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**
PLEASE CHECK BACK SOON
Download the files above while you wait.






Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1564342
Sex: M
Age: 66
State: OH

Vax Date: 03/04/2021
Onset Date: 02/07/2021
Rec V Date: 08/15/2021
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: Sore arm; Very tired; Headache; Burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BURNING SENSATION (Burning sensation), FATIGUE (Very tired) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Feb-2021, the patient experienced BURNING SENSATION (Burning sensation) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very tired) had resolved and BURNING SENSATION (Burning sensation) and HEADACHE (Headache) outcome was unknown. Not Provided No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: TCR received: Outcome of the event & 2nd dose was mentioned.

Other Meds:

Current Illness:

ID: 1564343
Sex: M
Age:
State: FL

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
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: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included CILOSTAZOL for an unknown indication. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (sore arm). On 26-Feb-2021, MYALGIA (sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was taking Cilostazol for a blockage in his right leg and was concerned about a bleeding risk. No treatment information was provided.

Other Meds: CILOSTAZOL

Current Illness:

ID: 1564344
Sex: M
Age: 17
State: CA

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
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: Vaccinated a 17 year old; A spontaneous report was received from a health care professional concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was provided. Concomitant product use was not provided by the reporter. On 02 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013A21A) for prophylaxis of COVID-19 infection. On 02 Mar 2021, The patient experienced vaccinated at 17 years old. Treatment information was none. Action taken with mRNA-1273 in response to the events was not provided. The outcome of event vaccinated at 17 years old was considered resolved on 02 Mar 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 013A21A) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1564345
Sex: F
Age: 65
State: CA

Vax Date: 03/02/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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: difficulty breathing; chest discomfort; Cough; Fever; body aches; body aches , headaches , chest pains; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (chest discomfort), COUGH (Cough), PYREXIA (Fever) and MYALGIA (body aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Asthma. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (chest discomfort), COUGH (Cough), PYREXIA (Fever), MYALGIA (body aches) and HEADACHE (body aches , headaches , chest pains). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (chest discomfort), COUGH (Cough), PYREXIA (Fever), MYALGIA (body aches) and HEADACHE (body aches , headaches , chest pains) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported.

Other Meds:

Current Illness:

ID: 1564346
Sex: F
Age: 57
State: TX

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
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: my heart was pounding; metal taste, kind of like a fuzziness, in my tongue; heartburn; chills; random rashes on my body and it disappears in 15 minutes; felt tightness in chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (felt tightness in chest), PALPITATIONS (my heart was pounding), DYSGEUSIA (metal taste, kind of like a fuzziness, in my tongue), DYSPEPSIA (heartburn) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dermographism. Concomitant products included ATORVASTATIN, CALCIUM CITRATE, ZINC, MULTIVITAMINS [VITAMINS NOS], ALPRAZOLAM, PROBIOTICS NOS and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced CHEST DISCOMFORT (felt tightness in chest) and RASH (random rashes on my body and it disappears in 15 minutes). On 26-Feb-2021, the patient experienced PALPITATIONS (my heart was pounding), DYSGEUSIA (metal taste, kind of like a fuzziness, in my tongue), DYSPEPSIA (heartburn) and CHILLS (chills). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of UNK dosage form. On 25-Feb-2021, CHEST DISCOMFORT (felt tightness in chest) had resolved. At the time of the report, PALPITATIONS (my heart was pounding), DYSGEUSIA (metal taste, kind of like a fuzziness, in my tongue), DYSPEPSIA (heartburn), CHILLS (chills) and RASH (random rashes on my body and it disappears in 15 minutes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Contact information & new AE added

Other Meds: ATORVASTATIN; CALCIUM CITRATE; ZINC; MULTIVITAMINS [VITAMINS NOS]; ALPRAZOLAM; PROBIOTICS NOS; VIT D [COLECALCIFEROL]

Current Illness: Dermographism

ID: 1564347
Sex: M
Age: 41
State: TX

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/15/2021
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: Tiredness and agitation; Tiredness and agitation; nausea, chills with no fever and shortness of breath for a day; nausea, chills with no fever and shortness of breath for a day; nausea, chills with no fever and shortness of breath for a day; soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (Tiredness and agitation), PAIN IN EXTREMITY (soreness in his arm), DYSPNOEA (nausea, chills with no fever and shortness of breath for a day), FATIGUE (Tiredness and agitation) and NAUSEA (nausea, chills with no fever and shortness of breath for a day) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma and Allergy NOS. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm). On 25-Feb-2021, the patient experienced DYSPNOEA (nausea, chills with no fever and shortness of breath for a day), NAUSEA (nausea, chills with no fever and shortness of breath for a day) and CHILLS (nausea, chills with no fever and shortness of breath for a day). On 08-Mar-2021, the patient experienced AGITATION (Tiredness and agitation) and FATIGUE (Tiredness and agitation). The patient was treated with SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) at a dose of 1 dosage form; LORATADINE (CLARITINE) at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. On 15-Feb-2021, PAIN IN EXTREMITY (soreness in his arm) had resolved. On 26-Feb-2021, DYSPNOEA (nausea, chills with no fever and shortness of breath for a day), NAUSEA (nausea, chills with no fever and shortness of breath for a day) and CHILLS (nausea, chills with no fever and shortness of breath for a day) had resolved. At the time of the report, AGITATION (Tiredness and agitation) and FATIGUE (Tiredness and agitation) 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.

Other Meds:

Current Illness: Asthma

ID: 1564348
Sex: F
Age: 65
State: PA

Vax Date: 01/18/2021
Onset Date: 02/23/2021
Rec V Date: 08/15/2021
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: day after arm was red below deltoid in between bicept and tricep; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (day after arm was red below deltoid in between bicept and tricep) and VACCINATION SITE PRURITUS (itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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 VACCINATION SITE ERYTHEMA (day after arm was red below deltoid in between bicept and tricep) and VACCINATION SITE PRURITUS (itching). At the time of the report, VACCINATION SITE ERYTHEMA (day after arm was red below deltoid in between bicept and tricep) and VACCINATION SITE PRURITUS (itching) had not resolved. Treatment included coconut oil application to injection site for itching. No concomitant medications reported. Action taken with mRNA 1273 in response to event was not applicable.

Other Meds:

Current Illness:

ID: 1564349
Sex: M
Age: 35
State: WA

Vax Date: 02/07/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
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: Received dose from temperature excursion vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from temperature excursion vial) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029a21a and 013m20a) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 07-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from temperature excursion vial). On 07-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from temperature excursion vial) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 with no associated AEs.

Other Meds:

Current Illness:

ID: 1564350
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) 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 URTICARIA (Hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported.

Other Meds:

Current Illness:

ID: 1564351
Sex: M
Age:
State: LA

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
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: Can't lift his arm that he received the vaccine in; Moving his arm is so painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't lift his arm that he received the vaccine in) and VACCINATION SITE PAIN (Moving his arm is so painful) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 VACCINATION SITE MOVEMENT IMPAIRMENT (Can't lift his arm that he received the vaccine in) and VACCINATION SITE PAIN (Moving his arm is so painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't lift his arm that he received the vaccine in) and VACCINATION SITE PAIN (Moving his arm is so painful) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up 1: Event outcomes were changed from not recovered to recovered.

Other Meds:

Current Illness:

ID: 1564352
Sex: U
Age:
State: ME

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
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: dose administered with gray particulates from vial; 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 QUALITY ISSUE (dose administered with gray particulates from vial) in a not specif patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 09-Mar-2021, the patient experienced PRODUCT QUALITY ISSUE (dose administered with gray particulates from vial). On 09-Mar-2021, PRODUCT QUALITY ISSUE (dose administered with gray particulates from vial) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications or treatment details reported.

Other Meds:

Current Illness:

ID: 1564353
Sex: F
Age: 54
State: OH

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Swelling under left arm; Limited range of motion; Rotator cuff tendonitis, left; Acute pain of both shoulders; Fatigue; Achiness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Swelling under left arm), MOBILITY DECREASED (Limited range of motion), PAIN (Achiness), ROTATOR CUFF SYNDROME (Rotator cuff tendonitis, left) and ARTHRALGIA (Acute pain of both shoulders) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Grass allergy, Pollen allergy, Allergy to plants (Pine), Allergy to animals (Rabbit hair), Allergic to cats, Hypothyroidism since 19-Jul-2017, Seasonal allergic rhinitis (Acute) and Hypercholesterolemia since 19-Jul-2017. Concomitant products included CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ZYRTEC-D) for Allergy, BUPROPION from 09-Dec-2020 to an unknown date for Depression, ATORVASTATIN from 17-Jul-2017 to an unknown date for Hypercholesteremia, LEVOTHYROXINE from 17-Jul-2017 to an unknown date for Hypothyroidism, ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 17-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (Achiness) and FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swelling under left arm), MOBILITY DECREASED (Limited range of motion) and ARTHRALGIA (Acute pain of both shoulders). 19-Feb-2021, the patient experienced ROTATOR CUFF SYNDROME (Rotator cuff tendonitis, left). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form; ACETAMINOPHEN at a dose of 1 dosage form; Physical therapy (Exercises daily) for Mobility decreased; Physical therapy for Rotator cuff syndrome and Physical therapy for Arthralgia. On 21-Feb-2021, PERIPHERAL SWELLING (Swelling under left arm) had resolved. At the time of the report, MOBILITY DECREASED (Limited range of motion) was resolving, PAIN (Achiness) and FATIGUE (Fatigue) outcome was unknown and ROTATOR CUFF SYNDROME (Rotator cuff tendonitis, left) and ARTHRALGIA (Acute pain of both shoulders) had not resolved. Action taken with mRNA-1273 in response to the events was not Applicable. Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Additional information received on 05-Jun-2021 had updated patient details, other relevant history. Added concomitant and treatment medications. Added second dose details of a patient. Added new events fatigue, pain, rotator cuff tendonitis of the left shoulder. Updated the time of first dose.

Other Meds: ZYRTEC-D; LEVOTHYROXINE; ATORVASTATIN; BUPROPION; LIPITOR

Current Illness: Allergic to cats; Allergy to animals (Rabbit hair); Allergy to plants (Pine); Grass allergy; Hypercholesterolemia; Hypothyroidism; Pollen allergy; Seasonal allergic rhinitis (Acute)

ID: 1564354
Sex: F
Age: 66
State: CA

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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: vertigo; headache; nauses; Needed to rest it out/ fatigue/ lightheaded; Rough night/ trouble sleeping; stomach issues; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Needed to rest it out/ fatigue/ lightheaded), INSOMNIA (Rough night/ trouble sleeping), ABDOMINAL DISCOMFORT (stomach issues), VERTIGO (vertigo) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LISINOPRIL and ATENOLOL for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INSOMNIA (Rough night/ trouble sleeping) and ABDOMINAL DISCOMFORT (stomach issues). On 06-Mar-2021, the patient experienced FATIGUE (Needed to rest it out/ fatigue/ lightheaded). On 08-Mar-2021, the patient experienced VERTIGO (vertigo), HEADACHE (headache) and NAUSEA (nauses). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, FATIGUE (Needed to rest it out/ fatigue/ lightheaded), INSOMNIA (Rough night/ trouble sleeping), ABDOMINAL DISCOMFORT (stomach issues), VERTIGO (vertigo), HEADACHE (headache) and NAUSEA (nauses) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: LISINOPRIL; ATENOLOL

Current Illness:

ID: 1564355
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: Diarrhea; Shortness of breath upon exertion; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and DYSPNOEA EXERTIONAL (Shortness of breath upon exertion) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products TREPROSTINIL SODIUM gas for Secondary pulmonary arterial hypertension and TADALAFIL for an unknown indication. Concurrent medical conditions included Pulmonary arterial hypertension. On 24-Nov-2020, the patient started TREPROSTINIL SODIUM (unknown route) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TADALAFIL (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and DYSPNOEA EXERTIONAL (Shortness of breath upon exertion). At the time of the report, DIARRHOEA (Diarrhea) and DYSPNOEA EXERTIONAL (Shortness of breath upon exertion) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment for the event ,was not provided. Reporter did not allow further contact

Other Meds: TREPROSTINIL SODIUM; TADALAFIL;

Current Illness: Pulmonary arterial hypertension

ID: 1564356
Sex: F
Age: 26
State: TX

Vax Date: 02/04/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
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: Missed her second Moderna; Got 104 F fever just 1 day before second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed her second Moderna) and PYREXIA (Got 104 F fever just 1 day before second dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Got 104 F fever just 1 day before second dose). On 04-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her second Moderna). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 04-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed her second Moderna) had resolved. At the time of the report, PYREXIA (Got 104 F fever just 1 day before second dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 104 (High) Fever. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient received their first dose of Moderna vaccine 04-Feb-2021 and was perfectly fine after that dose, The patient's second dose was scheduled on 04-Mar-2021, but the patient missed their second Moderna dose as on 03-Mar-2021 in night the patient got 104 F fever. The patient took Tylenol and Ibuprofen for the symptoms, but symptoms didn't go away. The patient visited doctors and they prescribed antibiotics and steroids. Reportedly, the doctor said that if it was viral infection then the patient has to take these medications. No Concomitant product use was reported. Treatment medications prescribed to the patient included antibiotics and steroids.

Other Meds:

Current Illness:

ID: 1564357
Sex: F
Age: 68
State:

Vax Date: 01/21/2021
Onset Date: 01/01/2021
Rec V Date: 08/15/2021
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: no voice due to swelling in her throat; hives; redness; Swelling; allergic reaction; cannot speak; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), ERYTHEMA (redness), SWELLING (Swelling), PHARYNGEAL SWELLING (no voice due to swelling in her throat) and SPEECH DISORDER (cannot speak) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy (History of allergies.). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. In January 2021, the patient experienced SPEECH DISORDER (cannot speak). On 22-Jan-2021, the patient experienced URTICARIA (hives), ERYTHEMA (redness), SWELLING (Swelling) and HYPERSENSITIVITY (allergic reaction). On an unknown date, the patient experienced PHARYNGEAL SWELLING (no voice due to swelling in her throat). The patient was treated with PREDNISONE for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, URTICARIA (hives), ERYTHEMA (redness), SWELLING (Swelling), PHARYNGEAL SWELLING (no voice due to swelling in her throat), SPEECH DISORDER (cannot speak) and HYPERSENSITIVITY (allergic reaction) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness: Allergy (History of allergies.)

ID: 1564358
Sex: F
Age: 79
State: FL

Vax Date: 02/02/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
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: Extreme lower back pain; Fever of 102 Degrees; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Extreme lower back pain), PYREXIA (Fever of 102 Degrees) and FATIGUE (Tiredness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE and LOSARTAN for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever of 102 Degrees) and FATIGUE (Tiredness). On an unknown date, the patient experienced BACK PAIN (Extreme lower back pain). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Extreme lower back pain) had not resolved and PYREXIA (Fever of 102 Degrees) and FATIGUE (Tiredness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 102 (High) 102 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Other treatment information included heating pad.

Other Meds: LEVOTHYROXINE; LOSARTAN

Current Illness:

ID: 1564359
Sex: F
Age: 48
State: TX

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
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: sick to stomach; diarrhea; Chills; headache; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (sick to stomach), DIARRHOEA (diarrhea), CHILLS (Chills) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (sick to stomach), DIARRHOEA (diarrhea), CHILLS (Chills) and HEADACHE (headache). At the time of the report, ABDOMINAL PAIN UPPER (sick to stomach), DIARRHOEA (diarrhea), CHILLS (Chills) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1564360
Sex: F
Age: 69
State: TX

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
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: Unable to breathe for a few minutes; Chest pain; Joint pain; Pain at the injection site; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events joint pain, pain at the injection site, chest pain and unable to breathe for a few minutes.. The patient's medical history, as provided by the reporter, included gallbladder surgery and allergy to lentils. No relevant concomitant medications were reported. On 6 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 6 Mar 2021, the patient experienced the event(s) joint pain, pain at the injection site, chest pain and unable to breathe for a few minutes. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 6 Mar 2021 the outcome of event, unable to breathe for a few minutes was resolved. On 8 Mar 2021 the outcome of event, joint pain, pain at the injection site, chest pain was resolved.; 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. Further information has been requested.

Other Meds:

Current Illness:

ID: 1564361
Sex: F
Age: 57
State: TX

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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: on injection site itchy; on injection site red; on injection site warm to the touch; on injection site rash; on injection site rash getting bigger; on injection site hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (on injection site itchy), VACCINATION SITE ERYTHEMA (on injection site red), VACCINATION SITE WARMTH (on injection site warm to the touch), VACCINATION SITE RASH (on injection site rash) and VACCINATION SITE RASH (on injection site rash getting bigger) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Narcolepsy, Cirrhosis of liver, Squamous cell carcinoma and Melanoma (Left arm). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Narcolepsy, FUROSEMIDE, PREDNISONE, SPIRONOLACTONE and PREGABALIN (LYRICA) for an unknown indication. On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (on injection site itchy), VACCINATION SITE ERYTHEMA (on injection site red), VACCINATION SITE WARMTH (on injection site warm to the touch), VACCINATION SITE RASH (on injection site rash), VACCINATION SITE RASH (on injection site rash getting bigger) and VACCINATION SITE MASS (on injection site hard). At the time of the report, VACCINATION SITE PRURITUS (on injection site itchy), VACCINATION SITE ERYTHEMA (on injection site red), VACCINATION SITE WARMTH (on injection site warm to the touch), VACCINATION SITE RASH (on injection site rash), VACCINATION SITE RASH (on injection site rash getting bigger) and VACCINATION SITE MASS (on injection site hard) outcome was unknown. No treatment details reported.

Other Meds: ADDERALL; FUROSEMIDE; PREDNISONE; SPIRONOLACTONE; LYRICA

Current Illness: Cirrhosis of liver; Melanoma (Left arm); Narcolepsy; Squamous cell carcinoma

ID: 1564362
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: Aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012AZ1A) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced PAIN (Aches) and FATIGUE (Fatigue). At the time of the report, PAIN (Aches) and FATIGUE (Fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1564363
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (had a reaction to report) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (had a reaction to report). At the time of the report, ADVERSE REACTION (had a reaction to report) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported.No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1564364
Sex: F
Age: 66
State: FL

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
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: very tired; tingling in lips; chest tightening; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling in lips), CHEST DISCOMFORT (chest tightening), HEADACHE (slight headache) and FATIGUE (very tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. Concomitant products included AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling in lips), CHEST DISCOMFORT (chest tightening) and HEADACHE (slight headache). On 03-Mar-2021, the patient experienced FATIGUE (very tired). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at a dose of UNK dosage form. On 03-Mar-2021, PARAESTHESIA ORAL (tingling in lips), CHEST DISCOMFORT (chest tightening) and HEADACHE (slight headache) had resolved. On 07-Mar-2021, FATIGUE (very tired) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: AMLODIPINE; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1564365
Sex: F
Age:
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Nausea; dizzy; feels like burn from shoulder up to the elbow.; L arm swelling; L arm extremely itchy; Arm is red as the day when she got the injection; fever low grade; immediate fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), BURNING SENSATION (feels like burn from shoulder up to the elbow.), INJECTION SITE REACTION (L arm swelling), INJECTION SITE REACTION (L arm extremely itchy) and INJECTION SITE REACTION (Arm is red as the day when she got the injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Gastrointestinal disorder NOS, Migraine and Allergy NOS. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Gastrointestinal disorder, ALPRAZOLAM (XANAX), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and BACLOFEN for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizzy), BURNING SENSATION (feels like burn from shoulder up to the elbow.), INJECTION SITE REACTION (L arm swelling), INJECTION SITE REACTION (L arm extremely itchy), INJECTION SITE REACTION (Arm is red as the day when she got the injection), PYREXIA (fever low grade) and FATIGUE (immediate fatigue). On 04-Mar-2021, the patient experienced NAUSEA (Nausea). At the time of the report, DIZZINESS (dizzy), BURNING SENSATION (feels like burn from shoulder up to the elbow.), INJECTION SITE REACTION (L arm swelling), INJECTION SITE REACTION (L arm extremely itchy), INJECTION SITE REACTION (Arm is red as the day when she got the injection), PYREXIA (fever low grade), FATIGUE (immediate fatigue) and NAUSEA (Nausea) outcome was unknown. Additional concomitant medications included loinzeff for gastro issues and migraines medicines (once a month) which was stopped on 03 Feb 2021. Treatment for the event included diphenhydramine (Benadryl) and acetaminophen (Tylenol). The patient took the medicine when she felt bad.

Other Meds: XANAX; PROTONIX [OMEPRAZOLE]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; TRINTELLIX; BACLOFEN

Current Illness: Allergy NOS; Gastrointestinal disorder NOS; Migraine

ID: 1564366
Sex: F
Age: 79
State: MA

Vax Date: 02/22/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
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: Covid arm; itchiness on the left arm; a circular red rash which lasted and went worse and spread a couple of days. Gradually is going away; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (a circular red rash which lasted and went worse and spread a couple of days. Gradually is going away), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE PRURITUS (itchiness on the left arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced RASH ERYTHEMATOUS (a circular red rash which lasted and went worse and spread a couple of days. Gradually is going away) and VACCINATION SITE PRURITUS (itchiness on the left arm). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm). At the time of the report, RASH ERYTHEMATOUS (a circular red rash which lasted and went worse and spread a couple of days. Gradually is going away), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE PRURITUS (itchiness on the left arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Events and second dose details updated

Other Meds:

Current Illness:

ID: 1564367
Sex: F
Age: 69
State: CA

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Soreness of arm; Depression; Swollen glands of breast; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), DEPRESSION (Depression) and LYMPHADENOPATHY (Swollen glands of breast) 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm), DEPRESSION (Depression) and LYMPHADENOPATHY (Swollen glands of breast). At the time of the report, PAIN IN EXTREMITY (Soreness of arm), DEPRESSION (Depression) and LYMPHADENOPATHY (Swollen glands of breast) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1564368
Sex: F
Age: 67
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: BODY ACHES; COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET; COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET; MUSCLE ACHES; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (BODY ACHES), RASH PRURITIC (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), BURNING SENSATION (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), MYALGIA (MUSCLE ACHES) and PYREXIA (FEVER) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-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 PAIN (BODY ACHES), RASH PRURITIC (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), BURNING SENSATION (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), MYALGIA (MUSCLE ACHES) and PYREXIA (FEVER). At the time of the report, PAIN (BODY ACHES), RASH PRURITIC (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), BURNING SENSATION (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), MYALGIA (MUSCLE ACHES) and PYREXIA (FEVER) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1564369
Sex: F
Age: 53
State: MA

Vax Date: 01/04/2021
Onset Date: 01/11/2021
Rec V Date: 08/15/2021
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: Positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID-19) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced COVID-19 (Positive for COVID-19). On 22-Jan-2021, COVID-19 (Positive for COVID-19) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. 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. On 11JAN2021 patient had COVID 19 symptoms (eye pain, sore throat and headache).

Other Meds:

Current Illness:

ID: 1564370
Sex: F
Age: 29
State: WI

Vax Date: 03/09/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
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: vomiting; arm is sore; Stomach issue; motion sickness; temp was 99/temperature went up to 100/checked her temperature again and it is 99.1; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore), ABDOMINAL DISCOMFORT (Stomach issue), MOTION SICKNESS (motion sickness), PYREXIA (temp was 99/temperature went up to 100/checked her temperature again and it is 99.1) and VOMITING (vomiting) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M208) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm is sore), ABDOMINAL DISCOMFORT (Stomach issue), MOTION SICKNESS (motion sickness) and PYREXIA (temp was 99/temperature went up to 100/checked her temperature again and it is 99.1). On an unknown date, the patient experienced VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm is sore), ABDOMINAL DISCOMFORT (Stomach issue), MOTION SICKNESS (motion sickness), PYREXIA (temp was 99/temperature went up to 100/checked her temperature again and it is 99.1) and VOMITING (vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 99 (High) 99, 100 (High) 100 and 99.1 (High) 99.1. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Treatment for the events included acetaminophen (Tylenol), ginger and motion sickness medicine unspecified. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1564371
Sex: F
Age: 62
State: CT

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: swelling; allergic reaction related to vaccine because I've never had a problem with Bacitracin before; rash; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction related to vaccine because I've never had a problem with Bacitracin before), RASH (rash), SWELLING (swelling) and PAIN IN EXTREMITY (pain in arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 08-Mar-2021, the patient experienced HYPERSENSITIVITY (allergic reaction related to vaccine because I've never had a problem with Bacitracin before) and RASH (rash). On 09-Mar-2021, the patient experienced SWELLING (swelling). On 05-Mar-2021, PAIN IN EXTREMITY (pain in arm) had resolved. At the time of the report, HYPERSENSITIVITY (allergic reaction related to vaccine because I've never had a problem with Bacitracin before), RASH (rash) and SWELLING (swelling) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient believes the allergic reaction to Bacitracin could be related to the Moderna Covid-19 vaccine. She reports that she applied Cortizone cream to help with the itching but the symptoms are ongoing. Treatment details included Bacitracin topical ointment, Cortizone cream.

Other Meds:

Current Illness:

ID: 1564372
Sex: F
Age: 42
State: IL

Vax Date: 02/09/2021
Onset Date:
Rec V Date: 08/15/2021
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: Diarrhea; 103.0 fever reduced to 100.9; Chills; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (103.0 fever reduced to 100.9), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (103.0 fever reduced to 100.9), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PYREXIA (103.0 fever reduced to 100.9), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: abnormal (abnormal) 103.0 fever has come down to 100. 9.. Concomitant product use was not provided by the reporter. Lab details were not provided.

Other Meds:

Current Illness:

ID: 1564373
Sex: M
Age: 67
State: NC

Vax Date: 02/03/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
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: Disoriented; Dizziness; No energy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disoriented), DIZZINESS (Dizziness), ASTHENIA (No energy) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced DISORIENTATION (Disoriented), DIZZINESS (Dizziness), ASTHENIA (No energy) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISORIENTATION (Disoriented), DIZZINESS (Dizziness), ASTHENIA (No energy) and HEADACHE (Headache) had not resolved. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1564374
Sex: F
Age: 73
State: WA

Vax Date: 03/02/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
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: Nausea; Experienced diarrhea later that afternoon; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Experienced diarrhea later that afternoon) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. Concurrent medical conditions included Glaucoma. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIARRHOEA (Experienced diarrhea later that afternoon). On 09-Mar-2021, the patient experienced NAUSEA (Nausea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. On 09-Mar-2021, DIARRHOEA (Experienced diarrhea later that afternoon) had resolved. At the time of the report, NAUSEA (Nausea) 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 assessment. Concomitant products included vitamins and eye drops for glaucoma.

Other Meds:

Current Illness: Glaucoma

ID: 1564375
Sex: F
Age:
State: NC

Vax Date: 02/17/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
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: Swelling of the face, first right and then left side; feels like needles; Red all over; Tingling; Broke up in hives; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swelling of the face, first right and then left side), URTICARIA (Broke up in hives), PAIN (feels like needles), ERYTHEMA (Red all over) and PARAESTHESIA (Tingling) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced URTICARIA (Broke up in hives), ERYTHEMA (Red all over) and PARAESTHESIA (Tingling). On an unknown date, the patient experienced SWELLING FACE (Swelling of the face, first right and then left side) and PAIN (feels like needles). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 2 tablets, some times 3.. At the time of the report, SWELLING FACE (Swelling of the face, first right and then left side), URTICARIA (Broke up in hives), PAIN (feels like needles), ERYTHEMA (Red all over) and PARAESTHESIA (Tingling) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Antibiotic, Another Antibiotic (didn't specify), Benadryl 2 tablets, some times 3, Steroids. No concomitant medication information was provided. Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up information was received and contact number was updated.

Other Meds:

Current Illness:

ID: 1564376
Sex: M
Age: 79
State:

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 08/15/2021
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: Extremely sleepy; Arm hurts; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (Extremely sleepy) and PAIN IN EXTREMITY (Arm hurts) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 032M20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, 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 SOMNOLENCE (Extremely sleepy) and PAIN IN EXTREMITY (Arm hurts). At the time of the report, SOMNOLENCE (Extremely sleepy) and PAIN IN EXTREMITY (Arm hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No treatment information was provided Caller provides consent for Safety to follow up with them or their HCP.

Other Meds:

Current Illness:

ID: 1564377
Sex: F
Age: 41
State: AZ

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
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: Hot flashes; Inability to maintain body temp; Waking up drenched in sweat; Problems sleeping at night; Body aches; Headache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), BODY TEMPERATURE FLUCTUATION (Inability to maintain body temp), HYPERHIDROSIS (Waking up drenched in sweat), INSOMNIA (Problems sleeping at night) and PAIN (Body aches) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MEDROXYPROGESTERONE ACETATE and NAPROXEN for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced HOT FLUSH (Hot flashes), BODY TEMPERATURE FLUCTUATION (Inability to maintain body temp), HYPERHIDROSIS (Waking up drenched in sweat), INSOMNIA (Problems sleeping at night), PAIN (Body aches), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). On 27-Feb-2021, PAIN (Body aches), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. At the time of the report, HOT FLUSH (Hot flashes), BODY TEMPERATURE FLUCTUATION (Inability to maintain body temp), HYPERHIDROSIS (Waking up drenched in sweat) and INSOMNIA (Problems sleeping at night) 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. Treatment details included Tylenol PM. Patient has taken Tylenol PM to help relieve symptoms, with no relief. HCP information gathered. Patient agreed for follow up with Safety.

Other Meds: MEDROXYPROGESTERONE ACETATE; NAPROXEN

Current Illness:

ID: 1564378
Sex: F
Age: 68
State: VA

Vax Date: 02/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
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: Did not give her the second covid-19 vaccine; Severe hives for 3 weeks; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of URTICARIA (Severe hives for 3 weeks) and INTENTIONAL DOSE OMISSION (Did not give her the second covid-19 vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. No medical history information reported. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced URTICARIA (Severe hives for 3 weeks). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Did not give her the second covid-19 vaccine). At the time of the report, URTICARIA (Severe hives for 3 weeks) outcome was unknown and INTENTIONAL DOSE OMISSION (Did not give her the second covid-19 vaccine) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. concomitant medication including thyroid meds was reported Treatment using diphenhydramine was reported Reporter did not want to share email, does not have any other patient info Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Reporter stated intentional omission of second dose, event updated

Other Meds: WELLBUTRIN

Current Illness:

ID: 1564379
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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: It looks like an allergic reaction; Bumpy injection site; Itches like crazy injection site; Red injection site; Rashes at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPERSENSITIVITY (It looks like an allergic reaction), VACCINATION SITE MASS (Bumpy injection site), VACCINATION SITE PRURITUS (Itches like crazy injection site) and VACCINATION SITE ERYTHEMA (Red injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. 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 PAIN IN EXTREMITY (Sore arm). On 09-Mar-2021, the patient experienced VACCINATION SITE HYPERSENSITIVITY (It looks like an allergic reaction), VACCINATION SITE MASS (Bumpy injection site), VACCINATION SITE PRURITUS (Itches like crazy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE RASH (Rashes at injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPERSENSITIVITY (It looks like an allergic reaction), VACCINATION SITE MASS (Bumpy injection site), VACCINATION SITE PRURITUS (Itches like crazy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE RASH (Rashes at injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-JUN-2021: Outcome of the events has been updated to recovered /resolved.

Other Meds:

Current Illness:

ID: 1564380
Sex: M
Age: 76
State: WI

Vax Date: 03/06/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
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: Severe shaking on entire body; Scared to death; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Severe shaking on entire body) and FEAR OF DEATH (Scared to death) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included COPD and Neck injury NOS (damage on his neck). Concomitant products included ALBUTEROL [SALBUTAMOL] for COPD, VITAMINS NOS, CALCIUM and MAGNESIUM for an unknown indication. On 06-Mar-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 08-Mar-2021, the patient experienced TREMOR (Severe shaking on entire body) and FEAR OF DEATH (Scared to death). On 08-Mar-2021, TREMOR (Severe shaking on entire body) and FEAR OF DEATH (Scared to death) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was told by his physician that he would need surgery for his damage on neck. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: follow up received no significant information

Other Meds: VITAMINS NOS; ALBUTEROL [SALBUTAMOL]; CALCIUM; MAGNESIUM

Current Illness: COPD; Neck injury NOS (damage on his neck)

ID: 1564381
Sex: F
Age: 69
State: GA

Vax Date: 02/21/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
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: Broke out in hives; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (Broke out in hives) 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 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Broke out in hives). At the time of the report, URTICARIA (Broke out in hives) 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. Treatment: Patient broke out in hives last weekend and has been on an oral dose of prednisone. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1564382
Sex: F
Age: 71
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Her arm is hurting; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Her arm is hurting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included PREDNISONE and VITAMINS NOS for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE PAIN (Her arm is hurting). At the time of the report, INJECTION SITE PAIN (Her arm is hurting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment details were provided

Other Meds: PREDNISONE; VITAMINS NOS

Current Illness:

ID: 1564383
Sex: F
Age: 68
State: NJ

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 08/15/2021
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: On 8th day after receiving the vaccination, patient noticed a pecan size lump under the injection site; Rash around and under the injection site; Rash is slightly itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (On 8th day after receiving the vaccination, patient noticed a pecan size lump under the injection site), VACCINATION SITE RASH (Rash around and under the injection site) and RASH PRURITIC (Rash is slightly itchy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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 an unknown date, the patient experienced VACCINATION SITE MASS (On 8th day after receiving the vaccination, patient noticed a pecan size lump under the injection site), VACCINATION SITE RASH (Rash around and under the injection site) and RASH PRURITIC (Rash is slightly itchy). At the time of the report, VACCINATION SITE MASS (On 8th day after receiving the vaccination, patient noticed a pecan size lump under the injection site), VACCINATION SITE RASH (Rash around and under the injection site) and RASH PRURITIC (Rash is slightly itchy) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient agreed to follow-up with safety

Other Meds:

Current Illness:

ID: 1564384
Sex: M
Age: 60
State: MD

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

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

Lab Data:

Allergies:

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

Symptoms: Adverse event NOS; dizzy for 2-3 seconds; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy for 2-3 seconds) and ADVERSE EVENT (Adverse event NOS) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (dizzy for 2-3 seconds). On an unknown date, the patient experienced ADVERSE EVENT (Adverse event NOS). At the time of the report, DIZZINESS (dizzy for 2-3 seconds) and ADVERSE EVENT (Adverse event NOS) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products was reported. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Outcome of event updated

Other Meds:

Current Illness:

ID: 1564385
Sex: F
Age: 55
State: TX

Vax Date: 02/28/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
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: Redness had increased; 2-2.5inch raised circle; Redness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), INJECTION SITE PRURITUS (Itchiness), INJECTION SITE SWELLING (2-2.5inch raised circle) and INJECTION SITE ERYTHEMA (Redness had increased) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. Concomitant products included METFORMIN HYDROCHLORIDE;SITAGLIPTIN, METFORMIN HYDROCHLORIDE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, ROSUVASTATIN;TELMISARTAN and KETOTIFEN for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Itchiness). On 08-Mar-2021, the patient experienced ERYTHEMA (Redness) and INJECTION SITE SWELLING (2-2.5inch raised circle). On 09-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness had increased). At the time of the report, ERYTHEMA (Redness), INJECTION SITE PRURITUS (Itchiness), INJECTION SITE SWELLING (2-2.5inch raised circle) and INJECTION SITE ERYTHEMA (Redness had increased) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided

Other Meds: METFORMIN HYDROCHLORIDE;SITAGLIPTIN; METFORMIN HYDROCHLORIDE; BISOPROLOL FUMARATE; ACETYLSALICYLIC ACID; ROSUVASTATIN;TELMISARTAN; KETOTIFEN

Current Illness:

ID: 1564386
Sex: F
Age: 61
State: WA

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/15/2021
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: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Migraine since an unknown date. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 06-Feb-2021, HEADACHE (Headache) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported

Other Meds:

Current Illness: Migraine

ID: 1564387
Sex: F
Age: 74
State: NY

Vax Date: 03/05/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
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: swelling below the knee; swelling of the toe; swelling of the feet; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling below the knee), SWELLING (swelling of the toe) and PERIPHERAL SWELLING (swelling of the feet) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced SWELLING (swelling below the knee), SWELLING (swelling of the toe) and PERIPHERAL SWELLING (swelling of the feet). At the time of the report, SWELLING (swelling below the knee), SWELLING (swelling of the toe) and PERIPHERAL SWELLING (swelling of the feet) 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. No concomitant medication reported No treatment information was provided

Other Meds:

Current Illness:

ID: 1564388
Sex: M
Age: 69
State: CT

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 08/15/2021
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: Sore Throat; Muscle Pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), MYALGIA (Muscle Pain) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), MYALGIA (Muscle Pain) and FATIGUE (Fatigue). On 18-Feb-2021, OROPHARYNGEAL PAIN (Sore Throat) and MYALGIA (Muscle Pain) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided Concomitant medication list also included asthma medication. No treatment was provided. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received

Other Meds: MONTELUKAST; ASPIRIN (E.C.)

Current Illness: Asthma

ID: 1564389
Sex: F
Age:
State: PA

Vax Date: 02/06/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
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: Heat around injection site; Hard around injection site; Redness around injection site; Swelling around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat around injection site), VACCINATION SITE INDURATION (Hard around injection site), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE SWELLING (Swelling around injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 030C20) for COVID-19 vaccination. Concurrent medical conditions included Arthritis. Concomitant products included IBUPROFEN and ACETAMINOPHEN for Arthritis, HYDROCHLOROTHIAZIDE, FAMOTIDINE, GABAPENTIN, MELATONIN, ALPRAZOLAM (ALPRAZOLAN), ROSUVASTATIN, UBIDECARENONE (COENZYME Q-GEL), HYDROXYZINE, CARVEDILOL, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Heat around injection site), VACCINATION SITE INDURATION (Hard around injection site), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE SWELLING (Swelling around injection site). At the time of the report, VACCINATION SITE WARMTH (Heat around injection site), VACCINATION SITE INDURATION (Hard around injection site), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE SWELLING (Swelling around injection site) had resolved. Action taken with mRNA-1273 in response to the events was not applicable. turmeric unknown strength ibuprofen 400 mg PO BID and acetaminophen 2300 mg PO daily in divided doses (as ongoing concomitant meds for pre-existing arthritis.) Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Event Outcome update

Other Meds: HYDROCHLOROTHIAZIDE; FAMOTIDINE; GABAPENTIN; MELATONIN; ALPRAZOLAN; ROSUVASTATIN; COENZYME Q-GEL; IBUPROFEN; HYDROXYZINE; CARVEDILOL; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; ACETAMINOPHEN

Current Illness: Arthritis

ID: 1564390
Sex: F
Age: 78
State: IL

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 08/15/2021
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: Achy arm in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achy arm in injection arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. Concomitant products included LISINOPRIL, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), COLECALCIFEROL (VITAMIN D 3), LANSOPRAZOLE, PROBIOTICS NOS, MAGNESIUM OXIDE and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Achy arm in injection arm). At the time of the report, PAIN IN EXTREMITY (Achy arm in injection arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other concomitant medications include Estrogen Vaginal Cream, Omega 3 Esters, Ferrous Fumarate, Cranberry Capsules, Calcium Carbonate for an unknown indication. No treatment information was provided.

Other Meds: LISINOPRIL; ATORVASTATIN; BABY ASPIRIN; VITAMIN D 3; LANSOPRAZOLE; PROBIOTICS NOS; MAGNESIUM OXIDE; VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1564391
Sex: F
Age:
State: IL

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
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: Uncontrolled cough over a week come in night and it's hard and dry; Lethargic feeling no desire to do anything; Congestion in head; No desire to eat; Sore throat; Sore arm; Fever on and off around 98 degree; Chill on and off; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Uncontrolled cough over a week come in night and it's hard and dry), LETHARGY (Lethargic feeling no desire to do anything), HEAD DISCOMFORT (Congestion in head), DECREASED APPETITE (No desire to eat) and OROPHARYNGEAL PAIN (Sore throat) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011421A) 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 HYDROCHLOROTHIAZIDE for Hypertension, VITAMINS NOS for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced COUGH (Uncontrolled cough over a week come in night and it's hard and dry), LETHARGY (Lethargic feeling no desire to do anything), HEAD DISCOMFORT (Congestion in head), DECREASED APPETITE (No desire to eat), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever on and off around 98 degree), CHILLS (Chill on and off) and HEADACHE (Headache). At the time of the report, COUGH (Uncontrolled cough over a week come in night and it's hard and dry), LETHARGY (Lethargic feeling no desire to do anything), HEAD DISCOMFORT (Congestion in head), DECREASED APPETITE (No desire to eat), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever on and off around 98 degree), CHILLS (Chill on and off) and HEADACHE (Headache) 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. No treatment information was provided.

Other Meds: HYDROCHLOROTHIAZIDE; VITAMINS NOS

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm