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: 1594737
Sex: F
Age: 73
State: TX

Vax Date: 01/04/2021
Onset Date: 01/29/2021
Rec V Date: 08/21/2021
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: Rapid heartbeat; Shaking all over; Eyes crossed; In general felt terrible; didn't get much sleep; Fever(102.4?F); Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat), TREMOR (Shaking all over), STRABISMUS (Eyes crossed), FEELING ABNORMAL (In general felt terrible) and SLEEP DEFICIT (didn't get much sleep) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat), TREMOR (Shaking all over), STRABISMUS (Eyes crossed), FEELING ABNORMAL (In general felt terrible), SLEEP DEFICIT (didn't get much sleep), PYREXIA (Fever(102.4?F)), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with CLONIDINE for Blood pressure high, at an unspecified dose and frequency. On 31-Jan-2021, HEART RATE INCREASED (Rapid heartbeat), TREMOR (Shaking all over), STRABISMUS (Eyes crossed), FEELING ABNORMAL (In general felt terrible), SLEEP DEFICIT (didn't get much sleep), PYREXIA (Fever(102.4?F)), CHILLS (Chills) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Blood pressure measurement: 200 mmHg (Inconclusive) 200 or something like that at 9pm. On 29-Jan-2021, Body temperature: 102.4 (High) at 9pm. No concomitant medications were provided. This case was linked to MOD21-16954 (Patient Link).

Other Meds:

Current Illness:

ID: 1594738
Sex: F
Age:
State: FL

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 08/21/2021
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: Inappropriate scheduled of second dose (within 25 days); Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of second dose (within 25 days)) 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 (No medical history reported). On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of second dose (within 25 days)). On 26-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of second dose (within 25 days)) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Relevant concomitant medications were not reported. Treatment information was not provided. This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown, with pain in extremity.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown, with pain in extremity.

Other Meds:

Current Illness:

ID: 1594739
Sex: F
Age: 75
State: FL

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/21/2021
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: having headaches most everyday since the shot; Cough; COVID-19; Pain in legs; Fatigue; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in legs), COVID-19 (COVID-19), COUGH (Cough), FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Osteoarthritis. Concomitant products included LISINOPRIL for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain at injection site). On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in legs). On 13-Jan-2021, the patient experienced COVID-19 (COVID-19). On 15-Jan-2021, the patient experienced COUGH (Cough). On an unknown date, the patient experienced HEADACHE (having headaches most everyday since the shot). The patient was treated with IBUPROFEN at a dose of 1 dosage form as required. On 13-Jan-2021, FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in legs), COVID-19 (COVID-19), COUGH (Cough) and HEADACHE (having headaches most everyday since the shot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: positive Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up added- Patient reported new event and stated she did not fill the form as it is too big and detailed.

Other Meds: LISINOPRIL

Current Illness:

ID: 1594740
Sex: F
Age: 75
State: GA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/21/2021
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: Arm was extremely swollen; Arm is hard; Arm Feverish; Its itchy/itchiness is in any part of her body that comes and goes away; Can barely lift the right arm; Arm really red; Chills; Right arm was sore/ extremely sore; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore/ extremely sore), PERIPHERAL SWELLING (Arm was extremely swollen), INDURATION (Arm is hard), SKIN WARM (Arm Feverish) and PRURITUS (Its itchy/itchiness is in any part of her body that comes and goes away) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Neck surgery (Neck surgery that had repercussion on her arm.) in September 2020. Previously administered products included for Varicella zoster: SHINGRIX (When she had the shingle?s vaccine, some years ago, she had a really bad reaction with the 1st dose and but did not last that long.). Past adverse reactions to the above products included Reaction allergic (NOS) with SHINGRIX. Concurrent medical conditions included Drug allergy (Pregabalin), Blood pressure high, Cholesterol, Heart disease, unspecified and Allergy (Some allergies). On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore/ extremely sore) and CHILLS (Chills). On 18-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm was extremely swollen), INDURATION (Arm is hard), SKIN WARM (Arm Feverish), PRURITUS (Its itchy/itchiness is in any part of her body that comes and goes away), INJECTED LIMB MOBILITY DECREASED (Can barely lift the right arm) and ERYTHEMA (Arm really red). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 17-Feb-2021 at a dose of every 5 to 6 hours and PARACETAMOL (TYLENOL) on 17-Feb-2021 at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Right arm was sore/ extremely sore), PERIPHERAL SWELLING (Arm was extremely swollen), DYSPNOEA (Shortness of breath) and ERYTHEMA (Arm really red) had resolved and INDURATION (Arm is hard), SKIN WARM (Arm Feverish), PRURITUS (Its itchy/itchiness is in any part of her body that comes and goes away), INJECTED LIMB MOBILITY DECREASED (Can barely lift the right arm) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: increased (High) Her blood pressure was high. In February 2021, Heart rate: high (High) Fast heart beat. Concomitant medications included blood pressure medication, cholesterol medication and heart medication. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-020473 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Relevant medical history was updated, event outcomes was changed for right arm was sore, arm is really red and arm is swollen from unknown to recovered/resolved. On 12-Jul-2021: No significant information was reported.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-020473:Same patient, 1st dose

Other Meds:

Current Illness: Allergy (Some allergies); Blood pressure high; Cholesterol; Drug allergy (Pregabalin); Heart disease, unspecified

ID: 1594741
Sex: F
Age: 82
State: NM

Vax Date: 01/15/2021
Onset Date: 02/16/2021
Rec V Date: 08/21/2021
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: Can't raise that arm to use bands or wieghts; Losing function of that muscle; Left deltoid where she received both injections started hurting; Lower back ache; Couldn't sleep; Could hardly move; Felt Achy; Chills; Headache; Felt generally lousy; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Can't raise that arm to use bands or wieghts), INSOMNIA (Couldn't sleep), MUSCLE DISORDER (Losing function of that muscle), BACK PAIN (Lower back ache) and FEELING ABNORMAL (Felt generally lousy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder and Allergy. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced FEELING ABNORMAL (Felt generally lousy), MYALGIA (Felt Achy), CHILLS (Chills) and HEADACHE (Headache). On 20-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep), BACK PAIN (Lower back ache) and HYPOKINESIA (Could hardly move). On an unknown date, the patient experienced MOBILITY DECREASED (Can't raise that arm to use bands or wieghts), MUSCLE DISORDER (Losing function of that muscle) and VACCINATION SITE PAIN (Left deltoid where she received both injections started hurting). On 17-Feb-2021, FEELING ABNORMAL (Felt generally lousy), MYALGIA (Felt Achy), CHILLS (Chills) and HEADACHE (Headache) had resolved. On 21-Feb-2021, INSOMNIA (Couldn't sleep) had resolved. At the time of the report, MOBILITY DECREASED (Can't raise that arm to use bands or wieghts), MUSCLE DISORDER (Losing function of that muscle), BACK PAIN (Lower back ache) and VACCINATION SITE PAIN (Left deltoid where she received both injections started hurting) had not resolved and HYPOKINESIA (Could hardly move) outcome was unknown. Concomitant medications used by the patient included, thyroid and allergy medications. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: New events updated in follow up. On 04-Jun-2021: New events updated in follow up.

Other Meds:

Current Illness: Allergy; Thyroid disorder

ID: 1594742
Sex: F
Age: 85
State: MD

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/21/2021
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: redness between the elbow and the shoulder; wheals between the elbow and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness between the elbow and the shoulder) and URTICARIA (wheals between the elbow and shoulder) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness between the elbow and the shoulder) and URTICARIA (wheals between the elbow and shoulder). At the time of the report, ERYTHEMA (redness between the elbow and the shoulder) and URTICARIA (wheals between the elbow and shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment history was not provided.

Other Meds:

Current Illness:

ID: 1594743
Sex: F
Age:
State: IL

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 08/21/2021
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: weakness; pain over body; difficulty walking; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN (pain over body) and GAIT DISTURBANCE (difficulty walking) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-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 ASTHENIA (weakness), PAIN (pain over body) and GAIT DISTURBANCE (difficulty walking). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), PAIN (pain over body) and GAIT DISTURBANCE (difficulty walking) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication included blood thinner.

Other Meds:

Current Illness:

ID: 1594744
Sex: F
Age:
State:

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 08/21/2021
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: I can't lift my left arm without excruciating pain from neck down to fingers; I can't lift my left arm without excruciating pain from neck down to fingers; could not feel left arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced could not feel left arm and I can't lift my left arm without excruciating pain from neck down to fingers. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on 25 Jan 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient received the vaccine on 25 Jan 2021, in left arm. Four hours after dose, she stated, ?I could not feel left arm all the way up to her neck'. It was twelve-thirty-one pm (post-meridiam) and patient stated, ?I can't lift my arm without excruciating pain from neck down to fingers'. No further information was reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event could not feel left arm was unknown. The outcome of the event I can't lift my left arm without excruciating pain from neck down to fingers was not resolved. The reporter did not provide an assessment for the events, could not feel left arm and I can't lift my left arm without excruciating pain from neck down to fingers.

Other Meds:

Current Illness:

ID: 1594745
Sex: F
Age: 24
State: MI

Vax Date: 01/18/2021
Onset Date: 01/25/2021
Rec V Date: 08/21/2021
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: Chills; Body aches; Sore throat; Hot at the injection site; Itchy circle at the injection site; vaccination site erythema; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy circle at the injection site), VACCINATION SITE ERYTHEMA (vaccination site erythema) and CHILLS (Chills) in a 24-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 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 25-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy circle at the injection site), VACCINATION SITE ERYTHEMA (vaccination site erythema) and MYALGIA (Body aches). On 25-Feb-2021, the patient experienced CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy circle at the injection site), VACCINATION SITE ERYTHEMA (vaccination site erythema), CHILLS (Chills) and MYALGIA (Body aches) 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.

Other Meds:

Current Illness:

ID: 1594746
Sex: F
Age: 46
State: TX

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/21/2021
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: nausea; injection site pain; lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), NAUSEA (nausea) and VACCINATION SITE PAIN (injection site pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Gastroesophageal reflux disease. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication. On 22-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 DIZZINESS (lightheadedness) and VACCINATION SITE PAIN (injection site pain). On 25-Jan-2021, the patient experienced NAUSEA (nausea). On 23-Jan-2021, DIZZINESS (lightheadedness) had resolved. On 24-Jan-2021, VACCINATION SITE PAIN (injection site pain) had resolved. At the time of the report, NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: PRILOSEC [OMEPRAZOLE MAGNESIUM]; PROTONIX [OMEPRAZOLE]

Current Illness:

ID: 1594747
Sex: F
Age: 71
State: PA

Vax Date: 02/04/2021
Onset Date: 02/14/2021
Rec V Date: 08/21/2021
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: very pale; Vertigo; nauseated; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (very pale), VERTIGO (Vertigo), NAUSEA (nauseated) and FATIGUE (fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination. The patient's past medical history included Pancreaticoduodenectomy (For pancreatitis). Concurrent medical conditions included Iodine contrast media allergy, Osteoporosis (worsening, now on Prolia (every 6 mos. injections).) since June 2014, Seasonal allergy, Acute pancreatitis (Recurrent) since May 2009, High cholesterol since December 2014, Carotid artery disease (Blocked carotid artery) since December 2014 and Asthma. Concomitant products included ATORVASTATIN for High cholesterol, DENOSUMAB (PROLIA) for Osteoporosis. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced PALLOR (very pale), VERTIGO (Vertigo), NAUSEA (nauseated) and FATIGUE (fatigue). On 18-Feb-2021, PALLOR (very pale), VERTIGO (Vertigo), NAUSEA (nauseated) and FATIGUE (fatigue) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No treatment information was reported. This case was linked to MOD-2021-271984 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Added patient demographics, medical history and concomitant medications.

Other Meds: ATORVASTATIN; PROLIA

Current Illness: Acute pancreatitis (Recurrent); Asthma; Carotid artery disease (Blocked carotid artery); High cholesterol; Iodine contrast media allergy; Osteoporosis (worsening, now on Prolia (every 6 mos. injections).); Seasonal allergy

ID: 1594748
Sex: F
Age:
State: NY

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/21/2021
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: Lump on Tongue; Red mark on injection site; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (Lump on Tongue) and VACCINATION SITE ERYTHEMA (Red mark on injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced TONGUE DISORDER (Lump on Tongue) and VACCINATION SITE ERYTHEMA (Red mark on injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, TONGUE DISORDER (Lump on Tongue) and VACCINATION SITE ERYTHEMA (Red mark on injection site) outcome was unknown. The patient's concomitant medication was not reported. It was reported that the patient was better now. The action taken with mRNA with the events was considered as not applicable. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: The follow-up was received on 6-JULY-2021 and date of onset of event was updated.

Other Meds:

Current Illness:

ID: 1594749
Sex: M
Age: 72
State: GA

Vax Date: 01/16/2021
Onset Date: 01/18/2021
Rec V Date: 08/21/2021
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: Arm had redness; Arm warm to touch; Arm knot 4-5 inches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm had redness), SKIN WARM (Arm warm to touch) and LIMB MASS (Arm knot 4-5 inches) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ERYTHEMA (Arm had redness), SKIN WARM (Arm warm to touch) and LIMB MASS (Arm knot 4-5 inches). On 21-Jan-2021, SKIN WARM (Arm warm to touch) and LIMB MASS (Arm knot 4-5 inches) had resolved. At the time of the report, ERYTHEMA (Arm had redness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product used was not provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1594750
Sex: F
Age:
State: TX

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/21/2021
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: Bruises at the site with a size of a dime; It is warm to touch; Sore arm; Hardness on the site; Itchy at site; Red at site; Swelling on the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruises at the site with a size of a dime), VACCINATION SITE WARMTH (It is warm to touch), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Hardness on the site) and VACCINATION SITE PRURITUS (Itchy at site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Bruises at the site with a size of a dime), VACCINATION SITE WARMTH (It is warm to touch), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Hardness on the site), VACCINATION SITE PRURITUS (Itchy at site), VACCINATION SITE ERYTHEMA (Red at site) and VACCINATION SITE SWELLING (Swelling on the site). At the time of the report, VACCINATION SITE BRUISING (Bruises at the site with a size of a dime), VACCINATION SITE WARMTH (It is warm to touch), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Hardness on the site), VACCINATION SITE PRURITUS (Itchy at site), VACCINATION SITE ERYTHEMA (Red at site) and VACCINATION SITE SWELLING (Swelling on the site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1594751
Sex: F
Age: 31
State:

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 08/21/2021
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: Sick for 24 hs; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Sick for 24 hs) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced ILLNESS (Sick for 24 hs). At the time of the report, ILLNESS (Sick for 24 hs) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Upon in internal review on 21 May 2021, the age was corrected to unknown age. No relevant concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up was received on 06-JUL-2021: Contain No new information.

Other Meds:

Current Illness:

ID: 1594752
Sex: F
Age: 82
State: CA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/21/2021
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: a swollen lower lip; White color; The swelling went down under the chin; bumpy; swollen flesh below the lower lip; spills some liquid on the side while she talks; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (a swollen lower lip), LIP DISCOLOURATION (White color), SWELLING FACE (The swelling went down under the chin), LIP DISORDER (bumpy) and LIP SWELLING (swollen flesh below the lower lip) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medication history information was reported. Concomitant products included GLIPIZIDE, SITAGLIPTIN, HYDROCHLOROTHIAZIDE, VALSARTAN, PROBIOTICS NOS and ALPHA-AMYLASE SWINE PANCREAS, CELLULASE, LIPASE, PROTEASE NOS (DIGESTIVE ENZYME) for an unknown indication. 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 LIP SWELLING (a swollen lower lip), LIP DISCOLOURATION (White color), SWELLING FACE (The swelling went down under the chin), LIP DISORDER (bumpy), LIP SWELLING (swollen flesh below the lower lip) and SALIVARY HYPERSECRETION (spills some liquid on the side while she talks). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at a dose of 1 dosage form. At the time of the report, LIP SWELLING (a swollen lower lip), LIP DISCOLOURATION (White color), SWELLING FACE (The swelling went down under the chin), LIP DISORDER (bumpy), LIP SWELLING (swollen flesh below the lower lip) and SALIVARY HYPERSECRETION (spills some liquid on the side while she talks) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication include PreserVision Eye Vitamin. Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Follow-up information received on 10-Jul-2021 contains no new information.

Other Meds: GLIPIZIDE; SITAGLIPTIN; HYDROCHLOROTHIAZIDE; VALSARTAN; PROBIOTICS NOS; DIGESTIVE ENZYME

Current Illness:

ID: 1594753
Sex: F
Age:
State: NE

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 08/21/2021
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: my head still feels a little strange; got sick at 3am; soreness at the arm; so weak she could not get out of bed; a little dizzy in the head; could hardly work without help; pain at the injection site; slight fever; headache; extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick at 3am), PAIN IN EXTREMITY (soreness at the arm), ASTHENIA (so weak she could not get out of bed), DIZZINESS (a little dizzy in the head) and HEAD DISCOMFORT (my head still feels a little strange) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported by the patient. Concomitant products included CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CLOBETASOL for an unknown indication. On 22-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness at the arm), ASTHENIA (so weak she could not get out of bed), DIZZINESS (a little dizzy in the head), MYALGIA (could hardly work without help), VACCINATION SITE PAIN (pain at the injection site), PYREXIA (slight fever), HEADACHE (headache) and FATIGUE (extremely fatigued). On 23-Jan-2021 at 3:00 AM, the patient experienced ILLNESS (got sick at 3am). On 25-Jan-2021, the patient experienced HEAD DISCOMFORT (my head still feels a little strange). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 25-Jan-2021, PAIN IN EXTREMITY (soreness at the arm) had resolved. At the time of the report, ILLNESS (got sick at 3am), ASTHENIA (so weak she could not get out of bed), DIZZINESS (a little dizzy in the head), HEAD DISCOMFORT (my head still feels a little strange), MYALGIA (could hardly work without help), VACCINATION SITE PAIN (pain at the injection site), PYREXIA (slight fever), HEADACHE (headache) and FATIGUE (extremely fatigued) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 99.6 (High) 99.6. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08-Jun-2021 did not contain any new information.

Other Meds: CALCIUM; VITAMIN D 2000; CLOBETASOL

Current Illness:

ID: 1594754
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 01/28/2021
Rec V Date: 08/21/2021
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: sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 28-Jan-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. 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 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided No treatment information provided Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up received on 31-may-2021 contains no new information.

Other Meds:

Current Illness:

ID: 1594755
Sex: M
Age:
State:

Vax Date: 01/15/2021
Onset Date: 01/23/2021
Rec V Date: 08/21/2021
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: getting second shot >35 days; Itchy; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), RASH (Rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (getting second shot >35 days) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination. No Medical History information was reported. On 15-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Jan-2021, the patient was diagnosed with PRURITUS (Itchy) and RASH (Rash). On an unknown date, the patient was diagnosed with INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (getting second shot >35 days). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PRURITUS (Itchy), RASH (Rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (getting second shot >35 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided by reporter. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up received on 03-jun-2021,event was updated, treatment updated

Other Meds:

Current Illness:

ID: 1594756
Sex: F
Age:
State: PA

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/21/2021
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: lower back pain after exercise; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain after exercise) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The patient's past medical history included No adverse reaction (no reported medical history). On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced BACK PAIN (lower back pain after exercise). At the time of the report, BACK PAIN (lower back pain after exercise) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Consumer declined further follow up.

Other Meds:

Current Illness:

ID: 1594757
Sex: F
Age: 59
State:

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/21/2021
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: Incontinence; Aches all over the body; Shortness of breath; Fever > 102?F; Headache; Pain in the arm of the injection; Tiredness; A Spondaneous report was received from a Healthcare professional concerning a 70 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pain in the arm of the injection, Tiredness, Incontinence, Fever > 102?F, Aches all over the body, Headache, Shortness of breath, sore arm The patient's medical history was not given. No information about the concomitant medication was given. On 22-01-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 batch no: 011J20A intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 22-01-2021, The patient experienced Pain in the arm of the injection, Tiredness. On 23-01-2021, the patient experienced incontinence, Fever > 102?F, Aches all over the body, headache, Shortness of Breath, Sore arm. The laboratory information is not given. The patient was given Tylenol as treatment medication. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events pain in the arm of the injection, Tiredness, Incontinence was resolved on 24-01-2021. The outcome of the events , Fever > 102?F, Aches all over the body, headache, Shortness of Breath, Sore arm are unknown.

Other Meds:

Current Illness:

ID: 1594758
Sex: F
Age: 50
State: NM

Vax Date: 01/30/2021
Onset Date: 02/21/2021
Rec V Date: 08/21/2021
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: Hives/ Hives appear in different areas of body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/ Hives appear in different areas of body) in a 50-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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced URTICARIA (Hives/ Hives appear in different areas of body). At the time of the report, URTICARIA (Hives/ Hives appear in different areas of body) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Updated reported term of event Hives. Patient continued to have issues with hives. NNI.

Other Meds:

Current Illness:

ID: 1594759
Sex: F
Age:
State: NJ

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 08/21/2021
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: hives; soreness at the injection; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives) and VACCINATION SITE PAIN (soreness at the injection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL, LEVOTHYROXINE, OXYBUTYNIN and BUPROPION HYDROCHLORIDE (WELLBUTRIN). On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection). On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) and VACCINATION SITE PAIN (soreness at the injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. unspecified topical antihistamines were used by patient as treatment. Reporter did not allow further contact

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; METOPROLOL; LEVOTHYROXINE; OXYBUTYNIN; WELLBUTRIN

Current Illness:

ID: 1594760
Sex: F
Age:
State:

Vax Date:
Onset Date: 02/14/2021
Rec V Date: 08/21/2021
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: 6-inch mass of swollen red; 6-inch mass of swollen red; 6-inch mass of swollen red; nauseous; extremely gassy; heart burn; A spontaneous report was received from a other healthcare professional concerning a 55 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID arm (6-inch mass of swollen red)/limb mass peripheral swelling erythema, heart burn/dyspepsia, extremely gassy/flatulence and nausea. The patient's medical history was not provided by the reporter.The relevant concomitant medications use were not reported. On 12 Jan 2021, about 2-3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) through unknown route for prophylaxis of COVID-19 infection. On 14 Dec 2020,about 2-3 days after vaccination the patient experienced COVID arm (6-inch mass of swollen red), extremely gassy, heart burn and nauseous. No treatment information was provided. Lab details were not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, COVID arm (6-inch mass of swollen red), extremely gassy, heart burn and nauseous were considered unknown.

Other Meds:

Current Illness:

ID: 1594761
Sex: F
Age:
State:

Vax Date:
Onset Date: 02/01/2021
Rec V Date: 08/21/2021
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: Area is tender , but not painful; at the site of the injection, there is an approximate 3" circular red rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (at the site of the injection, there is an approximate 3" circular red rash) and VACCINATION SITE PAIN (Area is tender , but not painful) 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) (unknown route) 1 dosage form. In February 2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (at the site of the injection, there is an approximate 3" circular red rash). On an unknown date, the patient experienced VACCINATION SITE PAIN (Area is tender , but not painful). At the time of the report, VACCINATION SITE RASH (at the site of the injection, there is an approximate 3" circular red rash) and VACCINATION SITE PAIN (Area is tender , but not painful) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1594762
Sex: F
Age: 52
State: IN

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 08/21/2021
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: Redness that is spreading below the injection site; Warmness of arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warmness of arm) and VACCINATION SITE ERYTHEMA (Redness that is spreading below the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warmness of arm). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness that is spreading below the injection site). At the time of the report, INJECTION SITE WARMTH (Warmness of arm) and VACCINATION SITE ERYTHEMA (Redness that is spreading below the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant information provided. No Treatment information provided Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received updated reporter contact details and is considered non-significant.

Other Meds:

Current Illness:

ID: 1594763
Sex: F
Age: 78
State: GA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/21/2021
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: Coughing; Soreness; Felt tightness in chest that lasted for 45min-1hr; Lump on center of chest, that lasted for 45min-1hr; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), PAIN IN EXTREMITY (Soreness in arm), CHEST DISCOMFORT (Felt tightness in chest that lasted for 45min-1hr), MASS (Lump on center of chest, that lasted for 45min-1hr) and PAIN (Soreness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm). On 03-Feb-2021, the patient experienced CHEST DISCOMFORT (Felt tightness in chest that lasted for 45min-1hr) and MASS (Lump on center of chest, that lasted for 45min-1hr). On 04-Feb-2021, the patient experienced PAIN (Soreness). On 04-Feb-2021 at 6:00 AM, the patient experienced COUGH (Coughing). On 03-Feb-2021, PAIN IN EXTREMITY (Soreness in arm), CHEST DISCOMFORT (Felt tightness in chest that lasted for 45min-1hr) and MASS (Lump on center of chest, that lasted for 45min-1hr) had resolved. At the time of the report, COUGH (Coughing) had resolved and PAIN (Soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Patient took ibuprofen to treat symptoms. Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up TCR report received included no new information.

Other Meds:

Current Illness:

ID: 1594764
Sex: F
Age: 81
State: OH

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/21/2021
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: I felt like I had the flu/I was really sick.; I started to feel achy; My arm hurt/Felt like someone sucker-punched me in the arm; ince I got the shot, I got more pain in my spine area. I had to increase the frequency of Ibuprofen; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (ince I got the shot, I got more pain in my spine area. I had to increase the frequency of Ibuprofen), ILLNESS (I felt like I had the flu/I was really sick.), PAIN (I started to feel achy) and VACCINATION SITE PAIN (My arm hurt/Felt like someone sucker-punched me in the arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The patient's past medical history included Breast cancer (In left breast.). Concomitant products included LISINOPRIL, ATENOLOL, CLONIDINE, OMEPRAZOLE, ROSUVASTATIN and AMLODIPINE BESYLATE for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced SPINAL PAIN (ince I got the shot, I got more pain in my spine area. I had to increase the frequency of Ibuprofen) and VACCINATION SITE PAIN (My arm hurt/Felt like someone sucker-punched me in the arm). On 02-Feb-2021, the patient experienced ILLNESS (I felt like I had the flu/I was really sick.) and PAIN (I started to feel achy). The patient was treated with IBUPROFEN on 20-Jan-2021 for Pain in arm, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 02-Feb-2021 for Flu like symptoms, at a dose of 2 dosage form. On 21-Jan-2021, VACCINATION SITE PAIN (My arm hurt/Felt like someone sucker-punched me in the arm) had resolved. On 05-Feb-2021, SPINAL PAIN (ince I got the shot, I got more pain in my spine area. I had to increase the frequency of Ibuprofen), ILLNESS (I felt like I had the flu/I was really sick.) and PAIN (I started to feel achy) had resolved. Split for coding purposes The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included Vitamin D, E and Ibuprofen as needed. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Non-significant follow-up information was received.

Other Meds: LISINOPRIL; ATENOLOL; CLONIDINE; OMEPRAZOLE; ROSUVASTATIN; AMLODIPINE BESYLATE

Current Illness:

ID: 1594765
Sex: M
Age: 42
State: TX

Vax Date: 01/27/2021
Onset Date: 01/31/2021
Rec V Date: 08/21/2021
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 on both shoulders/ a little on stomach/ on his back/ on the thighs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on both shoulders/ a little on stomach/ on his back/ on the thighs) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced RASH (Rash on both shoulders/ a little on stomach/ on his back/ on the thighs). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on both shoulders/ a little on stomach/ on his back/ on the thighs) outcome was unknown. Not Provided No concomitant medications were reported. On 31-Jan-2021, the patient had a rash on both shoulders and a little on stomach. It was spreading more and more. It was also on his back and thighs. It was looking like mosquito bites. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: only e-mail address provided

Other Meds:

Current Illness:

ID: 1594766
Sex: M
Age: 77
State: MA

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 08/21/2021
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: had a bruise; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (had a bruise) and VACCINATION SITE PAIN (arm was a little sore) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (Medical history was not provided.). On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE BRUISING (had a bruise) and VACCINATION SITE PAIN (arm was a little sore). At the time of the report, VACCINATION SITE BRUISING (had a bruise) and VACCINATION SITE PAIN (arm was a little sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19th Apr 2021 is non significant.Consumer denied further follow up.NNI

Other Meds:

Current Illness:

ID: 1594767
Sex: M
Age:
State: MD

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/21/2021
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: A really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (A really bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 HEADACHE (A really bad headache). At the time of the report, HEADACHE (A really bad headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient took no treatment for events.

Other Meds:

Current Illness:

ID: 1594768
Sex: M
Age:
State: ID

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/21/2021
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: muscle pain at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (muscle pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (muscle pain at the injection site). At the time of the report, VACCINATION SITE PAIN (muscle pain at the injection site) had not resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator No treatment medications provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1594769
Sex: F
Age: 77
State: CA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 08/21/2021
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: rash; itching; swollen; sore; tired; warmth; red rash at site of injection; redness; swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (red rash at site of injection), INJECTION SITE WARMTH (warmth), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE RASH (rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A029L20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy (water blisters on hands) since 1960, Allergy to antibiotic (cipro, sore muscles, tingling) since 2004, Allergy to antibiotic (tetracycline) since 1997 and Allergy to antibiotic (sulfa, red itching rash, head to toe) since 1963. Concomitant products included SIMVASTATIN (ZOCOR) for Hypercholesteremia, ZOLPIDEM TARTRATE (AMBIEN) for Sleep problem, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), MULTIVITAMINS & MINERALS PLUS LUTEIN, ZINC, VITAMIN D3, CYANOCOBALAMIN (VITAMINE B12), VITAMIN C [ASCORBIC ACID] and PANTOPRAZOLE for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling). On 01-Feb-2021, the patient experienced HYPERSENSITIVITY (red rash at site of injection). On 03-Feb-2021, the patient experienced INJECTION SITE WARMTH (warmth), VACCINATION SITE RASH (rash), VACCINATION SITE PRURITUS (itching), INJECTION SITE SWELLING (swollen), MYALGIA (sore) and FATIGUE (tired). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency. On 27-Jan-2021, VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) had resolved. On 08-Feb-2021, HYPERSENSITIVITY (red rash at site of injection) had resolved. At the time of the report, INJECTION SITE WARMTH (warmth), VACCINATION SITE RASH (rash), VACCINATION SITE PRURITUS (itching), INJECTION SITE SWELLING (swollen), MYALGIA (sore) and FATIGUE (tired) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events were Not Applicable. No treatment drugs are not provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Patient medical history was updated, New adverse event - hypersensitivity reaction was updated,Second dose information was updated.

Other Meds: PROTONIX [OMEPRAZOLE]; ZOCOR; AMBIEN; MULTIVITAMINS & MINERALS PLUS LUTEIN; ZINC; VITAMIN D3; VITAMINE B12; VITAMIN C [ASCORBIC ACID]; PANTOPRAZOLE

Current Illness: Allergy to antibiotic (tetracycline); Allergy to antibiotic (sulfa, red itching rash, head to toe); Allergy to antibiotic (cipro, sore muscles, tingling); Penicillin allergy (water blisters on hands)

ID: 1594770
Sex: F
Age: 92
State:

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 08/21/2021
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: severe allergic reaction; Hives and itching throughout body; Hives and itching throughout body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction), URTICARIA (Hives and itching throughout body) and PRURITUS (Hives and itching throughout body) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HYPERSENSITIVITY (severe allergic reaction), URTICARIA (Hives and itching throughout body) and PRURITUS (Hives and itching throughout body). The patient was treated with PREDNISONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (severe allergic reaction), URTICARIA (Hives and itching throughout body) and PRURITUS (Hives and itching throughout body) had not resolved. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1594771
Sex: F
Age: 60
State: CA

Vax Date: 02/18/2021
Onset Date: 02/22/2021
Rec V Date: 08/21/2021
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: sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) 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.

Other Meds:

Current Illness:

ID: 1594772
Sex: F
Age: 73
State: NV

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 08/21/2021
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: Diarrhea; nauseated; Bad headache; Body aches and pain; Sleep all day; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleep all day), DIARRHOEA (Diarrhea), NAUSEA (nauseated), HEADACHE (Bad headache) and MYALGIA (Body aches and pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (nauseated), HEADACHE (Bad headache) and MYALGIA (Body aches and pain). On an unknown date, the patient experienced SOMNOLENCE (Sleep all day). The patient was treated with CITRIC ACID, GLUCOSE, POTASSIUM CHLORIDE, SODIUM CHLORIDE (PEDIALYTE [CITRIC ACID;GLUCOSE;POTASSIUM CHLORIDE;SODIUM CHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form; PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form and NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of UNK dosage form. On 22-Jan-2021, DIARRHOEA (Diarrhea), NAUSEA (nauseated), HEADACHE (Bad headache) and MYALGIA (Body aches and pain) had resolved. At the time of the report, SOMNOLENCE (Sleep all day) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant drug was used. The BRAT diet was taken by patient on advice of pharmacist. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received contains non-significant information.

Other Meds:

Current Illness:

ID: 1594773
Sex: M
Age: 70
State: TN

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/21/2021
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: Fever, temperature of 101.4; Chills; Tired; Second dose given on day 24(14th Jan 2021-1st dose & 7th feb-2nd dose); Sore Left Arm (within 24 hours of first dose); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24 (14th Jan 2021-1st dose & 7th Feb-2nd dose)), PYREXIA (Fever, temperature of 101.4), CHILLS (Chills), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore Left Arm (within 24 hours of first dose)) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] 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 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Left Arm (within 24 hours of first dose)). On 07-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24(14th Jan 2021-1st dose & 7th feb-2nd dose)). On an unknown date, the patient experienced PYREXIA (Fever, temperature of 101.4), CHILLS (Chills) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24 (14th Jan 2021-1st dose & 7th feb-2nd dose)), PYREXIA (Fever, temperature of 101.4), CHILLS (Chills), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore Left Arm (within 24 hours of first dose)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 101.4 (High) 101.4 F. Patient reported unspecified blood pressure and statin medication as concomitant medication. This case was linked to MOD-2021-021749 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Significant Follow up added. Dose details and action taken was updated. Concomitant and treatment medication information added. New Event Vaccination site pain was added.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1594774
Sex: F
Age: 30
State: KS

Vax Date: 01/28/2021
Onset Date: 02/26/2021
Rec V Date: 08/21/2021
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: Pregnant patient received second dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received second dose) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 04L320A) for COVID-19 vaccination. The patient's past medical history included Pregnancy normal (Live full term birth.) on 11-Aug-2018, Miscarriage (miscarriage approximately in 9 weeks, Spontaneous abortion.) on 14-Aug-2020 and Irritable bowel syndrome in 1990. Concurrent medical conditions included Low blood pressure in 2007. Concomitant products included IRON from 20-Jul-2021 to an unknown date for Anemia, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], VITAMIN B6, DOXYLAMINE SUCCINATE (UNISOM 2) and FISH OIL for Pregnancy. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 05-Jan-2021 and the estimated date of delivery was 12-Oct-2021. On 26-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received second dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the seventh week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 26-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood glucose normal: 15jul2021 (normal) normal. On 12-Feb-2021, Pregnancy test: positive (Positive) Positive. On 12-Feb-2021, Ultrasound abdomen normal: 23feb2021 (normal) normal and 04oct2021 (normal) normal. No treatment medication were reported. Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: significant followup received including medical history, concomitant medication and action taken updated.

Other Meds: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; VITAMIN B6; UNISOM 2; FISH OIL; IRON

Current Illness:

ID: 1594775
Sex: M
Age: 68
State:

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/21/2021
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: Counterfeit product administered; A spontaneous report was received from a Consumer concerning a 68 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) reported regarding a possible vaccine counterfeit. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number - 012M20A) via unknown route for COVID-19 infection and reported regarding a possible vaccine counterfeit. No Treatment information has been provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome, counterfeit product administered, was considered resolved.; Reporter's Comments: This report refers to a case of counterfeit product for mRNA-1273, batch number - 012M20A, with no associated AEs. Causality is not applicable.

Other Meds:

Current Illness:

ID: 1594776
Sex: F
Age: 54
State: FL

Vax Date: 01/18/2021
Onset Date: 01/26/2021
Rec V Date: 08/21/2021
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: Red; Warm; Itchy; soreness at the injection site; A spontaneous report was received from a consumer concerning, a 54-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events warm, itchy, red, and sore at the injection site. The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient experienced warmth, itchiness, redness at the injection site. The patient later developed soreness at the injection site. The redness at the injection site was still growing. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. On an unknown date, the outcome of events, warm, itchy, and sore at the injection site were considered unknown. On an unknown date, the outcome of the event, red at the injection site was considered not resolved.

Other Meds:

Current Illness:

ID: 1594777
Sex: M
Age: 69
State:

Vax Date: 02/08/2021
Onset Date: 02/15/2021
Rec V Date: 08/21/2021
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: Blood pressure 184/82; ankles swollen up; Sweat; 101?F temp; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure 184/82), JOINT SWELLING (ankles swollen up), HYPERHIDROSIS (Sweat), PYREXIA (101?F temp) and CHILLS (severe chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in September 2020. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure 184/82), JOINT SWELLING (ankles swollen up), HYPERHIDROSIS (Sweat), PYREXIA (101?F temp) and CHILLS (severe chills). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure 184/82), JOINT SWELLING (ankles swollen up), HYPERHIDROSIS (Sweat), PYREXIA (101?F temp) and CHILLS (severe chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Blood pressure measurement: 184/82 (High) increased. On 15-Feb-2021, Body temperature: 101 (High) degree F. 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 29-Mar-2021: Follow-up information received on 29 Mar 2021 reporter contact details updated. On 31-Mar-2021: Follow up was received on 31 Mar 2021 included no new information.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1594778
Sex: F
Age: 45
State: MI

Vax Date: 01/23/2021
Onset Date: 02/20/2021
Rec V Date: 08/21/2021
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: Localized allergic response on her arm; Red bump that is really big (around 3 inches) and spreading and looks like it is beginning to become cellulite; Injection site hard; Arm was sore right away; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Localized allergic response on her arm), ERYTHEMA (Red bump that is really big (around 3 inches) and spreading and looks like it is beginning to become cellulite), VACCINATION SITE INDURATION (Injection site hard) and VACCINATION SITE PAIN (Arm was sore right away) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ATOMOXETINE HYDROCHLORIDE (STRATTERA), SERTRALINE HYDROCHLORIDE (ZOLOFT), ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Injection site hard) and VACCINATION SITE PAIN (Arm was sore right away). On an unknown date, the patient experienced HYPERSENSITIVITY (Localized allergic response on her arm) and ERYTHEMA (Red bump that is really big (around 3 inches) and spreading and looks like it is beginning to become cellulite). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site induration and Redness, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Localized allergic response on her arm), ERYTHEMA (Red bump that is really big (around 3 inches) and spreading and looks like it is beginning to become cellulite), VACCINATION SITE INDURATION (Injection site hard) and VACCINATION SITE PAIN (Arm was sore right away) had resolved. Concomitant products included unspecified statin. Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received: contains updated event outcome.

Other Meds: STRATTERA; ZOLOFT; ASPIRIN [ACETYLSALICYLIC ACID]; METOPROLOL; ALLEGRA; SINGULAIR

Current Illness:

ID: 1594779
Sex: F
Age:
State: OH

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 08/21/2021
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: Itching; Red for two days 2" by 2" at injection site; little pink a week later but not itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), INJECTION SITE ERYTHEMA (Red for two days 2" by 2" at injection site) and SKIN DISCOLOURATION (little pink a week later but not itchy) in a female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 19-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 PRURITUS (Itching), INJECTION SITE ERYTHEMA (Red for two days 2" by 2" at injection site) and SKIN DISCOLOURATION (little pink a week later but not itchy). At the time of the report, PRURITUS (Itching), INJECTION SITE ERYTHEMA (Red for two days 2" by 2" at injection site) and SKIN DISCOLOURATION (little pink a week later but not itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1594780
Sex: M
Age: 65
State: VA

Vax Date: 01/27/2021
Onset Date:
Rec V Date: 08/21/2021
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: swelling, and "it moved": from the wrist, to the groin area to the thyroid area; left hand blew up like a balloon; I couldn't use my hand at all; couldn't use his hand at all, and it was very painful; Because of the pain I lost strength; In the thyroid area patient feels like a pressure, he feels it near his neck and throat and it is very uncomfortable; It is uncomfortable; burning sensation; general pain here and there; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling, and "it moved": from the wrist, to the groin area to the thyroid area), VACCINATION SITE SWELLING (left hand blew up like a balloon), MOBILITY DECREASED (I couldn't use my hand at all), VACCINATION SITE PAIN (couldn't use his hand at all, and it was very painful) and ASTHENIA (Because of the pain I lost strength) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced SWELLING (swelling, and "it moved": from the wrist, to the groin area to the thyroid area), VACCINATION SITE SWELLING (left hand blew up like a balloon), MOBILITY DECREASED (I couldn't use my hand at all), VACCINATION SITE PAIN (couldn't use his hand at all, and it was very painful), ASTHENIA (Because of the pain I lost strength), DISCOMFORT (In the thyroid area patient feels like a pressure, he feels it near his neck and throat and it is very uncomfortable), FEELING ABNORMAL (It is uncomfortable), BURNING SENSATION (burning sensation) and MYALGIA (general pain here and there). In 2021, MOBILITY DECREASED (I couldn't use my hand at all) and VACCINATION SITE PAIN (couldn't use his hand at all, and it was very painful) had resolved. At the time of the report, SWELLING (swelling, and "it moved": from the wrist, to the groin area to the thyroid area), VACCINATION SITE SWELLING (left hand blew up like a balloon), DISCOMFORT (In the thyroid area patient feels like a pressure, he feels it near his neck and throat and it is very uncomfortable), FEELING ABNORMAL (It is uncomfortable), BURNING SENSATION (burning sensation) and MYALGIA (general pain here and there) outcome was unknown and ASTHENIA (Because of the pain I lost strength) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported. This case was linked to MOD-2021-024056 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up information received and captured product details and additional events.

Other Meds:

Current Illness:

ID: 1594781
Sex: M
Age: 65
State: VA

Vax Date: 01/27/2021
Onset Date: 02/24/2021
Rec V Date: 08/21/2021
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: Because of the pain I lost strength; thyroid area swelled; Feels like a pressure, near my neck and throat; feeling uncomfortable; Swelling/swelling moved: from wrist to groin to thyroid area; Burning sensation; Left hand blew up like a balloon; Sore arm/ couldn't use his hand at all and it was very painful; mild headache; I couldn't use my hand at all; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021. The most recent information was received on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm/ couldn't use his hand at all and it was very painful), PERIPHERAL SWELLING (Left hand blew up like a balloon), MOVEMENT DISORDER (I couldn't use my hand at all), ASTHENIA (Because of the pain I lost strength) and PHARYNGEAL SWELLING (thyroid area swelled) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A. and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/ couldn't use his hand at all and it was very painful). 24-Feb-2021, the patient experienced HEADACHE (mild headache). On an unknown date, the patient experienced PERIPHERAL SWELLING (Left hand blew up like a balloon), MOVEMENT DISORDER (I couldn't use my hand at all), ASTHENIA (Because of the pain I lost strength), PHARYNGEAL SWELLING (thyroid area swelled), THROAT TIGHTNESS (Feels like a pressure, near my neck and throat), DISCOMFORT (feeling uncomfortable), SWELLING (Swelling/swelling moved: from wrist to groin to thyroid area) and BURNING SENSATION (Burning sensation). At the time of the report, PAIN IN EXTREMITY (Sore arm/ couldn't use his hand at all and it was very painful) and ASTHENIA (Because of the pain I lost strength) was resolving, PERIPHERAL SWELLING (Left hand blew up like a balloon), PHARYNGEAL SWELLING (thyroid area swelled), THROAT TIGHTNESS (Feels like a pressure, near my neck and throat), DISCOMFORT (feeling uncomfortable), SWELLING (Swelling/swelling moved: from wrist to groin to thyroid area), BURNING SENSATION (Burning sensation) and HEADACHE (mild headache) outcome was unknown and MOVEMENT DISORDER (I couldn't use my hand at all) had resolved. Concomitant medications were not provided. Treatment information was not reported. The action taken with mRNA with the events was considered as not applicable. This case was linked to MOD-2021-024053 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up information received on 4-AUG-2021 contains updated patient details, Added dose 1 details, added events - Swelling, Peripheral swelling, Movement disorder, Pain in extremity, Asthenia, Pharyngeal swelling, Throat tightness, Discomfort, Burning sensation, updated outcome of the event Pain in extremity from Unknown to Recovering

Other Meds:

Current Illness:

ID: 1594782
Sex: F
Age: 75
State:

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 08/21/2021
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: Bad reaction; Not feeling well; Bad headache; A spontaneous report was received from a consumer, concerning herself, a 74-years-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bad reaction, was not feeling well and had a bad headache. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 22 Feb 2021, after second dose of vaccination, all day Monday, the patient experienced bad reaction, bad headache and was not feeling well. Patient also had other health issues; no specifics were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of event bad reaction, bad headache and not feeling well were resolved on 24 Feb 2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested

Other Meds:

Current Illness:

ID: 1594783
Sex: F
Age: 69
State: VA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 08/21/2021
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: Arm continued swelling 8 days later; Pain in arm at injection site; Arm red; Arm itchy; Arm puffy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in arm at injection site), VACCINATION SITE ERYTHEMA (Arm red), PRURITUS (Arm itchy), OEDEMA (Arm puffy) and PERIPHERAL SWELLING (Arm continued swelling 8 days later) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history Provided.). On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm at injection site), VACCINATION SITE ERYTHEMA (Arm red), PRURITUS (Arm itchy) and OEDEMA (Arm puffy). On 08-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm continued swelling 8 days later). At the time of the report, VACCINATION SITE PAIN (Pain in arm at injection site), VACCINATION SITE ERYTHEMA (Arm red), PRURITUS (Arm itchy), OEDEMA (Arm puffy) and PERIPHERAL SWELLING (Arm continued swelling 8 days later) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. patient has taken treatment and applied anti itch cream concomitant medicataion for blood pressure

Other Meds:

Current Illness:

ID: 1594784
Sex: M
Age: 30
State: OK

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/21/2021
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: arm was sore; low, low energy; almost went to sleep; felt very sleepy; felt high; very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), ASTHENIA (low, low energy), SOMNOLENCE (almost went to sleep; felt very sleepy), EUPHORIC MOOD (felt high) and FATIGUE (very tired) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder. On 27-Jan-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 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), ASTHENIA (low, low energy), SOMNOLENCE (almost went to sleep; felt very sleepy), EUPHORIC MOOD (felt high) and FATIGUE (very tired). At the time of the report, PAIN IN EXTREMITY (arm was sore), ASTHENIA (low, low energy), SOMNOLENCE (almost went to sleep; felt very sleepy), EUPHORIC MOOD (felt high) and FATIGUE (very tired) outcome was unknown. Concomitant medication included thyroid medication. No treatment information was provided. This case was linked to MOD-2021-027173 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Additional information was received on 21-May-2021. Contact details updated (email updated).

Other Meds:

Current Illness: Thyroid disorder

ID: 1594785
Sex: F
Age: 69
State: MS

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 08/21/2021
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: Blood pressure was 203; Pulse was 113; ear ringing; A spontaneous report was received from a Healthcare Professional concerning a 69-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events blood pressure was 203, her pulse was 113, ear ringing. The patient's medical history was not provided. No relevant concomitant medications were reported. On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 4 Feb 2021, the patient experienced the events blood pressure was 203. her pulse was 113, ear ringing. Treatment details included She doubled the dose of lisinopril 5mg Action taken with mRNA-1273 in response to the events was not reported. On an unknown date the outcome of events, blood pressure was 203, On an unknown date the outcome of events, her pulse was 113, On an unknown date the outcome of events, ear ringing was not reported.

Other Meds:

Current Illness:

ID: 1594786
Sex: F
Age: 76
State: WA

Vax Date: 01/26/2021
Onset Date: 02/04/2021
Rec V Date: 08/21/2021
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: Itchiness at the injection site; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The patient's past medical history included Lupus syndrome (Lupus for almost 40 years.) since an unknown date. Concurrent medical conditions included Dermatomyositis (atypical dermatomyositis). Concomitant products included LISINOPRIL, MULTIVITAMINS [VITAMINS NOS], FOLIC ACID, VITAMIN D NOS, CYANOCOBALAMIN (VIT B12), VITAMIN C [ASCORBIC ACID], CALCIUM and ATORVASTATIN for an unknown indication. On 26-Jan-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 PRURITUS (Itchiness at the injection site) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE RASH (Rash at the 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. As treatment the patient used some scentless cream on skin. Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: No consent for further follow up.

Other Meds: LISINOPRIL; MULTIVITAMINS [VITAMINS NOS]; FOLIC ACID; VITAMIN D NOS; VIT B12; VITAMIN C [ASCORBIC ACID]; CALCIUM; ATORVASTATIN

Current Illness: Dermatomyositis (atypical dermatomyositis); Lupus syndrome (Lupus for almost 40 years.)

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm