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: 1566557
Sex: F
Age: 51
State: PA

Vax Date: 03/06/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: COVID-arm; redness grew bigger; looks blotchy; bump on her arm; itchy; This spontaneous case was reported by a consumer and describes the occurrence of MASS EXCISION (bump on her arm), PRURITUS (itchy), HYPERSENSITIVITY (COVID-arm), ERYTHEMA (redness grew bigger) and RASH MACULAR (looks blotchy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MASS EXCISION (bump on her arm) and PRURITUS (itchy). On 14-Mar-2021, the patient experienced HYPERSENSITIVITY (COVID-arm), ERYTHEMA (redness grew bigger) and RASH MACULAR (looks blotchy). At the time of the report, MASS EXCISION (bump on her arm), PRURITUS (itchy), HYPERSENSITIVITY (COVID-arm), ERYTHEMA (redness grew bigger) and RASH MACULAR (looks blotchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Birth control pills were included as concomitant medications

Other Meds:

Current Illness:

ID: 1566558
Sex: U
Age:
State: VA

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: a little vaccine dripped on the patient's arm while it was being administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (a little vaccine dripped on the patient's arm while it was being administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (a little vaccine dripped on the patient's arm while it was being administered). At the time of the report, UNDERDOSE (a little vaccine dripped on the patient's arm while it was being administered) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1566559
Sex: U
Age: 37
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: lump in arm; tooth ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump in arm), TOOTHACHE (tooth ache) and HEADACHE (headache) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE MASS (lump in arm), TOOTHACHE (tooth ache) and HEADACHE (headache). On 17-Feb-2021, VACCINATION SITE MASS (lump in arm), TOOTHACHE (tooth ache) and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Reporter stated that Patient was planning to see a dentist.

Other Meds:

Current Illness:

ID: 1566560
Sex: F
Age:
State: FL

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Diagnosed with Covid-19; Dizziness; Weakness; No appetite; Fever; Chills; Tiredness/Fatigue; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid-19), DIZZINESS (Dizziness), ASTHENIA (Weakness), DECREASED APPETITE (No appetite) and PYREXIA (Fever) 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 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), DECREASED APPETITE (No appetite), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headaches). On 22-Feb-2021, the patient experienced COVID-19 (Diagnosed with Covid-19). The patient was treated with AZITHROMYCIN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Diagnosed with Covid-19), DIZZINESS (Dizziness), ASTHENIA (Weakness), DECREASED APPETITE (No appetite), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headaches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. The patient reported that she diagnosed with Covid-19 on 22-feb-2021 with positive test. She went to an urgent care on 27-feb-2021 where she was received azithromycin, and symptoms resolved in 3-4 days. She stated that she got covid-19 from her son who was visiting to them, and not from the vaccine. She is scheduled to get second dose on 19-mar-2021. She was asking if she should get the second dose of the vaccination or wait.

Other Meds:

Current Illness:

ID: 1566561
Sex: F
Age:
State: AZ

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

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

Lab Data:

Allergies:

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

Symptoms: redness at the injection site; rash at the injection site; site was swollen like a big ball; itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE RASH (rash at the injection site), INJECTION SITE SWELLING (site was swollen like a big ball) and PRURITUS (itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE RASH (rash at the injection site), INJECTION SITE SWELLING (site was swollen like a big ball) and PRURITUS (itchy). At the time of the report, INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE RASH (rash at the injection site), INJECTION SITE SWELLING (site was swollen like a big ball) and PRURITUS (itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1566562
Sex: F
Age: 69
State: OH

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

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

Lab Data:

Allergies:

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

Symptoms: Arm started tingling; Arm became numb; Soreness in arm; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Arm started tingling), HYPOAESTHESIA (Arm became numb), PAIN IN EXTREMITY (Soreness in arm) and VACCINATION SITE RASH (Rash at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis and Cardiac disorder NOS. Concomitant products included IBUPROFEN for Arthritis. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PARAESTHESIA (Arm started tingling), HYPOAESTHESIA (Arm became numb), PAIN IN EXTREMITY (Soreness in arm) and VACCINATION SITE RASH (Rash at injection site). At the time of the report, PARAESTHESIA (Arm started tingling), HYPOAESTHESIA (Arm became numb), PAIN IN EXTREMITY (Soreness in arm) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported that she took ibuprofen which she was already taking for arthritis. This case was linked to MOD-2021-044537 (Patient Link).

Other Meds: IBUPROFEN

Current Illness: Arthritis; Cardiac disorder NOS

ID: 1566563
Sex: F
Age: 77
State: IN

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Hurt alot; Sore arm; Red lump with a 2 inch diameter; it was tender, sore and itchy; it was tender, sore and itchy; Red lump with a 2 inch diameter; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurt alot), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Red lump with a 2 inch diameter), VACCINATION SITE PRURITUS (it was tender, sore and itchy) and VACCINATION SITE PAIN (it was tender, sore and itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included LEVOTHYROXINE, ATENOLOL and METFORMIN for an unknown indication. On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN (Hurt alot), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Red lump with a 2 inch diameter), VACCINATION SITE PRURITUS (it was tender, sore and itchy), VACCINATION SITE PAIN (it was tender, sore and itchy) and VACCINATION SITE ERYTHEMA (Red lump with a 2 inch diameter). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 23-Feb-2021, PAIN (Hurt alot), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (it was tender, sore and itchy) and VACCINATION SITE PAIN (it was tender, sore and itchy) had resolved. At the time of the report, VACCINATION SITE MASS (Red lump with a 2 inch diameter) and VACCINATION SITE ERYTHEMA (Red lump with a 2 inch diameter) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: LEVOTHYROXINE; ATENOLOL; METFORMIN

Current Illness:

ID: 1566564
Sex: M
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: had mild symptoms, not that severe effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had mild symptoms, not that severe effects) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 VACCINATION COMPLICATION (had mild symptoms, not that severe effects). At the time of the report, VACCINATION COMPLICATION (had mild symptoms, not that severe effects) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information received captured reporter details.

Other Meds:

Current Illness:

ID: 1566565
Sex: F
Age: 59
State: AZ

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Very weak; Trouble breathing; Fever; Very nauseous; Shaky; Kind of dizzy; Bad headache; Muscle ache/ full on body ache; Fatigue (couldn't do anything but sit on the couch)/ very tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), TREMOR (Shaky), ASTHENIA (Very weak), DIZZINESS (Kind of dizzy) and HEADACHE (Bad headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced TREMOR (Shaky), HEADACHE (Bad headache), MYALGIA (Muscle ache/ full on body ache) and FATIGUE (Fatigue (couldn't do anything but sit on the couch)/ very tired). 09-Mar-2021, the patient experienced DIZZINESS (Kind of dizzy). On 14-Mar-2021, the patient experienced DYSPNOEA (Trouble breathing), ASTHENIA (Very weak), PYREXIA (Fever) and NAUSEA (Very nauseous). At the time of the report, DYSPNOEA (Trouble breathing), TREMOR (Shaky), ASTHENIA (Very weak), DIZZINESS (Kind of dizzy), HEADACHE (Bad headache), MYALGIA (Muscle ache/ full on body ache), FATIGUE (Fatigue (couldn't do anything but sit on the couch)/ very tired), PYREXIA (Fever) and NAUSEA (Very nauseous) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. On 09-Mar-2021, the patient had muscle aches and on 14-Mar-2021, the patient felt full on body ache. She did not take any medication for her symptoms. All symptoms were still present at the time of reporting. No other treatment information was provided.

Other Meds:

Current Illness:

ID: 1566566
Sex: F
Age: 65
State: TN

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No Medical History was provided by the reporter. Concomitant products included POTASSIUM, SIMVASTATIN and LOSARTAN for an unknown indication. On 11-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 LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) for Swollen lymph nodes, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reportedly, the patient's HCP suggested that she should get the second shot in the opposite arm. The patient was also treated with heat pad.

Other Meds: POTASSIUM; SIMVASTATIN; LOSARTAN

Current Illness:

ID: 1566567
Sex: F
Age: 74
State: NY

Vax Date: 02/14/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Brain fog; Memory problems; Concentration; Hard to speak; Severe headaches; Muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Brain fog), MEMORY IMPAIRMENT (Memory problems), DISTURBANCE IN ATTENTION (Concentration), DYSARTHRIA (Hard to speak) and HEADACHE (Severe headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031I20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (in left eye). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), GABAPENTIN, LOSARTAN, ACETYLSALICYLIC ACID (BAYER ASPIRIN) and PREDNISOLONE for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog), MEMORY IMPAIRMENT (Memory problems), DISTURBANCE IN ATTENTION (Concentration), DYSARTHRIA (Hard to speak), HEADACHE (Severe headaches) and MYALGIA (Muscle pain). At the time of the report, FEELING ABNORMAL (Brain fog), MEMORY IMPAIRMENT (Memory problems), DISTURBANCE IN ATTENTION (Concentration), DYSARTHRIA (Hard to speak), HEADACHE (Severe headaches) and MYALGIA (Muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient stated that she seen a doctor and did some exercising for brain. The patient stated that she had surgery in left eye and believed that the medicine does not work well with the vaccine.

Other Meds: LEXAPRO; GABAPENTIN; LOSARTAN; BAYER ASPIRIN; PREDNISOLONE

Current Illness:

ID: 1566568
Sex: U
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: 3 patients received the 2nd dose of the vaccine before 28 days; A spontaneous report was received from a nurse concerning three patients (age and gender unspecified) who received second dose of Moderna's COVID-19 vaccine (mRNA-1273), before the recommended window of 28 days, after 1st dose. The patients' medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patients received their first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route of administration and unknown arm, for prophylaxis of COVID-19 infection. On an unspecified date, one patient received the second dose 14 days after the 1st dose and 2 patients received the second dose 20 days after the 1st dose (inappropriate schedule of vaccine administered). No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the event was not applicable. The outcome of the event of 3 patients received the 2nd dose of the vaccine before 28 days was considered as resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1566569
Sex: F
Age: 81
State: MI

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

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

Lab Data:

Allergies:

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

Symptoms: Severe itching knee to neck / itching in clear area with no rash; Big rashes, some are red and some are brown; Leg weakness; Doesn't feel strong / not gain energy at all; can't sleep; rash has a burning feeling; breathing affected a little bit; discomfort around area of her heart; concerned about something going on inside her body; Chills; Heavy nose bleeds/ left nostril nose bleed (multiple episodes) / right nostril nose bleed (multiple episodes); Spongiotic Dermatitis Eosinophilia; Spongiotic Dermatitis Eosinophilia; Itchy rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Spongiotic Dermatitis Eosinophilia), EOSINOPHILIA (Spongiotic Dermatitis Eosinophilia), RASH PRURITIC (Itchy rash all over the body), PRURITUS (Severe itching knee to neck / itching in clear area with no rash) and RASH ERYTHEMATOUS (Big rashes, some are red and some are brown) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), ROSUVASTATIN and CETIRIZINE HCL for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ECZEMA (Spongiotic Dermatitis Eosinophilia), EOSINOPHILIA (Spongiotic Dermatitis Eosinophilia) and RASH PRURITIC (Itchy rash all over the body). In March 2021, the patient experienced EPISTAXIS (Heavy nose bleeds/ left nostril nose bleed (multiple episodes) / right nostril nose bleed (multiple episodes)). On an unknown date, the patient experienced PRURITUS (Severe itching knee to neck / itching in clear area with no rash), RASH ERYTHEMATOUS (Big rashes, some are red and some are brown), MUSCULAR WEAKNESS (Leg weakness), ASTHENIA (Doesn't feel strong / not gain energy at all), INSOMNIA (can't sleep), BURNING SENSATION (rash has a burning feeling), DYSPNOEA (breathing affected a little bit), CARDIAC DISCOMFORT (discomfort around area of her heart), FEELING ABNORMAL (concerned about something going on inside her body) and CHILLS (Chills). The patient was treated with TRIAMCINOLONE ACETONIDE for Rash, at a dose of 1 dosage form. On 08-Jul-2021, EPISTAXIS (Heavy nose bleeds/ left nostril nose bleed (multiple episodes) / right nostril nose bleed (multiple episodes)) had resolved. At the time of the report, ECZEMA (Spongiotic Dermatitis Eosinophilia), EOSINOPHILIA (Spongiotic Dermatitis Eosinophilia), RASH PRURITIC (Itchy rash all over the body), PRURITUS (Severe itching knee to neck / itching in clear area with no rash), RASH ERYTHEMATOUS (Big rashes, some are red and some are brown), MUSCULAR WEAKNESS (Leg weakness) and ASTHENIA (Doesn't feel strong / not gain energy at all) had not resolved and INSOMNIA (can't sleep), BURNING SENSATION (rash has a burning feeling), DYSPNOEA (breathing affected a little bit), CARDIAC DISCOMFORT (discomfort around area of her heart), FEELING ABNORMAL (concerned about something going on inside her body) and CHILLS (Chills) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: spongiotic dermatitis eosinophilia (Inconclusive) revealed in biopsy. 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. She also mentioned that her HCP (who got information from CDC) had told her not to get the second dose of vaccination. Later the patient reported that she had leg weakness and did not feel strong. She had not gained energy at all. The patient had severe itching from knee to neck and the rash was still there described as big rashes, some were red and some were brown. There was Itching in clear area with no rash. Sometime in Mar-2021, the patient had nosebleeds (she never had before).On 16-Apr-2021, 20-Apr-2021, 23-Apr-2021, 28-Apr-2021, and 01-May-2021 she had right nostril nose bleeds. On 15-May-2021, 17-May-2021, 20-May-2021, 24-May-2021 she had heavy bleeding from left nostril. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional information appended on 24-MAY-2021:included vaccine batch #, concomitant products, and additional events. On 14-Jul-2021: Follow-up document appended on24-MAY-2021:Significant follow up appended to AER

Other Meds: CRESTOR; BABY ASPIRIN; ROSUVASTATIN; CETIRIZINE HCL

Current Illness:

ID: 1566570
Sex: M
Age:
State: AZ

Vax Date: 03/12/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Feeling cool / felt like 2-3 days after a cold; Very tired; Very minor chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cool / felt like 2-3 days after a cold), FATIGUE (Very tired) and CHILLS (Very minor chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FEELING COLD (Feeling cool / felt like 2-3 days after a cold), FATIGUE (Very tired) and CHILLS (Very minor chills). At the time of the report, FEELING COLD (Feeling cool / felt like 2-3 days after a cold), FATIGUE (Very tired) and CHILLS (Very minor chills) outcome was unknown. Treatment information was not provided. Action taken with mRNA-1273 in response to the event/s was not applicable

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1566571
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: lymph nodes changed( non specified); redness of injection side; swelling of injection side; 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 LYMPHADENOPATHY (lymph nodes changed( non specified)), INJECTION SITE ERYTHEMA (redness of injection side) and INJECTION SITE SWELLING (swelling of injection side) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes changed( non specified)), INJECTION SITE ERYTHEMA (redness of injection side) and INJECTION SITE SWELLING (swelling of injection side). At the time of the report, LYMPHADENOPATHY (lymph nodes changed( non specified)), INJECTION SITE ERYTHEMA (redness of injection side) and INJECTION SITE SWELLING (swelling of injection side) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1566572
Sex: M
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: Bruising on the arm/ bruise spread to under arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising on the arm/ bruise spread to under arm) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CONTUSION (Bruising on the arm/ bruise spread to under arm). At the time of the report, CONTUSION (Bruising on the arm/ bruise spread to under arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. Reportedly, the patient had bruising on the arm since 10-Mar-2021 and on 14-Mar-2021 it started spreading to his under arm. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1566573
Sex: F
Age: 87
State: FL

Vax Date: 02/27/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Off and on they've been a little tired; started itching, It was quite intense, it itched in their fingers, arms, the one that they had the shot was itching more than the other/ Chest was itching; woke up in the middle of the night scratching her right arm, couldn't stop scratching; It's a bit red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (started itching, It was quite intense, it itched in their fingers, arms, the one that they had the shot was itching more than the other/ Chest was itching), SLEEP DISORDER (woke up in the middle of the night scratching her right arm, couldn't stop scratching), VACCINATION SITE ERYTHEMA (It's a bit red) and FATIGUE (Off and on they've been a little tired) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PRURITUS (started itching, It was quite intense, it itched in their fingers, arms, the one that they had the shot was itching more than the other/ Chest was itching), SLEEP DISORDER (woke up in the middle of the night scratching her right arm, couldn't stop scratching) and VACCINATION SITE ERYTHEMA (It's a bit red). On an unknown date, the patient experienced FATIGUE (Off and on they've been a little tired). The patient was treated with ISOPROPANOL (RUBBING ALCOHOL) (topical) for Adverse event, at an unspecified dose and frequency. On 11-Mar-2021, PRURITUS (started itching, It was quite intense, it itched in their fingers, arms, the one that they had the shot was itching more than the other/ Chest was itching) and VACCINATION SITE ERYTHEMA (It's a bit red) had resolved. At the time of the report, SLEEP DISORDER (woke up in the middle of the night scratching her right arm, couldn't stop scratching) and FATIGUE (Off and on they've been a little tired) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient was not taking any concomitant medications. This case was linked to MOD-2021-246741 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up information included reporter contact information, treatment information, and new events added. The patient received 2nd vaccine on 28APR2021.

Other Meds:

Current Illness:

ID: 1566574
Sex: F
Age: 57
State: CT

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002821A) for COVID-19 vaccination. No Medical History information was reported. On 13-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts). At the time of the report, PAIN IN EXTREMITY (Arm hurts) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1566575
Sex: F
Age: 72
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ERYTHEMA (Bright red face) and FEELING HOT (Hot face/hot ears). On 09-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid-19 arm). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and HYDROCORTISONE at a dose of 1 dosage form. On 12-Mar-2021, VACCINATION SITE REACTION (Covid-19 arm) had resolved. At the time of the report, ERYTHEMA (Bright red face) outcome was unknown and FEELING HOT (Hot face/hot ears) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: SYNTHROID; LOSARTAN

Current Illness:

ID: 1566576
Sex: F
Age: 23
State: WI

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

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

Lab Data:

Allergies:

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

Symptoms: Headache; Nausea; Threw up some stomach bile; A little soreness in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little soreness in my arm), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Threw up some stomach bile) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (A little soreness in my arm). On 15-Mar-2021, the patient experienced HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Threw up some stomach bile). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) on 15-Mar-2021 at a dose of UNK dosage form and PARACETAMOL (TYLENOL RAPID RELEASE GELS) at a dose of UNK dosage form. In March 2021, PAIN IN EXTREMITY (A little soreness in my arm) had resolved, NAUSEA (Nausea) was resolving, VOMITING (Threw up some stomach bile) had resolved. At the time of the report, HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1566577
Sex: U
Age:
State: NJ

Vax Date: 03/01/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Lyme disease. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced BACK PAIN (Lower back pain). At the time of the report, BACK PAIN (Lower back pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 09-Mar-2021, the patient reported of having lower back pain. Reportedly, the patient had a prior history of Lymes disease. No Concomitant product use was reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1566578
Sex: F
Age: 64
State: NJ

Vax Date: 03/01/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: couldn't walk on that leg; head ache; flared up in the knee joint on the same leg as the arm that was inoculated; big red heated patch and itchy bumps under the skin; big red heated patch and itchy bumps under the skin; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (couldn't walk on that leg), ERYTHEMA (big red heated patch and itchy bumps under the skin), PRURITUS (big red heated patch and itchy bumps under the skin), HEADACHE (head ache) and ARTHRALGIA (flared up in the knee joint on the same leg as the arm that was inoculated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (big red heated patch and itchy bumps under the skin) and PRURITUS (big red heated patch and itchy bumps under the skin). On an unknown date, the patient experienced GAIT DISTURBANCE (couldn't walk on that leg), HEADACHE (head ache) and ARTHRALGIA (flared up in the knee joint on the same leg as the arm that was inoculated). The patient was treated with NAPROXEN SODIUM (ALEVE) for Knee pain, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (couldn't walk on that leg), ERYTHEMA (big red heated patch and itchy bumps under the skin), PRURITUS (big red heated patch and itchy bumps under the skin), HEADACHE (head ache) and ARTHRALGIA (flared up in the knee joint on the same leg as the arm that was inoculated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Histamine level: high (High) Histamine level high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information not provided.

Other Meds:

Current Illness:

ID: 1566579
Sex: M
Age:
State: NJ

Vax Date: 01/17/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Water retention and swelling in legs below knee; Water retention and swelling in legs below knee; Lower Limb Edema; This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (Water retention and swelling in legs below knee), PERIPHERAL SWELLING (Water retention and swelling in legs below knee) and OEDEMA PERIPHERAL (Lower Limb Edema) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-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 FLUID RETENTION (Water retention and swelling in legs below knee), PERIPHERAL SWELLING (Water retention and swelling in legs below knee) and OEDEMA PERIPHERAL (Lower Limb Edema). At the time of the report, FLUID RETENTION (Water retention and swelling in legs below knee), PERIPHERAL SWELLING (Water retention and swelling in legs below knee) and OEDEMA PERIPHERAL (Lower Limb Edema) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Relevant concomitant medications included, medications for hypertension were reported. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Patient's contact details updated, newevent added.

Other Meds:

Current Illness: Hypertension

ID: 1566580
Sex: F
Age: 60
State: KY

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Numbness of tongue; Numbness of fingers and toes; Sweaty palms; Tingling of fingers and toes; Severe rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (Numbness of tongue), HYPOAESTHESIA (Numbness of fingers and toes), HYPERHIDROSIS (Sweaty palms), PARAESTHESIA (Tingling of fingers and toes) and RASH (Severe rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. Concomitant products included ESOMEPRAZOLE for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness of tongue), HYPOAESTHESIA (Numbness of fingers and toes), HYPERHIDROSIS (Sweaty palms), PARAESTHESIA (Tingling of fingers and toes) and RASH (Severe rash). At the time of the report, HYPOAESTHESIA ORAL (Numbness of tongue), HYPOAESTHESIA (Numbness of fingers and toes), HYPERHIDROSIS (Sweaty palms), PARAESTHESIA (Tingling of fingers and toes) and RASH (Severe rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Heart rate: increased (High) Increased. 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. Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up received on 26-MAY-2021 and contact information was updated.

Other Meds: ESOMEPRAZOLE

Current Illness:

ID: 1566581
Sex: F
Age: 49
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Rush of a metallic taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Rush of a metallic taste in mouth) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DYSGEUSIA (Rush of a metallic taste in mouth). At the time of the report, DYSGEUSIA (Rush of a metallic taste in mouth) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment medications were provided. The patient only had an egg and spinach that morning.

Other Meds:

Current Illness:

ID: 1566582
Sex: M
Age: 68
State: OH

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

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

Lab Data:

Allergies:

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

Symptoms: Swollen tongue; Swollen lip; Blotchy red; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip) and RASH MACULAR (Blotchy red) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip) and RASH MACULAR (Blotchy red). At the time of the report, SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip) and RASH MACULAR (Blotchy red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1566583
Sex: F
Age: 60
State: CA

Vax Date: 02/12/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No medical history was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 at a dose of UNK dosage form. At the time of the report, HEADACHE (Headache) had not resolved. Reportedly, the patient was taking concomitant medication (not specified). The patient took paracetamol, but it was not helpful.

Other Meds:

Current Illness:

ID: 1566584
Sex: M
Age: 66
State:

Vax Date: 02/19/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Chest pain; Pain (side pain, in their arm); Nausea; Headaches; This spontaneous case was reported by a physician and describes the occurrence of CHEST PAIN (Chest pain), PAIN (Pain (side pain, in their arm)), NAUSEA (Nausea) and HEADACHE (Headaches) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Myeloma (Patient has cancer (myeloma) for the last 5 years. Patient go to chemotherapy once a month.) since 2016 and Hypertension. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (Headaches). On an unknown date, the patient experienced CHEST PAIN (Chest pain), PAIN (Pain (side pain, in their arm)) and NAUSEA (Nausea). At the time of the report, CHEST PAIN (Chest pain), PAIN (Pain (side pain, in their arm)), NAUSEA (Nausea) and HEADACHE (Headaches) 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. Concomitant therapy included blood pressure medicine and chemotherapy. Patient experienced headaches that seems to go and come back so patient does not know if it's side effect of the vaccine or the chemotherapy. Patient never had headache like that. Treatment information was not provided.

Other Meds:

Current Illness: Hypertension; Myeloma (Patient has cancer (myeloma) for the last 5 years. Patient go to chemotherapy once a month.)

ID: 1566585
Sex: M
Age: 65
State: VT

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

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

Lab Data:

Allergies:

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

Symptoms: Right arm started hurting too; Fast heartbeat; Pain went up into left ear; Eye began to hurt; Sore throat; Upset stomach; Shaking; Sweating; Dizziness; I couldn't function too good; Could not lift left arm; Pain across shoulders up into neck; I got a wicked headache; Feel like I have a temperature; Still feel a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm started hurting too), HEART RATE INCREASED (Fast heartbeat), EAR PAIN (Pain went up into left ear), EYE PAIN (Eye began to hurt) and OROPHARYNGEAL PAIN (Sore throat) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. G4EA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Open heart surgery (patient had heart surgery 5 years ago) in 2016. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm started hurting too), HEART RATE INCREASED (Fast heartbeat), EAR PAIN (Pain went up into left ear), EYE PAIN (Eye began to hurt), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), MALAISE (I couldn't function too good), PAIN IN EXTREMITY (Could not lift left arm), ARTHRALGIA (Pain across shoulders up into neck), HEADACHE (I got a wicked headache), PYREXIA (Feel like I have a temperature) and FATIGUE (Still feel a little tired). On 14-Mar-2021, PAIN IN EXTREMITY (Right arm started hurting too), HEART RATE INCREASED (Fast heartbeat), EAR PAIN (Pain went up into left ear), EYE PAIN (Eye began to hurt), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), MALAISE (I couldn't function too good), PAIN IN EXTREMITY (Could not lift left arm), ARTHRALGIA (Pain across shoulders up into neck), HEADACHE (I got a wicked headache) and PYREXIA (Feel like I have a temperature) had resolved. At the time of the report, FATIGUE (Still feel a little tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment and concomitant medicines were not included Action taken with mRNA-1273 in response to the event was unknown

Other Meds:

Current Illness:

ID: 1566586
Sex: F
Age: 28
State: CO

Vax Date: 01/19/2021
Onset Date: 02/16/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Lowgrade fever; Chills; Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia), PYREXIA (Lowgrade fever) and CHILLS (Chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy. Concomitant products included LEVONORGESTREL (KYLEENA) for Birth control, VITAMIN C [ASCORBIC ACID] for Immune disorder (NOS), CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Seasonal allergy, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D deficiency. 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 16-Feb-2021 at 8:30 AM, the patient experienced TACHYCARDIA (Tachycardia). On an unknown date, the patient experienced PYREXIA (Lowgrade fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 18-Feb-2021, TACHYCARDIA (Tachycardia) had resolved. At the time of the report, PYREXIA (Lowgrade fever) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Heart rate: 140 (High) heart rate remained high for about 15 hours.. Treatment included fluids. Action taken with mRNA-1273 in response to the events was not Applicable This case was linked to MOD-2021-044470 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 7-Jun-2021, reporter details, patient demographics, patient date of birth, concomitant medications, event (tachycardia) start date, stop date were added. Outcome for the event tachycardia was updated to recovered from unknown.

Other Meds: CLARITIN [CLARITHROMYCIN]; VITAMIN D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID]; KYLEENA

Current Illness: Seasonal allergy

ID: 1566587
Sex: M
Age: 71
State: MA

Vax Date: 03/11/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Spike in sugars; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Spike in sugars) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced HYPERGLYCAEMIA (Spike in sugars). At the time of the report, HYPERGLYCAEMIA (Spike in sugars) had not resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Blood glucose: high (High) Sugar level spiked. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient ate greens as treatment.

Other Meds:

Current Illness:

ID: 1566588
Sex: F
Age: 73
State: IL

Vax Date: 02/12/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Vaccination site discoloration; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and PRURITUS (Itchiness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included ATORVASTATIN CALCIUM and IRBESARTAN for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and PRURITUS (Itchiness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and PRURITUS (Itchiness) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient had itchiness and stated it was pink only 3 inches.

Other Meds: ATORVASTATIN CALCIUM; IRBESARTAN

Current Illness:

ID: 1566589
Sex: F
Age:
State: CA

Vax Date: 03/14/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fall on an already injured knee; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall on an already injured knee) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Knee injury. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FALL (Fall on an already injured knee). At the time of the report, FALL (Fall on an already injured knee) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1566590
Sex: F
Age: 57
State: LA

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: I feel dizzy; Fever of 101?F for 4 days; My arm is swollen at injection site; My arm is red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I feel dizzy), PYREXIA (Fever of 101?F for 4 days), VACCINATION SITE SWELLING (My arm is swollen at injection site) and VACCINATION SITE ERYTHEMA (My arm is red at injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in October 2020. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (I feel dizzy), PYREXIA (Fever of 101?F for 4 days), VACCINATION SITE SWELLING (My arm is swollen at injection site) and VACCINATION SITE ERYTHEMA (My arm is red at injection site). On 16-Mar-2021, PYREXIA (Fever of 101?F for 4 days) had resolved. At the time of the report, DIZZINESS (I feel dizzy), VACCINATION SITE SWELLING (My arm is swollen at injection site) and VACCINATION SITE ERYTHEMA (My arm is red at injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 101?f (Inconclusive) 101?F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment details included paracetamol and ice.

Other Meds:

Current Illness:

ID: 1566591
Sex: F
Age: 46
State: GA

Vax Date: 03/12/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: swelling quadrupole in size; arm SORENESS; arm started to swell, warm and red.; arm redness; warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm SORENESS), PERIPHERAL SWELLING (arm started to swell, warm and red.), ERYTHEMA (arm redness), VACCINATION SITE WARMTH (warm) and PERIPHERAL SWELLING (swelling quadrupole in size) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder (Autoimmune Disease - Undifferentiated Connective Tissue Disease.), Constipation, Heartburn and Allergy (indoor and outdoor allergies). Concomitant products included LINACLOTIDE (LINZESS) for Constipation, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Heartburn, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) for Joint pain, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Multiple allergies, VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for Supplementation therapy. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm SORENESS), PERIPHERAL SWELLING (arm started to swell, warm and red.), ERYTHEMA (arm redness) and VACCINATION SITE WARMTH (warm). On 14-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling quadrupole in size). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm SORENESS), PERIPHERAL SWELLING (arm started to swell, warm and red.), ERYTHEMA (arm redness), VACCINATION SITE WARMTH (warm) and PERIPHERAL SWELLING (swelling quadrupole in size) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No medical history was reported

Other Meds: LINZESS; PLAQUENIL S; ALLEGRA; VITAMIN D NOS; MULTIVITAMIN [VITAMINS NOS]; PROTONIX [OMEPRAZOLE]

Current Illness: Allergy (indoor and outdoor allergies); Autoimmune disorder (Autoimmune Disease - Undifferentiated Connective Tissue Disease.); Constipation; Heartburn

ID: 1566592
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Metallic taste in the mouth; Tongue went numb; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (Metallic taste in the mouth), HYPOAESTHESIA ORAL (Tongue went numb) and PAIN IN EXTREMITY (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040-21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste in the mouth), HYPOAESTHESIA ORAL (Tongue went numb) and PAIN IN EXTREMITY (Sore arm). At the time of the report, DYSGEUSIA (Metallic taste in the mouth) outcome was unknown and HYPOAESTHESIA ORAL (Tongue went numb) and PAIN IN EXTREMITY (Sore arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Patient provided email address and wanted to have details of her second shot when she received it, for documentation purposes. On 22-May-2021: The patient stated that she had not experienced nausea

Other Meds:

Current Illness:

ID: 1566593
Sex: M
Age: 75
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: Belly pain; Restless arm syndrome; Fatigue; Fever /Chills; Diarrhea, 5-6 times per day; Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea, 5-6 times per day), PAIN IN EXTREMITY (Little sore arm), ABDOMINAL PAIN (Belly pain), RESTLESS ARM SYNDROME (Restless arm syndrome) and PYREXIA (Fever /Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included High cholesterol (High cholesterol) in 2000. Concomitant products included TAMSULOSIN for Benign prostatic hyperplasia, PRAVASTATIN, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), TRAMADOL, VITAMIN C [ASCORBIC ACID], VITAMINS NOS (MULTIPLE VITAMIN) and GLUCOSAMINE HCL for an unknown indication. On 04-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (Diarrhea, 5-6 times per day), PAIN IN EXTREMITY (Little sore arm) and PYREXIA (Fever /Chills). On an unknown date, the patient experienced ABDOMINAL PAIN (Belly pain), RESTLESS ARM SYNDROME (Restless arm syndrome) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) ongoing from 14-Mar-2021 for Diarrhea, at an unspecified dose and frequency. On 07-Feb-2021, PYREXIA (Fever /Chills) had resolved. On 12-Feb-2021, PAIN IN EXTREMITY (Little sore arm) had resolved. On 15-May-2021, DIARRHOEA (Diarrhea, 5-6 times per day) had resolved with sequelae. At the time of the report, ABDOMINAL PAIN (Belly pain) outcome was unknown, RESTLESS ARM SYNDROME (Restless arm syndrome) had not resolved and FATIGUE (Fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. There were not changes in patient diet or everyday activities Patient had no history of COVID-19 This case was linked to MOD-2021-044568 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on07MAY2021, updated reporter details, patient demographics, past medical history, additional concomitant medications Vitamin C, Multiple vitamins, Tamsulosin and additional event Fever. On 14-Jul-2021: Significant follow-up received on 14-jul-2021, updated concomitant drug details and outcome of events

Other Meds: PRAVASTATIN; FLOMAX [MORNIFLUMATE]; TRAMADOL; TAMSULOSIN; VITAMIN C [ASCORBIC ACID]; MULTIPLE VITAMIN; GLUCOSAMINE HCL

Current Illness:

ID: 1566594
Sex: F
Age:
State: CA

Vax Date: 03/03/2021
Onset Date: 03/14/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Joint pain; Low grade fever; Rash at injection site; Sore at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (Joint pain), PYREXIA (Low grade fever), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PAIN (Sore at injection site) 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 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced ARTHRALGIA (Joint pain), PYREXIA (Low grade fever), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PAIN (Sore at injection site). At the time of the report, ARTHRALGIA (Joint pain), PYREXIA (Low grade fever), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PAIN (Sore at injection site) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant and treatment medications were reported.

Other Meds:

Current Illness:

ID: 1566595
Sex: F
Age: 54
State: OH

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dizziness/ light headed; Brain fog; Temperature of 99; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/ light headed), FEELING ABNORMAL (Brain fog) and PYREXIA (Temperature of 99) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure fluctuation. Concomitant products included PANTOPRAZOLE and HYDROXYCHLOROQUINE for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (Dizziness/ light headed), FEELING ABNORMAL (Brain fog) and PYREXIA (Temperature of 99). At the time of the report, DIZZINESS (Dizziness/ light headed), FEELING ABNORMAL (Brain fog) and PYREXIA (Temperature of 99) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 99 (Inconclusive) 99. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-046395 (Patient Link).

Other Meds: PANTOPRAZOLE; HYDROXYCHLOROQUINE

Current Illness: Blood pressure fluctuation

ID: 1566596
Sex: F
Age:
State: IA

Vax Date: 01/14/2021
Onset Date: 01/16/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) 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 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1566597
Sex: M
Age: 72
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Cyst-like red rashes on the chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Cyst-like red rashes on the chest) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history provided). On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced RASH ERYTHEMATOUS (Cyst-like red rashes on the chest). At the time of the report, RASH ERYTHEMATOUS (Cyst-like red rashes on the chest) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-058216, MOD-2021-058216 (Patient Link).

Other Meds:

Current Illness:

ID: 1566598
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: Bumps and lumps are spread all over the body; Patient started with bumps and lumps that started itching; When she goes out in Sun, they get aggravated; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient started with bumps and lumps that started itching), PRURITUS (When she goes out in Sun, they get aggravated) and SWELLING (Bumps and lumps are spread all over the body) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Sulfa allergy). Concomitant products included CALCIUM and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Mar-2021, the patient experienced PRURITUS (Patient started with bumps and lumps that started itching) and PRURITUS (When she goes out in Sun, they get aggravated). On 15-Mar-2021, the patient experienced SWELLING (Bumps and lumps are spread all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Patient started with bumps and lumps that started itching), PRURITUS (When she goes out in Sun, they get aggravated) and SWELLING (Bumps and lumps are spread all over the body) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication also included acidophillus. Treatment medication also included steroid cream.

Other Meds: CALCIUM; VITAMIN C [ASCORBIC ACID]

Current Illness: Drug allergy (Sulfa allergy)

ID: 1566599
Sex: M
Age: 66
State: TN

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: dull ache in the arm spread down the arm below the elbow to the inside; Very warm; Very hot; Rash continues to grow every day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Very hot), FEELING HOT (Very warm), PAIN IN EXTREMITY (dull ache in the arm spread down the arm below the elbow to the inside) and RASH (Rash continues to grow every day) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No medical history was provided by the reporter. . Concomitant products included METFORMIN, LISINOPRIL and FLUTICASONE for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING HOT (Very hot) and RASH (Rash continues to grow every day). On 27-Feb-2021, the patient experienced FEELING HOT (Very warm). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (dull ache in the arm spread down the arm below the elbow to the inside). The patient was treated with LORATADINE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 27-Feb-2021, FEELING HOT (Very hot) had resolved. On 02-Mar-2021, FEELING HOT (Very warm) had resolved. On 14-Mar-2021, PAIN IN EXTREMITY (dull ache in the arm spread down the arm below the elbow to the inside) outcome was unknown. At the time of the report, RASH (Rash continues to grow every day) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: METFORMIN; LISINOPRIL; FLUTICASONE

Current Illness:

ID: 1566600
Sex: F
Age: 69
State: OH

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

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

Lab Data:

Allergies:

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

Symptoms: Flu-like symptoms; Started feeling bad; Lower back pain; Achy all over; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING ABNORMAL (Started feeling bad), BACK PAIN (Lower back pain), MYALGIA (Achy all over) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis and Cardiac disorder NOS. Concomitant products included IBUPROFEN for Arthritis. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING ABNORMAL (Started feeling bad), BACK PAIN (Lower back pain), MYALGIA (Achy all over), HEADACHE (Headache) and CHILLS (Chills). On 11-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING ABNORMAL (Started feeling bad), BACK PAIN (Lower back pain), MYALGIA (Achy all over), HEADACHE (Headache) and CHILLS (Chills) had resolved. Reportedly, the symptoms started in the afternoon on the day of vaccination. The patient took ibuprofen which she was taking for arthritis. This case was linked to MOD-2021-044492 (Patient Link).

Other Meds: IBUPROFEN

Current Illness: Cardiac disorder NOS

ID: 1566601
Sex: F
Age:
State: CA

Vax Date: 03/14/2021
Onset Date: 03/14/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Headache; Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN (Achy). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, PAIN (Achy) and HEADACHE (Headache) outcome was unknown. Concomitant and treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1566602
Sex: F
Age: 79
State: NY

Vax Date: 02/15/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Hot to Touch - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of UNK dosage form. On 26-Feb-2021, VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 05 May 2021 included reporter information.

Other Meds:

Current Illness:

ID: 1566603
Sex: M
Age: 67
State: MI

Vax Date: 02/23/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Cold sore on lip; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sore on lip) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. Concomitant products included METFORMIN, LISINOPRIL, CARVEDILOL, ALLOPURINOL, FINASTERIDE and LOVASTATIN for an unknown indication. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ORAL HERPES (Cold sore on lip). The patient was treated with BENZOCAINE, WHITE SOFT PARAFFIN (CARMEX COLD SORE) at an unspecified dose and frequency and BENZOCAINE, WHITE SOFT PARAFFIN (CARMEX COLD SORE) for Cold sores lip, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Cold sore on lip) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: METFORMIN; LISINOPRIL; CARVEDILOL; ALLOPURINOL; FINASTERIDE; LOVASTATIN

Current Illness:

ID: 1566604
Sex: F
Age: 51
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Swollen arm; red and raised rash about 3 inches around the injection; Extreme nausea; Shaky; Itchy; red and raised rash about 3 inches around the injection; Migraines; Swollen arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines), TREMOR (Shaky), VACCINATION SITE PRURITUS (Itchy), the first episode of PERIPHERAL SWELLING (Swollen arm) and the second episode of PERIPHERAL SWELLING (Swollen arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hepatitis autoimmune since an unknown date. Concomitant products included OMEPRAZOLE, PROMETHAZINE and METHADONE for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MIGRAINE (Migraines), the first episode of PERIPHERAL SWELLING (Swollen arm) and NAUSEA (Nausea). On 14-Mar-2021, the patient experienced TREMOR (Shaky), VACCINATION SITE PRURITUS (Itchy), the second episode of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE RASH (red and raised rash about 3 inches around the injection), NAUSEA (Extreme nausea) and VACCINATION SITE ERYTHEMA (red and raised rash about 3 inches around the injection). The patient was treated with HYDROCORTISONE (topical) at a dose of 2 %. On 04-Mar-2021, MIGRAINE (Migraines) and NAUSEA (Nausea) had resolved. At the time of the report, TREMOR (Shaky), VACCINATION SITE PRURITUS (Itchy), the last episode of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE RASH (red and raised rash about 3 inches around the injection), NAUSEA (Extreme nausea) and VACCINATION SITE ERYTHEMA (red and raised rash about 3 inches around the injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: OMEPRAZOLE; PROMETHAZINE; METHADONE

Current Illness: Hepatitis autoimmune

ID: 1566605
Sex: M
Age: 78
State: IN

Vax Date: 02/16/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient took the first dose was on Feb 16th 2 weeks prior to second dose; Wobbly; Shaking; Nervousness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the first dose was on Feb 16th 2 weeks prior to second dose), BALANCE DISORDER (Wobbly), TREMOR (Shaking), NERVOUSNESS (Nervousness) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 013A21A) 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) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the first dose was on Feb 16th 2 weeks prior to second dose). 02-Mar-2021, the patient experienced BALANCE DISORDER (Wobbly), TREMOR (Shaking), NERVOUSNESS (Nervousness) and CHILLS (Chills). On 02-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the first dose was on Feb 16th 2 weeks prior to second dose) had resolved. At the time of the report, BALANCE DISORDER (Wobbly), TREMOR (Shaking), NERVOUSNESS (Nervousness) and CHILLS (Chills) outcome 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. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up information received and does not contains any new information. This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Mar-2021. The most recent information was received on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the first dose was on Feb 16th 2 weeks prior to second dose), BALANCE DISORDER (Wobbly), TREMOR (Shaking), NERVOUSNESS (Nervousness) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 013A21A) 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) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the first dose was on Feb 16th 2 weeks prior to second dose). 02-Mar-2021, the patient experienced BALANCE DISORDER (Wobbly), TREMOR (Shaking), NERVOUSNESS (Nervousness) and CHILLS (Chills). On 02-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the first dose was on Feb 16th 2 weeks prior to second dose) had resolved. At the time of the report, BALANCE DISORDER (Wobbly), TREMOR (Shaking), NERVOUSNESS (Nervousness) and CHILLS (Chills) outcome 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. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up information received and does not contains any new information.

Other Meds:

Current Illness:

ID: 1566606
Sex: M
Age: 76
State: FL

Vax Date: 01/25/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Received his 2nd dose 44-46 days after his 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his 2nd dose 44-46 days after his 1st dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 039K20A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included LAMOTRIGINE and ESCITALOPRAM OXALATE for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his 2nd dose 44-46 days after his 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his 2nd dose 44-46 days after his 1st dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information not provided. Concomitant medications were not provided.

Other Meds: LAMOTRIGINE; ESCITALOPRAM OXALATE

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm