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
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: 1552135
Sex: F
Age: 65
State: NY

Vax Date: 02/14/2021
Onset Date: 02/21/2021
Rec V Date: 08/13/2021
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: Big lump; Numbness in arm; Swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big lump), HYPOAESTHESIA (Numbness in arm) and VACCINATION SITE SWELLING (Swelling in arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20A) for COVID-19 vaccination. Concomitant products included Blood Pressure for Blood pressure, INSULIN DETEMIR (LEVEMIR), INSULIN and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE MASS (Big lump), HYPOAESTHESIA (Numbness in arm) and VACCINATION SITE SWELLING (Swelling in arm). At the time of the report, VACCINATION SITE MASS (Big lump), HYPOAESTHESIA (Numbness in arm) and VACCINATION SITE SWELLING (Swelling in arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided.

Other Meds: LEVEMIR; INSULIN; Blood Pressure; VITAMINS A & D

Current Illness:

ID: 1552136
Sex: F
Age:
State: IL

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 08/13/2021
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: lump on the injection site/tumor like; Injection site lump was described by patient as dark; Injection site lump was described by patient as hard; headache; Injection site lump was described by patient as swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE MASS (lump on the injection site/tumor like), INJECTION SITE DISCOLOURATION (Injection site lump was described by patient as dark), INJECTION SITE INDURATION (Injection site lump was described by patient as hard), HEADACHE (headache) and INJECTION SITE SWELLING (Injection site lump was described by patient as swollen) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-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 INJECTION SITE MASS (lump on the injection site/tumor like), INJECTION SITE DISCOLOURATION (Injection site lump was described by patient as dark), INJECTION SITE INDURATION (Injection site lump was described by patient as hard), HEADACHE (headache) and INJECTION SITE SWELLING (Injection site lump was described by patient as swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE MASS (lump on the injection site/tumor like), INJECTION SITE DISCOLOURATION (Injection site lump was described by patient as dark), INJECTION SITE INDURATION (Injection site lump was described by patient as hard), HEADACHE (headache) and INJECTION SITE SWELLING (Injection site lump was described by patient as swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1552137
Sex: F
Age: 77
State: TX

Vax Date: 02/12/2021
Onset Date:
Rec V Date: 08/13/2021
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: Soreness in arm which lasted a few days; Rash at injection site which lasted a few days; Very itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm which lasted a few days), VACCINATION SITE RASH (Rash at injection site which lasted a few days) and VACCINATION SITE PRURITUS (Very itchy at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The patient's past medical history included Asthma since an unknown date and COPD since an unknown date. Concomitant products included LEVOTHYROXINE, POTASSIUM and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in arm which lasted a few days), VACCINATION SITE RASH (Rash at injection site which lasted a few days) and VACCINATION SITE PRURITUS (Very itchy at injection site). At the time of the report, PAIN IN EXTREMITY (Soreness in arm which lasted a few days), VACCINATION SITE RASH (Rash at injection site which lasted a few days) and VACCINATION SITE PRURITUS (Very itchy at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. This case was linked to MOD-2021-098781 (Patient Link).

Other Meds: LEVOTHYROXINE; POTASSIUM; SINGULAIR

Current Illness: Asthma; COPD

ID: 1552138
Sex: F
Age: 70
State: MD

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 08/13/2021
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: The patient's past medical history included Hypertension since an unknown date. Concomitant products included VITAMINS NOS for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced SKIN DISCOLOURATION (she noticed two pink circles in the under arm around a circle flat and itchy) and PRURITUS (she noticed two pink circles in the under arm around a circle flat and itchy). On 21-Feb-2021, the patient experienced INJECTION SITE RASH (rash around the injection site, which she felt). At the time of the report, SKIN DISCOLOURATION (she noticed two pink circles in the under arm around a circle flat and itchy), PRURITUS (she noticed two pink circles in the under arm around a circle flat and itchy) and INJECTION SITE RASH (rash around the injection site, which she felt) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (she noticed two pink circles in the under arm around a circle flat and itchy), PRURITUS (she noticed two pink circles in the under arm around a circle flat and itchy) and INJECTION SITE RASH (rash around the injection site, which she felt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006m20k) for COVID-19 vaccination. The patient's past medical history included Hypertension since an unknown date. Concomitant products included VITAMINS NOS for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced SKIN DISCOLOURATION (she noticed two pink circles in the under arm around a circle flat and itchy) and PRURITUS (she noticed two pink circles in the under arm around a circle flat and itchy). On 21-Feb-2021, the patient experienced INJECTION SITE RASH (rash around the injection site, which she felt). At the time of the report, SKIN DISCOLOURATION (she noticed two pink circles in the under arm around a circle flat and itchy), PRURITUS (she noticed two pink circles in the under arm around a circle flat and itchy) and INJECTION SITE RASH (rash around the injection site, which she felt) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided.

Other Meds: VITAMINS NOS

Current Illness: Hypertension

ID: 1552139
Sex: F
Age:
State: OH

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 08/13/2021
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: Within 3 hours of shot I had achy body like flu symptoms; Within 3 hours of shot I had achy body like flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Within 3 hours of shot I had achy body like flu symptoms) and INFLUENZA (Within 3 hours of shot I had achy body like flu symptoms) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included AMLODIPINE and TIMOLOL for an unknown indication. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN (Within 3 hours of shot I had achy body like flu symptoms) and INFLUENZA (Within 3 hours of shot I had achy body like flu symptoms). At the time of the report, PAIN (Within 3 hours of shot I had achy body like flu symptoms) and INFLUENZA (Within 3 hours of shot I had achy body like flu symptoms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds: AMLODIPINE; TIMOLOL

Current Illness:

ID: 1552140
Sex: F
Age: 73
State: WY

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/13/2021
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: \ On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore). On 20-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot arm), PYREXIA (fever of 99.7 degrees) and VACCINATION SITE RASH (rash on arm where shot was given about 3x5 inches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (hot arm), PYREXIA (fever of 99.7 degrees), VACCINATION SITE PAIN (sore) and VACCINATION SITE RASH (rash on arm where shot was given about 3x5 inches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: (High) 99.7 DEGREES. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant Concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: updated events outcome as recovered/resolved This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021. The most recent information was received on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (hot arm), PYREXIA (fever of 99.7 degrees), VACCINATION SITE PAIN (sore) and VACCINATION SITE RASH (rash on arm where shot was given about 3x5 inches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History Information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore). On 20-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot arm), PYREXIA (fever of 99.7 degrees) and VACCINATION SITE RASH (rash on arm where shot was given about 3x5 inches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (hot arm), PYREXIA (fever of 99.7 degrees), VACCINATION SITE PAIN (sore) and VACCINATION SITE RASH (rash on arm where shot was given about 3x5 inches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: (High) 99.7 DEGREES. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant Concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: updated events outcome as recovered/resolved

Other Meds:

Current Illness:

ID: 1552141
Sex: F
Age: 60
State: MS

Vax Date: 01/06/2021
Onset Date: 02/03/2021
Rec V Date: 08/13/2021
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: Joint swelling in Fingers and in ankles; Tingling Sensation; Fever - Temperature of 100.4F; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (Joint swelling in Fingers and in ankles), PARAESTHESIA (Tingling Sensation) and PYREXIA (Fever - Temperature of 100.4F) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced JOINT SWELLING (Joint swelling in Fingers and in ankles), PARAESTHESIA (Tingling Sensation) and PYREXIA (Fever - Temperature of 100.4F). The patient was treated with NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at an unspecified dose and frequency. On 04-Feb-2021, JOINT SWELLING (Joint swelling in Fingers and in ankles), PARAESTHESIA (Tingling Sensation) and PYREXIA (Fever - Temperature of 100.4F) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 100.4 (High) fever 100.4F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was Not applicable. Concomitant medication also included Anti-inflammatory to alleviate symptoms.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1552142
Sex: F
Age: 26
State: PA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/13/2021
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: Injection site is swollen; Injection site is red; Hurt initially, Injection site is very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE PAIN (Hurt initially, Injection site is very painful) and VACCINATION SITE ERYTHEMA (Injection site is red) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Hurt initially, Injection site is very painful). On 28-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red). At the time of the report, VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE PAIN (Hurt initially, Injection site is very painful) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1552143
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 02/22/2021
Rec V Date: 08/13/2021
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: my arm has a big lump; feels a little bit warm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (my arm has a big lump) and FEELING HOT (feels a little bit warm) 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 22-Feb-2021, the patient experienced LIMB MASS (my arm has a big lump) and FEELING HOT (feels a little bit warm). At the time of the report, LIMB MASS (my arm has a big lump) and FEELING HOT (feels a little bit warm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1552144
Sex: M
Age: 65
State: WI

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/13/2021
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: Hot to the Touch Injection Site; Pain Injection Site/ Tender Injection Site; Red Injection Site; Tender injection site; Delayed Injection Site Reactions; Fell sleep in a chair; Back Pain; Could hardly get up from a chair and move to the bed; Tense Back Muscles; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Fell sleep in a chair), BACK PAIN (Back Pain), DYSSTASIA (Could hardly get up from a chair and move to the bed), MUSCLE TIGHTNESS (Tense Back Muscles) and VACCINATION SITE REACTION (Delayed Injection Site Reactions) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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-Feb-2021, the patient experienced SOMNOLENCE (Fell sleep in a chair), BACK PAIN (Back Pain), DYSSTASIA (Could hardly get up from a chair and move to the bed) and MUSCLE TIGHTNESS (Tense Back Muscles). On 17-Feb-2021, the patient experienced VACCINATION SITE REACTION (Delayed Injection Site Reactions), VACCINATION SITE PAIN (Pain Injection Site/ Tender Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and INJECTION SITE PAIN (Tender injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to the Touch Injection Site). On 10-Feb-2021, SOMNOLENCE (Fell sleep in a chair) had resolved. On 18-Feb-2021, VACCINATION SITE PAIN (Pain Injection Site/ Tender Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and INJECTION SITE PAIN (Tender injection site) outcome was unknown. At the time of the report, BACK PAIN (Back Pain), DYSSTASIA (Could hardly get up from a chair and move to the bed), MUSCLE TIGHTNESS (Tense Back Muscles), VACCINATION SITE REACTION (Delayed Injection Site Reactions) and VACCINATION SITE WARMTH (Hot to the Touch Injection Site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Fell sleep in a chair), BACK PAIN (Back Pain), DYSSTASIA (Could hardly get up from a chair and move to the bed), MUSCLE TIGHTNESS (Tense Back Muscles) and VACCINATION SITE REACTION (Delayed Injection Site Reactions) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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-Feb-2021, the patient experienced SOMNOLENCE (Fell sleep in a chair), BACK PAIN (Back Pain), DYSSTASIA (Could hardly get up from a chair and move to the bed) and MUSCLE TIGHTNESS (Tense Back Muscles). On 17-Feb-2021, the patient experienced VACCINATION SITE REACTION (Delayed Injection Site Reactions), VACCINATION SITE PAIN (Pain Injection Site/ Tender Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and INJECTION SITE PAIN (Tender injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to the Touch Injection Site). On 10-Feb-2021, SOMNOLENCE (Fell sleep in a chair) had resolved. On 18-Feb-2021, VACCINATION SITE PAIN (Pain Injection Site/ Tender Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and INJECTION SITE PAIN (Tender injection site) outcome was unknown. At the time of the report, BACK PAIN (Back Pain), DYSSTASIA (Could hardly get up from a chair and move to the bed), MUSCLE TIGHTNESS (Tense Back Muscles), VACCINATION SITE REACTION (Delayed Injection Site Reactions) and VACCINATION SITE WARMTH (Hot to the Touch Injection Site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided.

Other Meds:

Current Illness:

ID: 1552145
Sex: F
Age: 66
State: CA

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
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: COVID-19 diagnosis; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 diagnosis) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (COVID-19 diagnosis). At the time of the report, COVID-19 (COVID-19 diagnosis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, COVID-19: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. No relevant concomitant medications reported.

Other Meds:

Current Illness:

ID: 1552146
Sex: F
Age: 80
State: WA

Vax Date: 01/29/2021
Onset Date: 02/08/2021
Rec V Date: 08/13/2021
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: rash that is 10 by 15 centimeters; Itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash that is 10 by 15 centimeters) and PRURITUS (Itching) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070L20A) for COVID-19 vaccination. Concomitant products included LISINOPRIL, GLIPIZIDE, PRAVASTATIN, GABAPENTIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTI VITAMIN & MINERAL for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH (rash that is 10 by 15 centimeters) and PRURITUS (Itching). On 13-Feb-2021, RASH (rash that is 10 by 15 centimeters) and PRURITUS (Itching) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment details included topical Benadryl cream.

Other Meds: LISINOPRIL; GLIPIZIDE; PRAVASTATIN; GABAPENTIN; BABY ASPIRIN; VITAMIN D 2000; MULTI VITAMIN & MINERAL

Current Illness:

ID: 1552147
Sex: F
Age: 66
State: PR

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 08/13/2021
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: Nausea; Vomiting; Diarrhea; Rash; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting), DIARRHOEA (Diarrhea) and RASH (Rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and Hypertension. On 16-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 NAUSEA (Nausea), VOMITING (Vomiting), DIARRHOEA (Diarrhea) and RASH (Rash). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting), DIARRHOEA (Diarrhea) and RASH (Rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness: Diabetes; Hypertension

ID: 1552148
Sex: F
Age: 61
State: OR

Vax Date: 01/16/2021
Onset Date:
Rec V Date: 08/13/2021
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: arm hurt; Tiredness; headache; fever; little nausea; had some tenderness at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), FATIGUE (Tiredness), HEADACHE (headache), PYREXIA (fever) and NAUSEA (little nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt), FATIGUE (Tiredness), HEADACHE (headache), PYREXIA (fever), NAUSEA (little nausea), VACCINATION SITE PAIN (had some tenderness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, PAIN IN EXTREMITY (arm hurt), FATIGUE (Tiredness), HEADACHE (headache), PYREXIA (fever), NAUSEA (little nausea), VACCINATION SITE PAIN (had some tenderness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-015789 (Patient Link).

Other Meds:

Current Illness:

ID: 1552149
Sex: F
Age: 43
State: FL

Vax Date: 01/06/2021
Onset Date: 02/03/2021
Rec V Date: 08/13/2021
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: Body aches; Swelling; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), SWELLING (Swelling) and PAIN (pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029V20A or 029K20A and 025J20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced SWELLING (Swelling) and PAIN (pain). On 04-Feb-2021, the patient experienced PAIN (Body aches). At the time of the report, PAIN (Body aches), SWELLING (Swelling) and PAIN (pain) outcome was unknown. Treatment included antibiotics and anti-inflammatory after 1st dose . Benadryl and ibuprofen after 2nd dose.

Other Meds:

Current Illness:

ID: 1552150
Sex: F
Age: 80
State: FL

Vax Date: 01/27/2021
Onset Date: 02/18/2021
Rec V Date: 08/13/2021
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: headache; gingivitis in gums; lot of pain, very severe on her mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), ORAL PAIN (lot of pain, very severe on her mouth) and GINGIVITIS (gingivitis in gums) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included Hypertension since an unknown date. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), THYROID, ATORVASTATIN CALCIUM (LIPITOR) and VITAMINS NOS for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced ORAL PAIN (lot of pain, very severe on her mouth). On an unknown date, the patient experienced HEADACHE (headache) and GINGIVITIS (gingivitis in gums). The patient was treated with DIPHENHYDRAMINE HCL;LIDOCAINE;NYSTATIN for Adverse event, at an unspecified dose and frequency and AMOXICILLIN for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), ORAL PAIN (lot of pain, very severe on her mouth) and GINGIVITIS (gingivitis in gums) 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. Patient went to urgent care for the reported events. Concomitant medications reported were Blood pressure pill, heart pills, stomach indigestion pills, and blood clots pills for drug use for unknown indication. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), ORAL PAIN (lot of pain, very severe on her mouth) and GINGIVITIS (gingivitis in gums) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included Hypertension since an unknown date. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), THYROID, ATORVASTATIN CALCIUM (LIPITOR) and VITAMINS NOS for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced ORAL PAIN (lot of pain, very severe on her mouth). On an unknown date, the patient experienced HEADACHE (headache) and GINGIVITIS (gingivitis in gums). The patient was treated with DIPHENHYDRAMINE HCL;LIDOCAINE;NYSTATIN for Adverse event, at an unspecified dose and frequency and AMOXICILLIN for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), ORAL PAIN (lot of pain, very severe on her mouth) and GINGIVITIS (gingivitis in gums) 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. Patient went to urgent care for the reported events. Concomitant medications reported were Blood pressure pill, heart pills, stomach indigestion pills, and blood clots pills for drug use for unknown indication.

Other Meds: ASPIRIN (E.C.); THYROID; LIPITOR; VITAMINS NOS

Current Illness: Hypertension

ID: 1552151
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. 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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1552152
Sex: F
Age: 81
State: CA

Vax Date: 02/11/2021
Onset Date: 02/18/2021
Rec V Date: 08/13/2021
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: a rash on her upper arm; itchiness that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (a rash on her upper arm) and PRURITUS (itchiness that comes and goes) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination. No Medical History Information was reported. The patient's past medical history included Thyroid disorder since an unknown date. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE RASH (a rash on her upper arm) and PRURITUS (itchiness that comes and goes). The patient was treated with HYDROCORTISONE for Adverse event, at a dose of Cream and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE RASH (a rash on her upper arm) and PRURITUS (itchiness that comes and goes) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications included an unknown pill for a thyroid disorder daily. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (a rash on her upper arm) and PRURITUS (itchiness that comes and goes) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination. No Medical History Information was reported. The patient's past medical history included Thyroid disorder since an unknown date. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE RASH (a rash on her upper arm) and PRURITUS (itchiness that comes and goes). The patient was treated with HYDROCORTISONE for Adverse event, at a dose of Cream and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE RASH (a rash on her upper arm) and PRURITUS (itchiness that comes and goes) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications included an unknown pill for a thyroid disorder daily.

Other Meds:

Current Illness: Thyroid disorder.

ID: 1552153
Sex: F
Age:
State:

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 08/13/2021
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: Bleeding at the injection site; Arm twitching; numbness from elbow to forearm; Itching; injection site pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), INJECTION SITE HAEMORRHAGE (Bleeding at the injection site), MUSCLE TWITCHING (Arm twitching), HYPOAESTHESIA (numbness from elbow to forearm) and PRURITUS (Itching) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History Information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced MYALGIA (Muscle pain), MUSCLE TWITCHING (Arm twitching), HYPOAESTHESIA (numbness from elbow to forearm), PRURITUS (Itching) and VACCINATION SITE PAIN (injection site pain). On 22-Feb-2021, the patient experienced INJECTION SITE HAEMORRHAGE (Bleeding at the injection site). At the time of the report, MYALGIA (Muscle pain), INJECTION SITE HAEMORRHAGE (Bleeding at the injection site), MUSCLE TWITCHING (Arm twitching), HYPOAESTHESIA (numbness from elbow to forearm), PRURITUS (Itching) and VACCINATION SITE PAIN (injection site pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was provided by the reporter. No treatment was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up was received. Patient demographics were added (email Id). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), INJECTION SITE HAEMORRHAGE (Bleeding at the injection site), MUSCLE TWITCHING (Arm twitching), HYPOAESTHESIA (numbness from elbow to forearm) and PRURITUS (Itching) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History Information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced MYALGIA (Muscle pain), MUSCLE TWITCHING (Arm twitching), HYPOAESTHESIA (numbness from elbow to forearm), PRURITUS (Itching) and VACCINATION SITE PAIN (injection site pain). On 22-Feb-2021, the patient experienced INJECTION SITE HAEMORRHAGE (Bleeding at the injection site). At the time of the report, MYALGIA (Muscle pain), INJECTION SITE HAEMORRHAGE (Bleeding at the injection site), MUSCLE TWITCHING (Arm twitching), HYPOAESTHESIA (numbness from elbow to forearm), PRURITUS (Itching) and VACCINATION SITE PAIN (injection site pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was provided by the reporter. No treatment was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up was received. Patient demographics were added (email Id).

Other Meds:

Current Illness:

ID: 1552154
Sex: F
Age: 81
State: MD

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 08/13/2021
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: Fairly large red spot - 5 inch rectangular area in upper left arm; Ring around red spot - left arm, rim around it and the inside part is fading; Itching at the vaccination site - left arm; Bit of pain at the vaccination site; Redness at the vaccination site - left arm, fairly large red spot 5 inch rectangular area in upper left arm, ring around red spot; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Fairly large red spot - 5 inch rectangular area in upper left arm), RASH (Ring around red spot - left arm, rim around it and the inside part is fading), VACCINATION SITE PRURITUS (Itching at the vaccination site - left arm), VACCINATION SITE PAIN (Bit of pain at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site - left arm, fairly large red spot 5 inch rectangular area in upper left arm, ring around red spot) in an 81-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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Fairly large red spot - 5 inch rectangular area in upper left arm), RASH (Ring around red spot - left arm, rim around it and the inside part is fading), VACCINATION SITE PRURITUS (Itching at the vaccination site - left arm), VACCINATION SITE PAIN (Bit of pain at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site - left arm, fairly large red spot 5 inch rectangular area in upper left arm, ring around red spot). At the time of the report, RASH MACULAR (Fairly large red spot - 5 inch rectangular area in upper left arm), RASH (Ring around red spot - left arm, rim around it and the inside part is fading), VACCINATION SITE PRURITUS (Itching at the vaccination site - left arm), VACCINATION SITE PAIN (Bit of pain at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site - left arm, fairly large red spot 5 inch rectangular area in upper left arm, ring around red spot) 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 information provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1552155
Sex: M
Age: 82
State: TX

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 08/13/2021
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: balance is off; brain fog; breath is not as deep; doesn't feel like himself; A low-grade fever; Felt nauseated; when went to go to sleep, couldn't relax; Sweat a lot; Weak; Progressively began to feel tired; Hard chills and he needed six blankets to keep himself warm; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), SLEEP DISORDER (when went to go to sleep, couldn't relax), HYPERHIDROSIS (Sweat a lot), ASTHENIA (Weak) and BALANCE DISORDER (balance is off) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and CHILLS (Hard chills and he needed six blankets to keep himself warm). On 26-Jan-2021, the patient experienced SLEEP DISORDER (when went to go to sleep, couldn't relax), HYPERHIDROSIS (Sweat a lot), ASTHENIA (Weak), FATIGUE (Progressively began to feel tired) and NAUSEA (Felt nauseated). On 27-Jan-2021, the patient experienced PYREXIA (A low-grade fever). On an unknown date, the patient experienced BALANCE DISORDER (balance is off), FEELING ABNORMAL (brain fog), HYPOPNOEA (breath is not as deep) and FEELING ABNORMAL (doesn't feel like himself). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm was sore), SLEEP DISORDER (when went to go to sleep, couldn't relax), HYPERHIDROSIS (Sweat a lot), ASTHENIA (Weak), BALANCE DISORDER (balance is off), FEELING ABNORMAL (brain fog), HYPOPNOEA (breath is not as deep), FEELING ABNORMAL (doesn't feel like himself), FATIGUE (Progressively began to feel tired), CHILLS (Hard chills and he needed six blankets to keep himself warm), PYREXIA (A low-grade fever) and NAUSEA (Felt nauseated) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication include Unspecified blood pressure medication, Unspecified cholesterol medication. This case was linked to US-MODERNATX, INC.-MOD-2021-083734 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: significant follow up , events were added; Sender's Comments: US-MODERNATX, INC.-MOD-2021-083734:

Other Meds: BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness:

ID: 1552156
Sex: F
Age:
State:

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 08/13/2021
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: Severe Chills; Felt tired; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness), CHILLS (Severe Chills) and FATIGUE (Felt tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness). On 21-Feb-2021, the patient experienced CHILLS (Severe Chills) and FATIGUE (Felt tired). At the time of the report, INJECTION SITE PAIN (Soreness), CHILLS (Severe Chills) and FATIGUE (Felt tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. Treatment included Advil.

Other Meds:

Current Illness:

ID: 1552157
Sex: F
Age: 36
State: IN

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 08/13/2021
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: Swelling; itching; hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), PRURITUS (itching) and INDURATION (hard to touch) in a 37-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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SWELLING (Swelling), PRURITUS (itching) and INDURATION (hard to touch). At the time of the report, SWELLING (Swelling), PRURITUS (itching) and INDURATION (hard to touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1552158
Sex: F
Age: 31
State: MA

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 08/13/2021
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: Pregnant; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 27-Oct-2021. On an unknown date, the patient experienced PREGNANCY (Pregnant). At the time of the report, PREGNANCY (Pregnant) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1552159
Sex: F
Age:
State: MI

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 08/13/2021
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: Tested positive to covid; Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive to covid), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history). On 08-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 COVID-19 (Tested positive to covid), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). At the time of the report, COVID-19 (Tested positive to covid), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, COVID-19: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1552160
Sex: F
Age: 34
State: ND

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 08/13/2021
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: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 34-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Pregnancy (Previous Pregnancies). Concurrent medical conditions included Drug allergy (allergic to metaclopramide). On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Dec-2020 and the estimated date of delivery was 16-Sep-2021. On 23-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the second week of the pregnancy. On 23-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Pregnancy test: positive (Positive) positive. No concomitant medication provided by the reporter. No treatment information provided by the reporter

Other Meds:

Current Illness: Drug allergy (allergic to metaclopramide)

ID: 1552161
Sex: F
Age:
State: NY

Vax Date: 01/17/2021
Onset Date: 01/24/2021
Rec V Date: 08/13/2021
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: 24,25,26 Jan2021 caller had the worst side effects symptoms; felt very very tired all week long; 5 or 6 days after receiving the shot: Nausea; arm was very swollen; sore; red around the injection site around 3x3 inches; 5 or 6 days after receiving the shot: headache; 5 or 6 days after receiving the shot: sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (24,25,26 Jan2021 caller had the worst side effects symptoms), FATIGUE (felt very very tired all week long), NAUSEA (5 or 6 days after receiving the shot: Nausea), HEADACHE (5 or 6 days after receiving the shot: headache) and INJECTION SITE PAIN (5 or 6 days after receiving the shot: sore left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced HEADACHE (5 or 6 days after receiving the shot: headache), INJECTION SITE PAIN (5 or 6 days after receiving the shot: sore left arm) and INJECTION SITE ERYTHEMA (red around the injection site around 3x3 inches). On an unknown date, the patient experienced ADVERSE DRUG REACTION (24,25,26 Jan2021 caller had the worst side effects symptoms), FATIGUE (felt very very tired all week long), NAUSEA (5 or 6 days after receiving the shot: Nausea), INJECTION SITE SWELLING (arm was very swollen) and PAIN (sore). At the time of the report, ADVERSE DRUG REACTION (24,25,26 Jan2021 caller had the worst side effects symptoms), FATIGUE (felt very very tired all week long), NAUSEA (5 or 6 days after receiving the shot: Nausea), HEADACHE (5 or 6 days after receiving the shot: headache), INJECTION SITE PAIN (5 or 6 days after receiving the shot: sore left arm), INJECTION SITE SWELLING (arm was very swollen), INJECTION SITE ERYTHEMA (red around the injection site around 3x3 inches) and PAIN (sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1552162
Sex: M
Age: 30
State: TX

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 08/13/2021
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: severe abdominal pain; nausea; vomiting; bowels have been getting smaller and smaller, and have been really hard to excrete; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (severe abdominal pain), NAUSEA (nausea), VOMITING (vomiting) and FUNCTIONAL GASTROINTESTINAL DISORDER (bowels have been getting smaller and smaller, and have been really hard to excrete) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The patient's past medical history included No adverse event. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ABDOMINAL PAIN (severe abdominal pain), NAUSEA (nausea), VOMITING (vomiting) and FUNCTIONAL GASTROINTESTINAL DISORDER (bowels have been getting smaller and smaller, and have been really hard to excrete). On 20-Feb-2021, VOMITING (vomiting) outcome was unknown. At the time of the report, ABDOMINAL PAIN (severe abdominal pain), NAUSEA (nausea) and FUNCTIONAL GASTROINTESTINAL DISORDER (bowels have been getting smaller and smaller, and have been really hard to excrete) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medications reported. Treatment included Tylenol and Tums.

Other Meds:

Current Illness:

ID: 1552163
Sex: F
Age: 93
State: NJ

Vax Date: 02/21/2021
Onset Date: 02/21/2021
Rec V Date: 08/13/2021
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: lost appetite; very thirsty; increase urination; 102 fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost appetite), THIRST (very thirsty), POLLAKIURIA (increase urination), PYREXIA (102 fever) and FATIGUE (fatigue) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high and Hypercholesteremia. On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced DECREASED APPETITE (lost appetite), THIRST (very thirsty), POLLAKIURIA (increase urination), PYREXIA (102 fever) and FATIGUE (fatigue). At the time of the report, DECREASED APPETITE (lost appetite), THIRST (very thirsty), POLLAKIURIA (increase urination), PYREXIA (102 fever) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 102 (Inconclusive) 102 fever. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Concomitant medications included unspecified high blood pressure and cholesterol medication.

Other Meds:

Current Illness: Blood pressure high; Hypercholesteremia

ID: 1552164
Sex: F
Age: 82
State: MI

Vax Date: 01/29/2021
Onset Date: 02/17/2021
Rec V Date: 08/13/2021
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: Flushing of the face; Rapid heart beat; Elevated blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing of the face), HEART RATE INCREASED (Rapid heart beat) and HYPERTENSION (Elevated blood pressure) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included LISINOPRIL, AMLODIPINE, PHENYTOIN (DILANTIN [PHENYTOIN]) and LEVOTHYROXINE for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FLUSHING (Flushing of the face), HEART RATE INCREASED (Rapid heart beat) and HYPERTENSION (Elevated blood pressure). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 21-Feb-2021, FLUSHING (Flushing of the face), HEART RATE INCREASED (Rapid heart beat) and HYPERTENSION (Elevated blood pressure) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included BENADRYL.

Other Meds: LISINOPRIL; AMLODIPINE; DILANTIN [PHENYTOIN]; LEVOTHYROXINE

Current Illness:

ID: 1552165
Sex: M
Age: 65
State: OK

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 08/13/2021
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: Arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore at the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Arm was sore at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1552166
Sex: F
Age: 71
State: FL

Vax Date: 02/04/2021
Onset Date: 02/07/2021
Rec V Date: 08/13/2021
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: severe dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (severe dizziness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History Information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (severe dizziness). On 14-Feb-2021, DIZZINESS (severe dizziness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (severe dizziness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History Information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (severe dizziness). On 14-Feb-2021, DIZZINESS (severe dizziness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No Treatment information for the event was provided.

Other Meds:

Current Illness:

ID: 1552167
Sex: F
Age:
State:

Vax Date: 01/29/2021
Onset Date: 02/22/2021
Rec V Date: 08/13/2021
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: Itching from head to toe; Her tongue was very dry about 20 minutes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching from head to toe) and TONGUE DRY (Her tongue was very dry about 20 minutes) 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PRURITUS (Itching from head to toe). On an unknown date, the patient experienced TONGUE DRY (Her tongue was very dry about 20 minutes). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching from head to toe) and TONGUE DRY (Her tongue was very dry about 20 minutes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant Concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching from head to toe) and TONGUE DRY (Her tongue was very dry about 20 minutes) 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PRURITUS (Itching from head to toe). On an unknown date, the patient experienced TONGUE DRY (Her tongue was very dry about 20 minutes). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching from head to toe) and TONGUE DRY (Her tongue was very dry about 20 minutes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant Concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1552168
Sex: F
Age:
State:

Vax Date: 01/07/2021
Onset Date: 01/20/2021
Rec V Date: 08/13/2021
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: COVID-19 Test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Test) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced COVID-19 (COVID-19 Test). At the time of the report, COVID-19 (COVID-19 Test) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1552169
Sex: F
Age: 67
State: CO

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 08/13/2021
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: felt hot; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FEELING HOT (felt hot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Feb-2021, the patient experienced FEELING HOT (felt hot). On 20-Feb-2021, FEELING HOT (felt hot) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. Treatment included Tylenol

Other Meds:

Current Illness:

ID: 1552170
Sex: F
Age:
State: GA

Vax Date: 02/18/2021
Onset Date:
Rec V Date: 08/13/2021
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: red arm - at the injection site - left arm; swollen arm - at the injection site - left arm; had heat in it - at the injection site - left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm - at the injection site - left arm), VACCINATION SITE SWELLING (swollen arm - at the injection site - left arm) and VACCINATION SITE WARMTH (had heat in it - at the injection site - left arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031LZ0A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red arm - at the injection site - left arm), VACCINATION SITE SWELLING (swollen arm - at the injection site - left arm) and VACCINATION SITE WARMTH (had heat in it - at the injection site - left arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (red arm - at the injection site - left arm), VACCINATION SITE SWELLING (swollen arm - at the injection site - left arm) and VACCINATION SITE WARMTH (had heat in it - at the injection site - left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. This case was linked to MOD-2021-020389 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm - at the injection site - left arm), VACCINATION SITE SWELLING (swollen arm - at the injection site - left arm) and VACCINATION SITE WARMTH (had heat in it - at the injection site - left arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031LZ0A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red arm - at the injection site - left arm), VACCINATION SITE SWELLING (swollen arm - at the injection site - left arm) and VACCINATION SITE WARMTH (had heat in it - at the injection site - left arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (red arm - at the injection site - left arm), VACCINATION SITE SWELLING (swollen arm - at the injection site - left arm) and VACCINATION SITE WARMTH (had heat in it - at the injection site - left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. This case was linked to MOD-2021-020389 (Patient Link).

Other Meds:

Current Illness:

ID: 1552171
Sex: F
Age:
State: NJ

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 08/13/2021
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: Red; Swollen; Itchy; Arm Hurt; Shoulder hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Hurt), ARTHRALGIA (Shoulder hurt), INJECTION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen) and PRURITUS (Itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Hurt) and ARTHRALGIA (Shoulder hurt). On 22-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen) and PRURITUS (Itchy). At the time of the report, PAIN IN EXTREMITY (Arm Hurt), ARTHRALGIA (Shoulder hurt), INJECTION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen) and PRURITUS (Itchy) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1552172
Sex: F
Age: 81
State: NY

Vax Date: 02/15/2021
Onset Date: 02/22/2021
Rec V Date: 08/13/2021
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: Warm to touch; Redness 2 and 1/2 inch around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History Information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site) 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 relevant Concomitant medications were reported. No Treatment information for the event was provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up information received on 3-jun -2021 does not contain any new information. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History Information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Redness 2 and 1/2 inch around injection site) 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 relevant Concomitant medications were reported. No Treatment information for the event was provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up information received on 3-jun -2021 does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1552173
Sex: F
Age: 56
State: HI

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 08/13/2021
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: Compazine, Phrenagin, septra

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

Symptoms: Immediate redness, then swelling, raised local area that became hot to touch, by that night I was running fever, had headache, nausea, overall fatigue, body ache, glands in neck seemed swollen... these symptoms lasted for 5 days. After the 5 days when fever broke, my legs felt weak and started to have spasms that locked my legs into stretched out position. My legs became painful, starting with mostly on the right, but then both. By the next week I started to lose use of my legs and I ended up in a wheelchair because unable to walk. It is now in August and I am no longer in a wheelchair and although I am about to walk some, I still have difficulty and must rest a lot or I am unable to take normal steps, the legs still cause a lot of pain, but even that is improving.

Other Meds: Potassium Citrate, sertraline, calcium citrate, adult vit, Synthroid,

Current Illness: Blood pressure issues

ID: 1552175
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: hands and feet also were cold/ had chills; "COVID arm" around the injection site.; hardness at that site and swelling; COVID arm" around the injection site., big donut sized raised hives; COVID arm" around the injection site., big donut sized raised hives and rash; hardness at that site and swelling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (hands and feet also were cold/ had chills), VACCINATION SITE REACTION ("COVID arm" around the injection site.), VACCINATION SITE INDURATION (hardness at that site and swelling), VACCINATION SITE URTICARIA (COVID arm" around the injection site., big donut sized raised hives) and VACCINATION SITE RASH (COVID arm" around the injection site., big donut sized raised hives and rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 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 FEELING COLD (hands and feet also were cold/ had chills), VACCINATION SITE REACTION ("COVID arm" around the injection site.), VACCINATION SITE INDURATION (hardness at that site and swelling), VACCINATION SITE URTICARIA (COVID arm" around the injection site., big donut sized raised hives), VACCINATION SITE RASH (COVID arm" around the injection site., big donut sized raised hives and rash) and VACCINATION SITE SWELLING (hardness at that site and swelling). At the time of the report, FEELING COLD (hands and feet also were cold/ had chills), VACCINATION SITE REACTION ("COVID arm" around the injection site.), VACCINATION SITE INDURATION (hardness at that site and swelling), VACCINATION SITE URTICARIA (COVID arm" around the injection site., big donut sized raised hives), VACCINATION SITE RASH (COVID arm" around the injection site., big donut sized raised hives and rash) and VACCINATION SITE SWELLING (hardness at that site and swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was reported Treatment information was not provided

Other Meds:

Current Illness:

ID: 1552176
Sex: F
Age: 92
State: FL

Vax Date: 01/01/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
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: Scrapes on left leg; This spontaneous case was reported by a consumer and describes the occurrence of SKIN ABRASION (Scrapes on left leg) in a 92-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 (No reported medical history). In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced SKIN ABRASION (Scrapes on left leg). At the time of the report, SKIN ABRASION (Scrapes on left leg) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1552177
Sex: F
Age: 51
State: VA

Vax Date: 01/12/2021
Onset Date: 02/08/2021
Rec V Date: 08/13/2021
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: Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19) in a 51-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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) 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. No treatment information provided.

Other Meds:

Current Illness:

ID: 1552178
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: rash all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History Information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over her body). At the time of the report, RASH (rash all over her body) 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. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History Information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over her body). At the time of the report, RASH (rash all over her body) 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.

Other Meds:

Current Illness:

ID: 1552179
Sex: F
Age: 78
State: NM

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
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: itches frequently; Not able to sleep; Shingles rash; Severe back pain; Shingles on her left side; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles on her left side), PAIN IN EXTREMITY (sore arm), PRURITUS (itches frequently), INSOMNIA (Not able to sleep) and BACK PAIN (Severe back pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 11-Feb-2021, the patient experienced HERPES ZOSTER (Shingles on her left side) and BACK PAIN (Severe back pain). On 01-Mar-2021, the patient experienced RASH (Shingles rash). On an unknown date, the patient experienced PRURITUS (itches frequently) and INSOMNIA (Not able to sleep). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Rash on face, at a dose of UNK dosage form; PREDNISONE at a dose of UNK dosage form and GABAPENTIN for Pain, at a dose of UNK dosage form. On 13-Mar-2021, BACK PAIN (Severe back pain) outcome was unknown. At the time of the report, HERPES ZOSTER (Shingles on her left side), PAIN IN EXTREMITY (sore arm), PRURITUS (itches frequently), INSOMNIA (Not able to sleep) and RASH (Shingles rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications were not provided. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received .Patient's demographic details, Treatment product as Gabapentin, New event Severe back pain, Rash and Insomnia were added. Outcome of Shingles event added. Causality of Shingles event was added.

Other Meds:

Current Illness:

ID: 1552180
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: Potential side effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 03-Feb-2021. Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Potential side effects) 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 recorded medical history). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Potential side effects). At the time of the report, ADVERSE REACTION (Potential side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1552181
Sex: M
Age: 69
State: MI

Vax Date: 02/12/2021
Onset Date:
Rec V Date: 08/13/2021
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: excessive sleeping; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History Information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired). At the time of the report, HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History Information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired). At the time of the report, HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No Treatment information for the event was provided.

Other Meds:

Current Illness:

ID: 1552182
Sex: F
Age:
State:

Vax Date:
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
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: Horrible reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Horrible reaction to the 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) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION COMPLICATION (Horrible reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (Horrible reaction to the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and treatment information were not provided.

Other Meds:

Current Illness:

ID: 1552183
Sex: F
Age: 90
State: PA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
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: tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 014M20A) for COVID-19 vaccination. The patient's past medical history included Cold. Concomitant products included LISINOPRIL for Blood pressure management, RIVAROXABAN (XARELTO) for Circulating anticoagulant, AMLODIPINE BESILATE (NORVASC) for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information includes nebulizer oxygen and different meds. Treatment medication information was not provided by the reporter. Patient was loss of taste and smell after first shot of vaccine. Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow Up document received on 15-jul-2021 contains Significant information of patient identifiers , concomitant medication. On 23-Jul-2021: follow up received contain no new information

Other Meds: LISINOPRIL; NORVASC; XARELTO

Current Illness:

ID: 1552184
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: my hematology blood count is higher than it has normally been; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Polycythemia since an unknown date. 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 BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been). At the time of the report, BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: High. On an unknown date, Haemoglobin: High. On an unknown date, Red blood cell count: High. No relevant concomitant medications were reported. No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Polycythemia since an unknown date. 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 BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been). At the time of the report, BLOOD COUNT ABNORMAL (my hematology blood count is higher than it has normally been) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: High. On an unknown date, Haemoglobin: High. On an unknown date, Red blood cell count: High. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness: Polycythemia

ID: 1552185
Sex: F
Age: 77
State:

Vax Date: 01/31/2021
Onset Date: 02/08/2021
Rec V Date: 08/13/2021
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: small bumps, like little rashes; Itching all over the body; Itching at the injection site; Rashes all over the body, especially ankles and behind knees; This spontaneous case was reported by a nurse and describes the occurrence of RASH PAPULAR (small bumps, like little rashes), PRURITUS (Itching all over the body), VACCINATION SITE PRURITUS (Itching at the injection site) and RASH (Rashes all over the body, especially ankles and behind knees) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH PAPULAR (small bumps, like little rashes), PRURITUS (Itching all over the body), VACCINATION SITE PRURITUS (Itching at the injection site) and RASH (Rashes all over the body, especially ankles and behind knees). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of 15 milligram. On 15-Feb-2021, RASH PAPULAR (small bumps, like little rashes), PRURITUS (Itching all over the body), VACCINATION SITE PRURITUS (Itching at the injection site) and RASH (Rashes all over the body, especially ankles and behind knees) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-021656 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: NNI

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm