VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1569322
Sex: F
Age:
State: CA

Vax Date: 02/10/2021
Onset Date: 03/11/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Heart was jumping really fast; Heart got palpitations; Felt uncomfortable; Lot of fatigue/trouble staying awake, so tired; Fever; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PALPITATIONS (Heart got palpitations), FEELING ABNORMAL (Felt uncomfortable), PALPITATIONS (Heart was jumping really fast) and FATIGUE (Lot of fatigue/trouble staying awake, so tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pneumonia. Concurrent medical conditions included Cystitis interstitial and Chronic back pain (severe). Concomitant products included OXYCODONE HYDROCHLORIDE (OXYCONTIN) for Back pain, HYDROCODONE, TIZANIDINE, LOVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ), GABAPENTIN and PENTOSAN POLYSULFATE SODIUM (ELMIRON) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (Dizzy), FATIGUE (Lot of fatigue/trouble staying awake, so tired) and PYREXIA (Fever). On 12-Mar-2021, the patient experienced PALPITATIONS (Heart got palpitations) and FEELING ABNORMAL (Felt uncomfortable). On 15-Mar-2021, the patient experienced PALPITATIONS (Heart was jumping really fast). At the time of the report, DIZZINESS (Dizzy), PALPITATIONS (Heart got palpitations), FEELING ABNORMAL (Felt uncomfortable), PALPITATIONS (Heart was jumping really fast), FATIGUE (Lot of fatigue/trouble staying awake, so tired) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: high (High) little bit high. On 15-Mar-2021, Heart rate: high (High) high. On 15-Mar-2021, patient visited ER for about two and half hours where multiple tests were done. Results were not provided. No treatment medication reported. This case was linked to MOD-2021-049953 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up correspondence attached

Other Meds: OXYCONTIN; HYDROCODONE; TIZANIDINE; LOVASTATIN; LISINOPRIL/HCTZ; GABAPENTIN; ELMIRON

Current Illness: Chronic back pain (severe); Cystitis interstitial

ID: 1569323
Sex: M
Age: 70
State: GA

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Localized rash flare up in his groin area; More tired than usual; Felt soreness in the arm; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Felt soreness in the arm), PRURITUS (Itchy), RASH (Localized rash flare up in his groin area) and FATIGUE (More tired than usual) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. Concurrent medical conditions included Skin rash (The patient had a couple of rashes) and Athlete's foot. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Felt soreness in the arm), PRURITUS (Itchy) and FATIGUE (More tired than usual). On an unknown date, the patient experienced RASH (Localized rash flare up in his groin area). The patient was treated with TERBINAFINE HYDROCHLORIDE (LAMISIL [TERBINAFINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 17-Mar-2021, PAIN IN EXTREMITY (Felt soreness in the arm) and FATIGUE (More tired than usual) had resolved. At the time of the report, PRURITUS (Itchy) and RASH (Localized rash flare up in his groin area) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that the next day he felt soreness in the arm, more tired than usual and a localized rash flare up in his groin area, it is also itchy. The soreness and tiredness went away the next day. He put Lamisil on the rash but it does not seem to be affective. The patient had a skin rash for the last couple of years and athletes foot so he said it could be a coincidence. Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 07-May-2021 contains information regarding reporter mail address.

Other Meds:

Current Illness: Athlete's foot; Skin rash (The patient had a couple of rashes)

ID: 1569324
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: like I tangled with stinging nettle; It burns; It itches; had this crazy rash since a couple days after my first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (like I tangled with stinging nettle), BURNING SENSATION (It burns), PRURITUS (It itches) and RASH (had this crazy rash since a couple days after my first vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (like I tangled with stinging nettle), BURNING SENSATION (It burns), PRURITUS (It itches) and RASH (had this crazy rash since a couple days after my first vaccine). At the time of the report, PAIN (like I tangled with stinging nettle), BURNING SENSATION (It burns), PRURITUS (It itches) and RASH (had this crazy rash since a couple days after my first vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication were not provided treatment drugs were not provided This case was linked to MOD-2021-052802, MOD-2021-052802 (Patient Link).

Other Meds:

Current Illness:

ID: 1569325
Sex: F
Age: 81
State: KS

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: "it was awful; shook like a leaf; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("it was awful), TREMOR (shook like a leaf), CHILLS (chills) and MYALGIA (body aches) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Tested positive for Covid.) in January 2020. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (chills) and MYALGIA (body aches). On an unknown date, the patient experienced FEELING ABNORMAL ("it was awful) and TREMOR (shook like a leaf). At the time of the report, FEELING ABNORMAL ("it was awful), TREMOR (shook like a leaf), CHILLS (chills) and MYALGIA (body aches) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No other relevant concomitant medication were reported. No treatment information were reported.

Other Meds:

Current Illness:

ID: 1569326
Sex: F
Age: 53
State: OH

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: there are bumps on the roof of my mouth; it feels like when I eat something hard or too hot; slight white, small dots; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISORDER (there are bumps on the roof of my mouth), EATING DISORDER (it feels like when I eat something hard or too hot) and APHTHOUS ULCER (slight white, small dots) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ORAL DISORDER (there are bumps on the roof of my mouth), EATING DISORDER (it feels like when I eat something hard or too hot) and APHTHOUS ULCER (slight white, small dots). At the time of the report, ORAL DISORDER (there are bumps on the roof of my mouth), EATING DISORDER (it feels like when I eat something hard or too hot) and APHTHOUS ULCER (slight white, small dots) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was provided

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1569327
Sex: F
Age: 37
State: MI

Vax Date: 03/11/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Swelling in the left Armpit; Very Very Sore Left Armpit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in the left Armpit) and PAIN IN EXTREMITY (Very Very Sore Left Armpit) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced SWELLING (Swelling in the left Armpit) and PAIN IN EXTREMITY (Very Very Sore Left Armpit). At the time of the report, SWELLING (Swelling in the left Armpit) and PAIN IN EXTREMITY (Very Very Sore Left Armpit) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was included. No treatment medication was included. This case was linked to MOD-2021-050013 .

Other Meds:

Current Illness:

ID: 1569328
Sex: F
Age: 32
State: MN

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Tingling sensation; redness; rash; Dizziness; Soreness right at the site of injection; Raised area on her left arm; COVID arm; Chills; she noticed 3 spots on her bicep/spots moved up to the back of her left side of neck/shingles; Arm was sore; Arm was itchy/itchy area on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (she noticed 3 spots on her bicep/spots moved up to the back of her left side of neck/shingles), DIZZINESS (Dizziness), PERIPHERAL SWELLING (Raised area on her left arm), PARAESTHESIA (Tingling sensation) and VACCINATION SITE REACTION (COVID arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Allergy to amoxycillin.drug rash - little checkered spots). Concomitant products included LORAZEPAM from 30-Jan-2021 to 20-Jun-2021 for Anxiety. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (Arm was itchy/itchy area on her left arm). On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 10-Mar-2021, the patient experienced HERPES ZOSTER (she noticed 3 spots on her bicep/spots moved up to the back of her left side of neck/shingles). On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (Raised area on her left arm), VACCINATION SITE REACTION (COVID arm) and CHILLS (Chills). On 17-Mar-2021, the patient experienced DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Soreness right at the site of injection). On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation), ERYTHEMA (redness) and RASH (rash). The patient was treated with VALACYCLOVIR [VALACICLOVIR] from 15-Mar-2021 to 25-Mar-2021 at an unspecified dose and frequency. On 07-Mar-2021, PAIN IN EXTREMITY (Arm was sore) had resolved with sequelae. At the time of the report, HERPES ZOSTER (she noticed 3 spots on her bicep/spots moved up to the back of her left side of neck/shingles), DIZZINESS (Dizziness), PERIPHERAL SWELLING (Raised area on her left arm), PARAESTHESIA (Tingling sensation), VACCINATION SITE REACTION (COVID arm), PRURITUS (Arm was itchy/itchy area on her left arm), VACCINATION SITE PAIN (Soreness right at the site of injection), ERYTHEMA (redness), RASH (rash) and CHILLS (Chills) had resolved with sequelae. 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. Complaint title: Vaccine too strong for thin persons Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Added other relevant history. Added concomitant medications. Added treatment medication details. Updated event outcome.

Other Meds: LORAZEPAM

Current Illness: Drug allergy (Allergy to amoxycillin.drug rash - little checkered spots)

ID: 1569329
Sex: F
Age:
State: OR

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: positive experience; feeling better with NO joint pain; hips and shoulders NO longer hurting; Used to be in a lot of pain but so much better and definitely not as painful as it had bee; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF RELAXATION (positive experience), ARTHRALGIA (feeling better with NO joint pain), PAIN (hips and shoulders NO longer hurting) and PAIN (Used to be in a lot of pain but so much better and definitely not as painful as it had bee) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Mar-2021, the patient experienced FEELING OF RELAXATION (positive experience), ARTHRALGIA (feeling better with NO joint pain), PAIN (hips and shoulders NO longer hurting) and PAIN (Used to be in a lot of pain but so much better and definitely not as painful as it had bee). At the time of the report, FEELING OF RELAXATION (positive experience) and PAIN (Used to be in a lot of pain but so much better and definitely not as painful as it had bee) outcome was unknown and ARTHRALGIA (feeling better with NO joint pain) and PAIN (hips and shoulders NO longer hurting) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1569330
Sex: F
Age: 75
State: TN

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: soreness in my arm; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in my arm) and PYREXIA (low grade fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031120A) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in my arm) and PYREXIA (low grade fever). At the time of the report, PAIN IN EXTREMITY (soreness in my arm) and PYREXIA (low grade fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102. 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: 1569331
Sex: F
Age: 65
State: NY

Vax Date: 01/30/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Hives around her neck; Temperature of 101 degrees Fahrenheit; Arm was aching; Lethargy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was aching), LETHARGY (Lethargy), URTICARIA (Hives around her neck) and PYREXIA (Temperature of 101 degrees Fahrenheit) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was aching), LETHARGY (Lethargy) and PYREXIA (Temperature of 101 degrees Fahrenheit). On 13-Mar-2021, the patient experienced URTICARIA (Hives around her neck). At the time of the report, PAIN IN EXTREMITY (Arm was aching), LETHARGY (Lethargy), URTICARIA (Hives around her neck) and PYREXIA (Temperature of 101 degrees Fahrenheit) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101 degrees Fahrenheit. Action taken for mRNA-1273 was Not Applicable. Information on concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1569332
Sex: F
Age: 63
State: NJ

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: low energy; fatigue; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The patient's past medical history included Multiple sclerosis (Mild multiple sclerosis). Concomitant products included INTERFERON and CYANOCOBALAMIN (VIT B12) for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ASTHENIA (low energy), FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, ASTHENIA (low energy), FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness at the injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcome was updated.

Other Meds: INTERFERON; VIT B12

Current Illness:

ID: 1569333
Sex: F
Age: 51
State: NH

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: ringing in her ears; aphasia; sever fatigue; headaches; A Spontaneous report was received from the nurse concerning 51 year old female patient who received the second dose of moderna's COVID-19 vaccine(mRNA -1273) and experienced aphasia, sever fatigue, headaches and buzzing/ringing in her ears. The patient medical history and concomitant medications were not provided. On 03-FEB-2021, prior to onset of events the patient received two doses of mRNA (Batch no: 004M220A)vaccine for prophylaxis of COVID-19 infection. After receiving the second dose, she had neurological symptoms. She has buzzing or ringing in her ears and aphasia, severe fatigue. She cannot work for more than 4 hours and she had continous headaches. The ringing gets worse when she gets tired. Two neurologist have put the patient on concision protocol for two weeks Action taken with mRNA response to the events was not reported. The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Fatigue and headache are consistent with the product known safety profile.

Other Meds:

Current Illness:

ID: 1569334
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: hot to the touch; swollen on her left arm; patch on her left arm; tired; sore arm/arm hurts when she lifts it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/arm hurts when she lifts it), VACCINATION SITE WARMTH (hot to the touch), PERIPHERAL SWELLING (swollen on her left arm), FATIGUE (tired) and ERYTHEMA (patch on her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/arm hurts when she lifts it) and FATIGUE (tired). On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch), PERIPHERAL SWELLING (swollen on her left arm) and ERYTHEMA (patch on her left arm). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 200 milligram. On 07-Mar-2021, FATIGUE (tired) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (sore arm/arm hurts when she lifts it), VACCINATION SITE WARMTH (hot to the touch), PERIPHERAL SWELLING (swollen on her left arm) and ERYTHEMA (patch on her left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. As a treatment patient applied a Cold Rag. Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: No new information.

Other Meds:

Current Illness:

ID: 1569335
Sex: M
Age: 32
State: CA

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Penis tingled/vibrated; Headache; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of GENITAL DISCOMFORT (Penis tingled/vibrated), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-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 17-Mar-2021, the patient experienced GENITAL DISCOMFORT (Penis tingled/vibrated), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 17-Mar-2021, GENITAL DISCOMFORT (Penis tingled/vibrated) had resolved. On 18-Mar-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown. Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Non significant follow up received on 07-MAY-2021, no new information On 15-Jun-2021: Non significant follow up received on 15-JUN-2021, no new information

Other Meds:

Current Illness:

ID: 1569336
Sex: F
Age:
State: NY

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: 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 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 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced 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 10-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1569337
Sex: F
Age: 79
State: IL

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm is swelling a little bit; arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swelling a little bit) and PAIN IN EXTREMITY (arm is sore) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821a) 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) 1 dosage form. On 18-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm is swelling a little bit) and PAIN IN EXTREMITY (arm is sore). At the time of the report, PERIPHERAL SWELLING (Arm is swelling a little bit) and PAIN IN EXTREMITY (arm is sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details not provided.

Other Meds:

Current Illness:

ID: 1569338
Sex: F
Age:
State: CA

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

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

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

Symptoms: Itching; Arm swollen; Hot to the touch; Redness has an extension of 4 inches; Redness at the injection site; Stomach pain; Itching all over the body; Pain in the upper part of the back; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), PRURITUS (Itching all over the body), BACK PAIN (Pain in the upper part of the back), PRURITUS (Itching) and PERIPHERAL SWELLING (Arm swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), PRURITUS (Itching all over the body), BACK PAIN (Pain in the upper part of the back) and HEADACHE (Headaches). On 16-Mar-2021, the patient experienced PRURITUS (Itching), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Redness has an extension of 4 inches) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Back pain, at an unspecified dose and frequency and IBUPROFEN for Back pain and Headache, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), PRURITUS (Itching all over the body), BACK PAIN (Pain in the upper part of the back), PRURITUS (Itching), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Redness has an extension of 4 inches), HEADACHE (Headaches) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; ALENDRONATE

Current Illness:

ID: 1569339
Sex: F
Age: 69
State: MA

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: some of the vaccine leaked out of patient's arm; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (some of the vaccine leaked out of patient's arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (some of the vaccine leaked out of patient's arm). At the time of the report, UNDERDOSE (some of the vaccine leaked out of patient's arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided No treatment medication was provided

Other Meds:

Current Illness:

ID: 1569340
Sex: F
Age:
State:

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

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: diarrhea; felt like flu; achy arm; chills; little fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (felt like flu), PAIN IN EXTREMITY (achy arm), CHILLS (chills) and PYREXIA (little fever) 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 DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (felt like flu), PAIN IN EXTREMITY (achy arm), CHILLS (chills) and PYREXIA (little fever). At the time of the report, DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (felt like flu), PAIN IN EXTREMITY (achy arm), CHILLS (chills) and PYREXIA (little fever) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. No concomitant and treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1569341
Sex: F
Age:
State:

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

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

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

Symptoms: COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. No treatment information was reported. Upon internal review on 24-May-2021, the age was corrected to unknown.

Other Meds:

Current Illness:

ID: 1569342
Sex: F
Age: 66
State: GA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Fever; Chills; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M2OA) for COVID-19 vaccination. The patient's past medical history included Chest discomfort, AFib on 09-Sep-2020 and COVID-19. Concurrent medical conditions included Shellfish allergy (Patient is allergic shrimp). Concomitant products included APIXABAN (ELIQUIS), CARVEDILOL, LISINOPRIL and VITAMIN D NOS for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2020, SARS-CoV-2 test negative: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-028450 (Patient Link).

Other Meds: ELIQUIS; CARVEDILOL; LISINOPRIL; VITAMIN D NOS

Current Illness:

ID: 1569343
Sex: F
Age: 35
State: CA

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (lump and hardness to injection site), MASS (bubble next to injection site (Pictures sent to safety)), PALPITATIONS (heart racing), VACCINATION SITE WARMTH (very hot at injection site) and NAUSEA (Nauseous) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-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 16-Mar-2021, the patient experienced VACCINATION SITE INDURATION (lump and hardness to injection site), MASS (bubble next to injection site (Pictures sent to safety)), PALPITATIONS (heart racing), VACCINATION SITE WARMTH (very hot at injection site), NAUSEA (Nauseous), HEADACHE (headache), CHILLS (chills), VACCINATION SITE SWELLING (lump and hardness to injection site), MYALGIA (body ache) and PYREXIA (mild fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. On 17-Mar-2021, NAUSEA (Nauseous), HEADACHE (headache), MYALGIA (body ache) and PYREXIA (mild fever) had resolved. On 18-Mar-2021, PALPITATIONS (heart racing) had resolved. At the time of the report, VACCINATION SITE INDURATION (lump and hardness to injection site), MASS (bubble next to injection site (Pictures sent to safety)), VACCINATION SITE WARMTH (very hot at injection site), CHILLS (chills) and VACCINATION SITE SWELLING (lump and hardness to injection site) outcome was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1569344
Sex: F
Age: 78
State: MO

Vax Date: 02/13/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: delayed itchiness down lower part of arm/delayed itchiness around neck/ it progressed after the 2nd shot to terrible itching on neck and chest; redness on arm/ red spots on arms and legs and body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (delayed itchiness down lower part of arm/delayed itchiness around neck/ it progressed after the 2nd shot to terrible itching on neck and chest) and ERYTHEMA (redness on arm/ red spots on arms and legs and body) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 immunisation. Concurrent medical conditions included Allergy (Seasonal allergies) and UTI on 11-Mar-2021. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID), LOSARTAN, ATORVASTATIN, METOPROLOL and CALCIUM for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (redness on arm/ red spots on arms and legs and body). On an unknown date, the patient experienced PRURITUS (delayed itchiness down lower part of arm/delayed itchiness around neck/ it progressed after the 2nd shot to terrible itching on neck and chest). At the time of the report, PRURITUS (delayed itchiness down lower part of arm/delayed itchiness around neck/ it progressed after the 2nd shot to terrible itching on neck and chest) and ERYTHEMA (redness on arm/ red spots on arms and legs and body) outcome was unknown. Took generic allergy pills for treatment. Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Patient demography, medical history and concomitant drugs were added

Other Meds: SYNTHYROID; LOSARTAN; ATORVASTATIN; METOPROLOL; CALCIUM

Current Illness: Allergy (Seasonal allergies)

ID: 1569345
Sex: F
Age:
State: MA

Vax Date: 02/10/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Face redness; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Face redness), PYREXIA (Fever) and FATIGUE (Fatigue) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (Face redness), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 UNK. On 12-Mar-2021, ERYTHEMA (Face redness), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved. Upon internal review on 24-May-2021, the age was corrected to unknown.

Other Meds:

Current Illness:

ID: 1569346
Sex: F
Age: 24
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: possible invalid dose; pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) and INCORRECT DOSE ADMINISTERED (possible invalid dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 18-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (possible invalid dose). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown and INCORRECT DOSE ADMINISTERED (possible invalid dose) had resolved. Not Provided No concomitant medication were provided No treatment medications were provided This case was linked to US-MODERNATX, INC.-MOD-2021-050279 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-050279:crosslinked for Dose 2

Other Meds:

Current Illness:

ID: 1569347
Sex: U
Age:
State: CA

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: received their second dose of the Moderna vaccine 8 days prior to the 28 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Patient received the second does 8 day prior to 28 days. This case was linked to US-MODERNATX, INC.-MOD-2021-098304 (E2B Linked Report). This case was linked to MOD-2021-050287 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 07-may-2021 contains non-significant information.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-098304:

Other Meds:

Current Illness:

ID: 1569348
Sex: F
Age: 24
State: PA

Vax Date: 02/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Possible invalid dose/extra of the vaccine from the syringe; She felt her arm was wet after dose; A spontaneous report was received from a consumer concerning a 24-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and felt her arm was wet after dose/ exposure via skin contact and administered the dose said that was extra of the vaccine from the syringe and that he overfilled the syringe/ inappropriate dose of vaccine administered The patient's past medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported. On 18 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient stated that she felt her arm wet after the dose, as the pharmacist administered the dose that was extra (overfilled the syringe). Treatment details were not reported. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events felt her arm was wet after dose/ exposure via skin contact and administered the dose said that was extra of the vaccine from the syringe and that he overfilled the syringe/ inappropriate dose of vaccine administered were considered as unknown.; Reporter's Comments: This report refers to a case of incorrect dose administered, exposure via skin contact for mRNA-1273 with no associated AEs.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-050266:crosslinked for Dose 1

Other Meds:

Current Illness:

ID: 1569349
Sex: U
Age:
State: CA

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: received their second dose of the Moderna vaccine 8 days prior to the 28 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No relevant medical history provided. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days). On 17-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant information was provided. No Treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-098304 (E2B Linked Report). This case was linked to MOD-2021-050270 (Patient Link).; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs. US-MODERNATX, INC.-MOD-2021-098304:

Other Meds:

Current Illness:

ID: 1569350
Sex: F
Age: 63
State: OH

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: About 3 or 4 min after she got the shoot she starting feeling hot like she was fainting and dizziness; dizziness; About 3 or 4 min after she got the shoot she starting feeling hot like she was fainting and dizziness; her head was cloudy; soreness in her arm; her head was cloudy soreness in her arm and nausea; A spontaneous report was received from consumer concerning a 63-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced syncope, about 3 or 4 min after she got the shot she starting feeling hot like she was fainting and dizziness, her head was cloudy, soreness in her arm and nausea and soreness in her arm. The patient's past medical history included Cancer since an unknown date. Concomitant products included metoclopramide, olaparib, metoprolol and laxatives. On 17-Mar-2021, the patient received first of the two planned doses of mRNA-1273 (lot number: 048a21a) intramuscularly for the prophylaxis of COVID-19 infection. Patient reported that about 3 or 4 min after she got the shot she started feeling hot like she was fainting and dizziness which lasted for a long time (1hs or 2 hours). She felt her head was cloudy, soreness in her arm and nausea and then she slept for 3 hours. At the time of report, patient was experiencing soreness in her arm. Treatment medication included none. No lab tests were mentioned. The event syncope was considered as serious with criteria of important medical event. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event soreness in her arm was considered not resolved and all other events were resolved on 18 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: METOCLOPRAMIDE; OLAPARIB; METOPROLOL

Current Illness: Cancer

ID: 1569351
Sex: U
Age:
State: SC

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: patient received 2nd dose of Moderna vaccine on 23 days after 1st dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (patient received 2nd dose of Moderna vaccine on 23 days after 1st dose of Moderna vaccine) 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. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (patient received 2nd dose of Moderna vaccine on 23 days after 1st dose of Moderna vaccine). At the time of the report, OFF LABEL USE (patient received 2nd dose of Moderna vaccine on 23 days after 1st dose of Moderna vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1569352
Sex: M
Age: 65
State: PA

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Dizzy; Loopy; Body aches; Running a low grade fever; Woke up 2:30 am with chills; Muscle aches; Joint ache; Feel very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEELING ABNORMAL (Loopy), PAIN (Body aches), PYREXIA (Running a low grade fever) and CHILLS (Woke up 2:30 am with chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (Dizzy), FEELING ABNORMAL (Loopy), PAIN (Body aches), PYREXIA (Running a low grade fever), CHILLS (Woke up 2:30 am with chills), MYALGIA (Muscle aches), ARTHRALGIA (Joint ache) and FATIGUE (Feel very tired). At the time of the report, DIZZINESS (Dizzy), FEELING ABNORMAL (Loopy), PAIN (Body aches), PYREXIA (Running a low grade fever), CHILLS (Woke up 2:30 am with chills), MYALGIA (Muscle aches), ARTHRALGIA (Joint ache) and FATIGUE (Feel very tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 99.6 f (Borderline) 99.6 F. Concomitant product used was not provided by the reporter. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1569353
Sex: M
Age: 74
State:

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: diarrhoea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (diarrhoea) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) 1 dosage form. On 17-Mar-2021, the patient experienced DIARRHOEA (diarrhoea). On 17-Mar-2021, DIARRHOEA (diarrhoea) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported No treatment medication were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1569354
Sex: F
Age:
State: NE

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (A little bit of nausea) 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 COVID-19 (went away after about 10 days) in August 2020. On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (A little bit of nausea). On 17-Mar-2021, FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (A little bit of nausea) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product used was not provided by the reporter Treatment information was not provided by the reporter

Other Meds:

Current Illness:

ID: 1569355
Sex: F
Age: 65
State: MN

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: felt horrible; arm hot; achy; stayed in bed all day; chills; low grade fever; she wouldn't track (her eyes were fluttering); face got white; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (she wouldn't track (her eyes were fluttering)), PALLOR (face got white), PAIN IN EXTREMITY (arm hurt), FEELING ABNORMAL (felt horrible) and FEELING HOT (arm hot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Headache. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PHOTOPSIA (she wouldn't track (her eyes were fluttering)), PALLOR (face got white) and PAIN IN EXTREMITY (arm hurt). On 27-Feb-2021, the patient experienced FEELING ABNORMAL (felt horrible), FEELING HOT (arm hot), PAIN (achy), BEDRIDDEN (stayed in bed all day), CHILLS (chills) and PYREXIA (low grade fever). On 26-Feb-2021, PHOTOPSIA (she wouldn't track (her eyes were fluttering)) and PALLOR (face got white) had resolved. On 27-Feb-2021, PAIN IN EXTREMITY (arm hurt) had resolved. On 28-Feb-2021, FEELING ABNORMAL (felt horrible), FEELING HOT (arm hot), PAIN (achy), BEDRIDDEN (stayed in bed all day), CHILLS (chills) and PYREXIA (low grade fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. The patient used ice on hurt arm.

Other Meds:

Current Illness: Headache

ID: 1569356
Sex: F
Age: 73
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Arm discomfort at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm discomfort at the site) in a 73-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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm discomfort at the site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm discomfort at the site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 103 (High) 103 fever. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. no concomitant medications are provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-034872 (Patient Link).

Other Meds:

Current Illness:

ID: 1569357
Sex: M
Age: 75
State: NY

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

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

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

Symptoms: serious chest pressure pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (serious chest pressure pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced CHEST PAIN (serious chest pressure pain). On 09-Mar-2021, CHEST PAIN (serious chest pressure pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient has stents. No treatment was reported. The second night after the first dose around 7p patient had serious chest pressure pain. This lasted for 2-3 nights. He did inform his doctor.

Other Meds: PLAVIX; BABY ASPIRIN

Current Illness:

ID: 1569358
Sex: M
Age:
State: IN

Vax Date: 03/11/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Injection site pain; injection site redness; injection site swelling; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling). At the time of the report, INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication history not provided by reporter. Treatment information is not provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: The follow up received on 24-May-2021 contain no new information.

Other Meds:

Current Illness:

ID: 1569359
Sex: U
Age:
State: MS

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: 14 people receive vaccine from an excursion vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (14 people receive vaccine from an excursion vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (14 people receive vaccine from an excursion vial). At the time of the report, PRODUCT STORAGE ERROR (14 people receive vaccine from an excursion vial) had resolved. 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. Concomitant medication information was not reported Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021 contains there was no temperature excursion.

Other Meds:

Current Illness:

ID: 1569360
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Swelling of lips; Redness over arm; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling of lips) and ERYTHEMA (Redness over arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced LIP SWELLING (Swelling of lips) and ERYTHEMA (Redness over arm). At the time of the report, LIP SWELLING (Swelling of lips) and ERYTHEMA (Redness over arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. No treatment was provided by the reporter.

Other Meds:

Current Illness:

ID: 1569361
Sex: F
Age:
State: GA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of pain (sore to the touch), erythema (noticed it was red) and erythema (got red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011A21A) for COVID-19 vaccination. No medical history reported. On Mar 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 2, 2021, patient experienced erythema (noticed it was red). On Mar 9, 2021, patient experienced erythema (got red). On Mar 18, 2021, patient experienced pain (sore to the touch). The patient was treated with diphenhydramine hydrochloride), at an unspecified dose and frequency; and antibiotics, at an unspecified dose and frequency. At the time of the report, pain (sore to the touch), erythema (noticed it was red) and erythema (got red) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Blood pressure medicines were taken as concomitant medication.

Other Meds:

Current Illness:

ID: 1569362
Sex: F
Age:
State: CO

Vax Date: 03/09/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Minor aches and pains; Headache; Small fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Minor aches and pains), HEADACHE (Headache) and PYREXIA (Small fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (Small fever). On an unknown date, the patient experienced PAIN (Minor aches and pains) and HEADACHE (Headache). At the time of the report, PAIN (Minor aches and pains), HEADACHE (Headache) and PYREXIA (Small fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided. No treatment information mentioned.

Other Meds:

Current Illness:

ID: 1569363
Sex: F
Age: 50
State: NY

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: lethargy; dry cough; fatigue; chills; slight fever, 99.9; soreness in her left arm; hot, then cold; cant shake symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (soreness in her left arm), FEELING HOT (hot, then cold), FEELING ABNORMAL (cant shake symptoms), LETHARGY (lethargy) and COUGH (dry cough) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm), FEELING HOT (hot, then cold), FEELING ABNORMAL (cant shake symptoms), COUGH (dry cough), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (slight fever, 99.9). On an unknown date, the patient experienced LETHARGY (lethargy). At the time of the report, PAIN IN EXTREMITY (soreness in her left arm), FEELING HOT (hot, then cold), FEELING ABNORMAL (cant shake symptoms), LETHARGY (lethargy), COUGH (dry cough), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (slight fever, 99.9) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medicines were not reported. Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07 May 2021 and updated lab test and patient email id.

Other Meds:

Current Illness:

ID: 1569364
Sex: F
Age: 70
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Red rash in left leg/rash on both legs; Turned dark; This spontaneous case was reported by a physician and describes the occurrence of RASH ERYTHEMATOUS (Red rash in left leg/rash on both legs) and RASH (Turned dark) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Hyperlipidemia, Chronic kidney disease (CKD 3), Vitamin D deficiency and Thrombocythemia. Concomitant products included DICLOFENAC for Arthritis, SIMVASTATIN for Hyperlipidemia, AMLODIPINE and IRBESARTAN (AVAPRO) for Hypertension, VITAMIN D NOS for Vitamin D deficiency. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash in left leg/rash on both legs) and RASH (Turned dark). The patient was treated with CLOBETASOL PROPIONATE at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash in left leg/rash on both legs) and RASH (Turned dark) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Medication was high blood pressure medicine as provided by the patient. Treatment information include OTC tropical cream. Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up received on 10 May 2021 contain information: Patient demographic details updated. Medical history was updated, Concomitant products was updated. Event onset date and outcome was updated.

Other Meds: AMLODIPINE; SIMVASTATIN; AVAPRO; DICLOFENAC; VITAMIN D NOS

Current Illness: Chronic kidney disease (CKD 3); Hyperlipidemia; Hypertension; Thrombocythemia; Vitamin D deficiency

ID: 1569365
Sex: F
Age: 33
State: TX

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 1, para 0) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 12-Mar-2021 at 4:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in November 2020 and the estimated date of delivery was 26-Aug-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medicines were reported. No treatment information were reported.

Other Meds:

Current Illness:

ID: 1569366
Sex: U
Age:
State:

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: tested positive and have symptoms of COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive and have symptoms of COVID) 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 medical history). On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 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 COVID-19 (tested positive and have symptoms of COVID). At the time of the report, COVID-19 (tested positive and have symptoms of COVID) outcome was unknown. No concomitant medication reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1569367
Sex: M
Age: 34
State: LA

Vax Date: 12/23/2020
Onset Date: 01/20/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Fatigue; Temp 99.7; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue) and PYREXIA (Temp 99.7) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (Allergy to Augmentin.), Hypothyroidism and Borderline diabetes. Concomitant products included THYROID (ARMOUR THYROID), IBUPROFEN (ADVIL [IBUPROFEN]), CETIRIZINE HYDROCHLORIDE (WAL ZYR), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), ZINC, IODINE (IOD [IODINE]) and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced FATIGUE (Fatigue) and PYREXIA (Temp 99.7). On 20-Jan-2021, FATIGUE (Fatigue) and PYREXIA (Temp 99.7) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2020-001271 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: This follow-up will be processed at the same time as the initial. Duration for the symptoms was reported as only lasting one day after dose #2.

Other Meds: ARMOUR THYROID; ADVIL [IBUPROFEN]; WAL ZYR; B12 [CYANOCOBALAMIN]; ZINC; IOD [IODINE]; VITAMIN C [ASCORBIC ACID]

Current Illness: Allergy to antibiotic (Allergy to Augmentin.); Borderline diabetes; Hypothyroidism

ID: 1569368
Sex: F
Age:
State: WI

Vax Date: 02/13/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Feels weak; Awaken from sleep; Headache/headache on her left side of head; She couldn't breathe; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She couldn't breathe), ASTHENIA (Feels weak), INSOMNIA (Awaken from sleep) and HEADACHE (Headache/headache on her left side of head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001BZ21A and 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Sleep apnea. Concomitant products included GABAPENTIN, PARACETAMOL (TYLENOL) and CORTISONE for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (She couldn't breathe), INSOMNIA (Awaken from sleep) and HEADACHE (Headache/headache on her left side of head). On 18-Mar-2021, the patient experienced ASTHENIA (Feels weak). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DYSPNOEA (She couldn't breathe), ASTHENIA (Feels weak), INSOMNIA (Awaken from sleep) and HEADACHE (Headache/headache on her left side of head) outcome was unknown. Patient was advised to lay on her side with a proper pillow under her head when sleeping and to take rest. Healthcare provider was aware of the Moderna vaccine administration at the time of cortisone injection. Patient is not sure about the lot number as writing was not legible on the card.(might be 20B21A).

Other Meds: GABAPENTIN; TYLENOL; CORTISONE

Current Illness: Sleep apnea

ID: 1569369
Sex: M
Age: 70
State: TX

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Same thing happened after the second dose,More redder than the first dose; itching more than 1st dose; reaction is little more than the reaction with 1st shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Same thing happened after the second dose,More redder than the first dose), PRURITUS (itching more than 1st dose) and VACCINATION SITE REACTION (reaction is little more than the reaction with 1st shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Same thing happened after the second dose,More redder than the first dose), PRURITUS (itching more than 1st dose) and VACCINATION SITE REACTION (reaction is little more than the reaction with 1st shot). At the time of the report, ERYTHEMA (Same thing happened after the second dose,More redder than the first dose), PRURITUS (itching more than 1st dose) and VACCINATION SITE REACTION (reaction is little more than the reaction with 1st shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1569370
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L204) 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) (Intramuscular) 1 dosage form. On an unknown date, 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) (Intramuscular) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided. Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: NNI This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jan-2021 and was forwarded to Moderna on 19-Jan-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L204) 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) (Intramuscular) 1 dosage form. On an unknown date, 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) (Intramuscular) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided. Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: NNI

Other Meds:

Current Illness:

ID: 1569371
Sex: F
Age:
State: IN

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: vaccination site pain; vaccination site swelling; vaccination site erythema; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site erythema) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site erythema) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm