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: 1556288
Sex: F
Age: 62
State: IL

Vax Date: 02/11/2021
Onset Date: 02/17/2021
Rec V Date: 08/14/2021
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: Arm was hot to touch and itchy; Purple hue around the injection site; hot and warm from the elbow to her shoulder; Had inflammation; Arm was hot to touch and itchy; Sore arm; Welt that was hard and hot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was hot to touch and itchy), VACCINATION SITE DISCOLOURATION (Purple hue around the injection site), FEELING HOT (hot and warm from the elbow to her shoulder), INFLAMMATION (Had inflammation) and VACCINATION SITE PRURITUS (Arm was hot to touch and itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. Concomitant products included ATORVASTATIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm was hot to touch and itchy), VACCINATION SITE DISCOLOURATION (Purple hue around the injection site), FEELING HOT (hot and warm from the elbow to her shoulder), INFLAMMATION (Had inflammation), VACCINATION SITE PRURITUS (Arm was hot to touch and itchy), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE URTICARIA (Welt that was hard and hot at the injection site). At the time of the report, VACCINATION SITE WARMTH (Arm was hot to touch and itchy), VACCINATION SITE DISCOLOURATION (Purple hue around the injection site), FEELING HOT (hot and warm from the elbow to her shoulder), INFLAMMATION (Had inflammation), VACCINATION SITE PRURITUS (Arm was hot to touch and itchy), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE URTICARIA (Welt that was hard and hot at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications include Benadryl and advil.

Other Meds: ATORVASTATIN; LEXAPRO

Current Illness: Hypertension

ID: 1556289
Sex: F
Age: 78
State: TX

Vax Date: 01/08/2021
Onset Date: 01/24/2021
Rec V Date: 08/14/2021
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: bigger and bigger; little red (good size) and itch; Itch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (little red (good size) and itch), PRURITUS (Itch) and PERIPHERAL SWELLING (bigger and bigger) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0371620A) for COVID-19 vaccination. No Medical History information was reported. On 08-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 ERYTHEMA (little red (good size) and itch) and PRURITUS (Itch). On an unknown date, the patient experienced PERIPHERAL SWELLING (bigger and bigger). At the time of the report, ERYTHEMA (little red (good size) and itch), PRURITUS (Itch) and PERIPHERAL SWELLING (bigger and bigger) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1556290
Sex: F
Age: 69
State: NC

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 08/14/2021
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: Arm is still very inflammed; arm was red; arm was hot, still warm; arm was sore; Headache; Low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is still very inflammed), ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was hot, still warm), PAIN IN EXTREMITY (arm was sore) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (The illness lasted for 2 weeks and she did not have any major symptoms from it) in November 2020 and Appendectomy (Emergency appendectomy) on 20-Jun-2021. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 23-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 PERIPHERAL SWELLING (Arm is still very inflammed), ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was hot, still warm), PAIN IN EXTREMITY (arm was sore), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm is still very inflammed), ERYTHEMA (arm was red) and VACCINATION SITE WARMTH (arm was hot, still warm) had not resolved and PAIN IN EXTREMITY (arm was sore), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other concomitant medications included blood pressure medications and hormone replacement therapy. Treatment information provided included application of ice on arm. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received and added surgical procedure (emergency appendectomy) and updated reporter's contact information.; Sender's Comments: Based on the current available information which shows a strong temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded. Headache, low grade fever and fatigue are consistent with the known safety profile of the mRNA-1273.

Other Meds: LEXAPRO

Current Illness:

ID: 1556291
Sex: F
Age: 49
State: TX

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/14/2021
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: Itchy Sensation of Arm; Itchy Sensation of Throat; Itchy Sensation of Tongue; Wheezing; Rash - Near Injection Site; Aches; pains; A spontaneous report was received from a consumer concerning a 49-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itchy sensation of arm, itchy sensation of throat, itchy sensation of tongue, body aches, body pain, wheezing, rash - near injection site. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient experienced the events itchy sensation of arm. itchy sensation of throat, itchy sensation of tongue, body aches, body pain, wheezing, rash - near injection site. The patient sought professional guidance from her pharmacist. Treatment included diphenhydramine hydrochloride. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events include itchy sensation of arm, itchy sensation of throat, itchy sensation of tongue, body aches, body pain, wheezing, rash - near injection site was unknown/not reported.; Reporter's Comments: This case concerns a 49-year-old female who experienced NS unexpected events of pruritus, throat irritation, tongue pruritus, wheezing and NS expected events of injection site rash, myalgia. The events occurred the same day as the first dose of mRNA-1273. Treatment included diphenhydramine. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1556292
Sex: F
Age: 42
State: TX

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/14/2021
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: injection site pain; nasty headache now; body pain; Nausea; fever; shakes; fatigue; her upper right arm started hurting bad; sore legs; no smell; back pain; sore throat; she has no appetite; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her upper right arm started hurting bad), PAIN IN EXTREMITY (sore legs), ANOSMIA (no smell), BACK PAIN (back pain) and OROPHARYNGEAL PAIN (sore throat) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (She had COVID on 18 Dec 2020 and recovered in 3 weeks.) on 18-Dec-2020. Concurrent medical conditions included Asthma on 01-Nov-2007 and Allergies (Iodine, Shellfish). On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (her upper right arm started hurting bad), PAIN IN EXTREMITY (sore legs), ANOSMIA (no smell), BACK PAIN (back pain), OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (she has no appetite), NAUSEA (Nausea), PYREXIA (fever), CHILLS (shakes) and FATIGUE (fatigue). On 27-Jan-2021 at 8:30 AM, the patient experienced PAIN (body pain). On 28-Jan-2021, the patient experienced HEADACHE (nasty headache now). On 29-Jan-2021 at 5:30 AM, the patient experienced INJECTION SITE PAIN (injection site pain). At the time of the report, PAIN IN EXTREMITY (her upper right arm started hurting bad), PAIN IN EXTREMITY (sore legs), ANOSMIA (no smell), BACK PAIN (back pain), OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (she has no appetite), PAIN (body pain), NAUSEA (Nausea), PYREXIA (fever), CHILLS (shakes), FATIGUE (fatigue), HEADACHE (nasty headache now) and INJECTION SITE PAIN (injection site pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Pyrexia: 100.9 ?F (High) ranged from 100.9F - 101.3 F. On 29-Jan-2021, Pyrexia: 99 ?F High. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications include Tylenol with codeine and 1 tablet Flexeril muscle relaxant and hydration.

Other Meds:

Current Illness:

ID: 1556293
Sex: F
Age: 72
State: FL

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/14/2021
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: vomiting; sore ears; overnight chills; nose burning; difficulty getting out of bed; difficulty eating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VOMITING (vomiting), EAR PAIN (sore ears), CHILLS (overnight chills), NASAL DISCOMFORT (nose burning) and HYPOKINESIA (difficulty getting out of bed) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting), EAR PAIN (sore ears), CHILLS (overnight chills), NASAL DISCOMFORT (nose burning), HYPOKINESIA (difficulty getting out of bed) and EATING DISORDER (difficulty eating). At the time of the report, VOMITING (vomiting), EAR PAIN (sore ears), CHILLS (overnight chills), NASAL DISCOMFORT (nose burning), HYPOKINESIA (difficulty getting out of bed) and EATING DISORDER (difficulty eating) had not resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-MAY-2021 and contains NNI.

Other Meds:

Current Illness:

ID: 1556294
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: had a terrible headache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (had a terrible headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received 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 HEADACHE (had a terrible headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown and IBUPROFEN (MOTRIN IB) at an unspecified dose and frequency. At the time of the report, HEADACHE (had a terrible headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient had no reaction from the first, and had a terrible headache after the second dose.

Other Meds:

Current Illness:

ID: 1556295
Sex: M
Age: 73
State: VT

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
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: A little off with his food; A little arm puffiness; Fatigue/more tired; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (A little off with his food), PERIPHERAL SWELLING (A little arm puffiness) and FATIGUE (Fatigue/more tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced EATING DISORDER (A little off with his food), PERIPHERAL SWELLING (A little arm puffiness) and FATIGUE (Fatigue/more tired). At the time of the report, EATING DISORDER (A little off with his food), PERIPHERAL SWELLING (A little arm puffiness) and FATIGUE (Fatigue/more tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1556296
Sex: M
Age: 72
State: NJ

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 08/14/2021
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: Sinus drainage; Cough; Warm; A little weak; Fatigue; Chilled; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Sinus drainage), COUGH (Cough), FEELING HOT (Warm), ASTHENIA (A little weak) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sinusitis. On 16-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 RHINORRHOEA (Sinus drainage), COUGH (Cough), FEELING HOT (Warm), ASTHENIA (A little weak), FATIGUE (Fatigue) and CHILLS (Chilled). At the time of the report, RHINORRHOEA (Sinus drainage), COUGH (Cough), FEELING HOT (Warm), ASTHENIA (A little weak), FATIGUE (Fatigue) and CHILLS (Chilled) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness: Sinusitis

ID: 1556297
Sex: F
Age: 69
State: FL

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/14/2021
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 Touch Sensation - Near Injection Site; Swelling (hardness) - Near Injection Site; Fever; Chills; Arm Pain - Near Injection Site; Body Aches; Arm Pain - Near Injection Site; Redness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches), VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE INDURATION (Swelling (hardness) - Near Injection Site), the first episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension and Herpes NOS. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Herpes NOS, HYDROCHLOROTHIAZIDE and LOSARTAN for Hypertension, VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]) for Vitamin B complex supplementation, VITAMIN D [VITAMIN D NOS] for Vitamin D supplementation. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN (Body Aches), the first episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE INDURATION (Swelling (hardness) - Near Injection Site), PYREXIA (Fever), CHILLS (Chills) and the second episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site). The patient was treated with NAPROXEN at an unspecified dose and frequency. On 30-Jan-2021, PAIN (Body Aches), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE INDURATION (Swelling (hardness) - Near Injection Site), PYREXIA (Fever), CHILLS (Chills) and the last episode of VACCINATION SITE PAIN (Arm Pain - Near 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 treatment information was reported.

Other Meds: HYDROCHLOROTHIAZIDE; LOSARTAN; VALACYCLOVIR HCL; SUPER B COMPLEX [VITAMIN B COMPLEX]; VITAMIN D [VITAMIN D NOS]

Current Illness: Herpes NOS; Hypertension

ID: 1556298
Sex: F
Age: 78
State: CA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/14/2021
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: Hot Tongue; Redness (Injection Site); Sore Arm; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm/vaccination site pain, redness (injection site)/injection site erythema, hot tongue/glossitis. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient experienced the event sore arm. On 6 Feb 2021, the patient experienced the events, redness (injection site) and hot tongue. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, sore arm, redness (injection site), hot tongue was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1556299
Sex: F
Age: 65
State: FL

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/14/2021
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: a rash on their upper arm, not exactly on the site of the injection, of around 2x3 inches, and it is a little itchy; arm was sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and RASH PRURITIC (a rash on their upper arm, not exactly on the site of the injection, of around 2x3 inches, and it is a little itchy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 04-Feb-2021, the patient experienced RASH PRURITIC (a rash on their upper arm, not exactly on the site of the injection, of around 2x3 inches, and it is a little itchy). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown and RASH PRURITIC (a rash on their upper arm, not exactly on the site of the injection, of around 2x3 inches, and it is a little itchy) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1556300
Sex: M
Age: 76
State: MD

Vax Date: 02/27/2021
Onset Date: 01/30/2021
Rec V Date: 08/14/2021
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: Itchy rash 3 days later on his torso; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itchy rash 3 days later on his torso) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced RASH PRURITIC (Itchy rash 3 days later on his torso). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Itchy rash 3 days later on his torso) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications reported. Patient took cortizone cream 1%.

Other Meds:

Current Illness:

ID: 1556301
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Erythema around vaccination site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Erythema around vaccination site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Erythema around vaccination site). At the time of the report, VACCINATION SITE ERYTHEMA (Erythema around vaccination 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 concomitant medications provided. No Treatment medications provided. The reporter does not recall any further information regarding the events. Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Patient and event details updated

Other Meds:

Current Illness:

ID: 1556302
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Injection Site Pain; Headache; 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 VACCINATION SITE PAIN (Injection Site Pain) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection Site Pain) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Injection Site Pain) and HEADACHE (Headache) outcome was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1556303
Sex: F
Age: 33
State: FL

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 08/14/2021
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: Tingling sensation in lips and tongue; Burning sensation in tongue; Could not sleep that night; She felt sick; Did not go for second dose; Headache; Fatigue; Low grade fever; Diarrhea; Elevated heart rate; Metallic taste; Burning sensation on lips; This spontaneous case was reported by a patient and describes the occurrence of ORAL DISCOMFORT (Burning sensation on lips), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Elevated heart rate), DYSGEUSIA (Metallic taste) and PARAESTHESIA ORAL (Tingling sensation in lips and tongue) in a 33-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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ORAL DISCOMFORT (Burning sensation on lips), HEART RATE INCREASED (Elevated heart rate) and DYSGEUSIA (Metallic taste). On 27-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Low grade fever). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling sensation in lips and tongue), TONGUE DISCOMFORT (Burning sensation in tongue), INSOMNIA (Could not sleep that night), ILLNESS (She felt sick) and PRODUCT DOSE OMISSION ISSUE (Did not go for second dose). On 28-Jan-2021, HEART RATE INCREASED (Elevated heart rate) had resolved. At the time of the report, ORAL DISCOMFORT (Burning sensation on lips), DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste), PARAESTHESIA ORAL (Tingling sensation in lips and tongue), TONGUE DISCOMFORT (Burning sensation in tongue), INSOMNIA (Could not sleep that night), ILLNESS (She felt sick), PRODUCT DOSE OMISSION ISSUE (Did not go for second dose), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Low grade fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Start date for mRNA-1273 was updated to 25-Jan-2021 and Anatomical Location updated to left arm. New events, tingling sensation in lips and tongue, burning sensation in tongue, could not sleep that night, felt sick and did not go for second dose were added.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded. Headache, fever and fatigue are consistent with the known safety profile of the mRNA-1273 vaccine

Other Meds:

Current Illness:

ID: 1556304
Sex: M
Age: 72
State: FL

Vax Date: 01/14/2021
Onset Date: 01/21/2021
Rec V Date: 08/14/2021
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: cellulitis; redness from shoulder to elbow- left arm; redness at the injection site - left arm; swollen at the injection site - left arm; A spontaneous report was received from a consumer (patient's wife) and concerning a 72-year old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, redness at the injection site - left arm, redness from shoulder to elbow- left arm, swollen at the injection site - left arm. The patient's medical history includes lung disease. No concomitant medications were reported. On 14-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through unknown route in the left arm for prophylaxis of COVID-19 infection. On 21-Jan-2021, that is a week later after receiving first dose of vaccination patient experienced a redness at the injection site, which kept traveling, and now is past his elbow. It ranges from shoulder to elbow. She reports it was swollen in the beginning and the redness is now fading. He used topical hydrocortisone cream as advised by a pharmacist. The reporter had called the patient's doctor and the nurse told her that it is likely cellulitis that he picked up during injection. The adverse event of cellulitis was assessed as medically significant. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event cellulitis, swollen at the injection site - left arm was unknown. The outcome of the event redness at the injection site - left arm, redness from shoulder to elbow- left arm was recovering.; 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.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-024815:Case for patient

Other Meds:

Current Illness: Lung disease

ID: 1556305
Sex: F
Age: 36
State: CA

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/14/2021
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: shortness of breath; itchy patch under injection; fatigue; body ache; sore; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), VACCINATION SITE PRURITUS (itchy patch under injection), FATIGUE (fatigue), MYALGIA (body ache) and VACCINATION SITE PAIN (sore) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DYSPNOEA (shortness of breath), VACCINATION SITE PRURITUS (itchy patch under injection), FATIGUE (fatigue), MYALGIA (body ache), VACCINATION SITE PAIN (sore) and CHILLS (chills). At the time of the report, DYSPNOEA (shortness of breath), VACCINATION SITE PRURITUS (itchy patch under injection), FATIGUE (fatigue), MYALGIA (body ache), VACCINATION SITE PAIN (sore) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1556306
Sex: F
Age: 82
State: TX

Vax Date: 01/09/2021
Onset Date: 02/07/2021
Rec V Date: 08/14/2021
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: Weakness; Dizzy spells; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizzy spells) and HEADACHE (Headaches) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no reported medical history). Concomitant products included MIRABEGRON (MYRBETRIQ), SIMVASTATIN, APIXABAN (ELIQUIS), OMEPRAZOLE, OLMESARTAN, OLODATEROL, METOPROLOL, POTASSIUM, FUROSEMIDE, AMLODIPINE BESILATE (AMDEPIN) and EPOETIN ALFA (PROCRIT) for an unknown indication. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizzy spells) and HEADACHE (Headaches). At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizzy spells) and HEADACHE (Headaches) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information included Tylenol (paracetamol).

Other Meds: MYRBETRIQ; SIMVASTATIN; ELIQUIS; OMEPRAZOLE; OLMESARTAN; OLODATEROL; METOPROLOL; POTASSIUM; FUROSEMIDE; AMDEPIN; PROCRIT

Current Illness:

ID: 1556307
Sex: M
Age:
State: CA

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 08/14/2021
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: Mild cold symptoms; Mild sore throat; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Mild cold symptoms) and OROPHARYNGEAL PAIN (Mild sore throat) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Mild cold symptoms) and OROPHARYNGEAL PAIN (Mild sore throat). At the time of the report, NASOPHARYNGITIS (Mild cold symptoms) and OROPHARYNGEAL PAIN (Mild sore throat) outcome was unknown.

Other Meds:

Current Illness:

ID: 1556308
Sex: F
Age: 64
State: OR

Vax Date: 01/31/2021
Onset Date: 02/08/2021
Rec V Date: 08/14/2021
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: a red spot the size of a silver dollar at the vaccination site on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a red spot the size of a silver dollar at the vaccination site on her left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (a red spot the size of a silver dollar at the vaccination site on her left arm). At the time of the report, VACCINATION SITE ERYTHEMA (a red spot the size of a silver dollar at the vaccination site on her left arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1556309
Sex: F
Age:
State:

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 08/14/2021
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: nasal congestion; Diarhhea; cough; fever; chills; Muscle aches; headache; This spontaneous case was reported by a physician and describes the occurrence of NASAL CONGESTION (nasal congestion), DIARRHOEA (Diarhhea), COUGH (cough), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 an unknown date, the patient experienced NASAL CONGESTION (nasal congestion), DIARRHOEA (Diarhhea), COUGH (cough), PYREXIA (fever), CHILLS (chills), MYALGIA (Muscle aches) and HEADACHE (headache). The patient was treated with ZINC (oral) from 24-Jan-2021 to 07-Feb-2021 for Adverse event, at a dose of 25 mg once a day; VITAMIN C [ASCORBIC ACID] (oral) from 24-Jan-2021 to 07-Feb-2021 for Adverse event, at a dose of 2000 mg once a day and VITAMIN D3 (oral) from 24-Jan-2021 to 07-Feb-2021 for Adverse event, at a dose of 1000 mg once a day. At the time of the report, NASAL CONGESTION (nasal congestion), DIARRHOEA (Diarhhea), COUGH (cough), PYREXIA (fever), CHILLS (chills), MYALGIA (Muscle aches) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, SARS-CoV-2 test: positive (Positive) positive and positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up was received. Additional events- pyrexia, nasal congestion, chills, headache, myalgia, diarrhea and headache were added. Treatment medications were added.

Other Meds:

Current Illness:

ID: 1556310
Sex: F
Age: 72
State:

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 08/14/2021
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: Bled from injection site; Soreness in right arm; soreness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (Bled from injection site), TENDERNESS (Soreness in right arm) and PAIN IN EXTREMITY (soreness in right arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Neuropathy. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HAEMORRHAGE (Bled from injection site), TENDERNESS (Soreness in right arm) and PAIN IN EXTREMITY (soreness in right arm). At the time of the report, INJECTION SITE HAEMORRHAGE (Bled from injection site) and TENDERNESS (Soreness in right arm) outcome was unknown and PAIN IN EXTREMITY (soreness in right arm) was resolving. Consumer reports taking lidocaine patch for neuropathy. No treatment information was provided. No concomitant medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Live follow up received on 20-Apr-2021: Event related information updated: Patient had second shot in right arm and left arm and both arms are still Sore.

Other Meds:

Current Illness: Neuropathy

ID: 1556311
Sex: F
Age: 46
State: CA

Vax Date: 01/11/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
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: pain on the arm; swelling on both clavicles; pain at the bone and shivers; on the left side a little ball right on top of the left clavicle bone; A spontaneous report was received from a consumer concerning a 46-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling on both clavicles, on the left side a little ball right on top of the left clavicle bone/Furuncle, the swelling doesn't hurt/swelling, it moves each time that tries to touch it, it's like if it is loose, pain at the bone and shivers/Bone pain, pain on the arm/arm pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly for prophylaxis of COVID-19 infection. On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Not available) intramuscularly for prophylaxis of COVID-19 infection. On 5 Feb 2021, the patient experienced the event(s) swelling on both clavicles. On the left side a little ball right on top of the left clavicle bone, the swelling doesn't hurt, t it moves each time that tries to touch it, it's like if it is loose, pain at the bone and shivers. On an unknown date, the patient experienced the event(s) pain on the arm. Treatment details included None. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), swelling on both clavicles, on the left side a little ball right on top of the left clavicle bone, the swelling doesn't hurt, t it moves each time that tries to touch it, it's like if it is loose, pain at the bone and shivers, pain on the arm was unknown.

Other Meds:

Current Illness:

ID: 1556312
Sex: F
Age:
State: CA

Vax Date: 01/22/2021
Onset Date: 01/25/2021
Rec V Date: 08/14/2021
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: Achy body; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy body), PYREXIA (Fever) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-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 MYALGIA (Achy body), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, MYALGIA (Achy body), PYREXIA (Fever) and HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up information received on 16-Apr-2021 contains non-significant information.

Other Meds:

Current Illness:

ID: 1556313
Sex: M
Age: 49
State: MD

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 08/14/2021
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: rash on his nose (1/4 of inches); This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his nose (1/4 of inches)) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension since 15-Jan-2019 and Anxiety (guessing). Concomitant products included LOSARTAN from 15-Jan-2019 to an unknown date for Blood pressure, MULTIVITAMIN [VITAMINS NOS], WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]) from 2018 to an unknown date, VITAMIN D3 and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH (rash on his nose (1/4 of inches)). On 24-Feb-2021, RASH (rash on his nose (1/4 of inches)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 100 (High) 100. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment medications were reported. multivitamin Indiactionis for well being. COq-10 indication for heart health. This case was linked to MOD-2021-255653 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Updated patient demographics (Height, weight, Race], medical history. Added suspect drug is given to left arm. Concomitant medicines .Added Vaccination centre details. Added event start date and end date. Updated outcome of events from Unknown to Recovered.

Other Meds: LOSARTAN; MULTIVITAMIN [VITAMINS NOS]; ASHWAGANDHA [WITHANIA SOMNIFERA]; VITAMIN D3; COQ10 [UBIDECARENONE]

Current Illness: Anxiety (guessing); Hypertension

ID: 1556314
Sex: F
Age: 69
State: NC

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/14/2021
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: vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No medical history was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VOMITING (vomiting) and NAUSEA (nausea). On 27-Jan-2021, VOMITING (vomiting) and NAUSEA (nausea) 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 Concomitant information was provided. No Treatment information was provided.

Other Meds:

Current Illness:

ID: 1556315
Sex: F
Age: 74
State: AZ

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/14/2021
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: Prickling/tingling; Numbness face/ neck; Feeling hot; Flushing; Inappropriate schedule of vaccine administered; Headache; Burning on the left side of the neck; burning on the left side of the ear; swelling on the left side of the face; Stiff neck on the left side side of the neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Burning on the left side of the neck), EAR DISCOMFORT (burning on the left side of the ear), MUSCULOSKELETAL STIFFNESS (Stiff neck on the left side side of the neck), PARAESTHESIA (Prickling/tingling) and HYPOAESTHESIA (Numbness face/ neck) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer (Cancer removed: radiation/on Letrazole) on 30-Jun-2017, Hay fever, GERD, High cholesterol and Hypothyroidism. Concurrent medical conditions included Allergy to antibiotic (Keflex), Penicillin allergy, Sulfonamide allergy and Hashimoto's disease since 01-Jan-1986. Concomitant products included LETROZOLE from 01-Jan-2017 to an unknown date for Breast cancer, OMEPRAZOLE from 01-Jan-2001 to an unknown date for GERD, LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Jan-1986 to an unknown date and LIOTHYRONINE SODIUM (CYTOMEL) from 01-Jan-2001 to an unknown date for Hashimoto's disease, ROSUVASTATIN from 01-Jan-2015 to an unknown date for High cholesterol. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Burning on the left side of the neck), EAR DISCOMFORT (burning on the left side of the ear), MUSCULOSKELETAL STIFFNESS (Stiff neck on the left side side of the neck) and HEADACHE (Headache). On an unknown date, the patient experienced PARAESTHESIA (Prickling/tingling), HYPOAESTHESIA (Numbness face/ neck), FEELING HOT (Feeling hot), FLUSHING (Flushing) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of UNK decigram. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Burning on the left side of the neck), EAR DISCOMFORT (burning on the left side of the ear), MUSCULOSKELETAL STIFFNESS (Stiff neck on the left side side of the neck), PARAESTHESIA (Prickling/tingling), HYPOAESTHESIA (Numbness face/ neck), FEELING HOT (Feeling hot), FLUSHING (Flushing), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and HEADACHE (Headache) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 29 Jan 2021 as well as 26 Feb 2021, the patient was seen by her PCP (primary care provider) for the adverse events. The patient was advised by her doctor to not receive the second Moderna vaccine. On 05 Mar 2021, the patient was seen by and ENT (Ear, Nose & Throat) doctor. It was recommended that the patient have a CT (computerized tomography) scan of the left side of her face and reported a swollen salivary gland. On 01 Apr 2021, the patient was seen by an allergist for her symptoms. The allergist also advised her to have the CT scan done. CT scan was scheduled for 27 Apr 2021 and had not been done at the time of reporting. It was reported there were no side effects after giving the second dose to the patient. Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Reporter details and patient details were updated On 02-Jul-2021: 2nd dose date, batch number, vaccination location

Other Meds: SYNTHROID; CYTOMEL; OMEPRAZOLE; ROSUVASTATIN; LETROZOLE

Current Illness: Allergy to antibiotic (Keflex); Hashimoto's disease; Penicillin allergy; Sulfonamide allergy

ID: 1556316
Sex: F
Age: 68
State: FL

Vax Date: 01/07/2021
Onset Date: 02/04/2021
Rec V Date: 08/14/2021
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: Rash arm in same arm as injection; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection site) and INJECTION SITE RASH (Rash arm in same arm as injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 039K20A) 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 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PAIN (pain at injection site). On 06-Feb-2021, the patient experienced INJECTION SITE RASH (Rash arm in same arm as injection). On 08-Feb-2021, INJECTION SITE PAIN (pain at injection site) had resolved. At the time of the report, INJECTION SITE RASH (Rash arm in same arm as injection) outcome was unknown. Events for dose 2 of 2 The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1556317
Sex: M
Age: 86
State: CA

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 08/14/2021
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: massive headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (massive headache) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History Information was reported. On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (massive headache). At the time of the report, HEADACHE (massive headache) 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 08-Feb-2021 and was forwarded to Moderna on 09-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (massive headache) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History Information was reported. On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (massive headache). At the time of the report, HEADACHE (massive headache) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1556318
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: first her right cheek is little bit swollen and now the left cheek is also little bit swollen; slight reaction around the site (redness); This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (first her right cheek is little bit swollen and now the left cheek is also little bit swollen) and VACCINATION SITE ERYTHEMA (slight reaction around the site (redness)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (first her right cheek is little bit swollen and now the left cheek is also little bit swollen) and VACCINATION SITE ERYTHEMA (slight reaction around the site (redness)). At the time of the report, SWELLING FACE (first her right cheek is little bit swollen and now the left cheek is also little bit swollen) and VACCINATION SITE ERYTHEMA (slight reaction around the site (redness)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1556319
Sex: F
Age:
State: MI

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/14/2021
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: stiffness in hands; tightness in hands; toes curling under; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness in hands), MUSCULOSKELETAL STIFFNESS (tightness in hands), FOOT DEFORMITY (toes curling under) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 04-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 MUSCULOSKELETAL STIFFNESS (stiffness in hands), MUSCULOSKELETAL STIFFNESS (tightness in hands), FOOT DEFORMITY (toes curling under) and HEADACHE (headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness in hands), MUSCULOSKELETAL STIFFNESS (tightness in hands), FOOT DEFORMITY (toes curling under) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided No Treatment information provided Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1556320
Sex: F
Age: 89
State: AZ

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/14/2021
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: Very minor side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Very minor side effects) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ADVERSE DRUG REACTION (Very minor side effects). The patient was treated with ACETAMINOPHEN ongoing from 19-Jan-2021 for Adverse event following immunisation, at a dose of UNK dosage form. At the time of the report, ADVERSE DRUG REACTION (Very minor side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Patient took preventatively a dose of acetaminophen in the morning of vaccination.; 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: 1556321
Sex: F
Age: 83
State: CA

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 08/14/2021
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: got a little scared; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (got a little scared) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy (allergic to sulfa). On 26-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 PANIC ATTACK (got a little scared). At the time of the report, PANIC ATTACK (got a little scared) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Allergy (allergic to sulfa)

ID: 1556322
Sex: F
Age: 76
State: TX

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/14/2021
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: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (Asthma but it is intensified today), INJECTION SITE PRURITUS (itchy), INJECTION SITE SWELLING (arm is swollen) and VACCINATION SITE PAIN (arm soreness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The patient's past medical history included Asthma. Concurrent medical conditions included Shellfish allergy. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm soreness). On 08-Feb-2021, the patient experienced ASTHMA (Asthma but it is intensified today), INJECTION SITE PRURITUS (itchy) and INJECTION SITE SWELLING (arm is swollen). At the time of the report, ASTHMA (Asthma but it is intensified today), INJECTION SITE PRURITUS (itchy), INJECTION SITE SWELLING (arm is swollen) and VACCINATION SITE PAIN (arm soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included patient consulted her doctor and gave her some pills.

Other Meds:

Current Illness: Shellfish allergy

ID: 1556323
Sex: F
Age: 44
State: NE

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/14/2021
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: Rash at the injection site; Itchy injection site; Really warm injection site; Sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE WARMTH (Really warm injection site) and INJECTION SITE PAIN (Sore injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included MULTIVITAMIN & MINERAL for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore injection site). On 15-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE WARMTH (Really warm injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE WARMTH (Really warm injection site) and INJECTION SITE PAIN (Sore injection site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: MULTIVITAMIN & MINERAL

Current Illness:

ID: 1556324
Sex: F
Age:
State: NE

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 08/14/2021
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: Shortness of breath; Swollen stomach; Upset stomach, still feels sick after they eat; Had to lay on the floor after a bath because they were afraid they couldn't move; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), ABDOMINAL DISTENSION (Swollen stomach), ABDOMINAL DISCOMFORT (Upset stomach, still feels sick after they eat), FEELING ABNORMAL (Had to lay on the floor after a bath because they were afraid they couldn't move) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-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 DYSPNOEA (Shortness of breath), ABDOMINAL DISTENSION (Swollen stomach), ABDOMINAL DISCOMFORT (Upset stomach, still feels sick after they eat), FEELING ABNORMAL (Had to lay on the floor after a bath because they were afraid they couldn't move) and CHILLS (Chills). At the time of the report, DYSPNOEA (Shortness of breath), ABDOMINAL DISTENSION (Swollen stomach), ABDOMINAL DISCOMFORT (Upset stomach, still feels sick after they eat), FEELING ABNORMAL (Had to lay on the floor after a bath because they were afraid they couldn't move) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1556325
Sex: M
Age: 77
State: CA

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/14/2021
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: Chill; shingles; Loss of taste; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chill), VACCINATION SITE PAIN (Soreness), HERPES ZOSTER (shingles) and AGEUSIA (Loss of taste) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concomitant products included LOSARTAN, ATORVASTATIN, METFORMIN and VITAMINS NOS for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness). On 05-Feb-2021, the patient experienced CHILLS (Chill), HERPES ZOSTER (shingles) and AGEUSIA (Loss of taste). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, VACCINATION SITE PAIN (Soreness) had resolved. At the time of the report, CHILLS (Chill) and AGEUSIA (Loss of taste) had not resolved and HERPES ZOSTER (shingles) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: LOSARTAN; ATORVASTATIN; METFORMIN; VITAMINS NOS

Current Illness:

ID: 1556326
Sex: F
Age: 62
State: PA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: neck was red; face was red; forehead was red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (neck was red), ERYTHEMA (face was red) and ERYTHEMA (forehead was red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ROSUVASTATIN, METOPROLOL, RAMIPRIL and VITAMIN D3 for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced ERYTHEMA (neck was red), ERYTHEMA (face was red) and ERYTHEMA (forehead was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 05-Feb-2021 at a dose of UNK dosage form and PREDNISONE on 05-Feb-2021 at a dose of UNK dosage form. On 05-Feb-2021, ERYTHEMA (neck was red), ERYTHEMA (face was red) and ERYTHEMA (forehead was red) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported.

Other Meds: BRILINTA; ASPIRIN (E.C.); ROSUVASTATIN; METOPROLOL; RAMIPRIL; VITAMIN D3

Current Illness: High cholesterol; Hypertension

ID: 1556327
Sex: F
Age:
State: CA

Vax Date: 01/21/2021
Onset Date: 01/30/2021
Rec V Date: 08/14/2021
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: Bump; Itching; Rash; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Bump), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swelling) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Bump), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swelling). On 04-Feb-2021, VACCINATION SITE INDURATION (Bump), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swelling) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product details was not provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: NNI - email response On 10-Jul-2021: Follow up document received on 10 - JUL-2021 contains No New Information

Other Meds:

Current Illness:

ID: 1556328
Sex: F
Age: 76
State: FL

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 08/14/2021
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: itching started; the arm is still red, but not so red anymore; hives started but went away after 2 days; a little bit sore but it went away; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching started), ERYTHEMA (the arm is still red, but not so red anymore), URTICARIA (hives started but went away after 2 days) and MYALGIA (a little bit sore but it went away) in a 76-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. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (a little bit sore but it went away). On an unknown date, the patient experienced PRURITUS (itching started), ERYTHEMA (the arm is still red, but not so red anymore) and URTICARIA (hives started but went away after 2 days). At the time of the report, PRURITUS (itching started) and ERYTHEMA (the arm is still red, but not so red anymore) had not resolved and URTICARIA (hives started but went away after 2 days) and MYALGIA (a little bit sore but it went away) 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 was provided.

Other Meds:

Current Illness:

ID: 1556329
Sex: F
Age: 80
State: CT

Vax Date: 01/28/2021
Onset Date: 02/07/2021
Rec V Date: 08/14/2021
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: red rash at injection site rectangular in shape 1 by 2 inches; A spontaneous report was received from a consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red rash at injection site rectangular in shape 1 by 2 inches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 051L20A) intramuscularly for prophylaxis of COVID-19 infection. On 7 Feb 2021, the patient experienced the event(s) red rash at injection site rectangular in shape 1 by 2 inches. Treatment details included none. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), red rash at injection site rectangular in shape 1 by 2 inches was unknown.

Other Meds:

Current Illness:

ID: 1556330
Sex: M
Age:
State: FL

Vax Date: 02/05/2021
Onset Date: 02/08/2021
Rec V Date: 08/14/2021
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: injection arm is swollen; injection arm is swollen and extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injection arm is swollen) and VACCINATION SITE PRURITUS (injection arm is swollen and extremely itchy) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced INJECTION SITE SWELLING (injection arm is swollen) and VACCINATION SITE PRURITUS (injection arm is swollen and extremely itchy). At the time of the report, INJECTION SITE SWELLING (injection arm is swollen) and VACCINATION SITE PRURITUS (injection arm is swollen and extremely itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and treatment information were not provided.

Other Meds:

Current Illness:

ID: 1556331
Sex: F
Age:
State: OH

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/14/2021
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: loss of appetite; "just like having COVID-19 infection"; laid in bed; Chlls; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), CHILLS (Chlls), MYALGIA (body aches), FEELING ABNORMAL ("just like having COVID-19 infection") and ASTHENIA (laid in bed) 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 Thyroid disorder. Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included LISINOPRIL for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DECREASED APPETITE (loss of appetite), MYALGIA (body aches), FEELING ABNORMAL ("just like having COVID-19 infection") and ASTHENIA (laid in bed). On an unknown date, the patient experienced CHILLS (Chlls). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (loss of appetite), CHILLS (Chlls), MYALGIA (body aches), FEELING ABNORMAL ("just like having COVID-19 infection") and ASTHENIA (laid in bed) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds: LISINOPRIL

Current Illness: High cholesterol; Hypertension

ID: 1556332
Sex: M
Age: 72
State: NV

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/14/2021
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: sore arm; Temp of 100.4 fever; Chills; felt wiped out like fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (Temp of 100.4 fever), CHILLS (Chills) and FATIGUE (felt wiped out like fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. Concomitant products included ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL), ATORVASTATIN, CARVEDILOL, CLOPIDOGREL, GABAPENTIN, GLIPIZIDE, HYDRALAZINE and LISINOPRIL for an unknown indication, METFORMIN, PANTOPRAZOLE and LIRAGLUTIDE (VICTOZA). On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (Temp of 100.4 fever), CHILLS (Chills) and FATIGUE (felt wiped out like fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg three times a day. On 29-Jan-2021, PAIN IN EXTREMITY (sore arm), PYREXIA (Temp of 100.4 fever), CHILLS (Chills) and FATIGUE (felt wiped out like fatigue) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Body temperature: 100.4 ?F (High) High. 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.

Other Meds: ACYCLOVIR ABBOTT VIAL; ATORVASTATIN; CARVEDILOL; CLOPIDOGREL; GABAPENTIN; GLIPIZIDE; HYDRALAZINE; LISINOPRIL; METFORMIN; PANTOPRAZOLE; VICTOZA

Current Illness:

ID: 1556333
Sex: F
Age: 82
State: CO

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/14/2021
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: Blister on elbow; Rash Leg (R) above ankle; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blister on elbow) and RASH (Rash Leg (R) above ankle) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 129L20A) for COVID-19 vaccination. The patient's past medical history included Hypertension since an unknown date. Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Sulfonamide allergy (Sulfa allergy). On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced BLISTER (Blister on elbow) and RASH (Rash Leg (R) above ankle). The patient was treated with ZINC OXIDE at an unspecified dose and frequency. At the time of the report, BLISTER (Blister on elbow) and RASH (Rash Leg (R) above ankle) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included High blood pressure medication. Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Re[porter address and email updated This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blister on elbow) and RASH (Rash Leg (R) above ankle) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 129L20A) for COVID-19 vaccination. The patient's past medical history included Hypertension since an unknown date. Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Sulfonamide allergy (Sulfa allergy). On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced BLISTER (Blister on elbow) and RASH (Rash Leg (R) above ankle). The patient was treated with ZINC OXIDE at an unspecified dose and frequency. At the time of the report, BLISTER (Blister on elbow) and RASH (Rash Leg (R) above ankle) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included High blood pressure medication. Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Re[porter address and email updated

Other Meds:

Current Illness: Hypertension; Sulfonamide allergy (Sulfa allergy)

ID: 1556334
Sex: F
Age: 60
State: PA

Vax Date: 01/30/2021
Onset Date:
Rec V Date: 08/14/2021
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: Lymph nodes above the collar bone have swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes above the collar bone have swollen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph nodes above the collar bone have swollen). At the time of the report, LYMPHADENOPATHY (Lymph nodes above the collar bone have swollen) 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 was provided.

Other Meds:

Current Illness:

ID: 1556335
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Adverse effects on the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse effects on 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 was provided by the reporter. 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 (Adverse effects on the vaccine). At the time of the report, ADVERSE REACTION (Adverse effects on the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1556336
Sex: F
Age: 57
State: TX

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 08/14/2021
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: Sneezing; runny nose; Prickling/Tingling; Rash/ Rash on my forearm and top of my both hands; Redness; Chills; Joint pain; headache; fever; diarrhea; Soreness/ Muscle pain; Red spot that go all over her body; Hives on the opposite arm of injection site/ Hives on right arm, foot, breast/ Itchy hives about an inch on her hands and fingers; Itchy hives about an inch on her hands and fingers; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness/ Muscle pain), RASH MACULAR (Red spot that go all over her body), URTICARIA (Hives on the opposite arm of injection site/ Hives on right arm, foot, breast/ Itchy hives about an inch on her hands and fingers), PRURITUS (Itchy hives about an inch on her hands and fingers) and SNEEZING (Sneezing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Protein S deficiency, Myocardial disorder (Obstructive hypertrophic), Thyroid disorder, Prediabetes, Hysterectomy (Rash after procedure, treated by IV Benadryl) in 2013 and Root canal procedure in 2014. Concurrent medical conditions included Hypersensitivity, Hay fever, Urticaria, Drug allergy (Hydrocodone Treated with Prednisone), Penicillin allergy (Treated with Prednisone), Solar sensitiveness, Sweat rash and Blood pressure increased. Concomitant products included METOPROLOL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Cardiac disorder, VALSARTAN for Hypertension. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced MYALGIA (Soreness/ Muscle pain), RASH MACULAR (Red spot that go all over her body), URTICARIA (Hives on the opposite arm of injection site/ Hives on right arm, foot, breast/ Itchy hives about an inch on her hands and fingers) and PRURITUS (Itchy hives about an inch on her hands and fingers). On an unknown date, the patient experienced SNEEZING (Sneezing), RHINORRHOEA (runny nose), PARAESTHESIA (Prickling/Tingling), RASH (Rash/ Rash on my forearm and top of my both hands), ERYTHEMA (Redness), CHILLS (Chills), ARTHRALGIA (Joint pain), HEADACHE (headache), PYREXIA (fever) and DIARRHOEA (diarrhea). At the time of the report, MYALGIA (Soreness/ Muscle pain), RASH MACULAR (Red spot that go all over her body), URTICARIA (Hives on the opposite arm of injection site/ Hives on right arm, foot, breast/ Itchy hives about an inch on her hands and fingers), PRURITUS (Itchy hives about an inch on her hands and fingers), SNEEZING (Sneezing), RHINORRHOEA (runny nose), PARAESTHESIA (Prickling/Tingling), RASH (Rash/ Rash on my forearm and top of my both hands), ERYTHEMA (Redness), CHILLS (Chills), ARTHRALGIA (Joint pain), HEADACHE (headache), PYREXIA (fever) and DIARRHOEA (diarrhea) outcome was unknown. Height of the patient is 5.8 The action taken with mRNA-1273 with the events was considered as not applicable The patient administers concomitant medication for thyroid disorder. No Treatment Medication reported by reporter. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Patient Race, Ethnicity,Medical History, Events and Second dose information was updated

Other Meds: METOPROLOL; VALSARTAN; ASPIRIN (E.C.)

Current Illness: Blood pressure increased; Drug allergy (Hydrocodone Treated with Prednisone); Hay fever; Hypersensitivity; Penicillin allergy (Treated with Prednisone); Solar sensitiveness; Sweat rash; Urticaria

ID: 1556337
Sex: M
Age: 77
State: FL

Vax Date: 01/23/2021
Onset Date: 01/25/2021
Rec V Date: 08/14/2021
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: rash on my torso that developed within 48 hours of the vaccination, rash on his chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my torso that developed within 48 hours of the vaccination, rash on his chest) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH (rash on my torso that developed within 48 hours of the vaccination, rash on his chest). On 26-Jan-2021, RASH (rash on my torso that developed within 48 hours of the vaccination, rash on his chest) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not provided. Second dose is scheduled for 20Feb2021.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm