VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1566060
Sex: F
Age:
State: VA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/15/2021
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Lab Data:

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Symptom List:

Symptoms: Bottom lip on left side corner started swelling the size of small bubble/swollen into a big bubble; Lip was hard; Bubble on part of right side of face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (Bottom lip on left side corner started swelling the size of small bubble/swollen into a big bubble), SKIN INDURATION (Lip was hard) and ACNE (Bubble on part of right side of face) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma, Diabetes and Environmental allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN), LISINOPRIL, HYDROCHLOROTHIAZIDE, METFORMIN HCL, CETIRIZINE HYDROCHLORIDE (CETRIZINE) and COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) for an unknown indication. On 17-Feb-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced SKIN INDURATION (Lip was hard) and ACNE (Bubble on part of right side of face). On 17-Feb-2021 at 3:45 PM, the patient experienced LIP SWELLING (Bottom lip on left side corner started swelling the size of small bubble/swollen into a big bubble). On 18-Feb-2021, SKIN INDURATION (Lip was hard) had resolved. On 18-Feb-2021 at 9:00 AM, LIP SWELLING (Bottom lip on left side corner started swelling the size of small bubble/swollen into a big bubble) had resolved. At the time of the report, ACNE (Bubble on part of right side of face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: age, race, weight, height of patient, current conditions and allergy added, additional events added

Other Meds: ASPIRIN; LISINOPRIL; HYDROCHLOROTHIAZIDE; METFORMIN HCL; CETRIZINE; VITAMIN D COMPLEX

Current Illness: Asthma; Diabetes; Environmental allergy

ID: 1566061
Sex: F
Age: 80
State: WA

Vax Date: 01/13/2021
Onset Date: 01/22/2021
Rec V Date: 08/15/2021
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Symptoms: couple of other people came in with the same delayed reaction; Itching/pruritus; Redness/erythema; Arm Rash; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (couple of other people came in with the same delayed reaction), HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itching/pruritus) and ERYTHEMA (Redness/erythema) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (allergic to sulpha-swallen skin, itching). Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for Osteopenia, CALCIUM, VITAMIN C [ASCORBIC ACID] and FISH OIL for an unknown indication. On 13-Jan-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021 at 1:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced VACCINATION COMPLICATION (couple of other people came in with the same delayed reaction), PRURITUS (Itching/pruritus) and ERYTHEMA (Redness/erythema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 22-Jan-2021 to 25-Jan-2021 at a dose of 1 dosage form. On 25-Jan-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. At the time of the report, VACCINATION COMPLICATION (couple of other people came in with the same delayed reaction) had resolved and PRURITUS (Itching/pruritus) and ERYTHEMA (Redness/erythema) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: mmHg (normal) normal. On an unknown date, Heart rate: (normal) normal. On an unknown date, Respiratory rate: (normal) normal. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up information received on 22-APR-2021. Added second dose details, event outcome, concomitant medications and patient details. On 08-Jun-2021: Follow-up information received on 09-JUN-2021. Added concomitant medication-fish oil and diagnostic results.

Other Meds: ALENDRONATE; CALCIUM; VITAMIN C [ASCORBIC ACID]; FISH OIL

Current Illness: Drug allergy (allergic to sulpha-swallen skin, itching)

ID: 1566062
Sex: F
Age: 78
State: NY

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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Symptoms: couldn't move her arm; so sore; stiff arm; hurt so bad to move the arm; hurt from her shoulder to her elbow; she fell backwards and it has started hurting more to move it since her fall.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), MYALGIA (so sore), MUSCULOSKELETAL STIFFNESS (stiff arm), VACCINATION SITE PAIN (hurt so bad to move the arm) and PAIN (hurt from her shoulder to her elbow) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included DICLOFENAC POTASSIUM (VOLTAREN ACTI) for an unknown indication. On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), MYALGIA (so sore), MUSCULOSKELETAL STIFFNESS (stiff arm), VACCINATION SITE PAIN (hurt so bad to move the arm), PAIN (hurt from her shoulder to her elbow) and FALL (she fell backwards and it has started hurting more to move it since her fall.). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), MYALGIA (so sore), MUSCULOSKELETAL STIFFNESS (stiff arm), VACCINATION SITE PAIN (hurt so bad to move the arm), PAIN (hurt from her shoulder to her elbow) and FALL (she fell backwards and it has started hurting more to move it since her fall.) outcome was unknown.

Other Meds: VOLTAREN ACTI

Current Illness:

ID: 1566063
Sex: F
Age: 47
State: ID

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 08/15/2021
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Symptoms: tiredness; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of fatigue (tiredness) and injection site pain (soreness at the injection site) in an 87-year-old female patient who received mrna-1273 (Moderna covid-19 vaccine) (batch no. 031l20a) for covid-19 vaccination. the patient's past medical history included no adverse event (no historical condition reported.). concomitant products included blood thinners, hydrochlorothiazide and atorvastatin calcium (atorvastatin an), blood thinner and acelol. on 13-feb-2021, the patient received dose of mrna-1273 (Moderna covid-19 vaccine) of (batch no. 031l20a) by (unknown route) at an unspecified dose for prophylaxis of COVID-19 infection. The action taken with mrna-1273 (Moderna covid-19 vaccine) (unknown) was unknown. No treatment medication was reported. on 13-feb-2021, the patient experienced fatigue (tiredness) and injection site pain (soreness at the injection site). on 13-feb-2021, injection site pain (soreness at the injection site) had resolved. at the time of the report, fatigue (tiredness) outcome was unknown.

Other Meds: blood thinners; HYDROCHLOROTHIAZIDE; ATORVASTATIN AN

Current Illness:

ID: 1566064
Sex: F
Age: 89
State: FL

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 08/15/2021
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Symptoms: diarrhea (golden color) that occur 2-3x a week; Shoulder ache; A spontaneous report was received from a consumer concerning a 89-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Shoulder ache and diarrhea (golden color) that occur 2-3x a week . The patient's medical history was not provided by the reporter. Concomitant medications include Metformin ,digoxin, Hydrochlorothiazide ,Levothyroxine ,propranolol, losartan and acyclovir. She had taken Bismuth Subsalicylate to treat Stomach relief . On 24 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) via intra muscular in unknown anatomical location for prophylaxis of COVID-19 infection. After receiving the first dose ,the patient experienced shoulder ache pain for couple of hours . On 26 Jan 2021 patient experienced diarrhea (golden color) that occur 2-3x a week. Diarrhea is still evident. Action taken with mRNA-1273 in response to the events was not unknown. The events of outcome shoulder ache was Recovered /Resolved and the outcome of diarrhea was unknown.

Other Meds: METFORMIN; DIGOXIN; HYDROCHLOROTHIAZIDE; LEVOTHYROXINE; LOSARTAN; PROPANOLOL [PROPRANOLOL]; ACYCLOVIR ACTAVIS

Current Illness:

ID: 1566065
Sex: F
Age: 52
State: OH

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 08/15/2021
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Symptoms: big rump that is warm to the touch; Headache; Pain at the site of injection; A spontaneous report was received from a consumer concerning a female patient of 52 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced headache,vaccination site pain and big rump that is warm to the touch. The patients medical history was not provided.No relevant Concomitant medications were reported. On 13 feb 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 031M20A) vaccine in the left arm for prophylaxis of COVID-19 infection. On 13-feb-2021,couple of hours later,patient experienced headache,vaccination site pain. On 20-feb-2021,patient experienced big rump that is warm to the touch. No Treatment information for the event was provided. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome for the events headache,vaccination site pain and big rump that is warm to the touch was not provided.

Other Meds:

Current Illness:

ID: 1566066
Sex: F
Age:
State:

Vax Date: 02/09/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: sore arm; red arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ERYTHEMA (red arm) 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 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 PAIN IN EXTREMITY (sore arm) and ERYTHEMA (red arm). At the time of the report, PAIN IN EXTREMITY (sore arm) and ERYTHEMA (red arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. no concomitant medications are provided. treatment to the events not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1566067
Sex: F
Age: 38
State: WY

Vax Date: 01/07/2021
Onset Date: 01/10/2021
Rec V Date: 08/15/2021
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Symptoms: Fever; Chills; Body ache; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer concerning a 38-year-old, female patient who Vaccine exposure during pregnancy, Fever/pyrexia and Body ache/Myalgia. The patient's medical history was not provided. Concomitant product includes prenatal vitamins. The patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) on 07 Jan 2021. On 04 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. First dose of vaccine was administrated on 07 Jan 2021 and second dose on 04 feb 2021. Patient is received vaccine during the pregnancy. And experienced chills, fever and body ache. Treatment for the event included Tylenol 500 mg. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events was not reported.

Other Meds:

Current Illness:

ID: 1566068
Sex: F
Age: 78
State: NY

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptoms: rash; pain; esophagus spasm; sneezing; gas; not feeling like herself; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), PAIN (pain), OESOPHAGEAL SPASM (esophagus spasm), SNEEZING (sneezing) and FLATULENCE (gas) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. no medical history is provided and concomitant drugs are provided. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE SODIUM (CYTOMEL), GUAIFENESIN (MUCINEX), FAMOTIDINE, CYCLOBENZAPRINE, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), TRANEXAMIC ACID (XANEXTRA), LEVOSALBUTAMOL (LEVOLIN [LEVOSALBUTAMOL]), ACETYLSALICYLIC ACID (BABY ASPIRIN), BUDESONIDE (PULMICORT), MOMETASONE FUROATE (NASONEX), DICLOFENAC POTASSIUM (VOLTAREN ACTI), METRONIDAZOLE (NORITATE) and MINOXIDIL (ROGAINE). On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 08-Feb-2021, the patient experienced OESOPHAGEAL SPASM (esophagus spasm), SNEEZING (sneezing), FLATULENCE (gas) and DISCOMFORT (not feeling like herself). On 15-Feb-2021, the patient experienced RASH (rash) and PAIN (pain). On 09-Feb-2021, OESOPHAGEAL SPASM (esophagus spasm), SNEEZING (sneezing) and FLATULENCE (gas) had resolved. On 10-Feb-2021, DISCOMFORT (not feeling like herself) had resolved. On 22-Feb-2021, PAIN (pain) had resolved. At the time of the report, RASH (rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: SYNTHROID; CYTOMEL; MUCINEX; FAMOTIDINE; CYCLOBENZAPRINE; XYZAL; XANEXTRA; LEVOLIN [LEVOSALBUTAMOL]; BABY ASPIRIN; PULMICORT; NASONEX; VOLTAREN ACTI; NORITATE; ROGAINE

Current Illness:

ID: 1566069
Sex: F
Age: 42
State: SC

Vax Date: 02/14/2021
Onset Date: 02/22/2021
Rec V Date: 08/15/2021
Hospital:

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Symptoms: extremely red; injection site welt; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (injection site welt), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE ERYTHEMA (extremely red) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced INJECTION SITE INDURATION (injection site welt) and INJECTION SITE PRURITUS (itching at the injection site). On 23-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (extremely red). At the time of the report, INJECTION SITE INDURATION (injection site welt), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE ERYTHEMA (extremely red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1566070
Sex: F
Age:
State:

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptoms: Left arm feels weak; Burning sensation at the center of her back; Swollen left arm; Rash at injection site; Soreness at the injection site; Fatigue; A spontaneous report was received from a consumer who is a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, vaccination site pain, arm swelling, vaccination site erythema, burning sensation on the back, and muscular weakness. The patient's medical history was not provided . No relevant concomitant medications were reported. On 15-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown, route of administration:unknown) in the left arm for prophylaxis of COVID-19 infection. On 15-Jan-2021, the patient experienced fatigue and vaccination site pain. On 25-Jan-2021, the patient experienced arm swelling, vaccination site erythema and burning sensation on the back. On 05-Feb-2021, the patient experienced muscular weakness. Treatment details include Benadryl and Tylenol. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events fatigue and vaccination site pain was considered to be recovered/resolved. The outcome for the events arm swelling, vaccination site erythema, burning sensation on the back, and muscular weakness was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1566071
Sex: M
Age:
State:

Vax Date:
Onset Date: 01/29/2021
Rec V Date: 08/15/2021
Hospital:

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Symptoms: Tested positive for Covid; A spontaneous report was received from a healthcare professional (pharmacist) concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for Covid/ SARS-CoV-2 test positive. The patient's medical history included Urinary tract infection, in the hospital, patient got plasma and antibiotics for Urinary tract infection. Concomitant medications reported were Metformin for drug use for unknown indication. On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient experienced the event(s) tested positive for Covid. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, tested positive for Covid was unknown.

Other Meds: METFORMIN

Current Illness:

ID: 1566072
Sex: F
Age: 84
State: VA

Vax Date: 01/23/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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Symptoms: Couldn't walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Couldn't walk) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included LETROZOLE, LEVOTHYROXINE and AMLODIPINE for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Couldn't walk). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (Couldn't walk) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's concomitant medication included Bendsarthan.

Other Meds: LETROZOLE; LEVOTHYROXINE; AMLODIPINE

Current Illness:

ID: 1566073
Sex: M
Age:
State: FL

Vax Date: 02/18/2021
Onset Date: 02/01/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptoms: pain that felt like two golf balls; really thirsty; Felt immune system compromised; bad shivering; tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain that felt like two golf balls), THIRST (really thirsty), MALAISE (Felt immune system compromised), CHILLS (bad shivering) and FATIGUE (tired) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN (pain that felt like two golf balls), THIRST (really thirsty), MALAISE (Felt immune system compromised), CHILLS (bad shivering) and FATIGUE (tired). At the time of the report, PAIN (pain that felt like two golf balls), THIRST (really thirsty), MALAISE (Felt immune system compromised), CHILLS (bad shivering) and FATIGUE (tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient took no treatment. Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: No new information

Other Meds:

Current Illness:

ID: 1566074
Sex: M
Age: 71
State: IN

Vax Date: 02/22/2021
Onset Date: 02/21/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptoms: Soreness everywhere; Chills; fever; Constant belching; Joint pain; Nausea; Constipation; A spontaneous report was received from a (Consumer) concerning a- 71 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Soreness everywhere, chills, fever, constant belching, constipation, joint pain and nausea. The patient's medical history not reported. No relevant concomitant medications were reported. On 22 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:013M20A) unknown route and site for prophylaxis of COVID-19 infection. On 21 Feb 2021, the patient experienced Soreness everywhere, chills, fever, constant belching, constipation, joint pain and nausea. Laboratory details not provided. Treatment was taken as Advil and diazepam. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events were Not Recovered/ Not Resolving.

Other Meds:

Current Illness:

ID: 1566075
Sex: F
Age: 65
State: WA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Allergies:

Symptom List:

Symptoms: Tingling in her chest; distaste in her mouth; tingling of the tongue and lips, they actually became swollen and after a certain point, it became numb; tingling of the tongue and lips, they actually became swollen and after a certain point, it became numb; tingling of the tongue and lips, they actually became swollen and after a certain point, it became numb; tingling of the tongue and lips, they actually became swollen and after a certain point, it became numb; chest tightness; A spontaneous report was received from a consumer concerning, a 65-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling and tightening of chest/paraesthesia, chest discomfort, tingling of tongue and lips/ paraesthesia oral, additional taste in their mouth/ taste disorder, lips and tongue began to swell/swollen lips, swollen tongue and tongue and lips eventually became numb/hypoaesthesia oral. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, immediately after receiving the vaccine the patient had tingling of tongue and lips and also experienced tingling and tightening of chest. After two hours of vaccine lips and tongue began to swell and later the patient's tongue and lips eventually became numb. The patient also felt an additional taste in their mouth On the same day, four hours after receiving the vaccine, the patient reported their tingling and tightness went away. The patient was scheduled for their second dose on 25 Feb 2021 and contacted their doctor on 22 Feb 2021 to determine if patient should take the vaccine. No treatment information was provided for the event. Action taken with mRNA-1273 in response to the event(s) was not reported. The outcome of the events tingling and tightening of chest, tingling of tongue and lips, additional taste in their mouth, lips and tongue began to swell and tongue and lips eventually became numb were considered resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1566076
Sex: F
Age: 66
State: CA

Vax Date: 02/08/2021
Onset Date: 02/22/2021
Rec V Date: 08/15/2021
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Symptom List:

Symptoms: Fatigue; Diarrhoea; Fever (101.3); Chills; Body aches; tches but not too much; blotchy rash on injection site down arm about 6 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (tches but not too much), VACCINATION SITE RASH (blotchy rash on injection site down arm about 6 inches), FATIGUE (Fatigue), DIARRHOEA (Diarrhoea) and PYREXIA (Fever (101.3)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Allergic to Codeine). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (tches but not too much) and VACCINATION SITE RASH (blotchy rash on injection site down arm about 6 inches). On 08-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), PYREXIA (Fever (101.3)), CHILLS (Chills) and PAIN (Body aches). On 09-Mar-2021, the patient experienced FATIGUE (Fatigue). On 10-Mar-2021, DIARRHOEA (Diarrhoea), PYREXIA (Fever (101.3)), CHILLS (Chills) and PAIN (Body aches) had resolved. At the time of the report, VACCINATION SITE PRURITUS (tches but not too much), VACCINATION SITE RASH (blotchy rash on injection site down arm about 6 inches) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: SYNTHROID; CRESTOR

Current Illness: Drug allergy (Allergic to Codeine)

ID: 1566077
Sex: F
Age: 32
State: NY

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
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Symptom List:

Symptoms: Pregnant; Sore arm; A spontaneous report was received from a consumer concerning a 32-year old pregnant female patient who experienced exposure to vaccine during pregnancy and a sore arm. The patient's medical history was not provided. Concomitant medication provided mentions prenatal vitamins. The patient received their first of two planned doses of mRNA-1273 (Batch number:014M20A) on 25 Feb 2021 for prophylaxis of COVID-19 infection. Patient got a positive pregnancy test on 03 Jan 2021. Her last menstrual period was 06 Dec 2020, and estimated date of conception was not provided. The patients estimated due date is 16 Sep 2021. On 25 Feb 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. She would like to be enrolled to the pregnancy registry. On 25 Feb 2021, after the vaccination, the patient reported she experienced a sore arm. Treatment information was not provided. Action taken with mRNA-1273 in response to the event is not mentioned. The outcome of the event, [sore arm] was considered unknown.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1566078
Sex: U
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/15/2021
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Symptom List:

Symptoms: trouble breathing; swelling in my throat; rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing), PHARYNGEAL SWELLING (swelling in my throat) and HEART RATE INCREASED (rapid heart rate) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DYSPNOEA (trouble breathing), PHARYNGEAL SWELLING (swelling in my throat) and HEART RATE INCREASED (rapid heart rate). At the time of the report, DYSPNOEA (trouble breathing) and PHARYNGEAL SWELLING (swelling in my throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment medications was not provided.

Other Meds:

Current Illness:

ID: 1566079
Sex: F
Age: 29
State: CA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/15/2021
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Symptoms: Report AE from second vaccine/Had and every other symptom on fact sheet; Pain in rib; Pain all the way pain down spine; Pain in Knee; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report AE from second vaccine/Had and every other symptom on fact sheet), MUSCULOSKELETAL CHEST PAIN (Pain in rib), BACK PAIN (Pain all the way pain down spine) and ARTHRALGIA (Pain in Knee) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 027L20A,) for COVID-19 vaccination. The patient's past medical history included Open heart surgery. Concomitant products included LORAZEPAM and ESCITALOPRAM for an unknown indication. On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION COMPLICATION (Report AE from second vaccine/Had and every other symptom on fact sheet), MUSCULOSKELETAL CHEST PAIN (Pain in rib), BACK PAIN (Pain all the way pain down spine) and ARTHRALGIA (Pain in Knee). On 09-Feb-2021, VACCINATION COMPLICATION (Report AE from second vaccine/Had and every other symptom on fact sheet), MUSCULOSKELETAL CHEST PAIN (Pain in rib), BACK PAIN (Pain all the way pain down spine) and ARTHRALGIA (Pain in Knee) had resolved. There was no treatment taken for symptoms Action taken with mRNA-1273 in response to the events was not applicable Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient age, gender, medical history entered. In products tab, first and second vaccination lot number, anatomical position and date of second vaccination updated. Concomitant Products updated. New events back pain, musculoskeletal chest pain, arthralgia, vaccination complication entered and outcome of events updated.

Other Meds: LORAZEPAM; ESCITALOPRAM

Current Illness:

ID: 1566080
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction). At the time of the report, ADVERSE REACTION (adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and treatment information were not provided.

Other Meds:

Current Illness:

ID: 1566081
Sex: F
Age: 84
State: IL

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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Symptoms: Itching on ears, necks and all over body; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on ears, necks and all over body) and PAIN (Pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (medical history not reported.). On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching on ears, necks and all over body) and PAIN (Pain). At the time of the report, PRURITUS (Itching on ears, necks and all over body) and PAIN (Pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1566082
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: was more like a brain fog; Dizziness; A spontaneous report (United States) was received from a consumer concerning, a female patient of an unknown age who received Moderna (mRNA-1273) vaccine and experienced lots of dizziness/dizziness and more like brain fog / feeling abnormal. The patient's medical history provided included the patient received both the first and second of their planned doses of mRNA-1273. Concomitant product use was unknown by the reporter. The patient received both the first and second of their planned doses of mRNA-1273 (Lot number: unknown for both) via unknown route for prophylaxis of COVID-19 infection. The patient experienced events from both the doses. Post receiving the first dose of (mRNA-1273) vaccine the patient experienced lots of dizziness, which more felt like brain fog. The patient was able to do stuff but still felt dizzy. The patient experienced more fatigued after the second dose of mRNA. It has been 3 weeks still patient felt dizzy in doing stuffs. Treatment information was unknown. Action taken with mRNA-1273 in response to the event(s) was Not applicable. The outcome of the events, experienced lots of dizziness more like brain fog, can do stuff but it still felt dizzy were not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1566083
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) 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 an unknown date, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown. No concomitant medications reported by investigator. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.

Other Meds:

Current Illness:

ID: 1566084
Sex: F
Age: 80
State: OH

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/15/2021
Hospital:

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Symptoms: Inappropriate schedule of vaccine; Woozy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Woozy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included METRONIDAZOLE for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced DIZZINESS (Woozy). On 19-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). On 19-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) had resolved. At the time of the report, DIZZINESS (Woozy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: METRONIDAZOLE

Current Illness:

ID: 1566085
Sex: M
Age: 66
State: DC

Vax Date: 02/16/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
Hospital:

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Symptoms: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included ALLOPURINOL, ENTECAVIR, INDAPAMIDE, LOSARTAN POTASSIUM (LOSARTIN), METOPROLOL and NIFEDIPINE for an unknown indication. On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. No treatment information was provided.

Other Meds: ALLOPURINOL; ENTECAVIR; INDAPAMIDE; LOSARTIN; METOPROLOL; NIFEDIPINE

Current Illness:

ID: 1566086
Sex: F
Age: 51
State: AL

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

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Symptom List:

Symptoms: Arm became to itch incessantly; Injection site becoming red and puffy; Injection site soreness; Has considerable amount of discomfort; Headache; Difficulty sleeping; Problem with left leg; Pain started from hip down to thigh in the back side of leg; Painful to walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Problem with left leg), PAIN (Pain started from hip down to thigh in the back side of leg), GAIT DISTURBANCE (Painful to walk), PRURITUS (Arm became to itch incessantly) and INSOMNIA (Difficulty sleeping) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes since 2017, Arthritis (Early onset of arthritis) since August 2020, Pollen allergy (Experienced headache), Allergy NOS and Drug allergy (Sulfur based medicine). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal). On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced LIMB DISCOMFORT (Problem with left leg), PAIN (Pain started from hip down to thigh in the back side of leg), GAIT DISTURBANCE (Painful to walk) and INSOMNIA (Difficulty sleeping). On 05-Mar-2021, the patient experienced DISCOMFORT (Has considerable amount of discomfort) and HEADACHE (Headache). On an unknown date, the patient experienced PRURITUS (Arm became to itch incessantly), VACCINATION SITE ERYTHEMA (Injection site becoming red and puffy) and VACCINATION SITE PAIN (Injection site soreness). The patient was treated with NAPROXEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency; AVENA SATIVA FLUID EXTRACT (AVEENO) for Itch, at an unspecified dose and frequency; ISOPROPANOL (RUBBING ALCOHOL) for Itching, at an unspecified dose and frequency and MENTHOL (ABSORBINE JR) for Itching, at an unspecified dose and frequency. On 05-Mar-2021, HEADACHE (Headache) had resolved. On 06-Mar-2021, PAIN (Pain started from hip down to thigh in the back side of leg) had resolved. At the time of the report, LIMB DISCOMFORT (Problem with left leg), GAIT DISTURBANCE (Painful to walk), PRURITUS (Arm became to itch incessantly), INSOMNIA (Difficulty sleeping), DISCOMFORT (Has considerable amount of discomfort), VACCINATION SITE ERYTHEMA (Injection site becoming red and puffy) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, X-ray: unknown (Inconclusive) Thought it was torn meniscus. On an unknown date, Body temperature: elevated (High) Elevated. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information received on 03-JUN-2021 contains significant information: Added patient demographics, medical history (allergy: Sulfa based medicine, current condition: Diabetes), 2nd dose of vaccine information, concomitant medications, treatment medications, new events "Injection site becoming red and puffy", "Injection site soreness", "Arm began to itch". The outcome of the events "Pain radiating from hip to upper thigh" and "Headache" changed from unknown to resolved.

Other Meds: OMEPRAZOLE

Current Illness: Allergy NOS; Arthritis (Early onset of arthritis); Diabetes; Drug allergy (Sulfur based medicine); Pollen allergy (Experienced headache)

ID: 1566087
Sex: F
Age: 76
State: GA

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
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Symptom List:

Symptoms: Itching on chest and arms; Beginning of rash; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (Itching on chest and arms) and RASH (Beginning of rash) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concurrent medical conditions included Allergy (sulfa allergy). On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Feb-2021, the patient experienced PRURITUS (Itching on chest and arms) and RASH (Beginning of rash). At the time of the report, PRURITUS (Itching on chest and arms) and RASH (Beginning of rash) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1566088
Sex: F
Age: 67
State: CA

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 08/15/2021
Hospital:

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Symptom List:

Symptoms: heart rate is usually normal at 58 - 60, but right now it is 85; stuffy nose; dizziness; really tired; fever of 101.5F; weird metallic taste in her mouth; Tender Injection Site; Swollen Injection Site; Red rash on the injection site (5" X 3"); Hot to the touch Injection Site; A Little Sore Injection Site,arm is very sore; A little Red Injection Site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore), INJECTION SITE ERYTHEMA (A little Red Injection Site), INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE RASH (Red rash on the injection site (5" X 3")) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore) and INJECTION SITE ERYTHEMA (A little Red Injection Site). On 01-Feb-2021, the patient experienced INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE RASH (Red rash on the injection site (5" X 3")) and INJECTION SITE WARMTH (Hot to the touch Injection Site). On 15-Feb-2021, the patient experienced PYREXIA (fever of 101.5F), DYSGEUSIA (weird metallic taste in her mouth), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness) and FATIGUE (really tired). On an unknown date, the patient experienced HEART RATE INCREASED (heart rate is usually normal at 58 - 60, but right now it is 85). On 20-Jan-2021, INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore) and INJECTION SITE ERYTHEMA (A little Red Injection Site) outcome was unknown. At the time of the report, INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE RASH (Red rash on the injection site (5" X 3")), INJECTION SITE WARMTH (Hot to the touch Injection Site), PYREXIA (fever of 101.5F), DYSGEUSIA (weird metallic taste in her mouth), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness) and FATIGUE (really tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1566089
Sex: F
Age: 54
State: NY

Vax Date: 01/07/2021
Onset Date: 02/05/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: muscle aches; chills; rash on their arm and their chest, with little hives or vesicles that now have started to dry up; sensation of being like in a fog like state, mentally for 24-48 hours; skin would get red as a lobster, like a skin flushing, that came and went for 48 hours; rash on their arm and their chest, with little hives or vesicles that now have started to dry up; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH VESICULAR (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), FEELING ABNORMAL (sensation of being like in a fog like state, mentally for 24-48 hours), ERYTHEMA (skin would get red as a lobster, like a skin flushing, that came and went for 48 hours), VACCINATION SITE RASH (rash on their arm and their chest, with little hives or vesicles that now have started to dry up) and MYALGIA (muscle aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced RASH VESICULAR (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), FEELING ABNORMAL (sensation of being like in a fog like state, mentally for 24-48 hours), ERYTHEMA (skin would get red as a lobster, like a skin flushing, that came and went for 48 hours) and VACCINATION SITE RASH (rash on their arm and their chest, with little hives or vesicles that now have started to dry up). On an unknown date, the patient experienced MYALGIA (muscle aches) and CHILLS (chills). At the time of the report, RASH VESICULAR (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), FEELING ABNORMAL (sensation of being like in a fog like state, mentally for 24-48 hours), ERYTHEMA (skin would get red as a lobster, like a skin flushing, that came and went for 48 hours), VACCINATION SITE RASH (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), MYALGIA (muscle aches) and CHILLS (chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1566090
Sex: F
Age:
State: MN

Vax Date: 02/06/2021
Onset Date: 02/09/2021
Rec V Date: 08/15/2021
Hospital:

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Symptoms: fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (Chills) 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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (fever) and CHILLS (Chills). At the time of the report, PYREXIA (fever) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: NNI

Other Meds:

Current Illness:

ID: 1566091
Sex: F
Age: 69
State: FL

Vax Date: 01/28/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
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Symptoms: Anxiety; chills; headache; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ANXIETY (Anxiety), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). On an unknown date, the patient experienced ANXIETY (Anxiety). At the time of the report, PAIN IN EXTREMITY (sore arm), ANXIETY (Anxiety), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) outcome was unknown. Concomitant medication information was not reported. Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.

Other Meds:

Current Illness:

ID: 1566092
Sex: F
Age: 25
State: LA

Vax Date: 01/25/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
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Symptoms: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of in a 25-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 032L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No past medical history not provided) and Pregnancy (Pregnancy end date, Live full term birth 1 previous pregnancy) on 24-Apr-2018. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (DICLEGIS) for Morning sickness, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 30-Sep-2020 and the estimated date of delivery was 07-Jul-2021. The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-first week of the pregnancy. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood test: was carrier for genetic disease with lip accumulat (Inconclusive) was carrier for genetic disease with lip accumulation. On an unspecified date the patient had a normal ultrasound and anatomy scan,

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; DICLEGIS; LEXAPRO; FLONASE [FLUTICASONE PROPIONATE]

Current Illness:

ID: 1566093
Sex: F
Age: 84
State: NC

Vax Date: 02/17/2021
Onset Date: 02/21/2021
Rec V Date: 08/15/2021
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Symptoms: Body tremor/body shakes without temperature/her hands very shaky; Coughing; Creaky sounding voice; Slept alot that day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Creaky sounding voice), HYPERSOMNIA (Slept alot that day), COUGH (Coughing) and TREMOR (Body tremor/body shakes without temperature/her hands very shaky) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for an unknown indication. Concurrent medical conditions included Myasthenia gravis. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced DYSPHONIA (Creaky sounding voice) and HYPERSOMNIA (Slept alot that day). On 23-Feb-2021, the patient experienced COUGH (Coughing). On 24-Feb-2021, the patient experienced TREMOR (Body tremor/body shakes without temperature/her hands very shaky). At the time of the report, DYSPHONIA (Creaky sounding voice), HYPERSOMNIA (Slept alot that day) and COUGH (Coughing) outcome was unknown and TREMOR (Body tremor/body shakes without temperature/her hands very shaky) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. 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. The patient's medical condition of myasthenia gravis and advanced age are contributing factors. 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. The patient's medical condition of myasthenia gravis and advanced age are contributing factors.

Other Meds:

Current Illness:

ID: 1566094
Sex: M
Age:
State: IL

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Worse depression; Insomnia; Tiredness; A spontaneous report was received from a consumer concerning, a male patient of an unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed worse depression, tiredness, and insomnia. The patient's medical history included depression. Concomitant product use was not provided by the reporter. On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 011M20A) for prophylaxis of COVID-19 infection. On an unknown date, after vaccination patient developed worse depression, tiredness, and insomnia. No laboratory details were provided. Treatment information for the event was not provided by the reporter. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. On an unknown date, the outcome of the events, worse depression, tiredness, and insomnia, were considered unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness: Depression

ID: 1566095
Sex: U
Age:
State: VA

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Rec V Date: 08/15/2021
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Symptoms: enlarged lymp nodes in left clavicle; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events enlarged lymph nodes in her left clavicle. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, patient experienced enlarged lymph nodes in her left clavicle. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. On an unknown date the outcome of events, enlarged lymph nodes in her left clavicle was not reported.

Other Meds:

Current Illness:

ID: 1566096
Sex: F
Age: 74
State:

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
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Symptoms: nausea, vomiting, and legs and arm ache; nausea, vomiting, and legs and arm ache; cold from the feet up; chest and back hurt, she is experiencing weakness, and shortness of breathe.; chest and back hurt, she is experiencing weakness, and shortness of breathe.; only able to eat one meal per day.; chest and back hurt, she is experiencing weakness, and shortness of breathe.; tired and fatigue; chills to the bone; unable to eat or drink all day.; nausea, vomiting, and legs and arm ache; headache; "every symptom that was described on that sheet of paper."; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills to the bone), FEELING COLD (cold from the feet up), FEEDING DISORDER (unable to eat or drink all day.), NAUSEA (nausea, vomiting, and legs and arm ache) and the first episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (chills to the bone), FEEDING DISORDER (unable to eat or drink all day.), NAUSEA (nausea, vomiting, and legs and arm ache), HEADACHE (headache) and ADVERSE REACTION ("every symptom that was described on that sheet of paper."). On 28-Feb-2021, the patient experienced FATIGUE (tired and fatigue). On 02-Mar-2021, the patient experienced BACK PAIN (chest and back hurt, she is experiencing weakness, and shortness of breathe.), DYSPNOEA (chest and back hurt, she is experiencing weakness, and shortness of breathe.) and DECREASED APPETITE (only able to eat one meal per day.). On an unknown date, the patient experienced FEELING COLD (cold from the feet up), the first episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache), the second episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache) and ASTHENIA (chest and back hurt, she is experiencing weakness, and shortness of breathe.). At the time of the report, CHILLS (chills to the bone), FEEDING DISORDER (unable to eat or drink all day.), HEADACHE (headache), ADVERSE REACTION ("every symptom that was described on that sheet of paper."), FATIGUE (tired and fatigue), BACK PAIN (chest and back hurt, she is experiencing weakness, and shortness of breathe.) and DECREASED APPETITE (only able to eat one meal per day.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1566097
Sex: F
Age:
State: NJ

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Rec V Date: 08/15/2021
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Symptoms: Joint pain; Dizziness; Positive COVID-19 test; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), DIZZINESS (Dizziness) and COVID-19 (Positive covid-19 test) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 ARTHRALGIA (Joint pain), DIZZINESS (Dizziness) and COVID-19 (Positive covid-19 test). At the time of the report, ARTHRALGIA (Joint pain), DIZZINESS (Dizziness) and COVID-19 (Positive covid-19 test) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1566098
Sex: M
Age: 28
State: MN

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/15/2021
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Symptoms: sweating; chills; muscle pain; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (sweating), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Details regarding concomitant and treatment medications were not provided.

Other Meds:

Current Illness:

ID: 1566099
Sex: F
Age:
State:

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Rec V Date: 08/15/2021
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Symptoms: bone pain; flu like sumptoms; muscle pain; chills; fever; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of BONE PAIN (bone pain), INFLUENZA LIKE ILLNESS (flu like sumptoms), MYALGIA (muscle pain), CHILLS (chills) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 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 BONE PAIN (bone pain), INFLUENZA LIKE ILLNESS (flu like sumptoms), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, BONE PAIN (bone pain), INFLUENZA LIKE ILLNESS (flu like sumptoms), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant product use was reported No treatment information was provided Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Additional information received on 27-APR-2021 and does not contain any new information

Other Meds:

Current Illness:

ID: 1566100
Sex: F
Age: 85
State: NY

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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Symptoms: nausea; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; fever of 100.1?F; couldn't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), CHILLS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), HEADACHE (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), MYALGIA (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness) and DIZZINESS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cellulitis of leg (Cellulitis on the right leg.) in January 2021 and Bypass surgery (Three bypass). On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced NAUSEA (nausea), CHILLS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), HEADACHE (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), MYALGIA (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), DIZZINESS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), EAR PAIN (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), PYREXIA (fever of 100.1?F) and BEDRIDDEN (couldn't get out of bed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), CHILLS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), HEADACHE (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), MYALGIA (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), DIZZINESS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), EAR PAIN (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), PYREXIA (fever of 100.1?F) and BEDRIDDEN (couldn't get out of bed) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The Patient outcome of the events not provided.

Other Meds: ELIQUIS; PLAVIX; METOPROLOL; LISINOPRIL

Current Illness:

ID: 1566101
Sex: F
Age: 54
State: MS

Vax Date: 01/19/2021
Onset Date: 01/21/2021
Rec V Date: 08/15/2021
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Symptoms: tender; redness on her arm appeared 2-3 days later which started on the front of her deltoid; same typical side effects; itchy; fever; tired; felt crappy; arm was really sore; good bit of swelling about 1/2 inch and diameter of 2 inches; redness; itchy; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (same typical side effects), PRURITUS (itchy), TENDERNESS (tender) and INJECTION SITE ERYTHEMA (redness on her arm appeared 2-3 days later which started on the front of her deltoid) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PRURITUS (itchy). On 25-Feb-2021, the patient experienced VACCINATION COMPLICATION (same typical side effects). On 27-Feb-2021, the patient experienced TENDERNESS (tender) and INJECTION SITE ERYTHEMA (redness on her arm appeared 2-3 days later which started on the front of her deltoid). At the time of the report, VACCINATION COMPLICATION (same typical side effects), PRURITUS (itchy) and TENDERNESS (tender) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds:

Current Illness:

ID: 1566102
Sex: F
Age: 60
State:

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 08/15/2021
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Symptoms: rash at the injection site the size of a tennis ball that took almost 5 five days before it started to; massive headache; She could not even touch the injection arm for like 3 days, it hurt even to touch it, she could not; did not feel like doing anything; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (did not feel like doing anything), HEADACHE (massive headache), VACCINATION SITE PAIN (She could not even touch the injection arm for like 3 days, it hurt even to touch it, she could not) and VACCINATION SITE RASH (rash at the injection site the size of a tennis ball that took almost 5 five days before it started to) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The patient's past medical history included Stomach cancer (stage 3) in 2010 and Lymph node excision (Removal of abdominal lymph nodes). Concomitant products included CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced DISCOMFORT (did not feel like doing anything) and VACCINATION SITE PAIN (She could not even touch the injection arm for like 3 days, it hurt even to touch it, she could not). On 14-Feb-2021, the patient experienced HEADACHE (massive headache). On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site the size of a tennis ball that took almost 5 five days before it started to). On 16-Feb-2021, DISCOMFORT (did not feel like doing anything) had resolved. On 21-Feb-2021, VACCINATION SITE PAIN (She could not even touch the injection arm for like 3 days, it hurt even to touch it, she could not) had resolved. At the time of the report, HEADACHE (massive headache) and VACCINATION SITE RASH (rash at the injection site the size of a tennis ball that took almost 5 five days before it started to) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: VITAMIN B 1-6-12

Current Illness:

ID: 1566103
Sex: F
Age: 56
State: TX

Vax Date: 03/01/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
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Symptoms: fatigue; body aches; headache; fever of 100?F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever of 100?F) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever of 100?F). At the time of the report, PYREXIA (fever of 100?F) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1566104
Sex: M
Age: 41
State: CT

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Vertigo went away (resolved); This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo went away (resolved)) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011L20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 and Dizziness. Concurrent medical conditions included Vertigo. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-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 VERTIGO (Vertigo went away (resolved)). At the time of the report, VERTIGO (Vertigo went away (resolved)) had resolved. No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.

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Current Illness: Vertigo

ID: 1566105
Sex: F
Age:
State: WI

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Onset Date: 02/25/2021
Rec V Date: 08/15/2021
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Symptoms: Irritable Bowl Syndrome-diarrhea; Gut ache; Loose stool; Stomach ache; Diarrhea; Hip Pain/Hips hurt; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable Bowl Syndrome-diarrhea), GASTROINTESTINAL PAIN (Gut ache), DIARRHOEA (Diarrhea), DIARRHOEA (Loose stool) and ABDOMINAL PAIN UPPER (Stomach ache) in a female 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. The patient's past medical history included Irritable bowel syndrome (Patient had IBS-D with monthly occurrences ). On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ARTHRALGIA (Hip Pain/Hips hurt) and AXILLARY PAIN (Sore arm). On 26-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache). On 02-Mar-2021, the patient experienced GASTROINTESTINAL PAIN (Gut ache) and DIARRHOEA (Loose stool). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable Bowl Syndrome-diarrhea). On 26-Feb-2021, ARTHRALGIA (Hip Pain/Hips hurt) and AXILLARY PAIN (Sore arm) had resolved. On 27-Feb-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable Bowl Syndrome-diarrhea), GASTROINTESTINAL PAIN (Gut ache), DIARRHOEA (Loose stool) and ABDOMINAL PAIN UPPER (Stomach ache) outcome was unknown. This case was linked to MOD-2021-032382 (Patient Link).

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Current Illness:

ID: 1566106
Sex: F
Age: 71
State:

Vax Date: 02/08/2021
Onset Date: 02/01/2021
Rec V Date: 08/15/2021
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Symptoms: Diarrhea; teeth were hurting; nose was dripping; could not even lay down or sit up; severe headache, my head felt like it was going to blow up; Vomiting; nausea; A spontaneous report was received from a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vomiting, diarrhea, severe headache/headache, teeth were hurting/toothache, nose was dripping/rhinorrhea, could not even lay down or sit up/discomfort and nausea. The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event included nortriptilina, cranberry [vaccinium macrocarpon], ginger [zingiber officinale rhizome], ubidecarenone, vitamin d3 and diazepam, isopropamide iodide. On 08-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly on left upper arm for prophylaxis of COVID-19 infection. In Feb-2021, the patient stated that she had a bad reaction to the vaccine, and she experienced vomiting, diarrhea, severe headache and her head felt like it was going to blow up. The patient's teeth hurt like she had four root canals done without even actually getting anything. The patient also had dripping nose. The patient was not able to lay down or sit up and she felt awful. The patient had been to the emergency room where she was given an intravenous drip (IV) for nausea and medications for pain. Patient felt better after 24 hours but she stated that she still felt like beaten up but was much better. The patient took Motrin (ibuprofen) couple of times a day. The patient had little bit of headache at the time of the report. Action taken with mRNA-1273 was unknown. The outcome of the events, vomiting, diarrhea, teeth were hurting, nose was dripping, could not even lay down or sit up and nausea was recovering/resolving and the outcome for severe headache my head felt like it was going to blow up were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.

Other Meds: NORTRIPTILINA; CRANBERRY [VACCINIUM MACROCARPON]; GINGER [ZINGIBER OFFICINALE RHIZOME]; COQ-10; VITAMIN D3; VALTRAX

Current Illness:

ID: 1566107
Sex: F
Age: 78
State: KS

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 08/15/2021
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Symptoms: her eyes are watery; She has a Sore nose; she had a bout of sneezing; some coughing; She also felt a slight ache in the center of her chest; She has Drainage; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), SNEEZING (she had a bout of sneezing), COUGH (some coughing), CHEST PAIN (She also felt a slight ache in the center of her chest) and LACRIMATION INCREASED (her eyes are watery) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. no medical history is provided. and concomitant drugs are provided. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), XYLOMETAZOLINE HYDROCHLORIDE (XYZOLINE), CLOPIDOGREL BISULFATE (PLAVIX), LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCT), CARVEDILOL, Low dose aspirin, SPIRONOLACTONE and Labetolol as needed for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RHINORRHOEA (She has Drainage). On 12-Feb-2021, the patient experienced SNEEZING (she had a bout of sneezing), COUGH (some coughing) and CHEST PAIN (She also felt a slight ache in the center of her chest). On an unknown date, the patient experienced LACRIMATION INCREASED (her eyes are watery). On 12-Feb-2021, COUGH (some coughing) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), SNEEZING (she had a bout of sneezing), CHEST PAIN (She also felt a slight ache in the center of her chest) and RHINORRHOEA (She has Drainage) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC.-MOD-2021-033759 (E2B Linked Report).

Other Meds: SINGULAIR; XYZOLINE; PLAVIX; SYNTHROID; MONTELUKAST; LOSARTAN HCT; CARVEDILOL; Low dose aspirin; SPIRONOLACTONE; Labetolol as needed

Current Illness:

ID: 1566108
Sex: F
Age: 58
State: NJ

Vax Date: 03/02/2021
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Rec V Date: 08/15/2021
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Symptoms: Eye (RIGHT) swelling; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye (RIGHT) swelling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Eye (RIGHT) swelling). At the time of the report, EYE SWELLING (Eye (RIGHT) swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. The treatment for the event included peroxide and warn cloth.

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Current Illness:

ID: 1566109
Sex: F
Age:
State: TX

Vax Date: 02/28/2021
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Rec V Date: 08/15/2021
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Symptoms: fever; chills; body aches; headaches; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN (body aches), HEADACHE (headaches) and DIZZINESS (dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-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 PYREXIA (fever), CHILLS (chills), PAIN (body aches), HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), CHILLS (chills), PAIN (body aches), HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

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Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm