VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

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

Incidents per State

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

Date Died: 03/05/2021

ID: 1398476
Sex: M
Age:
State: NY

Vax Date: 01/17/2021
Onset Date: 02/15/2021
Rec V Date: 06/15/2021
Hospital: Y

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: Death; Felt like he was dying; Can't move; Hurting pain over the whole body; Weak; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), FEELING ABNORMAL (Felt like he was dying), MOVEMENT DISORDER (Can't move), PAIN (Hurting pain over the whole body) and ASTHENIA (Weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 028L20A) for COVID-19 vaccination. The patient's past medical history included Coronary artery disease in 2000 and Stroke (recovered) in 1992. Concurrent medical conditions included Diabetes since 2000, Blood pressure high (stable) since 1964, Atherosclerosis since 2016 and Heart attack (recovered) since 2019. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure, DULOXETINE for Depression, METFORMIN HYDROCHLORIDE for Diabetes, FERROUS SULFATE HEPTAHYDRATE (FERROUS SULFATE [FERROUS SULFATE HEPTAHYDRATE]) for Iron deficiency, LAMOTRIGINE for Seizure, ACETYLSALICYLIC ACID (ASPIRIN 81) from 18-Jul-2017 to an unknown date, CALCITRIOL, CLOPIDOGREL, FUROSEMIDE, ISOSORBIDE, VITAMIN B12 NOS, COLECALCIFEROL (VITAMIN D3 1000), INSULIN GLARGINE (LANTUS), ACITRETIN, ATORVASTATIN, LOSARTAN POTASSIUM (COZAAR), DULAGLUTIDE (TRULICITY), METFORMIN HYDROCHLORIDE (METFORMINE HCL) and LAMOTRIGINE for an unknown indication. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (Felt like he was dying) (seriousness criteria death and hospitalization), MOVEMENT DISORDER (Can't move) (seriousness criteria death and hospitalization), PAIN (Hurting pain over the whole body) (seriousness criteria death and hospitalization) and ASTHENIA (Weak) (seriousness criteria death and hospitalization). The patient was treated with TRAMADOL for Pain, at a dose of 50 mg; LORAZEPAM for Anxiety, at a dose of 0.5 mg and MECLIZINE [MECLOZINE] for Dizziness, at a dose of 25 mg. The patient died on 05-Mar-2021. The reported cause of death was heart and kidney failure and Kidney failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: unknown (Inconclusive) Inconclusive. This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received, includes patient's gender. On 07-Jun-2021: Follow up received, includes Patient information, historical conditions, batch number, cause of death, concomitant drugs.; Sender's Comments: This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Heart and kidney failure; kidney failure

Other Meds: ASPIRIN 81; CALCITRIOL; CLOPIDOGREL; FERROUS SULFATE [FERROUS SULFATE HEPTAHYDRATE]; FUROSEMIDE; ISOSORBIDE; LAMOTRIGINE; METFORMIN HYDROCHLORIDE; METOPROLOL; PANTOPRAZOLE; VITAMIN B12 NOS; VITAMIN D3 1000; LANTUS; ACITRETIN; DULOXETINE; AT

Current Illness: Atherosclerosis; Blood pressure high (stable); Diabetes; Heart attack (recovered)

ID: 1398477
Sex: F
Age: 66
State: NJ

Vax Date: 02/24/2021
Onset Date: 03/28/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Gastritis; Tinnitus was worse/ ringing is daily; Severe heartburn; Feeling of fullness; Still feeling off; nausea; Temporary vision loss; Migraine aura/migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (Temporary vision loss), MIGRAINE (Migraine aura/migraine headache), GASTRITIS (Gastritis), TINNITUS (Tinnitus was worse/ ringing is daily) and DYSPEPSIA (Severe heartburn) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 022M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Migraine headache (Family history of cardiovascular disease). Family history included Family history of cardiovascular disorder since an unknown date. Concurrent medical conditions included COPD (The patient experienced trouble in deep breathing after vaccine.) since 2011, Gastritis (Patient experienced severe bout of gastritis a few weeks after the vaccine.) since 2010, TMJ syndrome (Patient had TMJ since his 30's.), Tinnitus (Patient had Tinnitus since his 30's.), Allergy (Allergy to mushrooms), High cholesterol and Vegan. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced BLINDNESS TRANSIENT (Temporary vision loss) and MIGRAINE (Migraine aura/migraine headache). On 30-Mar-2021, the patient experienced NAUSEA (nausea). In April 2021, the patient experienced VACCINATION COMPLICATION (Still feeling off). On an unknown date, the patient experienced GASTRITIS (Gastritis), TINNITUS (Tinnitus was worse/ ringing is daily), DYSPEPSIA (Severe heartburn) and ABDOMINAL DISTENSION (Feeling of fullness). On 29-Mar-2021, BLINDNESS TRANSIENT (Temporary vision loss) and MIGRAINE (Migraine aura/migraine headache) had resolved. On 30-Mar-2021, NAUSEA (nausea) had resolved. At the time of the report, GASTRITIS (Gastritis), TINNITUS (Tinnitus was worse/ ringing is daily), DYSPEPSIA (Severe heartburn), VACCINATION COMPLICATION (Still feeling off) and ABDOMINAL DISTENSION (Feeling of fullness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: blood pressure (normal) Blood Pressure. In 2021, Electrocardiogram: ekg (normal) EKG. In 2021, Full blood count: full blood work (normal) Full blood work. In 2021, Heart rate: heart rate (normal) Heart rate. No treatment information was provided. Action taken with the drug in response to 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 events, a causal relationship cannot be excluded. Case is confounded by multiple comorbidities. The patient had woke up with half of the vision gone on the next after receiving the second dose of moderna vaccine. The patient had history of migraines. The patient was known that migraine was beginning which resolved in few minutes. And after 30 minutes, another aura began which is also resolved in few minutes. Migrains began in an hour, or so, then resolved by the end of the day. Patient had breathing issues that is continuing from the first dose. Approximately 3 weeks after the second dose, Patient's tinnitus was worse, had ringing in the ear daily, constant and in a higher level. Gastritis was also worse after the second dose with pain doubing, severe heartburn, nausea and feeling of fullness. This case was linked to MOD21-047977 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: A follow-up email was received from patient with no new information. The patient stated she would send in follow-up forms. On 03-Jun-2021: Follow-up was received on 03-JUN-2021 has significant information. Patient medical history were added. New events ( Breathing difficulty, tinnitus aggravated, heartburn, feeling of fullness, gastritis aggravated) were added. Information about the first dose and its events were added.; 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. Case is confounded by multiple comorbidities.

Other Meds: LIPITOR

Current Illness: Allergy (Allergy to mushrooms); COPD (The patient experienced trouble in deep breathing after vaccine.); Family history of cardiovascular disorder; Gastritis (Patient experienced severe bout of gastritis a few weeks after the vaccine.); High cholesterol; Tinnitus (Patient had Tinnitus since his 30's.); TMJ syndrome (Patient had TMJ since his 30's.); Vegan

ID: 1398478
Sex: F
Age: 65
State: AZ

Vax Date: 02/15/2021
Onset Date: 03/15/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she can't get up without passing out; chills; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she can't get up without passing out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 057G120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (she can't get up without passing out) (seriousness criterion medically significant), CHILLS (chills), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, LOSS OF CONSCIOUSNESS (she can't get up without passing out), CHILLS (chills), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information 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.; 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: 1398479
Sex: F
Age: 74
State: CA

Vax Date: 02/15/2021
Onset Date: 03/16/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: rheumatoid arthritis she had a flare; run over by a truck; became stiff and hurt all over; jaw hurt; headache; hurt all over/ achy feeling; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatoid arthritis. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) (seriousness criterion medically significant), FEELING ABNORMAL (run over by a truck), MUSCULOSKELETAL STIFFNESS (became stiff and hurt all over), PAIN IN JAW (jaw hurt), HEADACHE (headache) and MYALGIA (hurt all over/ achy feeling). The patient was treated with Physical therapy for Rheumatoid arthritis; Physical therapy for Feeling abnormal; Physical therapy for Musculoskeletal stiffness; Physical therapy for Pain in jaw; Physical therapy for Headache and Physical therapy for Myalgia. On 17-Mar-2021, PAIN IN JAW (jaw hurt) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) had not resolved and FEELING ABNORMAL (run over by a truck), MUSCULOSKELETAL STIFFNESS (became stiff and hurt all over), HEADACHE (headache) and MYALGIA (hurt all over/ achy feeling) outcome was unknown. No relevant concomitant medications were reported. The patient stated how long this flare up would last and should she continue to go to physical therapy. 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. This case was linked to US-MODERNATX, INC.-MOD-2021-048039 (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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1398480
Sex: F
Age: 59
State: OR

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: acute allergic reaction; Acute anaphylactoid type reaction; Throat swelling; Redness around neck; HIves/Urticaria; Swelling of upper airway; Sensation of throat closing; Hoarseness; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (acute allergic reaction) and ANAPHYLACTOID REACTION (Acute anaphylactoid type reaction) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Acute conjunctivitis, Cough and Dysphagia. Concurrent medical conditions included Hypothyroidism, Drug allergy (Allergy to Amoxicillin - Diarrhea), Drug allergy (Allergy to Codeine - nausea and vomiting), Sulfonamide allergy (Hives), Drug allergy (Tetracycline), Drug allergy (Zithromax), Latex allergy, Alcohol use (occasional) and Caffeine consumption (moderate). Concomitant products included LEVOTHYROXINE for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HYPERSENSITIVITY (acute allergic reaction) (seriousness criterion intervention required), ANAPHYLACTOID REACTION (Acute anaphylactoid type reaction) (seriousness criterion medically significant), PHARYNGEAL SWELLING (Throat swelling), ERYTHEMA (Redness around neck), URTICARIA (HIves/Urticaria), SWELLING (Swelling of upper airway), THROAT TIGHTNESS (Sensation of throat closing) and DYSPHONIA (Hoarseness). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) (oral) on 17-Mar-2021 at a dose of 5 mg once a day; FAMOTIDINE (intravenous) on 17-Mar-2021 at a dose of 20 mg; SODIUM CHLORIDE (SODIUM CHLORIDE IV) (intravenous) on 17-Mar-2021 at a dose of 1 LNS; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) (intravenous) on 17-Mar-2021 at a dose of 125 mg; FAMOTIDINE (PEPCID [FAMOTIDINE]) (oral) on 17-Mar-2021 at a dose of 20 mg once a day and PREDNISONE (oral) on 17-Mar-2021 at a dose of 20 mg once a day. On 17-Mar-2021, HYPERSENSITIVITY (acute allergic reaction), ANAPHYLACTOID REACTION (Acute anaphylactoid type reaction), URTICARIA (HIves/Urticaria), SWELLING (Swelling of upper airway), THROAT TIGHTNESS (Sensation of throat closing) and DYSPHONIA (Hoarseness) had resolved. At the time of the report, PHARYNGEAL SWELLING (Throat swelling) and ERYTHEMA (Redness around neck) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood pressure measurement: 193/100 (Inconclusive) sitting L arm. On 17-Mar-2021, Body temperature: 98.2 ?F (Inconclusive) Temporal artery (36.78 degree Celsius). On 17-Mar-2021, Ear, nose and throat examination: inconclusive (Inconclusive) Right Ear & Left Ear: TM, Clear Nasopharynx: Clear Pharynx: Airway clear Tonsil: No Trismus or abscess and normal Neck: Supple and Trachea Midline.. On 17-Mar-2021, Heart rate: > 100 (High) Increased and 82 (normal) bpm regular. On 17-Mar-2021, Neurological examination: normal (normal) Intact and non-focal. On 17-Mar-2021, Oxygen saturation: 99 % (Inconclusive) room air at rest. On 17-Mar-2021, Respiratory rate: 18 (Inconclusive) 18. 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 visited the clinic 1 hour after receiving the vaccine with throat swelling and redness around her neck. The patient was observed for an hour. 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 Drug allergies conditions could be potentially co-suspects for the events. Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Lab data, treatment, outcome of event, patient identifiers, events and medical history were 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 events, a causal relationship cannot be excluded. Concomitant Drug allergies conditions could be potentially co-suspects for the events.

Other Meds: LEVOTHYROXINE

Current Illness: Drug allergy (Zithromax); Drug allergy (Tetracycline); Drug allergy (Allergy to Codeine - nausea and vomiting); Drug allergy (Allergy to Amoxicillin - Diarrhea); Hypothyroidism; Latex allergy; Sulfonamide allergy (Hives)

ID: 1398481
Sex: F
Age: 67
State: TX

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 06/15/2021
Hospital: Y

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: Feel sick; Felt really bad; Neck Pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Feel sick) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MALAISE (Feel sick) (seriousness criterion hospitalization), FEELING ABNORMAL (Felt really bad), NECK PAIN (Neck Pain) and NAUSEA (Nausea). At the time of the report, MALAISE (Feel sick), FEELING ABNORMAL (Felt really bad), NECK PAIN (Neck Pain) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Laboratory test: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 13-Mar-2021, the patient felt very sick that she ended up going to Emergency. The patient stated that she stayed in hospital for a whole da. 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: 1398482
Sex: F
Age: 77
State: WA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: can't sleep; she is angry, been crying, is depressed and is taking an antidepressant; headache; couldn't hear anything out of one of her ears temporarily; brain is ringing/debilitating/ringing in head; received vaccine and has been sick; stuttering words; body shaking; trouble walking; This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily) (seriousness criterion medically significant), TINNITUS (brain is ringing/debilitating/ringing in head), MALAISE (received vaccine and has been sick), DYSPHEMIA (stuttering words), TREMOR (body shaking) and GAIT DISTURBANCE (trouble walking). On an unknown date, the patient experienced SLEEP DISORDER (can't sleep), DEPRESSED MOOD (she is angry, been crying, is depressed and is taking an antidepressant) and HEADACHE (headache). At the time of the report, SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily), MALAISE (received vaccine and has been sick), DYSPHEMIA (stuttering words), TREMOR (body shaking) and GAIT DISTURBANCE (trouble walking) outcome was unknown and TINNITUS (brain is ringing/debilitating/ringing in head), SLEEP DISORDER (can't sleep), DEPRESSED MOOD (she is angry, been crying, is depressed and is taking an antidepressant) and HEADACHE (headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that, the patient was taking antidepressants for being angry, been crying, was depressed . The patient also stated that she bought silencil an over the counter medication that she bought on the internet but it didn't help. She wanted to know if she could get a tetanus shot. 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. The patient's age and concomitant use of antidepressants are confounding factors that may play possible contributory roles. No further information is expected at this time. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Added 1 new serious and 3 non-serious events. This case is upgraded per addition of serious event.; 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. The patient's age and concomitant use of antidepressants are confounding factors that may play possible contributory roles. No further information is expected at this time.

Other Meds:

Current Illness:

ID: 1398483
Sex: M
Age: 80
State: IL

Vax Date: 01/29/2021
Onset Date: 02/12/2021
Rec V Date: 06/15/2021
Hospital: Y

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: trouble with breathing, breathing difficult, " my breathing went to hell"; Could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 APIXABAN (ELIQUIS) and DOXAZOSIN for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") (seriousness criterion hospitalization). On an unknown date, the patient experienced INSOMNIA (Could not sleep). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") had not resolved and INSOMNIA (Could not sleep) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The patient stated that two weeks after the vaccination he went to Emergency room due to breathing difficulty and was admitted. He reportedly spent two days in the ICU. The patient continued to have trouble and did not get the second dose due to the breathing difficulty he experienced. The patient reported that he could not sleep since he could not breathe. Additional concomitant medications included heart medications and heart burn medications. Treatment medications included an Albuterol inhaler. This case concerns an 80-year-old male hospitalized with a serious unexpected event of dyspnea, and nonserious unexpected event of insomnia. Patient treated with antibiotics. Event latency 15 days after 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. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Case upgraded to serious, Patient demographics updated, additional event reported (could not sleep).; Sender's Comments: This case concerns an 80-year-old male hospitalized with a serious unexpected event of dyspnea, and nonserious unexpected event of insomnia. Patient treated with antibiotics. Event latency 15 days after 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: ELIQUIS; DOXAZOSIN

Current Illness:

ID: 1398484
Sex: M
Age: 53
State: NJ

Vax Date: 02/16/2021
Onset Date: 03/17/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Ringing in the left ear after the 2nd dose; Terrible migraine headache after the 2nd dose; Pain behind his eyes after the 2nd dose; Lower really bad back pain after the 2nd dose; blurry vision; neck pain; could hardly even walk; can't pick something off the ground; Pain in jaw; burning feet; Burning pain in his hands after the 2nd dose; Knees are so bad; Soreness in the arm after the 2nd dose; Extra dose administered; Little worse headache after the 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in the left ear after the 2nd dose), MIGRAINE (Terrible migraine headache after the 2nd dose), EYE PAIN (Pain behind his eyes after the 2nd dose), BACK PAIN (Lower really bad back pain after the 2nd dose), VISION BLURRED (blurry vision), NECK PAIN (neck pain), GAIT DISTURBANCE (could hardly even walk), MOVEMENT DISORDER (can't pick something off the ground), PAIN IN JAW (Pain in jaw), PAIN IN EXTREMITY (burning feet), PAIN (Burning pain in his hands after the 2nd dose) and ARTHRALGIA (Knees are so bad) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE for Allergy, LEVOTHYROXINE and DOXAZOSIN MESILATE (DOXAZOCIN) for an unknown indication. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm after the 2nd dose), EXTRA DOSE ADMINISTERED (Extra dose administered) and HEADACHE (Little worse headache after the 2nd dose). On 31-Mar-2021, the patient experienced TINNITUS (Ringing in the left ear after the 2nd dose) (seriousness criterion disability), MIGRAINE (Terrible migraine headache after the 2nd dose) (seriousness criterion disability), EYE PAIN (Pain behind his eyes after the 2nd dose) (seriousness criterion disability), BACK PAIN (Lower really bad back pain after the 2nd dose) (seriousness criterion disability), VISION BLURRED (blurry vision) (seriousness criterion disability), NECK PAIN (neck pain) (seriousness criterion disability), GAIT DISTURBANCE (could hardly even walk) (seriousness criterion disability), MOVEMENT DISORDER (can't pick something off the ground) (seriousness criterion disability) and PAIN IN JAW (Pain in jaw) (seriousness criterion disability). 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (burning feet) (seriousness criterion disability), PAIN (Burning pain in his hands after the 2nd dose) (seriousness criterion disability) and ARTHRALGIA (Knees are so bad) (seriousness criterion disability). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 21-Mar-2021, PAIN IN EXTREMITY (Soreness in the arm after the 2nd dose) and HEADACHE (Little worse headache after the 2nd dose) had resolved. At the time of the report, TINNITUS (Ringing in the left ear after the 2nd dose), MIGRAINE (Terrible migraine headache after the 2nd dose), EYE PAIN (Pain behind his eyes after the 2nd dose), BACK PAIN (Lower really bad back pain after the 2nd dose), VISION BLURRED (blurry vision), NECK PAIN (neck pain), GAIT DISTURBANCE (could hardly even walk), MOVEMENT DISORDER (can't pick something off the ground), PAIN IN JAW (Pain in jaw), PAIN IN EXTREMITY (burning feet), ARTHRALGIA (Knees are so bad) and EXTRA DOSE ADMINISTERED (Extra dose administered) outcome was unknown and PAIN (Burning pain in his hands after the 2nd dose) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal there was nothing life-threatening on the CT scan. 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-2021-133281 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow up was received on 05-JUN-2021. Additional events (pain in the jaw, knee pain, burning feet, gait disturbance, blurry vision, movement disorder, neck pain) were added. Primary source reporter causality was updated to probable. Case was upgraded to serious (disabling).; 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; DOXAZOCIN; CETIRIZINE

Current Illness: Allergy

ID: 1398485
Sex: F
Age: 60
State: LA

Vax Date: 03/03/2021
Onset Date: 05/24/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: When she goes to the bathroom blood gushes out in clot/the blood just start gushing out; been bleeding since i got the shot/bleeding; felt like peeing and blood start pouring out/feeling like they are having a period for 3 days then stop then come back; got pain, had to sit down, like someone pulling your insides out pain was excruciating/pain/there is so much pain/pain everyday/pain like period or having a baby; egg like secretion down there; waking up soaking wet down there; pain in the belly; Leg gave out/feels like someone is pulling her bones apart down below/left leg felt like coming apart; anemic; bleeding every week for 2 to 7 days followed by white stuff and back to bleeding; Other staff is coming from my body/ feeling something travelling through my body; Blow up in leg; pain different from sciatica; afraid for my life; don't feel like I am going to live/feeling terrible; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (When she goes to the bathroom blood gushes out in clot/the blood just start gushing out) in a 60-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. Concomitant products included GABAPENTIN for Sciatica. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced ANXIETY (afraid for my life) and FEELING OF DESPAIR (don't feel like I am going to live/feeling terrible). On an unknown date, the patient experienced HAEMORRHAGE URINARY TRACT (When she goes to the bathroom blood gushes out in clot/the blood just start gushing out) (seriousness criterion medically significant), HAEMORRHAGE (been bleeding since i got the shot/bleeding), GENITAL HAEMORRHAGE (felt like peeing and blood start pouring out/feeling like they are having a period for 3 days then stop then come back), PAIN (got pain, had to sit down, like someone pulling your insides out pain was excruciating/pain/there is so much pain/pain everyday/pain like period or having a baby), GENITAL DISCHARGE (egg like secretion down there), HYPERHIDROSIS (waking up soaking wet down there), ABDOMINAL PAIN (pain in the belly), LIMB DISCOMFORT (Leg gave out/feels like someone is pulling her bones apart down below/left leg felt like coming apart), ANAEMIA (anemic), VAGINAL DISCHARGE (bleeding every week for 2 to 7 days followed by white stuff and back to bleeding), FEELING ABNORMAL (Other staff is coming from my body/ feeling something travelling through my body), PERIPHERAL SWELLING (Blow up in leg) and PAIN (pain different from sciatica). The patient was treated with GABAPENTIN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HAEMORRHAGE URINARY TRACT (When she goes to the bathroom blood gushes out in clot/the blood just start gushing out), HAEMORRHAGE (been bleeding since i got the shot/bleeding), GENITAL HAEMORRHAGE (felt like peeing and blood start pouring out/feeling like they are having a period for 3 days then stop then come back), PAIN (got pain, had to sit down, like someone pulling your insides out pain was excruciating/pain/there is so much pain/pain everyday/pain like period or having a baby), GENITAL DISCHARGE (egg like secretion down there), HYPERHIDROSIS (waking up soaking wet down there), ANXIETY (afraid for my life), FEELING OF DESPAIR (don't feel like I am going to live/feeling terrible), ABDOMINAL PAIN (pain in the belly), LIMB DISCOMFORT (Leg gave out/feels like someone is pulling her bones apart down below/left leg felt like coming apart), ANAEMIA (anemic), VAGINAL DISCHARGE (bleeding every week for 2 to 7 days followed by white stuff and back to bleeding), FEELING ABNORMAL (Other staff is coming from my body/ feeling something travelling through my body), PERIPHERAL SWELLING (Blow up in leg) and PAIN (pain different from sciatica) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Smear cervix: normal (normal) normal. Patient sought out help from Primary care, was referred to a OBGYN, got a pap smear normal and said that the HCPs did not provide information on what may be causing the symptoms. She received Gabapentin and Tylenol as treatment without symptoms' relief. Reporter provide additional phone number 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. 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-2021-163813 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: updated reporter information and new 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.

Other Meds: GABAPENTIN

Current Illness:

ID: 1398486
Sex: M
Age: 66
State: NJ

Vax Date: 02/13/2021
Onset Date: 02/20/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Stiffness all over; Couldn't sleep; Treated as though he has Polymyalgia Rheumatica; Lost weight; Body was pulsating; Muscle ache; Injection site itchy; pain radiating down pelvis, legs, thighs, feet, toes; Systemic body inflammation/bad case of inflammation; Immune system compromised; Poor sleep; Chest congestion; Bone weakness; Loss dexterity in fingers cannot attach garden hose; Pressure heart pain after walking; Muscle stiffness/stiffness all over/Consumer couldn't sleep, was waking up stiff; Muscle weakness; Pain at injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (Treated as though he has Polymyalgia Rheumatica) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Broken ankle in 2017. Concurrent medical conditions included Neck pain since 2018, Shoulder pain since 2018, Chronic arthritis and Diabetes. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 27-Feb-2021, the patient experienced IMMUNE SYSTEM DISORDER (Immune system compromised), POOR QUALITY SLEEP (Poor sleep), CHEST DISCOMFORT (Chest congestion), BONE DENSITY DECREASED (Bone weakness), FINE MOTOR SKILL DYSFUNCTION (Loss dexterity in fingers cannot attach garden hose), CARDIAC DISCOMFORT (Pressure heart pain after walking), MUSCULOSKELETAL STIFFNESS (Muscle stiffness/stiffness all over/Consumer couldn't sleep, was waking up stiff), MUSCULAR WEAKNESS (Muscle weakness), PAIN IN EXTREMITY (pain radiating down pelvis, legs, thighs, feet, toes), INFLAMMATION (Systemic body inflammation/bad case of inflammation), MYALGIA (Muscle ache) and VACCINATION SITE PRURITUS (Injection site itchy). On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Treated as though he has Polymyalgia Rheumatica) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Stiffness all over), INSOMNIA (Couldn't sleep) and PALPITATIONS (Body was pulsating). The patient was treated with MELOXICAM at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form and Physical therapy for Polymyalgia rheumatica. At the time of the report, POLYMYALGIA RHEUMATICA (Treated as though he has Polymyalgia Rheumatica), IMMUNE SYSTEM DISORDER (Immune system compromised), MUSCULOSKELETAL STIFFNESS (Stiffness all over), INSOMNIA (Couldn't sleep), POOR QUALITY SLEEP (Poor sleep), CHEST DISCOMFORT (Chest congestion), BONE DENSITY DECREASED (Bone weakness), FINE MOTOR SKILL DYSFUNCTION (Loss dexterity in fingers cannot attach garden hose), CARDIAC DISCOMFORT (Pressure heart pain after walking), MUSCULOSKELETAL STIFFNESS (Muscle stiffness/stiffness all over/Consumer couldn't sleep, was waking up stiff), MUSCULAR WEAKNESS (Muscle weakness), PAIN IN EXTREMITY (pain radiating down pelvis, legs, thighs, feet, toes), INFLAMMATION (Systemic body inflammation/bad case of inflammation), PALPITATIONS (Body was pulsating), MYALGIA (Muscle ache), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE PRURITUS (Injection site itchy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, C-reactive protein: 17.2 (abnormal) Polymyalgia Rheumatica.. Treatment included non-specific "steroids." A 66 Y/O M developed serious unexpected polymyalgia rheumatica, and NS immune system disorder, musculoskeletal stiffness, insomnia, poor quality sleep, chest discomfort, bone density decreased, fine motor skill dysfunction, cardiac discomfort, muscular weakness, pain in extremity, inflammation, palpitations and other expected events. Based on current available information and temporal association between 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 09-Jun-2021: The follow up document was added and Treatment medications, lab data, events were updated.; Sender's Comments: A 66 Y/O M developed serious unexpected polymyalgia rheumatica, and NS immune system disorder, musculoskeletal stiffness, insomnia, poor quality sleep, chest discomfort, bone density decreased, fine motor skill dysfunction, cardiac discomfort, muscular weakness, pain in extremity, inflammation, palpitations and other expected events. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Chronic arthritis; Diabetes; Neck pain; Shoulder pain

ID: 1398487
Sex: M
Age:
State:

Vax Date:
Onset Date: 02/01/2021
Rec V Date: 06/15/2021
Hospital: Y

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: Myocarditis; This spontaneous case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in February 2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (Myocarditis) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. 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 this 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 this event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1398488
Sex: F
Age: 75
State: NY

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: mild soreness; Peripheral neuropathy; heightened sensory feelings at night; Feet feel different; feels heat and warmth; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) 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 ATENOLOL, ACETYLSALICYLIC ACID (ASPIRIN 81), COLECALCIFEROL (VITAMIN D 3) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy) (seriousness criterion medically significant), SENSORY DISTURBANCE (heightened sensory feelings at night), LIMB DISCOMFORT (Feet feel different) and FEELING HOT (feels heat and warmth). On an unknown date, the patient experienced PAIN (mild soreness). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy), SENSORY DISTURBANCE (heightened sensory feelings at night), LIMB DISCOMFORT (Feet feel different), FEELING HOT (feels heat and warmth) and PAIN (mild soreness) outcome was unknown. Action taken with mRNA-1273 in response to the events was not applicable. No treatment was prescribed for her events. The patient received both vaccine doses by a Pharmacy. The patient shared that she had heightened sensory feelings at nighttime within the sheets and that her feet started feeling different in February. At the end of March she saw an Internist who did blood work for her because of a procedure she was to have to remove basal cancer from her nose. The patient thought her Vitamin B12 levels might have been low, however from lab work her B12 levels were actually high and she was advised to stop taking her B12 supplementation at that time. The patient had a future appointment scheduled for August but wanted answers sooner regarding her inquiry. 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-2021-194667 (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: ATENOLOL; ASPIRIN 81; VITAMIN D 3; VITAMIN B12 [VITAMIN B12 NOS]

Current Illness:

ID: 1398489
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: severe allergic reaction; shortness of breath; rapid breathing; asthma; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction) 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 HYPERSENSITIVITY (severe allergic reaction) (seriousness criterion medically significant), DYSPNOEA (shortness of breath), RESPIRATORY RATE INCREASED (rapid breathing) and ASTHMA (asthma). At the time of the report, HYPERSENSITIVITY (severe allergic reaction), DYSPNOEA (shortness of breath), RESPIRATORY RATE INCREASED (rapid breathing) and ASTHMA (asthma) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient had severe allergic reaction to first dose of vaccine. Patient had shortness of breath and rapid breathing. Patient went to ER and they told patient got asthma and steroids and inhaler were given to patient. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.

Other Meds:

Current Illness:

ID: 1398490
Sex: F
Age: 61
State: OH

Vax Date: 04/07/2021
Onset Date: 05/07/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: psoriasis; autoimmune disorders; She is losing her hair, the hair on the back of her wrist and arms are lost.; red rash all over face, head, ears, neck; back in hell; Broke out scalp; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (back in hell) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Autoimmune arthritis. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-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 DISABILITY (back in hell) (seriousness criteria disability and medically significant), SKIN DISORDER (Broke out scalp) and RASH (red rash all over face, head, ears, neck). On an unknown date, the patient experienced PSORIASIS (psoriasis), AUTOIMMUNE DISORDER (autoimmune disorders) and ALOPECIA (She is losing her hair, the hair on the back of her wrist and arms are lost.). The patient was treated with TRIAMCINOLONE ACETONIDE for Rash on face, at a dose of UNK dosage form and ULOBETASOL PROPIONATE (LEXETTE) for Scalp rash, at a dose of UNK dosage form. At the time of the report, DISABILITY (back in hell), SKIN DISORDER (Broke out scalp), PSORIASIS (psoriasis), AUTOIMMUNE DISORDER (autoimmune disorders), ALOPECIA (She is losing her hair, the hair on the back of her wrist and arms are lost.) and RASH (red rash all over face, head, ears, neck) outcome was unknown. Concomitant medication use was not provided. Action taken with mRNA-1273 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. This case was linked to MOD-2021-194580 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Significant follow-up added on 02-JUN-2021, Contact information 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 events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1398491
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rheumatoid arthritis flare up; Burning leg; Cramps legs; Foot cramps; Swelling of legs; Lower extremities weakness; Generalized aching; CHILLS; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. 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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), BURNING SENSATION (Burning leg), MUSCLE SPASMS (Cramps legs), MUSCLE SPASMS (Foot cramps), PERIPHERAL SWELLING (Swelling of legs), MUSCULAR WEAKNESS (Lower extremities weakness), PAIN (Generalized aching), CHILLS (CHILLS) and HEADACHE (Headache). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BURNING SENSATION (Burning leg), MUSCULAR WEAKNESS (Lower extremities weakness), PAIN (Generalized aching), CHILLS (CHILLS) and HEADACHE (Headache) outcome was unknown and MUSCLE SPASMS (Cramps legs), MUSCLE SPASMS (Foot cramps) and PERIPHERAL SWELLING (Swelling of legs) had not resolved. No concomitant medications were reported.No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Company Comment: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04 Jun 2021.Second dose events were added.; Sender's Comments: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1398492
Sex: F
Age: 48
State: NY

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: triggered something in her body to cause an autoimmune disease; terrible itchy rash/it is on my arms and legs and extremely itchy; rash on her shin, calf and ankle and arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AUTOIMMUNE DISORDER (triggered something in her body to cause an autoimmune disease) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (triggered something in her body to cause an autoimmune disease) (seriousness criterion medically significant), RASH PRURITIC (terrible itchy rash/it is on my arms and legs and extremely itchy) and RASH (rash on her shin, calf and ankle and arm). At the time of the report, AUTOIMMUNE DISORDER (triggered something in her body to cause an autoimmune disease), RASH PRURITIC (terrible itchy rash/it is on my arms and legs and extremely itchy) and RASH (rash on her shin, calf and ankle and arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment included for the events were antihistamine which did not help and topical steroid which helped a little bit for the event rash. The patient had been to a general practitioner, an allergist and a dermatologist and she was having an appointment with a demonologist to follow up. 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. Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Initial_Additional1 Follow-up received: updated patient details, added new event and reporter details.; 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: 1398493
Sex: M
Age:
State: OK

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Bells-Palsy after 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (Bells-Palsy after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bells-Palsy after 1st dose) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells-Palsy after 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1398494
Sex: F
Age: 65
State: TX

Vax Date: 01/16/2021
Onset Date:
Rec V Date: 06/15/2021
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: heart attack; Heart palpitations elevated; Heart rate went high; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack), PALPITATIONS (Heart palpitations elevated) and HEART RATE INCREASED (Heart rate went high) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Heart palpitations elevated) (seriousness criterion hospitalization) and HEART RATE INCREASED (Heart rate went high) (seriousness criterion hospitalization). At the time of the report, MYOCARDIAL INFARCTION (heart attack), PALPITATIONS (Heart palpitations elevated) and HEART RATE INCREASED (Heart rate went high) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High. Other concomitant product include high blood pressure medication. Treatment information was not reported. Action taken with mRNA-1273 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: MULTIVITAMINS [VITAMINS NOS]

Current Illness:

Date Died: 03/06/2021

ID: 1398495
Sex: M
Age: 74
State: IL

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Myalgia; Chills; Taste loss; Smell loss; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia), CHILLS (Chills), AGEUSIA (Taste loss) and ANOSMIA (Smell loss) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 007M20A) for COVID-19 vaccination. No medical history information was provided. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Myalgia) (seriousness criterion death), CHILLS (Chills) (seriousness criterion death), AGEUSIA (Taste loss) (seriousness criterion death) and ANOSMIA (Smell loss) (seriousness criterion death). The patient died on 06-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No Concomitant medication information was provided. No treatment medication information was provided. Company Comment: This is a case of sudden death in a 74-year-old male patient with unknown medical history died after receiving vaccine. Very limited information has been provided at this time.; Sender's Comments: This is a case of sudden death in a 74-year-old male patient with unknown medical history died after receiving vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1398496
Sex: U
Age:
State:

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: High blood pressure; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High blood pressure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (High blood pressure) (seriousness criterion medically significant). At the time of the report, HYPERTENSION (High blood pressure) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) high. On an unknown date, Fibrin D dimer: unknown (Inconclusive) unknown. No concomitant medications were reported. Patient ended up in the ER on 02-MAY-2021 where he reported a DIMER was done. They were able to get his blood pressure down after 2 different medications. The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable. Company comment: Based on the current available information which includes a strong 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 which includes a strong 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: 1398497
Sex: F
Age: 63
State: MI

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 06/15/2021
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: Unevaluable event

Symptoms: Passed out; Feels worn out; Cramps like she never did before; Broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 63-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. On 20-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 20-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant), MUSCLE SPASMS (Cramps like she never did before) and URTICARIA (Broke out in hives). On an unknown date, the patient experienced FATIGUE (Feels worn out). The patient was hospitalized for 2 days due to LOSS OF CONSCIOUSNESS. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), MUSCLE SPASMS (Cramps like she never did before), URTICARIA (Broke out in hives) and FATIGUE (Feels worn out) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Haemoglobin: abnormal (abnormal) out of whack. The patient stated she experienced cramps like she never did before, broke out in hives everywhere, passed out, and now feels worn out. Th patient reported she did not experience any side effects from the first dose of the vaccine, which she received a few weeks prior. The patient noted she had never taken drugs prior to her second dose administration and she was perfectly healthy until now. Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medications, if any, were not provided by the reporter. Treatment medications also included steroids (unspecified) at the hospital, and an antihistamine (unspecified). 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. Further information has been requested.; 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: 1398498
Sex: F
Age: 56
State: CA

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Anaphylactic shock; throat started to close; tongue started swelling; hoarseness; coughing; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), LEVOCETIRIZINE DIHYDROCHLORIDE (PROVENT), ALBUTEROL [SALBUTAMOL], DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), METFORMIN, EXENATIDE (BYDUREON), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), DILTIAZEM, ALPRAZOLAM (XANAX), BACLOFEN, SERTRALINE HYDROCHLORIDE (ZOLOFT), EPINEPHRINE (EPIPEN) and PREDNISONE for an unknown indication. On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), THROAT IRRITATION (throat started to close), SWOLLEN TONGUE (tongue started swelling), DYSPHONIA (hoarseness), COUGH (coughing) and FATIGUE (fatigued). The patient was treated with Hospice care (Intubation) for Anaphylactic shock. On 20-May-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock), THROAT IRRITATION (throat started to close), SWOLLEN TONGUE (tongue started swelling) and COUGH (coughing) had resolved. At the time of the report, DYSPHONIA (hoarseness) and FATIGUE (fatigued) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient received medical treatment since she was at the hospital.Since then she has been fatigued and experiencing hoarseness. Concomitant product include Singulair , Zyrtec , Flonase , Proair , Provent , Neb.Albuterol , Benadryl , Metformin , Bydureon , Keppra ,Diltiazem , Xanax , Baclofen , Zoloft , EpiPen ,Prednisone for unknown indication. Patient was intubated. Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds: SINGULAIR; ZYRTEC ALLERGY; FLONASE ALLERGY RELIEF; PROAIR [SALBUTAMOL SULFATE]; PROVENT; ALBUTEROL [SALBUTAMOL]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; METFORMIN; BYDUREON; KEPPRA [LEVETIRACETAM]; DILTIAZEM; XANAX; BACLOFEN; ZOLOFT; EPIP

Current Illness:

ID: 1398499
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/15/2021
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: COVID19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID19) in a male 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 COVID-19 (COVID19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information was not provided. Treatment medication information was not provided. Company comment: Based on the mechanism of action of mRNA1273, it does not cause Covid 19, therefore the event is unlikely related to the vaccine.; Sender's Comments: Based on the mechanism of action of mRNA1273, it does not cause Covid 19, therefore the event is unlikely related to the vaccine.

Other Meds:

Current Illness:

ID: 1398500
Sex: M
Age: 86
State: CA

Vax Date: 01/28/2021
Onset Date: 05/01/2021
Rec V Date: 06/15/2021
Hospital: Y

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: reed blodd cells/hemoglobin down; white blood cells down; possible lymphoma; platelets down; Spleen enlarged; liver enlarged; Not feeling well overall; Dizziness; Throwing up bile; shortness of breath; Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), GENERAL PHYSICAL HEALTH DETERIORATION (Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly), HEPATOMEGALY (liver enlarged), ANAEMIA (reed blodd cells/hemoglobin down), LYMPHOPENIA (white blood cells down), LYMPHOMA (possible lymphoma), THROMBOCYTOPENIA (platelets down), SPLENOMEGALY (Spleen enlarged), MALAISE (Not feeling well overall), DIZZINESS (Dizziness) and VOMITING (Throwing up bile) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. The patient's past medical history included Blood transfusion (Patient has had 4 blood transfusions, has been hospitalized). Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), COLECALCIFEROL (VITAMIN D3), IRON, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), MACROGOL 3350 (MIRALAX), DOCUSATE SODIUM (COLACE), WARFARIN SODIUM (COUMADIN), ASPIRIN [ACETYLSALICYLIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced MALAISE (Not feeling well overall) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization) and VOMITING (Throwing up bile) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), GENERAL PHYSICAL HEALTH DETERIORATION (Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly) (seriousness criterion hospitalization), HEPATOMEGALY (liver enlarged) (seriousness criteria hospitalization and medically significant), ANAEMIA (reed blodd cells/hemoglobin down) (seriousness criterion hospitalization), LYMPHOPENIA (white blood cells down) (seriousness criterion hospitalization), LYMPHOMA (possible lymphoma) (seriousness criteria hospitalization and medically significant), THROMBOCYTOPENIA (platelets down) (seriousness criteria hospitalization and medically significant) and SPLENOMEGALY (Spleen enlarged) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 7 days due to DYSPNOEA and GENERAL PHYSICAL HEALTH DETERIORATION. The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at an unspecified dose and frequency; CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) at an unspecified dose and frequency and IRON at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), GENERAL PHYSICAL HEALTH DETERIORATION (Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly), HEPATOMEGALY (liver enlarged), ANAEMIA (reed blodd cells/hemoglobin down), LYMPHOPENIA (white blood cells down), LYMPHOMA (possible lymphoma), THROMBOCYTOPENIA (platelets down), SPLENOMEGALY (Spleen enlarged), MALAISE (Not feeling well overall), DIZZINESS (Dizziness) and VOMITING (Throwing up bile) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy bone marrow: unknown (Inconclusive) Inconclusive. In 2021, Biopsy liver: unknown (Inconclusive) Inconclusive. In 2021, Blood smear test: unknown (Inconclusive) Inconclusive. In 2021, Haemoglobin: low (Low) Low. In 2021, Platelet count: low (Low) Low. In 2021, Red blood cell count: low (Low) Low. In 2021, White blood cell count: low (Low) Low. Concomitant medications also include an inhaler (unspecified). 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.; 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: PROZAC; VITAMIN D3; IRON; PRILOSEC [OMEPRAZOLE]; MIRALAX; COLACE; COUMADIN; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN B12 [CYANOCOBALAMIN]; LIPITOR

Current Illness:

ID: 1398501
Sex: U
Age:
State:

Vax Date: 03/11/2021
Onset Date: 03/30/2021
Rec V Date: 06/15/2021
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: Heart attack; Clots in my coronary arteries; Lot o itching especially on my arms and legs; Skin rashes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack), CORONARY ARTERY THROMBOSIS (Clots in my coronary arteries), PRURITUS (Lot o itching especially on my arms and legs) and RASH (Skin rashes) 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 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRURITUS (Lot o itching especially on my arms and legs) (seriousness criterion life threatening) and RASH (Skin rashes) (seriousness criterion life threatening). On 28-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization, medically significant and life threatening) and CORONARY ARTERY THROMBOSIS (Clots in my coronary arteries) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and CORONARY ARTERY THROMBOSIS (Clots in my coronary arteries) was resolving and PRURITUS (Lot o itching especially on my arms and legs) and RASH (Skin rashes) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, Angiogram: clots in findings (abnormal) Clots in coronary arteries. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. 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. Patient was discharged and is continuing the treatment as prescribed. Company comment: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.; Sender's Comments: 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.

Other Meds:

Current Illness:

ID: 1398502
Sex: M
Age: 65
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: auto immune disorder; both wrist started swelling\Swollen Knee/swollen ankle; Swollen hands\swollen feet; muscle pain every night\Pain became persistent and wont go away.; Joint (and muscle ) pain; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (auto immune disorder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 004M20A) 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 QUINAPRIL for an unknown indication. 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. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (auto immune disorder) (seriousness criterion medically significant), JOINT SWELLING (both wrist started swelling\Swollen Knee/swollen ankle) and MYALGIA (muscle pain every night\Pain became persistent and wont go away.). an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen hands\swollen feet) and ARTHRALGIA (Joint (and muscle ) pain). At the time of the report, AUTOIMMUNE DISORDER (auto immune disorder), JOINT SWELLING (both wrist started swelling\Swollen Knee/swollen ankle), PERIPHERAL SWELLING (Swollen hands\swollen feet) and ARTHRALGIA (Joint (and muscle ) pain) outcome was unknown and MYALGIA (muscle pain every night\Pain became persistent and wont go away.) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, White blood cell count: high (High) extremely high but no visible sign of infection.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the events included steroids. It was reported that, side effects from both doses were alike and started on the night of vaccination. Two weeks after 2nd dose of vaccine, both wrists started swelling followed by the joint and muscle pain every night. Pain became persistent and won't go away. Pain only subsided 5-6 hours after taking steroids. It's been 6-8 weeks of extended inflammation. The laboratory exams performed to further understand the event included number of drug test and results pointed to an auto immune disorder. 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: QUINAPRIL

Current Illness:

ID: 1398503
Sex: U
Age:
State:

Vax Date: 01/01/2021
Onset Date: 06/03/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Diagnosed with Pneumonia after receiving both the doses of Moderna vaccine 3 months ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Diagnosed with Pneumonia after receiving both the doses of Moderna vaccine 3 months ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Pneumonia (7 months after receiving Moderna vaccine). In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced PNEUMONIA (Diagnosed with Pneumonia after receiving both the doses of Moderna vaccine 3 months ago) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Diagnosed with Pneumonia after receiving both the doses of Moderna vaccine 3 months ago) outcome was unknown. No concomitant products were reported. No treatment information was provided. Very limited information regarding the events has been provided at this time. Case without patient identifiers and contact information.; Sender's Comments: Very limited information regarding the events has been provided at this time. Case without patient identifiers and contact information.

Other Meds:

Current Illness:

ID: 1398504
Sex: M
Age: 61
State: NY

Vax Date: 03/23/2021
Onset Date: 05/05/2021
Rec V Date: 06/15/2021
Hospital: Y

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: Diagnosed with Posterior Leukoencephalopathy.; This spontaneous case was reported by a consumer and describes the occurrence of LEUKOENCEPHALOPATHY (Diagnosed with Posterior Leukoencephalopathy.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cholesterol. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LEUKOENCEPHALOPATHY (Diagnosed with Posterior Leukoencephalopathy.) (seriousness criteria hospitalization and medically significant). At the time of the report, LEUKOENCEPHALOPATHY (Diagnosed with Posterior Leukoencephalopathy.) outcome was unknown. Concomitant products include Cholesterol medication. Treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Reporter described the event as Brain inflammation and delirium. Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness: Cholesterol

ID: 1398505
Sex: M
Age: 25
State: MA

Vax Date: 05/01/2021
Onset Date: 05/29/2021
Rec V Date: 06/15/2021
Hospital: Y

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: Palpitation; Heart was acting erratically; Numbness on the left side; Puffiness on the left side; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation), HEART RATE ABNORMAL (Heart was acting erratically), HYPOAESTHESIA (Numbness on the left side) and SWELLING (Puffiness on the left side) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. 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 29-May-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced PALPITATIONS (Palpitation) (seriousness criterion hospitalization), HEART RATE ABNORMAL (Heart was acting erratically) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness on the left side) (seriousness criterion hospitalization) and SWELLING (Puffiness on the left side) (seriousness criterion hospitalization). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1once a day; IBUPROFEN (ADVIL 12 HOUR) on 29-May-2021 at a dose of 1 UNK and PARACETAMOL (TYLENOL) from 29-May-2021 to 30-May-2021 at a dose of 1 UNK. At the time of the report, PALPITATIONS (Palpitation), HEART RATE ABNORMAL (Heart was acting erratically), HYPOAESTHESIA (Numbness on the left side) and SWELLING (Puffiness on the left side) had not resolved. No relevant concomitant medications were provided. The reporter was in contact with physician and also went to emergency room (ER) but they were not able to resolve the problem. The reporter confirmed that these side effects were still going on. 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: 1398506
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Heartache pain; Ocular migraine; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heartache pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 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 ANGINA PECTORIS (Heartache pain) (seriousness criterion medically significant) and OPHTHALMIC MIGRAINE (Ocular migraine). At the time of the report, ANGINA PECTORIS (Heartache pain) and OPHTHALMIC MIGRAINE (Ocular migraine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product details not provided. Patient developed heart ache pain for 2 weeks and ocular migraine which the patient never had before in her life. Treatment details not provided. Company comment: 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: 1398507
Sex: M
Age: 81
State: FL

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 06/15/2021
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: COVID; COVID Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and COVID-19 PNEUMONIA (COVID Pneumonia) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The patient's past medical history included Ex-smoker. Concurrent medical conditions included Lung disease (patient states that he has an underlying condition on his lungs which he sleeps with masks and takes medication ). Concomitant products included BISACODYL (ELITON [BISACODYL]) and SALMETEROL XINAFOATE (PULMOTEROL) for an unknown indication. On 15-Apr-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 (COVID) (seriousness criterion hospitalization) and COVID-19 PNEUMONIA (COVID Pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 30-Apr-2021 to 15-May-2021 due to COVID-19 and COVID-19 PNEUMONIA. At the time of the report, COVID-19 (COVID) and COVID-19 PNEUMONIA (COVID Pneumonia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient refers that he didn't receive any treatment after discharge and does not recall the treatment he received while hospitalized. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.

Other Meds: ELITON [BISACODYL]; PULMOTEROL

Current Illness:

ID: 1398508
Sex: F
Age: 61
State: PA

Vax Date: 05/21/2021
Onset Date: 05/21/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: incorrect route of product administration; shaky; lightheaded; fever; sore arm; cold sweats; no strength,very weak; slept all day; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), ASTHENIA (no strength,very weak), SOMNOLENCE (slept all day), TREMOR (shaky), DIZZINESS (lightheaded) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A21A or 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Confined in the hospital for 3 weeks) on 23-Oct-2020. On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced COLD SWEAT (cold sweats) (seriousness criterion medically significant), ASTHENIA (no strength,very weak) (seriousness criterion medically significant), SOMNOLENCE (slept all day) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and PAIN IN EXTREMITY (sore arm). On 24-May-2021, the patient experienced TREMOR (shaky) (seriousness criterion medically significant) and DIZZINESS (lightheaded) (seriousness criterion medically significant). On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (incorrect route of product administration). On 21-May-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 24-May-2021, COLD SWEAT (cold sweats), ASTHENIA (no strength,very weak), SOMNOLENCE (slept all day) and PYREXIA (fever) had resolved. On 27-May-2021, TREMOR (shaky) and DIZZINESS (lightheaded) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (incorrect route of product administration) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Oxygen saturation: 82% percent (Low) decreased 82%. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided Treatment included oxygen inhalation to 8l pm Patient stated that she discharged on NOV 2020 with oxygen inhalation of 5lpm during night time and 2.5-3 lpm as needed during day time. 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: 1398509
Sex: M
Age: 58
State: TX

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Can't hear out of one of his ears after 2nd dose; Intense body aches after vaccine/ Intense body pains after vaccine; 2nd dose given sooner than 25 days after 1st dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (Can't hear out of one of his ears after 2nd dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leg amputation. Concurrent medical conditions included Diabetes, Blindness (nearly blind and has no legs), Cholesterol high and Physical disability (Patient has no Legs.). On 28-Apr-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 28-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given sooner than 25 days after 1st dose). On an unknown date, the patient experienced DEAFNESS UNILATERAL (Can't hear out of one of his ears after 2nd dose) (seriousness criterion medically significant) and MYALGIA (Intense body aches after vaccine/ Intense body pains after vaccine). On 28-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given sooner than 25 days after 1st dose) had resolved. At the time of the report, DEAFNESS UNILATERAL (Can't hear out of one of his ears after 2nd dose) and MYALGIA (Intense body aches after vaccine/ Intense body pains after vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Relevant concomitant medications included, antihistamines were reported. It was reported, the patient has no cough and his head is not stuffed up. 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.; 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: Blindness (nearly blind and has no legs); Cholesterol high; Diabetes; Physical disability (Patient has no Legs.)

ID: 1398510
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/15/2021
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: Erythema, Pruritus

Symptoms: Got COVID-19 4 days later; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID-19 4 days later) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID-19 4 days later) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Got COVID-19 4 days later) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Treatment information was not provided. The patient stated that she got COVID-19 4 days later and was hospitalized for 11 days. Company comment: Based on reporter's causality and mechanism of action mRna -1273 vaccine, does not cause the Covid -19 disease. The event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on reporter's causality and mechanism of action mRna -1273 vaccine, does not cause the Covid -19 disease. The event is assessed as unlikely related to mRNA-1273.

Other Meds:

Current Illness:

ID: 1398511
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: had a miscarriage; had vaccine during the first 10 weeks and had a miscarriage; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (had a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (had a miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (had vaccine during the first 10 weeks and had a miscarriage). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (had a miscarriage) and EXPOSURE DURING PREGNANCY (had vaccine during the first 10 weeks and had a miscarriage) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication and treatment drug was reported. It was reported that the baby died Company comment: This is a case of product exposure during pregnancy which resulted in Spontaneous Abortion, for this female with undocumented age. Very limited information has been provided at this time.; Sender's Comments: This is a case of product exposure during pregnancy which resulted in Spontaneous Abortion, for this female with undocumented age. Very limited information has been provided at this time.

Other Meds:

Current Illness:

ID: 1398512
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: got pneumonia after receiving first vaccine shot,the vaccine caused her pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (got pneumonia after receiving first vaccine shot,the vaccine caused her pneumonia) in an 89-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (got pneumonia after receiving first vaccine shot,the vaccine caused her pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (got pneumonia after receiving first vaccine shot,the vaccine caused her pneumonia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient refuses to go for second shot as she is convinced that the vaccine caused her pneumonia. Company comment Very limited information regarding this event has been provided at this time. No further information is expected at this time. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.

Other Meds:

Current Illness:

ID: 1398513
Sex: F
Age:
State: TX

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: diastolic blood pressure shot up around 150 mmHG; a swollen tongue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE DIASTOLIC INCREASED (diastolic blood pressure shot up around 150 mmHG) and SWOLLEN TONGUE (a swollen tongue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced BLOOD PRESSURE DIASTOLIC INCREASED (diastolic blood pressure shot up around 150 mmHG) (seriousness criterion medically significant) and SWOLLEN TONGUE (a swollen tongue) (seriousness criterion medically significant). On 18-Mar-2021, BLOOD PRESSURE DIASTOLIC INCREASED (diastolic blood pressure shot up around 150 mmHG) and SWOLLEN TONGUE (a swollen tongue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Blood pressure diastolic: 150 mmHg (High) Elevated. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment medications 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: 1398514
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: palsy after 1 week of taking moderna covid -19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (palsy after 1 week of taking moderna covid -19 vaccine) 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 PARALYSIS (palsy after 1 week of taking moderna covid -19 vaccine) (seriousness criterion medically significant). At the time of the report, PARALYSIS (palsy after 1 week of taking moderna covid -19 vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient experienced palsy a week after taking Moderna Covid-19 vaccine. No treatment or concomitant medications were reported by the reporter. 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: 1398515
Sex: F
Age:
State:

Vax Date: 06/03/2021
Onset Date: 06/04/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: moderate to severe fainting spell; tingling in legs and hands; profuse sweating; chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (moderate to severe fainting spell) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Jun-2021 at 2:10 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PARAESTHESIA (tingling in legs and hands), HYPERHIDROSIS (profuse sweating) and CHILLS (chills). On 04-Jun-2021 at 12:15 PM, the patient experienced SYNCOPE (moderate to severe fainting spell) (seriousness criterion medically significant). On 04-Jun-2021, SYNCOPE (moderate to severe fainting spell), HYPERHIDROSIS (profuse sweating) and CHILLS (chills) had resolved. At the time of the report, PARAESTHESIA (tingling in legs and hands) outcome was unknown. It was reported the patient did not go to ER but did consider calling an ambulance if the initial part of the spell did not pass within another 30 minutes. No treatment and concomitant medication information 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: 1398516
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 06/15/2021
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: Seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 27-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Seizure) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, SEIZURE (Seizure) had not resolved. No concomitant medications were reported. Treatment medications were not provided. 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:

ID: 1398517
Sex: F
Age:
State: PA

Vax Date: 02/19/2021
Onset Date: 03/19/2021
Rec V Date: 06/15/2021
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: shortness of breath at Rest (Comes and goes) After Second Dose; Chest Pain at Rest and when Deep Breathing (After Second Vaccine); Became dependent on others after second dose; Headache; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA AT REST (shortness of breath at Rest (Comes and goes) After Second Dose) and CHEST PAIN (Chest Pain at Rest and when Deep Breathing (After Second Vaccine)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Became dependent on others after second dose), HEADACHE (Headache) and NAUSEA (Nausea). On 20-Mar-2021, the patient experienced DYSPNOEA AT REST (shortness of breath at Rest (Comes and goes) After Second Dose) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (Chest Pain at Rest and when Deep Breathing (After Second Vaccine)) (seriousness criterion hospitalization). On 24-Mar-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, DYSPNOEA AT REST (shortness of breath at Rest (Comes and goes) After Second Dose), CHEST PAIN (Chest Pain at Rest and when Deep Breathing (After Second Vaccine)) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Became dependent on others after second dose) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) scan of lungs and Cardiac scan showed clear, all tests were normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported by the reporter. No treatment medications were reporter by the reporter. 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: 1398518
Sex: F
Age: 62
State: PA

Vax Date: 05/21/2021
Onset Date: 05/21/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Cellulitis in arm; Arm has a bruise that is getting larger over time; Swollen arm bright red in color, hot to the touch; Swollen arm bright red in color, hot to the touch; Swollen arm bright red in color, hot to the touch; Fever of 103.8 degrees Fahrenheit; Vomiting; words slurring; Sweating profusely; Became truly delirious; Scab at the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DELIRIUM (Became truly delirious) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Guillain Barre syndrome and Cutaneous lupus erythematosus. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), TOPIRAMATE (TOPAMAX), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), IMMUNOGLOBULINS NOS and LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication. On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced VACCINATION SITE SCAB (Scab at the site of injection). On 22-May-2021, the patient experienced DELIRIUM (Became truly delirious) (seriousness criterion medically significant), DYSARTHRIA (words slurring), HYPERHIDROSIS (Sweating profusely), PYREXIA (Fever of 103.8 degrees Fahrenheit) and VOMITING (Vomiting). On 23-May-2021, the patient experienced CELLULITIS (Cellulitis in arm), INJECTION SITE BRUISING (Arm has a bruise that is getting larger over time), VACCINATION SITE WARMTH (Swollen arm bright red in color, hot to the touch), VACCINATION SITE SWELLING (Swollen arm bright red in color, hot to the touch) and VACCINATION SITE ERYTHEMA (Swollen arm bright red in color, hot to the touch). The patient was treated with CEFTRIAXONE (CEFTIN [CEFTRIAXONE]) ongoing since an unknown date for Cellulitis, at an unspecified dose and frequency; ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Fever, at a dose of UNK dosage form. On 22-May-2021, DELIRIUM (Became truly delirious), DYSARTHRIA (words slurring), HYPERHIDROSIS (Sweating profusely) and VOMITING (Vomiting) had resolved. On 23-May-2021, PYREXIA (Fever of 103.8 degrees Fahrenheit) had resolved. On 24-May-2021, CELLULITIS (Cellulitis in arm), VACCINATION SITE WARMTH (Swollen arm bright red in color, hot to the touch), VACCINATION SITE SWELLING (Swollen arm bright red in color, hot to the touch) and VACCINATION SITE ERYTHEMA (Swollen arm bright red in color, hot to the touch) had resolved. At the time of the report, INJECTION SITE BRUISING (Arm has a bruise that is getting larger over time) and VACCINATION SITE SCAB (Scab at the site of injection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, Body temperature: 103.8 (High) 103.8 degrees Fahrenheit. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included intravenous fluids in Emergency Room. 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. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: contained significant information: lot number updated. On 08-Jun-2021: non-significant information: contact details 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 events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds: WELLBUTRIN; TOPAMAX; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; IMMUNOGLOBULINS NOS; VYVANSE

Current Illness: Cutaneous lupus erythematosus; Guillain Barre syndrome

ID: 1398519
Sex: M
Age: 58
State: CA

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: choking; Burping after the first dose; Hands and face red; Hands and face swollen; Hands and face swollen; Anaphylactic shock; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Thyroid cancer (history of thyroid cancer). Concurrent medical conditions included HIV infection (HIV positive and on a regimen and undetectable for 20 years) and Renal pain (kidneys hurt once in a while and stated as not taking booster dose in October). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE SODIUM (LEVOTIRON), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), CHOKING (choking), ERUCTATION (Burping after the first dose), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), CHOKING (choking), ERUCTATION (Burping after the first dose), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen) had resolved. The patient reported having anaphylactic shock after receiving vaccine on 12-Mar-2021. Patient reported burping, hands and face red after reaching home about 45mins after receiving the first dose and was rushed to Emergency room where the patient experienced choking and swollen hand and face. No corrective treatment was provided. The action taken with mRNA-1273 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. This case was linked to MOD-2021-209375 (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: LIPITOR; LEVOTIRON; PRILOSEC [OMEPRAZOLE]; GENVOYA

Current Illness: HIV infection (HIV positive and on a regimen and undetectable for 20 years); Renal pain (kidneys hurt once in a while and stated as not taking booster dose in October)

ID: 1398520
Sex: M
Age: 58
State: PA

Vax Date: 05/04/2021
Onset Date: 05/01/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Sharp/stabbing pain in the right part of the abdomen; Difficulty moving or turning body; Ringing in ear predominantly in right ear; the patient has extensive hearing loss, with hearing loss being worse in the right ear; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss worsened a little each day, after a week I could hardly hear(right ear)) in a 58-year-old male 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 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 DEAFNESS UNILATERAL (Hearing loss worsened a little each day, after a week I could hardly hear(right ear)) (seriousness criterion medically significant), ABDOMINAL PAIN (Sharp/stabbing pain in the right part of the abdomen), HYPOKINESIA (Difficulty moving or turning body) and TINNITUS (Ringing in ear predominantly in right ear). On 05-May-2021, ABDOMINAL PAIN (Sharp/stabbing pain in the right part of the abdomen) and HYPOKINESIA (Difficulty moving or turning body) had resolved. At the time of the report, DEAFNESS UNILATERAL (Hearing loss worsened a little each day, after a week I could hardly hear(right ear)) and TINNITUS (Ringing in ear predominantly in right ear) 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 medication was reported. No treatment was reported. Patient reported that a week after having received the vaccine the patient claims they could barely hear, and were reading lips to communicate. The patient has visited an Ear Nose and Throat specialist physician who has confirmed that the patient has extensive hearing loss. Patient is not planning on receiving the second dose of the Moderna COVID-19 vaccine.; 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: 1398521
Sex: U
Age:
State:

Vax Date: 05/21/2021
Onset Date: 05/21/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Myocarditis; Chest pain, crushing pain in my heart; Fever; Body ache; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Myocarditis) in an adult patient of an unknown 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 21-May-2021 at 8:30 AM, 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 21-May-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills). On 25-May-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On 23-May-2021, PYREXIA (Fever), MYALGIA (Body ache) and CHILLS (Chills) had resolved. At the time of the report, MYOCARDITIS (Myocarditis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Angiogram: unknown Unknown. On 24-May-2021, Electrocardiogram: abnormal (abnormal) Abnormal. On 24-May-2021, Magnetic resonance imaging: unknown Unknown. Concomitant product use was not reported. It was reported that by that evening, patient felt the usual symptoms of fever, body ache and chills, which continued for the next 48 hours. By Sunday, 23-May-2021, patient was feeling back to normal and in good health. The next morning, Monday, 24-May-2021, patient woke up with chest pain, a crushing pain in heart and went to the ER. An EKG was taken, and the cardiologist mentioned that it was abnormal and that a catheter angiogram needed to be done to check the arteries. Treatment included overnight monitoring by the cardiology team. Next morning, the cardiologist told the patient that the patient has myocarditis, and that it is showing up in younger adults who have taken the vaccine. Patient is currently on medication over the course of the next month, till follow up visit with the cardiologist. 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: 1398522
Sex: M
Age: 61
State: KY

Vax Date: 03/02/2021
Onset Date: 03/06/2021
Rec V Date: 06/15/2021
Hospital: Y

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: Mini-stroke; Mini-stroke; Stroke; Blood pressure was high; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), the second episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) and the first episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Stenosis. Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN 81) and EVOLOCUMAB (REPATHA) for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 09-Mar-2021, the patient experienced the first episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) (seriousness criteria hospitalization and medically significant). On 10-May-2021, the patient experienced the second episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was high). The patient was hospitalized from 06-Mar-2021 to 07-Mar-2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with NITROGLYCERIN on 10-Mar-2021 for Hypertension, at a dose of 1 dosage form. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), the last episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) and BLOOD PRESSURE INCREASED (Blood pressure was high) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 06March2021 he was taken to the hospital by ambulance where he was diagnosed with having had a stroke. He was discharged home on 07March2021. The evening of 09March2021 he had a mini-stroke but remainded at home. Early morning on 10March2021 he had another mimi-stroke and was taken to the emergency room by ambulance. Patient states his blood pressure was high and he thinks he was treated with nitroglyercin but cannot recall the names of other meds given. He was discharged from the emergency room later that night of 10March2021. Patient declines to give me his full list of daily meds because that are too many 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. Other contributing factors were reported (concomitant disease). This case was linked to MOD-2021-209430 (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 contributing factors were reported (concomitant disease).

Other Meds: BRILINTA; ASPIRIN 81; REPATHA

Current Illness: Stenosis

ID: 1398523
Sex: M
Age: 58
State: CA

Vax Date: 03/12/2021
Onset Date: 04/17/2021
Rec V Date: 06/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Anaphylactic shock; choking; Burping; Hands and face red; Hands and face swollen; Hands and face swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Thyroid cancer (history of thyroid cancer). Concurrent medical conditions included HIV infection (HIV positive and on a regimen and undetectable for 20 years) and Renal pain (kidneys hurt once in a while and stated as not taking booster dose in October). On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), CHOKING (choking), ERUCTATION (Burping), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen). On 17-Apr-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock), CHOKING (choking), ERUCTATION (Burping), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen) had resolved. No corrective treatment was provided. It was reported that, after receiving 2nd dose, patient was having similar reaction in 5 minutes when under medical supervision and was revived." to "Patient reported as burping, hands and face red after reaching home about 45mins after receiving the first dose on 12th Mar 2021 and was rushed to Emergency room where caller mentioned as experienced choking and swollen hand and face. Caller received second dose on 17th Apr 2021 and mentioned as having similar reaction in 5 mins when under medical supervision and was revived. 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-2021-209326 (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: HIV infection (HIV positive and on a regimen and undetectable for 20 years); Renal pain (kidneys hurt once in a while and stated as not taking booster dose in October)

ID: 1398524
Sex: F
Age: 68
State: IA

Vax Date: 01/28/2021
Onset Date: 03/25/2021
Rec V Date: 06/15/2021
Hospital: Y

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: large blood clot in the right lung/smaller blood clot in the left lung; blood clot in the calf of the left leg; Baker's cyst behind the left knee; "I still didn't feel right or good"; "problems with my kidneys"; dull pain; "really bad chest pains"; "knee got swollen up"; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) and THROMBOSIS (blood clot in the calf of the left leg) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included LOSARTAN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), OMEPRAZOLE, EZETIMIBE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), VITAMIN D [VITAMIN D NOS], CALCIUM, MULTIVITAMINS [VITAMINS NOS] and APIXABAN (ELIQUIS) for an unknown indication. On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced JOINT SWELLING ("knee got swollen up"). On 26-Apr-2021, the patient experienced PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) (seriousness criteria hospitalization and medically significant) and CHEST PAIN ("really bad chest pains"). On an unknown date, the patient experienced THROMBOSIS (blood clot in the calf of the left leg) (seriousness criterion medically significant), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain). At the time of the report, PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung), THROMBOSIS (blood clot in the calf of the left leg), JOINT SWELLING ("knee got swollen up"), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), CHEST PAIN ("really bad chest pains"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Company comment: Very limited information regarding this events has been provided at this time. 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.; Sender's Comments: Very limited information regarding this events has been provided at this time. 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: LOSARTAN; BYSTOLIC; OMEPRAZOLE; EZETIMIBE; ZYRTEC ALLERGY; VITAMIN D [VITAMIN D NOS]; CALCIUM; MULTIVITAMINS [VITAMINS NOS]; ELIQUIS

Current Illness:

ID: 1398525
Sex: F
Age:
State: CA

Vax Date: 03/11/2021
Onset Date: 04/06/2021
Rec V Date: 06/15/2021
Hospital: Y

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: I have an autoimmune disease, it exacerbated that I think; Haven't been able to sleep well in the last week,; I feel energized and exhausted at the same time; I feel worn out /I feel energized and exhausted at the same time; Weak; and was having trouble walking; Body ache; Extreme joint pain; Headache/I still have pain in my head on top and the back of head; I had chest pain; A lot pressure in my head; A lot of vertigo; Very shaky/I feel like I have a shock in my body; Dizziness; Anxiety/Anxiety attack; Panic attack; I immediately had nausea; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (I have an autoimmune disease, it exacerbated that I think) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Migraine and Autoimmune disorder NOS. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for Depression, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced AUTOIMMUNE DISORDER (I have an autoimmune disease, it exacerbated that I think) (seriousness criteria hospitalization and medically significant), DIZZINESS (Dizziness), ANXIETY (Anxiety/Anxiety attack), PANIC ATTACK (Panic attack) and NAUSEA (I immediately had nausea). On 03-May-2021, the patient experienced CHEST PAIN (I had chest pain), HEAD DISCOMFORT (A lot pressure in my head), VERTIGO (A lot of vertigo), TREMOR (Very shaky/I feel like I have a shock in my body), GAIT DISTURBANCE (and was having trouble walking), HEADACHE (Headache/I still have pain in my head on top and the back of head), MYALGIA (Body ache) and ARTHRALGIA (Extreme joint pain). On 03-Jun-2021, the patient experienced ASTHENIA (Weak). On 05-Jun-2021, the patient experienced INSOMNIA (Haven't been able to sleep well in the last week,), ENERGY INCREASED (I feel energized and exhausted at the same time) and FATIGUE (I feel worn out /I feel energized and exhausted at the same time). The patient was hospitalized from 03-May-2021 to 04-May-2021 due to AUTOIMMUNE DISORDER. The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Vertigo, at a dose of 1 dosage form; ACRIVASTINE (BENADRYL OTC) at a dose of 1 dosage form; IBUPROFEN at a dose of 200 mg three times a day and PARACETAMOL (TYLENOL 8 HOUR) at a dose of 1 dosage form. At the time of the report, AUTOIMMUNE DISORDER (I have an autoimmune disease, it exacerbated that I think), DIZZINESS (Dizziness), ANXIETY (Anxiety/Anxiety attack), PANIC ATTACK (Panic attack), CHEST PAIN (I had chest pain), HEAD DISCOMFORT (A lot pressure in my head), VERTIGO (A lot of vertigo), TREMOR (Very shaky/I feel like I have a shock in my body), ASTHENIA (Weak), GAIT DISTURBANCE (and was having trouble walking), INSOMNIA (Haven't been able to sleep well in the last week,), ENERGY INCREASED (I feel energized and exhausted at the same time), HEADACHE (Headache/I still have pain in my head on top and the back of head), NAUSEA (I immediately had nausea), MYALGIA (Body ache), ARTHRALGIA (Extreme joint pain) and FATIGUE (I feel worn out /I feel energized and exhausted at the same time) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Blood test: normal No findings. On 03-May-2021, Electrocardiogram: no blood clots normal. On 03-May-2021, Ultrasound chest: no blood clots normal. Patient does not have DVT. She is allergic to many allergens so the Emergency Room did not prescribe her any medications.Treatment information mentioned IV fluids NOS. Additional information mentioned, the patient had a few similar events occur after the second dose as well. She went to the emergency room to get treated. Post that, still had some events and has scheduled a doctors appointment. 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 case was linked to MOD-2021-209781 (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 event, a causal relationship cannot be excluded.

Other Meds: WELLBUTRIN XL; SYNTHROID

Current Illness: Autoimmune disorder NOS; Migraine

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm