VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer

Incidents per State

State Total
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: 1563696
Sex: F
Age: 71
State: OH

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Immune system type reactions; Vaccine dose from 2 vials; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine dose from 2 vials) and IMMUNE-MEDIATED ADVERSE REACTION (Immune system type reactions) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 30-Dec-2020, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine dose from 2 vials). On 28-Jan-2021, the patient experienced IMMUNE-MEDIATED ADVERSE REACTION (Immune system type reactions). On 28-Jan-2021, PRODUCT ADMINISTRATION ERROR (Vaccine dose from 2 vials) had resolved. At the time of the report, IMMUNE-MEDIATED ADVERSE REACTION (Immune system type reactions) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Relevant concomitant medications were not reported. Treatment information was not provided. This case was linked to MOD-2021-028537 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: No new information received. On 18-Mar-2021: Follow-up information included patient's age, gender and date of birth changed, dose and unit.

Other Meds:

Current Illness:

ID: 1563697
Sex: F
Age: 65
State: MI

Vax Date: 02/11/2021
Onset Date: 02/16/2021
Rec V Date: 08/15/2021
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Symptoms: Swollen throat; Feels her body is swelling; No energy; Her stomach hurts every time she eats or drinks; Gaining weight even thought she is not eating; A spontaneous report was received from a consumer in the concerning a 65-year-old female patient who experienced swollen throat/MedDRA PT: pharyngeal swelling, no energy/MedDRA PT: asthenia, feels her body is swelling/MedDRA PT: swelling, stomach hurts every time she eats or drinks/MedDRA PT: abdominal pain upper and gaining weight even though she is not eating/MedDRA PT: abnormal weight gain after she was administered mRNA-1273 vaccine The patient's medical history includes kidney transplant. Concomitant medications include (2) anti-rejection medications, high blood pressure medication, cholesterol med and vitamins NOS. On 11-Feb-2021, five days prior to start of symptoms, this patient received their first planned dose of mRNA-1273 solution for injection (Lot/Batch number: 031l20a) in her right arm for prophylaxis of COVID-19 infection. On 16-Feb-2021, this patient developed swollen throat and has experienced no energy, her stomach hurts every time she eats or drinks, is gaining weight even though she is not eating and feels her body is swelling. She was tested for covid-19 and for white blood cell count, results are pending. The patient is scheduled next week for her second dose and wonders if she should wait. Action taken with mRNA-1273 in response to the event was unknown. The outcome for the events, swollen throat, no energy, feels her body is swelling, stomach hurts every time she eats or drinks,and gaining weight even though she is not eating were not recovered.; 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: VITAMINS

Current Illness:

ID: 1563698
Sex: F
Age:
State: WI

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
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Symptoms: Arm unbelievably painful; Aches and pains; Very weak, no strength, No energy to do anything; Cannot eat or drink.; Head and ears ringing.; Cannot sleep; Splitting headache; A spontaneous report was received from a consumer who was also a 77-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who was very weak, no strength; no energy to do anything(asthenia), head and ears ringing( tinnitus), splitting headache( headache), cannot sleep(insomnia), cannot eat or drink(decreased appetite), arm unbelievably painful (vaccination site pain), and aches and pains (myalgia). The patient's medical history was not provided. Relevant current conditions included asthma, chronic obstructive pulmonary disease, heart problems, and osteoarthritis. No relevant concomitant medications were reported. On 5 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 05 Mar 2021, patient had very weak, no strength, no energy to do anything, splitting headache, cannot eat or drink. The patient also had head and ears ringing, and cannot sleep. On an unknown date, the patient had arm unbelievably painful and aches and pains. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Asthma; COPD; Heart disorder; Osteoarthritis

ID: 1563699
Sex: F
Age:
State: NY

Vax Date: 02/14/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
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Symptoms: Very red; slightly raised; hot to the touch; Covid arm; large rash; arm itching/itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Very red), INJECTION SITE MASS (slightly raised), FEELING HOT (hot to the touch), DERMATITIS ALLERGIC (Covid arm) and RASH (large rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE PRURITUS (arm itching/itching). On 28-Feb-2021, the patient experienced ERYTHEMA (Very red), INJECTION SITE MASS (slightly raised), FEELING HOT (hot to the touch), DERMATITIS ALLERGIC (Covid arm) and RASH (large rash). At the time of the report, ERYTHEMA (Very red), INJECTION SITE MASS (slightly raised), FEELING HOT (hot to the touch), DERMATITIS ALLERGIC (Covid arm), RASH (large rash) and INJECTION SITE PRURITUS (arm itching/itching) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant medication information was not reported. Treatment information as not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563700
Sex: F
Age: 24
State: NY

Vax Date: 02/27/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
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Symptoms: itchy; Rash started on left arm on 07Mar2021, and today spread to both arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and RASH (Rash started on left arm on 07Mar2021, and today spread to both arms) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01/A2A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PRURITUS (itchy) and RASH (Rash started on left arm on 07Mar2021, and today spread to both arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Mar-2021 for Itchy, at a dose of 1 dosage form. At the time of the report, PRURITUS (itchy) and RASH (Rash started on left arm on 07Mar2021, and today spread to both arms) 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: 1563701
Sex: F
Age: 72
State: WV

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
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Symptoms: Weak; Short of breath; Dizzy; Feels lousy; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DYSPNOEA (Short of breath), DIZZINESS (Dizzy), MALAISE (Feels lousy) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) 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 05-Mar-2021, the patient experienced ASTHENIA (Weak), DYSPNOEA (Short of breath), DIZZINESS (Dizzy), MALAISE (Feels lousy), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, ASTHENIA (Weak), DYSPNOEA (Short of breath), DIZZINESS (Dizzy), MALAISE (Feels lousy), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product used was not provided by the reporter. Treatment information was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-May-2021 included no new information.

Other Meds:

Current Illness:

ID: 1563702
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: lymph node swelling; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph node swelling). At the time of the report, LYMPHADENOPATHY (lymph node swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant Medications were provided. No Treatment History was provided. Action taken with mRNA-1273 in response to the event was unknown

Other Meds:

Current Illness:

ID: 1563703
Sex: U
Age:
State: VA

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

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Symptoms: Body aches; Headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MYALGIA (Body aches) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches) and HEADACHE (Headaches). At the time of the report, MYALGIA (Body aches) and HEADACHE (Headaches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator No treatment medications provided by the reporter. Reporter states that his wife's friends had the second dose of the Moderna COVID-19 vaccine and experienced body aches and headaches. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563704
Sex: F
Age: 71
State: NJ

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
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Symptoms: Hypersensitive reaction; rash on face and arm; Chills; tiredness; itchy; hives; vaccination site pain; vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitive reaction), PRURITUS (itchy), URTICARIA (hives), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE ERYTHEMA (vaccination site erythema) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Shingles (A year ago) and Cataract operation (cataract surgery in November and December). Concomitant products included ASCORBIC ACID (VIT C), MULTIVITAMIN [VITAMINS NOS], CALCIUM and KERATIN for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE ERYTHEMA (vaccination site erythema). On 06-Mar-2021, the patient experienced PRURITUS (itchy) and URTICARIA (hives). On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitive reaction), RASH (rash on face and arm), CHILLS (Chills) and FATIGUE (tiredness). At the time of the report, HYPERSENSITIVITY (Hypersensitive reaction), PRURITUS (itchy), URTICARIA (hives), VACCINATION SITE ERYTHEMA (vaccination site erythema), CHILLS (Chills) and FATIGUE (tiredness) outcome was unknown, VACCINATION SITE PAIN (vaccination site pain) had resolved and RASH (rash on face and arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that the patient received 1st dose in left arm(non-dominant) on 26 Feb 2021 with lot# 012A21A at the pharmacy. Patient stated she is healthy 73-year-old who just takes vitamins. Patient stated she didn't wait the 15 minutes. Her arm hurt for 18 hours and was in agony. Patient took nothing for pain and has a high threshold for pain, Arm pain went away after 18 hours but still red. Then on Saturday, 6 March her arm started itching and hives. She put alcohol on it and by Sunday it stopped itching. Patient said ok for safety to contact. Patient said her husband (heart patient) had a sore arm and on Saturday his arm was a bothering him but not as bad as hers. Patient feels HCP doesn't know much about the virus. First dose patient had a rash on face and arm and tiredness for about 2 weeks. Still had rash on face and arm. Today patient still have something on her arm where the vaccine went in. It is like a birth mark or something. It is elevated. Does not bother her anymore. Patient face still has a rash. She never had a reaction to anything. she was perfectly healthy, took a covid test and was negative. people were saying she must have had covid. patient don't think so. she did not go anyplace for 2 years! Mask on etc. This case was linked to MOD-2021-102149 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up report received on 03-MAY-2021 and included no new information On 22-Jun-2021: Follow up received on 22-Jun-2021 and included significant information such as new events were added, new medical history was added, New concomitant drugs were added.

Other Meds: VIT C; MULTIVITAMIN [VITAMINS NOS]; CALCIUM; KERATIN

Current Illness:

ID: 1563705
Sex: F
Age:
State:

Vax Date: 03/06/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
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Symptom List:

Symptoms: heartburn; nauseous; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DYSPEPSIA (heartburn) and NAUSEA (nauseous) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. A21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DYSPEPSIA (heartburn) and NAUSEA (nauseous). At the time of the report, DYSPEPSIA (heartburn) and NAUSEA (nauseous) 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 included, medications for depression, were reported. Treatment information included, a pill for the heartburn but they forgot taking it for the last three days so they think it may be the cause.

Other Meds:

Current Illness:

ID: 1563706
Sex: F
Age: 37
State: CA

Vax Date: 02/27/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Wanted to cry all day; Swelling of the head, neck, and face; Became very nervous; Anxiety; pain in right side of her face; Depression; Hands and feet numb; Burning sensation in the skin, like sunburn; Rash on the face, hands and feet; Rash was itching like needles; Felt her arm was heavy; Felt like thorns on lips; Lot of headaches; Very dizzy; Trembling; Sensation that something travelled inside her body; Spines in her mouth; Weak; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Trembling), FEELING ABNORMAL (Sensation that something travelled inside her body), STOMATITIS (Spines in her mouth), ASTHENIA (Weak) and HYPOAESTHESIA (Hands and feet numb) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anxiety attack. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN and OMEPRAZOLE for Type 2 diabetes mellitus. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced TREMOR (Trembling), FEELING ABNORMAL (Sensation that something travelled inside her body), STOMATITIS (Spines in her mouth), ASTHENIA (Weak), DIZZINESS (Very dizzy), LIMB DISCOMFORT (Felt her arm was heavy), CHEILITIS (Felt like thorns on lips) and HEADACHE (Lot of headaches). On 02-Mar-2021, the patient experienced RASH PRURITIC (Rash was itching like needles) and RASH (Rash on the face, hands and feet). On 04-Mar-2021, the patient experienced HYPOAESTHESIA (Hands and feet numb), SKIN BURNING SENSATION (Burning sensation in the skin, like sunburn) and DEPRESSION (Depression). On an unknown date, the patient experienced CRYING (Wanted to cry all day), FACIAL PAIN (pain in right side of her face), SWELLING (Swelling of the head, neck, and face), NERVOUSNESS (Became very nervous) and ANXIETY (Anxiety). The patient was treated with DOXYCYCLINE HYDROCHLORIDE (ATRAX) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache and Inflammation, at an unspecified dose and frequency. At the time of the report, TREMOR (Trembling), FEELING ABNORMAL (Sensation that something travelled inside her body), STOMATITIS (Spines in her mouth), ASTHENIA (Weak), HYPOAESTHESIA (Hands and feet numb), SKIN BURNING SENSATION (Burning sensation in the skin, like sunburn), CRYING (Wanted to cry all day), DIZZINESS (Very dizzy), RASH PRURITIC (Rash was itching like needles), FACIAL PAIN (pain in right side of her face), LIMB DISCOMFORT (Felt her arm was heavy), CHEILITIS (Felt like thorns on lips), SWELLING (Swelling of the head, neck, and face), NERVOUSNESS (Became very nervous), ANXIETY (Anxiety), DEPRESSION (Depression), RASH (Rash on the face, hands and feet) and HEADACHE (Lot of headaches) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. This case was linked to MOD-2021-079374 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-MAY-2021 contains significant information: Name corrected email ID added, new event "Pain in the right side of her face" added.

Other Meds: METFORMIN; OMEPRAZOLE

Current Illness: Type 2 diabetes mellitus

ID: 1563707
Sex: F
Age: 66
State: NC

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

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Symptoms: Some sore arm; Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some sore arm) and PAIN (Achy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Knee replacement. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Some sore arm) and PAIN (Achy). At the time of the report, PAIN IN EXTREMITY (Some sore arm) and PAIN (Achy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information mentioned.

Other Meds:

Current Illness:

ID: 1563708
Sex: F
Age:
State: AL

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

Vax Type:
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Symptom List:

Symptoms: pretty severe pain throughout entire body; pain at injection site; injection site was feverish/fever 101.5; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pretty severe pain throughout entire body), INJECTION SITE PAIN (pain at injection site) and PYREXIA (injection site was feverish/fever 101.5) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL EXTRA STRENGTH) for Fever and Pain. 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 PAIN (pretty severe pain throughout entire body), INJECTION SITE PAIN (pain at injection site) and PYREXIA (injection site was feverish/fever 101.5). At the time of the report, PAIN (pretty severe pain throughout entire body), INJECTION SITE PAIN (pain at injection site) and PYREXIA (injection site was feverish/fever 101.5) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications reported included Back pain medication. Treatment detail also included Tylenol Extra Strength for fever and pain.

Other Meds: TYLENOL EXTRA STRENGTH

Current Illness: Arthritis

ID: 1563709
Sex: M
Age: 73
State: FL

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

Vax Type:
Manufacturer:
Vax Name:
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Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: outbreak of shingles; A spontaneous report was received from a consumer (patient's wife) concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced outbreak of shingles. The patient's medical history included shingles episodes. Concomitant medications included multiple unknown medications. On 5 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011A21A) intramuscularly for prophylaxis of COVID-19 infection. On the same day immediately following administration of the vaccine patient experienced an outbreak of shingles. The outbreaks occurred in the locations where patient had previously experienced shingles episodes. Treatment details included Valtrex (valaciclovir) and cream for shingles. Action taken with mRNA-1273 in response to the event was unknown. The outcome of event(s), outbreak of shingles was unknown. The reporter did not provide the assessment for the event, outbreak of shingles.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1563710
Sex: M
Age: 83
State: SC

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

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: cold with rigors; body ache; chills; tired; rigors; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold with rigors), PAIN (body ache), CHILLS (chills), FATIGUE (tired) and CHILLS (rigors) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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 an unknown date, the patient experienced NASOPHARYNGITIS (cold with rigors), PAIN (body ache), CHILLS (chills), FATIGUE (tired) and CHILLS (rigors). At the time of the report, NASOPHARYNGITIS (cold with rigors), PAIN (body ache), CHILLS (chills), FATIGUE (tired) and CHILLS (rigors) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Relevant concomitant product usage were not reported by the reporter. Treatment included some tonic water with quinine.

Other Meds:

Current Illness:

ID: 1563711
Sex: F
Age: 83
State: AZ

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

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Lab Data:

Allergies:

Symptom List:

Symptoms: Rash on the body , arms and legs ,that goes away but returns on other places of the body; Skipped the second dose; Tongue swelling; Lips are swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue swelling), LIP SWELLING (Lips are swelling), RASH (Rash on the body , arms and legs ,that goes away but returns on other places of the body) and INCOMPLETE COURSE OF VACCINATION (Skipped the second dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 07-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 SWOLLEN TONGUE (Tongue swelling), LIP SWELLING (Lips are swelling), RASH (Rash on the body , arms and legs ,that goes away but returns on other places of the body) and INCOMPLETE COURSE OF VACCINATION (Skipped the second dose). At the time of the report, SWOLLEN TONGUE (Tongue swelling), LIP SWELLING (Lips are swelling) and INCOMPLETE COURSE OF VACCINATION (Skipped the second dose) outcome was unknown and RASH (Rash on the body , arms and legs ,that goes away but returns on other places of the body) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1563712
Sex: F
Age:
State: OR

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

Vax Type:
Manufacturer:
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Allergies:

Symptom List:

Symptoms: Hardness at injection site; Redness at injection site; Swelling at injection site; Hot area at injection site; extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOMFORT (Hardness at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE PAIN (Hot area at injection site) and INJECTION SITE PRURITUS (extremely itchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Asthma since 1970. Concurrent medical conditions included Hypertension since 2000. Concomitant products included LISINOPRIL, METOPROLOL SUCCINATE (METOPROLOL succ ER), ATORVASTATIN CALCIUM and PROBIOTIC 30 BILLION for an unknown indication. 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 INJECTION SITE DISCOMFORT (Hardness at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE PAIN (Hot area at injection site) and INJECTION SITE PRURITUS (extremely itchy). At the time of the report, INJECTION SITE DISCOMFORT (Hardness at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE PAIN (Hot area at injection site) and INJECTION SITE PRURITUS (extremely itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: follow up received on 12-may-2021,patient demographics updated, concomitent medication added, medical history updated

Other Meds: LISINOPRIL; METOPROLOL succ ER; ATORVASTATIN CALCIUM; PROBIOTIC 30 BILLION

Current Illness: Asthma; Hypertension

ID: 1563713
Sex: M
Age: 57
State: NC

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

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Symptom List:

Symptoms: Vaccine leaked out entirely from the syringe; Vaccine leaked out entirely from the syringe; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Vaccine leaked out entirely from the syringe) and DEVICE CONNECTION ISSUE (Vaccine leaked out entirely from the syringe) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced UNDERDOSE (Vaccine leaked out entirely from the syringe) and DEVICE CONNECTION ISSUE (Vaccine leaked out entirely from the syringe). At the time of the report, UNDERDOSE (Vaccine leaked out entirely from the syringe) and DEVICE CONNECTION ISSUE (Vaccine leaked out entirely from the syringe) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered UNDERDOSE (Vaccine leaked out entirely from the syringe) and DEVICE CONNECTION ISSUE (Vaccine leaked out entirely from the syringe) to be not applicable. This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 026A12A with no associated AEs. Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: NNI On 17-Jul-2021: Follow up received and it contains no new information.; Sender's Comments: This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 026A12A with no associated AEs.

Other Meds:

Current Illness:

ID: 1563714
Sex: F
Age:
State: NY

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

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Allergies:

Symptom List:

Symptoms: stomach cramps; diarrhea; lower back pain; constant nausea; lymph node under left armpit swollen; chills; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), BACK PAIN (lower back pain), NAUSEA (constant nausea) and LYMPHADENOPATHY (lymph node under left armpit swollen) in a 52-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 06-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 ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), BACK PAIN (lower back pain), NAUSEA (constant nausea), LYMPHADENOPATHY (lymph node under left armpit swollen), CHILLS (chills) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), BACK PAIN (lower back pain), NAUSEA (constant nausea), LYMPHADENOPATHY (lymph node under left armpit swollen), CHILLS (chills) and MYALGIA (muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1563715
Sex: F
Age: 73
State: AL

Vax Date: 02/05/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptoms: confusion; extreme weakness; Sore arm; unable to put words together; dizziness; headache; injection site redness; fever; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confusion), ASTHENIA (extreme weakness), PAIN IN EXTREMITY (Sore arm), SPEECH DISORDER (unable to put words together) and DIZZINESS (dizziness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-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 CONFUSIONAL STATE (confusion), ASTHENIA (extreme weakness), PAIN IN EXTREMITY (Sore arm), SPEECH DISORDER (unable to put words together), DIZZINESS (dizziness), HEADACHE (headache), INJECTION SITE ERYTHEMA (injection site redness) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CONFUSIONAL STATE (confusion), ASTHENIA (extreme weakness), PAIN IN EXTREMITY (Sore arm), SPEECH DISORDER (unable to put words together), DIZZINESS (dizziness), HEADACHE (headache), INJECTION SITE ERYTHEMA (injection site redness) and PYREXIA (fever) outcome was unknown. concomitant medications were not reported. Patient gave consent to safety for Follow-up. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.

Other Meds:

Current Illness:

ID: 1563716
Sex: F
Age: 69
State: MA

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

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Symptoms: Pain in arm; Mild soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild soreness of arm) and PAIN IN EXTREMITY (Pain in arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) 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 PAIN IN EXTREMITY (Mild soreness of arm). On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in arm, at a dose of 1 dosage form and NAPROXEN SODIUM (ALEVE) for Pain, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Mild soreness of arm) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included blood pressure medications. Patient gave verbal consent for safety to Follow-up.

Other Meds:

Current Illness:

ID: 1563717
Sex: F
Age:
State: IL

Vax Date: 03/07/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Arm aches; Earache; Been in bed drinking fluids; Stomach Cramps; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm aches), EAR PAIN (Earache), BEDRIDDEN (Been in bed drinking fluids), ABDOMINAL PAIN UPPER (Stomach Cramps) and HEADACHE (Headache) in a 48-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 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm aches), EAR PAIN (Earache), BEDRIDDEN (Been in bed drinking fluids), ABDOMINAL PAIN UPPER (Stomach Cramps), HEADACHE (Headache) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm aches), EAR PAIN (Earache), BEDRIDDEN (Been in bed drinking fluids), ABDOMINAL PAIN UPPER (Stomach Cramps), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown. Concomitant medications include blood pressure medications. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable. Patient gave consent for safety to Follow-up.

Other Meds:

Current Illness:

ID: 1563718
Sex: F
Age: 88
State: SC

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

Vax Type:
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Symptoms: Neck swollen on left side; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Neck swollen on left side) and VACCINATION SITE PAIN (Sore left arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) 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 02-Mar-2021, the patient experienced SWELLING (Neck swollen on left side) and VACCINATION SITE PAIN (Sore left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SWELLING (Neck swollen on left side) and VACCINATION SITE PAIN (Sore left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1563719
Sex: F
Age:
State: IA

Vax Date: 03/05/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: dizzy; ell like she was going to pass out; felt like a panic attack; felt very sleepy; lost her autonomy; She couldn't walk or control her sphincters (she peed all over her); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), MALAISE (ell like she was going to pass out), PANIC ATTACK (felt like a panic attack), SOMNOLENCE (felt very sleepy) and FLAT AFFECT (lost her autonomy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (dizzy), MALAISE (ell like she was going to pass out), PANIC ATTACK (felt like a panic attack), SOMNOLENCE (felt very sleepy), FLAT AFFECT (lost her autonomy) and GAIT DISTURBANCE (She couldn't walk or control her sphincters (she peed all over her)). The patient was treated with DIAZEPAM at an unspecified dose and frequency. On 06-Mar-2021, PANIC ATTACK (felt like a panic attack) had resolved. On 07-Mar-2021, DIZZINESS (dizzy), MALAISE (ell like she was going to pass out), SOMNOLENCE (felt very sleepy), FLAT AFFECT (lost her autonomy) and GAIT DISTURBANCE (She couldn't walk or control her sphincters (she peed all over her)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided.

Other Meds:

Current Illness:

ID: 1563720
Sex: F
Age:
State: NC

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

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: Sore arm day after 2nd shot; Red knot on arm day after 2nd shot; Red knot on arm day after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm day after 2nd shot), ERYTHEMA (Red knot on arm day after 2nd shot) and INJECTION SITE NODULE (Red knot on arm day after 2nd shot) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002a21a and 030l2la) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE, METOPROLOL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE), PREDNISONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm day after 2nd shot). 06-Mar-2021, the patient experienced ERYTHEMA (Red knot on arm day after 2nd shot) and INJECTION SITE NODULE (Red knot on arm day after 2nd shot). At the time of the report, PAIN IN EXTREMITY (Sore arm day after 2nd shot), ERYTHEMA (Red knot on arm day after 2nd shot) and INJECTION SITE NODULE (Red knot on arm day after 2nd shot) outcome was unknown. Treatment medication include Tylenol twice per day and noticed arm pain was more when the Tylenol started wearing off. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable. Reporter did not allow further contact

Other Meds: LEVOTHYROXINE; METOPROLOL; TRIAMTERENE/HYDROCHLOROTHIAZIDE; PREDNISONE; BABY ASPIRIN; JANUVIA [SITAGLIPTIN PHOSPHATE]; GABAPENTIN; TYLENOL

Current Illness:

ID: 1563721
Sex: F
Age: 84
State: FL

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: Felt like a truck ran over her; Was very sore and achy all over; Severe hot flashes; sweating all over body; Weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt like a truck ran over her), MYALGIA (Was very sore and achy all over), HOT FLUSH (Severe hot flashes), HYPERHIDROSIS (sweating all over body) and ASTHENIA (Weak) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The patient's past medical history included Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, FUROSEMIDE for Fluid and electrolyte imbalance, ATENOLOL for Heart rate. On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN (Felt like a truck ran over her), MYALGIA (Was very sore and achy all over), HOT FLUSH (Severe hot flashes), HYPERHIDROSIS (sweating all over body) and ASTHENIA (Weak). On 07-Feb-2021, PAIN (Felt like a truck ran over her), MYALGIA (Was very sore and achy all over), HOT FLUSH (Severe hot flashes) and HYPERHIDROSIS (sweating all over body) had resolved and ASTHENIA (Weak) was resolving. Not Provided treatment to the events not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-008873. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: additional information received patient demographic details, patient historical condition, concomitant medications, outcome if the events are updated from recovering to recovered .

Other Meds: ATENOLOL; XARELTO; FUROSEMIDE

Current Illness:

ID: 1563722
Sex: F
Age: 76
State: AZ

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

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. Concomitant products included IBUPROFEN for an unknown indication. On 05-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 PAIN IN EXTREMITY (Arm soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, PAIN IN EXTREMITY (Arm soreness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: IBUPROFEN

Current Illness:

ID: 1563723
Sex: F
Age:
State: MI

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

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Did not feel well over the weekend; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well over the weekend), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 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 MALAISE (Did not feel well over the weekend), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, MALAISE (Did not feel well over the weekend), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1563724
Sex: F
Age: 67
State: WI

Vax Date: 02/26/2021
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:

Symptoms: redness at injection site; swelling at injection site; achiness at injection site; fatigue; itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (achiness at injection site) and FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. Concomitant products included DOXYCYCLINE and PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at injection site). On 06-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (achiness at injection site) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PRURITUS (itchiness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (achiness at injection site) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were reported. Patient gave consent to safety for Follow-up.

Other Meds: DOXYCYCLINE; PAXIL [PAROXETINE HYDROCHLORIDE]

Current Illness:

ID: 1563725
Sex: F
Age: 42
State: TX

Vax Date: 02/27/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
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Symptoms: Really hot to the touch; The injection site itchy; The injection site is red; The injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Really hot to the touch), VACCINATION SITE PRURITUS (The injection site itchy), VACCINATION SITE ERYTHEMA (The injection site is red) and VACCINATION SITE SWELLING (The injection site is swollen) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Really hot to the touch), VACCINATION SITE PRURITUS (The injection site itchy), VACCINATION SITE ERYTHEMA (The injection site is red) and VACCINATION SITE SWELLING (The injection site is swollen). At the time of the report, VACCINATION SITE WARMTH (Really hot to the touch), VACCINATION SITE PRURITUS (The injection site itchy), VACCINATION SITE ERYTHEMA (The injection site is red) and VACCINATION SITE SWELLING (The injection site is swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1563726
Sex: F
Age: 67
State: CT

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Bumpy at the injection site, down to her elbow and left side of her breast; Blotches at the injection site, down to her elbow and left side of her breast; Itchy at the injection site, down to her elbow and left side of her breast; Soreness; Red at the injection site, down to her elbow and left side of her breast; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (Bumpy at the injection site, down to her elbow and left side of her breast), RASH MACULAR (Blotches at the injection site, down to her elbow and left side of her breast), VACCINATION SITE PRURITUS (Itchy at the injection site, down to her elbow and left side of her breast), VACCINATION SITE PAIN (Soreness) and VACCINATION SITE ERYTHEMA (Red at the injection site, down to her elbow and left side of her breast) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Bumpy at the injection site, down to her elbow and left side of her breast), RASH MACULAR (Blotches at the injection site, down to her elbow and left side of her breast), VACCINATION SITE PRURITUS (Itchy at the injection site, down to her elbow and left side of her breast), VACCINATION SITE PAIN (Soreness), VACCINATION SITE ERYTHEMA (Red at the injection site, down to her elbow and left side of her breast) and HEADACHE (Headache). At the time of the report, VACCINATION SITE MASS (Bumpy at the injection site, down to her elbow and left side of her breast), RASH MACULAR (Blotches at the injection site, down to her elbow and left side of her breast), VACCINATION SITE PRURITUS (Itchy at the injection site, down to her elbow and left side of her breast), VACCINATION SITE PAIN (Soreness), VACCINATION SITE ERYTHEMA (Red at the injection site, down to her elbow and left side of her breast) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant and treatment medication information was reported.

Other Meds:

Current Illness:

ID: 1563727
Sex: F
Age:
State: NC

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

Other Meds:

Current Illness:

ID: 1563728
Sex: F
Age: 85
State: OH

Vax Date: 02/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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Symptoms: blood pressure was high; vaccine effected memory; woke up sick again; body pain/muscle pain; chills; heart palpitation; pain in throat; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was high), MEMORY IMPAIRMENT (vaccine effected memory), PALPITATIONS (heart palpitation), OROPHARYNGEAL PAIN (pain in throat) and ILLNESS (woke up sick again) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma (Athletic asthma). On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PALPITATIONS (heart palpitation), OROPHARYNGEAL PAIN (pain in throat), MYALGIA (body pain/muscle pain) and CHILLS (chills). On 07-Mar-2021, the patient experienced ILLNESS (woke up sick again). On an unknown date, the patient experienced HYPERTENSION (blood pressure was high) and MEMORY IMPAIRMENT (vaccine effected memory). At the time of the report, HYPERTENSION (blood pressure was high), MEMORY IMPAIRMENT (vaccine effected memory), PALPITATIONS (heart palpitation), OROPHARYNGEAL PAIN (pain in throat), ILLNESS (woke up sick again), MYALGIA (body pain/muscle pain) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Heart rate: abnormal (abnormal) abnormal.. No concomitant drugs were reported. No treatment information was reported.

Other Meds:

Current Illness: Asthma (Athletic asthma)

ID: 1563729
Sex: F
Age: 61
State: FL

Vax Date: 03/06/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
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Symptoms: Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported Treatment medications was not provided

Other Meds:

Current Illness:

ID: 1563730
Sex: F
Age: 76
State: FL

Vax Date: 03/03/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
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Symptoms: chills; had symptoms and did not receive second dose; ear infection in one ear and felt ears would clog up; felt symptoms of a sinus infection; became very sick after first dose; severe migraine; brain fog; ears blocked; fever; body ache; Nausea; Headache; Arm Pain; light headedness; dizziness; Weakness; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), DIZZINESS (light headedness; dizziness), ASTHENIA (Weakness), ILLNESS (became very sick after first dose) and MIGRAINE (severe migraine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Type 1 diabetes mellitus, COPD and Hypothyroidism. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for COPD. On 03-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 PAIN IN EXTREMITY (Arm Pain), DIZZINESS (light headedness; dizziness), ASTHENIA (Weakness), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (body ache). On 06-Mar-2021, the patient experienced ILLNESS (became very sick after first dose), MIGRAINE (severe migraine), FEELING ABNORMAL (brain fog), EAR DISCOMFORT (ears blocked) and PYREXIA (fever). On 12-Mar-2021, the patient experienced SINUSITIS (felt symptoms of a sinus infection). On 27-Mar-2021, the patient experienced EAR INFECTION (ear infection in one ear and felt ears would clog up). On 07-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (had symptoms and did not receive second dose). On an unknown date, the patient experienced CHILLS (chills). On 08-Mar-2021, PAIN IN EXTREMITY (Arm Pain), DIZZINESS (light headedness; dizziness), ASTHENIA (Weakness), NAUSEA (Nausea) and MYALGIA (body ache) had resolved. On 07-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (had symptoms and did not receive second dose) had resolved. At the time of the report, ILLNESS (became very sick after first dose), MIGRAINE (severe migraine), FEELING ABNORMAL (brain fog), EAR DISCOMFORT (ears blocked), SINUSITIS (felt symptoms of a sinus infection), EAR INFECTION (ear infection in one ear and felt ears would clog up), CHILLS (chills) and PYREXIA (fever) had resolved and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood glucose fluctuation: low (Low) low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reports current medications as thyroid medication, over the counter eye drops, insulin pump, and insulin four times daily. 27-Mar-2021 Patient went to her physician and was given an antibiotic for an ear infection on one side. It was not disclosed which ear was infected. Patient states her physician did mention her symptoms could be due to vaccine side effects. Treatment medications are listed as Aleve and an antibiotic. At time of follow-up report, the only ongoing symptom was a constant headache. 07-Apr-2021 Patient was supposed to receive her second dose of vaccine. Patient had symptoms and did not receive her second dose. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up report received. Medical history, medications, adverse events, and treatments were updated per new report information.

Other Meds: TRELEGY

Current Illness: COPD; Hypothyroidism; Type 1 diabetes mellitus

ID: 1563731
Sex: F
Age: 93
State: FL

Vax Date: 01/29/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
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Symptoms: neck pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination. The patient's past medical history included Angina pectoris since an unknown date. Concomitant products included GLYCERYL TRINITRATE (NITROGLYCERIN TRANSDERMAL SYSTEM) for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced NECK PAIN (neck pain). At the time of the report, NECK PAIN (neck pain) outcome was unknown. Not Provided Treatment information was unknown Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received on 03-MAY-2021, contains no new information.

Other Meds: NITROGLYCERIN TRANSDERMAL SYSTEM

Current Illness: Angina pectoris

ID: 1563732
Sex: F
Age: 53
State: TX

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
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Symptoms: she developed like a cold; teary eyes; congestion; chills; checked temperature and it was 90; body aches; woke up in the middle night all sweaty; her body was cold; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HYPERHIDROSIS (woke up in the middle night all sweaty), PERIPHERAL COLDNESS (her body was cold), NASOPHARYNGITIS (she developed like a cold) and LACRIMATION INCREASED (teary eyes) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LOSARTAN and PRAVASTATIN 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 05-Mar-2021, the patient experienced PAIN (body aches), HYPERHIDROSIS (woke up in the middle night all sweaty), PERIPHERAL COLDNESS (her body was cold), BODY TEMPERATURE (checked temperature and it was 90) and CHILLS (chills). On 06-Mar-2021, the patient experienced NASOPHARYNGITIS (she developed like a cold), LACRIMATION INCREASED (teary eyes) and NASAL CONGESTION (congestion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PAIN (body aches), HYPERHIDROSIS (woke up in the middle night all sweaty), PERIPHERAL COLDNESS (her body was cold), NASOPHARYNGITIS (she developed like a cold), LACRIMATION INCREASED (teary eyes) and NASAL CONGESTION (congestion) had resolved. At the time of the report, BODY TEMPERATURE (checked temperature and it was 90) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: Follow-up received on 9-mar-2021 which include Events Chills and checked Temperature and it was 90 and the Outcome of event was unknown .

Other Meds: LOSARTAN; PRAVASTATIN

Current Illness:

ID: 1563733
Sex: F
Age: 66
State: NY

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
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Symptom List:

Symptoms: swollen - left arm - it is like a square; red - left arm - it is like a square; hard - left arm- it is like a square; hot - left arm - it is like a square; raised like a hive - left arm - it is like a square; inflammation - left arm; soreness - left arm, arm hurt for a couple of days then went away - left arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen - left arm - it is like a square), ERYTHEMA (red - left arm - it is like a square), INJECTION SITE INFLAMMATION (inflammation - left arm), PAIN IN EXTREMITY (soreness - left arm, arm hurt for a couple of days then went away - left arm) and LIMB DISCOMFORT (hard - left arm- it is like a square) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced INJECTION SITE INFLAMMATION (inflammation - left arm) and PAIN IN EXTREMITY (soreness - left arm, arm hurt for a couple of days then went away - left arm). On 05-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen - left arm - it is like a square), ERYTHEMA (red - left arm - it is like a square), LIMB DISCOMFORT (hard - left arm- it is like a square), VACCINATION SITE WARMTH (hot - left arm - it is like a square) and URTICARIA (raised like a hive - left arm - it is like a square). At the time of the report, PERIPHERAL SWELLING (swollen - left arm - it is like a square), ERYTHEMA (red - left arm - it is like a square), INJECTION SITE INFLAMMATION (inflammation - left arm), PAIN IN EXTREMITY (soreness - left arm, arm hurt for a couple of days then went away - left arm), LIMB DISCOMFORT (hard - left arm- it is like a square), VACCINATION SITE WARMTH (hot - left arm - it is like a square) and URTICARIA (raised like a hive - left arm - it is like a square) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medications were not provided.

Other Meds: HUMIRA

Current Illness:

ID: 1563734
Sex: M
Age: 69
State: MS

Vax Date: 03/04/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
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Symptoms: legs gave out, he couldn't get up/legs still hurt. Little sore; difficult to stand up; bit dizzy; nauseous; fever/low fever but it keeps going down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs gave out, he couldn't get up/legs still hurt. Little sore), DYSSTASIA (difficult to stand up), DIZZINESS (bit dizzy), NAUSEA (nauseous) and PYREXIA (fever/low fever but it keeps going down) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 04-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) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs gave out, he couldn't get up/legs still hurt. Little sore), DYSSTASIA (difficult to stand up), DIZZINESS (bit dizzy), NAUSEA (nauseous) and PYREXIA (fever/low fever but it keeps going down). At the time of the report, PAIN IN EXTREMITY (legs gave out, he couldn't get up/legs still hurt. Little sore), DYSSTASIA (difficult to stand up), DIZZINESS (bit dizzy), NAUSEA (nauseous) and PYREXIA (fever/low fever but it keeps going down) outcome was unknown. Concomitant meds: a lot medications . Tx: nausea meds.

Other Meds:

Current Illness:

ID: 1563735
Sex: F
Age: 49
State: TN

Vax Date: 02/25/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
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Symptoms: Circular Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Circular Rash) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), FAMOTIDINE (PEPCID AC) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) 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 05-Mar-2021, the patient experienced RASH (Circular Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Prophylaxis, at an unspecified dose and frequency. At the time of the report, RASH (Circular Rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. patient was given steroid for treatment. Patient also took Benadryl on her own for treatment.

Other Meds: DEPO-PROVERA; PEPCID AC; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1563736
Sex: F
Age: 44
State: FL

Vax Date: 03/06/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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Symptoms: Felt like she was going to pass out; Had tightness in her chest; Sweating profusely; Could not walk; Felt very weak; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating profusely), GAIT INABILITY (Could not walk), ASTHENIA (Felt very weak), FEELING COLD (Freezing) and FEELING ABNORMAL (Felt like she was going to pass out) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HYPERHIDROSIS (Sweating profusely), GAIT INABILITY (Could not walk), ASTHENIA (Felt very weak) and FEELING COLD (Freezing). On an unknown date, the patient experienced FEELING ABNORMAL (Felt like she was going to pass out) and CHEST DISCOMFORT (Had tightness in her chest). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Urinary tract disorder prophylaxis, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating profusely), GAIT INABILITY (Could not walk), ASTHENIA (Felt very weak), FEELING COLD (Freezing), FEELING ABNORMAL (Felt like she was going to pass out) and CHEST DISCOMFORT (Had tightness in her chest) outcome was unknown. No Concomitant medications were provided

Other Meds:

Current Illness:

ID: 1563737
Sex: F
Age: 57
State:

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/15/2021
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Symptoms: thigh stiffness; pain at the injected arm; mild fever; body aches; body aches; mild fever; This spontaneous case was reported by a physician and describes the occurrence of the first episode of PYREXIA (mild fever), the first episode of PAIN (body aches), MUSCULOSKELETAL STIFFNESS (thigh stiffness), INJECTION SITE PAIN (pain at the injected arm) and the second episode of PYREXIA (mild fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced the first episode of PYREXIA (mild fever). On 12-Feb-2021, the patient experienced the first episode of PAIN (body aches), INJECTION SITE PAIN (pain at the injected arm), the second episode of PYREXIA (mild fever) and the second episode of PAIN (body aches). On 26-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (thigh stiffness). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (thigh stiffness), INJECTION SITE PAIN (pain at the injected arm), the last episode of PYREXIA (mild fever) and the last episode of PAIN (body aches) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. no concomitant medications were reported.

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Current Illness:

ID: 1563738
Sex: F
Age: 71
State: ME

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/15/2021
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Symptoms: Rapid heart beat; trouble breathing at the time; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat) and DYSPNOEA (trouble breathing at the time) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat) and DYSPNOEA (trouble breathing at the time). At the time of the report, HEART RATE INCREASED (Rapid heart beat) and DYSPNOEA (trouble breathing at the time) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Reporter details and vaccine details updated

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Current Illness:

ID: 1563739
Sex: F
Age: 71
State: MI

Vax Date: 02/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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Symptoms: Her arm is hanging, can move fingers but could not hold anything; Can hardly move her arm; Arm been sore and has a lot of pain; injection less than an inch under collar bone, does not agree on where she receive the vaccine, shot she received was too high; A spontaneous report was received from a consumer concerning a 71-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain,sore arm, hardly move her arm, arm was hanging like it doesn't belong to her, could move her fingers but could not hold anything and received injection less than an inch under collar bone, The patient's medical history, as provided by the reporter, included multiple sclerosis. Products known to have been used by patient, within two weeks prior to the event, included gabapentin. On 04-Feb-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 013M20A). On 04 Mar 2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 030A21A) for prophylaxis of COVID-19 infection. On 04-Mar-2021, the patient experienced sore arm and had a lot of pain, could hardly move her arm, her arm was hanging like it doesn't belong to her, could move her fingers but could not hold anything. Treatment included ibuprofen and acetaminophen. The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of events, experienced sore arm and had a lot of pain, could hardly move her arm, her arm was hanging like it doesn't belong to her, could move her fingers but could not hold anything and injection less than an inch under collar bone, were considered resolved on 08-Mar-2021.; 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: GABAPENTIN

Current Illness: MS (She has MS and she is usually has a ot of pain.)

ID: 1563740
Sex: F
Age: 73
State: MD

Vax Date: 02/10/2021
Onset Date: 02/14/2021
Rec V Date: 08/15/2021
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Symptoms: diverticulosis; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and DIVERTICULUM (diverticulosis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE for Hypothyroidism. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On an unknown date, the patient experienced DIVERTICULUM (diverticulosis). At the time of the report, OROPHARYNGEAL PAIN (sore throat) had not resolved and DIVERTICULUM (diverticulosis) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included salt water gargle. Sore throat is reported to be caused by pollution and other environmental factors. Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received - Outcome of the event sore throat updated, causality was updated and new event diverticulosis added.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1563741
Sex: F
Age: 59
State: MO

Vax Date: 02/06/2021
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Rec V Date: 08/15/2021
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Symptoms: Sore arm; Arm was hurting, felt pain down to the arm going to the wrist and fingers; Can't move because of the pain; Solid deep pain with moments of shooting pain; Headache; had bad chills with no fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Arm was hurting, felt pain down to the arm going to the wrist and fingers), MOBILITY DECREASED (Can't move because of the pain), PAIN (Solid deep pain with moments of shooting pain) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Type 2 diabetes mellitus (Pre-existing type 2 diabetes for 40 years.) and Neuropathy peripheral. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Arm was hurting, felt pain down to the arm going to the wrist and fingers), MOBILITY DECREASED (Can't move because of the pain), PAIN (Solid deep pain with moments of shooting pain), HEADACHE (Headache) and CHILLS (had bad chills with no fever). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Prophylaxis, at a dose of 2 Tab and TRAMADOL (oral) for Prophylaxis, at a dose of 1 Tab. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Arm was hurting, felt pain down to the arm going to the wrist and fingers), MOBILITY DECREASED (Can't move because of the pain), PAIN (Solid deep pain with moments of shooting pain), HEADACHE (Headache) and CHILLS (had bad chills with no fever) outcome was unknown. Treatment for the event included Tylenol extra strength two tablets and Tramadol 1 tablet. No Concomitant medications were provided

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Current Illness: Neuropathy peripheral; Type 2 diabetes mellitus (Pre-existing type 2 diabetes for 40 years.)

ID: 1563742
Sex: F
Age: 55
State: NJ

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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Symptoms: Felt worse than she did when she had COVID-19; Extremely light headed; Wasn't able to move; Vertigo; Trouble peeing; Headache; Had a 102 F fever; Chills; Unable to keep anything in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt worse than she did when she had COVID-19), DIZZINESS (Extremely light headed), MOVEMENT DISORDER (Wasn't able to move), VERTIGO (Vertigo) and DYSURIA (Trouble peeing) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (In December). Concomitant products included FENOFIBRATE, UBIDECARENONE (COQ10 EXCEL), CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION COMPLICATION (Felt worse than she did when she had COVID-19), DIZZINESS (Extremely light headed), MOVEMENT DISORDER (Wasn't able to move), VERTIGO (Vertigo), DYSURIA (Trouble peeing), HEADACHE (Headache), PYREXIA (Had a 102 F fever), CHILLS (Chills) and VOMITING (Unable to keep anything in). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 07-Mar-2021, VACCINATION COMPLICATION (Felt worse than she did when she had COVID-19), DIZZINESS (Extremely light headed), MOVEMENT DISORDER (Wasn't able to move), PYREXIA (Had a 102 F fever) and VOMITING (Unable to keep anything in) had resolved. At the time of the report, VERTIGO (Vertigo), DYSURIA (Trouble peeing), HEADACHE (Headache) and CHILLS (Chills) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: FENOFIBRATE; COQ10 EXCEL; CALCIUM; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1563743
Sex: F
Age:
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Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 08/15/2021
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Symptoms: vertigo; IBSD; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea ), VERTIGO (vertigo) and IRRITABLE BOWEL SYNDROME (IBSD) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced DIARRHOEA (diarrhea ) and IRRITABLE BOWEL SYNDROME (IBSD). On 08-Feb-2021, the patient experienced VERTIGO (vertigo). At the time of the report, DIARRHOEA (diarrhea ), VERTIGO (vertigo) and IRRITABLE BOWEL SYNDROME (IBSD) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were provided No Treatment information provided

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Current Illness:

ID: 1563744
Sex: F
Age: 87
State: CA

Vax Date: 02/03/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
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Symptoms: the red has faded out now and there are little puffy spots/dots and indentation in a couple of; left arm injection area is still sensitive; getting itchy; left arm was swollen; sore at injection site; Red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (the red has faded out now and there are little puffy spots/dots and indentation in a couple of), VACCINATION SITE SWELLING (left arm was swollen), VACCINATION SITE HYPERSENSITIVITY (left arm injection area is still sensitive), VACCINATION SITE PRURITUS (getting itchy) and VACCINATION SITE ERYTHEMA (Red at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Solitary kidney. Concomitant products included Thyroid pills, CALCIUM, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and ASCORBIC ACID, COPPER GLUCONATE, FISH OIL, TOCOPHEROL, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (OCUVITE ADULT 50+ [ASCORBIC ACID;COPPER GLUCONATE;FISH OIL;TOCOPHEROL;XANTOFYL;ZEAXANTHIN;ZINC OXIDE]) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red at the injection site). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (the red has faded out now and there are little puffy spots/dots and indentation in a couple of), VACCINATION SITE SWELLING (left arm was swollen), VACCINATION SITE HYPERSENSITIVITY (left arm injection area is still sensitive), VACCINATION SITE PRURITUS (getting itchy) and VACCINATION SITE PAIN (sore at injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (the red has faded out now and there are little puffy spots/dots and indentation in a couple of), VACCINATION SITE PRURITUS (getting itchy), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PAIN (sore at injection site) outcome was unknown, VACCINATION SITE SWELLING (left arm was swollen) had resolved and VACCINATION SITE HYPERSENSITIVITY (left arm injection area is still sensitive) had not resolved. No treatment medication was reported. This case was linked to MOD-2021-033117 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Live significant follow-up appended for case ID MOD21-085628for AE"s - Arm Swelling, Vaccination site hypersensitivity.

Other Meds: Thyroid pills; CALCIUM; VITAMINS A & D; CENTRUM A TO ZINC; OCUVITE ADULT 50+ [ASCORBIC ACID;COPPER GLUCONATE;FISH OIL;TOCOPHEROL;XANTOFYL;ZEAXANTHIN;ZINC OXIDE

Current Illness: Solitary kidney

ID: 1563745
Sex: F
Age:
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Vax Date: 02/23/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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Symptoms: arm is itchy; left arm got swollen; left arm got a large red circle on injection site; arm is painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm is itchy), VACCINATION SITE SWELLING (left arm got swollen), INJECTION SITE ERYTHEMA (left arm got a large red circle on injection site) and VACCINATION SITE PAIN (arm is painful) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) 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 04-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (arm is itchy), VACCINATION SITE SWELLING (left arm got swollen), INJECTION SITE ERYTHEMA (left arm got a large red circle on injection site) and VACCINATION SITE PAIN (arm is painful). The patient was treated with ARNICA MONTANA (ARNICARE) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (arm is itchy), VACCINATION SITE SWELLING (left arm got swollen), INJECTION SITE ERYTHEMA (left arm got a large red circle on injection site) and VACCINATION SITE PAIN (arm is painful) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient experienced delayed reaction. concomitant med- allergy medication. Reporter did not allow further contact

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Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 03 October 2021 5:28pm