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: 1419770
Sex: M
Age:
State:

Vax Date:
Onset Date: 06/18/2021
Rec V Date: 06/23/2021
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: DIZZY; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 18-JUN-2021, the subject experienced dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizzy was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1419771
Sex: F
Age:
State:

Vax Date:
Onset Date: 06/19/2021
Rec V Date: 06/23/2021
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: FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 19-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1419772
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 06/23/2021
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: SWOLLEN FACE; LEFT EYE WAS VERY SWOLLEN SO IT WAS DIFFICULT TO SEE OUT OF IT; ITCHY FACE; HOT FACE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced swollen face. On JUN-2021, the subject experienced left eye was very swollen so it was difficult to see out of it. On JUN-2021, the subject experienced itchy face. On JUN-2021, the subject experienced hot face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen face, hot face, left eye was very swollen so it was difficult to see out of it and itchy face was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1419773
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
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: VERTIGO; FOGGY FEELING; CONSTANT HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced vertigo, foggy feeling, and constant headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant headaches, and the outcome of vertigo and foggy feeling was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1419774
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: INJECTION SITE FELT ITCHY; ENTIRE BODY FLUSH; BODY SWEATY; FELT ROUGH; NAUSEATED; HEADACHE; HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced injection site felt itchy, entire body flush, body sweaty, felt rough, nauseated, headache, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and high fever, and the outcome of injection site felt itchy, entire body flush, nauseated, felt rough and body sweaty was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1419775
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 05/25/2021
Rec V Date: 06/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: VOMITING; BAD CHEST PAIN; NAUSEA; BAD HEADACHES; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced vomiting. On 25-MAY-2021, the subject experienced bad chest pain. On 25-MAY-2021, the subject experienced nausea. On 25-MAY-2021, the subject experienced bad headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, vomiting, bad headaches, and bad chest pain. This report was non-serious.

Other Meds:

Current Illness:

ID: 1419776
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
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: TUMOR; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tumor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tumor was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1419777
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 06/21/2021
Rec V Date: 06/23/2021
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: DOSE ADMINISTERED TO MINOR; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, and expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the subject experienced dose administered to minor. On 21-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose administered to minor and off label use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1419778
Sex: U
Age:
State: IL

Vax Date:
Onset Date: 06/21/2021
Rec V Date: 06/23/2021
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: VIAL WAS KEPT AT ROOM TEMPERATURE FOR 3 HOURS; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the subject experienced vial was kept at room temperature for 3 hours. On 21-JUN-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial was kept at room temperature for 3 hours and poor quality vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness: Allergic reaction to antibiotics

ID: 1419779
Sex: M
Age: 66
State: WA

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 06/23/2021
Hospital: Y

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: Stroke; numbness in left hand; Headache; Ataxia left arm,; Motor skill issues/steadiness, unbalance; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042C20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), ATAXIA (Ataxia left arm,), BALANCE DISORDER (Motor skill issues/steadiness, unbalance) and HEADACHE (Headache). On an unknown date, the patient experienced HYPOAESTHESIA (numbness in left hand). The patient was hospitalized from 25-Jan-2021 to 26-Jan-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) had resolved, ATAXIA (Ataxia left arm,) and HYPOAESTHESIA (numbness in left hand) had not resolved and BALANCE DISORDER (Motor skill issues/steadiness, unbalance) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that on an unspecified start date the patient is currently in OT. Treatment information not reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received by safety 10-Jun-2021 included an ADR added. Reporter address is updated. Patient height, weight, race and ethnicity is captured. Information of first and second vaccination updated. Event information was updated. new events, stroke and ataxia in left arm added and the events led the patient to visit ER.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LEVOTHYROXINE

Current Illness: Thyroid disorder

ID: 1419780
Sex: M
Age: 63
State: ID

Vax Date: 01/29/2021
Onset Date: 02/15/2021
Rec V Date: 06/23/2021
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: short of breath; Missed dose 2; heart rate dropped below 40; dizziness; "hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive); Pea Sized Nodes/nodes were tender; Sore Muscles; fatigue; fever; sore bones; patient felt like he was "hit by a bus"; This spontaneous case was reported by a consumer and describes the occurrence of BRADYCARDIA (heart rate dropped below 40) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced BONE PAIN (sore bones), MALAISE (patient felt like he was "hit by a bus"), MYALGIA (Sore Muscles), FATIGUE (fatigue) and PYREXIA (fever). On 16-Feb-2021, the patient experienced INJECTION SITE LYMPHADENOPATHY (Pea Sized Nodes/nodes were tender). On 18-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS ("hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive)). On 25-Feb-2021, the patient experienced DIZZINESS (dizziness). On 26-Feb-2021, the patient experienced BRADYCARDIA (heart rate dropped below 40) (seriousness criterion medically significant). On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose 2). On an unknown date, the patient experienced DYSPNOEA (short of breath). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and Surgery (Pacemaker) for Bradycardia. On 19-Feb-2021, INJECTION SITE LYMPHADENOPATHY (Pea Sized Nodes/nodes were tender) had resolved. On 21-Feb-2021, INFLUENZA LIKE ILLNESS ("hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive)) had resolved. At the time of the report, BRADYCARDIA (heart rate dropped below 40) was resolving and DIZZINESS (dizziness), DYSPNOEA (short of breath), BONE PAIN (sore bones), MALAISE (patient felt like he was "hit by a bus"), PRODUCT DOSE OMISSION ISSUE (Missed dose 2), MYALGIA (Sore Muscles), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative. On an unknown date, Heart rate: 40 bpm (Low) 40 BPM. It was reported that, in total the patient recorded 3 negative COVID tests. There was no history of cardiovascular disease in patient's family. The patient was advised by his doctor to not receive the second dose of the vaccine. Treatment medication include Advil. Company Comment : This case concerns a 63-year-old male patient who was advised by physician not to receive the second dose (product dose omission) due to adverse events. The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Injection site lymphadenopathy, myalgia, fatigue and fever are consistent with the product known safety profile. Product dose omission is not applicable. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Additional information received and case was upgraded to serious, Height, age, race and Ethnicity updated in patient tab, Suspect product Batch number and route of administration updated in products tab, Updated events and event outcome in events tab.; Sender's Comments: This case concerns a 63-year-old male patient who was advised by physician not to receive the second dose (product dose omission) due to adverse events. The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Injection site lymphadenopathy, myalgia, fatigue and fever are consistent with the product known safety profile. Product dose omission is not applicable.

Other Meds:

Current Illness:

ID: 1419781
Sex: M
Age: 55
State: NE

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 06/23/2021
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: Has not received 2nd dose; Arm pain; Shoulder blade catch sore muscle\ arm pain; Fatigue; Pain at injection site; Myocarditis; Shortness of breath; weakness; Chest pain; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included DULOXETINE, GLIMEPIRIDE, LISINOPRIL and METFORMIN for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), ASTHENIA (weakness), CHEST PAIN (Chest pain), NECK PAIN (Neck pain), PAIN (Arm pain), MYALGIA (Shoulder blade catch sore muscle\ arm pain), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). On 02-Apr-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, MYOCARDITIS (Myocarditis), ASTHENIA (weakness), PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose), MYALGIA (Shoulder blade catch sore muscle\ arm pain) and FATIGUE (Fatigue) outcome was unknown and DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), NECK PAIN (Neck pain) and PAIN (Arm pain) was resolving. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No treatment information was provided. Patient stated that he thinks he may have had COVID in Dec2019 or Jan2020. This case concerns a 55-year-old male patient did not receive the second dose 4-6 weeks post first dose of mRNA-1273 product dose omission, .The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Myalgia and pain are consistent with the product known safety profile. Product dose omission is not applicable. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Added new event and updated vaccine dose information.; Sender's Comments: This case concerns a 55-year-old male patient did not receive the second dose 4-6 weeks post first dose of mRNA-1273 product dose omission, .The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Myalgia and pain are consistent with the product known safety profile. Product dose omission is not applicable.

Other Meds: DULOXETINE; GLIMEPIRIDE; LISINOPRIL; METFORMIN

Current Illness:

ID: 1419782
Sex: F
Age: 56
State: NJ

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 06/23/2021
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: Paresthesia on the tips of both toes, fingertips of right hand, and entire left arm/ bilateral feet, bilateral ankles, and entire right hand; rash on my left arm around the injection site; Numbness in her deltoid at the injection site, that radiates distally; Paresthesia in her deltoid at the injection site, that radiates distally; Soreness at the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Paresthesia on the tips of both toes, fingertips of right hand, and entire left arm/ bilateral feet, bilateral ankles, and entire right hand) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046-B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Guillain-Barre syndrome in 1990. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, OXYCODONE for Nerve pain, AMLODIPINE, LEVOTHYROXINE SODIUM (LEVOXYL) and SENNA [SENNA ALEXANDRINA] for an unknown indication. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 04-May-2021 at 4:30 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE HYPOAESTHESIA (Numbness in her deltoid at the injection site, that radiates distally) and VACCINATION SITE PARAESTHESIA (Paresthesia in her deltoid at the injection site, that radiates distally). On 08-May-2021, the patient experienced PARAESTHESIA (Paresthesia on the tips of both toes, fingertips of right hand, and entire left arm/ bilateral feet, bilateral ankles, and entire right hand) (seriousness criterion medically significant) and VACCINATION SITE RASH (rash on my left arm around the injection site). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at a dose of 3 dosage form. On 30-Apr-2021, VACCINATION SITE PAIN (Soreness at the injection site) had resolved. On 22-May-2021, VACCINATION SITE RASH (rash on my left arm around the injection site) had resolved. At the time of the report, PARAESTHESIA (Paresthesia on the tips of both toes, fingertips of right hand, and entire left arm/ bilateral feet, bilateral ankles, and entire right hand) and VACCINATION SITE PARAESTHESIA (Paresthesia in her deltoid at the injection site, that radiates distally) had not resolved and VACCINATION SITE HYPOAESTHESIA (Numbness in her deltoid at the injection site, that radiates distally) 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. The patient was hospitalized on 05-May-2021 and discharged on 08-May-2021 due to unknown reason. On 08-May-2021, the patient developed paresthesia developed on the tips of both toes and fingertips of right hand and entire left arm. Then it progressed, and still to this day 11-Jun-2021, it is affecting her bilateral feet, bilateral ankles, and entire right hand. She also developed a rash on her left arm around the injection site, which started on 08-May-2021. It went away after about 2 weeks. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additionally, patient's medical history of Guillain-Barre syndrome is a confounding factor that may play a possible contributory role. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up received on 11-Jun-2021 and contains information regarding the reporter, the patient demographics, additional events (paresthesia, rash on her left arm) and the case was upgraded to serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additionally, patient's medical history of Guillain-Barre syndrome is a confounding factor that may play a possible contributory role. Further information has been requested.

Other Meds: AMLODIPINE; LEVOXYL; OXYCODONE; ALBUTEROL [SALBUTAMOL]; SENNA [SENNA ALEXANDRINA]

Current Illness:

ID: 1419783
Sex: F
Age: 14
State: NY

Vax Date: 05/25/2021
Onset Date: 05/25/2021
Rec V Date: 06/23/2021
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: Fainting episode; Dehydration; Received 1st Moderna dose at age 14; This spontaneous case was reported by a pharmacist and describes the occurrence of SYNCOPE (Fainting episode) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose at age 14). On an unknown date, the patient experienced SYNCOPE (Fainting episode) (seriousness criterion medically significant) and DEHYDRATION (Dehydration). On 25-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose at age 14) had resolved. At the time of the report, SYNCOPE (Fainting episode) and DEHYDRATION (Dehydration) 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 considered SYNCOPE (Fainting episode) to be not related. No further causality assessments were provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose at age 14) and DEHYDRATION (Dehydration). No concomitant medications were provided. No treatment medications were provided. Company Comment: This report refers to a case of product administered to patient of inappropriate age (14- year old) for mRNA-1273 (lot number 016C21A) with associated AEs reported as syncope and dehydration. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up received on 10 June 2021.Follow-up letter uploaded. New information included added events, including serious event of fainting. On 11-Jun-2021: Follow-up received on 11 June 2021.General tab information was updated (like information regarding the person completing form). In patient tab patient's height and weight was added.In product tab anatomical location was added.Events like syncope and dehydration were added in events tab.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (14- year old) for mRNA-1273 (lot number 016C21A) with associated AEs reported as syncope and dehydration.

Other Meds:

Current Illness:

ID: 1419784
Sex: F
Age: 45
State: NV

Vax Date: 03/01/2021
Onset Date: 05/08/2021
Rec V Date: 06/23/2021
Hospital: Y

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: Pneumonia; Meningitis; Sepsis; Probable lupus; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia), MENINGITIS (Meningitis), SEPSIS (Sepsis) and SYSTEMIC LUPUS ERYTHEMATOSUS (Probable lupus) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization prolonged and medically significant), MENINGITIS (Meningitis) (seriousness criteria hospitalization prolonged and medically significant), SEPSIS (Sepsis) (seriousness criteria hospitalization prolonged and medically significant) and SYSTEMIC LUPUS ERYTHEMATOSUS (Probable lupus) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized on 24-May-2021 due to MENINGITIS, PNEUMONIA, SEPSIS and SYSTEMIC LUPUS ERYTHEMATOSUS. At the time of the report, PNEUMONIA (Pneumonia), MENINGITIS (Meningitis), SEPSIS (Sepsis) and SYSTEMIC LUPUS ERYTHEMATOSUS (Probable lupus) had not resolved. Concomitant medication were not reported. No known allergies for the patient. No treatment information was provided. The reporter stated that the patient is currently admitted in a hospital on a critical condition. The patient was first hospitalized last month on 14 May 2021, and was discharged on 18 May 2021. The patient was re-admitted on 24 May 2021 under critical condition. The patient doesn't have the vaccination card and was unable to provide some important details. Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1419785
Sex: U
Age:
State:

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 06/23/2021
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: Afib came roaring back; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib came roaring back) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included Cardiac ablation in June 2020. Concurrent medical conditions included Atrial fibrillation. On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced ATRIAL FIBRILLATION (Afib came roaring back) (seriousness criterion medically significant). The patient was treated with Surgery (Cardiac ablation) for Atrial fibrillation. At the time of the report, ATRIAL FIBRILLATION (Afib came roaring back) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. Patient had to unfergo cardiac ablation again 3 Jun 2021. Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's history of atrial fibrillation may be a confounding factor. No further information is expected. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's history of atrial fibrillation may be a confounding factor. No further information is expected.

Other Meds:

Current Illness: Atrial fibrillation

ID: 1419786
Sex: F
Age:
State: FL

Vax Date: 03/26/2021
Onset Date: 04/24/2021
Rec V Date: 06/23/2021
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: Passed out; She dropped; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and FALL (She dropped). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) and FALL (She dropped) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Blood pressure measurement: low (Low) very low. Concomitant medication swere not reported. No treatment information was reported. The patient reported that the ambulance came and went to emergency room, a nd was admitted in the hospital for 3 hours. The patient had no other diseases, and was crying and asking for help about her bills, because she had no insurance and needed help.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1419787
Sex: M
Age:
State: VA

Vax Date: 04/08/2021
Onset Date: 05/05/2021
Rec V Date: 06/23/2021
Hospital: Y

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: Son fractured ankle on 5May2021 a day before he was supposed to get 2nd dose; 62 days since date of first dose 8Apr2021.; This spontaneous case was reported by a consumer and describes the occurrence of ANKLE FRACTURE (Son fractured ankle on 5May2021 a day before he was supposed to get 2nd dose) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-May-2021, the patient experienced ANKLE FRACTURE (Son fractured ankle on 5May2021 a day before he was supposed to get 2nd dose) (seriousness criterion hospitalization). On 06-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (62 days since date of first dose 8Apr2021.). The patient was treated with Surgery for Ankle fracture. On 06-May-2021, PRODUCT DOSE OMISSION ISSUE (62 days since date of first dose 8Apr2021.) had resolved. At the time of the report, ANKLE FRACTURE (Son fractured ankle on 5May2021 a day before he was supposed to get 2nd dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. Due to fractured ankle, the patient never received the second dose which was scheduled for 6May2021. The patient could not get the vaccine due to surgery for fractured ankle. This case concerns a 21-year-old male patient who did not to receive the second dose (product dose omission) due to fractured ankle. . The event of fracturesd ankle is assessed as not related to mRNA-1273 use based on biological implausibility. Product dose omission is assessed as not applicable. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Patient age was updated.; Sender's Comments: This case concerns a 21-year-old male patient who did not to receive the second dose (product dose omission) due to fractured ankle. . The event of fracturesd ankle is assessed as not related to mRNA-1273 use based on biological implausibility. Product dose omission is assessed as not applicable.

Other Meds:

Current Illness:

ID: 1419788
Sex: F
Age: 81
State: MI

Vax Date: 03/23/2021
Onset Date: 04/03/2021
Rec V Date: 06/23/2021
Hospital: Y

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: Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028921A) for COVID-19 vaccination. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced EPISTAXIS (Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off) (seriousness criterion hospitalization). The patient was hospitalized on 03-Apr-2021 due to EPISTAXIS. At the time of the report, EPISTAXIS (Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Treatment included saline, humidifier and other treatments, not specified. Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1419789
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
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: Seizure; Patient passed out; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) and LOSS OF CONSCIOUSNESS (Patient passed out) in an 18-year-old female 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, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Patient passed out) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) and LOSS OF CONSCIOUSNESS (Patient passed out) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Age at vaccination not reported. Concomitant medications not reported. Treatment information was not provided. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1419790
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
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: Had seizure immediately after getting the shot; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Had seizure immediately after getting the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Had seizure immediately after getting the shot) (seriousness criterion medically significant). At the time of the report, SEIZURE (Had seizure immediately after getting the shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. No treatment information was reported. Very limited information regarding the event has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding the event has been provided at this time. No further information is expected.

Other Meds:

Current Illness:

ID: 1419791
Sex: M
Age: 40
State: MI

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 06/23/2021
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: Passing out; pain; Difficulty breathing; Dizziness; Mental issues; Physical issues; Hypomanic; "Weird"; Weakness; pain in ankle; Gout pain; Feeling ill; Feels like he almost wants to fall asleep; Vaccination site bruising; Fatigue; headache; arm sore(left arm), muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 053621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypoxia (Low oxygen), Mental disorder and Ankle operation. Concurrent medical conditions included Gout. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising), HEADACHE (headache), MYALGIA (arm sore(left arm), muscle pain) and FATIGUE (Fatigue). On 09-Jun-2021, the patient experienced ILLNESS (Feeling ill) and SOMNOLENCE (Feels like he almost wants to fall asleep). On 13-Jun-2021, the patient experienced GOUT (Gout pain). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criterion medically significant), PAIN (pain), DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), MENTAL DISORDER (Mental issues), PHYSICAL DISABILITY (Physical issues), HYPOMANIA (Hypomanic), FEELING ABNORMAL ("Weird"), ASTHENIA (Weakness) and ARTHRALGIA (pain in ankle). The patient was treated with INDOMETHACIN [INDOMETACIN] for Gout, at an unspecified dose and frequency and IBUPROFEN for Gout, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passing out), VACCINATION SITE BRUISING (Vaccination site bruising), PAIN (pain), GOUT (Gout pain), ILLNESS (Feeling ill), DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), MENTAL DISORDER (Mental issues), PHYSICAL DISABILITY (Physical issues), HYPOMANIA (Hypomanic), SOMNOLENCE (Feels like he almost wants to fall asleep), FEELING ABNORMAL ("Weird"), ASTHENIA (Weakness), HEADACHE (headache), MYALGIA (arm sore(left arm), muscle pain), ARTHRALGIA (pain in ankle) and FATIGUE (Fatigue) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medications include unspecified mental health medications. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-215030 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Updated new events- Mental issues, physical issues, Loss of Consciousness, Gout, Arthralgia, Hypomania and feeling abnormal. Updated patient history and treatment medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Gout

ID: 1419792
Sex: M
Age: 66
State: TX

Vax Date: 01/29/2021
Onset Date: 05/01/2021
Rec V Date: 06/23/2021
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: Sore arm; Dry cough; Mind fog; Feeling weak; Tired; Low grade fever; Headache; Lung infection; Covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Lung infection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Smoker. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PNEUMONIA (Lung infection) (seriousness criterion medically significant) and COVID-19 (Covid-19 positive). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), COUGH (Dry cough), FEELING ABNORMAL (Mind fog), ASTHENIA (Feeling weak), FATIGUE (Tired), PYREXIA (Low grade fever) and HEADACHE (Headache). On 01-Jun-2021, COVID-19 (Covid-19 positive) had resolved. At the time of the report, PNEUMONIA (Lung infection), PAIN IN EXTREMITY (Sore arm), COUGH (Dry cough), FEELING ABNORMAL (Mind fog), ASTHENIA (Feeling weak), FATIGUE (Tired), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 test: positive (Positive) positive. On 01-Jun-2021, SARS-CoV-2 test: negative (Negative) negative. No concomitant medication reported. The patient experienced a sore arm and feeling weak and tired. The patient experienced low grade fever, dry cough, mind fog, and headaches for 2-3 days. The patient developed a lung infection and had to be placed on antibiotics. Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Headache fatigue and pyrexia are consistent with the product known safety profile. Based on biological implausibility, Covid-19 and pneumonia are assessed as not related to product use; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Headache fatigue and pyrexia are consistent with the product known safety profile. Based on biological implausibility, Covid-19 and pneumonia are assessed as not related to product use

Other Meds:

Current Illness: Smoker

ID: 1419793
Sex: M
Age: 30
State: MA

Vax Date: 05/04/2021
Onset Date: 05/01/2021
Rec V Date: 06/23/2021
Hospital: Y

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: trouble picking things up and raising his legs; Could talk but not rational; Fell on cement floor; Bleeding from nose; Confused; Brain Swelling; Multiple skull fractures; Passed out; Brain trauma; This spontaneous case was reported by a consumer and describes the occurrence of CRANIOCEREBRAL INJURY (Brain trauma), BRAIN OEDEMA (Brain Swelling), SKULL FRACTURE (Multiple skull fractures), LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell on cement floor), EPISTAXIS (Bleeding from nose), CONFUSIONAL STATE (Confused), MOVEMENT DISORDER (trouble picking things up and raising his legs) and SPEECH DISORDER (Could talk but not rational) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced CRANIOCEREBRAL INJURY (Brain trauma) (seriousness criteria hospitalization, disability, medically significant and life threatening), LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization, disability and medically significant), FALL (Fell on cement floor) (seriousness criteria hospitalization and medically significant), EPISTAXIS (Bleeding from nose) (seriousness criterion hospitalization) and SPEECH DISORDER (Could talk but not rational) (seriousness criteria hospitalization and disability). In May 2021, the patient experienced CONFUSIONAL STATE (Confused) (seriousness criteria hospitalization and disability). On an unknown date, the patient experienced BRAIN OEDEMA (Brain Swelling) (seriousness criteria hospitalization, disability, medically significant and life threatening), SKULL FRACTURE (Multiple skull fractures) (seriousness criteria hospitalization, disability, medically significant and life threatening) and MOVEMENT DISORDER (trouble picking things up and raising his legs) (seriousness criteria hospitalization and disability). The patient was hospitalized from 04-May-2021 to 20-May-2021 due to BRAIN OEDEMA, CRANIOCEREBRAL INJURY, LOSS OF CONSCIOUSNESS and SKULL FRACTURE. The patient was treated with Surgery (On 07-May-2021, right part of skull was removed surgically to control brain swelling.) for Brain oedema; Surgery (On 08-May-2021 surgery was performed to remove multiple skull fractures.) for Skull fracture; Rehabilitation therapy for Confusional state; Rehabilitation therapy for Movement disorder and Rehabilitation therapy for Speech disorder. At the time of the report, CRANIOCEREBRAL INJURY (Brain trauma), BRAIN OEDEMA (Brain Swelling), SKULL FRACTURE (Multiple skull fractures), CONFUSIONAL STATE (Confused) and SPEECH DISORDER (Could talk but not rational) was resolving, LOSS OF CONSCIOUSNESS (Passed out) had resolved, FALL (Fell on cement floor) and EPISTAXIS (Bleeding from nose) outcome was unknown and MOVEMENT DISORDER (trouble picking things up and raising his legs) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 26May21 patient moved to a rehabilitation facility where he still remains 9Jun21. He awoke on 17May21 but was still confused. He is now making good progress and can now walk and talk but needed therapy to relearn these. He will need out patient therapy when they release him. He still requires surgery to replace bone flap and has to wear a helmet. The goal is that he will be normal in 6 months but he is still having trouble picking things up and raising his legs. No concomitant medications provided. No treatment information provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unclear what caused the LOC and fall that appears to have resulted in the skull and brain injuries and resulting symtoms; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unclear what caused the LOC and fall that appears to have resulted in the skull and brain injuries and resulting symtoms

Other Meds:

Current Illness:

ID: 1419794
Sex: U
Age:
State:

Vax Date: 05/30/2021
Onset Date:
Rec V Date: 06/23/2021
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: vomiting blood; severe pain in left hip area; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATEMESIS (vomiting blood) in a patient of an unknown age and gender 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 30-May-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 an unknown date, the patient experienced HAEMATEMESIS (vomiting blood) (seriousness criterion medically significant) and ARTHRALGIA (severe pain in left hip area). At the time of the report, HAEMATEMESIS (vomiting blood) and ARTHRALGIA (severe pain in left hip area) outcome was unknown. No concomitant medication were provided by the reporter. The lot/batch number for mRNA-1273 was not provided. Treatment information was not provided. Very limited information regarding these events has been provided at this time. No further information is expected as the reporter did not allow further contact. Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected as the reporter did not allow further contact.

Other Meds:

Current Illness:

ID: 1419795
Sex: F
Age: 39
State: CT

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 06/23/2021
Hospital: Y

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: Fever; Headache; FLU; Suffocating; Almost had a heart attack; High blood pressure/pressure rose; Breathing is not well/the breath is short; Feels a pressure in the chest; Lost the desire to eat/doesn't get hungry; Heart was beating fast; Does not sleep well; Very dry mouth; Very thirsty; Has been unable to work; Lost about 8 pounds; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Almost had a heart attack), ASPHYXIA (Suffocating), DYSPNOEA (Breathing is not well/the breath is short), CHEST DISCOMFORT (Feels a pressure in the chest), DECREASED APPETITE (Lost the desire to eat/doesn't get hungry), PALPITATIONS (Heart was beating fast), INSOMNIA (Does not sleep well), DRY MOUTH (Very dry mouth), THIRST (Very thirsty), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has been unable to work), WEIGHT DECREASED (Lost about 8 pounds), PYREXIA (Fever), HEADACHE (Headache), INFLUENZA (FLU) and HYPERTENSION (High blood pressure/pressure rose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. No Medical History information was reported. On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced DYSPNOEA (Breathing is not well/the breath is short) (seriousness criterion hospitalization prolonged), CHEST DISCOMFORT (Feels a pressure in the chest) (seriousness criterion hospitalization prolonged), DECREASED APPETITE (Lost the desire to eat/doesn't get hungry) (seriousness criterion hospitalization prolonged), PALPITATIONS (Heart was beating fast) (seriousness criterion hospitalization prolonged), INSOMNIA (Does not sleep well) (seriousness criterion hospitalization), DRY MOUTH (Very dry mouth) (seriousness criterion hospitalization prolonged), THIRST (Very thirsty) (seriousness criterion hospitalization prolonged), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has been unable to work) (seriousness criterion hospitalization prolonged), WEIGHT DECREASED (Lost about 8 pounds) (seriousness criterion hospitalization prolonged), PYREXIA (Fever) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), INFLUENZA (FLU) (seriousness criterion hospitalization) and HYPERTENSION (High blood pressure/pressure rose) (seriousness criterion hospitalization prolonged). On 19-May-2021, the patient experienced MYOCARDIAL INFARCTION (Almost had a heart attack) (seriousness criteria hospitalization prolonged and medically significant). On 08-Jun-2021, the patient experienced ASPHYXIA (Suffocating) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized from 19-May-2021 to 22-May-2021 due to HYPERTENSION, MYOCARDIAL INFARCTION and PALPITATIONS. On 22-May-2021, MYOCARDIAL INFARCTION (Almost had a heart attack) and HYPERTENSION (High blood pressure/pressure rose) had resolved. At the time of the report, ASPHYXIA (Suffocating), DYSPNOEA (Breathing is not well/the breath is short), CHEST DISCOMFORT (Feels a pressure in the chest), DECREASED APPETITE (Lost the desire to eat/doesn't get hungry), PALPITATIONS (Heart was beating fast), INSOMNIA (Does not sleep well), DRY MOUTH (Very dry mouth), THIRST (Very thirsty), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has been unable to work), WEIGHT DECREASED (Lost about 8 pounds), PYREXIA (Fever), HEADACHE (Headache) and INFLUENZA (FLU) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Blood pressure measurement: high (High) Blood pressure rose. On 19-May-2021, Blood pressure measurement: high (High) Blood pressure rose. Concomitants medications were not reported. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-214924 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1419796
Sex: M
Age: 52
State: NJ

Vax Date: 12/30/2020
Onset Date: 04/19/2021
Rec V Date: 06/23/2021
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: eye inflammation; Vision lost in left eye; Panuveitis; Cystoid macular edema; Central blurring of the vision / central blurring is worsened; developed chalazion in eye; Stye in the left eye; redness in the eye; redness in the eye, pain and swelling; redness in the eye, pain and swelling; This spontaneous case was reported by a physician and describes the occurrence of BLINDNESS UNILATERAL (Vision lost in left eye), UVEITIS (Panuveitis) and CYSTOID MACULAR OEDEMA (Cystoid macular edema) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced OCULAR HYPERAEMIA (redness in the eye), EYE PAIN (redness in the eye, pain and swelling) and EYE SWELLING (redness in the eye, pain and swelling). On 21-Apr-2021, the patient experienced HORDEOLUM (Stye in the left eye). On 10-May-2021, the patient experienced CHALAZION (developed chalazion in eye). On 29-May-2021, the patient experienced VISION BLURRED (Central blurring of the vision / central blurring is worsened). On 04-Jun-2021, the patient experienced BLINDNESS UNILATERAL (Vision lost in left eye) (seriousness criterion medically significant), UVEITIS (Panuveitis) (seriousness criterion medically significant) and CYSTOID MACULAR OEDEMA (Cystoid macular edema) (seriousness criterion medically significant). On an unknown date, the patient experienced EYE INFLAMMATION (eye inflammation). The patient was treated with DEXAMETHASONE, TOBRAMYCIN (TOBRADEX) on 03-May-2021 for Stye, at a dose of UNK UNK, tid; DEXAMETHASONE, TOBRAMYCIN (TOBRADEX) from 21-Apr-2021 to 30-May-2021 for Stye, at a dose of UNK UNK, qid; DOXYCYCLINE on 03-May-2021 for Eye discharge, at a dose of UNK dosage form and BROMFENAC SODIUM (PROLENSA) on 08-Jun-2021 for Eye inflammation, at a dose of UNK dosage form. On 28-Apr-2021, OCULAR HYPERAEMIA (redness in the eye) and EYE SWELLING (redness in the eye, pain and swelling) had resolved. At the time of the report, BLINDNESS UNILATERAL (Vision lost in left eye), UVEITIS (Panuveitis), CYSTOID MACULAR OEDEMA (Cystoid macular edema), HORDEOLUM (Stye in the left eye), CHALAZION (developed chalazion in eye), EYE PAIN (redness in the eye, pain and swelling) and EYE INFLAMMATION (eye inflammation) outcome was unknown and VISION BLURRED (Central blurring of the vision / central blurring is worsened) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jun-2021, Alanine aminotransferase: 22 (normal) 22 IU/L Normal range: 0-44 IU/L. On 08-Jun-2021, Albumin globulin ratio: 2.2 (normal) 2.2 Normal range: 1.2-2.2. On 08-Jun-2021, Angiotensin converting enzyme (14-82): 55 (normal) 55 U/L Normal range: 14-82 U/L. On 08-Jun-2021, Aspartate aminotransferase (0-40): 22 (normal) 22 IU/L. On 08-Jun-2021, Basophil count (0.0-0.2): 0.1 (normal) 0.1 x10E3/ uL. On 08-Jun-2021, Basophil percentage: 1 (normal) 1 percent. On 08-Jun-2021, Blood albumin (3.8-4.9): 4.6 (normal) 4.6 g/dL. On 08-Jun-2021, Blood alkaline phosphatase (48-121): 82 (normal) 82 IU/L. On 08-Jun-2021, Blood bilirubin (0.0-1.2): 0.4 (normal) 0.4 mg/dL. On 08-Jun-2021, Blood calcium (8.7-10.2): 9.6 (normal) 9.6 mg/dL. On 08-Jun-2021, Blood chloride (96-106): 102 (normal) 102 mmol/L. On 08-Jun-2021, Blood creatinine (0.76-1.27): 0.87 (normal) 0.87 mg/dL. On 08-Jun-2021, Blood glucose (65-99): 98 (normal) 98 milligram per deciliter. On 08-Jun-2021, Blood potassium (3.5-5.2): 4.0 (normal) 4.0 mmol/L. On 08-Jun-2021, Blood sodium (134-144): 141 (normal) 141 mmol/L. On 08-Jun-2021, Blood urea (6-24): 11 (normal) 11 mg/ dL. On 08-Jun-2021, Blood urea nitrogen/creatinine ratio (9-20): 13 (normal) 13. On 08-Jun-2021, C-reactive protein (0-10): 2 (normal) 2 mg/L. On 08-Jun-2021, Carbon dioxide (20-29): 25 (normal) 25 mmol/L. On 08-Jun-2021, Eosinophil count (0,0-0.4): 0.1 (normal) 0.1 x10E3/uL. On 08-Jun-2021, Eosinophil percentage: 1 (Inconclusive) 1 percent. On 08-Jun-2021, Globulin (1.5-4.5): 2.1 (normal) 2.1 g/dL. On 08-Jun-2021, Glomerular filtration rate (Unknown->59): 99 (normal) 99 mL/min/1.73. On 08-Jun-2021, HIV test: negative (Negative) Non-reactive. On 08-Jun-2021, Haematocrit (37.5-51.0): 47.5 (normal) 47.5 percent. On 08-Jun-2021, Haemoglobin (13.0-17.7): 15.1 (normal) 15.1 gram per deciliter. On 08-Jun-2021, Immature granulocyte count (0.0-0.1): 0.0 (normal) 0.0 x10E3 u/L absolute count 0 percentage. On 08-Jun-2021, Lymphocyte count (0.7-3.1): 1.6 (normal) 1.6 x10E3/ uL absolute count. On 08-Jun-2021, Lymphocyte percentage: 28 (Inconclusive) 28 percent. On 08-Jun-2021, Lysozyme (3.0-12.8): 5.0 (normal) 5.0 ug/mL. On 08-Jun-2021, Mean cell haemoglobin (26.6-33.0): 27.2 (normal) 27.2 pg. On 08-Jun-2021, Mean cell haemoglobin concentration (31.5-35.7): 31.8 (normal) 31.8 g/dL. On 08-Jun-2021, Mean cell volume (79-97): 86 (normal) 86 fL. On 08-Jun-2021, Monocyte count (0.1-0.9): 0.5 (normal) 0.5 x10E3/ uL. On 08-Jun-2021, Monocyte percentage: 8 (Inconclusive) 8 percent. On 08-Jun-2021, Neutrophil count (1.4-7.0): 3.6 (normal) 3.6 x 10E3/ uL absolute count. On 08-Jun-2021, Neutrophil percentage: 62 (Inconclusive) 62 percent. On 08-Jun-2021, Platelet count (150-450): 339 (normal) 339 x10E3/ uL. On 08-Jun-2021, Protein total (6.0-8.5): 6.7 (normal) 6.7 g/dL. On 08-Jun-2021, Red blood cell count (4.14-5.80): 5.55 (normal) 5.55 x10E6/uL. On 08-Jun-2021, Red blood cell sedimentation rate (0-30): 2 (normal) 2 mm/hr. On 08-Jun-2021, Red cell distribution width (11.6-15.4): 13.1 (normal) 13.1 percent. On 08-Jun-2021, Rheumatoid factor (0.0-13.9): <10.0 (normal) <10.0 IU/mL. On 08-Jun-2021, Toxoplasma serology: negative (Negative) No serological evidence of infection with toxoplasma IgG antibodies <3.0 IgM antibodies <3.0. On 08-Jun-2021, Treponema test: negative (Negative) Non reactive and negative (Negative) T pallidum Ab (FTA-Ab) non-reactive. On 08-Jun-2021, White blood cell count (3.4-10.8): 5.9 (normal) 5.9 x10E3/uL. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 19-Apr-2021, the patient who was a physician started having problem related to the eye. On 21Apr2021, he was seen by an eye specialist, and was diagnosed with Stye in the left eye. on 28Apr2021, he had a second visit with the eye specialist. He reported that he stopped using Tobradex on an unspecified date, and had a relapse of eye problems as earlier. On 3May2021, he consulted an eye specialist and was asked to continue the same prescription. On 10-May2021 he felt better but developed chalazion in eye, and continued the antibiotic. From 29-May2021, he started experiencing central blurring of the vision. On 2-Jun2021, he consulted the ophthalmologist, OCT (Optical Coherence Tomography) was performed to check retina. He was advised to consult a retina specialist. On 4-Jun-2021, he saw a retina specialist. retino-angiogram, OCT test, tumor markers, quantiferon TB gold test, HLA B27 test, Lyme's total antibody tests were performed. Diagnosis given included pan uveitis, cystoid macular edema, eyeball immuno-privileged, vision lost in left eye and central blurring in left eye. On 8-Jun-2021, he visited retina specialist. An OCT test was done. Central blurring was worsened. The patient had an upcoming appointment with the retina specialist on 11Jun2021 and 15Jun2021. He mentioned that it was very difficult to work on computer with blurry vision from left eye and he could not work for more that 10-15 minutes. Concomitant medications were not reported. Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated

Other Meds:

Current Illness:

ID: 1419797
Sex: F
Age: 68
State: PA

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 06/23/2021
Hospital: Y

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: COVID pneumonia; Will receive the second dose of the vaccine more than 36 days after the first one; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 PNEUMONIA (COVID pneumonia) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided. Concomitant products included ALBUTEROL [SALBUTAMOL], CITALOPRAM, DESVENLAFAXINE, FLUTICASONE, LORAZEPAM and COLECALCIFEROL (VITAMIN D3) for an unknown indication. On 16-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 COVID-19 PNEUMONIA (COVID pneumonia) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Will receive the second dose of the vaccine more than 36 days after the first one). The patient was hospitalized on 01-Apr-2021 due to COVID-19 PNEUMONIA. At the time of the report, COVID-19 PNEUMONIA (COVID pneumonia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Will receive the second dose of the vaccine more than 36 days after the first one) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was not able to received the second dose due to hospitalization. No treatment information was provided. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up information will be processed at the same time as the initial report. Patient demographics were updated.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.

Other Meds: ALBUTEROL [SALBUTAMOL]; CITALOPRAM; DESVENLAFAXINE; FLUTICASONE; LORAZEPAM; VITAMIN D3

Current Illness:

ID: 1419798
Sex: F
Age: 66
State: NV

Vax Date: 05/04/2021
Onset Date: 05/11/2021
Rec V Date: 06/23/2021
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: Stomach/ abdominal pain; Looks like it got a sunburn over her shoulder; Rash to the back; Kidney Stone; Feeling Shaky; Feeling sick/not well; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney Stone) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product DUPILUMAB (DUPIXENT) injection for Atopic dermatitis. Concurrent medical conditions included Rash pruritic since 2020, Rash (At the time of the event, the patient had a rash that comes back intermittently, it's still coming back, it was black, dry and itchy, it's on her abdomen, shoulder, back of neck, and her face under her nostrils, she has allergies to many several things, the rash has been on and off for about a year.) since 2020, Hypersensitivity since 2020, Allergy (Patient is allergic to several things.) and Sleep disorder. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleep disorder, HYDROCORTISONE ACETATE (HYDROCORT [HYDROCORTISONE ACETATE]) for an unknown indication. On 04-May-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 mg once. On 11-May-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced TREMOR (Feeling Shaky) and MALAISE (Feeling sick/not well). On 20-May-2021, the patient experienced NEPHROLITHIASIS (Kidney Stone) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach/ abdominal pain), RASH ERYTHEMATOUS (Looks like it got a sunburn over her shoulder) and RASH (Rash to the back). The patient was treated with PARACETAMOL (TYLENOL) for Nervousness and Feeling sick, at an unspecified dose and frequency. At the time of the report, NEPHROLITHIASIS (Kidney Stone), TREMOR (Feeling Shaky), MALAISE (Feeling sick/not well), ABDOMINAL PAIN UPPER (Stomach/ abdominal pain), RASH ERYTHEMATOUS (Looks like it got a sunburn over her shoulder) and RASH (Rash to the back) outcome was unknown. The patient reported that she was participating in a patient support program and was receiving dupilumab injections subcutaneously for atopic dermatitis every other week. Post the second dose of m-RNA 1273 vaccine, she reported feeling shaky and being not well. The nurse from the doctor's office advised her to take Tylenol and after two days the patient reported feeling better. On 18-May-2021, she missed her maintenance dose injection of dupilumab as she was feeling sick with rash to the back and stomach pain. On 20-May-2021, the patient went to emergency room due to abdominal pain and was noted to have kidney stones. Treatment included nurse from the doctor's office advised to take Tylenol (acetaminophen), then 2 days later, she was better. No other treatment mentioned. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-215094 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds: HYDROCORT [HYDROCORTISONE ACETATE]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; DUPIXENT

Current Illness: Allergy (Patient is allergic to several things.); Hypersensitivity; Rash (At the time of the event, the patient had a rash that comes back intermittently, it's still coming back, it was black, dry and itchy, it's on her abdomen, shoulder, back of neck, and her face under her nostrils, she has allergies to many several things, the rash has been on and off for about a year.); Rash pruritic; Sleep disorder

ID: 1419799
Sex: F
Age: 67
State: IL

Vax Date: 03/17/2021
Onset Date: 05/01/2021
Rec V Date: 06/23/2021
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: Cataract; Cystoid macular edema; Could barely see from right eye; Blood on injection site; Uveitis; Vitreous degeneration; Epiretinal membrane; This spontaneous case was reported by a physician and describes the occurrence of CYSTOID MACULAR OEDEMA (Cystoid macular edema), CATARACT (Cataract), UVEITIS (Uveitis), VITREOUS DEGENERATION (Vitreous degeneration) and MACULAR FIBROSIS (Epiretinal membrane) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Rheumatoid arthritis. The patient's past medical history included Tobacco user (Half a pack of cigarettes a day) from 1974 to 2011, Cataract from November 2020 to 14-Mar-2021, Dry eyes in November 2020, Poor vision from January 2021 to 14-Mar-2021, Swelling of retina on 20-Mar-2021, Abstains from alcohol, Cataract operation on 25-Feb-2021 and Cataract operation on 14-Mar-2021. Concomitant products included METOPROLOL for Blood pressure high, KETOROLAC for Cataract, ATORVASTATIN for Cholesterol, METFORMIN for Diabetes. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced VISUAL IMPAIRMENT (Could barely see from right eye) and INJECTION SITE HAEMORRHAGE (Blood on injection site). In May 2021, the patient experienced UVEITIS (Uveitis) (seriousness criterion medically significant), VITREOUS DEGENERATION (Vitreous degeneration) (seriousness criterion medically significant) and MACULAR FIBROSIS (Epiretinal membrane) (seriousness criterion medically significant). On 20-May-2021, the patient experienced CYSTOID MACULAR OEDEMA (Cystoid macular edema) (seriousness criterion medically significant). On an unknown date, the patient experienced CATARACT (Cataract) (seriousness criterion medically significant). The patient was treated with DIFLUPREDNATE (DUREZOL) at an unspecified dose and frequency and NEPAFENAC (ILEVRO) at an unspecified dose and frequency. On 07-May-2021, INJECTION SITE HAEMORRHAGE (Blood on injection site) had resolved. At the time of the report, CYSTOID MACULAR OEDEMA (Cystoid macular edema), CATARACT (Cataract), UVEITIS (Uveitis), VITREOUS DEGENERATION (Vitreous degeneration), MACULAR FIBROSIS (Epiretinal membrane) and VISUAL IMPAIRMENT (Could barely see from right eye) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Laboratory test: unknown (Inconclusive) Unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CYSTOID MACULAR OEDEMA (Cystoid macular edema), CATARACT (Cataract), UVEITIS (Uveitis), VITREOUS DEGENERATION (Vitreous degeneration), MACULAR FIBROSIS (Epiretinal membrane), VISUAL IMPAIRMENT (Could barely see from right eye) and INJECTION SITE HAEMORRHAGE (Blood on injection site) to be not related. It was reported that, on an unknown date, patient took an unspecified steroid shot in her right eye before taking the co-suspect Humira. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: KETOROLAC; ATORVASTATIN; METFORMIN; METOPROLOL

Current Illness:

ID: 1419800
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
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: Started choking on spit; Everytime i cough my nose bleeds now; Everytime i cough my nose bleeds now; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Started choking on spit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHOKING (Started choking on spit) (seriousness criterion medically significant), COUGH (Everytime i cough my nose bleeds now) and EPISTAXIS (Everytime i cough my nose bleeds now). At the time of the report, CHOKING (Started choking on spit), COUGH (Everytime i cough my nose bleeds now) and EPISTAXIS (Everytime i cough my nose bleeds now) outcome was unknown. No concomitant product use was reported. No treatment information was provided Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1419801
Sex: F
Age: 70
State: CA

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 06/23/2021
Hospital: Y

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: Chest Pain; Open heart surgery; 2nd dose on 26Mar2021, which she missed; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain) and CARDIAC OPERATION (Open heart surgery) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure, Cholesterol and Diabetes. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose on 26Mar2021, which she missed). On 19-Mar-2021, the patient experienced CHEST PAIN (Chest Pain) (seriousness criteria hospitalization prolonged and life threatening) and CARDIAC OPERATION (Open heart surgery) (seriousness criteria hospitalization prolonged and life threatening). The patient was hospitalized until 03-Apr-2021 due to CHEST PAIN. The patient was treated with Surgery (Open heart surgery) for Chest pain. On 26-Feb-2021, PRODUCT DOSE OMISSION ISSUE (2nd dose on 26Mar2021, which she missed) had resolved. At the time of the report, CHEST PAIN (Chest Pain) and CARDIAC OPERATION (Open heart surgery) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided. The patient went to urgent care and they sent her to the hospital. At the hospital the patient and had to have an open-heart surgery. She was hospitalized until 03-Apr-Apr2021. Before the open-heart surgery consumer was taking medications for cholesterol, BP, and diabetes. After the open-heart surgery many meds were added for the patient, but patient does not know the name of the medications at the time. The was due for her 2nd dose on 26-Mar-2021, which was missed. The patient gave safety consent to follow up via phone. Based on the current available information and temporal association between the use of the product and the start date of the event chest pain! a causal relationship cannot be excluded; however, for the event "Product dose omission", assessed is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event chest pain! a causal relationship cannot be excluded; however, for the event "Product dose omission", assessed is not applicable.

Other Meds:

Current Illness: Blood pressure; Cholesterol; Diabetes

ID: 1419802
Sex: F
Age: 56
State: TX

Vax Date: 01/06/2021
Onset Date: 06/05/2021
Rec V Date: 06/23/2021
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: This spontaneous case was reported by a nurse and describes the occurrence of ARRHYTHMIA (Arrhythmia (PVC) after completing moderna vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypercholesterolemia. Concomitant products included LOVASTATIN for Cholesterol. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced ARRHYTHMIA (Arrhythmia (PVC) after completing moderna vaccine) (seriousness criterion medically significant). On an unknown date, the patient experienced VENTRICULAR EXTRASYSTOLES (PVC (Premature ventricular contractions)). At the time of the report, ARRHYTHMIA (Arrhythmia (PVC) after completing moderna vaccine) and VENTRICULAR EXTRASYSTOLES (PVC (Premature ventricular contractions)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. This case concerns a 57-year-old female with a serious unexpected event of arrhythmia, and non serious ventricular extrasystoles. Event latency 4 months after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 57-year-old female with a serious unexpected event of arrhythmia, and non serious ventricular extrasystoles. Event latency 4 months after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: LOVASTATIN

Current Illness: Hypercholesterolemia

ID: 1419803
Sex: F
Age: 63
State: OH

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 06/23/2021
Hospital: Y

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: Out of it and not acting like herself; Dizzy; 2nd dose administered before 25 days; This spontaneous case was reported by a pharmacist and describes the occurrence of ABNORMAL BEHAVIOUR (Out of it and not acting like herself) and DIZZINESS (Dizzy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 3041B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced ABNORMAL BEHAVIOUR (Out of it and not acting like herself) (seriousness criterion hospitalization), DIZZINESS (Dizzy) (seriousness criterion hospitalization) and OFF LABEL USE (2nd dose administered before 25 days). At the time of the report, ABNORMAL BEHAVIOUR (Out of it and not acting like herself), DIZZINESS (Dizzy) and OFF LABEL USE (2nd dose administered before 25 days) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient that received the Moderna 2nd dose 28-MAY-2021 (Exp; 10-Apr-21) 22 days after the 1st dose. Patient's daughter reported that the patient was dizzy, out of it and not acting like her after the 2nd dose. The patient was admitted to the hospital. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This report refers to a case of Off label use for mRNA-1273, lot # 3041B21A with no associated AE. No concomitant medicines were reported. No treatment information were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This report refers to a case of Off label use for mRNA-1273, lot # 3041B21A with no associated AE.

Other Meds:

Current Illness:

ID: 1419804
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
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: Heart Arrhythmias about three months after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Heart Arrhythmias about three months after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Heart Arrhythmias about three months after vaccination) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Heart Arrhythmias about three months after vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. On an unknown date in 2021, the patient received mRNA-1273 (Moderna COVID-19 Vaccine) and experienced Heart Arrhythmias about three months after vaccination. No relevant treatment medication reported. Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

Date Died: 03/23/2021

ID: 1419805
Sex: M
Age: 42
State: TX

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 06/23/2021
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: Died due to heart attack; Lot of blood was on the floor; He fell on bathroom tiles; Feeling weakness/Could not coming out of bed; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died due to heart attack) and HAEMORRHAGE (Lot of blood was on the floor) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes (was on anti-diabetic medicine.). On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills). On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died due to heart attack) (seriousness criteria death and medically significant), HAEMORRHAGE (Lot of blood was on the floor) (seriousness criterion medically significant) and FALL (He fell on bathroom tiles). The patient died on 23-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (Lot of blood was on the floor), FALL (He fell on bathroom tiles), ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Concomitant medication included was anti-diabetic medicine. The treatment information was not provided. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: heart attack

Other Meds:

Current Illness: Diabetes (was on anti-diabetic medicine.)

ID: 1419806
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
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: Heart Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Heart Inflammation) 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 CARDITIS (Heart Inflammation) (seriousness criterion medically significant). At the time of the report, CARDITIS (Heart Inflammation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information were reported. Company Comment: Very limited information regarding these events has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.

Other Meds:

Current Illness:

ID: 1419807
Sex: M
Age: 48
State: MI

Vax Date: 05/18/2021
Onset Date: 05/18/2021
Rec V Date: 06/23/2021
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: Passed out; Fainted; Collapsed on the floor and injured their arm and shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and SYNCOPE (Fainted) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). 18-May-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and LIMB INJURY (Collapsed on the floor and injured their arm and shoulder). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), SYNCOPE (Fainted) and LIMB INJURY (Collapsed on the floor and injured their arm and shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported It was reported that, within 15 minutes of receiving the dose the patient passed out and fainted. The patient collapsed on the floor and injured their arm and shoulder. The patient was seen by the doctor who confirmed no bones were broken. No treatment medication were reported. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1419808
Sex: F
Age: 71
State: IL

Vax Date: 02/02/2021
Onset Date: 03/01/2021
Rec V Date: 06/23/2021
Hospital: Y

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: Lymphoma; Lymphoma aggravated; Joint Instability; Lymph node disorder; This spontaneous case was reported by a health care professional and describes the occurrence of LYMPHOMA (Lymphoma) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease. The patient's past medical history included Tobacco user (Half a pack of cigarette sticks a day) from 1964 to 1985, Alcohol use (A glass of wine, Beer occasionally.) in 1968, Pinched nerve and Swelling of legs. Family history included Breast cancer and Colon cancer. Concurrent medical conditions included Sulfonamide allergy (Manifested by Hives), Drug allergy (Allergic to Artificial tear ointment Manifested by face all broke out.), Drug allergy (Allergic to quinine manifested by High Fever and Hives.), Drug allergy (Allergic to hydrocodone manifested by swelling.), Drug allergy (Allergic to Percocet manifested by Swelling.), Drug allergy (Allergic to Clonazepam manifested by swelling.), Allergy to antibiotic (Allergic to Amoxicillin manifested by Hives.), Penicillin allergy (Manifested by Hives), Drug allergy (Allergic to Omeprazole manifested by Rash.) and Lymphoma. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), ATORVASTATIN for Blood cholesterol, LOSARTAN for Blood pressure high, ALLOPURINOL for Gout, PROCHLORPERAZINE for Nausea, ONDANSETRON for Nausea and Vomiting, TRAZODONE for Sleep disorder NOS, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Supplementation therapy, MONTELUKAST for an unknown indication. In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) .4 ml once a day. On 02-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. In March 2021, the patient experienced LYMPHOMA (Lymphoma) (seriousness criteria hospitalization and medically significant), JOINT INSTABILITY (Joint Instability) and LYMPHADENOPATHY (Lymph node disorder). On 23-Mar-2021, the patient experienced CONDITION AGGRAVATED (Lymphoma aggravated). The patient was hospitalized on 23-Mar-2021 due to LYMPHOMA. At the time of the report, LYMPHOMA (Lymphoma), CONDITION AGGRAVATED (Lymphoma aggravated), JOINT INSTABILITY (Joint Instability) and LYMPHADENOPATHY (Lymph node disorder) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Biopsy: confirmed lymphoma cancer Confirmed Lymphoma Cancer. In March 2021, Magnetic resonance imaging: found lymph nodes at the back (Inconclusive) Found lymph nodes at the back. On 22-Mar-2021, Scan: abnormal (abnormal) Confirmed Lymphoma Cancer. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. In 2020, the patient experienced PINCH NERVE and LEG SWELLING. In 2020, the PINCH NERVE resolved. Treatment information included Chemotherapy. Action taken with mRNA-1273 in response to event was not applicable. Regarding Lymphoma, the event is assessed as unlikely related to mRNA-1273 based upon the biological feasibility and unlikely temporal association. Regarding other events, very limited information has been provided at this time. Further information has been requested.; Sender's Comments: Regarding Lymphoma, the event is assessed as unlikely related to mRNA-1273 based upon the biological feasibility and unlikely temporal association. Regarding other events, very limited information has been provided at this time. Further information has been requested.

Other Meds: ATORVASTATIN; PANTOPRAZOLE; VITAMIN D [COLECALCIFEROL]; ALLOPURINOL; LOSARTAN; MONTELUKAST; TRAZODONE; ONDANSETRON; PROCHLORPERAZINE

Current Illness: Allergy to antibiotic (Allergic to Amoxicillin manifested by Hives.); Drug allergy (Allergic to quinine manifested by High Fever and Hives.); Drug allergy (Allergic to Percocet manifested by Swelling.); Drug allergy (Allergic to Omeprazole manifested by Rash.); Drug allergy (Allergic to hydrocodone manifested by swelling.); Drug allergy (Allergic to Clonazepam manifested by swelling.); Drug allergy (Allergic to Artificial tear ointment Manifested by face all broke out.); Lymphoma; Penicillin allergy (Manifested by Hives); Sulfonamide allergy (Manifested by Hives)

ID: 1419809
Sex: F
Age: 79
State: WA

Vax Date: 01/29/2021
Onset Date: 02/18/2021
Rec V Date: 06/23/2021
Hospital: Y

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: I was hospitalized for the DRESS syndrome; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (I was hospitalized for the DRESS syndrome) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 001A21A) for COVID-19 vaccination. No medical history was reported. Concurrent medical conditions included DRESS syndrome (day of dose 1 of vaccination patient had just completed 2 month course of treatment for DRESS syndrome after severe reactions to medications containing sulfa) and Sulfonamide allergy (severe reactions to medications containing sulfa). Concomitant products included PREDNISONE from 30-Nov-2020 to 29-Jan-2021 for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (I was hospitalized for the DRESS syndrome) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 18-Feb-2021 to 21-Feb-2021 due to DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS. The patient was treated with PREDNISONE (intravenous) from 18-Feb-2021 to 20-Feb-2021 for DRESS syndrome, at a dose of 750 mg twice a day and PREDNISONE (oral) ongoing from 21-Feb-2021 for DRESS syndrome, at a dose of UNK Tab. On 21-Feb-2021, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (I was hospitalized for the DRESS syndrome) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood immunoglobulin G: Negative. On 08-Apr-2021, SARS-CoV-2 antibody test: Negative. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Product details updated. Patient gender updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: PREDNISONE

Current Illness: DRESS syndrome (day of dose 1 of vaccination patient had just completed 2 month course of treatment for DRESS syndrome after severe reactions to medications containing sulfa); Sulfonamide allergy (severe reactions to medications containing sulfa)

ID: 1419810
Sex: M
Age: 60
State:

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 06/23/2021
Hospital: Y

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: Atrial fibrillation; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product SELEXIPAG for Pulmonary hypertension. The patient's past medical history included Arrhythmia (Abnormal heart beat Rhythmn) on 26-Apr-2021. Concurrent medical conditions included Pulmonary hypertension. Concomitant products included AMBRISENTAN (LETAIRIS) and TADALAFIL (ADCIRCA) for an unknown indication. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started SELEXIPAG (Oral) 1600 mcg twice a day. On 10-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 10-May-2021 to 15-May-2021 due to ATRIAL FIBRILLATION. The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Blood disorder NOS, at a dose of 1 dosage form. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) 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. The patient was seen by his primary care physician on 10-May-2021, 12 hours after getting the Moderna vaccine. The physician admitted the patient to the hospital due to atrial fibrillation. The patient was discharged on 15-May-2021. The patient reported that he was in the hospital from 26-Apr-2021to 01-May-2021for abnormal heartbeat rhythm and the hospital ended up having to shock his heart to get it back to normal. The patient had the second Covid vaccine done around 1 week before reporting date 02-Jun-2021 and said he seems to be doing well. Treatment was not reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. No further information is expected. However, patient has a history of pulmonary hypertension,arrythmia and concomitant medication use of Selexipag considered as co-suspect that can be stated as confounding factors that may play a possible contributory role.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. No further information is expected. However, patient has a history of pulmonary hypertension,arrythmia and concomitant medication use of Selexipag considered as co-suspect that can be stated as confounding factors that may play a possible contributory role.

Other Meds: LETAIRIS; ADCIRCA

Current Illness: Pulmonary hypertension

ID: 1419811
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 02/25/2021
Rec V Date: 06/23/2021
Hospital: Y

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: Sepsis; hair loss; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Sepsis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L10A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ALOPECIA (hair loss). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in April 2021 due to SEPSIS. At the time of the report, SEPSIS (Sepsis) and ALOPECIA (hair loss) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided. Very limited information regarding the events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-216554 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1419812
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
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: Rheumatoid arthritis flare up in hands; Hands tingling; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in hands) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in hands) (seriousness criterion medically significant) and PARAESTHESIA (Hands tingling). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in hands) and PARAESTHESIA (Hands tingling) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were provided. No treatment information was provided. Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.

Other Meds: Humira

Current Illness: Rheumatoid arthritis (Moderate to severe)

ID: 1419813
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
Hospital: Y

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: anaphylactic event; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic event) in an elderly female 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 ANAPHYLACTIC REACTION (anaphylactic event) (seriousness criteria hospitalization and medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic event) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. Company comment:Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1419814
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
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: Psoriatic arthritis related to a reaction to Moderna vaccine; Injection Site Bled; Can Feel Under Skin Where Injected; Gave injection and much of medication; This spontaneous case was reported by a physician and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis related to a reaction to Moderna vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis. Previously administered products included for Diabetes: Insulin. Concurrent medical conditions included Diabetic. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis related to a reaction to Moderna vaccine) (seriousness criterion medically significant), INJECTION SITE HAEMORRHAGE (Injection Site Bled), PRODUCT ADMINISTRATION ERROR (Can Feel Under Skin Where Injected) and INCORRECT DOSE ADMINISTERED (Gave injection and much of medication). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis related to a reaction to Moderna vaccine), INJECTION SITE HAEMORRHAGE (Injection Site Bled), PRODUCT ADMINISTRATION ERROR (Can Feel Under Skin Where Injected) and INCORRECT DOSE ADMINISTERED (Gave injection and much of medication) 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. Concomitant medications were not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant administered medication could be potentially confounders/co-suspects for the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant administered medication could be potentially confounders/co-suspects for the events.

Other Meds:

Current Illness: Diabetic

ID: 1419815
Sex: M
Age: 64
State: OH

Vax Date: 03/05/2021
Onset Date: 04/01/2021
Rec V Date: 06/23/2021
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: no interest in work; Hypersensitive; No appetite; Put me in bed; Passed out, thought I was gone; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included DEXTROAMPHETAMINE [DEXAMFETAMINE], CLONAZEPAM (CLONAPIN), TEMAZEPAM and OMEPRAZOLE for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) (seriousness criterion medically significant). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (no interest in work), HYPERSENSITIVITY (Hypersensitive), DECREASED APPETITE (No appetite) and BEDRIDDEN (Put me in bed). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at a dose of UNK dosage form. On 02-Apr-2021 at 3:15 AM, LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) had resolved. At the time of the report, IMPAIRED WORK ABILITY (no interest in work), HYPERSENSITIVITY (Hypersensitive), DECREASED APPETITE (No appetite) and BEDRIDDEN (Put me in bed) outcome was unknown. It was reported that after the 2nd dose, within 75 min, the patient passed out after going home until 3:15AM the next morning (02Apr2021). The patient reported that the nurse at the vaccinating facility, after checking with the Doctor gave the 2nd dose in spite of the patient's concern (he was feeling sick on that day) if he needs to wait for the 2nd shot. The patient stated he made a terrible mistake getting the 2nd shot while still sick from the 1st shot. He is going for lab tests the next Monday (14 Jun 2021). Other treatment information include more amount water. company comment:Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-218564 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.

Other Meds: DEXTROAMPHETAMINE [DEXAMFETAMINE]; CLONAPIN; TEMAZEPAM; OMEPRAZOLE

Current Illness:

ID: 1419816
Sex: M
Age: 28
State: AR

Vax Date: 05/24/2021
Onset Date: 05/24/2021
Rec V Date: 06/23/2021
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: This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (Bad seizures) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 106B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included VSD (patient had heart and lung problems when he was born (VSD ). heart murmur.), Bronchopulmonary dysplasia (patient had heart and lung problems when he was born (BPD-bronchopulmonary dysplasia)), Epilepsy, Prematurity, Aspiration pneumonia, Gastroschisis, Inappropriate schedule of vaccine administered and Breathing arrested. Concomitant products included TOPIRAMATE (TOPAMAX) and GABAPENTIN (NEURONTIN) for Seizures, QUETIAPINE FUMARATE (SEROQUEL), SERTRALINE HYDROCHLORIDE (ZOLOFT), CLONAZEPAM (KLONOPIN), LACOSAMIDE (VIMPAT), TRAZODONE, BACLOFEN (LIORESAL), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), CIMETIDINE (TAGAMET [CIMETIDINE]) and EPINEPHRINE (EPIPEN) for an unknown indication. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced SEIZURE (Bad seizures) (seriousness criterion medically significant), CHEST PAIN (Chest Pain), URTICARIA (Big old welts / Hives), HEART RATE INCREASED (elevated heart rate) and PYREXIA (On and off fever). On an unknown date, the patient experienced CONDITION AGGRAVATED (condition aggravated/ seizures). The patient was treated with HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) at a dose of 50 mg three times a day. At the time of the report, SEIZURE (Bad seizures), CHEST PAIN (Chest Pain), URTICARIA (Big old welts / Hives), CONDITION AGGRAVATED (condition aggaravted/ seizures), HEART RATE INCREASED (elevated heart rate) and PYREXIA (On and off fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Heart rate increased: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was born between twenty two and a half and twenty three and a half weeks. Mother states she had German measles/Rubella while pregnant and was bleeding every week. patient was born with his intestine outside which had to be put back inside. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.

Other Meds: SEROQUEL; ZOLOFT; KLONOPIN; VIMPAT; TRAZODONE; LIORESAL; TOPAMAX; PRILOSEC [OMEPRAZOLE]; TAGAMET [CIMETIDINE]; NEURONTIN; EPIPEN

Current Illness:

ID: 1419817
Sex: F
Age: 64
State: PA

Vax Date: 05/01/2021
Onset Date: 05/02/2021
Rec V Date: 06/23/2021
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: Not getting 2nd dose; Left breast is swollen; Shortness of breath; Loss of smell; Loss of taste; Lost a lot of weight; diarrhea; She can't lift arm, can't do all the things she used to be able to do; Left breast is very painful; She is afraid; Swollen lymph of nodes; Muscle fatigue; Lump at injection site; heart beats quickly; Headache every night; Feels like she is wasting away; This spontaneous case was reported by a consumer and describes the occurrence of CACHEXIA (Feels like she is wasting away) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced CACHEXIA (Feels like she is wasting away) (seriousness criterion medically significant), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful), FEAR (She is afraid), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), INJECTION SITE MASS (Lump at injection site), HEART RATE INCREASED (heart beats quickly), and HEADACHE (Headache every night). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 UNK. At the time of the report, CACHEXIA (Feels like she is wasting away), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), HEART RATE INCREASED (heart beats quickly), INJECTION SITE MASS (Lump at injection site) and HEADACHE (Headache every night) had not resolved and FEAR (She is afraid) and PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Heart rate: increased (Inconclusive) heart beats quickly. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested

Other Meds:

Current Illness:

ID: 1419818
Sex: F
Age: 69
State: TX

Vax Date: 06/11/2021
Onset Date: 06/12/2021
Rec V Date: 06/23/2021
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: This morning I still felt bad but not as bad, felt exhausted; Still feel drained right now and sore, achy; Having aches; Chills; Passed out, became unconscious; Generally not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out, became unconscious) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included DRONEDARONE HYDROCHLORIDE (MULTAQ), RISPERIDONE, METOPROLOL, APIXABAN (ELIQUIS), TEMAZEPAM and TOPIRAMATE for an unknown indication. On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out, became unconscious) (seriousness criterion medically significant), MALAISE (Generally not feeling well), MYALGIA (Having aches) and CHILLS (Chills). On 13-Jun-2021, the patient experienced FATIGUE (This morning I still felt bad but not as bad, felt exhausted) and MYALGIA (Still feel drained right now and sore, achy). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 13-Jun-2021, LOSS OF CONSCIOUSNESS (Passed out, became unconscious), MALAISE (Generally not feeling well), MYALGIA (Having aches) and CHILLS (Chills) had resolved. At the time of the report, FATIGUE (This morning I still felt bad but not as bad, felt exhausted) and MYALGIA (Still feel drained right now and sore, achy) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment include fluids. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: MULTAQ; RISPERIDONE; METOPROLOL; ELIQUIS; TEMAZEPAM; TOPIRAMATE

Current Illness:

ID: 1419819
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
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: Blood clots; Tiny dots are showing up on arm of injection site; One larger dot on breast; Cold feeling in arm; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant), VACCINATION SITE DISCOLOURATION (Tiny dots are showing up on arm of injection site), BREAST DISCOLOURATION (One larger dot on breast) and PERIPHERAL COLDNESS (Cold feeling in arm). At the time of the report, THROMBOSIS (Blood clots), VACCINATION SITE DISCOLOURATION (Tiny dots are showing up on arm of injection site), BREAST DISCOLOURATION (One larger dot on breast) and PERIPHERAL COLDNESS (Cold feeling in arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment information in response to events was not provided. Company Comment Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm