VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1563096
Sex: F
Age: 87
State: TX

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: has yet to receive the second dose passed 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has yet to receive the second dose passed 42 days) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042l20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has yet to receive the second dose passed 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has yet to receive the second dose passed 42 days) had resolved. Treatment and concomitant medications were provided by reporter.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273, Lot #: 042l20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1563097
Sex: M
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash on his back that is itching a lot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 21-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 RASH PRURITIC (rash on his back that is itching a lot). At the time of the report, RASH PRURITIC (rash on his back that is itching a lot) had not resolved. No concomitant medications reported. No treatment information provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.

Other Meds:

Current Illness:

ID: 1563098
Sex: M
Age: 75
State: OH

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: poor circulation in right hand; poor circulation in right foot; blurry vision - reduce vision; L arm is still slightly sore and painfui; doesn't recover the complete control of the arm; injection site arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurry vision - reduce vision), PAIN IN EXTREMITY (L arm is still slightly sore and painfui), LIMB DISCOMFORT (doesn't recover the complete control of the arm), INJECTION SITE PAIN (injection site arm pain) and SENSATION OF BLOOD FLOW (poor circulation in right hand) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was reported. Concomitant products included LATANOPROST 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 VISION BLURRED (blurry vision - reduce vision), PAIN IN EXTREMITY (L arm is still slightly sore and painfui), LIMB DISCOMFORT (doesn't recover the complete control of the arm) and INJECTION SITE PAIN (injection site arm pain). On 13-Mar-2021, the patient experienced SENSATION OF BLOOD FLOW (poor circulation in right hand) and SENSATION OF BLOOD FLOW (poor circulation in right foot). At the time of the report, VISION BLURRED (blurry vision - reduce vision), PAIN IN EXTREMITY (L arm is still slightly sore and painfui), LIMB DISCOMFORT (doesn't recover the complete control of the arm), INJECTION SITE PAIN (injection site arm pain), SENSATION OF BLOOD FLOW (poor circulation in right hand) and SENSATION OF BLOOD FLOW (poor circulation in right foot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: follow-up received on 16-Mar-2021 addition of three more events injection site arm pain, poor circulation in right hand and poor circulation in right foot. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurry vision - reduce vision), PAIN IN EXTREMITY (L arm is still slightly sore and painfui), LIMB DISCOMFORT (doesn't recover the complete control of the arm), INJECTION SITE PAIN (injection site arm pain) and SENSATION OF BLOOD FLOW (poor circulation in right hand) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was reported. Concomitant products included LATANOPROST 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 VISION BLURRED (blurry vision - reduce vision), PAIN IN EXTREMITY (L arm is still slightly sore and painfui), LIMB DISCOMFORT (doesn't recover the complete control of the arm) and INJECTION SITE PAIN (injection site arm pain). On 13-Mar-2021, the patient experienced SENSATION OF BLOOD FLOW (poor circulation in right hand) and SENSATION OF BLOOD FLOW (poor circulation in right foot). At the time of the report, VISION BLURRED (blurry vision - reduce vision), PAIN IN EXTREMITY (L arm is still slightly sore and painfui), LIMB DISCOMFORT (doesn't recover the complete control of the arm), INJECTION SITE PAIN (injection site arm pain), SENSATION OF BLOOD FLOW (poor circulation in right hand) and SENSATION OF BLOOD FLOW (poor circulation in right foot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: follow-up received on 16-Mar-2021 addition of three more events injection site arm pain, poor circulation in right hand and poor circulation in right foot.

Other Meds: LATANOPROST

Current Illness:

ID: 1563099
Sex: M
Age: 66
State: OH

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. No reported medical history. Concomitant products included LOSARTAN, PANTOPRAZOLE, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), ROSUVASTATIN, BACLOFEN, OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and ACETYLSALICYLIC ACID (ASPIRIN 81) 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 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to US-MODERNATX, INC.-MOD-2021-044170 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-044170:Husband case

Other Meds: LOSARTAN; PANTOPRAZOLE; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; ROSUVASTATIN; BACLOFEN; PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]; ASPIRIN 81

Current Illness:

ID: 1563100
Sex: F
Age: 72
State: MT

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1563101
Sex: F
Age: 81
State: SC

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: arm was sore at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm was sore at the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE PAIN (arm was sore at the injection site). At the time of the report, INJECTION SITE PAIN (arm was sore at the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1563102
Sex: F
Age:
State: NY

Vax Date: 02/28/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: bump at the injection site; bump warm; bump is hard; bump itchy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (bump at the injection site), INJECTION SITE WARMTH (bump warm), MASS EXCISION (bump is hard) and RASH PRURITIC (bump itchy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE MASS (bump at the injection site), INJECTION SITE WARMTH (bump warm), MASS EXCISION (bump is hard) and RASH PRURITIC (bump itchy). At the time of the report, INJECTION SITE MASS (bump at the injection site), INJECTION SITE WARMTH (bump warm), MASS EXCISION (bump is hard) and RASH PRURITIC (bump itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment was reported. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: NNI TCR attached.

Other Meds:

Current Illness:

ID: 1563103
Sex: M
Age:
State: FL

Vax Date: 02/17/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: possible infection; redness left arm (injection site); itchy it was 4 inches wide 5 inches long; inflamed (injection site); hot to touch (injection site); hard to touch (injection site); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itchy it was 4 inches wide 5 inches long), VACCINATION SITE INFLAMMATION (inflamed (injection site)), VACCINATION SITE WARMTH (hot to touch (injection site)), VACCINATION SITE INDURATION (hard to touch (injection site)) and INFECTION (possible infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 26-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy it was 4 inches wide 5 inches long), VACCINATION SITE INFLAMMATION (inflamed (injection site)), VACCINATION SITE WARMTH (hot to touch (injection site)), VACCINATION SITE INDURATION (hard to touch (injection site)) and VACCINATION SITE ERYTHEMA (redness left arm (injection site)). On 02-Mar-2021, the patient experienced INFECTION (possible infection). On 01-Mar-2021, VACCINATION SITE PRURITUS (itchy it was 4 inches wide 5 inches long) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (inflamed (injection site)), VACCINATION SITE WARMTH (hot to touch (injection site)), VACCINATION SITE INDURATION (hard to touch (injection site)), INFECTION (possible infection) and VACCINATION SITE ERYTHEMA (redness left arm (injection site)) was resolving. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient was antibiotics due to possible infection. doctor said to get the 2nd shot the other arm, we are scheduled to get the 2nd dose on the 18th of March. Concomitant information not provided

Other Meds:

Current Illness:

ID: 1563104
Sex: F
Age: 36
State: KY

Vax Date: 02/01/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: congestion; blotchiness kind of like hives but they stay instead of come and go like hives.; terrible aches; immediate rash after the 2nd dose, Rashes are now starting to pop up after the second dose; severe chills; chronic fatigue; fever; floaters in the left eye after 2nd dose; visual disturbances; blurry left eye; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (floaters in the left eye after 2nd dose), VISUAL IMPAIRMENT (visual disturbances), VISION BLURRED (blurry left eye), NASAL CONGESTION (congestion) and URTICARIA (blotchiness kind of like hives but they stay instead of come and go like hives.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 VITREOUS FLOATERS (floaters in the left eye after 2nd dose), VISUAL IMPAIRMENT (visual disturbances) and VISION BLURRED (blurry left eye). On an unknown date, the patient experienced NASAL CONGESTION (congestion), URTICARIA (blotchiness kind of like hives but they stay instead of come and go like hives.), PAIN (terrible aches), RASH (immediate rash after the 2nd dose, Rashes are now starting to pop up after the second dose), CHILLS (severe chills), FATIGUE (chronic fatigue) and PYREXIA (fever). At the time of the report, VITREOUS FLOATERS (floaters in the left eye after 2nd dose), VISUAL IMPAIRMENT (visual disturbances), VISION BLURRED (blurry left eye), NASAL CONGESTION (congestion), URTICARIA (blotchiness kind of like hives but they stay instead of come and go like hives.), PAIN (terrible aches), RASH (immediate rash after the 2nd dose, Rashes are now starting to pop up after the second dose), CHILLS (severe chills), FATIGUE (chronic fatigue) and PYREXIA (fever) outcome was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563105
Sex: F
Age: 30
State: PA

Vax Date: 03/05/2021
Onset Date: 10/27/2020
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Pregnant patient received vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021. This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Type 1 diabetes mellitus since October 2004 and Penicillin allergy. Concomitant products included INSULIN LISPRO (HUMALOG), ACETYLSALICYLIC ACID (ASPIRIN 81), PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and DIPHENHYDRAMINE HYDROCHLORIDE (UNISOM SLEEPMELTS) for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Jul-2021. On 27-Oct-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound foetal: Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: HUMALOG; ASPIRIN 81; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; UNISOM SLEEPMELTS

Current Illness: Type 1 diabetes mellitus

ID: 1563106
Sex: F
Age:
State: TX

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Lethargy; I have a hard time getting her out of bed /she seems knocked out; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy) and FATIGUE (I have a hard time getting her out of bed /she seems knocked out) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01SM264) for COVID-19 vaccination. The patient's past medical history included Dementia. 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 LETHARGY (Lethargy) and FATIGUE (I have a hard time getting her out of bed /she seems knocked out). At the time of the report, LETHARGY (Lethargy) and FATIGUE (I have a hard time getting her out of bed /she seems knocked out) had not resolved. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1563107
Sex: F
Age: 52
State: NY

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Brain fog/felt like she was poisoned; Dizziness; Not feeling well; uneasiness; 99 Temp; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Brain fog/felt like she was poisoned), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Not feeling well) and DISCOMFORT (uneasiness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 06-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 IN EXTREMITY (sore arm), FEELING ABNORMAL (Brain fog/felt like she was poisoned), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Not feeling well), DISCOMFORT (uneasiness) and PYREXIA (99 Temp). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved and FEELING ABNORMAL (Brain fog/felt like she was poisoned), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Not feeling well), DISCOMFORT (uneasiness) and PYREXIA (99 Temp) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99f (Low) temperature-99. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was not provided

Other Meds:

Current Illness:

ID: 1563108
Sex: F
Age: 71
State: AZ

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: warm; arm felt sore again; itching; hard; the injection site is red; sore arm; hard spot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (arm felt sore again), INJECTION SITE PRURITUS (itching), INJECTION SITE INDURATION (hard spot) and INJECTION SITE INDURATION (hard) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History was provided by the reporter. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced INJECTION SITE INDURATION (hard spot) and INJECTION SITE PAIN (sore arm). On 03-Mar-2021, the patient experienced INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (arm felt sore again), INJECTION SITE PRURITUS (itching), INJECTION SITE INDURATION (hard) and VACCINATION SITE ERYTHEMA (the injection site is red). At the time of the report, INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (arm felt sore again), INJECTION SITE PRURITUS (itching), INJECTION SITE INDURATION (hard spot), INJECTION SITE INDURATION (hard), INJECTION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (the injection site is red) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment medications reported. Patient is fully vaccinated. Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: TCR attached -Events outcome updated.

Other Meds:

Current Illness:

ID: 1563109
Sex: F
Age: 64
State: CA

Vax Date: 02/01/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Outbreak of genital herpes; A spontaneous report was received from a consumer concerning a 64-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced outbreak of genital herpes. The patient's medical history included Genital Herpes(2011). Concomitant medication reported included paracetamol. On 1 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) in the left arm for prophylaxis of COVID-19 infection. On 5 Mar 2021, the patient experienced something going on, outbreak of genital herpes. Treatment details included Valacyclovir. Action taken with mRNA-1273 in response to the event outbreak of genital herpes was not reported. The outcome of event outbreak of genital herpes was not reported.; Reporter's Comments: Although a temporal association exist, there is not enough information based on the information provided to assess a causal relationship between the reported event and the product use. Critical details such as the patient's frequency of outbreaks and if prophylactic treatment was ongoing at the time of vaccine administration cannot be ascertained. Additional information has been requested.

Other Meds: TYLENOL

Current Illness:

ID: 1563110
Sex: F
Age:
State: MS

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: a red and warm spot around the injection site, with a size of a baseball ball; a red and warm spot around the injection site, with a size of a baseball ball; with a size of a baseball ball; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (a red and warm spot around the injection site, with a size of a baseball ball), INJECTION SITE WARMTH (a red and warm spot around the injection site, with a size of a baseball ball) and INJECTION SITE SWELLING (with a size of a baseball ball) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (a red and warm spot around the injection site, with a size of a baseball ball), INJECTION SITE WARMTH (a red and warm spot around the injection site, with a size of a baseball ball) and INJECTION SITE SWELLING (with a size of a baseball ball). At the time of the report, INJECTION SITE ERYTHEMA (a red and warm spot around the injection site, with a size of a baseball ball), INJECTION SITE WARMTH (a red and warm spot around the injection site, with a size of a baseball ball) and INJECTION SITE SWELLING (with a size of a baseball ball) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1563111
Sex: F
Age: 82
State: PA

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Heart was beating a little heavier than usual, racing heart skips a beat; memory issues; arm sore; warm in her chest and back and up through her neck and the back of her head; trouble talking; A spontaneous report was received from a consumer concerning an 82-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hot, warm in her chest and back and up through her neck and the back of her head, trouble talking, heart beating a little heavier, arm aches, arm sore, heart condition-racing heart-skips a beat, memory issues. The patient's medical history included transient ischemic attacks (TIAs), vertigo, and heart condition-racing heart-skips a beat since she was 36 years old. Concomitant medications reported were clopidogrel, levothyroxine, atorvastatin for drug use for unknown indication. On unknown date, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly for prophylaxis of COVID-19 infection. On 04 Mar 2021, the patient experienced the event(s) hot, warm in her chest and back and up through her neck and the back of her head, trouble talking, heart beating a little heavier. On 05 Mar 2021, the patient experienced the event(s) arm aches. arm sore. On an unknown date, the patient experienced the event(s) heart condition-racing heart-skips a beat. 2 TIA's, vertigo, memory issues. Treatment details included Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), hot was unknown, warm in her chest and back and up through her neck and the back of her headtrouble talkingheart beating a little heavier arm achesarm sore heart condition-racing heart-skips a beat2 tia's vertigo memory issues was unknown.; 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: PLAVIX; LEVOXYL; ATORVASTATIN

Current Illness:

ID: 1563112
Sex: F
Age: 40
State: FL

Vax Date: 03/04/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Arm Soreness; Sharp Pain; Numbness/Tingling in Hand; Shortness of Breath; Restlessness; Lethargic; Loss of Sleep; Increased Body Heat; Fever; Chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), PAIN (Sharp Pain), PARAESTHESIA (Numbness/Tingling in Hand), DYSPNOEA (Shortness of Breath) and RESTLESSNESS (Restlessness) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness), PAIN (Sharp Pain), PARAESTHESIA (Numbness/Tingling in Hand), DYSPNOEA (Shortness of Breath), RESTLESSNESS (Restlessness), LETHARGY (Lethargic), INSOMNIA (Loss of Sleep), BODY TEMPERATURE INCREASED (Increased Body Heat), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm Soreness), PAIN (Sharp Pain), PARAESTHESIA (Numbness/Tingling in Hand), DYSPNOEA (Shortness of Breath), RESTLESSNESS (Restlessness), LETHARGY (Lethargic), INSOMNIA (Loss of Sleep), BODY TEMPERATURE INCREASED (Increased Body Heat), PYREXIA (Fever) and CHILLS (Chills) 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. Concomitant medications were not reported. Treatment information in response to events was not provided.

Other Meds:

Current Illness:

ID: 1563113
Sex: F
Age: 70
State: WI

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Baseball-size red lump at the injection site; Tennis-ball-size red lump at the injection site/Baseball-size red lump at the injection site; A spontaneous report was received from a type concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tennis-ball-size red lump at the injection site, baseball-size red lump at the injection site. The patient's medical history was not provided. Concomitant medications reported were Prozac, Estradiol, Furosemide, Omeprazole, Somatostatin, vitamins for drug use for unknown indication. On 23 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 033M20A) intramuscularly for prophylaxis of COVID-19 infection. On 24 Feb 2021, the patient experienced the event(s) tennis-ball-size red lump at the injection site . On 3 Mar 2021, the patient experienced the event(s) baseball-size red lump at the injection site. Treatment details included Antibiotics. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, tennis-ball-size red lump at the injection site was considered resolved on 26 Feb 2021. The outcome of event, baseball-size red lump at the injection site, was unknown.

Other Meds: PROZAC; ESTRADIOL; FUROSEMIDE; OMEPRAZOLE; SOMATOSTATIN; VITAMINS NOS

Current Illness:

ID: 1563114
Sex: M
Age: 64
State: VA

Vax Date: 01/23/2021
Onset Date: 02/20/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Administered far up his upper arm almost on his shoulder; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered far up his upper arm almost on his shoulder) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered far up his upper arm almost on his shoulder). On 20-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered far up his upper arm almost on his shoulder) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered far up his upper arm almost on his shoulder) to be not applicable. Concomitant medications were not provided. Treatment details were not provided.

Other Meds:

Current Illness:

ID: 1563115
Sex: U
Age:
State:

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Chills; severe headache; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (severe headache) and NAUSEA (nausea) 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 03-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 04-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (severe headache) and NAUSEA (nausea). At the time of the report, CHILLS (Chills), HEADACHE (severe headache) and NAUSEA (nausea) outcome was unknown. Not Provided No concomitant medication information was provided. No treatment medication information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563116
Sex: F
Age:
State: FL

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: stiffness on right arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness on right arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included BROMELAINS (BROMELAIN), CALCIUM CITRATE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), DOXAZOSIN, BISACODYL (DULCOLAX [BISACODYL]), FLUTICASONE PROPIONATE (FLOVENT), FLUOROURACIL, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LEUCOVORIN CALCIUM, LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), LORAZEPAM, MULTIVITAMINS [VITAMINS NOS], OMEGA-3 FATTY ACIDS, OXALIPLATIN, POLICOSANOL, DABIGATRAN ETEXILATE MESILATE (PRADAXA), PROCHLORPERAZINE (COMPAZINE SPANSULE), TIOTROPIUM BROMIDE (SPIRIVA), CURCUMIN, VITAMIN C [ASCORBIC ACID] and VITAMIN D3 for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness on right arm). The patient was treated with CORTISONE at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness on right arm) outcome was unknown. This case was linked to MOD-2021-222946 (Patient Link).

Other Meds: BROMELAIN; CALCIUM CITRATE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; DOXAZOSIN; DULCOLAX [BISACODYL]; FLOVENT; FLUOROURACIL; FLONASE [FLUTICASONE PROPIONATE]; LEUCOVORIN CALCIUM; LISINOPRIL [LISINOPRIL DIHYDRATE]; LORAZEPAM; MULTIVITAMINS [VITAMI

Current Illness:

ID: 1563117
Sex: F
Age: 72
State: CA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Arm is tender now; Pain in her arm was uncomfortable, bothered me for 10 days; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm is tender now) and VACCINATION SITE PAIN (Pain in her arm was uncomfortable, bothered me for 10 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Arm is tender now). an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in her arm was uncomfortable, bothered me for 10 days). The patient was treated with MENTHOL, METHYL SALICYLATE (SALONPAS [MENTHOL;METHYL SALICYLATE]) at an unspecified dose and frequency. At the time of the report, TENDERNESS (Arm is tender now) and VACCINATION SITE PAIN (Pain in her arm was uncomfortable, bothered me for 10 days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported that she received the first dose of the Moderna COVID-19 vaccine on 18-Feb-2021 at 2:30PM, in her upper left arm. 11 hours later, her arm was quite sore. She described the pain in her arm to be very uncomfortable and bothered her for 10 days. She used a Salonpas patch tp help alleviate the discomfort. At this time, her arm is still tender. She does not take any other medications. She wanted to know whether Moderna advises on a specific needle size to use for the injection of the vaccine.

Other Meds:

Current Illness:

ID: 1563118
Sex: M
Age: 66
State: CA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Achy to shoulder in arm of injection; Soreness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achy to shoulder in arm of injection) and VACCINATION SITE PAIN (Soreness at site of injection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included LISINOPRIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) 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 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Achy to shoulder in arm of injection) and VACCINATION SITE PAIN (Soreness at site of injection). At the time of the report, PAIN IN EXTREMITY (Achy to shoulder in arm of injection) and VACCINATION SITE PAIN (Soreness at site of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds: LISINOPRIL; BABY ASPIRIN

Current Illness:

ID: 1563119
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Fever of 101.8; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.8) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 101.8). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (Fever of 101.8) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1563120
Sex: F
Age:
State: CA

Vax Date: 01/30/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-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 ILLNESS (ill). At the time of the report, ILLNESS (ill) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment details were not provided.

Other Meds:

Current Illness:

ID: 1563121
Sex: F
Age: 78
State: SC

Vax Date: 02/23/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: injection site red patch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site red patch) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site red patch). At the time of the report, VACCINATION SITE ERYTHEMA (injection site red patch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1563122
Sex: M
Age:
State: WA

Vax Date: 02/23/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Rash - dark red blotches about the size of a dime; Whole leg is covered with this and it is very unsightly/Rash looks like measles; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Rash - dark red blotches about the size of a dime) and RASH MORBILLIFORM (Whole leg is covered with this and it is very unsightly/Rash looks like measles) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 23-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 RASH MACULAR (Rash - dark red blotches about the size of a dime) and RASH MORBILLIFORM (Whole leg is covered with this and it is very unsightly/Rash looks like measles). The patient was treated with CLOBETASOL PROPIONATE for Rash, at a dose of 0.5 %. At the time of the report, RASH MACULAR (Rash - dark red blotches about the size of a dime) and RASH MORBILLIFORM (Whole leg is covered with this and it is very unsightly/Rash looks like measles) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received on 14-Jun-2021 and does not contain any new information

Other Meds:

Current Illness:

ID: 1563123
Sex: M
Age: 71
State: MD

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Injection site arm was hot to the touch; Injection site arm was hard; Injection site arm became red; Injection site arm was swollen; Nausea; Chills; No appetite; Dizziness; Fever of 103?F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site arm was hot to the touch), DECREASED APPETITE (No appetite), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection site arm was hard) and PYREXIA (Fever of 103?F) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Autoimmune disorder. Concomitant products included PREDNISONE for Autoimmune disorder NOS. On 28-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 28-Feb-2021, the patient experienced PYREXIA (Fever of 103?F). On 01-Mar-2021, the patient experienced DECREASED APPETITE (No appetite), DIZZINESS (Dizziness), NAUSEA (Nausea) and CHILLS (Chills). On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site arm was hot to the touch), VACCINATION SITE INDURATION (Injection site arm was hard), VACCINATION SITE ERYTHEMA (Injection site arm became red) and VACCINATION SITE SWELLING (Injection site arm was swollen). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site arm was hot to the touch), DECREASED APPETITE (No appetite), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection site arm was hard), PYREXIA (Fever of 103?F), NAUSEA (Nausea), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Injection site arm became red) and VACCINATION SITE SWELLING (Injection site arm was swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Body temperature: 103 (High) 103 degree fahrenheit. On 02-Mar-2021, Body temperature: 100 (High) 100 degree fahrenheit. On 03-Mar-2021, Body temperature: 102 (High) 102 degree fahrenheit. On 04-Mar-2021, Body temperature: 99.5 (Inconclusive) 99.5 degree fahrenheit. patient also used cold compresses as treatment. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds: PREDNISONE

Current Illness: Autoimmune disorder

ID: 1563124
Sex: F
Age:
State: TN

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

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

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

Symptoms: Pain on the foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on the foot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain on the foot). At the time of the report, PAIN IN EXTREMITY (Pain on the foot) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant and treatment information were not reported. This case was linked to MOD-2021-035550 (Patient Link).

Other Meds:

Current Illness:

ID: 1563125
Sex: F
Age: 82
State: MN

Vax Date: 03/02/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
Hospital:

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Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: stomach ache; multiple bowel movements; GI tract discomfort; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), BOWEL MOVEMENT IRREGULARITY (multiple bowel movements) and ABDOMINAL DISCOMFORT (GI tract discomfort) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The patient's past medical history included Irritable bowel syndrome. On 02-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 ABDOMINAL PAIN UPPER (stomach ache), BOWEL MOVEMENT IRREGULARITY (multiple bowel movements) and ABDOMINAL DISCOMFORT (GI tract discomfort). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and TRAMADOL at a dose of 1 dosage form. At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), BOWEL MOVEMENT IRREGULARITY (multiple bowel movements) and ABDOMINAL DISCOMFORT (GI tract discomfort) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications reported.

Other Meds:

Current Illness:

ID: 1563126
Sex: F
Age: 88
State: MA

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

Vax Type:
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Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: irregular heart beat; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (irregular heart beat) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The patient's past medical history included Cardiac disorder NOS (The patient has had some heart issues in the past, but nothing serious.). Concurrent medical conditions included Caffeine (sensitivity to caffeine). On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PALPITATIONS (irregular heart beat). On 05-Feb-2021, PALPITATIONS (irregular heart beat) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment and concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Caffeine (sensitivity to caffeine)

ID: 1563127
Sex: M
Age:
State:

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

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

Symptoms: Swollen Face; Potential Allergic Reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swollen Face) and DRUG HYPERSENSITIVITY (Potential Allergic Reaction to the vaccine) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SWELLING FACE (Swollen Face) and DRUG HYPERSENSITIVITY (Potential Allergic Reaction to the vaccine). At the time of the report, SWELLING FACE (Swollen Face) and DRUG HYPERSENSITIVITY (Potential Allergic Reaction to the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No medical history was provided by the reporter. No relevant concomitant medications reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563128
Sex: M
Age:
State: ND

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

Vax Type:
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Lab Data:

Allergies:

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

Symptoms: Chest Pain; Nasal Congestion; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), NASAL CONGESTION (Nasal Congestion) and FATIGUE (Tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 in December 2020. 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 CHEST PAIN (Chest Pain), NASAL CONGESTION (Nasal Congestion) and FATIGUE (Tiredness). At the time of the report, CHEST PAIN (Chest Pain), NASAL CONGESTION (Nasal Congestion) and FATIGUE (Tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1563129
Sex: F
Age:
State: LA

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

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Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Pains from the top of her shoulders to her fingers; Neck hurts; Upper arm hurts; Shoulder hurts; Lymph node hurts; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pains from the top of her shoulders to her fingers), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Upper arm hurts), VACCINATION SITE PAIN (Soreness of arm) and ARTHRALGIA (Shoulder hurts) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Type II diabetes mellitus, Hypertension, Osteoporosis, Arthritis, Fibromyalgia and Neuropathy. 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 VACCINATION SITE PAIN (Soreness of arm). On 14-Feb-2021, the patient experienced NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Upper arm hurts), ARTHRALGIA (Shoulder hurts) and LYMPHADENOPATHY (Lymph node hurts). On 28-Feb-2021, the patient experienced PAIN (Pains from the top of her shoulders to her fingers). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Pain management, at a dose of 1 dosage form. At the time of the report, PAIN (Pains from the top of her shoulders to her fingers) and VACCINATION SITE PAIN (Soreness of arm) outcome was unknown and NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Upper arm hurts), ARTHRALGIA (Shoulder hurts) and LYMPHADENOPATHY (Lymph node hurts) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications reported.

Other Meds:

Current Illness: Arthritis; Fibromyalgia; Hypertension; Neuropathy; Osteoporosis; Type II diabetes mellitus

ID: 1563130
Sex: F
Age: 70
State:

Vax Date: 02/02/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Sore arm; Blood sugar was 285; Bad headaches all night long; A spontaneous report was received from a Consumer concerning a 70-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed sore arm, bad headaches all night long and her blood sugar was 285. The patient's medical history included receving first dose of COVID-19 vaccine on 02 Feb 2021. No concomitant product use was reported. On 02 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (batch number: 012MZ0P) and received her second planned dose on 04 Mar 2021 (batch number: 029A21A) intramuscularly for prophylaxis of COVID-19 infection. On 04 Mar 2021, the patient had bad headaches all night long. On 05 Mar 2021, her blood sugar was 285 (unit not reported) in the morning when she woke up. Her right arm was sore. However, she did not have any fever, nausea or vomiting. Treatment information was not available at the time of this report. Action taken with mRNA-1273 in the response to the events was not applicable. The outcome of the events sore arm, bad headaches all night long and blood sugar was 285 was unknown. =; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1563131
Sex: F
Age: 86
State: NY

Vax Date: 01/20/2021
Onset Date: 02/09/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

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

Symptoms: 2nd dose at the end of March2020; severe cut on leg; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose at the end of March2020) and WOUND (severe cut on leg) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029420A) for COVID-19 vaccination. The patient's past medical history included Chemotherapy. Concurrent medical conditions included Cancer (Chronic cancer). On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced WOUND (severe cut on leg). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose at the end of March2020). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose at the end of March2020) and WOUND (severe cut on leg) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient received tetanus shot because she had severe cut. Due to that 2nd dose is scheduled on different date then usual scheduled date. In the follow-up form patient states that she did receive 2nd dose nearly 2 months after the first one & few days after she had chemotherapy. Concomitant medication information was not provided. Treatment information were not provided. Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Received on 20 Jul 2021, patient updated about second dose

Other Meds:

Current Illness: Cancer (Chronic cancer)

ID: 1563132
Sex: F
Age: 71
State: WA

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

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

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

Symptoms: ultrasound; Lymph node bumps at the left side of the neck; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021. The most recent information was received on 18-May-2021 and was forwarded to Moderna on 19-May-2021. This spontaneous case was reported by a consumer and describes the occurrence of ULTRASOUND SCAN ABNORMAL (ultrasound) and LYMPHADENOPATHY (Lymph node bumps at the left side of the neck) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. Concurrent medical conditions included Muscle spasm, Emphysema, Hypertension, Anxiety, Diabetes mellitus, Incontinence, Acid reflux (esophageal), Depression, COPD, Thyroid disorder NOS, Liver disorder (autoimmune liver disease), Allergy, Sleep apnea and Pain. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal), MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, ESCITALOPRAM OXALATE (LEXAPRO) and HYDROXYZINE for Anxiety, MONTELUKAST SODIUM (SINGULAIR) for Breathing difficult, FLUTICASONE (BRISOVENT DISKUS) for COPD and Emphysema, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, METFORMIN for Diabetes mellitus, ALBUTEROL [SALBUTAMOL] for Emphysema, LOSARTAN and AMLODIPINE BESILATE (NORVASC) for Hypertension, OXYBUTYNIN for Incontinence, URSODIOL for Liver disorder, BACLOFEN for Muscle spasm, IBUPROFEN and PARACETAMOL (TYLENOL) for Pain, MELATONIN for Sleep difficult, MULTI VIT, CALCIUM CARBONATE, COLECALCIFEROL, VITAMIN K NOS (CITRACAL [CALCIUM CARBONATE;COLECALCIFEROL;VITAMIN K NOS]), BIOTIN and VITAMIN D3 for Supplementation therapy, LEVOTHYROXINE for Thyroid disorder NOS, ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 09-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) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph node bumps at the left side of the neck). On 05-Mar-2021, the patient experienced ULTRASOUND SCAN ABNORMAL (ultrasound). At the time of the report, ULTRASOUND SCAN ABNORMAL (ultrasound) and LYMPHADENOPATHY (Lymph node bumps at the left side of the neck) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Ultrasound scan: lymph node bumps swollen lymph nodes.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment was provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Permission to F/U with physician.second dose was added.secondary reporter details was updated. On 18-May-2021: Non-significant follow-up appended to AER: update info about PCP.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds: BACLOFEN; ALBUTEROL [SALBUTAMOL]; LOSARTAN; LEXAPRO; METFORMIN; OXYBUTYNIN; PROTONIX [OMEPRAZOLE]; HYDROXYZINE; WELLBUTRIN; LIPITOR; NORVASC; LEVOTHYROXINE; SINGULAIR; BRISOVENT DISKUS; URSODIOL; MELATONIN; IBUPROFEN; FLONASE [MOMETASONE FU

Current Illness: Acid reflux (esophageal); Allergy; Anxiety; COPD; Depression; Diabetes mellitus; Emphysema; Hypertension; Incontinence; Liver disorder (autoimmune liver disease); Muscle spasm; Pain; Sleep apnea; Thyroid disorder NOS

ID: 1563133
Sex: M
Age: 74
State: MD

Vax Date: 03/04/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: itchy hands; itchy eyes; feels prickly; vision: car lit looks spikey with a lot of radiance; increase heart rate to 100bpm; BP reading of 90/52; O2 sat 92%; possible fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Mar-2021 and was forwarded to Moderna on 08-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy hands), EYE PRURITUS (itchy eyes), PARAESTHESIA (feels prickly), VISUAL IMPAIRMENT (vision: car lit looks spikey with a lot of radiance) and HEART RATE INCREASED (increase heart rate to 100bpm) in a 74-year-old male 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 Xorelto blood thinner, Benicar for hypertension, Hydrochlorothiazide diuretic, Naproxen for inflammation, Paroxetine for depression, Crestor for cholesterol, Vitamin D supplemental and Calmeg + Zinc supplemental 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 06-Mar-2021, the patient experienced PRURITUS (itchy hands), EYE PRURITUS (itchy eyes), PARAESTHESIA (feels prickly), VISUAL IMPAIRMENT (vision: car lit looks spikey with a lot of radiance), HEART RATE INCREASED (increase heart rate to 100bpm), BLOOD PRESSURE DECREASED (BP reading of 90/52), OXYGEN SATURATION ABNORMAL (O2 sat 92%) and PYREXIA (possible fever). On 07-Mar-2021, PRURITUS (itchy hands), EYE PRURITUS (itchy eyes), PARAESTHESIA (feels prickly), VISUAL IMPAIRMENT (vision: car lit looks spikey with a lot of radiance), HEART RATE INCREASED (increase heart rate to 100bpm), BLOOD PRESSURE DECREASED (BP reading of 90/52), OXYGEN SATURATION ABNORMAL (O2 sat 92%) and PYREXIA (possible fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds: Xorelto blood thinner; Benicar for hypertension; Hydrochlorothiazide diuretic; Naproxen

Current Illness:

ID: 1563134
Sex: F
Age:
State: NC

Vax Date: 02/04/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

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

Symptoms: Some fatigue off and on; Sensation in my left ear; Got real dizzy, Could hardly get out of bed because I was so dizzy and could not focus my eyes, Severe dizziness; Took temperature 102.5 F; Big rash about size of apple below injection site; Feeling severely cold; I had a terrible bad day yesterday; Mild pain at injection site for two days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling severely cold), FEELING ABNORMAL (I had a terrible bad day yesterday), EAR DISCOMFORT (Sensation in my left ear), DIZZINESS (Got real dizzy, Could hardly get out of bed because I was so dizzy and could not focus my eyes, Severe dizziness) and PYREXIA (Took temperature 102.5 F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CLINDAMYCIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATENOLOL, MIDODRINE and TIOTROPIUM BROMIDE (SPIRIVA HANDIHALER) for an unknown indication. On 04-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 FEELING COLD (Feeling severely cold), FEELING ABNORMAL (I had a terrible bad day yesterday), PYREXIA (Took temperature 102.5 F) and VACCINATION SITE RASH (Big rash about size of apple below injection site). On 18-Mar-2021, the patient experienced EAR DISCOMFORT (Sensation in my left ear) and DIZZINESS (Got real dizzy, Could hardly get out of bed because I was so dizzy and could not focus my eyes, Severe dizziness). On an unknown date, the patient experienced VACCINATION SITE PAIN (Mild pain at injection site for two days) and FATIGUE (Some fatigue off and on). The patient was treated with MECLIZINE [MECLOZINE] on 22-Mar-2021 at a dose of 1 dosage form. On 07-Mar-2021, FEELING ABNORMAL (I had a terrible bad day yesterday) had resolved. At the time of the report, FEELING COLD (Feeling severely cold), EAR DISCOMFORT (Sensation in my left ear), DIZZINESS (Got real dizzy, Could hardly get out of bed because I was so dizzy and could not focus my eyes, Severe dizziness), PYREXIA (Took temperature 102.5 F), VACCINATION SITE RASH (Big rash about size of apple below injection site), VACCINATION SITE PAIN (Mild pain at injection site for two days) and FATIGUE (Some fatigue off and on) outcome was unknown. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Added events mild pain at injection site, fatigue, sensation in my left ear , got real dizzy, could hardly get out of bed because I was so dizzy and could not focus my eyes and severe dizziness, all having outcome unknown.

Other Meds: CLINDAMYCIN; ASPIRIN (E.C.); ATENOLOL; MIDODRINE; SPIRIVA HANDIHALER

Current Illness:

ID: 1563135
Sex: M
Age:
State: NY

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: urine had a very strong odor like after eating a lot of asparagus; soreness in arm; felt a little tired; a little headache; This spontaneous case was reported by a consumer and describes the occurrence of URINE ODOUR ABNORMAL (urine had a very strong odor like after eating a lot of asparagus), MYALGIA (soreness in arm), FATIGUE (felt a little tired) and HEADACHE (a little headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included ATORVASTATIN, FAMOTIDINE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ), VITAMIN D NOS, ALPHA LIPOIC ACID and FISH OIL for an unknown indication. On 03-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 URINE ODOUR ABNORMAL (urine had a very strong odor like after eating a lot of asparagus), MYALGIA (soreness in arm), FATIGUE (felt a little tired) and HEADACHE (a little headache). At the time of the report, URINE ODOUR ABNORMAL (urine had a very strong odor like after eating a lot of asparagus), MYALGIA (soreness in arm), FATIGUE (felt a little tired) and HEADACHE (a little headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds: ATORVASTATIN; FAMOTIDINE; LISINOPRIL/HCTZ; VITAMIN D NOS; ALPHA LIPOIC ACID; FISH OIL

Current Illness:

ID: 1563136
Sex: F
Age: 66
State:

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptom List: Pain in extremity

Symptoms: chills; body aches; constant nausea "worse than carbon monoxide poisoning"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Mar-2021 and was forwarded to Moderna on 07-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (body aches) and NAUSEA (constant nausea "worse than carbon monoxide poisoning") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) 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 CHILLS (chills), MYALGIA (body aches) and NAUSEA (constant nausea "worse than carbon monoxide poisoning"). At the time of the report, CHILLS (chills), MYALGIA (body aches) and NAUSEA (constant nausea "worse than carbon monoxide poisoning") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. no concomitant medications are provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563137
Sex: M
Age:
State: SC

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Second dose scheduled past 36 day mark post first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled past 36 day mark post first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided). 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled past 36 day mark post first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled past 36 day mark post first dose) had resolved. 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. This case was linked to MOD-2021-035610 (Patient Link).; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot# unknown, with no associated adverse events.

Other Meds:

Current Illness:

ID: 1563138
Sex: F
Age: 75
State: NJ

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: felt tired; shaking; whole body shivering; felt her body was very heavy; had a 101.2-103.1 fever; nauseous; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Mar-2021 and was forwarded to Moderna on 07-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), CHILLS (whole body shivering), LIMB DISCOMFORT (felt her body was very heavy), PYREXIA (had a 101.2-103.1 fever) and NAUSEA (nauseous) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013Az1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in October 2020. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021 at 2:00 AM, the patient experienced TREMOR (shaking), CHILLS (whole body shivering), LIMB DISCOMFORT (felt her body was very heavy), PYREXIA (had a 101.2-103.1 fever) and NAUSEA (nauseous). On 04-Mar-2021 at 6:00 AM, the patient experienced FATIGUE (felt tired). On 04-Mar-2021, TREMOR (shaking), CHILLS (whole body shivering), LIMB DISCOMFORT (felt her body was very heavy) and PYREXIA (had a 101.2-103.1 fever) had resolved. On 04-Mar-2021 at 6:00 AM, NAUSEA (nauseous) had resolved. At the time of the report, FATIGUE (felt tired) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. She took Tylenol for the fever.

Other Meds:

Current Illness:

ID: 1563139
Sex: F
Age: 67
State: WV

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Felt a lot of heat in her body; Hot flashes; Had a dry mouth; Felt lousy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt a lot of heat in her body), HOT FLUSH (Hot flashes), DRY MOUTH (Had a dry mouth) and MALAISE (Felt lousy) in a 67-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 COVID-19 in 2020. 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 FEELING HOT (Felt a lot of heat in her body), HOT FLUSH (Hot flashes), DRY MOUTH (Had a dry mouth) and MALAISE (Felt lousy). At the time of the report, FEELING HOT (Felt a lot of heat in her body), HOT FLUSH (Hot flashes), DRY MOUTH (Had a dry mouth) and MALAISE (Felt lousy) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Outcome of events provided

Other Meds:

Current Illness:

ID: 1563140
Sex: M
Age: 88
State: IL

Vax Date: 02/24/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
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Symptom List: Vomiting

Symptoms: Extreme arm itching 6 days after 1st dose; Red from injection to elbow 6 days after 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Extreme arm itching 6 days after 1st dose) and VACCINATION SITE ERYTHEMA (Red from injection to elbow 6 days after 1st dose) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 24-Feb-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 PRURITUS (Extreme arm itching 6 days after 1st dose) and VACCINATION SITE ERYTHEMA (Red from injection to elbow 6 days after 1st dose). At the time of the report, PRURITUS (Extreme arm itching 6 days after 1st dose) and VACCINATION SITE ERYTHEMA (Red from injection to elbow 6 days after 1st dose) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications include hypertension meds and vitamins. Treatment included Alcohol and Gold Band Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 07 MAY 2021 contains No new information

Other Meds:

Current Illness: Hypertension

ID: 1563141
Sex: M
Age:
State: AZ

Vax Date: 03/03/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: low level of fatigue; shoulder is sore in one certain spot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (low level of fatigue) and ARTHRALGIA (shoulder is sore in one certain spot) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-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 FATIGUE (low level of fatigue) and ARTHRALGIA (shoulder is sore in one certain spot). At the time of the report, FATIGUE (low level of fatigue) and ARTHRALGIA (shoulder is sore in one certain spot) 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: 1563142
Sex: F
Age: 82
State: MO

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
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Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Shortness of breath; cold sweats; Skin is crawling; not feeling good; sore arm; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), COLD SWEAT (cold sweats), PARAESTHESIA (Skin is crawling), ILLNESS (not feeling good) and MYALGIA (sore arm) in an 82-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 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath), COLD SWEAT (cold sweats), PARAESTHESIA (Skin is crawling), ILLNESS (not feeling good), MYALGIA (sore arm) and NAUSEA (nausea). At the time of the report, DYSPNOEA (Shortness of breath), COLD SWEAT (cold sweats), PARAESTHESIA (Skin is crawling), ILLNESS (not feeling good) and NAUSEA (nausea) outcome was unknown and MYALGIA (sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications includes Blood pressure, Thyroid medicine, Food appetizer. No treatment information were reported.

Other Meds:

Current Illness:

ID: 1563143
Sex: F
Age: 70
State: WI

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/15/2021
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Symptom List: Injection site swelling, Limb discomfort

Symptoms: Sore arm; Body rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and RASH (Body rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013A21A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), POTASSIUM CHLORIDE, LISINOPRIL, LATANOPROST, CLONAZEPAM, GLIMEPIRIDE, METFORMIN HYDROCHLORIDE (METFORMIN ER), OMEPRAZOLE, LEVOTHYROXINE, VITAMIN D NOS, CALCIUM, ZINC and LORATADINE (CLARITINE) 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 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and RASH (Body rash). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. On 01-Feb-2021, PAIN IN EXTREMITY (Sore arm) and RASH (Body rash) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other Medications: advair diskus 250/50, albuterol inhaler, Claritin, Vitamin C, Flonase. This case was linked to MOD-2021-035612 (Patient Link).

Other Meds: ASPIRIN 81; POTASSIUM CHLORIDE; LISINOPRIL; LATANOPROST; CLONAZEPAM; GLIMEPIRIDE; METFORMIN ER; OMEPRAZOLE; LEVOTHYROXINE; VITAMIN D NOS; CALCIUM; ZINC; CLARITINE

Current Illness:

ID: 1563144
Sex: M
Age:
State: SC

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: second dose scheduled for 44 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled for 44 days after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled for 44 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled for 44 days after first dose) had resolved. No treatment and concomitant medications were provided. This case was linked to MOD-2021-035594 (Patient Link).; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273, (Lot number: Unknown), with no associated AEs.

Other Meds:

Current Illness:

ID: 1563145
Sex: F
Age: 72
State: TN

Vax Date: 02/19/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
Hospital:

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Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: not feeling well overall; nausea; redness at injection site; widespread pain throughout entire body; Left arm pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (widespread pain throughout entire body), PAIN IN EXTREMITY (Left arm pain), MALAISE (not feeling well overall), NAUSEA (nausea) and INJECTION SITE ERYTHEMA (redness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and CELECOXIB (CELEBREX) for an unknown indication. On 19-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 PAIN (widespread pain throughout entire body), PAIN IN EXTREMITY (Left arm pain) and INJECTION SITE ERYTHEMA (redness at injection site). On 05-Mar-2021, the patient experienced MALAISE (not feeling well overall) and NAUSEA (nausea). At the time of the report, PAIN (widespread pain throughout entire body), PAIN IN EXTREMITY (Left arm pain), MALAISE (not feeling well overall) and NAUSEA (nausea) outcome was unknown and INJECTION SITE ERYTHEMA (redness at injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient received treatment for the events - muscle relaxer, Bayer and Diclofenac potassium 50 mg tablets.

Other Meds: LOSARTIN; CELEBREX

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am