VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1548350
Sex: F
Age: 78
State: GA

Vax Date: 02/13/2021
Onset Date:
Rec V Date: 08/12/2021
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: uncontrolled blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE ABNORMAL (uncontrolled blood pressure) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included METOPROLOL, HYDRALAZINE and LOSARTAN for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (uncontrolled blood pressure). At the time of the report, BLOOD PRESSURE ABNORMAL (uncontrolled blood pressure) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment details were provided.

Other Meds: METOPROLOL; HYDRALAZINE; LOSARTAN

Current Illness:

ID: 1548351
Sex: F
Age: 60
State: MO

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/12/2021
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: Itchy; Hard; Very painful; Redness/big red; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Redness/big red), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PAIN (Very painful) and VACCINATION SITE INDURATION (Hard) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concomitant products included LITHIUM, CITALOPRAM and FREMANEZUMAB (AJOVY [FREMANEZUMAB]) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness/big red) and VACCINATION SITE SWELLING (Swelling). On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Very painful). On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE INDURATION (Hard). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Redness/big red), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PAIN (Very painful) and VACCINATION SITE INDURATION (Hard) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included unspecified lotion.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.

Other Meds: LITHIUM; CITALOPRAM; AJOVY [FREMANEZUMAB.]

Current Illness:

ID: 1548352
Sex: F
Age: 54
State: KY

Vax Date: 01/30/2021
Onset Date:
Rec V Date: 08/12/2021
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: was told that it was infected; Started itching below the injection site; lymph node under her arm that is sore and swollen; arm was red and swollen below the injection site; arm was red and swollen below the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INFECTION (was told that it was infected), VACCINATION SITE PRURITUS (Started itching below the injection site), VACCINATION SITE LYMPHADENOPATHY (lymph node under her arm that is sore and swollen), VACCINATION SITE SWELLING (arm was red and swollen below the injection site) and VACCINATION SITE ERYTHEMA (arm was red and swollen below the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Prozac allergy) and Drug allergy (Wellburtin allergy). Concomitant products included LORATADINE for Allergy, LISINOPRIL for Blood pressure high, ESTRADIOL and MEDROXYPROGESTERONE for Hormone therapy, CLONAZEPAM for Nerve pain. On 30-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 VACCINATION SITE INFECTION (was told that it was infected), VACCINATION SITE PRURITUS (Started itching below the injection site), VACCINATION SITE LYMPHADENOPATHY (lymph node under her arm that is sore and swollen), VACCINATION SITE SWELLING (arm was red and swollen below the injection site) and VACCINATION SITE ERYTHEMA (arm was red and swollen below the injection site). At the time of the report, VACCINATION SITE INFECTION (was told that it was infected), VACCINATION SITE PRURITUS (Started itching below the injection site), VACCINATION SITE LYMPHADENOPATHY (lymph node under her arm that is sore and swollen), VACCINATION SITE SWELLING (arm was red and swollen below the injection site) and VACCINATION SITE ERYTHEMA (arm was red and swollen below the injection site) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was prescribed Cephalexin 500mg, Atarax 10mg , Diflucan (Fluconazole)150mg, but she has not taken any of these yet. This case was linked to MOD-2021-017024 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up document was received. Patient's demography, relevant medical history and concomitant medications were updated. It contains significant information.

Other Meds: LISINOPRIL; ESTRADIOL; MEDROXYPROGESTERONE; CLONAZEPAM; LORATADINE

Current Illness: Drug allergy (Wellburtin allergy); Drug allergy (Prozac allergy)

ID: 1548353
Sex: F
Age: 72
State: KS

Vax Date: 02/03/2021
Onset Date: 02/14/2021
Rec V Date: 08/12/2021
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: This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021. The most recent information was received on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache/intense localized headache), ERYTHEMA (scalp redness/redness), HERPES ZOSTER (Shingles), BLOOD PRESSURE INCREASED (elevated blood pressure) and RASH (rash breakout on forhead and eyelide (unable to open)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Osteoporosis (no medical history) on 11-Jul-2014 and Cholesterol since 02-Jan-2014. Concomitant products included VITAMIN B COMPLEX from 20-Jun-2011 to an unknown date for Vitamin B complex deficiency NOS, ALENDRONATE SODIUM from 11-Jul-2014 to an unknown date, ATORVASTATIN from 18-Dec-2019 to an unknown date, CALCIUM, MAGNESIUM, ZINC (CALCIUM MAGNESIUM ZINC [CALCIUM;MAGNESIUM;ZINC]) from 20-Jun-2011 to an unknown date and VITAMIN B NOS from 20-Jun-2011 to an unknown date for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 14-Feb-2021, the patient experienced HERPES ZOSTER (Shingles), RASH (rash breakout on forhead and eyelide (unable to open)), SWELLING OF EYELID (unable to opne eye due to swollan watery eyelid) and VISION BLURRED (vision was densly blurry). On 04-Mar-2021, the patient experienced PHOTOPHOBIA (light senstivity/tearing frequently) and LACRIMATION INCREASED (light senstivity/tearing frequently). On an unknown date, the patient experienced HEADACHE (headache/intense localiged headache), ERYTHEMA (scalp redness/redness), BLOOD PRESSURE INCREASED (elevated blood pressure), PARAESTHESIA (prickling/tingling), PRURITUS (rash still evident and sever itching continues on forhead, eyebro and scalp) and EYE PRURITUS (red/itchy eyes). On 09-Mar-2021, HERPES ZOSTER (Shingles) had resolved. At the time of the report, HEADACHE (headache/intense localiged headache), ERYTHEMA (scalp redness/redness), BLOOD PRESSURE INCREASED (elevated blood pressure), RASH (rash breakout on forhead and eyelide (unable to open)), PARAESTHESIA (prickling/tingling), SWELLING OF EYELID (unable to opne eye due to swollan watery eyelid), PRURITUS (rash still evident and sever itching continues on forhead, eyebro and scalp), EYE PRURITUS (red/itchy eyes), VISION BLURRED (vision was densly blurry), PHOTOPHOBIA (light senstivity/tearing frequently) and LACRIMATION INCREASED (light senstivity/tearing frequently) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Computerised tomogram: negative Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment details were provided. This case was linked to MOD-2021-032861 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Non-significant; On 29-Jun-2021: Significant follow-up information received.

Other Meds: ALENDRONATE SODIUM; ATORVASTATIN; CALCIUM MAGNESIUM ZINC [CALCIUM;MAGNESIUM;ZINC]; VITAMIN B COMPLEX; VITAMIN B NOS

Current Illness:

ID: 1548354
Sex: M
Age:
State: MD

Vax Date: 02/12/2021
Onset Date: 02/01/2021
Rec V Date: 08/12/2021
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: Right arm became swollen; Red rash; Itchy in the area where he got injected; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Right arm became swollen), VACCINATION SITE RASH (Red rash) and VACCINATION SITE PRURITUS (Itchy in the area where he got injected) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE SWELLING (Right arm became swollen), VACCINATION SITE RASH (Red rash) and VACCINATION SITE PRURITUS (Itchy in the area where he got injected). At the time of the report, VACCINATION SITE SWELLING (Right arm became swollen), VACCINATION SITE RASH (Red rash) and VACCINATION SITE PRURITUS (Itchy in the area where he got injected) outcome was unknown.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.

Other Meds:

Current Illness:

ID: 1548355
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/12/2021
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: Sometimes sweats; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sometimes sweats) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sometimes sweats) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sometimes sweats) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.

Other Meds:

Current Illness:

ID: 1548356
Sex: F
Age:
State:

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 08/12/2021
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: Bloody nose bleed; Elevated BP; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Bloody nose bleed) and HYPERTENSION (Elevated BP) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced EPISTAXIS (Bloody nose bleed) and HYPERTENSION (Elevated BP). At the time of the report, EPISTAXIS (Bloody nose bleed) and HYPERTENSION (Elevated BP) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1548357
Sex: F
Age: 65
State: CA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/12/2021
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: super numb and tingling everywhere; muscles in her face were kind of frozen; sore arm at the injection site; feel strange throughout body; right side of body felt tingly, numb, and paralyzed; swollen neck glands under jaw and right side of neck; Blood pressure elevated; Right side of her neck hurt; Arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site), FEELING ABNORMAL (feel strange throughout body), HYPOAESTHESIA (right side of body felt tingly, numb, and paralyzed), LYMPHADENOPATHY (swollen neck glands under jaw and right side of neck) and BLOOD PRESSURE INCREASED (Blood pressure elevated) in a 65-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. The patient's past medical history included Hypothyroidism (The patient has a past medical history of Hypothyroidism.) and Rubella (The patient has a medical history of Rubella several times.). Concurrent medical conditions included Blood pressure increased (The patient reported elevated blood pressure after vaccination.), Allergy to plants (Tree), Allergy to nuts (Brazil nut) and Fruit allergy (Cantaloupe). Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site), FEELING ABNORMAL (feel strange throughout body), HYPOAESTHESIA (right side of body felt tingly, numb, and paralyzed), LYMPHADENOPATHY (swollen neck glands under jaw and right side of neck), BLOOD PRESSURE INCREASED (Blood pressure elevated), NECK PAIN (Right side of her neck hurt) and PAIN IN EXTREMITY (Arm pain). On an unknown date, the patient experienced PARAESTHESIA (super numb and tingling everywhere) and MUSCLE DISORDER (muscles in her face were kind of frozen). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Pain, at an unspecified dose and frequency. On 23-Jan-2021, VACCINATION SITE PAIN (sore arm at the injection site), FEELING ABNORMAL (feel strange throughout body), HYPOAESTHESIA (right side of body felt tingly, numb, and paralyzed), BLOOD PRESSURE INCREASED (Blood pressure elevated), NECK PAIN (Right side of her neck hurt) and PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, LYMPHADENOPATHY (swollen neck glands under jaw and right side of neck) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Blood pressure measurement: elevated abnormal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD21-13282, MOD-2021-138693 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Recovery date of lymphadenopathy updated.

Other Meds: ARMOUR THYROID

Current Illness: Allergy to nuts (Brazil nut); Allergy to plants (Tree); Fruit allergy (Cantaloupe)

ID: 1548358
Sex: M
Age: 74
State: WA

Vax Date: 02/04/2021
Onset Date: 02/09/2021
Rec V Date: 08/12/2021
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: Came down with a cold; On-going cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Came down with a cold) and COUGH (On-going cough) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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 09-Feb-2021, the patient experienced NASOPHARYNGITIS (Came down with a cold) and COUGH (On-going cough). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Came down with a cold) and COUGH (On-going cough) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications reported were blood pressure medicine. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1548359
Sex: F
Age: 53
State: MI

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/12/2021
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: Body ache; headache; Dizziness; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Body ache), HEADACHE (headache) and DIZZINESS (Dizziness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced MYALGIA (Body ache), HEADACHE (headache) and DIZZINESS (Dizziness). At the time of the report, MYALGIA (Body ache), HEADACHE (headache) and DIZZINESS (Dizziness) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant and treatment information was not provided Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up information received on 28may2021 contains updated contact details (email id)

Other Meds:

Current Illness:

ID: 1548360
Sex: F
Age: 59
State: OH

Vax Date: 01/05/2021
Onset Date: 02/02/2021
Rec V Date: 08/12/2021
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: Tingly feeling on face, hands; White patches on entire both hands,nose; Woke up through night; Chills; Left hand cramping; Left arm hurt; Sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Left hand cramping), PAIN IN EXTREMITY (Left arm hurt), HYPERHIDROSIS (Sweats), PARAESTHESIA (Tingly feeling on face, hands) and SKIN DISCOLOURATION (White patches on entire both hands,nose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 030C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (since then she has mucus in her throat.) in May 2020. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Thick nasal mucus. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced MUSCLE SPASMS (Left hand cramping), PAIN IN EXTREMITY (Left arm hurt) and HYPERHIDROSIS (Sweats). 02-Feb-2021, the patient experienced MIDDLE INSOMNIA (Woke up through night) and CHILLS (Chills). On 03-Feb-2021, the patient experienced PARAESTHESIA (Tingly feeling on face, hands) and SKIN DISCOLOURATION (White patches on entire both hands,nose). The patient was treated with FLURBIPROFEN (ANSAID) at an unspecified dose and frequency and LORATADINE at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Left hand cramping), PAIN IN EXTREMITY (Left arm hurt), HYPERHIDROSIS (Sweats), PARAESTHESIA (Tingly feeling on face, hands), SKIN DISCOLOURATION (White patches on entire both hands,nose), MIDDLE INSOMNIA (Woke up through night) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, COVID-19: positive (Inconclusive) positive. No information regarding corrective treatment was reported by the patient. Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received and reporter information was updated, patient demographics, Dose 1 added.

Other Meds: SINGULAIR.

Current Illness:

ID: 1548361
Sex: F
Age:
State: CO

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/12/2021
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: Pain; Redness; Tenderness; Redness widespread from from site of injection to her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), ERYTHEMA (Redness), TENDERNESS (Tenderness) and CONDITION AGGRAVATED (Redness widespread from from site of injection to her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), ERYTHEMA (Redness), TENDERNESS (Tenderness) and CONDITION AGGRAVATED (Redness widespread from from site of injection to her arm). At the time of the report, PAIN (Pain), ERYTHEMA (Redness), TENDERNESS (Tenderness) and CONDITION AGGRAVATED (Redness widespread from from site of injection to her arm) 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.

Other Meds:

Current Illness:

ID: 1548362
Sex: F
Age:
State: NY

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 08/12/2021
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: Little sore arm at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore arm at the injection site.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Breast cancer. On 11-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 VACCINATION SITE PAIN (Little sore arm at the injection site.). At the time of the report, VACCINATION SITE PAIN (Little sore arm at the injection site.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded. The reported event is consistent with the known safety profile of the vaccine.

Other Meds:

Current Illness: Breast cancer

ID: 1548363
Sex: F
Age:
State: WI

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/12/2021
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: she feels foggy; diarrhea; sore arm; dizziness; weakness; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she feels foggy), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced FEELING ABNORMAL (she feels foggy), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness), HEADACHE (headache), NAUSEA (nausea) and DIZZINESS (dizziness). At the time of the report, FEELING ABNORMAL (she feels foggy), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness), HEADACHE (headache), NAUSEA (nausea) and DIZZINESS (dizziness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1548364
Sex: U
Age:
State: AL

Vax Date: 02/04/2021
Onset Date: 02/12/2021
Rec V Date: 08/12/2021
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: In bed all day; Didnt have an appetite; few chills; Fatigue; Moderate headache enough to bother me; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (In bed all day), DECREASED APPETITE (Didnt have an appetite), HEADACHE (Moderate headache enough to bother me), CHILLS (few chills) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (Moderate headache enough to bother me). On 13-Feb-2021, the patient experienced BEDRIDDEN (In bed all day), DECREASED APPETITE (Didnt have an appetite), CHILLS (few chills) and FATIGUE (Fatigue). At the time of the report, BEDRIDDEN (In bed all day), DECREASED APPETITE (Didnt have an appetite), HEADACHE (Moderate headache enough to bother me), CHILLS (few chills) and FATIGUE (Fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 100.2 (High) fever-100.2. On 18-Feb-2021, Body temperature: 98 (High) fever-98. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. concomitant medications were not reported Treatment was not specified

Other Meds:

Current Illness:

ID: 1548365
Sex: M
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 08/12/2021
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: mild pain; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild pain) and VACCINATION SITE SWELLING (swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild pain) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE PAIN (mild pain) and VACCINATION SITE SWELLING (swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1548366
Sex: M
Age: 72
State: IL

Vax Date: 01/06/2021
Onset Date: 02/01/2021
Rec V Date: 08/12/2021
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: shingles; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), FATIGUE (fatigue) and HERPES ZOSTER (shingles) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concurrent medical conditions included Cholesterol, Diabetes, Enlarged prostate and Hypertension. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN for Diabetes, TAMSULOSIN for Enlarged prostate, VALSARTAN for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN) and OMEPRAZOLE for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Feb-2021, the patient experienced HERPES ZOSTER (shingles). In February 2021, the patient experienced MYALGIA (body aches) and FATIGUE (fatigue). At the time of the report, MYALGIA (body aches), FATIGUE (fatigue) and HERPES ZOSTER (shingles) outcome was unknown. No treatment details were provided.

Other Meds: ATORVASTATIN; METFORMIN; TAMSULOSIN; VALSARTAN; BABY ASPIRIN; OMEPRAZOLE

Current Illness: Cholesterol; Diabetes; Enlarged prostate

ID: 1548367
Sex: F
Age: 69
State: FL

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/12/2021
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: hot; tchy; red spot, size 2 coins; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (tchy) and VACCINATION SITE ERYTHEMA (red spot, size 2 coins) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U31620A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Dose 2. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (tchy) and VACCINATION SITE ERYTHEMA (red spot, size 2 coins). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (tchy) and VACCINATION SITE ERYTHEMA (red spot, size 2 coins) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment includes Benadryl. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1548368
Sex: F
Age: 69
State: NC

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/12/2021
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: Hot Sensation in Core of Body; Tingling Sensation in Feet; Rash Under Eyes; Blisters on opposite Side of the same Shoulder the Vaccine was Administered in; Hives on Chin/Hives on Both arms; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot Sensation in Core of Body), PARAESTHESIA (Tingling Sensation in Feet), RASH (Rash Under Eyes), BLISTER (Blisters on opposite Side of the same Shoulder the Vaccine was Administered in) and URTICARIA (Hives on Chin/Hives on Both arms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no reported medical history). On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FEELING HOT (Hot Sensation in Core of Body), PARAESTHESIA (Tingling Sensation in Feet), RASH (Rash Under Eyes), BLISTER (Blisters on opposite Side of the same Shoulder the Vaccine was Administered in) and URTICARIA (Hives on Chin/Hives on Both arms). On 17-Feb-2021, FEELING HOT (Hot Sensation in Core of Body), PARAESTHESIA (Tingling Sensation in Feet), RASH (Rash Under Eyes), BLISTER (Blisters on opposite Side of the same Shoulder the Vaccine was Administered in) and URTICARIA (Hives on Chin/Hives on Both arms) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1548369
Sex: F
Age:
State: CO

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/12/2021
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: Pain to the touch of her arm, armpit all the way to her collar bone area; Injection site pain; Redness widespread from site of injection to her arm, arm pit and collar bone; Injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain to the touch of her arm, armpit all the way to her collar bone area), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Redness widespread from site of injection to her arm, arm pit and collar bone) and INJECTION SITE PAIN (Injection site tenderness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain to the touch of her arm, armpit all the way to her collar bone area), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Redness widespread from site of injection to her arm, arm pit and collar bone) and INJECTION SITE PAIN (Injection site tenderness). At the time of the report, PAIN (Pain to the touch of her arm, armpit all the way to her collar bone area), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Redness widespread from site of injection to her arm, arm pit and collar bone) and INJECTION SITE PAIN (Injection site tenderness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to MOD-2021-017087 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1548370
Sex: F
Age: 54
State: TX

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/12/2021
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: arm hurt a little bit - left arm; heart rate was 192; blood pressure down to 92-99/70; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (heart rate was 192), BLOOD PRESSURE DECREASED (blood pressure down to 92-99/70) and PAIN IN EXTREMITY (arm hurt a little bit - left arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), ROSUVASTATIN and LOSARTAN. On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 10-Feb-2021, the patient experienced TACHYCARDIA (heart rate was 192) and BLOOD PRESSURE DECREASED (blood pressure down to 92-99/70). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt a little bit - left arm). On 11-Feb-2021, TACHYCARDIA (heart rate was 192) and BLOOD PRESSURE DECREASED (blood pressure down to 92-99/70) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (arm hurt a little bit - left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. No treatment details were provided.

Other Meds: XYZAL; ROSUVASTATIN; LOSARTAN

Current Illness:

ID: 1548371
Sex: M
Age: 75
State: IN

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 08/12/2021
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: Muscle pain; Chills; 101 degree fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (101 degree fever) and VOMITING (Vomiting) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. 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 18-Feb-2021, the patient experienced MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (101 degree fever) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Muscle pain, Chills, Vomiting and Fever, at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (101 degree fever) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 101 (High) 101 degree fever. Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events was not Applicable.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event, and the known safety profile of mRNA-1273 , a causal relationship with the event cannot be excluded.

Other Meds:

Current Illness:

ID: 1548372
Sex: F
Age: 71
State: TX

Vax Date: 02/09/2021
Onset Date: 02/11/2021
Rec V Date: 08/12/2021
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: red rash on injection site arm; red rash on injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red rash on injection site arm) and VACCINATION SITE RASH (red rash on injection site arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red rash on injection site arm) and VACCINATION SITE RASH (red rash on injection site arm). The patient was treated with CORTISONE for Rash, at a dose of UNK UNK, qd. At the time of the report, VACCINATION SITE ERYTHEMA (red rash on injection site arm) and VACCINATION SITE RASH (red rash on injection site arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported.

Other Meds:

Current Illness:

ID: 1548373
Sex: M
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: PAIN IN SHOULDER; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (PAIN IN SHOULDER) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The patient's past medical history included Lung cancer (The patient is scheduled PET scan 13 days later of 1st dose vaccine. The doctors found another spot of his lung.). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (PAIN IN SHOULDER). At the time of the report, ARTHRALGIA (PAIN IN SHOULDER) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. His second dose of the Moderna vaccine was scheduled for 25-Feb-2021,13 days later he was scheduled for a was due for petscan. He had no reaction to the second dose Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Event outcome and narrative was updated.

Other Meds:

Current Illness:

ID: 1548374
Sex: F
Age: 66
State: GA

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 08/12/2021
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: little soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). Concomitant products included LORATADINE for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (little soreness). At the time of the report, PAIN IN EXTREMITY (little soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment details were provided.

Other Meds: LORATADINE

Current Illness:

ID: 1548375
Sex: F
Age:
State: NV

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/12/2021
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: Injection site is warm to touch; Big red patch in the area surrounding the injection site; Knot at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE MASS (Knot at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Big red patch in the area surrounding the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE MASS (Knot at injection site) and VACCINATION SITE PAIN (Soreness at injection site). On 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is warm to touch) and VACCINATION SITE ERYTHEMA (Big red patch in the area surrounding the injection site). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE MASS (Knot at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Big red patch in the area surrounding the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included massaging.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1548376
Sex: F
Age: 76
State: CA

Vax Date: 01/26/2021
Onset Date: 02/04/2021
Rec V Date: 08/12/2021
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: Hot to the touch; Itchy rash; Red rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Hot to the touch), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced SKIN WARM (Hot to the touch), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SKIN WARM (Hot to the touch), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. List of concomitant medication were not given. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-JUN-2021 contains No New information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1548377
Sex: F
Age: 82
State: OH

Vax Date: 02/03/2021
Onset Date: 02/19/2021
Rec V Date: 08/12/2021
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: Swelling at the injection site from arm down to elbow; Redness at the injection site from arm down to elbow; A spontaneous report was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling at the injection site from arm down to elbow/vaccination site swelling and redness at the injection site from arm down to elbow/vaccination site erythema. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Feb 2021, approximately two weeks prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 19 Feb 2021, the patient experienced swelling and redness at the injection site from arm down to elbow. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, swelling at the injection site from arm down to elbow and redness at the injection site from arm down to elbow was unknown.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and the known safety profile of mRNA-1273, a causal relationship with the event cannot be excluded.

Other Meds:

Current Illness:

ID: 1548378
Sex: F
Age: 60
State: KY

Vax Date: 02/13/2021
Onset Date: 02/16/2021
Rec V Date: 08/12/2021
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: Migraine like feeling; Nausea; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine like feeling), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (Headache). On 17-Feb-2021, the patient experienced FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced MIGRAINE (Migraine like feeling) and NAUSEA (Nausea). At the time of the report, MIGRAINE (Migraine like feeling), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1548379
Sex: M
Age:
State: SC

Vax Date: 02/13/2021
Onset Date: 02/19/2021
Rec V Date: 08/12/2021
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: Tested positive for COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history.). On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown. Unknown DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test positive: COVID-19 Positive.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1548380
Sex: F
Age:
State: OH

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 08/12/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no reported medical history). On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment details were provided. This case was linked to MOD-2021-016959 (Patient Link).

Other Meds:

Current Illness:

ID: 1548381
Sex: M
Age: 70
State: TX

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 08/12/2021
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: Had redness; Itches a little at injection; 4x2 oblong oval adjacent to the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Had redness), VACCINATION SITE PRURITUS (Itches a little at injection) and VACCINATION SITE RASH (4x2 oblong oval adjacent to the site of injection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Had redness), VACCINATION SITE PRURITUS (Itches a little at injection) and VACCINATION SITE RASH (4x2 oblong oval adjacent to the site of injection). At the time of the report, ERYTHEMA (Had redness), VACCINATION SITE PRURITUS (Itches a little at injection) and VACCINATION SITE RASH (4x2 oblong oval adjacent to the site of injection) outcome was unknown. concomitant medications were not reported Treatment was not specified

Other Meds:

Current Illness:

ID: 1548382
Sex: F
Age: 72
State: GA

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 08/12/2021
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: Throat is scratchy and sore; Throat is scratchy and sore; injection site feels hot touch; Injection site reactions developing: red circle (like a red rash with a 2in diameter),; Startting to swell; Injection site is itchy; Injection site aches; Feels freezing; Chills; Eyes feel hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feels freezing), OROPHARYNGEAL PAIN (Throat is scratchy and sore), OROPHARYNGEAL DISCOMFORT (Throat is scratchy and sore), CHILLS (Chills) and FEELING HOT (Eyes feel hot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to sting (wasp sting). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE, CALCIUM, COLECALCIFEROL (CALCIUM + VITAMIN D3), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), GARLIC [ALLIUM SATIVUM] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING COLD (Feels freezing), CHILLS (Chills), FEELING HOT (Eyes feel hot) and INJECTION SITE PAIN (Injection site aches). On 25-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Throat is scratchy and sore), OROPHARYNGEAL DISCOMFORT (Throat is scratchy and sore), INJECTION SITE WARMTH (injection site feels hot touch), INJECTION SITE ERYTHEMA (Injection site reactions developing: red circle (like a red rash with a 2in diameter),), INJECTION SITE SWELLING (Startting to swell) and INJECTION SITE PRURITUS (Injection site is itchy). At the time of the report, FEELING COLD (Feels freezing), OROPHARYNGEAL PAIN (Throat is scratchy and sore), OROPHARYNGEAL DISCOMFORT (Throat is scratchy and sore), CHILLS (Chills), FEELING HOT (Eyes feel hot), INJECTION SITE WARMTH (injection site feels hot touch), INJECTION SITE ERYTHEMA (Injection site reactions developing: red circle (like a red rash with a 2in diameter),), INJECTION SITE SWELLING (Startting to swell), INJECTION SITE PRURITUS (Injection site is itchy) and INJECTION SITE PAIN (Injection site aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 101.9 (High) fever-101.9 F. Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: Treatment medications were added, events were updated, allergy was added

Other Meds: SYNTHROID; LIOTHYRONINE; CALCIUM + VITAMIN D3; VITAMIN D [COLECALCIFEROL]; GARLIC [ALLIUM SATIVUM]; BABY ASPIRIN

Current Illness: Allergy to sting (wasp sting)

ID: 1548383
Sex: F
Age: 76
State: NC

Vax Date: 01/19/2021
Onset Date: 02/17/2021
Rec V Date: 08/12/2021
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: i got sick; headache; no appetite; joint pain; temperature of 102.8 F; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (i got sick), HEADACHE (headache), DECREASED APPETITE (no appetite), ARTHRALGIA (joint pain) and BODY TEMPERATURE INCREASED (temperature of 102.8 F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced MALAISE (i got sick), HEADACHE (headache), DECREASED APPETITE (no appetite), ARTHRALGIA (joint pain) and BODY TEMPERATURE INCREASED (temperature of 102.8 F). At the time of the report, MALAISE (i got sick), HEADACHE (headache), DECREASED APPETITE (no appetite), ARTHRALGIA (joint pain) and BODY TEMPERATURE INCREASED (temperature of 102.8 F) outcome was unknown. Not Provided No concomitant medication was provided. Treatment details included acetaminophen.

Other Meds:

Current Illness:

ID: 1548384
Sex: F
Age: 79
State: FL

Vax Date: 02/10/2021
Onset Date: 02/20/2021
Rec V Date: 08/12/2021
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: Injection site redness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) in a 79-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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) in a 79-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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided.; 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

Other Meds:

Current Illness:

ID: 1548385
Sex: M
Age: 82
State: FL

Vax Date: 02/05/2021
Onset Date: 02/14/2021
Rec V Date: 08/12/2021
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: developed COVID19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (developed COVID19) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History Information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced COVID-19 (developed COVID19). At the time of the report, COVID-19 (developed COVID19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, SARS-CoV-2 test positive: positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (developed COVID19) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History Information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced COVID-19 (developed COVID19). At the time of the report, COVID-19 (developed COVID19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, SARS-CoV-2 test positive: positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1548386
Sex: M
Age: 76
State: FL

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 08/12/2021
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: Doesn't feel good; Temperature of 99.2; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Doesn't feel good), BODY TEMPERATURE INCREASED (Temperature of 99.2) and HEADACHE (Headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure and Cholesterol. On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Doesn't feel good), BODY TEMPERATURE INCREASED (Temperature of 99.2) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Doesn't feel good), BODY TEMPERATURE INCREASED (Temperature of 99.2) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 99.2 (Inconclusive) temperature of 99.2. Concomitant products used included blood pressure and cholesterol medications. No treatment medications was provided. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: TCR-follow-up received on 15-Jun-2021 contains no new information. Consumer reported everything was fine and declined further follow-up.

Other Meds:

Current Illness: Blood pressure; Cholesterol

ID: 1548387
Sex: F
Age:
State: IL

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 08/12/2021
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: Swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M207) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The reporter states that she wasn't undergone any treatment but may take naproxen if it keeps bothering her. No concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1548388
Sex: F
Age: 67
State: NY

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/12/2021
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: Swollen in the site of the shot again; Redness in the site of the shot /again; Itchiness in the site of the shot /again; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness in the site of the shot /again), INJECTION SITE PRURITUS (Itchiness in the site of the shot /again) and INJECTION SITE SWELLING (Swollen in the site of the shot again) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness in the site of the shot /again) and INJECTION SITE PRURITUS (Itchiness in the site of the shot /again). On 18-Feb-2021, the patient experienced INJECTION SITE SWELLING (Swollen in the site of the shot again). At the time of the report, INJECTION SITE ERYTHEMA (Redness in the site of the shot /again), INJECTION SITE PRURITUS (Itchiness in the site of the shot /again) and INJECTION SITE SWELLING (Swollen in the site of the shot again) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1548389
Sex: F
Age:
State: FL

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 08/12/2021
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: Experienced bad cold sweats; A spontaneous report was received from a consumer concerning herself, a female patient of an unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bad cold sweats. The patient's medical history was not provided. No relevant concomitant medications were reported. On 15 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 010m20a) via unknown route for prophylaxis of COVID-19 infection. On 15 Feb 2021 at night, the patient experienced bad cold sweats. The patient felt fine in the morning. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. The outcome of event, bad cold sweats, was considered as resolved on 16 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1548390
Sex: F
Age: 75
State: IL

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/12/2021
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: pains in neck; Pain in arm; spots on chin/side of face; Pains from neck to her head; pains in head; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pains in neck), PAIN IN EXTREMITY (Pain in arm), RASH MACULAR (spots on chin/side of face), PAIN (Pains from neck to her head) and HEADACHE (pains in head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included Thyroidectomy (Full thyroidectomy). Concurrent medical conditions included Hypertension, High cholesterol, Penicillin allergy and Nickel sensitivity. Concomitant products included OMEPRAZOLE, LEVOTHYROXINE, CLONIDINE and AMLODIPINE for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced NECK PAIN (pains in neck), PAIN IN EXTREMITY (Pain in arm), RASH MACULAR (spots on chin/side of face), PAIN (Pains from neck to her head) and HEADACHE (pains in head). On 09-Feb-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, NECK PAIN (pains in neck), RASH MACULAR (spots on chin/side of face), PAIN (Pains from neck to her head) and HEADACHE (pains in head) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Patient went to the emergency room where all tests were negative. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up document was received. It contains no new information.

Other Meds: OMEPRAZOLE; LEVOTHYROXINE; CLONIDINE; AMLODIPINE

Current Illness: High cholesterol; Hypertension; Nickel sensitivity; Penicillin allergy

ID: 1548391
Sex: F
Age:
State: NJ

Vax Date: 12/31/2020
Onset Date: 02/05/2021
Rec V Date: 08/12/2021
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: sore arm, just a little; a little tired and the arm a little bit more sore; sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), VACCINATION SITE PAIN (sore arm, just a little) and FATIGUE (a little tired and the arm a little bit more sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029L20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced SINUSITIS (sinus infection). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm, just a little) and FATIGUE (a little tired and the arm a little bit more sore). The patient was treated with DOXYCYCLINE HYDROCHLORIDE (DOXICYCLINE [DOXYCYCLINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and METRONIDAZOLE BENZOATE (METRODOL [METRONIDAZOLE BENZOATE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SINUSITIS (sinus infection), VACCINATION SITE PAIN (sore arm, just a little) and FATIGUE (a little tired and the arm a little bit more sore) outcome was unknown.

Other Meds:

Current Illness:

ID: 1548392
Sex: F
Age:
State: GA

Vax Date: 02/15/2021
Onset Date:
Rec V Date: 08/12/2021
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: Shoulder to elbow are swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Shoulder to elbow are swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Rotator cuff injury (The patient reports that she had injury at rotator cuff in 2015. and re-injured while shoveling or doing any hard work.). On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Shoulder to elbow are swollen). At the time of the report, PERIPHERAL SWELLING (Shoulder to elbow are swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness: Rotator cuff injury (The patient reports that she had injury at rotator cuff in 2015. and re-injured while shoveling or doing any hard work.)

ID: 1548393
Sex: F
Age: 59
State: FL

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 08/12/2021
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: Sore throat; Cough; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough) 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.

Other Meds:

Current Illness:

ID: 1548394
Sex: U
Age: 79
State: NJ

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 08/12/2021
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: Eyes feel a little heavy; Felt warm, his temperature was 99F; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENOPIA (Eyes feel a little heavy) and PYREXIA (Felt warm, his temperature was 99F) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced ASTHENOPIA (Eyes feel a little heavy) and PYREXIA (Felt warm, his temperature was 99F). At the time of the report, ASTHENOPIA (Eyes feel a little heavy) and PYREXIA (Felt warm, his temperature was 99F) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1548395
Sex: F
Age:
State: NJ

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 08/12/2021
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: aches; getting a little itching feeling around the injection site; red - around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), INJECTION SITE PRURITUS (getting a little itching feeling around the injection site) and INJECTION SITE ERYTHEMA (red - around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No medical history was provided by the reporter. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), INJECTION SITE PRURITUS (getting a little itching feeling around the injection site) and INJECTION SITE ERYTHEMA (red - around the injection site). At the time of the report, PAIN (aches), INJECTION SITE PRURITUS (getting a little itching feeling around the injection site) and INJECTION SITE ERYTHEMA (red - around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1548396
Sex: M
Age: 91
State: AL

Vax Date: 01/21/2021
Onset Date: 02/18/2021
Rec V Date: 08/12/2021
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: back pain; headache; A spontaneous report was received from a consumer concerning a 91 year old male patients who received Moderna's Covid 19 vaccine(mRNA1273) experienced headache and back pain. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Amlodipine, Finasteride, Aspirin, Semi Bi Statin, OraVital. The patient received their first of two planned doses of mRNA-1273Batch number:014L20A ) on 21-JAN-2021. On 18-FEB-2021 the patient received their second of two planned doses of mRNA-1273 (Batch number-unknown) intramuscularly for prophylaxis of Covid 19.Since administration of the second dose of vaccine patient had experienced back pain that has been constant as well as a headache that has not subsided. No other side effects were reported for the first vaccination. The treatment for the event include Tylenol and heating pad. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The outcome of the events, headache and backpain were considered as not recovered/not resolved.

Other Meds: AMLODIPINE; FINASTERIDE; ASPIRIN (E.C.)

Current Illness:

ID: 1548397
Sex: M
Age:
State: NY

Vax Date: 02/16/2021
Onset Date: 02/18/2021
Rec V Date: 08/12/2021
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: swelling around the injection site; Hot around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling around the injection site) and INJECTION SITE WARMTH (Hot around the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE SWELLING (swelling around the injection site) and INJECTION SITE WARMTH (Hot around the injection site). At the time of the report, INJECTION SITE SWELLING (swelling around the injection site) and INJECTION SITE WARMTH (Hot around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.

Other Meds:

Current Illness:

ID: 1548398
Sex: F
Age: 28
State: MA

Vax Date: 02/18/2021
Onset Date:
Rec V Date: 08/12/2021
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: Mild hives on arm, neck and face; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Mild hives on arm, neck and face) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 18-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 URTICARIA (Mild hives on arm, neck and face). At the time of the report, URTICARIA (Mild hives on arm, neck and face) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1548399
Sex: F
Age: 75
State: OR

Vax Date: 02/16/2021
Onset Date: 02/01/2021
Rec V Date: 08/12/2021
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: Redness on Arm; Difficulty Breathing; Vision Problems; Balance Problems; Headache; Tiredness; Low Oxygen Levels; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on Arm), DYSPNOEA (Difficulty Breathing), VISUAL IMPAIRMENT (Vision Problems), BALANCE DISORDER (Balance Problems) and HEADACHE (Headache) in a 75-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 COPD, Lung cancer (Small cell lung cancer) and Bell's palsy. Concomitant products included ACETAMINOPHEN, ALPRAZOLAM, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]), ERYTHROMYCIN, Corbideral, CLOPIDOGREL BISULFATE (PLAVIX), Gabastatin, HYDROCODONE, ALBUTEROL [SALBUTAMOL], LIOTHYRONINE SODIUM (CYTOMEL), MIRTAZAPINE (REMERON), MONTELUKAST SODIUM (SINGULAIR), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) and TRAMADOL for an unknown indication. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (Redness on Arm), DYSPNOEA (Difficulty Breathing), VISUAL IMPAIRMENT (Vision Problems), BALANCE DISORDER (Balance Problems), HEADACHE (Headache), FATIGUE (Tiredness) and OXYGEN SATURATION DECREASED (Low Oxygen Levels). The patient was treated with OXYGEN for Oxygen saturation low, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness on Arm), DYSPNOEA (Difficulty Breathing), VISUAL IMPAIRMENT (Vision Problems), BALANCE DISORDER (Balance Problems), HEADACHE (Headache), FATIGUE (Tiredness) and OXYGEN SATURATION DECREASED (Low Oxygen Levels) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ACETAMINOPHEN; ALPRAZOLAM; ASPIRIN [ACETYLSALICYLIC ACID]; AVASTIN [ATORVASTATIN CALCIUM]; ERYTHROMYCIN; Corbideral; PLAVIX; Gabastatin; HYDROCODONE; ALBUTEROL [SALBUTAMOL]; CYTOMEL; REMERON; SINGULAIR; PRILOSEC [OMEPRAZOLE MAGNESIUM]; SUDA

Current Illness: Bell's palsy; COPD; Lung cancer (Small cell lung cancer)

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm