VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1401661
Sex: U
Age:
State: MI

Vax Date:
Onset Date: 06/09/2021
Rec V Date: 06/16/2021
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: VACCINE ADMINISTERED TO PATIENT AFTER IT HAD BEEN IN ROOM TEMPERATURE FOR 7 HOURS; VACCINE LEFT OUT AT ROOM TEMPERATURE FOR 7 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUN-2021, the subject experienced vaccine administered to subject after it had been in room temperature for 7 hours. On 09-JUN-2021, the subject experienced vaccine left out at room temperature for 7 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patient after it had been in room temperature for 7 hours and vaccine left out at room temperature for 7 hours was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401662
Sex: U
Age:
State: OH

Vax Date:
Onset Date: 06/09/2021
Rec V Date: 06/16/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 51 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820096, expiry: 23-JUL-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure since case was assessed as non serious

Other Meds:

Current Illness:

ID: 1401663
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SWOLLEN KNEES; LOOSE JOINTS; CHARLEY HORSE; HIGH FEVER (3 DEGREES OVER NORMAL); SEVERE FATIGUE; MUSCLE SPASMS; SEVERE MUSCLE CRAMPS; DIFFICULTY WALKING/BARELY MOBILE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 180898L (or a 2 for last digit)) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced muscle spasms. On 06-APR-2021, the subject experienced severe muscle cramps. On 06-APR-2021, the subject experienced difficulty walking/barely mobile. On 06-APR-2021, the subject experienced charley horse. On 06-APR-2021, the subject experienced high fever (3 degrees over normal). On 06-APR-2021, the subject experienced severe fatigue. On 12-MAY-2021, the subject experienced swollen knees. On 12-MAY-2021, the subject experienced loose joints. On 04-JUN-2021, Laboratory data included: Blood test (NR: not provided) No blood clots detected., and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient recovered from high fever (3 degrees over normal), and severe fatigue on 14-APR-2021, and had not recovered from muscle spasms, severe muscle cramps, difficulty walking/barely mobile, swollen knees, loose joints, and charley horse. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401664
Sex: U
Age:
State: TN

Vax Date:
Onset Date: 05/11/2021
Rec V Date: 06/16/2021
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: POSSIBLE TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients. 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: 041A21A, 202A21A, and 205A21A expiry: 21-JUN-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced possible temperature excursion. On 11-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible temperature excursion and out of specification product use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401665
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: HAD LOWER BACK PAIN FOR AWHILE PRIOR TO VACCINE, AND IT WENT AWAY AFTER VACCINE AND HAD STAYED GONE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included back pain. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced had lower back pain for awhile prior to vaccine, and it went away after vaccine and had stayed gone. The action taken with covid-19 vaccine was not applicable. The outcome of had lower back pain for awhile prior to vaccine, and it went away after vaccine and had stayed gone was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401666
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: FLU-LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned an adult 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 (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 flu-like symptoms. The action taken with covid-19 vaccine was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401667
Sex: U
Age:
State: MI

Vax Date:
Onset Date: 06/09/2021
Rec V Date: 06/16/2021
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: OUT OF SPECIFICATION PRODUCT USE; VACCINE PLACE IN THE FRIDGE LONGER THAN THE 6HR PERIOD; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced out of specification product use. On 09-JUN-2021, the subject experienced vaccine place in the fridge longer than the 6hr period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and vaccine place in the fridge longer than the 6hr period was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401668
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 06/06/2021
Rec V Date: 06/16/2021
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: PROFUSE SWEATING; FELT LIKE I WANTED TO PASS OUT AND DIZZINESS; FEEL ICKY ALL OVER MY BODY AND FEELING CRAPPY; NO APPETITE; RACING HEART; DON'T FEEL WELL AND ILL ALL OVER; VERY WEAK; HEADACHES; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included severe nausea, and heart race, and concurrent conditions included depression, penicillin allergy, non alcohol user, and non smoker. The patient experienced drug allergy when treated with ciprofloxacin, erythromycin, and sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 13:30 for prophylactic vaccination. Concomitant medications included citalopram for depression. On 06-JUN-2021, the subject experienced profuse sweating. On 06-JUN-2021, the subject experienced felt like i wanted to pass out and dizziness. On 06-JUN-2021, the subject experienced feel icky all over my body and feeling crappy. On 06-JUN-2021, the subject experienced no appetite. On 06-JUN-2021, the subject experienced racing heart. On 06-JUN-2021, the subject experienced don't feel well and ill all over. On 06-JUN-2021, the subject experienced very weak. On 06-JUN-2021, the subject experienced headaches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from profuse sweating, felt like i wanted to pass out and dizziness, racing heart, and headaches, and had not recovered from don't feel well and ill all over, very weak, feel icky all over my body and feeling crappy, and no appetite. This report was non-serious.

Other Meds: CITALOPRAM

Current Illness: Abstains from alcohol; Depression; Non-smoker; Penicillin allergy

ID: 1401669
Sex: U
Age:
State: NJ

Vax Date:
Onset Date: 06/07/2021
Rec V Date: 06/16/2021
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: PATIENT GIVEN A SYRINGE WITH AIR INSTEAD OF VACCINE; VACCINE WAS DRAWN 8 TIMES RATHER THAN 5 TIMES FROM THE VIAL.; PAIN DOWN THE ARM; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUN-2021, the subject experienced subject given a syringe with air instead of vaccine. On 07-JUN-2021, the subject experienced vaccine was drawn 8 times rather than 5 times from the vial. On 07-JUN-2021, the subject experienced pain down the arm. The action taken with covid-19 vaccine was not applicable. The outcome of the patient given a syringe with air instead of vaccine, pain down the arm and vaccine was drawn 8 times rather than 5 times from the vial. was not reported. This report was non-serious. This report was associated with product quality complaint: 90000182251. The suspected product quality complaint has been confirmed to be void:y. it was reported that the nurse drew up 8 doses from the vial, which are 3 doses beyond what a vial should provide. therefore, the nurse might have administered air instead of vaccine into the consumer, who experienced pain on the administered arm. no product quality issue for janssen covid-19 vaccine is identified in this report. confirmed no pqc was identified within the reported complaint reported. based on the PQC evaluation/investigation performed.

Other Meds:

Current Illness:

ID: 1401670
Sex: U
Age:
State: NY

Vax Date:
Onset Date: 06/10/2021
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: BODY PAIN; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry date: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported. On 10-JUN-2021, the subject experienced body pain. On 10-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and body pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401671
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: IMMUNE TO EVERYTHING/ CURED LIVER ISSUES/INVINCIBLE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced immune to everything/ cured liver issues/invincible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immune to everything/ cured liver issues/invincible was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401672
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was taking allergy medicines. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine was not applicable. The outcome of chills was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401673
Sex: F
Age:
State:

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 06/16/2021
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: SWOLLEN LIPS; BODY BROKE OUT INTO HIVES; ITCH; ARMS BECOME EXTREMELY IRRITATED; ARMS BECOME EXTREMELY RED; SKIN FEELS LIKE IT'S IN FLAMES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-JUN-2021 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 JUN-2021, the subject experienced itch. On JUN-2021, the subject experienced arms become extremely irritated. On JUN-2021, the subject experienced arms become extremely red. On JUN-2021, the subject experienced skin feels like it's in flames. On 09-JUN-2021, the subject experienced body broke out into hives. On 11-JUN-2021, the subject experienced swollen lips. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body broke out into hives, swollen lips, itch, arms become extremely irritated, arms become extremely red and skin feels like it's in flames was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401674
Sex: F
Age:
State: MN

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 06/16/2021
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: LEFT SIDE OF TONGUE FEELS LAZY AND LINGERING; UNABLE TO PRODUCE WORDS OUT OF MOUTH; NOT ABLE TO SEE DUE TO SWOLLEN EYE; LEFT EYE ALMOST SWOLLEN SHUT; RIGHT SIDE BACK PAIN/KIDNEY-MID LOW BACK RIGHT SIDE; INNER THIGHS BOTH VEINS POPPING OUT; ANAPHYLACTIC SIDE EFFECT; LEFT EYE FELT NUMB/ LEFT EYE PIERCING; HEADACHE; FEEL WEIRD; This spontaneous report received from a patient concerned a 43-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy (itchy throat/swelling), and doxycycline allergy (throat swells shut and marbles in there). The patient was previously treated with escitalopram oxalate (Lexapro 20mg). 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: 203A21A expiry: UNKNOWN) dose was not reported,1 total administered on 09-APR-2021 15:30:00 on left deltoid for prophylactic vaccination. No concomitant medications were reported. It was reported that after vaccination on 9-APR-2021, the patient immediately got headache but her left eye felt numb. She waited 30 minute because she had anaphylactic side effects and it felt really weird. The headache and left eye felt numb/left eye piercing while she was driving back (from vaccination center) which lasted for hour and half (short lived and resolved). On 11-APR-2021 she experienced right back pain (that radiates) which lasted for about five days. After that her inner thigh veins all got bright red for 2 days (only inner thigh nowhere else) and she thought she had something on her and tried wiping it off. On 16-APR-2021, she went to the doctor it was about one week from she received the shot, her left eye was swollen almost shut and that swelling lasted about five days. She was not able to see out of her eyes. She was not able to produce a word which was kind of weird for her. After that, the side effect she had, was her left side of tongue felt lazy and was lingering. She went to the doctor 3 days later news of clot came out doctor said those were the side effect of Janssen COVID-19 vaccine and there was nothing to worry about. She was trying to figure out why her eye was so big and performed D-dimer test which came back normal. She attempted Benadryl for 2 days did nothing but made her tired and she stopped taking it. She thought may be those were allergies at that time. She used an ice pack on her eye, so that swelling would go down a little. There was no discharge from her eye it was just swollen. In APR- 2021, Laboratory data included: Fibrin D dimer (NR: not provided) as Normal. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride (Benadryl). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left eye felt numb/left eye piercing, and headache on 09-APR-2021, right side back pain/kidney-mid low back right side on 16-APR-2021, inner thighs both veins popping out on 13-APR-2021, and left eye almost swollen shut (not able to see due to swollen eye) on 21-APR-2021, had not recovered from left side of tongue feels lazy and lingering, and unable to produce words out of mouth, and the outcome of anaphylactic side effect, feel weird was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210624549-COVID-19 VACCINE AD26.COV2.S-Anaphylactic reaction. This event is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness: Penicillin allergy (itchy throat/swelling)

ID: 1401675
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BLOOD BEHIND THE RETINA; FATIGUE/FEELING TIRED; This spontaneous report received from a consumer concerned an 86 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, latex tape allergy, alcohol user (once in a while), and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 04-AUG-2021) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. The consumer reported that after taking the vaccine, for the first week the patient had no side effect and felt fine. In APR-2021 (about 3 weeks after vaccination), the patient experienced fatigue and feeling tired and both eyes got blurry and cloudy (left eye more severe than the right eye). Further consumer stated that, the patient went to see an eye doctor because the blurry cloudy vision persisted. The eye doctor referred him to a more specialized eye doctor who diagnosed him with blood behind the retina and gave him shots in the eye to help the blood dissipate. The patient's right eye had been cleared but the blurriness in the left eye had not been resolved. The consumer was concerned that it could had been a blood clot that traveled to the eye because the patient never had any issues like that before. And also mentioned that it could had been some age related eye issue but he was not sure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue/feeling tired, and blood behind the retina. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210626620-covid-19 vaccine ad26.cov2.s-blood behind the retina- This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

Other Meds:

Current Illness: Adhesive plaster sensitivity; Alcohol use (The patient was consuming alcohol once in a while.); Diabetes; Non-smoker

ID: 1401676
Sex: M
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: BLOOD CLOT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, 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. It was reported that on an unspecified date, the patient experienced a blood clot. There was no additional information provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210626844-COVID-19 VACCINE AD26.COV2.S-blood clot. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1401677
Sex: U
Age:
State:

Vax Date:
Onset Date: 06/12/2021
Rec V Date: 06/16/2021
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: JUST WANT TO SINK INTO SOMETHING AND NEVER GET UP; CHILLS; MUSCLE ACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-JUN-2021 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 12-JUN-2021, the subject experienced just want to sink into something and never get up. On 12-JUN-2021, the subject experienced chills. On 12-JUN-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and muscle aches, and the outcome of just want to sink into something and never get up was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401678
Sex: F
Age:
State:

Vax Date:
Onset Date: 06/11/2021
Rec V Date: 06/16/2021
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: SEVERE MUSCLE ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-JUN-2021, the subject experienced severe muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe muscle aches. This report was non-serious.

Other Meds:

Current Illness:

Date Died:

ID: 1401679
Sex: F
Age:
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: DIED; This spontaneous report received from a company representative via Social media concerned a 35-year-old female, unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. Post vaccination, after one week, on an unspecified date patient died, cause of death was unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210626951- Covid-19 vaccine ad26.cov2.s-Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1401680
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 06/11/2021
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: LEFT ARM UNDERNEATH THE ARMPIT AREA WAS SWOLLEN; LEFT ARMPIT AREA WAS PUFFY, FELT LIKE THE MEDICATION DRAINED INTO THE LYMPH NODES; This spontaneous report received from a patient concerned a 54 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced left arm underneath the armpit area was swollen. On 11-JUN-2021, the subject experienced left armpit area was puffy, felt like the medication drained into the lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm underneath the armpit area was swollen, and left armpit area was puffy, felt like the medication drained into the lymph nodes. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401681
Sex: F
Age:
State: UT

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: DIFFICULTY IN STANDING; SHARP MUSCLE PAIN; SEVERE PAIN IN HER HANDS IN SHOULDER; PAIN; SORENESS; MUSCLES ITCHED; FELT LIKE PINS AND NEEDLES; CRYING; JOINTS STIFF; This spontaneous report received from a patient concerned a 60 year old female, race and ethnicity not reported. Initial information was received on 12-JUN-2021 and processed with additional information received on 14-JUN-2021 via telephone call log. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis diagnosed approximately 15 years ago, thyroid issues, Addison's disease diagnosed approximately 15 years ago, fibromyalgia diagnosed approximately 15 years ago, bursitis, Gaucher diagnosed approximately 15 years ago, and myositis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on approximately 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diclofenac, gabapentin, hydroxychloroquine, hydroxyzine hydrochloride, levothyroxine, morphine, pravastatin, and valproate semisodium. The patient reported that approximately 1-1.5 weeks after the vaccine, she had a very sharp muscle pain and a 'pins and needles' feeling in them. Approximately two weeks post vaccine, she had severe pain in her hands in shoulders. Additionally patient reported that within a day, she started getting very sore arm, shoulder, shoulder blade, elbow, and hand on the arm where the vaccine was given. The patient thought the pain would go away with little time. The patient used ice, heat, and various lotions trying to combat the pain. The patient reported that after several weeks, she was in so much pain, she could not stand it. Her muscles itched, felts like pins and needles were attacking them. The patient sat and cried. She reported that her joints started reacting to the vaccine. Joints would lock up and sometimes would be so stiff and locked, that she couldn't get them to move. The patient sat in one position for hours until she could get them unlock and moved. The patient reported being to several doctors and they don't know what to do. The patient saw a doctor on 18-MAY-2021 and reported that 'he was of no use' and had 'no clue what to do'. Physician ordered full bloodwork for her and results were 'normal'. The patient tried to access lab records but she said they 'had been deleted already'. The patient is currently experiencing pain in hip, shoulder, and hands. The patient reported that the pain was better now than it was when it began after taking the vaccine. The patient's vision and balance were normal. She did not experience any unusual/prolonged bleeding or bruising since receiving vaccine. The patient reported that she never experienced painful events prior to receiving vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sharp muscle pain, severe pain in her hands in shoulder, and pain. The outcome of the soreness, difficulty in standing, muscles itched, crying, joints stiff, and felt like pins and needles was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient concerned a 60-year-old woman who experienced sharp muscle pains, soreness, stiff joins, and "pins and needles" 1-2 weeks after vaccine. Medical history included rheumatoid arthritis, thyroid issues, Addison's disease, fibromyalgia, bursitis, Gaucher disease, and myositis. Concomitant medications included diclofenac, gabapentin, hydroxychloroquine, hydroxyzine hydrochloride, levothyroxine, morphine, pravastatin, and valproate. The patient reported that approximately 1-1.5 weeks after the vaccine, she had a very sharp muscle pain and a 'pins and needles' feeling in them. Approximately two weeks post vaccine, she had severe pain in her hands in shoulders. The patient used ice, heat, and various lotions trying to combat the pain. Her muscles itched. The patient sat and cried. She reported that her joints started reacting to the vaccine. The patient reported being to several doctors and they don't know what to do. The patient saw a doctor and reported that 'he was of no use' and had 'no clue what to do'. Physician ordered full bloodwork for her and results were 'normal'. The patient reported that the pain was better now than it was when it began after taking the vaccine. The patient's vision and balance were normal. She did not experience any unusual/prolonged bleeding or bruising since receiving vaccine. She is recovering. Given a multitude of symptoms without a clear diagnosis, and a complicated underlying medical history, there may be alternate etiology for her pain and symptoms. However, given the temporal relationship, a relationship with vaccine can not be entirely excluded.

Other Meds: PRAVASTATIN; GABAPENTIN; MORPHINE; DICLOFENAC; LEVOTHYROXINE; DEPAKOTE; HYDROXYCHLOROQUINE; VISTARIL [HYDROXYZINE HYDROCHLORIDE]

Current Illness: Addison's disease; Bursitis; Fibromyalgia; Gaucher's disease; Myositis; Rheumatoid arthritis; Thyroid disorder NOS

ID: 1401682
Sex: F
Age:
State: CO

Vax Date:
Onset Date: 06/10/2021
Rec V Date: 06/16/2021
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: ELECTRICAL PULSES IN LEFT CALF; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-JUN-2021, the subject experienced electrical pulses in left calf. The action taken with covid-19 vaccine was not applicable. The outcome of electrical pulses in left calf was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401683
Sex: U
Age:
State: CO

Vax Date:
Onset Date: 06/10/2021
Rec V Date: 06/16/2021
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: EXPIRED DOSE OF JANSSEN COVID-19 VACCINE WAS ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. 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: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-JUN-2021 16:33 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced expired dose of Janssen covid-19 vaccine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose of Janssen covid-19 vaccine was administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401684
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: RASH AROUND FACE, NECK, CHEST; This spontaneous report received from a pharmacist concerned a 40 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: Unk) 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 rash around face, neck, chest. Treatment medications (dates unspecified) included: calamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash around face, neck, chest. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401685
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 06/10/2021
Rec V Date: 06/16/2021
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: UNABLE TO MOVE ARM AND NECK (COMPLETELY STIFF); BRUISES ALL OVER MY BODY FROM WHERE IT FELT LIKE VESSELS BURSTING; VOMITING; DIZZY; BACK PAIN; TIREDNESS; This spontaneous report received from a consumer via a company representative concerned a 5 decade 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-JUN-2021, the subject experienced unable to move arm and neck (completely stiff). On 10-JUN-2021, the subject experienced bruises all over my body from where it felt like vessels bursting. On 10-JUN-2021, the subject experienced vomiting. On 10-JUN-2021, the subject experienced dizzy. On 10-JUN-2021, the subject experienced back pain. On 10-JUN-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unable to move arm and neck (completely stiff), bruises all over my body from where it felt like vessels bursting, vomiting, dizzy, tiredness and back pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401686
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: SHIVERS; BIT OF A FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced shivers and bit of a fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shivers and bit of a fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401687
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: ACHES; A FEW DAYS WITH FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine (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. As per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, and a few days with fever. The action taken with covid-19 vaccine was not applicable. The outcome of the a few days with fever and aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210626803.

Other Meds:

Current Illness:

ID: 1401688
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: INCREDIBLE PAIN; PART OF HIS FACE WENT NUMB; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced incredible pain, and part of his face went numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incredible pain and part of his face went numb was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401689
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: FREQUENTLY HOT FACE AND HOT MOVES TO FEET; FEELS LOUSY; MOVING SUBJECTIVE FEVER; HOT AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 22 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced frequently hot face and hot moves to feet, feels lousy, moving subjective fever, and hot at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the moving subjective fever, hot at injection site, frequently hot face and hot moves to feet and feels lousy was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401690
Sex: F
Age:
State: IN

Vax Date:
Onset Date: 06/02/2021
Rec V Date: 06/16/2021
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: INTERMITTENT RAPID HEARTBEAT AND NOTICE MORE HEART BEATS WHILE SITTING; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. Patient was pretty health and does not take any medication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced intermittent rapid heartbeat and notice more heart beats while sitting. Laboratory data included: Heart rate (NR: not provided) intermittent rapid heart beat. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from intermittent rapid heartbeat and notice more heart beats while sitting. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker; Seasonal allergy

ID: 1401691
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: SORE; SWOLLEN NECK LYMPH NODES AND UNDER ARM LYMPH NODES; CHILLS; COULD HARDLY LIFT ARM; FEVER; FATIGUED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore, swollen neck lymph nodes and under arm lymph nodes, chills, could hardly lift arm, fever, and fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore, swollen neck lymph nodes and under arm lymph nodes, chills, could hardly lift arm, fever, and fatigued. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401692
Sex: F
Age:
State:

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 06/16/2021
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: VERY HUNGRY; BODY ACHES; ORGANS FEEL LIKE THEY HAVE BEEN SITTING OUT IN THE DESERT EVEN THOUGH CONSTANTLY DRINKING WATER; CHILLS; OVERALL FATIGUE; FEVER; VERY NAUSEOUS; This spontaneous report received from a patient via a company representative concerned a 2 decade 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: not reported) dose was not reported, administered on 12-JUN-2021 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 JUN-2021, the subject experienced very hungry. On JUN-2021, the subject experienced body aches. On JUN-2021, the subject experienced organs feel like they have been sitting out in the desert even though constantly drinking water. On JUN-2021, the subject experienced chills. On JUN-2021, the subject experienced overall fatigue. On JUN-2021, the subject experienced fever. On JUN-2021, the subject experienced very nauseous. Laboratory data included: Body temperature (NR: not provided) High as 103.4 (Units were not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, chills, very hungry, overall fatigue, organs feel like they have been sitting out in the desert even though constantly drinking water and very nauseous was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401693
Sex: U
Age:
State: MD

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 06/16/2021
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: PAIN IN BOTH CALVES OF LEGS/LEGS SORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pain in both calves of legs/legs sore. Laboratory data (dates unspecified) included: Sonogram (NR: not provided) Did not have any clots. The action taken with covid-19 vaccine was not applicable. The outcome of pain in both calves of legs/legs sore was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401694
Sex: U
Age:
State:

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 06/16/2021
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: FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAR-2021 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 JUN-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.5 (Unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1401695
Sex: M
Age:
State: OH

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: IMPROVEMENT IN ASTHMA SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma(excessive wheezing during strenuous activity).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on APR-2021 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 improvement in asthma symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of improvement in asthma symptoms was not reported. This report was non-serious.

Other Meds:

Current Illness: Asthma

ID: 1401696
Sex: F
Age: 75
State: CA

Vax Date: 02/06/2021
Onset Date: 02/10/2021
Rec V Date: 06/16/2021
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: Angioedema; Bleeding from soars/ulcerations throughout the mouth and under the tongue; swelling of upper airway; mouth is full of sores; mouth is swollen; Redness; Unusual taste; inability to eat; inability to drink or swallow; sensitivity to hot and cold; accompanied by considerable pain and discomfort; difficulty with clarity in enunciation; loss of pigmentation (similar to Vitiligo); This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema), ULCER HAEMORRHAGE (Bleeding from soars/ulcerations throughout the mouth and under the tongue) and RESPIRATORY TRACT OEDEMA (swelling of upper airway) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy (Reaction: Yeast Infections), Cervical disc disease since 1972 and Spinal stenosis since 1972. Concomitant products included MELOXICAM and VARENICLINE TARTRATE (CHANTIX) for an unknown indication. On 06-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), ULCER HAEMORRHAGE (Bleeding from soars/ulcerations throughout the mouth and under the tongue) (seriousness criterion medically significant), RESPIRATORY TRACT OEDEMA (swelling of upper airway) (seriousness criterion medically significant), STOMATITIS (mouth is full of sores), MOUTH SWELLING (mouth is swollen), ERYTHEMA (Redness), TASTE DISORDER (Unusual taste), FEEDING DISORDER (inability to eat), DYSPHAGIA (inability to drink or swallow), GINGIVAL PAIN (sensitivity to hot and cold), ORAL PAIN (accompanied by considerable pain and discomfort), SPEECH DISORDER (difficulty with clarity in enunciation) and VITILIGO (loss of pigmentation (similar to Vitiligo)). The patient was treated with ACICLOVIR (ACYLOVIR) at a dose of 800 mg twice a day. At the time of the report, ANGIOEDEMA (Angioedema), ULCER HAEMORRHAGE (Bleeding from soars/ulcerations throughout the mouth and under the tongue), RESPIRATORY TRACT OEDEMA (swelling of upper airway), STOMATITIS (mouth is full of sores), MOUTH SWELLING (mouth is swollen), ERYTHEMA (Redness), TASTE DISORDER (Unusual taste), FEEDING DISORDER (inability to eat), DYSPHAGIA (inability to drink or swallow), GINGIVAL PAIN (sensitivity to hot and cold), ORAL PAIN (accompanied by considerable pain and discomfort), SPEECH DISORDER (difficulty with clarity in enunciation) and VITILIGO (loss of pigmentation (similar to Vitiligo)) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 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 MOD21-039623 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Updated patient demographics. Patient medical history updated, suspect product details provided, concomitant medication added, additional event also 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: MELOXICAM; CHANTIX

Current Illness: Cervical disc disease; Penicillin allergy (Reaction: Yeast Infections); Spinal stenosis

ID: 1401697
Sex: F
Age:
State: NJ

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 06/16/2021
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: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: seizure; Rash on upper arm; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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 SEIZURE (seizure) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced RASH (Rash on upper arm). The patient was hospitalized on 26-Feb-2021 due to SEIZURE. At the time of the report, SEIZURE (seizure) and RASH (Rash on upper arm) had resolved. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-030292 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-030292:2nd Dose Case - Serious

Other Meds:

Current Illness:

ID: 1401698
Sex: F
Age:
State: NE

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 06/16/2021
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: Massive stroke; This spontaneous case was reported by a nurse and describes the occurrence of CEREBROVASCULAR ACCIDENT (Massive stroke) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Massive stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Massive stroke) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. No treatment information was provided. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1401699
Sex: M
Age: 83
State: MO

Vax Date: 03/03/2021
Onset Date: 03/31/2021
Rec V Date: 06/16/2021
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: Gets cold very easy; Out of breath; Strep through body; Swelled all over body/left foot still swollen; Weak; Paralyzed for over two weeks; Possible A-fib; Arthritis aggravated; Face was swollen; Hands were swollen; Not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARALYSIS (Paralyzed for over two weeks), FEELING COLD (Gets cold very easy), DYSPNOEA (Out of breath), STREPTOCOCCAL INFECTION (Strep through body), SWELLING (Swelled all over body/left foot still swollen), ASTHENIA (Weak) and ATRIAL FIBRILLATION (Possible A-fib) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis and Cane user. Concomitant products included HYDROCHLOROTHIAZIDE, FINASTERIDE, OLMESARTAN, SIMVASTATIN, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and PARACETAMOL (TYLENOL) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced MALAISE (Not feeling well). On 04-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRITIS (Arthritis aggravated), SWELLING FACE (Face was swollen) and PERIPHERAL SWELLING (Hands were swollen). On an unknown date, the patient experienced PARALYSIS (Paralyzed for over two weeks) (seriousness criteria hospitalization and medically significant), FEELING COLD (Gets cold very easy) (seriousness criterion hospitalization), DYSPNOEA (Out of breath) (seriousness criterion hospitalization), STREPTOCOCCAL INFECTION (Strep through body) (seriousness criterion hospitalization), SWELLING (Swelled all over body/left foot still swollen) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization) and ATRIAL FIBRILLATION (Possible A-fib) (seriousness criterion medically significant). The patient was hospitalized for 34 days due to PARALYSIS, then for 36 days due to ASTHENIA, DYSPNOEA, FEELING COLD, STREPTOCOCCAL INFECTION and SWELLING. The patient was treated with MORPHINE in April 2021 at an unspecified dose and frequency and Physical therapy for Paralysis. At the time of the report, PARALYSIS (Paralyzed for over two weeks) had resolved and FEELING COLD (Gets cold very easy), DYSPNOEA (Out of breath), STREPTOCOCCAL INFECTION (Strep through body), SWELLING (Swelled all over body/left foot still swollen), ASTHENIA (Weak), ATRIAL FIBRILLATION (Possible A-fib), ARTHRITIS (Arthritis aggravated), MALAISE (Not feeling well), SWELLING FACE (Face was swollen) and PERIPHERAL SWELLING (Hands were swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Hepatic enzyme: elevated (High) Patient experienced elevated liver enzymes.. In 2021, Heart rate: high (High) Heart rate- increased possible a Fib. Concomitant medication also includes an unspecified blood thinner. Patient was prescribed with Tramadol which was provided at discharge. 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. However, patient's hx of arthritis and being a cane user are confounding factors that may play a possible contributory role providing an alternative explanation. FU1 received additional serious AEs after second dose does not change company comment. Further information has been requested. This case was linked to US-MODERNATX, INC.-MOD-2021-067304, US-MODERNATX, INC.-MOD-2021-067204 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-JUN-2021, upgraded case to serious with the addition of event paralysis and hospitalization.; 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. However, patient's hx of arthritis and being a cane user are confounding factors that may play a possible contributory role providing an alternative explanation. FU1 received additional serious AEs after second dose does not change company comment. Further information has been requested. US-MODERNATX, INC.-MOD-2021-067304:First dose case US-MODERNATX, INC.-MOD-2021-067204:Crosslinked (family member)

Other Meds: HYDROCHLOROTHIAZIDE; FINASTERIDE; OLMESARTAN; SIMVASTATIN; PRILOSEC [OMEPRAZOLE MAGNESIUM]; VITAMIN D [COLECALCIFEROL]; TYLENOL

Current Illness: Arthritis; Cane user

ID: 1401700
Sex: M
Age: 61
State: NC

Vax Date: 03/12/2021
Onset Date: 04/09/2021
Rec V Date: 06/16/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination; slept a lot after the shot; covid like flu symptoms; very weak/very weak feeling; terrible diarrhea; Zero appetite now for 3 days although eating once a day; no longer able to sleep at night; pain in my heart/pain moved from left side heart area and slid toward my left side; neck glands swelled last week/2swollen neck glands; very tired/very fatigue; Bad headache; chills (no fever); heart attack-like pain; lost 20 pounds of his body in the next 24 hours,weight was 184/185; sweat really bad/terrible night sweats; I had pain which I felt like was in the right kidney and lower right abdominal area; I had pain which I felt like was in the right kidney and lower right abdominal area; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (heart attack-like pain) and POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Herpes virus infection (Improved after shingles vaccine. February 2020 second dose. October 2019 first dose.) on 24-Jun-2008. Previously administered products included for Shingles: Shingles vaccine in February 2020. Past adverse reactions to the above products included No adverse event with Shingles vaccine. Concurrent medical conditions included HIV disease since 18-Feb-1988, Renal agenesis, Drug allergy (Allergy to Floriquins), Allergy to chemicals (Contrast dye allergy), Asthma since 24-Jun-2008, Mitral valve disease since 12-Apr-2010 and Diarrhoea (Improved with daily morphine ER.) since 01-Oct-1996. Concomitant products included RITONAVIR, DOLUTEGRAVIR SODIUM (TIVICAY) and DARUNAVIR ETHANOLATE (PREZISTA) for HIV disease, AMLODIPINE BESYLATE, ACYCLOVIR [ACICLOVIR], PRAVASTATIN, FINASTERIDE, ABACAVIR SULFATE (ZIAGEN) and MORPHINE SULFATE (MORPHINE SULPHATE) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced WEIGHT DECREASED (lost 20 pounds of his body in the next 24 hours,weight was 184/185) and NIGHT SWEATS (sweat really bad/terrible night sweats). On 17-May-2021, the patient experienced ANGINA PECTORIS (heart attack-like pain) (seriousness criterion medically significant). On an unknown date, the patient experienced SOMNOLENCE (slept a lot after the shot), INFLUENZA LIKE ILLNESS (covid like flu symptoms), ASTHENIA (very weak/very weak feeling), RENAL PAIN (I had pain which I felt like was in the right kidney and lower right abdominal area), ABDOMINAL PAIN LOWER (I had pain which I felt like was in the right kidney and lower right abdominal area), DIARRHOEA (terrible diarrhea), DECREASED APPETITE (Zero appetite now for 3 days although eating once a day), INSOMNIA (no longer able to sleep at night), CHEST PAIN (pain in my heart/pain moved from left side heart area and slid toward my left side), LYMPHADENOPATHY (neck glands swelled last week/2swollen neck glands), FATIGUE (very tired/very fatigue), HEADACHE (Bad headache) and CHILLS (chills (no fever)). The patient was hospitalized from 09-Apr-2021 to 14-Apr-2021 due to POLYURIA. On 10-Apr-2021, POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) had resolved. At the time of the report, ANGINA PECTORIS (heart attack-like pain) had not resolved, WEIGHT DECREASED (lost 20 pounds of his body in the next 24 hours,weight was 184/185), NIGHT SWEATS (sweat really bad/terrible night sweats), SOMNOLENCE (slept a lot after the shot), INFLUENZA LIKE ILLNESS (covid like flu symptoms), ASTHENIA (very weak/very weak feeling), DIARRHOEA (terrible diarrhea), DECREASED APPETITE (Zero appetite now for 3 days although eating once a day), INSOMNIA (no longer able to sleep at night), CHEST PAIN (pain in my heart/pain moved from left side heart area and slid toward my left side), LYMPHADENOPATHY (neck glands swelled last week/2swollen neck glands), FATIGUE (very tired/very fatigue), HEADACHE (Bad headache) and CHILLS (chills (no fever)) outcome was unknown and RENAL PAIN (I had pain which I felt like was in the right kidney and lower right abdominal area) and ABDOMINAL PAIN LOWER (I had pain which I felt like was in the right kidney and lower right abdominal area) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) Positive. On an unknown date, Blood creatine: high (High) high. On an unknown date, Electrocardiogram: unknown (Inconclusive) unknown. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Concomitant medications included blood pressure medication. Follow-up received on 11-May-2021 included the completed ADR form with significant information about the patient's medical history and new events. Follow-up received on 12-May-2021 included additional details of lower abdominal pain experienced by the patient. The patient reported that he sought medical care from a doctor's office from 09-Apr-2021 to 15-Apr-2021. significant follow-up received on 03-june-2021 This is a report of a 61-years polymorbid male under multiple chronic therapies; who presented various adverse events after receiving the second dose of the product. For the event heart pain/angina pectoris, the patient was not hospitalized. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. This case was linked to MOD-2021-073550 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up included additional details about the adverse event reported in the initial SD of pain right side abdomen. On 03-Jun-2021: Significant follow-up 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. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.

Other Meds: AMLODIPINE BESYLATE; ACYCLOVIR [ACICLOVIR]; PRAVASTATIN; FINASTERIDE; RITONAVIR; TIVICAY; PREZISTA; ZIAGEN; MORPHINE SULPHATE

Current Illness: Asthma; Diarrhoea (Improved with daily morphine ER.); Drug allergy (Allergy to Floriquins); HIV disease; Mitral valve disease; Renal agenesis

ID: 1401701
Sex: F
Age: 68
State: CO

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Emergency hip replacement operation to correct an infection that was in the hip; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRITIS INFECTIVE (Emergency hip replacement operation to correct an infection that was in the hip) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS INFECTIVE (Emergency hip replacement operation to correct an infection that was in the hip) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (Emergency hip replacement operation) for Arthritis infective. At the time of the report, ARTHRITIS INFECTIVE (Emergency hip replacement operation to correct an infection that was in the hip) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were provided. 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: 1401702
Sex: F
Age: 55
State: OH

Vax Date: 03/18/2021
Onset Date: 04/15/2021
Rec V Date: 06/16/2021
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: passed out; feeling absolutely terrible; stong surge of heat wash over me; shuffled my way to bathroom; fall; hit my head on wooden floor divider; abrasion on left knee; moaning; gurgling; dehydrated; needed to increase my electrolytes; needed to be watched closely over weekend; body getting sore and achy all over/ tender body; immediate left side felt tingly from arm up to face; little exercise; my whole body was tender to touch; body started to feel like hit by truck; feeling broken, very weak/ like someone put a straw in my head and extracted all the energy; feeling cold; shakes; hot then cold; couldn't move I hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypothyroidism since 2003. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMIN [VITAMINS NOS] and ASCORBIC ACID (VITAMIN C ACID) for Supplementation therapy. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARAESTHESIA (immediate left side felt tingly from arm up to face), EXERCISE LACK OF (little exercise), TENDERNESS (my whole body was tender to touch), MALAISE (body started to feel like hit by truck), ASTHENIA (feeling broken, very weak/ like someone put a straw in my head and extracted all the energy), FEELING COLD (feeling cold), TREMOR (shakes), FEELING OF BODY TEMPERATURE CHANGE (hot then cold) and PAIN (couldn't move I hurt so bad). On 16-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), FEELING ABNORMAL (feeling absolutely terrible), HOT FLUSH (strong surge of heat wash over me), GAIT DISTURBANCE (shuffled my way to bathroom), FALL (fall), HEAD INJURY (hit my head on wooden floor divider), SKIN ABRASION (abrasion on left knee), MOANING (moaning), ABNORMAL BEHAVIOUR (gurgling), DEHYDRATION (dehydrated), ELECTROLYTE IMBALANCE (needed to increase my electrolytes), MEDICAL OBSERVATION (needed to be watched closely over weekend) and MYALGIA (body getting sore and achy all over/ tender body). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 18-Apr-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved with sequelae. At the time of the report, PARAESTHESIA (immediate left side felt tingly from arm up to face), EXERCISE LACK OF (little exercise), TENDERNESS (my whole body was tender to touch), MALAISE (body started to feel like hit by truck), ASTHENIA (feeling broken, very weak/ like someone put a straw in my head and extracted all the energy), FEELING COLD (feeling cold), TREMOR (shakes), FEELING OF BODY TEMPERATURE CHANGE (hot then cold), PAIN (couldn't move I hurt so bad), FEELING ABNORMAL (feeling absolutely terrible), HOT FLUSH (stong surge of heat wash over me), GAIT DISTURBANCE (shuffled my way to bathroom), FALL (fall), HEAD INJURY (hit my head on wooden floor divider), SKIN ABRASION (abrasion on left knee), MOANING (moaning), ABNORMAL BEHAVIOUR (gurgling), DEHYDRATION (dehydrated), ELECTROLYTE IMBALANCE (needed to increase my electrolytes), MEDICAL OBSERVATION (needed to be watched closely over weekend) and MYALGIA (body getting sore and achy all over/ tender body) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood glucose: normal (normal) normal. On 16-Apr-2021, Electrocardiogram: normal (normal) normal. On 16-Apr-2021, Urine analysis: normal (normal) normal. 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. No further information is expected at this time. This case was linked to MOD-2021-207690 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Vaccine adverse event reporting form 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. No further information is expected at this time.

Other Meds: LEVOTHYROXINE; MULTIVITAMIN [VITAMINS NOS]; VITAMIN C ACID

Current Illness: Hypothyroidism

ID: 1401703
Sex: M
Age: 56
State:

Vax Date: 03/20/2021
Onset Date: 04/17/2021
Rec V Date: 06/16/2021
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: second dose made it worse; increased seizure activity; some memory loss; motor control issue; out of work/ Have been unable to work since April 17th, 2021; loss of coordination in legs while walking/ loss of leg movement coordination; body aches; fevers ranging between 100-100.2 and a half for 10-20 hours a day/fevers ranging different temperatures on different parts of his head; extreme fatigue; headache/ severe headache; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (increased seizure activity) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Codeine allergy), Penicillin allergy, Drug allergy (Azithromycin allergy), Drug allergy (Dilantin allergy), Drug allergy (Trazadone allergy), Drug allergy (Levaquin allergy), Drug allergy (Aspirin allergy), Food allergy (Yellow onions allergy), Seafood allergy (All seafood except shrimp and flounder), Food allergy (Mild dairy allergy), Allergy to vaccine (Tetanus shot allergy), Allergy to vaccine (Flu shot allergy), Arthritis (worsening ever since received 1st vaccine.) since 01-Jun-1977, Asthma since 01-Feb-1987, Seizure (Frequency has increased by 300% since 2nd vaccine) since 01-Jul-1988, Aortic aneurysm (Aortic muscle damage caused by aneurysm) since 10-Oct-2011 and Crohn's disease since 01-May-1989. Concomitant products included BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) from 01-Aug-1998 to an unknown date for Asthma, MIRTAZAPINE from 01-Feb-2014 to an unknown date for Sleep disorder, MELATONIN, CALCIUM, MAGNESIUM, POTASSIUM, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), ZINC, INOSITOL and IODINE (KELP [IODINE]) for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced IMPAIRED WORK ABILITY (out of work/ Have been unable to work since April 17th, 2021), PYREXIA (fevers ranging between 100-100.2 and a half for 10-20 hours a day/fevers ranging different temperatures on different parts of his head), FATIGUE (extreme fatigue) and HEADACHE (headache/ severe headache). 17-Apr-2021, the patient experienced COORDINATION ABNORMAL (loss of coordination in legs while walking/ loss of leg movement coordination), MYALGIA (body aches) and ARTHRALGIA (joint aches). On 17-Apr-2021 at 11:00 PM, the patient experienced AMNESIA (some memory loss) and MOTOR DYSFUNCTION (motor control issue). On 20-Apr-2021, the patient experienced SEIZURE (increased seizure activity) (seriousness criterion medically significant). On 20-Apr-2021 at 1:00 PM, the patient experienced CONDITION AGGRAVATED (second dose made it worse). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at a dose of UNK dosage form. At the time of the report, SEIZURE (increased seizure activity), CONDITION AGGRAVATED (second dose made it worse), AMNESIA (some memory loss), MOTOR DYSFUNCTION (motor control issue), IMPAIRED WORK ABILITY (out of work/ Have been unable to work since April 17th, 2021), COORDINATION ABNORMAL (loss of coordination in legs while walking/ loss of leg movement coordination), MYALGIA (body aches), PYREXIA (fevers ranging between 100-100.2 and a half for 10-20 hours a day/fevers ranging different temperatures on different parts of his head), FATIGUE (extreme fatigue), HEADACHE (headache/ severe headache) and ARTHRALGIA (joint aches) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Antinuclear antibody: negative (Negative) negative. On 07-May-2021, Blood thyroid stimulating hormone (0.35-5.50): 3.19 (normal) 3.19 uIU/mL. On 07-May-2021, C-reactive protein: 0.5 (Low) <0.5 mg/dL. On 07-May-2021, Electrophoresis: normal (normal) No monoclonal proteins seen on serum. On 07-May-2021, Full blood count: normal (normal) Normal values. On 07-May-2021, Metabolic function test: normal (normal) Normal values. On 07-May-2021, Red blood cell sedimentation rate (0-15): 3 (normal) 3 mm/h. On 07-May-2021, Urine analysis: normal (normal) Normal values. On 07-May-2021, White blood cell count (4.0-10.5): 5.9 (normal) 5.9 K/uL. On 14-May-2021, Computerised tomogram: normal (normal) Normal study. On 17-May-2021, Computerised tomogram: normal (normal) Normal study. On 01-Jun-2021, Blood culture: no growth (normal) no growth. Lab investigations done 0n 05-May2021,included Quantiferon TB gold plus test which was reported as negative and Lyme antibodies, IgG and IgM tests which were reported as negative. Concomitant medications included various vitamins, minerals, enzymes,herbal extracts, amino acids and diet supplements. Patient reported that his primary care physician ordered a battery of lab investigations to rule out other causes than the vaccine for his symptoms, but the results were negative. The patient also maintained a log of the temperature fluctuations since 13-May-2021, for his doctor to establish a pattern. He reported that he has not been able to walk more than half a mile without getting extremely fatigued. He was not able to go to work since 17 April 2021. 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-2021-109846 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No specific follow-up information recorded. On 06-May-2021: Added non significant information which was patient's address and contact details. On 02-Jun-2021: No new information. On 07-Jun-2021: Added patient demographics, medical history, concomitant medications, lab test data, new events and case was upgraded to serious due to Seizure event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: MIRTAZAPINE; QVAR REDIHALER; MELATONIN; CALCIUM; MAGNESIUM; POTASSIUM; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; ZINC; INOSITOL; KELP [IODINE]

Current Illness: Allergy to vaccine (Tetanus shot allergy); Allergy to vaccine (Flu shot allergy); Aortic aneurysm (Aortic muscle damage caused by aneurysm); Arthritis (worsening ever since received 1st vaccine.); Asthma; Crohn's disease; Drug allergy (Trazadone allergy); Drug allergy (Levaquin allergy); Drug allergy (Dilantin allergy); Drug allergy (Codeine allergy); Drug allergy (Azithromycin allergy); Drug allergy (Aspirin allergy); Food allergy (Yellow onions allergy); Food allergy (Mild dairy allergy); Penicillin allergy; Seafood allergy (All seafood except shrimp and flounder); Seizure (Frequency has increased by 300% since 2nd vaccine)

ID: 1401704
Sex: F
Age: 65
State: MI

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 06/16/2021
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: Dehydration; High blood pressure; Fever 98.1 degrees fahrenheit); This spontaneous case was reported by an other caregiver and describes the occurrence of DEHYDRATION (Dehydration) and HYPERTENSION (High blood pressure) 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. Concomitant products included VITAMIN D NOS for an unknown indication. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion hospitalization prolonged) and HYPERTENSION (High blood pressure) (seriousness criterion hospitalization prolonged). On 01-Jun-2021, the patient experienced PYREXIA (Fever 98.1 degrees fahrenheit) ). The patient was hospitalized for 3 days due to DEHYDRATION and HYPERTENSION. The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 tablet. At the time of the report, DEHYDRATION (Dehydration), HYPERTENSION (High blood pressure) and PYREXIA (Fever 98.1 degrees fahrenheit) ) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment received while hospitalized was not reported. Company 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.; 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: VITAMIN D NOS

Current Illness:

Date Died:

ID: 1401705
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: Cardiac problems after receiving either Pfizer or Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC DISORDER (Cardiac problems after receiving either Pfizer or Moderna vaccine) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Cardiac problems after receiving either Pfizer or Moderna vaccine) (seriousness criterion death). The reported cause of death was Cardiac disorder NOS. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. 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.; Reported Cause(s) of Death: Cardiac disorder NOS

Other Meds:

Current Illness:

ID: 1401706
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: When I stand up I feel like I am going to pass out; My arm is so painful I cannot raise it up; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (When I stand up I feel like I am going to pass out) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (When I stand up I feel like I am going to pass out) (seriousness criterion medically significant), VACCINATION SITE PAIN (My arm is so painful I cannot raise it up), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, LOSS OF CONSCIOUSNESS (When I stand up I feel like I am going to pass out), VACCINATION SITE PAIN (My arm is so painful I cannot raise it up), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (High) 100.5. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported by the reporter. No treatment information was provided. Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1401707
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Talking to imaginary man; Exacerbation of Mental health disorder; talking to himself (full conversation); Mild Angry outburst; Diarrhea; insomnia; Not communicating with family members; This spontaneous case was reported by a patient and describes the occurrence of SCHIZOPHRENIA (Talking to imaginary man) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Mental disorder NOS. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SCHIZOPHRENIA (Talking to imaginary man) (seriousness criterion medically significant), MENTAL DISORDER (Exacerbation of Mental health disorder), SOLILOQUY (talking to himself (full conversation)), ANGER (Mild Angry outburst), DIARRHOEA (Diarrhea), INSOMNIA (insomnia) and SOCIAL AVOIDANT BEHAVIOUR (Not communicating with family members). At the time of the report, SCHIZOPHRENIA (Talking to imaginary man), MENTAL DISORDER (Exacerbation of Mental health disorder), SOLILOQUY (talking to himself (full conversation)), ANGER (Mild Angry outburst), DIARRHOEA (Diarrhea), INSOMNIA (insomnia) and SOCIAL AVOIDANT BEHAVIOUR (Not communicating with family members) 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. Treatment information was not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: Mental disorder NOS

ID: 1401708
Sex: F
Age:
State: NJ

Vax Date: 05/28/2020
Onset Date: 04/21/2021
Rec V Date: 06/16/2021
Hospital: Y

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: Saddle Pulmonary Embolism; DVT; This spontaneous case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Saddle Pulmonary Embolism) and DEEP VEIN THROMBOSIS (DVT) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products UBLITUXIMAB for an unknown indication, UMBRALISIB for an unknown indication and VENETOCLAX for an unknown indication. Concurrent medical conditions included Hypertension, Mantle cell lymphoma, Leukemia (relapsed or refractory CLL/SLL) and Richter's syndrome. On 28-May-2020, the patient started UBLITUXIMAB (Intravenous) 900 milligram and UMBRALISIB (Oral) 800 milligram. On 02-Sep-2020, the patient started VENETOCLAX (Oral) 400 milligram. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criteria hospitalization and medically significant). On 24-Apr-2021, the patient experienced PULMONARY EMBOLISM (Saddle Pulmonary Embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Apr-2021 to 26-Apr-2021 due to DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. The patient was treated with HEPARIN on 23-Apr-2021 for DVT, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Saddle Pulmonary Embolism) and DEEP VEIN THROMBOSIS (DVT) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Ultrasound scan: dvt (abnormal) Ultrasound of lower right extremity showed acute deep vein thrombosis, DVT.. On 24-Apr-2021, Computerised tomogram: saddle pulmonary embolism (abnormal) CT on chest with IV contrast showed a saddle pulmonary embolism .. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. 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: Hypertension; Leukemia (relapsed or refractory CLL/SLL); Mantle cell lymphoma

ID: 1401709
Sex: F
Age: 22
State: MI

Vax Date: 06/04/2021
Onset Date: 06/04/2021
Rec V Date: 06/16/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Anaphylactic Shock about 1 hour post vaccination; Hives all over the body; Swollen Throat; Itching all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic Shock about 1 hour post vaccination) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced URTICARIA (Hives all over the body), PHARYNGEAL SWELLING (Swollen Throat) and PRURITUS (Itching all over the body). On 04-Jun-2021 at 1:00 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic Shock about 1 hour post vaccination) (seriousness criteria hospitalization and medically significant). The patient was treated with EPINEPHRINE (EPIPEN) on 04-Jun-2021 for Anaphylactic shock, at a dose of 2 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 04-Jun-2021 for Hives, at a dose of 25 milligram every six hours. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic Shock about 1 hour post vaccination) and PHARYNGEAL SWELLING (Swollen Throat) outcome was unknown and URTICARIA (Hives all over the body) and PRURITUS (Itching all over the body) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. It was reported that as of 07 JUN 2021, the patient still had hives and itchiness. Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1401710
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: Severe thrombocytopenia; This spontaneous case was reported by a physician and describes the occurrence of THROMBOCYTOPENIA (Severe thrombocytopenia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Jun-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 01-Jun-2021, the patient experienced THROMBOCYTOPENIA (Severe thrombocytopenia) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, THROMBOCYTOPENIA (Severe thrombocytopenia) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. The patient experienced the event after administration of the 2nd dose. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm