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**
PLEASE CHECK BACK SOON
Download the files above while you wait.






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: 1435874
Sex: U
Age:
State: VA

Vax Date:
Onset Date: 06/26/2021
Rec V Date: 06/30/2021
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: PARTIAL DOSE OF VACCINE ADMINISTERED; 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: 1821288, and expiry: 01-AUG-2021) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced partial dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose of vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1435875
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 06/30/2021
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: NECK PAIN; OCCASIONAL BACK PAIN; PAIN AROUND LEFT EYE; PAIN IN MUSCLE FROM NECK TO SHOULDER WHILE TURNING HEAD TO LEFT AND RIGHT (MORE TO THE RIGHT); This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced occasional back pain. On APR-2021, the subject experienced pain around left eye. On APR-2021, the subject experienced pain in muscle from neck to shoulder while turning head to left and right (more to the right). Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, occasional back pain, pain around left eye and pain in muscle from neck to shoulder while turning head to left and right (more to the right) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1435876
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 03/31/2021
Rec V Date: 06/30/2021
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: SEVERE INFLAMMATION; WEAK RIGHT LEG; ANXIETY; SEVERE HEADACHES/ "BUBBLES" GOING UP THE BACK OF THE HEAD; SHOOTING PAIN IN FOREARM; NAUSEA; VALVES DAMAGED (SAME AREAS WHERE THE SPASMS WERE OCCURRING); NERVE PAIN; HARD TIME SLEEPING; SKIN HURT TO TOUCH (SENSATION OF BUGS CRAWLING UP THE LEG).; 4-5 BRUISES FROM CALF TO ANKLE THAT DID NOT LINE UP WITH THE PAIN.; SWELLING AROUND THE ANKLE, KNEE AND GROIN (ALL IN THE RIGHT LEG); PAIN AND CRAMPING IN CALF; DIFFICULT TO GET OUT OF THE BED (DUE TO THE SPAMS AND THE FEELING IN HER LEGS); LEGS FELT LIKE WEIGHED 500 LBS (NOT PAINFULL); STRANGE SPAMS LIKE FULL BODY TREMORED (CONCENTRATED IN THE LEGS AND GROIN)/ SPASM IN BOTH LEGS; NUMBNESS IN FOOT; SWELLING IN LEG; BURNING SENSATION; IRREGULAR MENSTRUAL CYCLE (NO SIGNS OF MENOPAUSE); EXTRA DOSE; CHILLS; ICKY; SMALL PATCH OF PAIN OF THE FOOT PAD TOWARDS THE OUTSIDE OF THE FOOT/ SORE ARM/ PAIN IN ARM/ AREA OF PAIN GOT BIGGER; FEVER; TIRED; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 115 pounds, and height was 62 inches. The patient's past medical history included spinal injury, and left sided sciatica pain, and concurrent conditions included non-smoker, gluten allergy, and alcohol user (occasionally (1 drink/day)), and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A421A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced irregular menstrual cycle (no signs of menopause). On 31-MAR-2021, the subject experienced extra dose. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced icky. On 31-MAR-2021, the subject experienced small patch of pain of the foot pad towards the outside of the foot/ sore arm/ pain in arm/ area of pain got bigger. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced tired. On APR-2021, the subject experienced swelling in leg. On APR-2021, the subject experienced burning sensation. On 01-APR-2021, the subject experienced strange spams like full body tremored (concentrated in the legs and groin) / spasm in both legs. On 01-APR-2021, the subject experienced numbness in foot. On 01-APR-2021, the subject experienced difficult to get out of the bed (due to the spams and the feeling in her legs). On 01-APR-2021, the subject experienced legs felt like weighed 500 lbs (not painfull). On 11-APR-2021, the subject experienced pain and cramping in calf. On 20-APR-2021, the subject experienced 4-5 bruises from calf to ankle that did not line up with the pain. On 20-APR-2021, the subject experienced swelling around the ankle, knee and groin (all in the right leg). On 20-APR-2021, the subject experienced skin hurt to touch (sensation of bugs crawling up the leg). Laboratory data included: Diagnostic ultrasound (NR: not provided) Didn't find a clot. On 23-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative. On 29-APR-2021, the subject experienced hard time sleeping. On 30-APR-2021, Laboratory data included: Ankle brachial index (NR: not provided) all clear, Computerized tomogram pelvis and abdomen (NR: not provided) all clear, and Spine X-ray (NR: not provided) all clear. On MAY-2021, the subject experienced valves damaged (same areas where the spasms were occurring). On MAY-2021, the subject experienced nerve pain. Laboratory data included: Cardiac ultrasound (NR: not provided) valvular damage coinciding with pain on legs. On 04-MAY-2021, Laboratory data included: CBC (NR: not provided) all normal, Platelet count (NR: not provided) 178 (lower than her normal), and Protein (NR: not provided) Result not reported. On JUN-2021, the subject experienced nausea. On an unspecified date, the subject experienced shooting pain in forearm, severe inflammation, anxiety, weak right leg, and severe headaches/ "bubbles" going up the back of the head. Laboratory data (dates unspecified) included: Reflex test (NR: not provided) result not reported, Right leg was weaker. Treatment medications (dates unspecified) included: ibuprofen, magnesium, acetylsalicylic acid, paracetamol, tocopheryl acetate, and ergocalciferol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strange spams like full body tremored (concentrated in the legs and groin)/ spasm in both legs, burning sensation, chills, fever, and tired, irregular menstrual cycle (no signs of menopause) on 31-MAR-2021, and difficult to get out of the bed (due to the spams and the feeling in her legs), and legs felt like weighed 500 lbs (not painfull) on 01-APR-2021, was recovering from small patch of pain of the foot pad towards the outside of the foot/ sore arm/ pain in arm/ area of pain got bigger, severe headaches/ "bubbles" going up the back of the head, numbness in foot, pain and cramping in calf, 4-5 bruises from calf to ankle that did not line up with the pain., weak right leg, nausea, icky, extra dose, swelling in leg, swelling around the ankle, knee and groin (all in the right leg), skin hurt to touch (sensation of bugs crawling up the leg)., hard time sleeping, severe inflammation, valves damaged (same areas where the spasms were occurring), nerve pain, and anxiety, and had not recovered from shooting pain in forearm. This report was non-serious.

Other Meds:

Current Illness: Alcohol use; Allergy to grains (bloating, negative for celiac disease); Non-smoker

ID: 1435877
Sex: M
Age:
State: KS

Vax Date:
Onset Date: 06/18/2021
Rec V Date: 06/30/2021
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: LOOSE BOWEL MOVEMENTS; UPSET STOMACH; ACHY; TIRED; FEVER; NAUSEA; WEAKNESS; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced loose bowel movements. On 18-JUN-2021, the subject experienced upset stomach. On 18-JUN-2021, the subject experienced achy. On 18-JUN-2021, the subject experienced tired. On 18-JUN-2021, the subject experienced fever. On 18-JUN-2021, the subject experienced nausea. On 18-JUN-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, achy, fever, nausea, upset stomach, and weakness, and the outcome of loose bowel movements was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1435878
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: SOME CHILLS; SLIGHT FEVER; EXHAUSTED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced some chills, slight fever, and exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever, some chills and exhausted was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1435884
Sex: F
Age: 53
State: PR

Vax Date: 12/30/2020
Onset Date: 01/07/2021
Rec V Date: 06/30/2021
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: Arthus reaction; arm hot to touch; swelling is 3cm around the injection site and it's more painful; Area of injection red; swelling is 3cm around the injection site and it's more painful/Arm felt sore; Inflammation; Allergic Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TYPE III IMMUNE COMPLEX MEDIATED REACTION (Arthus reaction) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Hyperlipidemia, Allergy (skin allergy) and Nasal allergy (nasal allergies). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, CANDESARTAN for Blood pressure high, SIMVASTATIN for Hyperlipidemia, GLUCOSAMINE, CALCIUM and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 30-Dec-2020 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (Inflammation), DERMATITIS ALLERGIC (Allergic Rash), VACCINATION SITE ERYTHEMA (Area of injection red) and VACCINATION SITE PAIN (swelling is 3cm around the injection site and it's more painful/Arm felt sore). On 07-Jan-2021 at 10:00 AM, the patient experienced VACCINATION SITE WARMTH (arm hot to touch) and VACCINATION SITE SWELLING (swelling is 3cm around the injection site and it's more painful). On an unknown date, the patient experienced TYPE III IMMUNE COMPLEX MEDIATED REACTION (Arthus reaction) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and HYDROCORTISONE at a dose of 1 dosage form. On 10-Jan-2021, VACCINATION SITE WARMTH (arm hot to touch), VACCINATION SITE ERYTHEMA (Area of injection red) and VACCINATION SITE SWELLING (swelling is 3cm around the injection site and it's more painful) had resolved. At the time of the report, TYPE III IMMUNE COMPLEX MEDIATED REACTION (Arthus reaction), INJECTION SITE INFLAMMATION (Inflammation), DERMATITIS ALLERGIC (Allergic Rash) and VACCINATION SITE PAIN (swelling is 3cm around the injection site and it's more painful/Arm felt sore) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Skin test negative: negative (Negative) Doctor said might have been Arthus reaction.. On January 7 2021 (8 days after the first vaccine),the patient developed a red welt hot to the touch and swollen and painful. The reporter stated they applied ice and hydrocortisone cream with the welt lasted for three to fours days showing signs of improvement each day. The patient went to the immunologist for patch testing to ensure they were not allergic to an ingredient of the vaccines in order to schedule the second dose. Patch testing came negative and physician concluded it could have been an Arhus reaction. The reporter stated they did not have a similar reaction with the second shot. The patient did feel tired, had a headache and was febrile but symptoms disappeared in 24 hrs. (on 23-Jun-2021 per Source Document) Patient applied Ice to treat the described red welt and hot feeling. Patients doctor states the events Area of injection red, swollen and hot to the touch can be due to Arthus reaction confirming by Negative patch test. 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-2021-233221 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Significant Follow-up contains updated patient demographic details, Medical history, Lab data, Vaccine and facility information, Concomitant medication, Treatment medication, New events and Updated event outcome: Outcome of Area of injection red, swollen and hot to touch updated to recovered/resolved from Unknown. As per MA data corrections Arm felt sore event was removed.; 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: ZYRTEC ALLERGY; SIMVASTATIN; CANDESARTAN; GLUCOSAMINE; CALCIUM; VITAMIN C [ASCORBIC ACID]

Current Illness: Allergy (skin allergy); Blood pressure high; Hyperlipidemia; Nasal allergy (nasal allergies)

ID: 1435885
Sex: F
Age: 40
State: AZ

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 06/30/2021
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: Cellulitis; right wrist area started swelling; painful to touch; Tender; bit of a rash; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced OEDEMA PERIPHERAL (right wrist area started swelling), PAIN IN EXTREMITY (painful to touch), TENDERNESS (Tender) and RASH (bit of a rash). On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis), OEDEMA PERIPHERAL (right wrist area started swelling), PAIN IN EXTREMITY (painful to touch), TENDERNESS (Tender) and RASH (bit of a rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information was not provided. Treatment information was not provided. For event of Cellulitis, the reporter assessed causality as not related. For events, right wrist area started swelling, painful to touch, tender and bit of rash, the reporter did not provide any causality assessments. Company Comment Based on reporter's causality of recent hospitalization for the event of cellulitis in the non-vaccinated upper limb, is assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Turns out it was cellulitis from a recent hospital visit and not related to the vaccine at all.; Sender's Comments: Based on reporter's causality of recent hospitalization for the event of cellulitis in the non-vaccinated upper limb, is assessed as unlikely related to mRNA-1273.

Other Meds:

Current Illness:

ID: 1435886
Sex: F
Age:
State: PA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 06/30/2021
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: Scratched silly to the point of bleeding; Itching didn't stop; Hives got worse; Hives under neck and back but they had not come out; Hives started on her arms; Rash appeared on left hip which was itchy; Anaphylactic reaction; Itching; Rash is so bad/Rash on right hip; Ready to rip her skin off; Hive/Legs both front and back were covered in hives/Hives on legs; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bee sting (Reaction: Swelling at the site of sting) and Shellfish allergy (Reaction: Hives). Concomitant products included PRAVASTATIN SODIUM (PRAVACHOL) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, unspecified. On 21-Jan-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced SKIN EXFOLIATION (Ready to rip her skin off), URTICARIA (Hive/Legs both front and back were covered in hives/Hives on legs), PRURITUS (Itching) and RASH (Rash is so bad/Rash on right hip). On 21-Jan-2021 at 4:30 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). On 22-Jan-2021, the patient experienced RASH PRURITIC (Rash appeared on left hip which was itchy). On 02-Feb-2021, the patient experienced URTICARIA CHRONIC (Hives got worse), URTICARIA (Hives under neck and back but they had not come out), URTICARIA (Hives started on her arms) and PRURITUS (Itching didn't stop). On an unknown date, the patient experienced SCRATCH (Scratched silly to the point of bleeding). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at a dose of 1 dosage form; CORTISONE for Itchy, at a dose of 1 dosage form; PREDNISONE for Hives, at a dose of 1 dosage form; OATMEAL at a dose of 1 dosage form; BAKING SODA at a dose of 1 dosage form; PREDNISONE (DELTASONE [PREDNISONE]) for Rash, at a dose of 40 mg and HYDROXYZINE HCL for Rash, at a dose of 25 mg. On 01-Mar-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. At the time of the report, SCRATCH (Scratched silly to the point of bleeding), SKIN EXFOLIATION (Ready to rip her skin off), URTICARIA (Hive/Legs both front and back were covered in hives/Hives on legs), URTICARIA CHRONIC (Hives got worse), URTICARIA (Hives under neck and back but they had not come out), URTICARIA (Hives started on her arms), RASH PRURITIC (Rash appeared on left hip which was itchy), PRURITUS (Itching), PRURITUS (Itching didn't stop) and RASH (Rash is so bad/Rash on right hip) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 119/85 (abnormal) abnormal. On an unknown date, Body temperature: 36.4 (Inconclusive) Inconclusive. On an unknown date, Heart rate: 94 (Inconclusive) Inconclusive. On an unknown date, Oxygen saturation: 100% (Inconclusive) Inconclusive. On an unknown date, Respiratory rate: 18 (Inconclusive) Inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient also took cold bath as treatment. On an unknown date, it was reported that the patient had a dermatologic examination where the dermatologist look at the patient's hives/rash; results were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16 Jun 2021, Added Patient's race, height, weight, lab details and information concomitant medications and new event details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: SYNTHROID; PRAVACHOL

Current Illness: Bee sting (Reaction: Swelling at the site of sting); Shellfish allergy (Reaction: Hives)

ID: 1435887
Sex: M
Age: 82
State: GA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 06/30/2021
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: had COVID-19 in October; had a stroke; has been receiving therapy, physical therapy; Chills/it throw him in a hard loop of chills.; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had a stroke) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in October 2020 and Stroke in 2020. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced CHILLS (Chills/it throw him in a hard loop of chills.). On an unknown date, the patient experienced COVID-19 (had COVID-19 in October), CEREBROVASCULAR ACCIDENT (had a stroke) (seriousness criterion medically significant) and PHYSIOTHERAPY (has been receiving therapy, physical therapy). On 26-Jan-2021, CHILLS (Chills/it throw him in a hard loop of chills.) had resolved. At the time of the report, COVID-19 (had COVID-19 in October), CEREBROVASCULAR ACCIDENT (had a stroke) and PHYSIOTHERAPY (has been receiving therapy, physical therapy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was reported.

Other Meds: ELIQUIS

Current Illness:

ID: 1435888
Sex: F
Age: 72
State: MA

Vax Date: 02/19/2021
Onset Date: 03/01/2021
Rec V Date: 06/30/2021
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: light pink rash on nose and cheeks; rash around neck, swelling; Angioedema; Hypersensitivity reaction; Numbness; Itching-Local; Blotchy red rash on left arm; Erythema redness left arm; Tenderness left arm; chest to belly itching rash, hives; face red all over and getting plumped and swollen; face red all over and getting plumped and swollen; This spontaneous case was reported by a nurse and describes the occurrence of ANGIOEDEMA (Angioedema) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Sulfa) since 1980, Penicillin allergy (Rash) since 1980 and Drug allergy (Compazine for vomiting- Dystonia of jaw after two doses of Compazine) since 1990. Concomitant products included FAMOTIDINE (PEPCID AC) for GERD, adult multivitamin, COLECALCIFEROL (D3) and CALCIUM CITRATE for Supplementation therapy. On 19-Feb-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), HYPERSENSITIVITY (Hypersensitivity reaction), HYPOAESTHESIA (Numbness), PRURITUS (Itching-Local), RASH MACULAR (Blotchy red rash on left arm), ERYTHEMA (Erythema redness left arm), TENDERNESS (Tenderness left arm), URTICARIA (chest to belly itching rash, hives), ERYTHEMA (face red all over and getting plumped and swollen), SWELLING FACE (face red all over and getting plumped and swollen) and RASH (rash around neck, swelling). On 03-Mar-2021, the patient experienced RASH (light pink rash on nose and cheeks). The patient was treated with PREDNISONE (oral) from 01-Mar-2021 to 15-Mar-2021 for Swelling, at a dose of 40 milligram; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 01-Mar-2021 to 07-Mar-2021 at a dose of 25 mg every four hours and LORATADINE (CLARITIN [LORATADINE]) (oral) from 01-Mar-2021 to 09-Mar-2021 at a dose of 10 mg twice a day. On 02-Mar-2021, TENDERNESS (Tenderness left arm) had resolved. On 21-Mar-2021, ANGIOEDEMA (Angioedema), HYPERSENSITIVITY (Hypersensitivity reaction), HYPOAESTHESIA (Numbness), PRURITUS (Itching-Local), RASH MACULAR (Blotchy red rash on left arm), ERYTHEMA (Erythema redness left arm), URTICARIA (chest to belly itching rash, hives), ERYTHEMA (face red all over and getting plumped and swollen), SWELLING FACE (face red all over and getting plumped and swollen), RASH (light pink rash on nose and cheeks) and RASH (rash around neck, swelling) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Hypersensitivity reaction , Angioedema, Numbness and Itching were added. On 20-Jun-2021: Added patient demographics, height, allergy, concomitant medications and events stop date.; 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: Adult multivitamin; D3; CALCIUM CITRATE; PEPCID AC

Current Illness: Drug allergy (Sulfa); Drug allergy (Compazine for vomiting- Dystonia of jaw after two doses of Compazine); Penicillin allergy (Rash)

ID: 1435889
Sex: M
Age: 52
State: TX

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Cellulitis in parotid gland; Jawline was swelling quite large; Swollen throat; Difficulty swallowing; Damage from surgery where my lip wont move in one part; Missing two teeth; Infection in my face; earache; Sore throat; Headache; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis in parotid gland), SWELLING FACE (Jawline was swelling quite large) and INFECTION (Infection in my face) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CELLULITIS (Cellulitis in parotid gland) (seriousness criteria hospitalization and medically significant). On 10-Mar-2021, the patient experienced EAR PAIN (earache), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and CHILLS (Chills). On 12-Mar-2021, the patient experienced INFECTION (Infection in my face) (seriousness criterion hospitalization). On an unknown date, the patient experienced SWELLING FACE (Jawline was swelling quite large) (seriousness criterion hospitalization), PHARYNGEAL SWELLING (Swollen throat), DYSPHAGIA (Difficulty swallowing), LIP DISORDER (Damage from surgery where my lip wont move in one part) and TOOTH LOSS (Missing two teeth). The patient was hospitalized from 13-Mar-2021 to 20-Mar-2021 due to CELLULITIS. On 20-Mar-2021, CELLULITIS (Cellulitis in parotid gland) had resolved with sequelae. At the time of the report, SWELLING FACE (Jawline was swelling quite large), INFECTION (Infection in my face), PHARYNGEAL SWELLING (Swollen throat), EAR PAIN (earache), OROPHARYNGEAL PAIN (Sore throat), DYSPHAGIA (Difficulty swallowing), LIP DISORDER (Damage from surgery where my lip wont move in one part), TOOTH LOSS (Missing two teeth), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. On 11-Mar-2021, the patient consulted the doctor because his sore throat and earache on the side of the injection site was painful. He was sent to the emergency room on 12-Mar-2021, for infection in the face. The doctor told the patient that the swelling and pain was from the vaccine and prescribed Motrin. The patient reported that he was getting worse and developed jawline swelling, He went to the hospital on an unspecified date. He was advised admission as he had severe infection and was prescribed antibiotics. On an unspecified date, surgery was done to drain the infection. Drainage was minimal. The patient had surgery a second time, to drain the swelling. He was admitted for a week in the hospital. The patient reported damage from the surgery which included loss of movement of lip in one part and loss of two teeth. 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 events, a causal relationship cannot be excluded.MR review complete. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-Jun-2021: Case was upgraded to serious, patient details were updated, additional events were added, hospitalization details and treatment details were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.MR review complete.

Other Meds:

Current Illness:

ID: 1435890
Sex: F
Age: 81
State: FL

Vax Date: 03/18/2021
Onset Date: 03/23/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: covid; cough; aches all over; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chemotherapy. Concurrent medical conditions included Cancer (seven and half years ago). On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced COUGH (cough), MYALGIA (aches all over), PYREXIA (fever) and HEADACHE (headache). On an unknown date, the patient experienced COVID-19 (covid) (seriousness criterion hospitalization). The patient was hospitalized for 24 days due to COVID-19. The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid), COUGH (cough), MYALGIA (aches all over), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 100.3 ?F (High) 100.3?F. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. Concomitant products included blood pressure medicine (unspecified). Reportedly, the patient had COVID five days after the first shot of vaccine. The patient had to stay three and a half weeks in hospital that destroyed her immune system and she said that it was coming back after medications. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Case upgraded to serious, includes- serious event of covid-19 (hospitalization) and historical condition of cancer and had chemotherapy.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: 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: Cancer (seven and half years ago)

ID: 1435891
Sex: F
Age: 44
State: FL

Vax Date: 03/26/2021
Onset Date: 03/29/2021
Rec V Date: 06/30/2021
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: Anaphylactic reaction; sensitive to touch / thighs were sensitive to touch; sore joints; drowsiness; knot on forhead over my eye; hives; Swallowing difficult; sore arm/ bilateral aching of hands; swollen lips; Angioedema; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema) and ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anaphylaxis. Concomitant products included MINOCYCLINE from 21-May-2010 to 20-May-2021 and CLINDAMYCIN PHOSPHATE from 11-Mar-2021 to an unknown date for Acne, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) from 22-Feb-2008 to an unknown date for Allergy, AMLODIPINE from 20-May-2010 to an unknown date and HCTZ from 21-May-2010 to an unknown date for Hypertension. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), LIP SWELLING (swollen lips), ARTHRALGIA (sore joints), SOMNOLENCE (drowsiness), SWELLING FACE (knot on forhead over my eye), URTICARIA (hives), DYSPHAGIA (Swallowing difficult) and MYALGIA (sore arm/ bilateral aching of hands). On 30-Mar-2021, the patient experienced SENSITIVE SKIN (sensitive to touch / thighs were sensitive to touch). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE (intramuscular) on 20-Apr-2021 for Adverse event, at a dose of .3 mg as required; METHYLPREDNISOLONE (oral) from 29-Mar-2021 to 03-Apr-2021 for Adverse event, at a dose of 04 mg METHYLPREDNISONE; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) (oral) ongoing from 22-Feb-2008 at a dose of 10 mg twice a day and FAMOTIDINE for Adverse event, at a dose of 20 mg four times per day. On 30-Mar-2021, ANGIOEDEMA (Angioedema), LIP SWELLING (swollen lips), SENSITIVE SKIN (sensitive to touch / thighs were sensitive to touch), ARTHRALGIA (sore joints), SOMNOLENCE (drowsiness), SWELLING FACE (knot on forhead over my eye), URTICARIA (hives), DYSPHAGIA (Swallowing difficult) and MYALGIA (sore arm/ bilateral aching of hands) had resolved. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Blood pressure measurement: 108/72 mmHg (Inconclusive) 108/72. On 29-May-2021, Body temperature: 99.1 (Inconclusive) 99.1 Fahrenheit. On 29-May-2021, Heart rate: 103 (Inconclusive) 103 beat per min. On 29-May-2021, Respiratory rate: 20 (Inconclusive) 20 breaths per minute. Patient reported that she experienced hypersensitivity in the skin of the thigh after shower and knot on forehead. Patient was diagnosed with anaphylactic reaction which was recovered on 30-Mar-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. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Patient received the second dose,, vitals reported, Urticaria ,swelling of the upper airway, difficulty swallowing, angioedema adverse events were reported. Treatment medications were reported. Outcome of the events were recovered/resolved .; 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: AMLODIPINE; HCTZ; MINOCYCLINE; CLINDAMYCIN PHOSPHATE; CLARITIN ALLERGIC

Current Illness:

ID: 1435892
Sex: F
Age:
State: SC

Vax Date: 02/13/2021
Onset Date: 03/04/2021
Rec V Date: 06/30/2021
Hospital: Y

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: Pneumonia; Did not get second dose within 36 days; Tested positive for COVID-19 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after 1st dose). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose within 36 days). At the time of the report, PNEUMONIA (Pneumonia) and COVID-19 (Tested positive for COVID-19 after 1st dose) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose within 36 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications were not reported. The treatment information was not provided. Based on the mechanism of action of mRNA-1273, a causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. The COVID-19 infection could be a possible confounding factor for the event of Pneumonia. Very limited information regarding the pneumonia event and hospitalization have been provided. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received on 17-Jun-2021 and had significant information. Updated event Pneumonia.Case Upgraded to serious.; Sender's Comments: Based on the mechanism of action of mRNA-1273, a causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. The COVID-19 infection could be a possible confounding factor for the event of Pneumonia. Very limited information regarding the pneumonia event and hospitalization have been provided. No further information is expected.

Other Meds:

Current Illness:

ID: 1435893
Sex: F
Age: 81
State: CA

Vax Date: 02/06/2021
Onset Date: 03/06/2021
Rec V Date: 06/30/2021
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: Flashing light hallucinations; Pain in joints; Numbing of toes both sides; Toes tingling/ Fingers tingling/ Occasionally numbing and tingling fingers both hands; Insomnia / Slept for 6 to 7 hrs knocked out completely / Cant sleep at night; Pain in hips and legs up to knees/ Pain in legs feet and fingers; Bone pain; Sleep seven hours in raw; "could not drive"; Body pain/ Constant pain in body; Tiredness/ Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, VISUAL (Flashing light hallucinations) in an 81-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. No medical history was provided by the reporter. Concurrent medical conditions included Drug allergy (Macrobid allergy), Fibromyalgia (Fibromyalgia was under control. Unbearable now.), Arthritis (Arthritis was under control. Unbearable now.) and Myalgia. Concomitant products included DOXYCYCLINE, VITAMIN A [RETINOL], VITAMIN B NOS, VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 06-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced BONE PAIN (Bone pain), MYALGIA (Body pain/ Constant pain in body) and FATIGUE (Tiredness/ Fatigue). 06-Mar-2021, the patient experienced HYPERSOMNIA (Sleep seven hours in raw) and IMPAIRED DRIVING ABILITY ("could not drive"). On 22-Mar-2021, the patient experienced HYPOAESTHESIA (Numbing of toes both sides), PARAESTHESIA (Toes tingling/ Fingers tingling/ Occasionally numbing and tingling fingers both hands), INSOMNIA (Insomnia / Slept for 6 to 7 hrs knocked out completely / Cant sleep at night) and PAIN IN EXTREMITY (Pain in hips and legs up to knees/ Pain in legs feet and fingers). On an unknown date, the patient experienced HALLUCINATION, VISUAL (Flashing light hallucinations) (seriousness criterion medically significant) and ARTHRALGIA (Pain in joints). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Myalgia, at a dose of 2 dosage form. On 08-Mar-2021, HYPERSOMNIA (Sleep seven hours in raw) and IMPAIRED DRIVING ABILITY ("could not drive") had resolved. At the time of the report, HALLUCINATION, VISUAL (Flashing light hallucinations) and ARTHRALGIA (Pain in joints) outcome was unknown and HYPOAESTHESIA (Numbing of toes both sides), PARAESTHESIA (Toes tingling/ Fingers tingling/ Occasionally numbing and tingling fingers both hands), INSOMNIA (Insomnia / Slept for 6 to 7 hrs knocked out completely / Cant sleep at night), PAIN IN EXTREMITY (Pain in hips and legs up to knees/ Pain in legs feet and fingers), BONE PAIN (Bone pain), MYALGIA (Body pain/ Constant pain in body) and FATIGUE (Tiredness/ Fatigue) had not resolved. The patient had implant dental work near 2 weeks ago around 10-Apr-2021 and received Doxycycline. The patient reported that the doctor won't return the call. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Additional information received included patient demographics race, relevant history details including Macrobid allergy, current condition fibromyalgia and arthritis; new concomitant medications added; Treatment medicines were added . Added New adverse event Flashing light hallucinations.; 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: DOXYCYCLINE; VITAMIN A [RETINOL]; VITAMIN B NOS; VITAMIN D NOS; MULTIVITAMIN [VITAMINS NOS]

Current Illness: Arthritis (Arthritis was under control. Unbearable now.); Drug allergy (Macrobid allergy); Fibromyalgia (Fibromyalgia was under control. Unbearable now.); Myalgia

ID: 1435894
Sex: M
Age: 80
State: NY

Vax Date: 03/13/2021
Onset Date: 05/06/2021
Rec V Date: 06/30/2021
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: Pneumonia; Very ill; Dysphagia; Got 3 Moderna vaccines; This spontaneous case was reported by a nurse and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 040B21A and 043B121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pre-existing disease. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 06-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 06-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Got 3 Moderna vaccines). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), ILLNESS (Very ill) and DYSPHAGIA (Dysphagia). On 06-May-2021, EXTRA DOSE ADMINISTERED (Got 3 Moderna vaccines) had resolved. At the time of the report, PNEUMONIA (Pneumonia), ILLNESS (Very ill) and DYSPHAGIA (Dysphagia) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medication were provided. Lot number of 3rd dose of mRNA-1273 - 043B121A. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-May-2021 contains no significant information. Updated lot number of 3rd dose of mRNA-1273. On 16-Jun-2021: Updated events - Pneumonia (medically significant), Illness and Dysphagia. Updated historical condition - comorbid conditions.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Pre-existing disease

ID: 1435895
Sex: F
Age: 76
State: TN

Vax Date: 01/01/2021
Onset Date: 02/08/2021
Rec V Date: 06/30/2021
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: Hives; Warm at the injection site; Itchy at the injection site; Red circle at the injection site, with the shape of a pear; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site, with the shape of a pear) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced URTICARIA (Hives), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site, with the shape of a pear). At the time of the report, URTICARIA (Hives), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site, with the shape of a pear) outcome was unknown. concomitant medication include diabetes medication. no treatment medication reported. This case was linked to MOD-2021-035951 (Patient Link).

Other Meds:

Current Illness: Diabetes

ID: 1435896
Sex: F
Age: 99
State: PA

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Mini stroke; Numbness from shoulder to hand opposite arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Mini stroke) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness from shoulder to hand opposite arm of injection). On 17-Jun-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Mini stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Mini stroke) and HYPOAESTHESIA (Numbness from shoulder to hand opposite arm of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product were not provided. Treatment medication was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Address, date of birth and serious event added upgrading the case; 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, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been requested.

Other Meds:

Current Illness:

ID: 1435897
Sex: F
Age: 68
State: NC

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 06/30/2021
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: Tingling sensation in fingers of left arm and going up on arm; Two fingers are numb; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation in fingers of left arm and going up on arm) and HYPOAESTHESIA (Two fingers are numb) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation in fingers of left arm and going up on arm) and HYPOAESTHESIA (Two fingers are numb). The patient was treated with CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling sensation in fingers of left arm and going up on arm) and HYPOAESTHESIA (Two fingers are numb) outcome was unknown. Concomitant medications were not provided. Company Comment : This case concerns a 68-year-old female with serious unexpected events of paraesthesia, and hypoaesthesia. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 68-year-old female with serious unexpected events of paraesthesia, and hypoaesthesia. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1435898
Sex: M
Age: 57
State: VA

Vax Date: 06/03/2021
Onset Date: 06/04/2021
Rec V Date: 06/30/2021
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: Block; cardiac arrest; This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC ARREST (cardiac arrest) and CAROTID ARTERY OCCLUSION (Block) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A,) for COVID-19 vaccination. Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CARVEDILOL PHOSPHATE and ROSUVASTATIN CALCIUM for an unknown indication. On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criterion medically significant). On an unknown date, the patient experienced CAROTID ARTERY OCCLUSION (Block) (seriousness criterion medically significant). At the time of the report, CARDIAC ARREST (cardiac arrest) had resolved and CAROTID ARTERY OCCLUSION (Block) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) Normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patients age, and concomitant medication with ticagrelor, aspirin, rosuvastatin suggest an underlying cardiovascular disease that is a potential confounder. Additional information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patients age, and concomitant medication with ticagrelor, aspirin, rosuvastatin suggest an underlying cardiovascular disease that is a potential confounder. Additional information has been requested.

Other Meds: BRILINTA; ASPIRIN (E.C.); CARVEDILOL PHOSPHATE; ROSUVASTATIN CALCIUM

Current Illness:

ID: 1435899
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
Hospital: Y

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: Admitted to a hospital ( ICU for 7 seven days); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HOSPITALISATION (Admitted to a hospital ( ICU for 7 seven days)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Admitted to a hospital ( ICU for 7 seven days)) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Admitted to a hospital ( ICU for 7 seven days)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication use was provided by the reporter. No treatment of events was reported. Company comment: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1435900
Sex: F
Age: 51
State: TX

Vax Date: 05/21/2021
Onset Date: 05/28/2021
Rec V Date: 06/30/2021
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: right side of face, lips droopped a little; throat irritation; lymph nodes swelling - under her chin; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (right side of face, lips droopped a little) in a 51-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. The patient's past medical history included Total hysterectomy in 2016 and Colonoscopy on 14-May-2021. Concurrent medical conditions included HIV disease, Spinal cord injury and Nerve injury. On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced FACIAL PARALYSIS (right side of face, lips droopped a little) (seriousness criterion medically significant), THROAT IRRITATION (throat irritation) and LYMPHADENOPATHY (lymph nodes swelling - under her chin). The patient was treated with NAPROXEN for Inflammation, at an unspecified dose and frequency. On 15-Jun-2021, FACIAL PARALYSIS (right side of face, lips droopped a little) had resolved. At the time of the report, THROAT IRRITATION (throat irritation) had not resolved and LYMPHADENOPATHY (lymph nodes swelling - under her chin) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication reporter were hypertension medication, hyperlipidemia medication and HIV medication. Cough lozenges were the treatment medication reported by reporter. Patient also said that she did not have these symptoms before the COVID shot 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: HIV disease; Nerve injury; Spinal cord injury

ID: 1435901
Sex: M
Age: 19
State: SC

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Anxiety is really bad; severe allergic reaction; seizure like activity; significant amount of shaking and diaphoresis; significant amount of shaking and diaphoresis; afraid to receive the second shot; This spontaneous case was reported by a nurse and describes the occurrence of ALLERGY TO VACCINE (severe allergic reaction), SEIZURE (seizure like activity), TREMOR (significant amount of shaking and diaphoresis), HYPERHIDROSIS (significant amount of shaking and diaphoresis) and ANXIETY (Anxiety is really bad) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced ALLERGY TO VACCINE (severe allergic reaction) (seriousness criteria hospitalization and life threatening), SEIZURE (seizure like activity) (seriousness criteria hospitalization, medically significant and life threatening), TREMOR (significant amount of shaking and diaphoresis) (seriousness criterion hospitalization) and HYPERHIDROSIS (significant amount of shaking and diaphoresis) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANXIETY (Anxiety is really bad) (seriousness criterion hospitalization) and INTENTIONAL PRODUCT USE ISSUE (afraid to receive the second shot). The patient was hospitalized on sometime in April 2021 due to ALLERGY TO VACCINE, HYPERHIDROSIS, SEIZURE and TREMOR. The patient was treated with EPINEPHRINE (EPIPEN) in April 2021 for Allergy to vaccine, at a dose of 1 dosage form, unknown. At the time of the report, ALLERGY TO VACCINE (severe allergic reaction), SEIZURE (seizure like activity), TREMOR (significant amount of shaking and diaphoresis), HYPERHIDROSIS (significant amount of shaking and diaphoresis) and ANXIETY (Anxiety is really bad) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (afraid to receive the second shot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: went way up (High) went way up. In April 2021, Heart rate: went way up (High) went way up. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. The patient received his first Moderna vaccine dose on maybe 02-Apr-2021 or 03-Apr-2021, possibly in his right arm. Within 5-10 minutes, he had a severe allergic reaction which consisted of seizure-like activities. The patient was treated with an EpiPen shot and sent to the emergency room. It was reported the patient had anxiety which was really bad and he was now being treated with an unspecified anti-anxiety medication to help. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1435902
Sex: F
Age: 66
State: WA

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: left knee gave out and buckled, and was hospitalized for 4 days; If it's in bed and put a pillow over it and is laying in bed, with some difficulty can lift it and it's normally the strong leg; Kinda like the whole left side of the body has been affected; Certain damage to the muscle; Weakness; Pain in the left arm; Really tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT INJURY (left knee gave out and buckled, and was hospitalized for 4 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Ehlers-Danlos syndrome. Concomitant products included RIVAROXABAN (XARELTO), VALETHAMATE BROMIDE (VALOSIN), DIGOXIN, EZETIMIBE, CICLOSPORIN (RESTASIS), SPIRONOLACTONE, SOTALOL, TRAZODONE, LORATADINE, FOLIC ACID (FOLATE), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), MAGNESIUM TAURATE, MELATONIN, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D3) for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT INJURY (left knee gave out and buckled, and was hospitalized for 4 days) (seriousness criterion hospitalization), MOBILITY DECREASED (If it's in bed and put a pillow over it and is laying in bed, with some difficulty can lift it and it's normally the strong leg), FEELING ABNORMAL (Kinda like the whole left side of the body has been affected), MUSCLE INJURY (Certain damage to the muscle), ASTHENIA (Weakness), VACCINATION SITE PAIN (Pain in the left arm) and FATIGUE (Really tired). The patient was treated with Physical therapy for Mobility decreased. At the time of the report, JOINT INJURY (left knee gave out and buckled, and was hospitalized for 4 days), MOBILITY DECREASED (If it's in bed and put a pillow over it and is laying in bed, with some difficulty can lift it and it's normally the strong leg), FEELING ABNORMAL (Kinda like the whole left side of the body has been affected), MUSCLE INJURY (Certain damage to the muscle), ASTHENIA (Weakness), VACCINATION SITE PAIN (Pain in the left arm) and FATIGUE (Really tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had a rare Genetic Disease,Ehlers Danlos Syndrome.,that affected the connective tissue and collagen in the body has been clinically diagnosed. Treatment information in response to events was not provided. Other concomitant medication included Metocapuilan. Very limited information regarding these events have been provided at this time. Patient's age and history of Ehlers-Danlos syndrome may be confounding factors to the event Knee Injury. No further information is expected. This case was linked to MOD-2021-222975 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. Patient's age and history of Ehlers-Danlos syndrome may be confounding factors to the event Knee Injury. No further information is expected.

Other Meds: XARELTO; VALOSIN; DIGOXIN; EZETIMIBE; RESTASIS; SPIRONOLACTONE; SOTALOL; TRAZODONE; LORATADINE; FOLATE; VITAMIN B12 [CYANOCOBALAMIN]; MAGNESIUM TAURATE; MELATONIN; VITAMIN C [ASCORBIC ACID]; VITAMIN D3

Current Illness: Ehlers-Danlos syndrome

ID: 1435903
Sex: M
Age: 59
State: IL

Vax Date: 12/20/2017
Onset Date:
Rec V Date: 06/30/2021
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: Pancreatitis; Flank Pain; Allergic reaction; Abdominal Pain; Pain; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PANCREATITIS (Pancreatitis) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia and SEMAGLUTIDE (OZEMPIC) for an unknown indication. Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), EMPAGLIFLOZIN (JARDIANCE) and METOPROLOL for an unknown indication. On 20-Dec-2017, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 140 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, IBRUTINIB (IMBRUVICA) (Oral) 280 milligram once a day and SEMAGLUTIDE (OZEMPIC) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criterion medically significant), FLANK PAIN (Flank Pain), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash). At the time of the report, PANCREATITIS (Pancreatitis), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash) outcome was unknown and FLANK PAIN (Flank Pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative. 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. Treatment information was not provided. Company comment: Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Other Meds: FARXIGA; JARDIANCE; METOPROLOL

Current Illness: Chronic lymphocytic leukemia

ID: 1435904
Sex: U
Age:
State: CT

Vax Date: 04/20/2021
Onset Date:
Rec V Date: 06/30/2021
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: passed out from the pain; Dry heaves; head felt swollen; my headache continued to move down to my right jaw; ever had migraines before; stomach sickness; arm hurt at the vaccination site; Chills; head was aching terribly; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out from the pain) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out from the pain) (seriousness criterion medically significant), RETCHING (Dry heaves), HEAD DISCOMFORT (head felt swollen), PAIN IN JAW (my headache continued to move down to my right jaw), MIGRAINE (ever had migraines before), ABDOMINAL DISCOMFORT (stomach sickness), VACCINATION SITE PAIN (arm hurt at the vaccination site), CHILLS (Chills) and HEADACHE (head was aching terribly). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (passed out from the pain), RETCHING (Dry heaves), HEAD DISCOMFORT (head felt swollen), MIGRAINE (ever had migraines before) and VACCINATION SITE PAIN (arm hurt at the vaccination site) outcome was unknown, PAIN IN JAW (my headache continued to move down to my right jaw) and HEADACHE (head was aching terribly) had not resolved and ABDOMINAL DISCOMFORT (stomach sickness) and CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: inconclusive (Inconclusive) Inconclusive did not showany problem. On an unknown date, Magnetic resonance imaging: inconclusive (Inconclusive) Inconclusive did not show any problem. On an unknown date, X-ray: inconclusive (Inconclusive) X-ray confirmed there was nothing wrong in my jaw.. Patient had done blood work that did not show problems No Concomitant medication information was provided. Action taken with mRNA-1273 in response to the events was Not Applicable. Company comment: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1435906
Sex: M
Age: 51
State: IL

Vax Date: 11/01/2019
Onset Date: 04/01/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Abscess; Skin discolouration; Pimple; Rheumatoid arthritis flare up; Pain; Ingrown hair on right butocks/grown to size of golf ball; High Blood Pressure; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of ABSCESS (Abscess) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis. The patient's past medical history included Alcoholic (BEER, MARGARITAS, Rarely) in 1988. Concurrent medical conditions included Asthma, Grass allergy, Allergy to animal (cats), Allergy to plants (Trees) and Penicillin allergy. In November 2019, the patient started UPADACITINIB (RINVOQ) (Oral) 15 mg once a day. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced HYPERTENSION (High Blood Pressure). On 20-May-2021, the patient experienced ABSCESS (Abscess) (seriousness criterion hospitalization) and INGROWN HAIR (Ingrown hair on right butocks/grown to size of golf ball). On 21-May-2021, the patient experienced PAIN (Pain). On 07-Jun-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). In 2021, the patient experienced FATIGUE (Tiredness). On an unknown date, the patient experienced SKIN DISCOLOURATION (Skin discolouration) and ACNE (Pimple). The patient was hospitalized from 24-May-2021 to 25-May-2021 due to ABSCESS. The patient was treated with VALSARTAN for Blood pressure high, at a dose of 1 dosage form; ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, at a dose of 1 dosage form; SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at a dose of 1 dosage form; METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) at a dose of 1 dosage form and Surgery for Abscess. At the time of the report, ABSCESS (Abscess), INGROWN HAIR (Ingrown hair on right butocks/grown to size of golf ball), PAIN (Pain), HYPERTENSION (High Blood Pressure), SKIN DISCOLOURATION (Skin discolouration), ACNE (Pimple) and FATIGUE (Tiredness) outcome was unknown and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Blood cholesterol: 293 (High) High cholesterol. In April 2021, Blood pressure measurement: 176 / 106 (High) High blood pressure. In April 2021, Cardiac stress test: normal (normal) No Blockage. On 02-Jun-2021, Liver function test: ast:57 alt:147 (High) AST:57, ALT:147 Elevated liver enzymes. On 03-Jun-2021, Blood cholesterol: 128 (normal) Normal cholesterol. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Company Comment: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness: Allergy to animal (cats); Allergy to plants (Trees); Asthma; Grass allergy; Penicillin allergy

ID: 1435907
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Copd before but now i have had heart an lung problems was in hosp for 6 days; Copd before but now i have had heart an lung problems was in hosp for 6 days; Bad breathing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days), LUNG DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days) and DYSPNOEA (Bad breathing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COPD. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days) (seriousness criterion hospitalization), LUNG DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days) (seriousness criterion hospitalization) and DYSPNOEA (Bad breathing) (seriousness criterion hospitalization). At the time of the report, CARDIAC DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days), LUNG DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days) and DYSPNOEA (Bad breathing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications were not provided. Treatment medications were not provided. Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.

Other Meds:

Current Illness:

ID: 1435908
Sex: U
Age:
State: RI

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 06/30/2021
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: I slept for most of the day; Anaphylactic shock; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) 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. Concurrent medical conditions included Drug allergy (to Codeine), Sulfonamide allergy (to sulfa drugs), Allergy to antibiotic (to tetracycline) and Insect bite allergy (to bites of various insects). On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant). On 08-Apr-2021, the patient experienced SOMNOLENCE (I slept for most of the day). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) 07-Apr-2021 for Allergic reaction, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock) and SOMNOLENCE (I slept for most of the day) outcome was unknown. Concomitant product use was not provided. The patient stated that she was monitored at hospital for several hours, as well as given another medication to counter the allergic reaction. 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: Allergy to antibiotic (to tetracycline); Drug allergy (to Codeine); Insect bite allergy (to bites of various insects); Sulfonamide allergy (to sulfa drugs)

ID: 1435909
Sex: U
Age:
State:

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 06/30/2021
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: felt like a bad bruise; injection site felt like I had been extremely punched hard in that spot/the pain was not debilitating; The next day, I slept for most of the day; Anaphylactic shock; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) 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. Concurrent medical conditions included Drug allergy (codeine), Drug allergy (sulpha drugs), Drug allergy (tetracyclines) and Allergy (Bites of insects). On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant) and HYPERSENSITIVITY (allergic reaction). On 08-Apr-2021, the patient experienced SOMNOLENCE (The next day, I slept for most of the day). On an unknown date, the patient experienced VACCINATION SITE BRUISING (felt like a bad bruise) and VACCINATION SITE PAIN (injection site felt like I had been extremely punched hard in that spot/the pain was not debilitating). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic reaction, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), VACCINATION SITE BRUISING (felt like a bad bruise), HYPERSENSITIVITY (allergic reaction), SOMNOLENCE (The next day, I slept for most of the day) and VACCINATION SITE PAIN (injection site felt like I had been extremely punched hard in that spot/the pain was not debilitating) outcome was unknown. No concomitant medication information was reported. Other treatment medications include an unspecified medication the patient received at the hospital for the allergic reaction. This case concerns a patient of unknown age and gender with a serious unexpected event of anaphylactic shock, and nonserious hypersensitivity, somnolence, vaccination site bruising and vaccination site pain. Event latency 5 minutes after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a patient of unknown age and gender with a serious unexpected event of anaphylactic shock, and nonserious hypersensitivity, somnolence, vaccination site bruising and vaccination site pain. Event latency 5 minutes after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Allergy (Bites of insects); Drug allergy (tetracyclines); Drug allergy (sulpha drugs); Drug allergy (codeine)

ID: 1435910
Sex: F
Age: 55
State: AR

Vax Date: 04/10/2021
Onset Date: 05/01/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PAINFUL RESPIRATION (right lung hurts when breathing) and MUSCULOSKELETAL CHEST PAIN (right rib cage hurts) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 02BA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic obstructive pulmonary disease (severe; needs 24 hour Oxygen) and Degenerative disc disease. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for Pain, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), CLONAZEPAM, FLUOXETINE HYDROCHLORIDE (PROZAC), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), TOLTERODINE and ROFLUMILAST (DALIRESP) for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE REACTION (covid arm), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL PAIN UPPER (stomach hurts), FEELING ABNORMAL (do not feel right/not herself/ no endurance left and hard to explain how she is feeling), VACCINATION COMPLICATION (dont feel well/good/right / she still not feeling good and herself ever since her 2nd shot) and FATIGUE (tired weak). 12-May-2021, the patient experienced VACCINATION COMPLICATION (took me down hard), ASTHENIA (tired weak) and MALAISE (took me down hard). In May 2021, the patient experienced DEHYDRATION (dehydrated). On 24-May-2021, the patient experienced PAINFUL RESPIRATION (right lung hurts when breathing) (seriousness criterion hospitalization) and MUSCULOSKELETAL CHEST PAIN (right rib cage hurts) (seriousness criterion hospitalization). The patient was treated with POTASSIUM (oral) ongoing since an unknown date for Dehydration, at a dose of 1 dosage form twice a day. In May 2021, VACCINATION COMPLICATION (took me down hard) had resolved. At the time of the report, PAINFUL RESPIRATION (right lung hurts when breathing), MUSCULOSKELETAL CHEST PAIN (right rib cage hurts), VACCINATION SITE REACTION (covid arm), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL PAIN UPPER (stomach hurts), DEHYDRATION (dehydrated), FEELING ABNORMAL (do not feel right/not herself/ no endurance left and hard to explain how she is feeling), ASTHENIA (tired weak), MALAISE (took me down hard) and FATIGUE (tired weak) outcome was unknown and VACCINATION COMPLICATION (dont feel well/good/right / she still not feeling good and herself ever since her 2nd shot) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) lung CT scan was done and the result of lung screen came back normal. The patient had several blood tests done which revealed no abnormal findings. 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: HYDROCODONE/ACETAMINOPHEN; PROPANOLOL [PROPRANOLOL]; CLONAZEPAM; PROZAC; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; TOLTERODINE; DALIRESP

Current Illness: Chronic obstructive pulmonary disease (severe; needs 24 hour Oxygen); Degenerative disc disease

ID: 1435911
Sex: F
Age: 29
State: FL

Vax Date: 06/10/2021
Onset Date: 06/11/2021
Rec V Date: 06/30/2021
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: worsen episode; heavy breathing; lightheadedness a day; passed out; the left arm was very weak then the whole body very weak; trouble breathing like a shortness breath; tingling feeling in the whole body; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), ASTHENIA (the left arm was very weak then the whole body very weak), DYSPNOEA (trouble breathing like a shortness breath) and PARAESTHESIA (tingling feeling in the whole body). On 12-Jun-2021, the patient experienced RESPIRATORY RATE INCREASED (heavy breathing) and DIZZINESS (lightheadedness a day). On 15-Jun-2021, the patient experienced CONDITION AGGRAVATED (worsen episode). The patient was treated with LORAZEPAM (ATIVAN) on 15-Jun-2021 at an unspecified dose and frequency. On 11-Jun-2021, LOSS OF CONSCIOUSNESS (passed out), DYSPNOEA (trouble breathing like a shortness breath) and PARAESTHESIA (tingling feeling in the whole body) had resolved. At the time of the report, RESPIRATORY RATE INCREASED (heavy breathing), DIZZINESS (lightheadedness a day), CONDITION AGGRAVATED (worsen episode) and ASTHENIA (the left arm was very weak then the whole body very weak) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications include birth control very low dose. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1435912
Sex: F
Age: 71
State: NJ

Vax Date: 03/19/2021
Onset Date: 06/10/2021
Rec V Date: 06/30/2021
Hospital: Y

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: Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high (had been put on hypertension medication). Concomitant products included LOSARTAN for Hypertension. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized for 2 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. Concomitant medications were not reported. Treatment medications were not provided. This case concerns a 71-year-old female hospitalized with a serious unexpected event of cerebrovascular accident. Event latency 55 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-066369 (Patient Link).; Sender's Comments: This case concerns a 71-year-old female hospitalized with a serious unexpected event of cerebrovascular accident. Event latency 55 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: LOSARTAN

Current Illness: Blood pressure high (had been put on hypertension medication)

ID: 1435913
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: the left side of my face became paralysed; my tongue became paralysed; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (the left side of my face became paralysed) and TONGUE PARALYSIS (my tongue became paralysed) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (the left side of my face became paralysed) (seriousness criterion medically significant) and TONGUE PARALYSIS (my tongue became paralysed) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (the left side of my face became paralysed) and TONGUE PARALYSIS (my tongue became paralysed) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was mentioned. No treatment medication information was mentioned. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1435914
Sex: F
Age: 81
State: CO

Vax Date: 05/16/2021
Onset Date: 05/16/2021
Rec V Date: 06/30/2021
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: redness and swelling of left bicep; redness and swelling of left bicep; fatigue; itching; pain at left arm "neuropathy"; pain at left arm "neuropathy"; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") (seriousness criterion medically significant) and PAIN IN EXTREMITY (pain at left arm "neuropathy"). On 13-Jun-2021, the patient experienced PRURITUS (itching). On 14-Jun-2021, the patient experienced FATIGUE (fatigue). On 15-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness and swelling of left bicep) and VACCINATION SITE SWELLING (redness and swelling of left bicep). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) at an unspecified dose and frequency and ETHANOL (ALCOHOL SWABS [ETHANOL]) at an unspecified dose and frequency. On 20-May-2021, NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") and PAIN IN EXTREMITY (pain at left arm "neuropathy") had resolved. On 15-Jun-2021, FATIGUE (fatigue) had resolved. At the time of the report, PRURITUS (itching), VACCINATION SITE ERYTHEMA (redness and swelling of left bicep) and VACCINATION SITE SWELLING (redness and swelling of left bicep) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1435915
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: Have pulmonary fibrosis; Have caught covid; I am fully vaccinated have been for over a month, have caught covid; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY FIBROSIS (Have pulmonary fibrosis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY FIBROSIS (Have pulmonary fibrosis) (seriousness criterion medically significant), COVID-19 (Have caught covid) and VACCINATION FAILURE (I am fully vaccinated have been for over a month, have caught covid). At the time of the report, PULMONARY FIBROSIS (Have pulmonary fibrosis), COVID-19 (Have caught covid) and VACCINATION FAILURE (I am fully vaccinated have been for over a month, have caught covid) outcome was unknown. No concomitant products were reported. No treatment information was provided. For the event Pulmonary fibrosis, based on the current available information; although the use of the product and the start date of the event was more than 30 days apart, a causal relationship cannot be excluded. Nevertheless, the event COVID-19 could a potential confounder /co-suspect for this event. For the event lack of efficacy of the product and COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.; Sender's Comments: For the event Pulmonary fibrosis, based on the current available information; although the use of the product and the start date of the event was more than 30 days apart, a causal relationship cannot be excluded. Nevertheless, the event COVID-19 could a potential confounder /co-suspect for this event. For the event lack of efficacy of the product and COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.

Other Meds:

Current Illness:

ID: 1435916
Sex: F
Age: 33
State:

Vax Date: 03/20/2021
Onset Date: 05/17/2021
Rec V Date: 06/30/2021
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: Non-stop flow of period bleeding like peeing Blood after second vaccine; Thrombocytopenia Diagnosis after second vaccine; Bruised all over the body after second vaccine; Platelet level was 5on blood test after second vaccine; Nose Bleeding; Oral Purpura on the Lip after second vaccine; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine) and THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. 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-May-2021, the patient experienced EPISTAXIS (Nose Bleeding) and ORAL PURPURA (Oral Purpura on the Lip after second vaccine). On 19-May-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine) (seriousness criteria hospitalization, medically significant and life threatening). On 27-May-2021, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine) (seriousness criteria medically significant and life threatening), CONTUSION (Bruised all over the body after second vaccine) and PLATELET COUNT DECREASED (Platelet level was 5on blood test after second vaccine). The patient was hospitalized from 27-May-2021 to 28-May-2021 due to HEAVY MENSTRUAL BLEEDING. At the time of the report, HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine), THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine), EPISTAXIS (Nose Bleeding), ORAL PURPURA (Oral Purpura on the Lip after second vaccine), CONTUSION (Bruised all over the body after second vaccine) and PLATELET COUNT DECREASED (Platelet level was 5on blood test after second vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: 5 (Low) 5. No concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1435917
Sex: F
Age: 66
State: CT

Vax Date: 06/02/2021
Onset Date: 06/08/2021
Rec V Date: 06/30/2021
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: blood clotting.; pain in right leg and knee; pain in right leg and knee; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clotting.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included ADHD, Anxiety, Inflammatory arthritis and Blood pressure high. Concomitant products included ATOMOXETINE HYDROCHLORIDE (STRATTERA) for Anxiety, SULFASALAZINE for Arthritis, PROPRANOLOL HYDROCHLORIDE (INDERAL) for Blood pressure high, PREDNISONE for Inflammatory arthritis. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced PAIN IN EXTREMITY (pain in right leg and knee) and ARTHRALGIA (pain in right leg and knee). On 11-Jun-2021, the patient experienced THROMBOSIS (blood clotting.) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clotting.), PAIN IN EXTREMITY (pain in right leg and knee) and ARTHRALGIA (pain in right leg and knee) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient visited ER due to pain the leg and knee and was diagnosed with blood clotting. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Added Reporter information(address, contact details), patient demographic information, medical history. Added vaccine batch number, route of administration, concomitant medication information. Start dates of the events pain in extremity and arthralgia 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: STRATTERA; INDERAL; PREDNISONE; SULFASALAZINE

Current Illness: ADHD; Anxiety; Blood pressure high; Inflammatory arthritis

ID: 1435918
Sex: F
Age: 49
State: OH

Vax Date: 05/27/2021
Onset Date: 06/02/2021
Rec V Date: 06/30/2021
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: headache; nausea; chills; Hemorrhage brain; stroke; subarachnoid hemorrhage; was asleep and not aware of anything for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Hemorrhage brain), CEREBROVASCULAR ACCIDENT (stroke), SUBARACHNOID HAEMORRHAGE (subarachnoid hemorrhage), HEADACHE (headache), LOSS OF CONSCIOUSNESS (was asleep and not aware of anything for 3 days), NAUSEA (nausea) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced CEREBRAL HAEMORRHAGE (Hemorrhage brain) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization, medically significant, life threatening and intervention required) and SUBARACHNOID HAEMORRHAGE (subarachnoid hemorrhage) (seriousness criteria hospitalization, medically significant, life threatening and intervention required). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criteria hospitalization, life threatening and intervention required), LOSS OF CONSCIOUSNESS (was asleep and not aware of anything for 3 days) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), NAUSEA (nausea) (seriousness criteria hospitalization and life threatening) and CHILLS (chills) (seriousness criteria hospitalization and life threatening). The patient was hospitalized on 02-Jun-2021 due to CEREBRAL HAEMORRHAGE, CEREBROVASCULAR ACCIDENT, HEADACHE and SUBARACHNOID HAEMORRHAGE. The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, CEREBRAL HAEMORRHAGE (Hemorrhage brain), CEREBROVASCULAR ACCIDENT (stroke), SUBARACHNOID HAEMORRHAGE (subarachnoid hemorrhage), HEADACHE (headache), LOSS OF CONSCIOUSNESS (was asleep and not aware of anything for 3 days), NAUSEA (nausea) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had brain hemorrhage and stroke. The patient was airlifted to nearby hospital from local hospital spent 8 days in the ICU. It was called subarachnoid hemorrhage. They took patient in ambulance and then they found blood in her brain so they flew her to nearby hospital for neurological ICU did EKG, MRIs and ultrasounds of brain (results were not provided). The patient had no underlying health conditions. After getting the vaccine, patient had the worse headache was screaming. The headaches very soon after the vaccine and it kept on getting worse and worse. The patient was taking Tylenol but it was not taking the pain away. The patient was asleep and not aware of anything for 3 days and then patient called an ambulance. The patient had nausea and chills was scared to get the second shot. No concomitant medication were provided. Company Comment: This case concerns a 49-year-old female hospitalized with serious unexpected events of cerebral haemorrhage, cerebrovascular accident, subarachnoid haemorrhage, loss of consciousness, headache, nausea, and chills. Event onset 6 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 49-year-old female hospitalized with serious unexpected events of cerebral haemorrhage, cerebrovascular accident, subarachnoid haemorrhage, loss of consciousness, headache, nausea, and chills. Event onset 6 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1435919
Sex: F
Age: 29
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Convulsions), DYSPNOEA (couldn't breathe) and OROPHARYNGEAL DISCOMFORT (felt like her throat was closing) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache). On 12-Jun-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criteria medically significant and intervention required), OROPHARYNGEAL DISCOMFORT (felt like her throat was closing) (seriousness criteria medically significant and intervention required), INSOMNIA (couldn't sleep), VACCINATION SITE SCAR (huge spot at injection site), NAUSEA (nausea) and VOMITING (vommitted). On an unknown date, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant) and VACCINATION SITE REACTION (She is still having an injection site reaction.). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 07-Jun-2021, DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache) had resolved. At the time of the report, SEIZURE (Convulsions), DYSPNOEA (couldn't breathe), OROPHARYNGEAL DISCOMFORT (felt like her throat was closing), INSOMNIA (couldn't sleep), VACCINATION SITE SCAR (huge spot at injection site), NAUSEA (nausea) and VOMITING (vommitted) outcome was unknown and VACCINATION SITE REACTION (She is still having an injection site reaction.) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. The patient went to emergency room and they gave her Benadryl she had convulsions, and she never had an issue with Benadryl. They then gave her steroids that helped with her symptoms of throat closing and breathing. She was still having an injection site reaction. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1435920
Sex: M
Age: 74
State: DC

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 06/30/2021
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: Hospitalized during vaccination process; Missed dose; This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (Hospitalized during vaccination process) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalized during vaccination process) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, HOSPITALISATION (Hospitalized during vaccination process) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. No Treatment information was provided. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1435921
Sex: F
Age: 48
State: NJ

Vax Date: 05/21/2021
Onset Date: 05/21/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Iron deficiency anemia; hurts to walk; headaches; chills; chest pain; throat pain; lip pain; trouble breathing; severe inflammation throughout the body; back pain; neck pain; I have autoimmune disorders and those levels went crazy; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (throat pain), LIP PAIN (lip pain), DYSPNOEA (trouble breathing), INFLAMMATION (severe inflammation throughout the body), BACK PAIN (back pain), NECK PAIN (neck pain), AUTOIMMUNE DISORDER (I have autoimmune disorders and those levels went crazy), CONDITION AGGRAVATED (Condition aggravated), IRON DEFICIENCY ANAEMIA (Iron deficiency anemia), PAIN IN EXTREMITY (hurts to walk), HEADACHE (headaches) and CHILLS (chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. No medical history was reported. Concurrent medical conditions included Anemia iron deficiency. Concomitant products included METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for an unknown indication. On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization), OROPHARYNGEAL PAIN (throat pain) (seriousness criterion hospitalization), LIP PAIN (lip pain) (seriousness criterion hospitalization), DYSPNOEA (trouble breathing) (seriousness criterion hospitalization), INFLAMMATION (severe inflammation throughout the body) (seriousness criterion hospitalization), BACK PAIN (back pain) (seriousness criterion hospitalization), NECK PAIN (neck pain) (seriousness criterion hospitalization), AUTOIMMUNE DISORDER (I have autoimmune disorders and those levels went crazy) (seriousness criteria hospitalization and medically significant), CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion hospitalization), PAIN IN EXTREMITY (hurts to walk) (seriousness criterion hospitalization), HEADACHE (headaches) (seriousness criterion hospitalization) and CHILLS (chills) (seriousness criterion hospitalization). On an unknown date, the patient experienced IRON DEFICIENCY ANAEMIA (Iron deficiency anemia) (seriousness criterion hospitalization). The patient was hospitalized from 21-May-2021 to 24-May-2021 due to AUTOIMMUNE DISORDER, BACK PAIN, CHEST PAIN, CHILLS, CONDITION AGGRAVATED, DYSPNOEA, HEADACHE, INFLAMMATION, IRON DEFICIENCY ANAEMIA, LIP PAIN, NECK PAIN, OROPHARYNGEAL PAIN and PAIN IN EXTREMITY. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Inflammation and Pain, at an unspecified dose and frequency and IRON for Iron deficiency anemia, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (throat pain), LIP PAIN (lip pain), DYSPNOEA (trouble breathing), INFLAMMATION (severe inflammation throughout the body), BACK PAIN (back pain), NECK PAIN (neck pain), AUTOIMMUNE DISORDER (I have autoimmune disorders and those levels went crazy), CONDITION AGGRAVATED (Condition aggravated), IRON DEFICIENCY ANAEMIA (Iron deficiency anemia), PAIN IN EXTREMITY (hurts to walk), HEADACHE (headaches) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: 8 (Low) Hemoglobin decreased. On an unknown date, Transferrin saturation: 4 (Low) Low iron saturation. 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. Patient received her first dose in left non dominant upper arm. She was put on heart monitor while on hospital. Healthcare professionals had difficulty in keeping her Hemoglobin elevated. Patient went to kidney doctor who stated that it might be a side effect from getting the Moderna Covid-19 vaccine. 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. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested *

Other Meds: MEDROL [METHYLPREDNISOLONE ACETATE]

Current Illness: Anemia iron deficiency

ID: 1435922
Sex: F
Age: 44
State: PA

Vax Date: 04/12/2021
Onset Date: 05/15/2021
Rec V Date: 06/30/2021
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: Passed out; Dizzy; Sweating; Pain in arm; aches; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Iodine allergy. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). 15-May-2021, the patient experienced DIZZINESS (Dizzy), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain in arm), MYALGIA (aches), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 17-May-2021, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Dizzy), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain in arm), MYALGIA (aches), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. Not Provided. Concomitant medication use was not provided. Action taken with mRNA-1273 in response to the event was not applicable. 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. This case was linked to MOD-2021-083017 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Iodine allergy

ID: 1435923
Sex: F
Age:
State:

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 06/30/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pregnancy resulted in a miscarriage; Did not receive 2nd dose; Found out she was pregnant after receiving 1st dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Found out she was pregnant after receiving 1st dose). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 22-Mar-2021, EXPOSURE DURING PREGNANCY (Found out she was pregnant after receiving 1st dose) had resolved. At the time of the report, ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) had resolved and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. It was reported that the patient received first shot and then found out she was pregnant. The pregnancy resulted in a miscarriage and patient wanted to knowif she should now get her 2nd shot, or restart the vaccination series. This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded. Also This report refers to a case of Product dose omission. further information is not expected. Reporter did not allow further contact; Sender's Comments: This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded. Also This report refers to a case of Product dose omission. further information is not expected.

Other Meds:

Current Illness:

ID: 1435924
Sex: F
Age:
State: CA

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 06/30/2021
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: Blackout; Muscle twitching; Tingling; Cramps legs; Facial spasm; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blackout) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0011321A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Blackout) (seriousness criterion medically significant), MUSCLE TWITCHING (Muscle twitching), PARAESTHESIA (Tingling), MUSCLE SPASMS (Cramps legs), FACIAL SPASM (Facial spasm) and MYALGIA (Myalgia). At the time of the report, LOSS OF CONSCIOUSNESS (Blackout), MUSCLE TWITCHING (Muscle twitching), PARAESTHESIA (Tingling), MUSCLE SPASMS (Cramps legs), FACIAL SPASM (Facial spasm) and MYALGIA (Myalgia) outcome was unknown. Concomitant product use was not provided. At the time of the report, the patient is awaiting results of a magnetic resonance imaging test. Treatment information was not provided. This case concerns a female of unknown age with a serious unexpected event of loss of consciousness, and nonserious muscle twitching, paraesthesia, muscle spasms, facial spasm, and myalgia. Event latency 4 weeks after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a female of unknown age with a serious unexpected event of loss of consciousness, and nonserious muscle twitching, paraesthesia, muscle spasms, facial spasm, and myalgia. Event latency 4 weeks after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

Date Died:

ID: 1435925
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: Fatal fevers; Septic shock; Product contamination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (Fatal fevers), SEPTIC SHOCK (Septic shock) and PRODUCT CONTAMINATION (Product contamination) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fatal fevers) (seriousness criterion death), SEPTIC SHOCK (Septic shock) (seriousness criteria death and medically significant) and PRODUCT CONTAMINATION (Product contamination) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided. 104 Patients received the vaccine. Treatment information was not 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.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1435926
Sex: F
Age: 78
State: IL

Vax Date: 01/29/2021
Onset Date: 02/01/2021
Rec V Date: 06/30/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: broken foot; Fall; Unevaluable event; Atrial fibrillation; Fall; Cerebral bleeding; Stroke; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL HAEMORRHAGE (Cerebral bleeding), CEREBROVASCULAR ACCIDENT (Stroke), the first episode of FALL (Fall), FOOT FRACTURE (broken foot), the second episode of FALL (Fall) and UNEVALUABLE EVENT (Unevaluable event) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 023M20A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Depression, Bladder disorder, Cholesterol, Abstains from alcohol and Non-smoker. Concomitant products included OXYBUTYNIN HYDROCHLORIDE (DITROPAN) for Bladder disorder, ATORVASTATIN for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, METOPROLOL for Heart disorder, MIRTAZAPINE (REMERON) for Unevaluable reaction. In 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced the first episode of FALL (Fall) (seriousness criteria hospitalization and disability). In February 2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral bleeding) (seriousness criteria hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 10-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant) and UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion hospitalization). On 08-Jun-2021, the patient experienced FOOT FRACTURE (broken foot) (seriousness criteria hospitalization and disability) and the second episode of FALL (Fall) (seriousness criteria hospitalization and disability). The patient was hospitalized from 15-Feb-2021 to 18-Feb-2021 due to ATRIAL FIBRILLATION, CEREBRAL HAEMORRHAGE, CEREBROVASCULAR ACCIDENT and FALL. On 08-Jun-2021, last episode of FALL (Fall) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL HAEMORRHAGE (Cerebral bleeding), CEREBROVASCULAR ACCIDENT (Stroke), FOOT FRACTURE (broken foot) and UNEVALUABLE EVENT (Unevaluable event) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Magnetic resonance imaging head: confirmed brain is bleeding (abnormal) Confirmed brain is bleeding. On 10-Mar-2021, Electrocardiogram: confirmed atrial fibrillation (abnormal) Confirmed Atrial fibrillation. On 08-Jun-2021, X-ray limb: confirmed broken foot (abnormal) Confirmed broken foot. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was sent to urgent care because the patient fell again and it was determined that her left foot was broken where a boot cast was put on her left leg and was advised to have bed rest and had the left leg elevated. The patient was waiting for brain bleeding to heal. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: METOPROLOL; REMERON; DITROPAN; WELLBUTRIN; ATORVASTATIN

Current Illness: Abstains from alcohol; Bladder disorder; Cholesterol; Depression; Non-smoker

ID: 1435927
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Plenty of blood clots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Plenty of blood clots) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Plenty of blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Plenty of blood clots) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. No Treatment information was provided. Very limited information regarding this event has been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested

Other Meds:

Current Illness:

ID: 1435928
Sex: M
Age:
State: NC

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 06/30/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: hearing loss/deafness; Fluid in middle ear; Ear infection; This spontaneous case was reported by an other health care professional and describes the occurrence of DEAFNESS (hearing loss/deafness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEUPRORELIN ACETATE (ELIGARD) for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DEAFNESS (hearing loss/deafness) (seriousness criterion medically significant), MIDDLE EAR EFFUSION (Fluid in middle ear) and EAR INFECTION (Ear infection). The patient was treated with PREDNISONE at a dose of 40 mg once a day. At the time of the report, DEAFNESS (hearing loss/deafness), MIDDLE EAR EFFUSION (Fluid in middle ear) and EAR INFECTION (Ear infection) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Patient had 60% hearing loss/deafness due to fluid buildup and infection in ears that developed shortly after his first Moderna vaccine after 14-Apr-2021. Patient developed same symptoms shortly after second vaccine on 15-May-1021. Both times the patient was treated with a 5-day course of Prednisone 40 mg PO QD, and events resolved. Action taken with mRNA-1273 in response to the event was not applicable. 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: ELIGARD

Current Illness:

ID: 1435929
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: stroke; always tired; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant) and FATIGUE (always tired). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) and FATIGUE (always tired) outcome was unknown. Concomitant product use was not provided by the reporter. The patient had stroke 3 months after taking the 2nd shot. Treatment information was not provided. Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm