VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1363957
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 05/30/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: CHEST PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04219-21A, expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chest pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363958
Sex: M
Age:
State: IN

Vax Date:
Onset Date: 05/24/2021
Rec V Date: 06/01/2021
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: HORRIBLE BACK PAIN (WITH A PAIN SCALE OF 7.5 OUT OF 10); SWOLLEN POUCH ON LEFT LOWER BACK APPROXIMATELY FOUR INCHES DIAMETER AND THREE INCHES HEIGHT DIAGNOSED AS LYMPHATIC ISSUE DUE TO VACCINE; FEVER OF MORE OR LESS 100 F; This spontaneous report received from a consumer concerned a 20 year old male. The patient's weight was 150 pounds, and height was 190 centimeters. The patient's pre-existing medical conditions included the patient had no pertinent medical history. the patient had no known allergies. the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced horrible back pain (with a pain scale of 7.5 out of 10). On 24-MAY-2021, the subject experienced swollen pouch on left lower back approximately four inches diameter and three inches height diagnosed as lymphatic issue due to vaccine. On 24-MAY-2021, the subject experienced fever of more or less 100 f. Laboratory data included: Body temperature (NR: not provided) more or less 100 F. Treatment medications included: paracetamol. On 25-MAY-2021, Laboratory data included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen pouch on left lower back approximately four inches diameter and three inches height diagnosed as lymphatic issue due to vaccine on MAY-2021, and was recovering from horrible back pain (with a pain scale of 7.5 out of 10), and fever of more or less 100 f. This report was non-serious. This case, from the same reporter is linked to 20210557778.

Other Meds:

Current Illness:

ID: 1363959
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 06/01/2021
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: HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious

Other Meds:

Current Illness:

ID: 1363960
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 05/28/2021
Rec V Date: 06/01/2021
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: LUMP IN THE CREASE OF ARM; BODY SORENESS; CHILLS; This spontaneous report received from a consumer concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced body soreness. On 28-MAY-2021, the subject experienced chills. On 29-MAY-2021, the subject experienced lump in the crease of arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAY-2021, and had not recovered from lump in the crease of arm, and body soreness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363961
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 05/20/2021
Rec V Date: 06/01/2021
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: LAYERS OF PUSTULES ON TOP OF PUSTULES ON HER LEFT ARM, PUSTULES STARTED LEAKING OUT; LESIONS ON HER RIGHT FOREARM AND WRIST, LESIONS CONTINUING TO SPREAD, LESION ON HER INTERIOR LOWER RIGHT LEG JUST ABOVE ANKLE; SKIN PEELED OFF ON THE LEFT FOREARM, SKIN PEELING FROM OTHER LESIONS; LESIONS ON HER RIGHT FOREARM AND WRIST, LESION ON HER INTERIOR LOWER RIGHT LEG JUST ABOVE ANKLE; RASH BOTH RIGHT AND LEFT FOREARMS, LEFT TORSO, CHEST, LEFT BREAST, RASHY SYMPTOMS" ON BOTH BUTTOCKS AND HIPS AND BOTH UPPER THIGHS, RASH ON THE BACK OF HER NECK, RASH ON FACE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included psoriatic arthritis, premature atrial complexes, microscopic colitis, psoriasis, partial knee replacement, total knee replacement, three tumor removals, complete hysterectomy, and clostridium difficile colitis, and concurrent conditions included dilaudid allergy, rare alcohol use, cigarette smoker, and nsaid allergy, and other pre-existing medical conditions included the patient had no known drug abuse or illicit drug usage and no egg allergy. The patient experienced itchiness and rash when treated with influenza vaccine, and itchiness when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. Concomitant medications included diltiazem, diphenhydramine hydrochloride, ergocalciferol, metoprolol succinate, ubidecarenone, and vitamin b complex. On 20-MAY-2021, the subject experienced lesions on her right forearm and wrist, lesion on her interior lower right leg just above ankle. On 20-MAY-2021, the subject experienced rash both right and left forearms, left torso, chest, left breast, rashy symptoms" on both buttocks and hips and both upper thighs, rash on the back of her neck, rash on face. On 22-MAY-2021, the subject experienced layers of pustules on top of pustules on her left arm, pustules started leaking out. On 22-MAY-2021, the subject experienced lesions on her right forearm and wrist, lesions continuing to spread, lesion on her interior lower right leg just above ankle. On 22-MAY-2021, the subject experienced skin peeled off on the left forearm, skin peeling from other lesions. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) slightly elevated sodium levels and high triglycerides. Treatment medications (dates unspecified) included: calamine/glycerol/zinc oxide, methylprednisolone, and hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash both right and left forearms, left torso, chest, left breast, rashy symptoms" on both buttocks and hips and both upper thighs, rash on the back of her neck, rash on face, layers of pustules on top of pustules on her left arm, pustules started leaking out, lesions on her right forearm and wrist, lesions continuing to spread, lesion on her interior lower right leg just above ankle, skin peeled off on the left forearm, skin peeling from other lesions, and lesions on her right forearm and wrist, lesion on her interior lower right leg just above ankle. This report was non-serious.

Other Meds: VITAMIN B COMPLEX; VITAMIN D [ERGOCALCIFEROL]; METOPROLOL SUCCINATE; CARDIZEM [DILTIAZEM]; COQ10 [UBIDECARENONE]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Alcohol use; Cigarette smoker (Half a pack a day usually but since on prednisone she was taking a pack per day); Drug allergy

ID: 1363962
Sex: M
Age:
State: OR

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

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

Lab Data:

Allergies:

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

Symptoms: NOT FEELING WELL; DIARRHEA; DRY COUGH; VOMITING TWICE; FEVER; NAUSEA; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergy, no medical history, not taking any routine medications. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 16:00 for prophylactic vaccination. Concomitant medications included dextromethorphan hydrobromide/ethanol/guaifenesin for dry cough, and paracetamol for headache. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced nausea. On 28-MAY-2021, the subject experienced headache. On 28-MAY-2021, the subject experienced fatigue. On 29-MAY-2021, the subject experienced diarrhea. On 29-MAY-2021, the subject experienced dry cough. On 29-MAY-2021, the subject experienced vomiting twice. Laboratory data included: Body temperature (NR: not provided) 103 F. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting twice, had not recovered from fever, nausea, headache, diarrhea, and dry cough, and the outcome of fatigue and not feeling well was not reported. This report was non-serious.

Other Meds: TYLENOL; ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE;ETHANOL;GUAIFENESIN]

Current Illness: Abstains from alcohol; Non-smoker

ID: 1363963
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/01/2021
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: SWELLING OF LEGS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included used to getting high, and concurrent conditions included citrus acid allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced swelling of legs. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swelling of legs was not reported. This report was non-serious.

Other Meds:

Current Illness: Fruit allergy

ID: 1363964
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: RAPID HEART BEAT; FEELING OUT OF BREATH; CHEST DISCOMFORT; SWEATING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced rapid heart beat. On 06-MAR-2021, the subject experienced feeling out of breath. On 06-MAR-2021, the subject experienced chest discomfort. On 06-MAR-2021, the subject experienced sweating. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, and fever, and had not recovered from rapid heart beat, feeling out of breath, and chest discomfort. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363965
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 05/25/2021
Rec V Date: 06/01/2021
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: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 29 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no illness at the time of vaccination. the patient had no past history of similar event. the patient had no adverse event after any previous vaccinations. the patient had no history of allergy to vaccine, drug or food. the patient had no pre-existing acute illness 30 days prior to vaccination. patient had no history of hospitalization in last 30 days, the patient had no family history of any disease (relevant to vaccination) or allergy. the patient was not pregnant at time of vaccination. the patient was not breastfeeding at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805029 expiry: 25-MAY-2021) .5 ml, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210549259.

Other Meds:

Current Illness:

ID: 1363966
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 06/01/2021
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: GREEN PHLEGM; EARS HURTING; PRESSURE/PAIN IN CHEST; SORE THROAT; TINGLING, BOTHERSOME, HURTING NECK GLANDS; HURTING NECK GLANDS; DISCOMFORT; SWELLING OF THE GLANDS IN THE NECK AREA; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included diagnosis of covid-19, and lost smell in one nostril. The patient was previously treated with ibuprofen for lost smell in one nostril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAY-2021 11:15 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced discomfort. On MAY-2021, the subject experienced swelling of the glands in the neck area. Treatment medications included: salbutamol sulfate. On 26-MAY-2021, the subject experienced tingling, bothersome, hurting neck glands. On 26-MAY-2021, the subject experienced hurting neck glands. On 27-MAY-2021, the subject experienced sore throat. On 28-MAY-2021, the subject experienced pressure/pain in chest. On 29-MAY-2021, the subject experienced green phlegm. On 29-MAY-2021, the subject experienced ears hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from discomfort, and the outcome of tingling, bothersome, hurting neck glands, sore throat, pressure/pain in chest, green phlegm, ears hurting, hurting neck glands and swelling of the glands in the neck area was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363967
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 05/24/2021
Rec V Date: 06/01/2021
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: HEAVY VAGINAL BLEEDING WITH CLOTS; SPOT; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced spot. On 29-MAY-2021, the subject experienced heavy vaginal bleeding with clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy vaginal bleeding with clots, and the outcome of spot was not reported. This report was non-serious.

Other Meds:

Current Illness: Hypertension

ID: 1363968
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 05/16/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: LIGHT COUGH; RUNNY NOSE; COLD; NASAL CONGESTION; CHILLS; BODY PAIN; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced body pain. On 16-MAY-2021, the subject experienced chills. On 28-MAY-2021, the subject experienced light cough. On 28-MAY-2021, the subject experienced runny nose. On 28-MAY-2021, the subject experienced cold. On 28-MAY-2021, the subject experienced nasal congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, and chills on 16-MAY-2021, and was recovering from light cough, runny nose, cold, and nasal congestion. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363969
Sex: M
Age: 68
State: CA

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 06/01/2021
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: suicidal thoughts; Depression; Chest pain; Fingers go numb/my arm feels numb; lack of sleep and sleeping issues; Nightmares; Stressed out; Weakness; Runny Nose; very angry; Headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (suicidal thoughts) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2019. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUICIDAL IDEATION (suicidal thoughts) (seriousness criterion medically significant), DEPRESSION (Depression), CHEST PAIN (Chest pain), HYPOAESTHESIA (Fingers go numb/my arm feels numb), SLEEP DISORDER (lack of sleep and sleeping issues), NIGHTMARE (Nightmares), STRESS (Stressed out), ASTHENIA (Weakness), RHINORRHOEA (Runny Nose), ANGER (very angry) and HEADACHE (Headache). At the time of the report, SUICIDAL IDEATION (suicidal thoughts) and ANGER (very angry) outcome was unknown and DEPRESSION (Depression), CHEST PAIN (Chest pain), HYPOAESTHESIA (Fingers go numb/my arm feels numb), SLEEP DISORDER (lack of sleep and sleeping issues), NIGHTMARE (Nightmares), STRESS (Stressed out), ASTHENIA (Weakness), RHINORRHOEA (Runny Nose) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, COVID-19: positve Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment medications was not provided. Company comment: Very limited information regarding the events has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Initial Additional information received On 04-May-2021: Initial Additional information received. On 10-May-2021: Initial Additional information received. On 17-May-2021: Initial Additional information received. On 20-May-2021: Initial Additional information received.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.

Other Meds:

Current Illness:

ID: 1363970
Sex: M
Age: 52
State: NC

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 06/01/2021
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: smelled an antiseptic smell / smells a chemicals all day and night/still persisting; showered and still smelled it/showered and still smelled it\ band-aid smell; Arm has minor soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (smelled an antiseptic smell / smells a chemicals all day and night/still persisting), SKIN ODOUR ABNORMAL (showered and still smelled it/showered and still smelled it\ band-aid smell) and MYALGIA (Arm has minor soreness) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-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 PAROSMIA (smelled an antiseptic smell / smells a chemicals all day and night/still persisting) (seriousness criterion medically significant), SKIN ODOUR ABNORMAL (showered and still smelled it/showered and still smelled it\ band-aid smell) (seriousness criterion medically significant) and MYALGIA (Arm has minor soreness) (seriousness criterion medically significant). At the time of the report, PAROSMIA (smelled an antiseptic smell / smells a chemicals all day and night/still persisting) had not resolved and SKIN ODOUR ABNORMAL (showered and still smelled it/showered and still smelled it\ band-aid smell) and MYALGIA (Arm has minor soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. The treatment information was unknown. This patient is going to continue to call Moderna until he gets a call back from the Safety department. Patient is very frustrated and bothered that Moderna has not made more information public even though millions of vaccines have been administered. He feels he is in a rare side effect group and that this information should be taken more serious. He has seen a specialist regarding his side effect which has not gone away after his first vaccine over 90 days ago. He states he "smells a chemical smell all day and night, it started immediately after receiving the vaccine". This has been the worst experience for this patient and he wishes he never got the vaccine. Patient explains that his doctor said the mRNA has woven itself into the endothelial cells and that's why he is smelling these strange cells". Follow-up 2: patient reported after receiving the 1st dose of Moderna vaccine. this was the fourth time the call was made. Caller mentioned, that I contacted the HCP as per Moderna advise, and the doctor has no information for the adverse reaction I developed after the vaccination and mentioned, that the mRNA grafted in to patient's olfactory Celia and in to my own DNA. Also mentioned if this adverse reaction of "antiseptic Smell" , persisting more than 60 days time period , then its going to remain with him for ever. So patient is very upset and safety Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Significant follow up appended. On 15-Apr-2021: Followup information was received on 24-Apr-2021. events was updated reason for his side effects is because the mRNA has attached itself tot he epithelial cells and havewoven themselves into the DNA. On 18-May-2021: Significant follow up appended; 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: 1363971
Sex: M
Age: 25
State: NJ

Vax Date: 03/28/2021
Onset Date: 04/12/2021
Rec V Date: 06/01/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: thrombocytopenia; ITP; Petechia rash; Tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOCYTOPENIA (thrombocytopenia) and IMMUNE THROMBOCYTOPENIA (ITP) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anxiety and Stomachache. Concomitant products included LAMOTRIGINE (LAMICTAL) for Anxiety, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Stomach discomfort. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced RASH (Petechia rash) and FATIGUE (Tiredness). On an unknown date, the patient experienced THROMBOCYTOPENIA (thrombocytopenia) (seriousness criteria hospitalization and medically significant) and IMMUNE THROMBOCYTOPENIA (ITP) (seriousness criteria hospitalization and medically significant). The patient was treated with IMMUNOGLOBULIN HUMAN NORMAL ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, THROMBOCYTOPENIA (thrombocytopenia), IMMUNE THROMBOCYTOPENIA (ITP), RASH (Petechia rash) and FATIGUE (Tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No laboratory details was given. Reportedly, the patient had to go to the hospital for a week and was still being monitored. Treatment information was given as steroids Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up information received on 20 May 2021 contain significant information includes updation of 2 more medically significant events and patient was hospitalized for the events too.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.

Other Meds: LAMICTAL; PROTONIX [OMEPRAZOLE]

Current Illness:

ID: 1363972
Sex: F
Age: 66
State: AZ

Vax Date: 01/19/2021
Onset Date: 02/17/2021
Rec V Date: 06/01/2021
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: Fainting spell; She couldn't remember her job or her boss's name, with whom she worked since 2009/she can't remember as good; Her right arm got kind of sore; Chills; Vomiting; Nausea; Fever; Diarrhea; Dizziness; Weak; She lost 6 pounds in 3 days; Confusion; Off work X 6 days; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (Fainting spell) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy, Diabetes, Heart disease, unspecified and Asthma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weak), WEIGHT DECREASED (She lost 6 pounds in 3 days), CONFUSIONAL STATE (Confusion), IMPAIRED WORK ABILITY (Off work X 6 days), PYREXIA (Fever), VOMITING (Vomiting) and NAUSEA (Nausea). On an unknown date, the patient experienced SYNCOPE (Fainting spell) (seriousness criterion medically significant), AMNESIA (She couldn't remember her job or her boss's name, with whom she worked since 2009/she can't remember as good), PAIN IN EXTREMITY (Her right arm got kind of sore) and CHILLS (Chills). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SYNCOPE (Fainting spell), AMNESIA (She couldn't remember her job or her boss's name, with whom she worked since 2009/she can't remember as good), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weak), WEIGHT DECREASED (She lost 6 pounds in 3 days), CONFUSIONAL STATE (Confusion), IMPAIRED WORK ABILITY (Off work X 6 days), PAIN IN EXTREMITY (Her right arm got kind of sore), PYREXIA (Fever), CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown. Concomitant medication use included medications for diabetes, heart disease and high blood pressure. Specific medications were not provided by the reporter. Treatment of the events included Zofran. On 11Feb2021, after receiving the first dose of vaccine but before the second, the patient "had a nuclear injection" before she went on a treadmill. The patient also stated that "she had radiation that may have affected her reaction to the vaccine." No further information was provided. Further clinical course is unknown at this 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. This case was linked to MOD-2021-155323 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up received on 20-May-2021included additional 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.

Other Meds: ASPIRIN (E.C.)

Current Illness: Asthma; Diabetes; Heart disease, unspecified; Penicillin allergy

ID: 1363973
Sex: M
Age: 56
State: DE

Vax Date: 04/05/2021
Onset Date: 04/12/2021
Rec V Date: 06/01/2021
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: Passing out, dry cough so bad that he would faint; Stood up to cough, passed out, and fell and his head hit the concrete; Head hit the concrete floor, hitting head on floor; Bad, dry cough; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out, dry cough so bad that he would faint) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. G17-C21A and G26-B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Smoker (30+ years of smoking.) and Vapor cigarette smoker (vaping the past two years.). Concomitant products included BENZTROPINE [BENZATROPINE], FLUOXETINE, TAMSULOSIN, CLONAZEPAM, AMLODIPINE and LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passing out, dry cough so bad that he would faint) (seriousness criterion medically significant), FALL (Stood up to cough, passed out, and fell and his head hit the concrete), HEAD INJURY (Head hit the concrete floor, hitting head on floor) and COUGH (Bad, dry cough). On 12-May-2021, LOSS OF CONSCIOUSNESS (Passing out, dry cough so bad that he would faint) and COUGH (Bad, dry cough) had resolved. At the time of the report, FALL (Stood up to cough, passed out, and fell and his head hit the concrete) and HEAD INJURY (Head hit the concrete floor, hitting head on floor) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: negative (Negative) Went to get tested for COVID-19 due to dry, bad cough and came back negative. The patient stated that approximately one week after the first dose, he was having a bad dry cough. The dry cough was so bad that when he was sitting on recliner he would cough so bad, he would faint and pass out. One time the patient stood up to cough, passed out, and fell and his head hit the concrete floor. He went to emergency department three times because of this cough. On 12 MAY 2021, the patient stopped experiencing coughing and passing out. The patient also stated that he has no other side effects and that his healthcare provider thinks this experience was attributed to the first vaccine. Patient was prescribed an "inhaler" from his healthcare provider to help with "lungs and stuff." The patient also has an appointment with a pulmonologist in June. Action taken with mRNA-1273 in response to the events was not applicable. Head injury was due to fall and thus cannot be directly associated with mRNA-1273 use. The other events are temporarily associated with the product use and a causal relationship cannot be excluded This case was linked to MOD-2021-138832 (Patient Link).; Sender's Comments: Head injury was due to fall and thus cannot be directly associated with mRNA-1273 use. The other events are temporarily associated with the product use and a causal relationship cannot be excluded

Other Meds: BENZTROPINE [BENZATROPINE]; FLUOXETINE; TAMSULOSIN; CLONAZEPAM; AMLODIPINE; LATUDA

Current Illness: Smoker (30+ years of smoking.); Vapor cigarette smoker (vaping the past two years.)

ID: 1363974
Sex: F
Age: 78
State: NJ

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 06/01/2021
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: Resurge in aplastic anemia; Swollen arm; Been cold; Chills; Running Fever; This spontaneous case was reported by a consumer and describes the occurrence of APLASTIC ANAEMIA (Resurge in aplastic anemia) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Aplastic anemia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL TARTRATE and FEBUXOSTAT for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever). On 23-Feb-2021, the patient experienced APLASTIC ANAEMIA (Resurge in aplastic anemia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 08-Feb-2021, PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever) had resolved. At the time of the report, APLASTIC ANAEMIA (Resurge in aplastic anemia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Platelet count: 60 (Inconclusive) Inconclusive. On 18-Dec-2020, Red blood cell analysis: 14 (Inconclusive) hemoglobin. On 23-Feb-2021, Haemoglobin: 10.8 (Low) dropped. On 23-Feb-2021, Platelet count: 21 (Low) dropped. On 14-May-2021, Haemoglobin: 8.8 (Low) dropped. On 14-May-2021, Platelet count: 13 (Low) dropped. On 14-May-2021, White blood cell count: 2.2 (Low) dropped. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient stated her aplastic anemia gotten worse after taking vaccine. The patient also stated that she had been under a lot of stress because her husband was sick, and she was not sure if that also a contributing factor. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional information received captured patient demographics.; 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: SYNTHROID; METOPROLOL TARTRATE; FEBUXOSTAT

Current Illness: Aplastic anemia

ID: 1363975
Sex: M
Age: 82
State: NJ

Vax Date: 02/06/2021
Onset Date: 04/27/2021
Rec V Date: 06/01/2021
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: Developed blood clot; Sever pain in his stomach; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clot) and ABDOMINAL PAIN UPPER (Sever pain in his stomach) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016L20A) for COVID-19 vaccination. Concomitant products included RIVAROXABAN (XARELTO), AMLODIPINE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR) for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Sever pain in his stomach) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Developed blood clot) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 28-Apr-2021 to 04-May-2021 due to ABDOMINAL PAIN UPPER and THROMBOSIS. The patient was treated with Surgery (leading to two and half feet of his small intestine removed) for Thrombosis. At the time of the report, THROMBOSIS (Developed blood clot) and ABDOMINAL PAIN UPPER (Sever pain in his stomach) outcome was unknown. Patient started having severe pain in his stomach on 27-Apr-2021. He was taken to the hospital on 28-Apr-2021, patient's doctor said that he had a clot in his intestine and that caused the pain, was operated removed to two and half feet of his small intestine. Patient was discharged from the hospital on 04-May-2021. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Company Comment : Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Other Meds: XARELTO; AMLODIPINE; BYSTOLIC; EDARBYCLOR

Current Illness:

ID: 1363976
Sex: F
Age:
State: FL

Vax Date: 02/06/2021
Onset Date: 05/17/2021
Rec V Date: 06/01/2021
Hospital: Y

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: Weakness; Weight decreased; Violent; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weakness), ABNORMAL LOSS OF WEIGHT (Weight decreased) and AGGRESSION (Violent) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 8CDPBC and 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced ASTHENIA (Weakness) (seriousness criterion hospitalization), ABNORMAL LOSS OF WEIGHT (Weight decreased) (seriousness criterion hospitalization) and AGGRESSION (Violent) (seriousness criterion hospitalization). At the time of the report, ASTHENIA (Weakness), ABNORMAL LOSS OF WEIGHT (Weight decreased) and AGGRESSION (Violent) outcome was unknown. No treatment information was provided. Action taken with the mRNA-1273 in response to the event is not applicable. Patient was currently admitted in the hospital and the doctors could not figure out the root cause of her illness. 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: 1363977
Sex: F
Age: 50
State: CA

Vax Date: 03/06/2021
Onset Date:
Rec V Date: 06/01/2021
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: Clots in left arm after taking 2 shots; Swollen arm after 2 vaccine shots; pain in left arm; 50 days gap between 2 vaccine doses; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Clots in left arm after taking 2 shots) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Idiopathic thrombocytopenic purpura, Spina bifida and Psoriasis. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-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 THROMBOSIS (Clots in left arm after taking 2 shots) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm after 2 vaccine shots), VACCINATION SITE PAIN (pain in left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 days gap between 2 vaccine doses). The patient was treated with APIXABAN (ELIQUIS) at a dose of 25 mg twice a day and APIXABAN (ELIQUIS) at a dose of 5 mg twice a day. At the time of the report, THROMBOSIS (Clots in left arm after taking 2 shots), PERIPHERAL SWELLING (Swollen arm after 2 vaccine shots) and VACCINATION SITE PAIN (pain in left arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 days gap between 2 vaccine doses) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: abnormal (abnormal) clot in the left arm. Patient went to emergency after 3 weeks of taking Moderna COVID-19 second Vaccine. No relevant concomitant medications were reported Reportedly, the treatment with Apixaban (Eliquis) needed to continue for 6 months. 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: Idiopathic thrombocytopenic purpura; Psoriasis; Spina bifida

ID: 1363978
Sex: M
Age: 49
State: NC

Vax Date: 01/20/2021
Onset Date: 02/01/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: pain in his hands disappeared but now moved to the thighs,His thighs were painful,thighs were inflamed, pain moved to knee and legs, pain in feet; arms and biceps were swollen, thighs were swollen,His feet were swollen; his skin (entire body) started to peel off,The skin on his whole body was gone; his skin was very itchy; developed blisters all over the body; did not get a second shot; his whole body started to be inflamed, thighs were inflamed; could not shower for a few days; Rash,also given Prednisone for 2 weeks for the rash; skin test diagnosed him with Bullous pemphigoid; his neck got worse,he could not turn his head; his neck was swollen.; did not sleep well.; experienced stiffness in his neck; This spontaneous case was reported by an other health care professional and describes the occurrence of PEMPHIGOID (skin test diagnosed him with Bullous pemphigoid) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (experienced stiffness in his neck). On 11-Feb-2021, the patient experienced INSOMNIA (did not sleep well.). On 15-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (his neck got worse,he could not turn his head) and SWELLING (his neck was swollen.). On 16-Feb-2021, the patient experienced PEMPHIGOID (skin test diagnosed him with Bullous pemphigoid) (seriousness criterion medically significant), PAIN (pain in his hands disappeared but now moved to the thighs,His thighs were painful,thighs were inflamed, pain moved to knee and legs, pain in feet), PERIPHERAL SWELLING (arms and biceps were swollen, thighs were swollen,His feet were swollen), SKIN EXFOLIATION (his skin (entire body) started to peel off,The skin on his whole body was gone), PRURITUS (his skin was very itchy), BLISTER (developed blisters all over the body), INTENTIONAL PRODUCT USE ISSUE (did not get a second shot), INFLAMMATION (his whole body started to be inflamed, thighs were inflamed), IMPAIRED SELF-CARE (could not shower for a few days) and RASH (Rash,also given Prednisone for 2 weeks for the rash). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form; ACETAMINOPHEN for Adverse event, at a dose of 1 dosage form; IBUPROFEN for Adverse event, at a dose of 1 dosage form; DOXYCYCLINE for Adverse event, at a dose of 1 dosage form; MESALAMINE for Adverse event, at a dose of 1 dosage form; CLOBETASOL PROPIONATE (CLOBETASOL [CLOBETASOL PROPIONATE]) (topical) for Adverse event, at a dose of 1 dosage form and HYDROXYZINE for Itching, at a dose of 1 dosage form. At the time of the report, PEMPHIGOID (skin test diagnosed him with Bullous pemphigoid), MUSCULOSKELETAL STIFFNESS (experienced stiffness in his neck), INSOMNIA (did not sleep well.), MUSCULOSKELETAL DISCOMFORT (his neck got worse,he could not turn his head), SWELLING (his neck was swollen.), PAIN (pain in his hands disappeared but now moved to the thighs,His thighs were painful,thighs were inflamed, pain moved to knee and legs, pain in feet), PERIPHERAL SWELLING (arms and biceps were swollen, thighs were swollen,His feet were swollen), SKIN EXFOLIATION (his skin (entire body) started to peel off,The skin on his whole body was gone), PRURITUS (his skin was very itchy), BLISTER (developed blisters all over the body), INTENTIONAL PRODUCT USE ISSUE (did not get a second shot), INFLAMMATION (his whole body started to be inflamed, thighs were inflamed), IMPAIRED SELF-CARE (could not shower for a few days) and RASH (Rash,also given Prednisone for 2 weeks for the rash) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Skin test: abnormal (abnormal) Skin test diagnosed him with bullous pemphigoid.. 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 were reported. It was noted that the patient was being treated by a dermatologist. A "skin test" was completed and results indicate a diagnosis of bullous pemphigoid. It was advised that the patient not receive the second dose of the vaccine. Company Comment : Very limited information regarding these events has been provided at this time. Additional information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. Additional information required.

Other Meds:

Current Illness:

ID: 1363979
Sex: F
Age: 67
State: IL

Vax Date: 06/01/2020
Onset Date: 02/12/2021
Rec V Date: 06/01/2021
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: Adrenal gland insufficiency; thyroid issues; fatigue; lymph nodes enlarged; abdominal pain; This spontaneous case was reported by a physician and describes the occurrence of ADRENAL INSUFFICIENCY (Adrenal gland insufficiency) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. The patient's past medical history included Cartilage disorder from October 2020 to 15-Jan-2021, Hip dislocation from October 2020 to 15-Jan-2021, COVID-19 (26-Oct-2020 nasal swab test COVID-19 positive) on 20-Oct-2020, Surgery (hand surgery) in 2011 and Hip surgery in 2020. Concurrent medical conditions included GERD since 1962, Indigestion since 1962, Pain in hip since 2011, Joint pain since 2011 and Drug allergy (MORPHINE ALLERGY MANIFESTED BY RASH, VOMITING, DELIRIUM CODEINE ALLERGY MANIFESTED BY RASH, VOMITING, DELIRIUM OXYCODONE ALLERGY MANIFESTED BY RASH, VOMITING, DELIRIUM). In June 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ABDOMINAL PAIN (abdominal pain). On 18-Feb-2021, the patient experienced LYMPHADENOPATHY (lymph nodes enlarged). On an unknown date, the patient experienced ADRENAL INSUFFICIENCY (Adrenal gland insufficiency) (seriousness criterion medically significant), THYROID DISORDER (thyroid issues) and FATIGUE (fatigue). The patient was treated with CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, ADRENAL INSUFFICIENCY (Adrenal gland insufficiency), ABDOMINAL PAIN (abdominal pain), THYROID DISORDER (thyroid issues), LYMPHADENOPATHY (lymph nodes enlarged) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: unknown (Inconclusive) Blood work done-results unknown. On 18-Feb-2021, Computerised tomogram: abnormal (abnormal) Enlarged lymph nodes in abdominal region. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ABDOMINAL PAIN (abdominal pain) and LYMPHADENOPATHY (lymph nodes enlarged) to be possibly related. No further causality assessments were provided for ADRENAL INSUFFICIENCY (Adrenal gland insufficiency), THYROID DISORDER (thyroid issues) and FATIGUE (fatigue). The patient was treated with CIPRO and PREDNISONE (indication not specified). Company comment:Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, further information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, further information required.

Other Meds:

Current Illness: Drug allergy (MORPHINE ALLERGY MANIFESTED BY RASH, VOMITING, DELIRIUM CODEINE ALLERGY MANIFESTED BY RASH, VOMITING, DELIRIUM OXYCODONE ALLERGY MANIFESTED BY RASH, VOMITING, DELIRIUM); GERD; Indigestion; Joint pain; Pain in hip

ID: 1363980
Sex: F
Age: 55
State: MD

Vax Date: 05/17/2021
Onset Date:
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Bells palsy in face; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Bells palsy in face) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. No Medical History information was reported. On 17-May-2021, 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 in face) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells palsy in face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. Company comment; Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1363981
Sex: M
Age: 74
State: NC

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Did not go for 2nd shot; Passed out; Extreme arm pain; Could not lift up arms; Trouble with bowels; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), PAIN IN EXTREMITY (Extreme arm pain), HYPOKINESIA (Could not lift up arms) and ABDOMINAL DISCOMFORT (Trouble with bowels). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Did not go for 2nd shot). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), PAIN IN EXTREMITY (Extreme arm pain), HYPOKINESIA (Could not lift up arms) and ABDOMINAL DISCOMFORT (Trouble with bowels) outcome was unknown and INTENTIONAL DOSE OMISSION (Did not go for 2nd shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment : Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1363982
Sex: F
Age: 19
State: NJ

Vax Date: 05/02/2021
Onset Date: 05/16/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Encephalitis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ENCEPHALITIS (Encephalitis) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014c219) for COVID-19 vaccination. No Medical History information was reported. On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 16-May-2021, the patient experienced ENCEPHALITIS (Encephalitis) (seriousness criterion medically significant). At the time of the report, ENCEPHALITIS (Encephalitis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were reported. The patient's mother reported that on 06-May-2021, patient developed a headache on both sides of her head and lost coherence and mobility. On 15-May-2021, she had the same episode and lasted seven hours and they went to the hospital and on 16-May-2021 she was diagnosed with encephalitis, and still waiting for autoimmune test result. No treatment information provided. Company Comment: Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1363983
Sex: M
Age: 34
State: PA

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 06/01/2021
Hospital: Y

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: Heart Attack; Panic attack; Couldnt breathe; Felt like chest caved in; Chest pain; Blood clot; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack), PAIN IN EXTREMITY (Arm Pain), PANIC ATTACK (Panic attack), DYSPNOEA (Couldnt breathe), CHEST DISCOMFORT (Felt like chest caved in), CHEST PAIN (Chest pain) and THROMBOSIS (Blood clot) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The patient's past medical history included Flu vaccination (received about 5 weeks ago before he got the Covid Shot and had chest pain) and Sinusitis (the patient stated that he violently threw up and he was sick for 2 weeks; the doctors then said that it may have been a stroke or a heart attack but he definitely had sinusitis.). Concurrent medical conditions included Diabetes, Cholesterol high and Blood pressure high. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain) (seriousness criterion hospitalization). On 15-May-2021, the patient experienced PANIC ATTACK (Panic attack) (seriousness criterion hospitalization), DYSPNOEA (Couldnt breathe) (seriousness criterion hospitalization), CHEST DISCOMFORT (Felt like chest caved in) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant). On 15-May-2021 at 4:00 PM, the patient experienced MYOCARDIAL INFARCTION (Heart Attack) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 3 days due to CHEST DISCOMFORT, CHEST PAIN, DYSPNOEA, MYOCARDIAL INFARCTION, PAIN IN EXTREMITY, PANIC ATTACK and THROMBOSIS. The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date at an unspecified dose and frequency; LISINOPRIL ongoing since an unknown date at a dose of 5 mg; METOPROLOL SUCCINATE ongoing since an unknown date at a dose of 50 mg; NITROGLYCERIN ongoing since an unknown date at a dose of 10 mg as required; PRASUGREL ongoing since an unknown date at a dose of 10 milligram; SPIRONOLACTONE ongoing since an unknown date at a dose of 25 mg and ROSUVASTATIN ongoing since an unknown date at a dose of 80 milligram. At the time of the report, MYOCARDIAL INFARCTION (Heart Attack), PAIN IN EXTREMITY (Arm Pain), PANIC ATTACK (Panic attack), DYSPNOEA (Couldnt breathe), CHEST DISCOMFORT (Felt like chest caved in), CHEST PAIN (Chest pain) and THROMBOSIS (Blood clot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. The patient reported that he had a heart attack on 15 May 2021, after football practice Patient was in the hospital for 3 days. Treatment also included catheter placement and then a stint in heart. 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: Cholesterol high; Diabetes

ID: 1363984
Sex: F
Age:
State: NC

Vax Date: 05/11/2021
Onset Date:
Rec V Date: 06/01/2021
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: wanted to rule out cellulitis; left arm is now the side of the softball; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (wanted to rule out cellulitis) 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 reported. On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (wanted to rule out cellulitis) (seriousness criterion medically significant) and INDURATION (left arm is now the side of the softball). At the time of the report, CELLULITIS (wanted to rule out cellulitis) and INDURATION (left arm is now the side of the softball) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications listed. No treatment listed. 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: 1363985
Sex: F
Age: 74
State: NY

Vax Date: 04/29/2021
Onset Date: 05/09/2021
Rec V Date: 06/01/2021
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: lost weight; lack appetite; Patient is taken to the hospital with chest pain, it like a knife going in chest; arm pain; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest), WEIGHT DECREASED (lost weight) and DECREASED APPETITE (lack appetite) in a 74-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 reported. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest) (seriousness criterion hospitalization). On an unknown date, the patient experienced WEIGHT DECREASED (lost weight) (seriousness criterion hospitalization), DECREASED APPETITE (lack appetite) (seriousness criterion hospitalization), PAIN IN EXTREMITY (arm pain) and CHILLS (Chills). The patient was hospitalized on 09-May-2021 due to CHEST PAIN, DECREASED APPETITE and WEIGHT DECREASED. The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) ongoing since an unknown date at a dose of UNK dosage form and CALCIUM CARBONATE (MYLANTA [CALCIUM CARBONATE]) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest), WEIGHT DECREASED (lost weight), DECREASED APPETITE (lack appetite), PAIN IN EXTREMITY (arm pain) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Electrocardiogram: normal (normal) arteries are clean and blood pressure is ok. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1363986
Sex: M
Age:
State: GA

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Strength less than half in his right hand; Paralyses started 72 hours after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralyses started 72 hours after vaccine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced ASTHENIA (Strength less than half in his right hand). In May 2021, the patient experienced PARALYSIS (Paralyses started 72 hours after vaccine) (seriousness criterion medically significant). At the time of the report, PARALYSIS (Paralyses started 72 hours after vaccine) and ASTHENIA (Strength less than half in his right hand) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported. Patient received covid vaccine on 15 May 2021. Per father son paralyses started 72 hours after strength less than half in his right hand. No treatment information was provided Company Comment : Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1363987
Sex: F
Age: 56
State: MN

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 06/01/2021
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: blood clot from ankle the groin; flu like symptoms; difficulty walking; soreness in Left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot from ankle the groin) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-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) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced THROMBOSIS (blood clot from ankle the groin) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (difficulty walking) and MYALGIA (soreness in Left arm). The patient was treated with RIVAROXABAN (XARELTO) ongoing since an unknown date for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clot from ankle the groin), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (difficulty walking) and MYALGIA (soreness in Left arm) outcome was unknown. No concomitant medications were provided. The patient went to the ER after experiencing the blood clot (from her ankle to the groin area) and was provided treatment with Xarelto. 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: 1363988
Sex: M
Age: 59
State: FL

Vax Date: 04/20/2021
Onset Date:
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bell's palsy 10 days after getting 1st dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's palsy 10 days after getting 1st dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-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 BELL'S PALSY (Bell's palsy 10 days after getting 1st dose) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy 10 days after getting 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. Concomitant product used was not provided by the reporter. This patient returned to take the second dose of vaccination and mentioned that 10 days after 1st dose of vaccination he noticed Bell's Palsy while taking shower. He did not see a HCP (Health Care Professional) nor given any medication. Pharmacist advised patient to see HCP and discuss about getting 2nd dose. Company comment: Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

Date Died: 05/17/2021

ID: 1363989
Sex: M
Age: 71
State: WI

Vax Date: 01/29/2021
Onset Date: 03/03/2021
Rec V Date: 06/01/2021
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: Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC CANCER (Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013A21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEPATIC CANCER (Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it) (seriousness criteria death and medically significant). The patient died on 17-May-2021. The reported cause of death was liver cancer. It is unknown if an autopsy was performed. No concomitant medications was reported. No treatment medications was provided. 03-Mar-2021: Husband was diagnosed with liver cancer. It was in his ducts and everything. He had cancer at the time we took both vaccines. He died 10 weeks after being diagnosed with liver cancer. Caller felt the vaccine escalated the process. Company comment: Very limited information regarding the event has been provided at this time. Further information has been requested. This case was linked to MODERNATX, INC.-MOD-2021-019697 (E2B Linked Report).; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested. MODERNATX, INC.-MOD-2021-019697:Wife's case; Reported Cause(s) of Death: Liver cancer

Other Meds:

Current Illness:

ID: 1363990
Sex: F
Age: 54
State:

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 06/01/2021
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: experiencing a cycle but has been menopausal; tinnitus in left ear; tingly feeling in arm, hands and back / feels like body parts are on pins and needles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (experiencing a cycle but has been menopausal) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history for the patient was reported. Concomitant products included SPIRONOLACTONE and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) 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 15-Apr-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (experiencing a cycle but has been menopausal) (seriousness criterion medically significant), TINNITUS (tinnitus in left ear) and PARAESTHESIA (tingly feeling in arm, hands and back / feels like body parts are on pins and needles). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (experiencing a cycle but has been menopausal), TINNITUS (tinnitus in left ear) and PARAESTHESIA (tingly feeling in arm, hands and back / feels like body parts are on pins and needles) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No medical history was provided by the reporter. Treatment information was not provided. Company comment: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds: SPIRONOLACTONE; PRESERVISION

Current Illness:

ID: 1363991
Sex: M
Age: 45
State: VA

Vax Date: 04/10/2021
Onset Date: 04/14/2021
Rec V Date: 06/01/2021
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: Heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization, disability, medically significant and life threatening). The patient was hospitalized on 14-Apr-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were reported. No treatment information provided. It was reported that three days after vaccination the patient had a heart attack. He was admitted to the ICU for three days, starting on 14-Apr-2021. He had seen his primary care doctor and his cardiologist multiple times since that incident and he was unsure of whether he should get the second vaccine dose or not.. Company comment: Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1363992
Sex: M
Age: 53
State: CA

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 06/01/2021
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: Facial paralysis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Facial paralysis) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 021C21A) for COVID-19 vaccination. The patient's past medical history included Stroke (one year ago). On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-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 FACIAL PARALYSIS (Facial paralysis) (seriousness criterion medically significant). The patient was treated with PREDNISONE ongoing since an unknown date for Facial paralysis, at a dose of UNK dosage form. At the time of the report, FACIAL PARALYSIS (Facial paralysis) had not resolved. No relevant concomitant medications were reported. The reporter stated that patient had no side effects with first dose, 2 or 3 days after receiving second vaccine, patient had a facial paralysis and emergency room (ER) told him it was due to the vaccine. Patient was treated with prednisone and antiviral medication. Action taken with mRNA-1273 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 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: 1363993
Sex: F
Age: 26
State: OH

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 06/01/2021
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: Miscarriage; Electing not to receive second Moderna dose after learning she was pregnant; Pregnant when she received her first Moderna dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. The patient's past medical history included Polycystic ovarian syndrome and Hypothyroidism. Concomitant products included LEVOTHYROXINE and METFORMIN for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 08-Oct-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose). On 05-Feb-2021, the patient experienced INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant). On 27-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the first week of the pregnancy. On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose) had resolved. On 05-Feb-2021, INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant) had resolved. On 27-Apr-2021, ABORTION SPONTANEOUS (Miscarriage) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No information regarding treatment was provided. Nurse reported she was unaware she was pregnant when she received her first Moderna dose on 08-Jan-2021. Nurse reported that she discovered she was pregnant a week 29-Jan-2021 prior to her scheduled second Moderna dose on 05-Feb-2021. Testing was performed on the fetus and physicians determined the baby was a normal healthy girl with no genetic abnormalities or findings. Reportedly, she stopped metformin during her pregnancy so glucose testing could be performed.

Other Meds: LEVOTHYROXINE; METFORMIN

Current Illness:

ID: 1363994
Sex: F
Age: 68
State: MI

Vax Date: 04/09/2021
Onset Date: 04/11/2021
Rec V Date: 06/01/2021
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: Heart fluttering; Palpitations; Ringing in ears; sleeping a lot; Pain in arm; feeling fatigued; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant), PALPITATIONS (Palpitations), TINNITUS (Ringing in ears), SOMNOLENCE (sleeping a lot), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (feeling fatigued). On 14-Apr-2021, CARDIAC FLUTTER (Heart fluttering), PALPITATIONS (Palpitations), TINNITUS (Ringing in ears), SOMNOLENCE (sleeping a lot), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (feeling fatigued) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. No treatment medication was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-155061 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1363995
Sex: M
Age: 30
State: FL

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 06/01/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: blurry vision five minutes after the shot; seizures on the same day; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurry vision five minutes after the shot) and SEIZURE (seizures on the same day) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (had covid-19 twice before receiving the vaccine once in APR-2021) in April 2021. Concurrent medical conditions included Epilepsy. Concomitant products included LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), LAMOTRIGINE, LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]), ATORVASTATIN, LORAZEPAM (ATIVAN), ONDANSETRON (ZOFRAN [ONDANSETRON]) and CLONAZEPAM (KLONOPIN) for an unknown indication. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced VISION BLURRED (blurry vision five minutes after the shot) (seriousness criterion hospitalization). 12-May-2021, the patient experienced SEIZURE (seizures on the same day) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 12-May-2021 to 19-May-2021 due to SEIZURE and VISION BLURRED. At the time of the report, VISION BLURRED (blurry vision five minutes after the shot) outcome was unknown and SEIZURE (seizures on the same day) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Computerised tomogram: unknown (Inconclusive) unknown. In April 2021, Lumbar puncture: unknown (Inconclusive) spinal tab from CNS fluid to make sure there was no cox in his brain. In April 2021, Magnetic resonance imaging: unknown (Inconclusive) unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The patient had epilepsy as pre-existing condition and he was on unspecified medication for that. The patient has seizures on the same day of vaccination and was transferred to hospital. Patient had magnetic resonance scan (MRI) and patient had seizures over there for which he was moved to sister hospital where they did scan under anesthesia. Before discharging patient from hospital they took spinal tab from central nervous system (CNS) fluid to make sure there was no Cyclooxygenase (COX) in his brain. Patient's physician told to not receive the second dose of Moderna vaccine. No treatment information was reported. Company 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 This case was linked to US-MODERNATX, INC.-MOD-2021-154269 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Additional information was received and events, hospitalization details and laboratory data 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 US-MODERNATX, INC.-MOD-2021-154269:Crosslinked case of reporter friend case

Other Meds: KEPPRA [LEVETIRACETAM]; LAMOTRIGINE; LOMOTIL [LOPERAMIDE HYDROCHLORIDE]; ATORVASTATIN; ATIVAN; ZOFRAN [ONDANSETRON]; KLONOPIN

Current Illness: Epilepsy

ID: 1363996
Sex: M
Age: 76
State: PA

Vax Date: 01/26/2021
Onset Date: 03/26/2021
Rec V Date: 06/01/2021
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: MRI of brain showed I had two strokes, one recent and one older; Difficulty walking/limp; Numbness; Stumbling; Weird feeling; Left leg was very weak; Arm weak feels heavy/left arm felt heavy; Episode of vertigo with difficulty walking; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stroke. Concurrent medical conditions included Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 26-Mar-2021, the patient experienced VERTIGO (Episode of vertigo with difficulty walking). On 18-Apr-2021, the patient experienced LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy) and MUSCULAR WEAKNESS (Left leg was very weak). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) (seriousness criterion medically significant), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), GAIT DISTURBANCE (Stumbling) and FEELING ABNORMAL (Weird feeling). The patient was treated with Physical therapy (Prescribed balance exercise) for Vertigo. At the time of the report, CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older), VERTIGO (Episode of vertigo with difficulty walking), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy), GAIT DISTURBANCE (Stumbling), FEELING ABNORMAL (Weird feeling) and MUSCULAR WEAKNESS (Left leg was very weak) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Cardiac monitoring: normal (normal) normal- no AF. On 22-Apr-2021, Echocardiogram: normal (normal) normal. On 22-Apr-2021, Magnetic resonance imaging head: abnormal (abnormal) Showed two strokes. On 22-Apr-2021, Ultrasound Doppler: abnormal (abnormal) Showed two strokes. Treatment information were 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.; 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: Penicillin allergy

ID: 1363997
Sex: F
Age: 66
State: NY

Vax Date: 12/29/2020
Onset Date: 04/01/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: having an auto immune reaction / auto immune symptoms started roughly around 6 weeks; Pain all 4 extremities / complains of hands; Inflammation all 4 extremities / wrists Inflammed; Rheumatoid factor positive; hands including wrists painful and inflammed; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of AUTOIMMUNE DISORDER (having an auto immune reaction / auto immune symptoms started roughly around 6 weeks) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Rheumatoid factor. Concomitant products included METOPROLOL for Hypertension, PANTOPRAZOLE and VITAMINS NOS for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced AUTOIMMUNE DISORDER (having an auto immune reaction / auto immune symptoms started roughly around 6 weeks) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain all 4 extremities / complains of hands), INFLAMMATION (Inflammation all 4 extremities / wrists Inflammed), RHEUMATOID FACTOR POSITIVE (Rheumatoid factor positive) and ARTHRALGIA (hands including wrists painful and inflammed). The patient was treated with NAPROXEN SODIUM (ALEVE) for Antiinflammatory therapy, at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE DISORDER (having an auto immune reaction / auto immune symptoms started roughly around 6 weeks), PAIN IN EXTREMITY (Pain all 4 extremities / complains of hands), INFLAMMATION (Inflammation all 4 extremities / wrists Inflammed), RHEUMATOID FACTOR POSITIVE (Rheumatoid factor positive) and ARTHRALGIA (hands including wrists painful and inflammed) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood test: abnormal (abnormal) auto immune reaction; with a positive CCP antibody and Rheumatoid Factor. On 01-Apr-2021, X-ray: normal (normal) Normal. 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: METOPROLOL; PANTOPRAZOLE; VITAMINS NOS

Current Illness:

ID: 1363998
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/17/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Respiratory infection; Got sick there; Tested again 5/17 this time Positive; 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 RESPIRATORY TRACT INFECTION (Respiratory infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The 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 17-May-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested again 5/17 this time Positive). On an unknown date, the patient experienced RESPIRATORY TRACT INFECTION (Respiratory infection) (seriousness criterion medically significant) and ILLNESS (Got sick there). At the time of the report, RESPIRATORY TRACT INFECTION (Respiratory infection), ILLNESS (Got sick there) and SARS-COV-2 TEST POSITIVE (Tested again 5/17 this time Positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 17-May-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant medications was not provided/ unknown. Text: AE submitted via social media: "I received 2 Moderna vaccines, 2/14 and 3/14. I traveled to another country 5/5 and got sick there (respiratory infection). Got Covid tested there 5/15, which was negative. (Antigen test). Tested again 5/17, this time Positive! Received Re" "Seems that my body did not produce enough antibodies to prevent infection. C I get re-vaccinated or would that even help?" Treatment information was provided/ unknown. Company Comment: Limited information regarding the reported sick / respiratory infection has been provided at this time and a causal relationship cannot be excluded. The positive test for Covid-19 is unlikely related to the previous administration Moderna vaccine.; Sender's Comments: Limited information regarding the reported sick / respiratory infection has been provided at this time and a causal relationship cannot be excluded. The positive test for Covid-19 is unlikely related to the previous administration Moderna vaccine

Other Meds:

Current Illness:

ID: 1363999
Sex: F
Age:
State: PA

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 06/01/2021
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: Swelling of eyes; Using bathroom alot; Nausea; Breathing problems; Swollen lymph nodes; Meningitis; Dizzy; Pain all over body; This spontaneous case was reported by a consumer and describes the occurrence of MENINGITIS (Meningitis) 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. Concurrent medical conditions included Common variable immunodeficiency. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced MENINGITIS (Meningitis) (seriousness criterion medically significant), DIZZINESS (Dizzy) and MYALGIA (Pain all over body). On 03-May-2021, the patient experienced RESPIRATION ABNORMAL (Breathing problems), EYE SWELLING (Swelling of eyes), MICTURITION URGENCY (Using bathroom alot), NAUSEA (Nausea) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, MENINGITIS (Meningitis), RESPIRATION ABNORMAL (Breathing problems), DIZZINESS (Dizzy), EYE SWELLING (Swelling of eyes), MICTURITION URGENCY (Using bathroom alot), NAUSEA (Nausea), MYALGIA (Pain all over body) and LYMPHADENOPATHY (Swollen lymph nodes) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Patient was put on a steroid and also put on a Nebulizer for breathing problems. 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: Common variable immunodeficiency

ID: 1364000
Sex: F
Age: 66
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: Surgery; The patient did not receive the second shot in time; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SURGERY (Surgery) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 28-Mar-2021, the patient experienced SURGERY (Surgery) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient did not receive the second shot in time). The patient was hospitalized from 28-Mar-2021 to 02-Apr-2021 due to SURGERY. The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) for Surgery, at a dose of UNK dosage form and METOPROLOL for Surgery, at a dose of UNK dosage form. At the time of the report, SURGERY (Surgery) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (The patient did not receive the second shot in time) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Description: The patient had surgery on 28 Mar 2021, the type of surgery was not specified and was hospitalized for six days. Due to this event patient did not receive the second shot in time.

Other Meds:

Current Illness:

ID: 1364001
Sex: M
Age: 39
State: NJ

Vax Date: 05/07/2021
Onset Date: 05/13/2021
Rec V Date: 06/01/2021
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: pain in calf; Deep vein thrombosis; Blood Clot; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) and THROMBOSIS (Blood Clot) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Deep vein thrombosis. On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion medically significant) and THROMBOSIS (Blood Clot) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in calf). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at a dose of 1 dosage form. At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis), THROMBOSIS (Blood Clot) and PAIN IN EXTREMITY (pain in calf) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Scan: blood clot (abnormal) blood clot. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included unspecified anti-coagulant and antibiotic. 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: Deep vein thrombosis

ID: 1364002
Sex: F
Age: 23
State: WA

Vax Date: 04/22/2021
Onset Date: 05/20/2021
Rec V Date: 06/01/2021
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: Passing out feeling when trying to stand up; Severe abdominal pain; Problem to breath in air all the way because of abdominal pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out feeling when trying to stand up) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 030B21A) 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 ARIPIPRAZOLE (ABILIFY) for an unknown indication. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passing out feeling when trying to stand up) (seriousness criterion medically significant), ABDOMINAL PAIN (Severe abdominal pain), DYSPNOEA (Problem to breath in air all the way because of abdominal pain), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, LOSS OF CONSCIOUSNESS (Passing out feeling when trying to stand up), DYSPNOEA (Problem to breath in air all the way because of abdominal pain), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and ABDOMINAL PAIN (Severe abdominal pain) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Since 20 May 2021, roughly since 9:00pm onwards, patient started the symptoms like fever, chills and passing out feeling when trying to stand up and severe abdominal pain and having problem to breath in air all the way because of abdominal pain. Patient took Ibuprofen two tablets for the symptoms developed and the abdominal pain still not better, according to the patient. Patient did not take the regular medication Abilify, today (on day of report) which patient used to take daily, because of abdominal pain. 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-2021-162196 (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: ABILIFY

Current Illness:

ID: 1364003
Sex: F
Age: 54
State: VA

Vax Date: 04/12/2021
Onset Date: 05/13/2021
Rec V Date: 06/01/2021
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: Abnormal clusters of lymph nodes in left of my brain and neck region; I could not not keep down water and medication; Extreme nausea; Headache; Neck pain; Extremely dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck pain), DIZZINESS (Extremely dizzy), LYMPHADENOPATHY (Abnormal clusters of lymph nodes in left of my brain and neck region), NAUSEA (Extreme nausea), HEADACHE (Headache) and VOMITING (I could not not keep down water and medication) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 006B21A) for COVID-19 vaccination. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion hospitalization), DIZZINESS (Extremely dizzy) (seriousness criterion hospitalization), NAUSEA (Extreme nausea) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). On 14-May-2021, the patient experienced LYMPHADENOPATHY (Abnormal clusters of lymph nodes in left of my brain and neck region) (seriousness criterion hospitalization) and VOMITING (I could not not keep down water and medication) (seriousness criterion hospitalization). The patient was hospitalized on 14-May-2021 due to HEADACHE, LYMPHADENOPATHY, NAUSEA and VOMITING. The patient was treated with BUTALBITAL ongoing since an unknown date for Headache, at an unspecified dose and frequency and ONDANSETRON ongoing since an unknown date for Nausea, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck pain), DIZZINESS (Extremely dizzy), LYMPHADENOPATHY (Abnormal clusters of lymph nodes in left of my brain and neck region), NAUSEA (Extreme nausea), HEADACHE (Headache) and VOMITING (I could not not keep down water and medication) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Computerised tomogram: (abnormal) Abnormal clusters of lymph nodes in left of my brain and neck region.. 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: MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1364004
Sex: F
Age: 76
State: NY

Vax Date: 03/04/2021
Onset Date: 04/02/2021
Rec V Date: 06/01/2021
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: Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom; Left foot was broken; Had fallen on her foot, fell; Mild aches; Bed was soaked with diarrhea after second dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (Bed was soaked with diarrhea after second dose). 02-Apr-2021, the patient experienced MYALGIA (Mild aches). On 19-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom) (seriousness criterion medically significant) and FOOT FRACTURE (Left foot was broken). 19-Apr-2021, the patient experienced FALL (Had fallen on her foot, fell). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Ache, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom), FOOT FRACTURE (Left foot was broken), DIARRHOEA (Bed was soaked with diarrhea after second dose), FALL (Had fallen on her foot, fell) and MYALGIA (Mild aches) outcome was unknown. Concomitant product use was unknown. The patient reported that the day after her second shot, she woke up and her bed was soaked with diarrhea. She has no memory of this, but on 19Apr2021, she woke up on the floor in the bathroom. She stated that she had fallen on her foot, and her left foot was broken. She also reported she had mild aches on 02Apr2021. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-162182 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1364005
Sex: F
Age: 58
State: GA

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: My tendons are loose; Tendon issues/ arch in her right foot has dropped; Congestion; Can I still get the 2nd dose; Pain at the injection site; Redness at the injection site; The bones in my right foot started popping; The bones in my neck started popping / It would pop with movement; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Congestion) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Charcot-Marie-Tooth disease (The patient's left foot has a brace on it) and Neuropathy since an unknown date. Concurrent medical conditions included Diabetes and Smoker. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (The bones in my right foot started popping), MUSCULOSKELETAL DISCOMFORT (The bones in my neck started popping / It would pop with movement), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 06-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Can I still get the 2nd dose). On 21-May-2021, the patient experienced PULMONARY CONGESTION (Congestion) (seriousness criterion medically significant), TENDON LAXITY (My tendons are loose) and TENDON DISORDER (Tendon issues/ arch in her right foot has dropped). On 06-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Can I still get the 2nd dose) had resolved. At the time of the report, PULMONARY CONGESTION (Congestion), TENDON LAXITY (My tendons are loose), TENDON DISORDER (Tendon issues/ arch in her right foot has dropped), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown and LIMB DISCOMFORT (The bones in my right foot started popping) and MUSCULOSKELETAL DISCOMFORT (The bones in my neck started popping / It would pop with movement) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported/ unknown. Treatment included Vancomycin and Cortisone epidural. 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 US-MODERNATX, INC.-MOD-2021-162325 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-162325:Crosslink

Other Meds:

Current Illness: Diabetes; Neuropathy; Smoker

ID: 1364006
Sex: F
Age: 68
State: TX

Vax Date: 01/11/2021
Onset Date: 02/08/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Meniere's disease; not able to do anything; throwing up; Dizzy/ Light headed; sick; Cannot drive; Ear stuffed up; Ringing in Ear; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (Meniere's disease) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History reported. Concomitant products included LISINOPRIL, LEVOTHYROXINE and SIMVASTATIN for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced TINNITUS (Ringing in Ear). On 11-Mar-2021, the patient experienced EAR DISCOMFORT (Ear stuffed up). On 14-Mar-2021, the patient experienced DIZZINESS (Dizzy/ Light headed), ILLNESS (sick), IMPAIRED DRIVING ABILITY (Cannot drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to do anything) and VOMITING (throwing up). On 21-Apr-2021, the patient experienced MENIERE'S DISEASE (Meniere's disease) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Ear discomfort, at an unspecified dose and frequency. At the time of the report, MENIERE'S DISEASE (Meniere's disease), EAR DISCOMFORT (Ear stuffed up), DIZZINESS (Dizzy/ Light headed), ILLNESS (sick), IMPAIRED DRIVING ABILITY (Cannot drive), TINNITUS (Ringing in Ear), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to do anything) and VOMITING (throwing up) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was also provided treatment with a low salt diet and an unspecified diuretic. 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: LISINOPRIL; LEVOTHYROXINE; SIMVASTATIN

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm