at an unspecified dose and frequency and METOPROLOL SUCCINATE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, STRESS CARDIOMYOPATHY (Takotsubo Cardiomyopathy), DIZZINESS (lightheadedness), MYALGIA (myalgia), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (headache) had resolved and CORONARY ARTERY DISEASE (coronary artery disease) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: abnormal (abnormal) showed only mild coronary artery disease. On an unknown date, Antinuclear antibody: normal (normal) normal. On an unknown date, Blood count: normal (normal) normal. On an unknown date, Blood creatinine: normal (normal) normal. On an unknown date, Blood lactate dehydrogenase: normal (normal) normal. On an unknown date, Blood urea: normal (normal) normal. On an unknown date, C-reactive protein: normal (normal) normal. On an unknown date, Chest X-ray: normal (normal) did not show any underlying cardiopulmonary process.. On an unknown date, Coxsackie virus test: negative (Negative) negative. On an unknown date, Echocardiogram: abnormal (abnormal) showed a reduced left ventricular ejection fraction of 35% with hypokinesis of the mid and distal segments and normal contraction of the basal segments with normal right ventricular function and resolution with ef of 60%?65% (Inconclusive) resolution with EF of 60%?65% with no wall-motion abnormalities (5 week follow up).. On an unknown date, Electrocardiogram: abnormal (abnormal) showed evolving ST-T changes suggestive of inferolateral ischemia. On an unknown date, Fibrin D dimer: normal (normal) normal and normal (normal) normal. On an unknown date, HIV test: negative (Negative) negative. On an unknown date, Heart rate: 40?s, bradycardia (abnormal) 40?s, bradycardia. On an unknown date, Influenza A virus test: negative (Negative) negative. On an unknown date, Influenza B virus test: negative (Negative) negative. On an unknown date, Procalcitonin: normal (normal) normal. On an unknown date, Red blood cell sedimentation rate: normal (normal) normal. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) negative. On an unknown date, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Serum ferritin: normal (normal) normal. On an unknown date, Thyroid function test: normal (normal) normal. On an unknown date, Troponin: 0.57 ng/dl (abnormal) was elevated to 0.57 ng/dL (normal , 0.034 ng/dL). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered STRESS CARDIOMYOPATHY (Takotsubo Cardiomyopathy), CORONARY ARTERY DISEASE (coronary artery disease), DIZZINESS (lightheadedness), MYALGIA (myalgia), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (headache) to be possibly related. Patient who presented with a chief complaint of chest pressure. She was in good health 3 days before when she received her first dose of the mRNA-1273 SARS-CoV-2 vaccine. However, later that day, she began to experience chest pressure associated with shortness of breath and lightheadedness. She did not have vomiting, diaphoresis, palpitation, fever, or chills. The findings were consistent with takotsubo cardiomyopathy. These findings were new compared with TTE 2 months before, which was performed as a part of evaluation for lightheadedness. She was a clinical social worker and was working remotely. She denied any recent emoti onal or physical stress. She denied any use of herbal supplements, recreational drugs, or alcohol. She did not have any known allergies to food, drugs, or vaccines. A plan for close follow-up and repeat echocardiogram was arranged. Therapy for the events was not 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. The event mild coronary artery disease is probably a finding during the work up for the Stress cardiomyopathy and was generated before vaccination, given the short latency between the first dose of the vaccine and the onset of this event. Patient?s comorbidities are confounders for the case. Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received by safety 08-Sep-2021 included an email from the team with an abstract and no new information.; 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. The event mild coronary artery disease is probably a finding during the work up for the Stress cardiomyopathy and was generated before vaccination, given the short latency between the first dose of the vaccine and the onset of this event. Patient?s comorbidities are confounders for the case.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; LATANOPROST; TIMOLOL

Current Illness: Asthma; Glaucoma; Hyperlipidemia; Lightheadedness (Transthoracic echocardiography (TTE) 2 months before because of this, with no findings regarding the ones from the TTE during hospitalization); Renal cell carcinoma

ID: 1707486
Sex: F
Age: 70
State: MO

Vax Date: 07/21/2021
Onset Date:
Rec V Date: 09/17/2021
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: Got scheduled second dose in 45 days which is outside the window period; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Got scheduled second dose in 45 days which is outside the window period) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 21-Jul-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 OFF LABEL USE (Got scheduled second dose in 45 days which is outside the window period). At the time of the report, OFF LABEL USE (Got scheduled second dose in 45 days which is outside the window period) 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. Her second dose scheduled on 04-SEP-2021 and couldn't take it due to health conditions. No concomitant medications reported. No treatment information was reported by reporter.

Other Meds:

Current Illness:

ID: 1707487
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) 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 SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment for the events were not provided. Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested

Other Meds:

Current Illness:

ID: 1707488
Sex: F
Age:
State:

Vax Date: 08/06/2021
Onset Date: 08/09/2021
Rec V Date: 09/17/2021
Hospital: Y

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

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

Allergies:

Symptom List: Nausea

Symptoms: 3 days later she got COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (3 days later she got COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-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 COVID-19 (3 days later she got COVID) (seriousness criterion hospitalization). The patient was hospitalized on sometime in August 2021 due to COVID-19. At the time of the report, COVID-19 (3 days later she got COVID) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment of the event included antiviral drugs. 3 days later the patient got covid. While the patient was in the hospital she was tested positive for covid and got antiviral on 11 AUG 2021 and she quarantined for 10 days. The patient is now due for her 2nd dose. Company comment- Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.

Other Meds:

Current Illness:

ID: 1707489
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: What Does it mean when you take the vaccine u get fever; What Does it mean when you take the vaccine u get chill; 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 PYREXIA (What Does it mean when you take the vaccine u get fever) and CHILLS (What Does it mean when you take the vaccine u get chill) 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 PYREXIA (What Does it mean when you take the vaccine u get fever) and CHILLS (What Does it mean when you take the vaccine u get chill). At the time of the report, PYREXIA (What Does it mean when you take the vaccine u get fever) and CHILLS (What Does it mean when you take the vaccine u get chill) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1707490
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Side effects) 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 ADVERSE REACTION (Side effects). At the time of the report, ADVERSE REACTION (Side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1707491
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Feeling pretty bad; Have no energy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling pretty bad) and ASTHENIA (Have no energy) 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 FEELING ABNORMAL (Feeling pretty bad) and ASTHENIA (Have no energy). At the time of the report, FEELING ABNORMAL (Feeling pretty bad) and ASTHENIA (Have no energy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1707492
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: I had blood clots in my left leg; Ultimately resulted in a below the knee left leg amputation; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (I had blood clots in my left leg) and LEG AMPUTATION (Ultimately resulted in a below the knee left leg amputation) 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 THROMBOSIS (I had blood clots in my left leg) (seriousness criteria disability and medically significant) and LEG AMPUTATION (Ultimately resulted in a below the knee left leg amputation) (seriousness criterion disability). At the time of the report, THROMBOSIS (I had blood clots in my left leg) and LEG AMPUTATION (Ultimately resulted in a below the knee left leg amputation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1707493
Sex: F
Age: 73
State: NJ

Vax Date: 08/06/2021
Onset Date:
Rec V Date: 09/17/2021
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: a little warm to the touch/warm and raised; a little sore/felt like the muscle was a little sore; itch/noticed it was huge/itchy; Huge rash; red/red mark from shoulder to arm/It is walking it's way down to her elbow; pretty big; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a little warm to the touch/warm and raised), VACCINATION SITE PAIN (a little sore/felt like the muscle was a little sore), VACCINATION SITE PRURITUS (itch/noticed it was huge/itchy), VACCINATION SITE RASH (Huge rash) and VACCINATION SITE ERYTHEMA (red/red mark from shoulder to arm/It is walking it's way down to her elbow) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078CZ1A and 078CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical History was reported. Concomitant products included VITAMINS NOS for an unknown indication. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (a little warm to the touch/warm and raised), VACCINATION SITE PAIN (a little sore/felt like the muscle was a little sore), VACCINATION SITE PRURITUS (itch/noticed it was huge/itchy), VACCINATION SITE RASH (Huge rash), VACCINATION SITE ERYTHEMA (red/red mark from shoulder to arm/It is walking it's way down to her elbow) and VACCINATION SITE SWELLING (pretty big). The patient was treated with GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (a little warm to the touch/warm and raised), VACCINATION SITE PAIN (a little sore/felt like the muscle was a little sore), VACCINATION SITE PRURITUS (itch/noticed it was huge/itchy), VACCINATION SITE RASH (Huge rash), VACCINATION SITE ERYTHEMA (red/red mark from shoulder to arm/It is walking it's way down to her elbow) and VACCINATION SITE SWELLING (pretty big) outcome was unknown.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1707494
Sex: U
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/17/2021
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: Dizziness/ Lightheadedness; equilibrium; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/ Lightheadedness) and BALANCE DISORDER (equilibrium) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 DIZZINESS (Dizziness/ Lightheadedness) and BALANCE DISORDER (equilibrium). At the time of the report, DIZZINESS (Dizziness/ Lightheadedness) and BALANCE DISORDER (equilibrium) outcome was unknown. No concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1707495
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: redness on injection side; itching on injection side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness on injection side) and VACCINATION SITE PRURITUS (itching on injection side) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness on injection side) and VACCINATION SITE PRURITUS (itching on injection side). At the time of the report, VACCINATION SITE ERYTHEMA (redness on injection side) and VACCINATION SITE PRURITUS (itching on injection side) outcome was unknown. Reportedly, Patient was willing to know whether redness and itching on injection side was normal. Concomitant product use was not provided. Treatment product information was not provided.

Other Meds:

Current Illness:

ID: 1707496
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: The day after I had the vaccine my eyes and face were very swollen; The day after I had the vaccine my eyes and face were very swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (The day after I had the vaccine my eyes and face were very swollen) and EYE SWELLING (The day after I had the vaccine my eyes and face were very swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 pneumonia in April 2021. 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 SWELLING FACE (The day after I had the vaccine my eyes and face were very swollen) and EYE SWELLING (The day after I had the vaccine my eyes and face were very swollen). At the time of the report, SWELLING FACE (The day after I had the vaccine my eyes and face were very swollen) and EYE SWELLING (The day after I had the vaccine my eyes and face were very swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1707497
Sex: U
Age:
State:

Vax Date: 08/04/2021
Onset Date: 08/20/2021
Rec V Date: 09/17/2021
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: Infected after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Infected after vaccination) 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 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced INFECTION (Infected after vaccination). At the time of the report, INFECTION (Infected after vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

Date Died:

ID: 1707498
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: A lady died after getting their second Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (A lady died after getting their second Moderna shot) in a 6-decade-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant medications were not reported. No treatment details were provided. Company Comment - Very limited information regarding this event has been provided at this time. Further information is not expected as no consent for follow up was obtained.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information is not expected as no consent for follow up was obtained.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1707499
Sex: F
Age:
State:

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Blood pressure is very low

Allergies:

Symptom List: Pain in extremity

Symptoms: blood pressure is very low/82 over 35; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (blood pressure is very low/82 over 35) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced HYPOTENSION (blood pressure is very low/82 over 35). At the time of the report, HYPOTENSION (blood pressure is very low/82 over 35) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 82/35 (Low) Blood pressure is very low. Concomitant product use was not provided. Treatment product information was not provided.

Other Meds:

Current Illness:

ID: 1707500
Sex: M
Age:
State:

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 09/17/2021
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: Blood clot; swelling in his leg; discoloration on leg; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In August 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 THROMBOSIS (Blood clot) (seriousness criterion medically significant), PERIPHERAL SWELLING (swelling in his leg) and SKIN DISCOLOURATION (discoloration on leg). At the time of the report, THROMBOSIS (Blood clot), PERIPHERAL SWELLING (swelling in his leg) and SKIN DISCOLOURATION (discoloration on leg) outcome was unknown. No Concomitants were reported. No treatments were reported. Company comment: Very limited information was provided. However, based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be fully excluded. Therefore, causality is assessed as possibly related.; Sender's Comments: Very limited information was provided. However, based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be fully excluded. Therefore, causality is assessed as possibly related.

Other Meds:

Current Illness:

ID: 1707501
Sex: M
Age:
State: AZ

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Name: SARS-COV-2Spike AB; Test Result: Negative ; Result Unstructured Data: SARS-COV-2Spike AB,Quant, S, results were less than .04U/ml per ml.

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: patient completed Pfizer COVID-19 series and got Moderna vaccine as third vaccine in error; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient completed Pfizer COVID-19 series and got Moderna vaccine as third vaccine in error) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The patient's past medical history included Colonic lymphoma (Malt a type of colon Lymphoma Mucosa Associated Lymphoid tissue) and Chronic lymphocytic leukemia. Previously administered products included for COVID-19 immunisation: Pfizer vaccine (First vaccine EW0162, given in the left arm deltoid muscle) on 22-Apr-2021, Pfizer vaccine (second EW0170 and was given on 11MAY2021) on 11-May-2021. Concurrent medical conditions included Immunocompromised. Concomitant products included RAMIPRIL (ALTACE) and ACALABRUTINIB (CALQUENCE) for an unknown indication. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient completed Pfizer COVID-19 series and got Moderna vaccine as third vaccine in error). On 12-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (patient completed Pfizer COVID-19 series and got Moderna vaccine as third vaccine in error) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: less than 0.04 (Negative) SARS-COV-2Spike AB,Quant, S, results were less than .04U/ml per ml.. Concomitant medication also include Gayza infusion last given on 21MAR2021 Completed the series. No treatment information were provided.

Other Meds: ALTACE; CALQUENCE

Current Illness: Immunocompromised

ID: 1707502
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Feeling very hot body; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling very hot body) and LETHARGY (Lethargic) 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 FEELING HOT (Feeling very hot body) and LETHARGY (Lethargic). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram. At the time of the report, FEELING HOT (Feeling very hot body) and LETHARGY (Lethargic) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. It was reported that patient took two Tylenol of 500 milligram which helped.

Other Meds:

Current Illness:

ID: 1707503
Sex: F
Age: 36
State: NC

Vax Date: 08/15/2021
Onset Date: 08/01/2021
Rec V Date: 09/17/2021
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: Became very ill; Nausea; Running a fever; Pain in my joints/ pain in my elbow; Pain in my underarm; Lymph nodes are the size of a golf ball; Extreme swelling in my left arm; Huge big ball of skin coming out; extreme pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Became very ill), PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain) and NAUSEA (Nausea) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History was provided. Concomitant products included GABAPENTIN for an unknown indication. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced MALAISE (Became very ill), NAUSEA (Nausea) and PYREXIA (Running a fever). In August 2021, the patient experienced PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain), ARTHRALGIA (Pain in my joints/ pain in my elbow), AXILLARY PAIN (Pain in my underarm) and LYMPHADENOPATHY (Lymph nodes are the size of a golf ball). At the time of the report, MALAISE (Became very ill), PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain), NAUSEA (Nausea), PYREXIA (Running a fever), ARTHRALGIA (Pain in my joints/ pain in my elbow), AXILLARY PAIN (Pain in my underarm) and LYMPHADENOPATHY (Lymph nodes are the size of a golf ball) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were provided. No treatment medications were provided.

Other Meds: GABAPENTIN

Current Illness:

ID: 1707504
Sex: U
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/17/2021
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: This spontaneous case reported by a consumer, describes the occurrence of nasopharyngitis (bad head cold) and nasal congestion in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. March 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced nasopharyngitis (bad head cold) and nasal congestion. At the time of the report, nasopharyngitis (bad head cold) and nasal congestion outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant production use or treatment medications provided. Reporter did not allow further contact.

Other Meds:

Current Illness:

ID: 1707505
Sex: F
Age: 45
State: MN

Vax Date: 08/06/2021
Onset Date: 08/06/2021
Rec V Date: 09/17/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (The vaccine put her down for a couple days.) and INFLUENZA LIKE ILLNESS (Felt like she had the flu really bad) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced ASTHENIA (The vaccine put her down for a couple days.) and INFLUENZA LIKE ILLNESS (Felt like she had the flu really bad). At the time of the report, ASTHENIA (The vaccine put her down for a couple days.) and INFLUENZA LIKE ILLNESS (Felt like she had the flu really bad) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medication information provided. No relevant treatment medication information provided. Patient reported that she received her 2nd dose of Moderna vaccine on her left arm on 07-Sep-2021. LOT # 017E21A; This case was linked to MOD-2021-312953 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality is assessed as possibly related.

Other Meds:

Current Illness:

ID: 1707506
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: feeling side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling side effects) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (feeling side effects). At the time of the report, VACCINATION COMPLICATION (feeling side effects) outcome was unknown. Reportedly, Consent for follow up was accepted. Concomitant product use was not provided. Treatment product information was not provided.

Other Meds:

Current Illness:

ID: 1707507
Sex: F
Age: 76
State: MO

Vax Date: 02/28/2021
Onset Date: 03/29/2021
Rec V Date: 09/17/2021
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: Felt like the food was lodged in her lower throat- collar bone area, only occurs with red meat, she can still eat fish; Its difficult to explain, but ever since she has felt wired; Can not remember anything that happened that night; She got tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Felt like the food was lodged in her lower throat- collar bone area, only occurs with red meat, she can still eat fish), FEELING ABNORMAL (Its difficult to explain, but ever since she has felt wired), AMNESIA (Can not remember anything that happened that night) and FATIGUE (She got tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 011A21A) for COVID-19 vaccination. No reported medical history. Concomitant products included APOAEQUORIN (PREVAGEN [APOAEQUORIN]) and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) for an unknown indication. On 28-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021 at 7:00 PM, the patient experienced FEELING ABNORMAL (Its difficult to explain, but ever since she has felt wired), AMNESIA (Can not remember anything that happened that night) and FATIGUE (She got tired). On 31-Mar-2021, the patient experienced DYSPHAGIA (Felt like the food was lodged in her lower throat- collar bone area, only occurs with red meat, she can still eat fish). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (Felt like the food was lodged in her lower throat- collar bone area, only occurs with red meat, she can still eat fish), FEELING ABNORMAL (Its difficult to explain, but ever since she has felt wired), AMNESIA (Can not remember anything that happened that night) and FATIGUE (She got tired) outcome was unknown. She took Tylenol. This case was linked to MOD-2021-312916.; 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: PREVAGEN [APOAEQUORIN]; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]

Current Illness:

ID: 1707508
Sex: F
Age: 73
State: AL

Vax Date: 07/07/2021
Onset Date:
Rec V Date: 09/17/2021
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: She is also diagnosed with rheumatoid arthritis; She started experiencing gout; She is complaining sever muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (She is also diagnosed with rheumatoid arthritis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) 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 METOPROLOL, FUROSEMIDE, LORAZEPAM, LEVOTHYROXINE SODIUM (SYNTHROID), COLECALCIFEROL (VITAMIN D3), PROBENECID, ESOMEPRAZOLE, TIZANIDINE and COLCHICINE (COLCRYS) for an unknown indication. On 07-Jul-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 RHEUMATOID ARTHRITIS (She is also diagnosed with rheumatoid arthritis) (seriousness criterion medically significant), GOUT (She started experiencing gout) and MYALGIA (She is complaining sever muscle pain). At the time of the report, RHEUMATOID ARTHRITIS (She is also diagnosed with rheumatoid arthritis), GOUT (She started experiencing gout) and MYALGIA (She is complaining sever muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information include steroids. 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: METOPROLOL; FUROSEMIDE; LORAZEPAM; SYNTHROID; VITAMIN D3; PROBENECID; ESOMEPRAZOLE; TIZANIDINE; COLCRYS

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am