VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer

Incidents per State

State Total
63,479
AK1,562
AL4,914
AR3,110
AS44
AZ12,730
CA54,886
CO10,464
CT7,347
DC1,568
DE1,561
FL33,514
FM3
GA12,508
GU74
HI2,078
IA4,130
ID2,361
IL18,091
IN22,023
KS4,061
KY6,276
LA4,395
MA13,121
MD11,272
ME2,858
MH8
MI16,697
MN10,689
MO8,360
MP30
MS2,487
MT2,035
NC14,437
ND1,184
NE2,562
NH2,717
NJ16,033
NM3,532
NV3,784
NY30,921
OH17,029
OK5,673
OR7,479
PA21,111
PR1,959
QM2
RI1,833
SC5,601
SD1,087
TN8,048
TX31,896
UT3,791
VA13,180
VI48
VT1,592
WA13,026
WI9,856
WV2,120
WY754
XB5
XL1
XV2

ID: 1608740
Sex: M
Age: 67
State: TX

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: Flu like symptoms; Body aches; Feels like garbage; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), MALAISE (Feels like garbage), CHILLS (Chills) and PYREXIA (Fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), MALAISE (Feels like garbage), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), MALAISE (Feels like garbage), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included High Blood Pressure Medications and Diabetic Medications.

Other Meds:

Current Illness:

ID: 1608741
Sex: M
Age:
State:

Vax Date: 03/24/2021
Onset Date: 04/09/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Migraine headaches; Sore/pain all over; Back pain; Jaw pain; Teeth pain; Scalp pain; Vision affected cant focus; Eyes feel like they have sand in them/had to look out of one eye while driving; Close one eye the other eye is fuzzy; Seeing doubles/while he was driving he had double vision; Knuckles pain; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headaches), PAIN (Sore/pain all over), BACK PAIN (Back pain), PAIN IN JAW (Jaw pain) and TOOTHACHE (Teeth pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300117) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Shortness of breath. Concomitant products included PARACETAMOL (TYLENOL ARTHRITIS) for Arthritis, TIOTROPIUM BROMIDE (SPIRIVA RESPIMAT), TIOTROPIUM BROMIDE MONOHYDRATE, FUROSEMIDE (FUROSIMIDE), ZOLMITRIPTAN, BECLOMETASONE DIPROPIONATE (MYLAN BECLO AQ) and LORAZEPAM (ATIVAN) for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced MIGRAINE (Migraine headaches), PAIN (Sore/pain all over), BACK PAIN (Back pain), PAIN IN JAW (Jaw pain), TOOTHACHE (Teeth pain), PAIN OF SKIN (Scalp pain), VISUAL IMPAIRMENT (Vision affected cant focus), OCULAR DISCOMFORT (Eyes feel like they have sand in them/had to look out of one eye while driving), VISION BLURRED (Close one eye the other eye is fuzzy), DIPLOPIA (Seeing doubles/while he was driving he had double vision) and ARTHRALGIA (Knuckles pain). At the time of the report, MIGRAINE (Migraine headaches), PAIN (Sore/pain all over), BACK PAIN (Back pain), PAIN IN JAW (Jaw pain), TOOTHACHE (Teeth pain), PAIN OF SKIN (Scalp pain), VISUAL IMPAIRMENT (Vision affected cant focus), OCULAR DISCOMFORT (Eyes feel like they have sand in them/had to look out of one eye while driving), VISION BLURRED (Close one eye the other eye is fuzzy), DIPLOPIA (Seeing doubles/while he was driving he had double vision) and ARTHRALGIA (Knuckles pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature fluctuation: abnormal (abnormal) temperature varies from 35.7C to above 36.8C. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: SPIRIVA RESPIMAT; TIOTROPIUM BROMIDE MONOHYDRATE; FUROSIMIDE; ZOLMITRIPTAN; MYLAN BECLO AQ; ATIVAN; TYLENOL ARTHRITIS

Current Illness: Shortness of breath

ID: 1608742
Sex: F
Age: 87
State: OK

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

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Symptom List:

Symptoms: Blood blisters in mouth; Rash on upper body that looks like measles but without the itching; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (Blood blisters in mouth), RASH MORBILLIFORM (Rash on upper body that looks like measles but without the itching) and ASTHENIA (Weakness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL MUCOSAL BLISTERING (Blood blisters in mouth), RASH MORBILLIFORM (Rash on upper body that looks like measles but without the itching) and ASTHENIA (Weakness). At the time of the report, ORAL MUCOSAL BLISTERING (Blood blisters in mouth) and RASH MORBILLIFORM (Rash on upper body that looks like measles but without the itching) had not resolved and ASTHENIA (Weakness) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. The patient received their first dose of Moderna vaccine and on an unknown date experienced weakness which resolved on an unknown date. Reportedly, the patient also developed blood blisters in their mouth and rash on upper body that looks like measles but without the itching. Both these symptoms were still ongoing. No Concomitant product use was reported. No treatment information was provided. This case was linked to MOD-2021-079485 (Patient Link).

Other Meds:

Current Illness:

ID: 1608743
Sex: F
Age:
State: OH

Vax Date: 03/08/2021
Onset Date: 04/05/2021
Rec V Date: 08/22/2021
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Symptom List:

Symptoms: Tingling lips; arm felt heavy; numb lip; funny feeling in throat; felt like she had been to a dentist office; Chemical in throat feeling; wake up every 2 hours during sleep to drink a glass of water to help with the feeling; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numb lip), OROPHARYNGEAL DISCOMFORT (funny feeling in throat), ORAL DISCOMFORT (felt like she had been to a dentist office), THROAT IRRITATION (Chemical in throat feeling) and SLEEP DISORDER (wake up every 2 hours during sleep to drink a glass of water to help with the feeling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy, Allergy to chemicals (IV Iodine), Soy allergy, Latex allergy, Seafood allergy and Asthma. Concomitant products included GABAPENTIN for Back pain, ZOLPIDEM for Insomnia. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (funny feeling in throat), ORAL DISCOMFORT (felt like she had been to a dentist office), THROAT IRRITATION (Chemical in throat feeling) and SLEEP DISORDER (wake up every 2 hours during sleep to drink a glass of water to help with the feeling). On 05-Apr-2021 at 4:05 AM, the patient experienced HYPOAESTHESIA ORAL (numb lip). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling lips) and LIMB DISCOMFORT (arm felt heavy). On 15-Mar-2021, LIMB DISCOMFORT (arm felt heavy) had resolved. On 06-Apr-2021, ORAL DISCOMFORT (felt like she had been to a dentist office), THROAT IRRITATION (Chemical in throat feeling) and SLEEP DISORDER (wake up every 2 hours during sleep to drink a glass of water to help with the feeling) had resolved. On 08-Apr-2021, HYPOAESTHESIA ORAL (numb lip), OROPHARYNGEAL DISCOMFORT (funny feeling in throat) and PARAESTHESIA ORAL (Tingling lips) had resolved. Not Provided Action taken with mRNA-1273 in response to the events was not applicable. Patient would wake up every 2 hours during sleep to drink a glass of water to help with the feeling. This case was linked to US-MODERNATX, INC.-MOD-2021-079459 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Reporter's address, Patient demographic details, Medical history, Product and concomitant information and event details were updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-079459:1st dose

Other Meds: GABAPENTIN; ZOLPIDEM

Current Illness: Allergy to chemicals (IV Iodine); Asthma; Latex allergy; Penicillin allergy; Seafood allergy; Soy allergy

ID: 1608744
Sex: M
Age: 72
State: FL

Vax Date: 03/26/2021
Onset Date: 03/28/2021
Rec V Date: 08/22/2021
Hospital:

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Symptoms: pressure behind right eye; annoying headache, which comes now and then usually when he wakes up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OCULAR DISCOMFORT (pressure behind right eye) and HEADACHE (annoying headache, which comes now and then usually when he wakes up) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced OCULAR DISCOMFORT (pressure behind right eye) and HEADACHE (annoying headache, which comes now and then usually when he wakes up). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT (pressure behind right eye) and HEADACHE (annoying headache, which comes now and then usually when he wakes up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No relevant concomitant medications were reported. Other treatment information included, prescription eye drops was provided. Patient stated that ophthalmologist was draining his eye in every visit. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021 contains no new information.

Other Meds:

Current Illness:

ID: 1608745
Sex: F
Age: 64
State: FL

Vax Date: 02/04/2021
Onset Date: 04/04/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Arm is sore; dizzy; Leg is swollen; Leg starting to hurt; Knee cap is the size of her thigh; Knee cap is the size of her thigh, hot, blood red and looks like fluid in it; knee hurt; Chills; Fever; Diarrhea; Has been so sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), MYALGIA (Arm is sore) and DIZZINESS (dizzy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 04-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea) and ILLNESS (Has been so sick). On 06-Apr-2021, the patient experienced MYALGIA (Arm is sore), DIZZINESS (dizzy), PERIPHERAL SWELLING (Leg is swollen), PAIN IN EXTREMITY (Leg starting to hurt), JOINT SWELLING (Knee cap is the size of her thigh), ERYTHEMA (Knee cap is the size of her thigh, hot, blood red and looks like fluid in it) and ARTHRALGIA (knee hurt). At the time of the report, CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), MYALGIA (Arm is sore), DIZZINESS (dizzy), PERIPHERAL SWELLING (Leg is swollen), PAIN IN EXTREMITY (Leg starting to hurt), JOINT SWELLING (Knee cap is the size of her thigh), ERYTHEMA (Knee cap is the size of her thigh, hot, blood red and looks like fluid in it), ILLNESS (Has been so sick) and ARTHRALGIA (knee hurt) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative (Negative) Patient states she tested negative for covid.. Concomitant Product: Antibiotic No treatment details were added.

Other Meds:

Current Illness:

ID: 1608746
Sex: M
Age: 66
State: CT

Vax Date: 03/21/2021
Onset Date:
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck; She felt very tired; She felt weak; lethargic; She had diarrhea as well; Her right hand has not healed, it feels swollen and tight; Her right hand has not healed, it feels swollen and tight; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck), FATIGUE (She felt very tired), ASTHENIA (She felt weak), LETHARGY (lethargic) and DIARRHOEA (She had diarrhea as well) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-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 (pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck), FATIGUE (She felt very tired), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight) and MUSCULOSKELETAL STIFFNESS (Her right hand has not healed, it feels swollen and tight). At the time of the report, PAIN (pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck), FATIGUE (She felt very tired), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight) and MUSCULOSKELETAL STIFFNESS (Her right hand has not healed, it feels swollen and tight) outcome was unknown. Not Provided Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1608747
Sex: M
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Dizziness; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness) and FATIGUE (Fatigue) 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. The concomitant medications were not provided. This case was linked to MOD-2021-079477 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information was received on 21-May-2021 contains information regarding the patient demographic details.

Other Meds:

Current Illness:

ID: 1608748
Sex: F
Age: 65
State: NY

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

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Symptom List:

Symptoms: Hacking cough; Loss of taste; and smell; not like herself; felt tired; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste) and ANOSMIA (and smell) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Mar-2021, the patient experienced FATIGUE (felt tired), NAUSEA (Nausea) and MALAISE (not like herself). On 16-Apr-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (and smell). On an unknown date, the patient experienced COUGH (Hacking cough). At the time of the report, FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste), ANOSMIA (and smell) and MALAISE (not like herself) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste) and ANOSMIA (and smell) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Mar-2021, the patient experienced FATIGUE (felt tired), NAUSEA (Nausea) and MALAISE (not like herself). On 16-Apr-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (and smell). On an unknown date, the patient experienced COUGH (Hacking cough). At the time of the report, FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste), ANOSMIA (and smell) and MALAISE (not like herself) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient did not take any medications. Reporter did not allow further contact Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1608749
Sex: F
Age: 16
State: MO

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

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Symptom List:

Symptoms: Below 18 years age female patient received 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Below 18 years age female patient received 1st dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Below 18 years age female patient received 1st dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Below 18 years age female patient received 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medications were not provided. The treatment medications were not provided.

Other Meds:

Current Illness:

ID: 1608750
Sex: F
Age: 58
State: FL

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 08/22/2021
Hospital:

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Symptoms: Fatty lumps around the injection site; Inflamed; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Fatty lumps around the injection site), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PAIN (Soreness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 081B21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE MASS (Fatty lumps around the injection site), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PAIN (Soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Fatty lumps around the injection site), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PAIN (Soreness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient applied ice on the injection site. Concomitant medications included unspecified blood pressure medications .

Other Meds:

Current Illness:

ID: 1608751
Sex: F
Age: 40
State: AL

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

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Symptom List:

Symptoms: Patient has not come on menstrual cycle which was due 1Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Patient has not come on menstrual cycle which was due 1Apr2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 01-Apr-2021, the patient experienced MENSTRUATION DELAYED (Patient has not come on menstrual cycle which was due 1Apr2021). At the time of the report, MENSTRUATION DELAYED (Patient has not come on menstrual cycle which was due 1Apr2021) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. She had three negative pregnancy test .

Other Meds:

Current Illness:

ID: 1608752
Sex: M
Age: 30
State: IN

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Sinus congestion; Sore throat; Couldn't lie on my left side; Couldn't move left arm , nor could lie on left side; Painful shoulder at injection site/ pain in the point where the vaccine was applied; Tiredness; Slight fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move left arm , nor could lie on left side), SINUS CONGESTION (Sinus congestion), OROPHARYNGEAL PAIN (Sore throat), MUSCULOSKELETAL DISCOMFORT (Couldn't lie on my left side) and HEADACHE (Headache) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Bloody nose after receiving the flu shot) and Thrombocytopenia. On 14-Apr-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Slight fever). On 14-Apr-2021 at 3:00 PM, the patient experienced VACCINATION SITE PAIN (Painful shoulder at injection site/ pain in the point where the vaccine was applied). 14-Apr-2021 at 3:00 PM, the patient experienced FATIGUE (Tiredness). On 15-Apr-2021 at 3:00 PM, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move left arm , nor could lie on left side) and MUSCULOSKELETAL DISCOMFORT (Couldn't lie on my left side). On 16-Apr-2021, the patient experienced SINUS CONGESTION (Sinus congestion) and OROPHARYNGEAL PAIN (Sore throat). The patient was treated with PARACETAMOL (PARALEN [PARACETAMOL]) for Headache, at a dose of 500 milligram. On 17-Apr-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move left arm , nor could lie on left side), HEADACHE (Headache), VACCINATION SITE PAIN (Painful shoulder at injection site/ pain in the point where the vaccine was applied), FATIGUE (Tiredness) and PYREXIA (Slight fever) had resolved, MUSCULOSKELETAL DISCOMFORT (Couldn't lie on my left side) outcome was unknown. At the time of the report, SINUS CONGESTION (Sinus congestion) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5?f (abnormal) Fever. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant information was not provided by the reporter. This case was linked to MOD-2021-152646 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up information received on 20-May-2021 contains information regarding the patient's demographics and additional events (tiredness and slight fever).

Other Meds:

Current Illness: Drug allergy (Bloody nose after receiving the flu shot); Thrombocytopenia

ID: 1608753
Sex: M
Age: 60
State: MD

Vax Date: 04/01/2021
Onset Date: 04/14/2021
Rec V Date: 08/22/2021
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Symptoms: Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Coronavirus test positive: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient's second vaccination is scheduled for 29Apr2021 and Ihe want to know that whether he can go ahead and get it on that date? Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1608754
Sex: F
Age: 44
State: NJ

Vax Date: 01/04/2021
Onset Date: 04/04/2021
Rec V Date: 08/22/2021
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Symptoms: tested positive for Covid-19; Lack of drug effect; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021. The most recent information was received on 16-Apr-2021 and was forwarded to Moderna on an unknown date. This spontaneous case was reported by an occupational therapist and describes the occurrence of COVID-19 (tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced COVID-19 (tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect). On 04-Apr-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative. On 04-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) POSITIVE. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was not provided by the reporter. Treatment information was unknown. This is a lack of efficacy of the vaccine. Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19 and mRNA-1273 use is assessed as not applicable. Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Upon internal review on 22-Jul-2021, an event (lack of drug effect) was added, event was recoded and onset date corrected. MAH causality for COVID-19 made not applicable after event recoding.; Sender's Comments: This is a lack of efficacy of the vaccine. Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19 and mRNA-1273 use is assessed as not applicable.

Other Meds:

Current Illness:

ID: 1608755
Sex: F
Age: 59
State: CO

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/22/2021
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Symptoms: sick tummy; pain in the back of neck; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (sick tummy), NECK PAIN (pain in the back of neck) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (sick tummy), NECK PAIN (pain in the back of neck) and CHILLS (chills). At the time of the report, ABDOMINAL PAIN UPPER (sick tummy), NECK PAIN (pain in the back of neck) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported No treatment drugs were reported for first dose events Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24 May 2021 and contains no new information On 31-May-2021: Follow-up added for second dose

Other Meds:

Current Illness:

ID: 1608756
Sex: M
Age:
State: CO

Vax Date: 03/20/2021
Onset Date:
Rec V Date: 08/22/2021
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Symptoms: exhaustion; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and FATIGUE (exhaustion) 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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and FATIGUE (exhaustion). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and FATIGUE (exhaustion) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: updated PO BOX

Other Meds:

Current Illness:

ID: 1608757
Sex: F
Age: 44
State: NJ

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 08/22/2021
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Symptoms: arm sore at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE SWELLING (arm sore at the injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Jan-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm sore at the injection site). At the time of the report, VACCINATION SITE SWELLING (arm sore at the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, COVID-19: negative negative. On 04-Apr-2021, COVID-19: positive positive. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged. No concomitant medication was taken. No treatment medication was taken. Action taken with mRNA-1273 in response to the drug was no change This case was linked to US-MODERNATX, INC.-MOD-2021-079498 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-079498:MOD-2021-079498

Other Meds:

Current Illness:

ID: 1608758
Sex: F
Age:
State: NJ

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 08/22/2021
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Symptoms: pain going down her arm; can't reach to put on the seatbelt; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (pain going down her arm) and LIMB DISCOMFORT (can't reach to put on the seatbelt) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain going down her arm) and LIMB DISCOMFORT (can't reach to put on the seatbelt). At the time of the report, PAIN IN EXTREMITY (pain going down her arm) and LIMB DISCOMFORT (can't reach to put on the seatbelt) outcome was unknown. Not Provided Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1608759
Sex: F
Age: 81
State: AZ

Vax Date: 03/18/2021
Onset Date: 04/15/2021
Rec V Date: 08/22/2021
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Symptoms: chills; fatigue; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and DIARRHOEA (diarrhea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 027821A.) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 15-Apr-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue) and DIARRHOEA (diarrhea). At the time of the report, CHILLS (chills), FATIGUE (fatigue) and DIARRHOEA (diarrhea) outcome was unknown. No concomitant medication are taken. No treatment medication are taken. This case was linked to US-MODERNATX, INC.-MOD-2021-079488 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-079488:First dose (Deleted from the system)

Other Meds:

Current Illness:

ID: 1608760
Sex: F
Age:
State: KS

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/22/2021
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Symptoms: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. Family history included Autoimmune disorder (large family history of autoimmune diseases.) and Allergy to antibiotic (Allergy to several antibiotics) since an unknown date. Concurrent medical conditions included Penicillin allergy and Drug allergy (Allergy to sulfones). Concomitant products included MELOXICAM from 12-Mar-2021 to an unknown date for Bursitis, PREGABALIN (LYRICA), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID; CALCIUM; MINERALS NOS; RETINOL; TOCOPHERYL ACETATE; VITAMIN B NOS; VITAMINS NOS; ZINC]) and HYDROXYZINE for an unknown indication. On 02-Feb-2021 at 9:30 AM, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 04-Feb-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-079514 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-MAY-2021 included reporter details physician details. Updated patient demographic details, Vaccination time, Concomitant medication information. On 20-May-2021: ADR & hypersensitivity forms returned. NNI, duplicate information received.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-079514: cross link to Dose 2

Other Meds: Meloxicam; Lyrica; Centrum Silver [Ascorbic Acid; Calcium; Minerals NOS; Retinol; Tocopheryl Acetate; Vitamin B NOS; Vitamins; Hydroxyzine

Current Illness: Allergy to antibiotic (Allergy to several antibiotics); Drug allergy (Allergy to sulfones); Penicillin allergy.

ID: 1608761
Sex: F
Age: 59
State: TX

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 08/22/2021
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Symptoms: Bothersome headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bothersome headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (Bothersome headache). At the time of the report, HEADACHE (Bothersome headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment or concomitant products reported. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information was 21-May-2021 contains information regarding the outcome of the event headache.

Other Meds:

Current Illness:

ID: 1608762
Sex: F
Age:
State: OH

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 08/22/2021
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Symptoms: vaccine rundown her arm and didn't feel she got the full dose; arm soreness; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (vaccine rundown her arm and didn't feel she got the full dose) and MYALGIA (arm soreness) 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 15-Apr-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 ACCIDENTAL UNDERDOSE (vaccine rundown her arm and didn't feel she got the full dose) and MYALGIA (arm soreness). At the time of the report, ACCIDENTAL UNDERDOSE (vaccine rundown her arm and didn't feel she got the full dose) and MYALGIA (arm soreness) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was taken. No treatment medication was taken.

Other Meds:

Current Illness:

ID: 1608763
Sex: F
Age:
State: KS

Vax Date: 02/02/2021
Onset Date: 03/02/2021
Rec V Date: 08/22/2021
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Symptoms: Heart valve regurgitation; Anxiety; Facial flushing; Face red; abdominal cramp; feeling hot; tingling; myalgia; nausea; vomiting; chest pain; Panic attack; Breathing difficult; Chest heaviness; Feeling abnormal; Burning sensation; Swelling; Neuralgia; Ache; DIarrhea; Fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART VALVE INCOMPETENCE (Heart valve regurgitation), DYSPNOEA (Breathing difficult), PAIN (Ache), BURNING SENSATION (Burning sensation) and CHEST DISCOMFORT (Chest heaviness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029a21a and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Shingles (The burning feels like the nerve pain she experienced when she had shingles.). Family history included Autoimmune disorder NOS since an unknown date. Concurrent medical conditions included Allergy to antibiotic (Erythromycin/clyndamycin/arihromycin), Penicillin allergy, Sulfonamide allergy and Drug allergy (Nitrofuran derivatives). Concomitant products included MELOXICAM from 12-Mar-2021 to an unknown date for Bruising, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN, PREGABALIN (LYRICA) and HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) for an unknown indication. On 02-Feb-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (Ache), PYREXIA (Fever) and CHILLS (Chills). 02-Mar-2021, the patient experienced DIARRHOEA (DIarrhea). On 04-Mar-2021, the patient experienced NEURALGIA (Neuralgia). On 04-Mar-2021 at 4:00 PM, the patient experienced SWELLING (Swelling). On 05-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation). On 12-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling abnormal). On 14-Mar-2021, the patient experienced DYSPNOEA (Breathing difficult), CHEST DISCOMFORT (Chest heaviness) and PANIC ATTACK (Panic attack). On 14-Mar-2021 at 9:00 AM, the patient experienced CHEST PAIN (chest pain). On an unknown date, the patient experienced HEART VALVE INCOMPETENCE (Heart valve regurgitation), ANXIETY (Anxiety), FLUSHING (Facial flushing), ERYTHEMA (Face red), ABDOMINAL PAIN (abdominal cramp), FEELING HOT (feeling hot), PARAESTHESIA (tingling), MYALGIA (myalgia), NAUSEA (nausea) and VOMITING (vomiting). The patient was treated with GABAPENTIN on 17-Mar-2021 at a dose of 600 milligram three times a day; PREGABALIN on 14-Apr-2021 at a dose of 50 milligram three times a day; PREGABALIN at a dose of 150 milligram three times a day; AMITRIPTYLINE at a dose of 10 milligram once a day and HYDROXYZINE at a dose of 25 milligram. On 14-Mar-2021, CHEST PAIN (chest pain) had resolved. At the time of the report, HEART VALVE INCOMPETENCE (Heart valve regurgitation), DYSPNOEA (Breathing difficult), PAIN (Ache), BURNING SENSATION (Burning sensation), CHEST DISCOMFORT (Chest heaviness), FEELING ABNORMAL (Feeling abnormal), PANIC ATTACK (Panic attack), ANXIETY (Anxiety), FLUSHING (Facial flushing), ERYTHEMA (Face red), ABDOMINAL PAIN (abdominal cramp), FEELING HOT (feeling hot), PARAESTHESIA (tingling), MYALGIA (myalgia), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown, NEURALGIA (Neuralgia) and SWELLING (Swelling) had not resolved and DIARRHOEA (DIarrhea), PYREXIA (Fever) and CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Chest X-ray: unknown (Inconclusive) UNKNOWN. On 14-Mar-2021, Computerised tomogram: unknown (Inconclusive) UNKNOWN. Action taken with mRNA-1273 in response to the event was not applicable This case was linked to US-MODERNATX, INC.-MOD-2021-079507 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Followup Received on 17-MAY-2021 : updated reporter details,updated Patient demographics,medical history, added new event Neuralgiaoutcome of event pyrexia,chills,diarrhoea, from unknown to recoveredoutcome of event swelling,rash from unknown to not recoveredcasuality of events Pain in extremity,pain,fever,diarrhoea,chills,swelling,neuralgia,rash updated from not provided to possibleadded new event Neuralgia On 20-May-2021: ADR & hypersensitivity forms was received contains no new information On 25-May-2021: Hypersensitivity Form; Sender's Comments: US-MODERNATX, INC.-MOD-2021-079507:cross link to Dose 1

Other Meds: MELOXICAM; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;; LYRICA; HYDROXIZINE

Current Illness: Allergy to antibiotic (Erythromycin/clyndamycin/arihromycin); Autoimmune disorder NOS; Drug allergy (Nitrofuran derivatives); Penicillin allergy; Sulfonamide allergy

ID: 1608764
Sex: M
Age: 65
State: OR

Vax Date: 03/31/2021
Onset Date: 04/13/2021
Rec V Date: 08/22/2021
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Symptoms: Lymph nodes swollen under armpit the size of a half mango; Lymph nodes started hurting really bad and aching in his left arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Lymph nodes started hurting really bad and aching in his left arm) and LYMPHADENOPATHY (Lymph nodes swollen under armpit the size of a half mango) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 31-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 13-Apr-2021, the patient experienced LYMPH NODE PAIN (Lymph nodes started hurting really bad and aching in his left arm). On 16-Apr-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes swollen under armpit the size of a half mango). At the time of the report, LYMPH NODE PAIN (Lymph nodes started hurting really bad and aching in his left arm) and LYMPHADENOPATHY (Lymph nodes swollen under armpit the size of a half mango) had not resolved. Not Provided Action taken with vaccine was not applicable. No concomitant medication was reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1608765
Sex: F
Age:
State: NY

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 08/22/2021
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Symptoms: Couldn't lift hand very high; Lump in injection site arm; 10 days of weakness; on and off chest pain for a couple days; 2-3 days after vaccine injection site arm soreness; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (Couldn't lift hand very high), VACCINATION SITE MASS (Lump in injection site arm), ASTHENIA (10 days of weakness), CHEST PAIN (on and off chest pain for a couple days) and MYALGIA (2-3 days after vaccine injection site arm soreness) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced MOBILITY DECREASED (Couldn't lift hand very high), VACCINATION SITE MASS (Lump in injection site arm), ASTHENIA (10 days of weakness), CHEST PAIN (on and off chest pain for a couple days) and MYALGIA (2-3 days after vaccine injection site arm soreness). On 03-Apr-2021, MOBILITY DECREASED (Couldn't lift hand very high), CHEST PAIN (on and off chest pain for a couple days) and MYALGIA (2-3 days after vaccine injection site arm soreness) had resolved. On 10-Apr-2021, ASTHENIA (10 days of weakness) had resolved. At the time of the report, VACCINATION SITE MASS (Lump in injection site arm) 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.

Other Meds:

Current Illness:

ID: 1608766
Sex: F
Age:
State:

Vax Date: 03/11/2021
Onset Date: 04/16/2021
Rec V Date: 08/22/2021
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Symptoms: Now has discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Now has discomfort) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DISCOMFORT (Now has discomfort). At the time of the report, DISCOMFORT (Now has discomfort) outcome was unknown.

Other Meds:

Current Illness:

ID: 1608767
Sex: F
Age: 59
State: CO

Vax Date: 03/17/2021
Onset Date: 04/14/2021
Rec V Date: 08/22/2021
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Symptoms: Pain in arm; Heart was beating really fast and really hard like it was going to beat out of her chest, and wouldn't calm down; Couldn't sleep; "really bad headache", like a migraine; Chills all night; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), HEART RATE INCREASED (Heart was beating really fast and really hard like it was going to beat out of her chest, and wouldn't calm down), INSOMNIA (Couldn't sleep), HEADACHE ("really bad headache", like a migraine) and CHILLS (Chills all night) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), HEART RATE INCREASED (Heart was beating really fast and really hard like it was going to beat out of her chest, and wouldn't calm down), INSOMNIA (Couldn't sleep), HEADACHE ("really bad headache", like a migraine), CHILLS (Chills all night) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at a dose of UNK dosage form. On 14-Apr-2021, PAIN IN EXTREMITY (Pain in arm), HEART RATE INCREASED (Heart was beating really fast and really hard like it was going to beat out of her chest, and wouldn't calm down), INSOMNIA (Couldn't sleep), CHILLS (Chills all night) and NAUSEA (Nausea) had resolved. On 16-Apr-2021, HEADACHE ("really bad headache", like a migraine) had resolved. No concomitant medications reported. Patient has an event when she eyes opened felt throwing up. No treatment was reported. This case was linked to MOD-2021-079499 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 24-May-2021 contains No new information. Patient is concerned about the safety of sending her personal information through mail attachment.; Sender's Comments: MOD-2021-079499:1st dose

Other Meds:

Current Illness:

ID: 1608768
Sex: F
Age: 72
State: TX

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 08/22/2021
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Symptoms: Feverish; Achy body; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feverish) and MYALGIA (Achy body) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and D25L20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included LOSARTAN for Blood pressure high, ATORVASTATIN CALCIUM (AVASTATIN) for High cholesterol. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Feverish) and MYALGIA (Achy body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Feverish) and MYALGIA (Achy body) had resolved. Other concomitant medications included Hormone replacement therapy (HRT). Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-002801 (Patient Link).

Other Meds: LOSARTAN; AVASTATIN

Current Illness: Blood pressure high; High cholesterol

ID: 1608769
Sex: M
Age:
State:

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Rec V Date: 08/22/2021
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Symptoms: Pain on left arm after vaccination; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain on left arm after vaccination) and PYREXIA (Fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE PAIN (Pain on left arm after vaccination) and PYREXIA (Fever). At the time of the report, INJECTION SITE PAIN (Pain on left arm after vaccination) outcome was unknown and PYREXIA (Fever) had resolved. No concomitant medications provided. This case was linked to MOD-2021-021153 (Patient Link).

Other Meds:

Current Illness:

ID: 1608770
Sex: M
Age:
State:

Vax Date: 03/15/2021
Onset Date: 04/14/2021
Rec V Date: 08/22/2021
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Symptoms: Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032321a and 027a21a) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history was reported.). On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CHEST PAIN (Chest pain). On 16-Apr-2021, CHEST PAIN (Chest pain) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Concomitant product use was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1608771
Sex: M
Age: 91
State: NV

Vax Date: 02/15/2021
Onset Date: 04/05/2021
Rec V Date: 08/22/2021
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Symptoms: Terrible Itch; Rash on both legs, back upper arms; swelling in both legs; swelling top of feet; Swelling in both ankles/Swelling in both knees; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in both legs), PERIPHERAL SWELLING (swelling top of feet), JOINT SWELLING (Swelling in both ankles/Swelling in both knees), PRURITUS (Terrible Itch) and RASH (Rash on both legs, back upper arms) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high, High cholesterol and Penicillin allergy (Joints swelled up.). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, LEVOTHYROXINE, AMLODIPINE and LOSARTAN POTASSIUM (TEMISARTAN) for an unknown indication. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in both legs), PERIPHERAL SWELLING (swelling top of feet) and JOINT SWELLING (Swelling in both ankles/Swelling in both knees). On 10-May-2021, the patient experienced RASH (Rash on both legs, back upper arms). On an unknown date, the patient experienced PRURITUS (Terrible Itch). At the time of the report, PERIPHERAL SWELLING (swelling in both legs) and RASH (Rash on both legs, back upper arms) had resolved, PERIPHERAL SWELLING (swelling top of feet) and JOINT SWELLING (Swelling in both ankles/Swelling in both knees) was resolving and PRURITUS (Terrible Itch) outcome was unknown. Not Provided Treatment medication included slept with feet on pillow for 6 nights and calamine lotion for rash. This case was linked to US-MODERNATX, INC.-MOD-2021-077853 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received on 17-May-2021 and updated patient address, demographics. Added concomitant products, New events were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-077853:first dose vaccination

Other Meds: CRESTOR; LEVOTHYROXINE; AMLODIPINE; TEMISARTAN

Current Illness: Penicillin allergy (Joints swelled up.)

ID: 1608772
Sex: F
Age: 68
State: MI

Vax Date: 01/26/2021
Onset Date: 02/23/2021
Rec V Date: 08/22/2021
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Symptoms: fever; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 004M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) had resolved. Not Provided No concomitant information was reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1608773
Sex: U
Age:
State: NJ

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/22/2021
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Symptoms: right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), LEVOTHYROXINE for Thyroid disorder NOS, ROSUVASTATIN for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (right arm soreness). At the time of the report, PAIN IN EXTREMITY (right arm soreness) had resolved. 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.

Other Meds: LEVOTHYROXINE; ROSUVASTATIN

Current Illness:

ID: 1608774
Sex: F
Age: 59
State: IN

Vax Date: 04/12/2021
Onset Date: 04/12/2021
Rec V Date: 08/22/2021
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Symptoms: nodules on her neck and clavicle; temperature of 102; woke up with golf ball size glands under arm; couldn't wear her bra bc it was so tender; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), BREAST TENDERNESS (couldn't wear her bra bc it was so tender), PARATRACHEAL LYMPHADENOPATHY (nodules on her neck and clavicle), LYMPHADENOPATHY (woke up with golf ball size glands under arm) and PYREXIA (temperature of 102) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in November 2019. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 13-Apr-2021, the patient experienced BREAST TENDERNESS (couldn't wear her bra bc it was so tender) and LYMPHADENOPATHY (woke up with golf ball size glands under arm). On 15-Apr-2021, the patient experienced PARATRACHEAL LYMPHADENOPATHY (nodules on her neck and clavicle) and PYREXIA (temperature of 102). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, Breast tenderness, Paratracheal lymphadenopathy, Lymphadenopathy and Pyrexia, at a dose of 1 dosage form and IBUPROFEN for Paratracheal lymphadenopathy, Lymphadenopathy, Pyrexia, Vaccination site pain and Breast tenderness, at a dose of 1 dosage form. On 15-Apr-2021, BREAST TENDERNESS (couldn't wear her bra bc it was so tender), LYMPHADENOPATHY (woke up with golf ball size glands under arm) and PYREXIA (temperature of 102) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) and PARATRACHEAL LYMPHADENOPATHY (nodules on her neck and clavicle) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 102 (High) Temperature of 102. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information was not reported Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received contained: Updated outcome of the events reported: Recovered from all the events; Follow up declined;

Other Meds:

Current Illness:

ID: 1608775
Sex: M
Age:
State: VA

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 08/22/2021
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Symptoms: dry cough/coughed all night; like choking; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough/coughed all night) and CHOKING SENSATION (like choking) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. Concurrent medical conditions included Parkinson's disease. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced COUGH (dry cough/coughed all night) and CHOKING SENSATION (like choking). At the time of the report, COUGH (dry cough/coughed all night) and CHOKING SENSATION (like choking) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. The patient received vaccination around 2:00.

Other Meds:

Current Illness: Parkinson's disease

ID: 1608776
Sex: F
Age: 49
State: TX

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 08/22/2021
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Symptoms: headaches; arm was sore, red, and feverish; arm was sore, red, and feverish; arm was sore, red, and feverish; arm itched; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headaches), PYREXIA (arm was sore, red, and feverish), VACCINATION SITE ERYTHEMA (arm was sore, red, and feverish), VACCINATION SITE PAIN (arm was sore, red, and feverish) and VACCINATION SITE PRURITUS (arm itched) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 021B21A) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches), PYREXIA (arm was sore, red, and feverish), VACCINATION SITE ERYTHEMA (arm was sore, red, and feverish), VACCINATION SITE PAIN (arm was sore, red, and feverish) and VACCINATION SITE PRURITUS (arm itched). At the time of the report, HEADACHE (headaches), PYREXIA (arm was sore, red, and feverish), VACCINATION SITE ERYTHEMA (arm was sore, red, and feverish), VACCINATION SITE PAIN (arm was sore, red, and feverish) and VACCINATION SITE PRURITUS (arm itched) outcome was unknown. Not Provided No concomitant medications was reported by the reporter No treatment medications was provided by the reporter.

Other Meds:

Current Illness: Seasonal allergy

ID: 1608777
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/22/2021
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Symptoms: sweating like a pig; hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month; no control over her body; hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating like a pig), the first episode of ALOPECIA (hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month), COORDINATION ABNORMAL (no control over her body) and the second episode of ALOPECIA (hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating like a pig), the first episode of ALOPECIA (hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month), COORDINATION ABNORMAL (no control over her body) and the second episode of ALOPECIA (hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month). At the time of the report, HYPERHIDROSIS (sweating like a pig), COORDINATION ABNORMAL (no control over her body) and the last episode of ALOPECIA (hair is falling out in chunks,when she touches her hair it comes out in clumps, bald in a month) outcome was unknown. Not Provided No relevant concomitant medications were reported. No treatment information was reported. This case was linked to MOD21-077234 (E2B Linked Report).; Sender's Comments: MOD21-077234:

Other Meds:

Current Illness:

ID: 1608778
Sex: U
Age:
State: NJ

Vax Date: 03/09/2021
Onset Date: 04/16/2021
Rec V Date: 08/22/2021
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Symptoms: rapid heart beat; left arm soreness; body ache; chills; fever of 101.5F; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (rapid heart beat), PAIN IN EXTREMITY (left arm soreness), MYALGIA (body ache), CHILLS (chills) and PYREXIA (fever of 101.5F) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced HEART RATE INCREASED (rapid heart beat), MYALGIA (body ache) and PYREXIA (fever of 101.5F). 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm soreness) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (rapid heart beat), PAIN IN EXTREMITY (left arm soreness), MYALGIA (body ache), CHILLS (chills) and PYREXIA (fever of 101.5F) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds: CRESTOR; SYNTHROID; OMEPRAZOLE

Current Illness:

ID: 1608779
Sex: F
Age:
State: IL

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Forehead broke out; On right cheek two small lumps; Top of head itching like crazy; Top of chest down to my boobs broke out; My back is starting to itch, like creepy ants crawling all over; Pin point red dots on stomach and legs but not itching; One arm is a little broke out; Real tired; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Forehead broke out), SWELLING FACE (On right cheek two small lumps), PRURITUS (Top of head itching like crazy), ACNE (Top of chest down to my boobs broke out) and PRURITUS (My back is starting to itch, like creepy ants crawling all over) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Panic attacks and Thyroid disorder NOS (Thyroid). Concomitant products included LEVOTHYROXINE and CLONAZEPAM for an unknown indication. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced ACNE (Forehead broke out), SWELLING FACE (On right cheek two small lumps), PRURITUS (Top of head itching like crazy), ACNE (Top of chest down to my boobs broke out), PRURITUS (My back is starting to itch, like creepy ants crawling all over), RASH ERYTHEMATOUS (Pin point red dots on stomach and legs but not itching), RASH (One arm is a little broke out) and FATIGUE (Real tired). At the time of the report, ACNE (Forehead broke out), SWELLING FACE (On right cheek two small lumps), PRURITUS (Top of head itching like crazy), ACNE (Top of chest down to my boobs broke out), PRURITUS (My back is starting to itch, like creepy ants crawling all over), RASH ERYTHEMATOUS (Pin point red dots on stomach and legs but not itching), RASH (One arm is a little broke out) and FATIGUE (Real tired) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medications were unknown.

Other Meds: LEVOTHYROXINE; CLONAZEPAM

Current Illness:

ID: 1608780
Sex: F
Age:
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Rec V Date: 08/22/2021
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Symptoms: headache; fever; tired; hot and cold; bone and joint ache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (headache), PYREXIA (fever), FATIGUE (tired), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and PAIN (bone and joint ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (headache), PYREXIA (fever), FATIGUE (tired), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and PAIN (bone and joint ache). Reporter did not allow further contact

Other Meds: OCREVUS; TYLENOL; VITAMIN C ACID; VITAMIN D 3; WELLBUTRIN; ZYRTEC ALLERGY; GABAPENTIN; VISTARIL [HYDROXYZINE EMBONATE]; MIRAPEX; ZOLOFT; VYVANSE

Current Illness:

ID: 1608781
Sex: M
Age:
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Rec V Date: 08/22/2021
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Symptoms: Bacterial infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACTERIAL INFECTION (Bacterial infection) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACTERIAL INFECTION (Bacterial infection). The patient was treated with CEFALEXIN (CEPHALEXINE) (oral) at a dose of 500 milligram three times a day. At the time of the report, BACTERIAL INFECTION (Bacterial infection) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient started with oral medication, cephalexin 500mg, 3 times a day for ten days for a bacterial infection. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1608782
Sex: F
Age:
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Rec V Date: 08/22/2021
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Symptoms: Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose; Fever; Fatigue; Sore arm and red rash at the injection site; Sore arm and red rash at the injection site; Sore arm and red rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose), PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore arm and red rash at the injection site) and VACCINATION SITE ERYTHEMA (Sore arm and red rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history 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 INTENTIONAL PRODUCT USE ISSUE (Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose), PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore arm and red rash at the injection site), VACCINATION SITE ERYTHEMA (Sore arm and red rash at the injection site) and VACCINATION SITE RASH (Sore arm and red rash at the injection site). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose) outcome was unknown and PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore arm and red rash at the injection site), VACCINATION SITE ERYTHEMA (Sore arm and red rash at the injection site) and VACCINATION SITE RASH (Sore arm and red rash at the injection site) had resolved. No concomitant medications provided. No treatment information was provided. This case was linked to MOD-2021-017852 (Patient Link).

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Current Illness:

ID: 1608783
Sex: F
Age:
State: VA

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 08/22/2021
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Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Osteoarthritis. Concomitant products included DICLOFENAC for Osteoarthritis. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient was advised from her doctor to stop taking her Diclofenac for her osteoarthritis and not to take Tylenol before her vaccine. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Outcome of event updated

Other Meds: DICLOFENAC

Current Illness: Osteoarthritis

ID: 1608784
Sex: F
Age: 67
State: NJ

Vax Date: 01/12/2021
Onset Date: 02/17/2021
Rec V Date: 08/22/2021
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Symptoms: Weakness; Chills; Redness at injection site; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Weakness), CHILLS (Chills) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 012L20A) for COVID-19 vaccination. The patient's past medical history included GERD and Short-bowel syndrome. Concurrent medical conditions included Hypertension. Concomitant products included FISH OIL for Cholesterol, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) from an unknown date to 20-May-2021 for GERD, LISINOPRIL for Hypertension, TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for Non-alcoholic steatohepatitis, VITAMIN D3 for Vitamin D deficiency. On 12-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ASTHENIA (Weakness), CHILLS (Chills) and INJECTION SITE ERYTHEMA (Redness at injection site). On 18-Feb-2021, ASTHENIA (Weakness), CHILLS (Chills) and INJECTION SITE ERYTHEMA (Redness at injection site) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-011287 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up received on 210521 and updated patient information, added medical History, concomitant medications, new event.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-011287:First dose

Other Meds: LISINOPRIL; PROTONIX [OMEPRAZOLE]; VITAMIN E [TOCOPHEROL]; VITAMIN D3; FISH OIL

Current Illness: Hypertension

ID: 1608785
Sex: F
Age: 70
State: IN

Vax Date: 04/08/2021
Onset Date: 04/09/2021
Rec V Date: 08/22/2021
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Allergies: Iodine allergy

Symptom List:

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of hyperhidrosis (feet sweating), paresthesia (hands are tingling/tingling; also went from shoulders down to hand), feeling hot (hot hands) and pain (feels like a sting down entire arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 021B21A and 030A21A) for COVID-19 immunization. Concurrent medical conditions included blood pressure, high cholesterol, diabetes, heart disorder and iodine allergy. On Mar 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 8, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 9, 2021, patient experienced hyperhidrosis (feet sweating), paresthesia (hands are tingling/tingling; also went from shoulders down to hand), feeling hot (hot hands) and pain (feels like a sting down entire arm). At the time of the report, hyperhidrosis (feet sweating), paresthesia (hands are tingling/tingling; also went from shoulders down to hand), feeling hot (hot hands) and pain (feels like a sting down entire arm) resolved. Reporter did not allow further contact. Most recent follow-up information incorporated: On May 19, 2021: Follow-up received on May 19, 2021 contained information regarding outcome of the events.

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Current Illness: Blood pressure; diabetes; heart disorder; high cholesterol

ID: 1608786
Sex: U
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Rec V Date: 08/22/2021
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Symptoms: rash on my injected arm; joint pains; fever; This spontaneous case was reported by an other and describes the occurrence of PYREXIA (fever), INJECTION SITE RASH (rash on my injected arm) and ARTHRALGIA (joint pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), INJECTION SITE RASH (rash on my injected arm) and ARTHRALGIA (joint pains). At the time of the report, PYREXIA (fever) had resolved, INJECTION SITE RASH (rash on my injected arm) outcome was unknown and ARTHRALGIA (joint pains) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.7. Action taken with mRNA-1273 in response to the event was not applicable. No concomitant drugs and treatment drugs were reported.

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Current Illness:

ID: 1608787
Sex: F
Age:
State: FL

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Rec V Date: 08/22/2021
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Symptoms: A little soreness; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little soreness) and HEADACHE (Mild headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 PAIN (A little soreness) and HEADACHE (Mild headache). At the time of the report, PAIN (A little soreness) and HEADACHE (Mild headache) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1608788
Sex: M
Age:
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Rec V Date: 08/22/2021
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Symptoms: Vaccination complication; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination complication) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination complication). At the time of the report, VACCINATION COMPLICATION (Vaccination complication) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient is reporting an interaction with their Warfarin medication after receiving the Moderna COVID-19 shot (did not indicate if 1st or 2nd). Reporter did not allow further contact

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Current Illness:

ID: 1608789
Sex: M
Age:
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Vax Date: 03/13/2021
Onset Date: 03/01/2021
Rec V Date: 08/22/2021
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Symptoms: Fever reached 101F; flu like symptoms; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (Fever reached 101F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product AZTREONAM LYSINE inhalation vapour, liquid for Cystic fibrosis. Concurrent medical conditions included Cystic fibrosis. Concomitant products included DORNASE ALFA (PULMOZYME) and ELEXACAFTOR, IVACAFTOR, TEZACAFTOR (TRIKAFTA) for an unknown indication. In 2018, the patient started AZTREONAM LYSINE (unknown route) 75 milligram. On 13-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On an unknown date, the patient experienced PYREXIA (Fever reached 101F). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and PYREXIA (Fever reached 101F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 101 (High) 101 F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information provided

Other Meds: PULMOZYME; TRIKAFTA

Current Illness: Cystic fibrosis

Total 2021 VAERS Injuries: 559,999

Page last modified: 03 October 2021 5:28pm