VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1660976
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 08/24/2021
Rec V Date: 09/01/2021
Hospital: Y

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

Lab Data: Test Date: 20210824; Test Name: Spinal tap; Result Unstructured Data: HIGH PROTEIN; Test Date: 20210824; Test Name: MRI; Result Unstructured Data: Not reported; Test Date: 20210824; Test Name: CT scan; Result Unstructured Data: Not reported

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: STROKE; This spontaneous report received from a consumer concerned a 56 year old male with unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: gall bladder removed recently (June 2021) due to upper Gastrointestinal (GI) issues, and concurrent conditions included: diabetic, blind, hyperlipidemia, and high blood pressure. The patient experienced drug intolerance and makes sick when treated with hydrocodone. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: unknown) dose was not reported, 1 total, administered on 16-AUG-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 20-AUG-2021 Friday, the patient was fine after receiving the vaccine, he even mowed the yard. On 21-AUG-2021 Saturday, at the morning patient woke up and could barely get out of bed and could not walk due to his feet being numb, then reported his hands were numb. On 23-AUG-2021 Monday, patient went to the hospital and received fluids and other care, and was discharged. On 24-AUG-2021, patient went to his health care provider (HCP), who sent him to the hospital via ambulance to be admitted through the emergency room (ER) for possible stroke, although reporter stated they doubted that diagnosis due to both sides of the body being affected. On 24-AUG-2021, the patient was admitted to the hospital and has had a spinal tap, Computer tomography (CT) scans, Magnetic resonance imaging (MRI), and other tests. As per the reporter patient were treated it as Guillain Barre Syndrome(GBS). The reporter was upset the vaccine facility gave the sheets with possible side effects to them after having received the vaccine. On 29-AUG-2021, reporter reported that patient was still in the hospital and that the physicians state they was treating it as Guillain Barre Syndrome and/or a stroke. The reporter stated that, patient was treated with shots in the stomach as well as intravenous (IV) medications possibly Immunoglobulins but reporter does not exactly know the names as currently the hospital was not allowing any visitors and so only form of communication with patient through phone. The reporter called back to update the diagnosis, which she stated hospital found high protein in the spinal fluid which could be markers for stroke. As per the reporter physician called it an unusual stroke being that it was close to the brain stem. The reporter repeated that she did not like the fact that the vaccine administrators provided the information about the vaccine after the shot was given and that not that it would have changed our minds at that moment but still maybe something that they could do to improve the vaccination process. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210858451-COVID-19 VACCINE AD26.COV2.S-Stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness: Blind; Blood pressure high; Diabetic; Hyperlipidemia

ID: 1660977
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 08/18/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: HARD TO WALK; STIFF KNEES; SUSPECTED GUILLAIN BARRE SYNDROME; TINGLING IN KNEES; INFLAMMATION IN KNEES; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included: knee replacement surgeries, and concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: Patient have no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 21-OCT-2021) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-AUG-2021, the patient experienced inflammation in knees. On an unspecified date, the patient experienced hard to walk, stiff knees, suspected guillain barre syndrome, and tingling in knees. Treatment medications (dates unspecified) included: tramadol hydrochloride, and diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inflammation in knees, hard to walk, tingling in knees, stiff knees, and suspected guillain barre syndrome. This report was non-serious.

Other Meds:

Current Illness: Alcohol use; Non-smoker

ID: 1660978
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 07/27/2021
Rec V Date: 09/01/2021
Hospital: Y

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: Test Date: 202108; Test Name: MRI; Result Unstructured Data: Not reported; Test Date: 202108; Test Name: Weight; Result Unstructured Data: lost about 12 lbs; Test Date: 202108; Test Name: CT scan; Result Unstructured Data: Not reported; Test Date: 202108; Test Name: Spinal tap; Result Unstructured Data: Not reported

Allergies:

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

Symptoms: GUILLAIN BARRE SYNDROME; LOST ABOUT 12 LBS; DIARRHOEA; SORE ARM; This spontaneous report received from a patient concerned a 63 year old White and non Hispanic or Latino female. The patient's weight was 149 pounds, and height was 64 inches. The patient's past medical history included: vertigo (rarely), and concurrent conditions included: hypertension, non alcoholic, smoker, and smokes marijuana, and other pre-existing medical conditions included: The patient was otherwise healthy. The patient experienced dry cough when treated with lisinopril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, 1 total, administered on 27-JUL-2021 to left arm for prophylactic vaccination. Concomitant medications included diazepam, losartan potassium, and valaciclovir hydrochloride. On 27-JUL-2021, right after vaccination, the patient experienced a bit of sore arm, which lasted a couple of days. The patient could not remember exact date for rest of report, but it was started possibly around on 15-AUG-2021 or 16-AUG-2021. The patient's feet started feeling strange, like pins and needles, and she was in a lot of pain. The patient had diarrhea three times. She went to the chiropractor because her back was bothering her. The patient could not endure the pain (started in the feet, then to legs, then to hips, and to upper back), so they went to Emergency room (ER) in the middle of the night. The ER gave her some pain medication (unspecified) and she left (not admitted). It was reported that two days later she was back in the ER, and was admitted for 9 days. In the hospital, she was diagnosed with Guillain barre syndrome (GBS). Advil did not help the pain at all. It was reported that the patient needed to move more slowly and was still in pain. The patient was going to see primary care physician (PCP) tomorrow for follow-up. There was no expiration date on vaccination card. The patient had lost about 12 lbs in the hospital. She did not have access to any of the hospital reports. The patient was admitted on 15-AUG-2021 or 16-AUG-2021 and was discharged on 25-AUG-2021. The patient had a nephrologist, neurologist; perform Magnetic resonance imaging (MRI), spinal taps, Computerized tomography (CT scan) scans. Laboratory data included: CT scan (NR: not provided) Not reported, MRI (NR: not provided) Not reported, and Spinal tap (NR: not provided) Not reported. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on JUL-2021, had not recovered from Guillain barre syndrome, and the outcome of lost about 12 lbs and diarrhoea was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210858474- COVID-19 VACCINE AD26.COV2.S- Lost about 12 lbs This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210858474-COVID-19 VACCINE AD26.COV2.S -Guillain Barre Syndrome. This event is labeled per RSI and is therefore considered potentially related

Other Meds: LOSARTAN POTASSIUM; VALTREX; DIAZEPAM

Current Illness: Abstains from alcohol; Hypertension; Marijuana abuse (On occasion); Smoker (One cigarette once a month; history of smoking)

ID: 1660979
Sex: U
Age:
State: WA

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: BELL'S PALSY; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported, administered 1 total, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that the consumer mentioned in passing about a friend of a friend who received the Janssen COVID-19 vaccine and then developed Bell's palsy on an unspecified date. The action taken with covid-19 vaccine was not applicable. The outcome of Bell's palsy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210854887.; Sender's Comments: V0: 20210858509- Covid-19 vaccine -Bell's palsy. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1660980
Sex: F
Age:
State: MA

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: Physical examination; Result Unstructured Data: Not reported

Allergies:

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

Symptoms: LIGHT TIGHTNESS AROUND NECK; MILD PRESSURE IN BRAIN; STARTLED BY A LOUD BANG LIKE SLAMMING DOOR,LOUD AND STRONG MOTOR ENGINEER SOUND,CAR ENGINEER SOUND, LIKE STARTING A CAR AND STOPPING; PRESSURE ON RIGHT EAR; HEAVY HEAD TO THE POINT,SLIGHT PRESSURE ON HEAD,MILD HEAVINESS ON BACK OF HEAD; SHORTENING OF MENSTRUAL CYCLE; THREE TIMES MORE FLUX THAN THE NORMAL; SCALP NUMB,NUMBNESS ON THE RIGHT SIDE OF FACE.LEFT ARM LITTLE NUMB, LEFT THIGH MILD NUMB; FELT LIKE POKED WITH NEDDLES ON FINGERS SPECIALLY UNDER NAILS,MILD TINGLING ON FACE , RIGHT SIDE TOWARDS UPPER LIP, TINGLING AND NEEDLE SENSATION ON LEFT HAND AND CROSS TO WRIST LINE BY ONE INCH; MILD NEUROPATHIC PAIN ON RIGHT ARM; FELT SEVERE PAIN, EXCRUCIATING PAIN IN RIGHT ARM; This spontaneous report received from a 54 year old female patient of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non transfusion thalassemia trait, and does not drink, and other pre-existing medical conditions included: Patient had no history of medical problem, no use of drug or any symptoms prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, expiry and batch number were not reported) dose was not reported, 1 total administered on 24-AUG-2021 around 17:15 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ergocalciferol (vitamin D), tocopherol (Vitamin E), and vitamin B complex (complex B). On JUL-2021, Laboratory data included: Physical examination (test) (NR: not provided) results not reported. On 25-AUG-2021 (in morning), the patient experienced mild neuropathic pain and (late afternoon) felt severe pain on right arm. On 26-AUG-2021, patient woke at 05:15 with thought she slept on her left hand and felt like poked with needles on fingers specially under nails, excruciating pain in right arm, the pain, tingling and needle sensation on left hand and crossed to wrist line by one inch. At 08:45 patient contacted customer service they recommended her to call primary care physician (PCP) if the symptoms worse. The patient called her PCP. On 26-AUG-2021 around 17:30 the needle sensation and pain were decreased. On 27-AUG-2021 at 05:30 patient experienced needle pain on her left hand was mild, felt mild pressure in brain and mild tingling on face, right side towards upper lip, pressure on right ear. At 09:43 the patient called her PCP, her head was heavy to the point that she had to rest, her scalp was numbed, numbness on the right side of face was more perceptive, the needle sensation was disappearing from her left hand, but left arm was little numbed too. On 27-AUG-2021 around 11:45 patient got period and never experienced period before right time ever, she was most regulated person and experienced shortening of menstrual cycle (fifteen day), three times more flux than the normal. Patient experienced decreased pressure in inside head and all the other tingling and numbness, but they did not disappear since she got period. On 27-AUG-2021 at 23:00 patient fell asleep and was startled by a loud bang like slamming door the house of patient was quiet, she was not sure where the sound came from, by that time felt like a slight pressure on her head. On 28-AUG-2021 around 03:39 patient woke up by loud and strong motor engineer sound but there was no real car on, she checked her body her left thigh was mildly numbed and numbness on the right side of her face was remained without tingling or needle symptoms, the pressure in her right ear was still the same. At 05:45 patient woke up from her bed when she heard car engineer sound again like starting a car and stopping that time, she realized it really came from inside her head, by 10:00 she felt like wearing a turtleneck shirt, not tight to give discomfort but felt an on and off very light tightness around her neck, her left thigh, right of face was still mildly numbed, her scalp felt like wore a tight ponytail and mild heaviness on back of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt severe pain, excruciating pain in right arm, mild pressure in brain, and felt like poked with neddles on fingers specially under nails,mild tingling on face, right side towards upper lip, tingling and needle sensation on left hand and cross to wrist line by one inch, had not recovered from pressure on right ear, heavy head to the point,slight pressure on head,mild heaviness on back of head, and scalp numb,numbness on the right side of face.left arm little numb, left thigh mild numb, and the outcome of mild neuropathic pain on right arm, shortening of menstrual cycle, three times more flux than the normal, light tightness around neck and startled by a loud bang like slamming door,loud and strong motor engineer sound,car engineer sound, like starting a car and stopping was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210858574-COVID-19 VACCINE AD26.COV2.S-Mild pressure in brain,Startled by a loud bang like slamming door,loud and strong motor engineer sound,car engineer sound,like starting a car and stopping. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: VITAMIN D [ERGOCALCIFEROL]; VITAMIN E [TOCOPHEROL]; COMPLEX B [VITAMIN B COMPLEX]

Current Illness: Abstains from alcohol; Thalassemia

ID: 1660981
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 04/10/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Name: Colonoscopy; Result Unstructured Data: Unspecified

Allergies:

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

Symptoms: SERIOUS MEDICAL PROCEDURE FOR ULCERATIVE COLITIS; COULDN'T WALK FROM CAR TO JOB; ENDED IN EMERGENCY ROOM FOR CONSTIPATION; REACTIONS IN THROAT FOR WHICH EGD PROCEDURE IS SCHEDULED; I WAS ILL, LIKE I HAD COVID AGAIN, WAS ON COUCH ALL DAY, AND DOWN ALL WEEKEND; BATHROOM ISSUES WENT FROM LOOSE TO COULDN'T GO TO BATHROOM; LEGS, FEET, HAND, WRIST, FINGERS, LOWER BACK DOWN WAS NUMB; This spontaneous report received from a patient concerned a 64 year old female of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and other pre-existing medical conditions included: The patient had no bowel issues, no numbness issues, no physical ailments before shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 at 10 or 10:30 hours to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 after vaccination by 17:00 hours patient experienced like she had covid 19 again, patient was on couch all the day and down all weekend and the patient had bathroom issues, couldn't walk from car to job, legs, feet, hand, wrist, fingers, lower back down was numb. This since 10-APR-2021 continued and symptoms worsened. The patient's bathroom issues went from loose to couldn't go to bathroom, she went to the physician's office and ended in Emergency Room for constipation, was referred to gastroenterologist. The patient has been under doctors care and had serious medical procedure for ulcerative colitis. Reactions in throat due to shot for which the patient has been scheduled for esophagogastroduodenoscopy procedure. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) Unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bathroom issues went from loose to couldn't go to bathroom, couldn't walk from car to job, and legs, feet, hand, wrist, fingers, lower back down was numb, and the outcome of ended in emergency room for constipation, serious medical procedure for ulcerative colitis, reactions in throat for which esophagogastroduodenoscopy procedure is scheduled and i was ill, like i had covid again, was on couch all day, and down all weekend was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210858787--Ulcerative colitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1660983
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 08/20/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: SWELLING IN THE FACE, VERY SWOLLEN; LITTLE ITCHINESS, RASH SPREADING BIGGER AND BIGGER, SPREADING ON FACE, EAR, NECK AND ALL OVER HER BODY LEG, THIGH, BACK, RASH BEING RED, ITCHY, ALL OVER HER BODY AND GETS WORSE WITH FRICTION; SEVERE ALLERGIC REACTION; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient was healthy at the time of vaccination. The patient experienced allergic reaction when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-AUG-2021, the patient experienced swelling in the face, very swollen. On 20-AUG-2021, the patient experienced little itchiness, rash spreading bigger and bigger, spreading on face, ear, neck and all over her body leg, thigh, back, rash being red, itchy, all over her body and gets worse with friction. On 20-AUG-2021, the patient experienced severe allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe allergic reaction, swelling in the face, very swollen, and little itchiness, rash spreading bigger and bigger, spreading on face, ear, neck and all over her body leg, thigh, back, rash being red, itchy, all over her body and gets worse with friction. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1660984
Sex: F
Age:
State: AL

Vax Date:
Onset Date: 08/28/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 20210828; Test Name: COVID-19 virus test; Result Unstructured Data: Positive

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: POSITIVE COVID TEST AFTER TAKING VACCINE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-AUG-2021, the patient experienced positive covid test after taking vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from positive covid test after taking vaccine. This report was non-serious. This report was associated with product quality complaint: 90000191409.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1660985
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: GOT COVID; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20210852596.

Other Meds:

Current Illness:

ID: 1660986
Sex: U
Age:
State: AZ

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: PULMONARY EMBOLISM IN BOTH LUNGS; 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) 1 total, dose was administered on unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date (within a month after vaccination), the patient had pulmonary embolism in both lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism in both my lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210859993-covid-19 vaccine ad26.cov2.s-Pulmonary embolism in both my lungs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1660987
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/01/2021
Hospital: Y

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

Lab Data: Test Name: Blood sugar abnormal; Result Unstructured Data: 600

Allergies:

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

Symptoms: 2 HEART ATTACKS; BLOOD SUGAR OF 600; WHOLE LOT OF OTHER SHIT; ALMOST DIED; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a consumer via social media (twitter) a company representative concerned a female of unspecified age, unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and other pre-existing medical conditions included: Patient had other medical issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, 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, after taking vaccine, the patient experienced 2 heart attacks, had blood sugar of 600 along with a whole lot of other shit and almost died so the patient was wound up in Intensive care unit. On AUG-2021, the patient experienced covid-19 infection and the suspected clinical vaccination failure and patient was still in Intensive care unit. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 600. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 2 heart attacks, covid-19 infection, blood sugar of 600, suspected clinical vaccination failure, whole lot of other shit and almost died was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint:90000191515.; Sender's Comments: V0: 20210860013- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210860013-Covid-19 vaccine ad26.cov2.s-2 heart attacks, covid-19 infection, and blood sugar of 600, whole lot of other shit, almost died. This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Diabetes

Date Died:

ID: 1660988
Sex: M
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: DEATH; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, 1 total, 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 spike protein was found in every organ of the patient and patient died after 7 days of vaccination from an unknown cause. It was unknown whether autopsy was done or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210860032-COVID-19 VACCINE AD26.COV2.S-DEATH. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1660989
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: COULDN'T SLEEP AT NIGHT; WHOLE BODY FELT LIKE IT GOT HIT BY A CAR; FEELING SICK; MASSIVE FEVER; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced couldn't sleep at night, whole body felt like it got hit by a car, feeling sick, and massive fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't sleep at night, whole body felt like it got hit by a car, feeling sick, and massive fever. This report was non-serious.

Other Meds:

Current Illness:

ID: 1660990
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 08/07/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: Skin biopsy; Result Unstructured Data: Unknown

Allergies:

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

Symptoms: RASH ON HER LEGS THEN APPEARED ON ARM, CHEST, FEET / RASH ALL OVER BODY; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included: multiple sclerosis, and concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug or non-drug allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, Laboratory data included: Skin biopsy (NR: not provided) Unknown. On 07-AUG-2021, the patient experienced rash on her legs then appeared on arm, chest, feet / rash all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on her legs then appeared on arm, chest, feet / rash all over body. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (once a week); Non-smoker

ID: 1660991
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 08/27/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ANXIETY ABOUT THE SHOT; ARM PAIN; TINGLING IN FINGERS OF LEFT HAND (SAME SIDE AS SHOT); HEADACHE; MORE TIRED THAN NORMAL; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: anemic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced arm pain. On 27-AUG-2021, the patient experienced tingling in fingers of left hand (same side as shot). On 27-AUG-2021, the patient experienced headache. On 27-AUG-2021, the patient experienced more tired than normal. On an unspecified date, the patient experienced anxiety about the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm pain, headache, tingling in fingers of left hand (same side as shot), and more tired than normal, and the outcome of anxiety about the shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20210860475.

Other Meds:

Current Illness: Anemic

ID: 1660992
Sex: F
Age:
State: NM

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

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

Lab Data: Test Name: ACTH stimulation test; Result Unstructured Data: Unknown; Test Name: Liver function test; Result Unstructured Data: Unknown; Test Name: Antibody test; Result Unstructured Data: Unknown

Allergies:

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

Symptoms: SHE WAS STILL IN BED; USES A WALKER TO GET AROUND; BLOTCHY SKIN/VITILIGO; DARKENING OF SKIN/DISCOLORATION OF SKIN; SKIN STARTED TANNING; COUGHED UP BLOOD CLOT; FELT SOMETHING TICKLING; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was 240 pounds, and height was 60 inches. The patient's concurrent conditions included: alcohol non user, non smoker, penicillin allergy, erythromycin allergy, sulfa allergy, hypertension, fungus flare up, and pain, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included alprazolam for drug used for unknown indication, melatonin for drug used for unknown indication, paracetamol for drug used for unknown indication, tizanidine for drug used for unknown indication, vitamins nos for drug used for unknown indication, ketoconazole for fungal infection, enalapril for hypertension, furosemide for hypertension, and tramadol for pain. On MAR-2021, the patient experienced coughed up blood clot. On MAR-2021, the patient experienced felt something tickling. On MAY-2021, the patient experienced blotchy skin/vitiligo. On MAY-2021, the patient experienced darkening of skin/discoloration of skin. On MAY-2021, the patient experienced skin started tanning. On an unspecified date, the patient experienced she was still in bed, and uses a walker to get around. Laboratory data (dates unspecified) included: ACTH stimulation test (NR: not provided) Unknown, Antibody test (NR: not provided) Unknown, and Liver function test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from darkening of skin/discoloration of skin, skin started tanning, blotchy skin/vitiligo, and she was still in bed, and the outcome of coughed up blood clot, felt something tickling and uses a walker to get around was not reported. This report was non-serious.

Other Meds: ENALAPRIL; FUROSEMIDE; MELATONIN; KETOCONAZOLE; TYLENOL; MVI [VITAMINS NOS]; TRAMADOL; TIZANIDINE; ALPRAZOLAM

Current Illness: Abstains from alcohol; Allergic reaction to antibiotics; Fungal infection; Hypertension; Non-smoker; Pain; Penicillin allergy

ID: 1660993
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 202105; Test Name: Blood pressure; Result Unstructured Data: 115/70 mmHg; Test Name: Blood pressure; Result Unstructured Data: 150/100 mmHg

Allergies:

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

Symptoms: BLOOD PRESSURE DROPPED AND NORMAL / LOW NORMAL NOW AND HAS REMAINED THERE A STEADY 115/70 BEFORE IT FLUCTUATES 150/100; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included atenolol. On MAY-2021, the patient experienced blood pressure dropped and normal / low normal now and has remained there a steady 115/70 before it fluctuates 150/100. Laboratory data included: Blood pressure (NR: not provided) 115/70 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 150/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood pressure dropped and normal / low normal now and has remained there a steady 115/70 before it fluctuates 150/100 was not reported. This report was non-serious.

Other Meds: ATENOL

Current Illness: Blood pressure high (The patient suffered from high blood pressure for many years.)

ID: 1660994
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 08/13/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 20210813; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: negative with an index of less than 0.01 or normal

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 59 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, 1 total administered to left arm on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient's laboratory data included: SARS-CoV-2 antibody test (NR: not provided) negative with an index of less than 0.01 or normal (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20210860141 -COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.

Other Meds:

Current Illness:

ID: 1660995
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/23/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: Blood test; Result Unstructured Data: Negative; Test Date: 202108; Test Name: X-ray; Result Unstructured Data: Negative

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: TRANSVERSE MYELITIS; RASH IN CHEST AREA AND BACK OF RIGHT ARM; HYPERSENSITIVITY; This spontaneous report received from a patient via a company representative concerned a 4 decade old white and non Hispanic or Latino female. The patient's height, and weight were not reported. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 19-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the patient experienced hypersensitivity, rash in chest area and back of right arm, strange sensation of having clothes on covering her whole body even when not wearing clothes, stiff neck and arm and could not feel feet for about one month. Patient's current doctor mentioned that it might be transverse myelitis. On an unspecified date in AUG-2021, Laboratory data included: Blood test (NR: not provided) Negative, and X-ray (NR: not provided) Negative. The patient had multiple X-rays and blood tests that had a negative result and as per the health care professional (HCP) nothing was wrong. As of 28-AUG-2021 (currently), the patient was experiencing numbness in both hands. Patient had a physician office visit for adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from transverse myelitis, and the outcome of hypersensitivity and rash in chest area and back of right arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210860147-COVID-19 VACCINE AD26.COV2.S-Transverse myelitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1660996
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/01/2021
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: BLOOD CLOT; This spontaneous report received from a consumer via a company representative via social media concerned a male of an unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, 1 total, 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 in AUG-2021, the patient experienced blood clot after the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210860159-covid-19 vaccine ad26.cov2.s-Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1660997
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: FELT LIKE CRAP; CHILLS; HEADACHE; 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. No concomitant medications were reported. On an unspecified date, the patient experienced felt like crap, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like crap, chills, and headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1660999
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: ARM HAS NOT STOPPED BEING SORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced arm has not stopped being sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm has not stopped being sore. This report was non-serious.

Other Meds:

Current Illness:

ID: 1661000
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 08/27/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 20210830; Test Name: CBC; Result Unstructured Data: Awaiting results; Test Date: 20210830; Test Name: Blood test; Result Unstructured Data: Awaiting results; Test Date: 20210830; Test Name: Platelet count; Result Unstructured Data: Awaiting results

Allergies:

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

Symptoms: LITTLE INFLAMMATION ON BOTH ANKLES; ANKLE LITTLE SWOLLEN; RED DOTS ON BOTH LOWER LEGS BELOW THE KNEE; This spontaneous report received from a consumer concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: knee replacement surgery 3 months ago, and concurrent conditions included: high blood pressure, high cholesterol, penicillin allergy, non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-AUG-2021, the patient experienced little inflammation on both ankles. On 27-AUG-2021, the patient experienced ankle little swollen. On 27-AUG-2021, the patient experienced red dots on both lower legs below the knee. On 30-AUG-2021, Laboratory data included: Blood test (NR: not provided) Awaiting results, CBC (NR: not provided) Awaiting results, and Platelet count (NR: not provided) Awaiting results. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red dots on both lower legs below the knee, little inflammation on both ankles, and ankle little swollen. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Blood pressure high; High cholesterol; Non-smoker; Penicillin allergy

ID: 1661001
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: CANT DO ANY STRENUOUS ACTIVITY WITHOUT GETTING SEVERE CHEST PAIN; NECK STIFFNESS; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 30 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced cant do any strenuous activity without getting severe chest pain. On AUG-2021, the patient experienced neck stiffness. On AUG-2021, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cant do any strenuous activity without getting severe chest pain, neck stiffness, and shortness of breath. This report was non-serious.

Other Meds:

Current Illness:

ID: 1661002
Sex: F
Age:
State: AL

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: Blood test; Result Unstructured Data: Negative antibodies

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 73 year old African American non Hispanic or Latino female. The patient's weight was 225 pounds, and height was 66 inches. The patient's concurrent conditions included endometrial cancer, penicillin allergy. The patient had no daily medication. The patient was on chemotherapy before and after receiving the vaccine. The patient stated that garlic caused her to be ill and nauseated. The patient experienced drug allergy when treated with codeine, hydrocodone bitartrate/paracetamol, and oxycodone hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: unknown) dose was not reported, 1 total, administered on 26-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in AUG-2021, the patient tested negative for antibody test (confirmed immunological vaccine failure) which she described as blood test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191551.; Sender's Comments: V0:20210860335 -covid-19 vaccine ad26.cov2.s-confirmed immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY,UNDERLYING DISEASE (CHEMOTHERAPY) SPECIAL SITUATIONS

Other Meds:

Current Illness: Chemotherapy (Patient was on chemotherapy before and after receiving the vaccine.); Endometrial cancer; Food allergy (Garlic causes patient to be ill and nauseated.); Penicillin allergy

ID: 1661003
Sex: F
Age:
State: TN

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 202106; Test Name: Antibody test; Result Unstructured Data: Negative

Allergies:

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

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DRUG EXPOSURE DURING PREGNANCY; ARM WAS A LITTLE SORE; This spontaneous pregnancy report received from a patient concerned an unspecified age, race and ethnicity female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pregnant at the time of reporting. It was not reported whether the patient had been pregnant before The patient received covid-19 (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 patient received the vaccine while pregnant second trimester, 22 weeks (drug exposure during pregnancy) and experienced arm was a little sore. On JUN-2021 (greater than 28 days after vaccine administration), the patient got an antibody test which resulted negative (confirmed immunological vaccine failure). The date of the patient's last menstrual period was not reported and was having C-section next week, expected delivery date was SEP-2021. The pregnancy was continuing. The action taken with covid-19 was not applicable. The patient had not recovered from drug exposure during pregnancy, and the outcome of arm was a little sore and confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191501.; Sender's Comments: V0: 20210860342-COVID-19 VACCINE- confirmed immunological vaccine failure This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1661004
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 08/06/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: LOWER BACK PAIN (STILL PRESENT BUT NOT AS BAD AS IT WAS); SEVERE MUSCLE WEAKNESS AND GOT WORSE WITH TIME; CHILLS; SEVERE BODY FATIGUE AND GOT WORSE WITH TIME; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 205 pounds, and height was 74 inches. The patient's concurrent conditions included: stress, blood pressure, social alcohol drinker, and non-smoker, and other pre-existing medical conditions included: Patient had no medical history and no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. Concomitant medications included methyldopa for stress, and blood pressure. On 06-AUG-2021, the patient experienced lower back pain (still present but not as bad as it was). On 06-AUG-2021, the patient experienced severe muscle weakness and got worse with time. On 06-AUG-2021, the patient experienced chills. On 06-AUG-2021, the patient experienced severe body fatigue and got worse with time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-AUG-2021, recovered with sequelae from severe muscle weakness and got worse with time on AUG-2021, was recovering from lower back pain (still present but not as bad as it was), and had not recovered from severe body fatigue and got worse with time. This report was non-serious.

Other Meds: METHYLDOPA

Current Illness: Blood pressure; Non-smoker; Social alcohol drinker (Occasionally); Stress

ID: 1661005
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: BREAKTHROUGH INFECTION; This spontaneous report received from a patient via a company representative concerned a 30 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced breakthrough infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breakthrough infection was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1661006
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 08/27/2021
Rec V Date: 09/01/2021
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: FEELS LIKE SHE HAS MONO AGAIN; LEFT SIDE AND SPLEEN SWELLING; LEFT SIDE PAIN; FEELING CRAPPY; FLU SYMPTOMS/HEADACHE/CHILLS/LOW GRADE FEVER/ACHY; ARM PAIN; This spontaneous report received from a consumer concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: anemic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced flu symptoms/headache/chills/low grade fever/achy. On 27-AUG-2021, the patient experienced arm pain. On 28-AUG-2021, the patient experienced left side and spleen swelling. On 28-AUG-2021, the patient experienced left side pain. On 28-AUG-2021, the patient experienced feeling crappy. On 30-AUG-2021, the patient experienced feels like she has mono again. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu symptoms/headache/chills/low grade fever/achy, and had not recovered from arm pain, feeling crappy, left side pain, left side and spleen swelling, and feels like she has mono again. This report was non-serious. This case, from the same reporter is linked to 20210860099.

Other Meds:

Current Illness: Anemic

ID: 1661007
Sex: M
Age:
State: MN

Vax Date:
Onset Date: 08/26/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 20210826; Test Name: Antibody test; Result Unstructured Data: Negative

Allergies:

Symptom List: Nausea

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085029 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 26-AUG-2021, he did an antibody test and it was negative test (confirmed immunological vaccine failure). After received the vaccine he had no side effects at all. The patient's arm was not even hurting from the injection. He could not even tell which arm he got the vaccine. He drove for a couple of hours to get the vaccine and on his way back he drank a couple of bottles of electrolytes as he was advised that this will help after getting the vaccine. The patient's doctor suggested to get another shot of Pfizer Covid-19 vaccine which he received on August 26th, 2021. The patient was not on any other medications other than OTC pain killers and vitamins. Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191530. This case, from the same reporter is linked to 20210860607 and 20210860781.; Sender's Comments: V0; 20210860500-COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds: BNT 162

Current Illness: Cancer

ID: 1661008
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: LUMPS UNDER SKIN; ITCHING; 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced lumps under skin, and itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lumps under skin and itching was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1661009
Sex: U
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: LETHARGY; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the patient experienced lethargy. On APR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, and fever on APR-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1661010
Sex: U
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: STINGING; ODD METAL TASTE IN MY MOUTH; RAISED PROTRUSIONS ALONG A VEIN FROM MY ANKLE TO MY GROIN/ BLUISH PROTRUSIONS WENT FROM MY ANKLE TO MY KNEE; PRESSURE IN THIGH AND GROIN; 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stinging, odd metal taste in my mouth, raised protrusions along a vein from my ankle to my groin/ bluish protrusions went from my ankle to my knee, and pressure in thigh and groin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stinging, odd metal taste in my mouth, raised protrusions along a vein from my ankle to my groin/ bluish protrusions went from my ankle to my knee and pressure in thigh and groin was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1661011
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: BLOOD CLOGS IN LUNGS AND ARMS; 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 was not reported, 1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced blood clogs caught in lungs and arms, and was hospitalized for unspecified days. The patient was just released from the hospital (date unspecified). The patient was concerned that it was because of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clogs in lungs and arms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210860637-covid-19 vaccine ad26.cov2.s- blood clogs in lungs and arms.This event is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1661012
Sex: F
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: NO ADEQUATE PROTECTION FROM JOHNSON & JOHNSON COVID-19 VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the reporter stated that she does not feel like she has adequate protection from Covid-19 after receiving Johnson & Johnson Covid-19 Vaccine and would not want a booster dose of the same vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of no adequate protection from johnson & johnson covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210834826. This report was associated with product quality complaint.; Sender's Comments: V0. 20210860735-COVID-19 VACCINE AD26.COV2.S.- no adequate protection from johnson & johnson covid-19 vaccine. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1661013
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: UNUSUAL FEELING IN SKIN, ALL OVER BODY AND HEAD; FEELING LIKE CRAWLING; ITCH ALL OVER; FEELING LIKE TINGLING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced unusual feeling in skin, all over body and head. On AUG-2021, the patient experienced feeling like crawling. On AUG-2021, the patient experienced itch all over. On AUG-2021, the patient experienced feeling like tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unusual feeling in skin, all over body and head, feeling like tingling, feeling like crawling, and itch all over. This report was non-serious.

Other Meds:

Current Illness:

ID: 1661014
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: COULDN'T WALK ALL DAY LIKE ANKLES BROKE; VERY DIZZY LIKE VERTIGO; FALLING ASLEEP; RED BLOTCHES ALL OVER LEGS BUTT AND BALLS; SWOLLEN ANKLES; 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, and batch number were not reported) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced swollen ankles. On AUG-2021, the patient experienced red blotches all over legs butt and balls. On 29-AUG-2021, the patient experienced couldn't walk all day like ankles broke. On 29-AUG-2021, the patient experienced very dizzy like vertigo. On 29-AUG-2021, the patient experienced falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen ankles, red blotches all over legs butt and balls, couldn't walk all day like ankles broke, very dizzy like vertigo and falling asleep was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1661015
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: MEDICATION ERROR; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication error was not reported. This report was non-serious.

Other Meds: BNT 162

Current Illness:

ID: 1661016
Sex: M
Age:
State: NJ

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

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

Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Negative

Allergies:

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

Symptoms: COLD SWEAT; SINUS ISSUE; COLD LIKE SYMPTOMS; INJECTION SITE BRUISING; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 212 pounds, and height was 71 inches. 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: influenza vaccine ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 21-AUG-2021 for flu. No concomitant medications were reported. On MAR-2021, the patient experienced injection site soreness. On 26-MAR-2021, the patient experienced injection site bruising. On 21-AUG-2021, the patient experienced cold like symptoms. On 21-AUG-2021, the patient experienced sinus issue. On an unspecified date, the patient experienced cold sweat. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site bruising on 14-JUN-2021, cold like symptoms, and sinus issue on 23-AUG-2021, and injection site soreness on JUN-2021, and the outcome of cold sweat was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1661017
Sex: F
Age: 74
State: FL

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: blood pressure went up

Allergies:

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

Symptoms: Head get pressure; Felt very lightheaded; Painful muscle in chest; Felt awful; Headache, gets on and off headaches/ major headache on the back and front of her head that went down to her neck; Lower jaw, lips tingling; Lower jaw pressure; Lips get pressure; Neck tingling /pressure sensation; Stomach tingling/pressure sensation/stomach squeezy; Chest palpitations/ Heart palpitations/ Feeling of rapid heart beat; Tingling on head, chest, neck, stomach; Pressure in chest; Jaw, lips and tongue were at the verge of going numb; Rising blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Lower jaw pressure), ORAL DISCOMFORT (Lips get pressure), HEAD DISCOMFORT (Head get pressure), PARAESTHESIA ORAL (Lower jaw, lips tingling) and PARAESTHESIA (Tingling on head, chest, neck, stomach) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Headache (stopped in 2011. Returned almost daily since vaccine) and Costochondritis (reoccurring low/moderate level of chest mussel pain) in 2009. Concurrent medical conditions included Drug allergy since 10-Aug-2014, Blood pressure high since 1995, GERD since 2008 and Irritable bowel syndrome since 2005. Concomitant products included CANDESARTAN from 2012 to an unknown date and HYDROCHLOROTHIAZIDE from 2012 to an unknown date for Blood pressure high, ESOMEPRAZOLE MAGNESIUM from 2008 to an unknown date for GERD, UBIDECARENONE (CO Q-10) for Muscle ache, ATORVASTATIN from 2017 to an unknown date and LIDOCAINE for an unknown indication. On 12-Feb-2021 at 8:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021 at 8:45 AM, the patient experienced PARAESTHESIA (Tingling on head, chest, neck, stomach), CHEST DISCOMFORT (Pressure in chest), ABDOMINAL DISCOMFORT (Stomach tingling/pressure sensation/stomach squeezy), PALPITATIONS (Chest palpitations/ Heart palpitations/ Feeling of rapid heart beat), HYPOAESTHESIA (Jaw, lips and tongue were at the verge of going numb) and BLOOD PRESSURE INCREASED (Rising blood pressure). On 15-Feb-2021, the patient experienced MUSCLE TIGHTNESS (Lower jaw pressure). 15-Feb-2021, the patient experienced ORAL DISCOMFORT (Lips get pressure), PARAESTHESIA ORAL (Lower jaw, lips tingling) and MUSCULOSKELETAL DISCOMFORT (Neck tingling /pressure sensation). On an unknown date, the patient experienced HEAD DISCOMFORT (Head get pressure), DIZZINESS (Felt very lightheaded), CHEST PAIN (Painful muscle in chest), FEELING ABNORMAL (Felt awful) and HEADACHE (Headache, gets on and off headaches/ major headache on the back and front of her head that went down to her neck). At the time of the report, MUSCLE TIGHTNESS (Lower jaw pressure), ORAL DISCOMFORT (Lips get pressure), HEAD DISCOMFORT (Head get pressure), PARAESTHESIA ORAL (Lower jaw, lips tingling), MUSCULOSKELETAL DISCOMFORT (Neck tingling /pressure sensation), DIZZINESS (Felt very lightheaded), CHEST PAIN (Painful muscle in chest), FEELING ABNORMAL (Felt awful) and HEADACHE (Headache, gets on and off headaches/ major headache on the back and front of her head that went down to her neck) outcome was unknown and PARAESTHESIA (Tingling on head, chest, neck, stomach), CHEST DISCOMFORT (Pressure in chest), ABDOMINAL DISCOMFORT (Stomach tingling/pressure sensation/stomach squeezy), PALPITATIONS (Chest palpitations/ Heart palpitations/ Feeling of rapid heart beat), HYPOAESTHESIA (Jaw, lips and tongue were at the verge of going numb) and BLOOD PRESSURE INCREASED (Rising blood pressure) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) blood pressure went up. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported. This case was linked to MOD-2021-253002 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up information was received and contain Reporter information added, and conmeds drug lidocaine added and Other Relevant History and lab data added, Vaccine information was updated, events Heart palpitation Dizziness ,headache added On 14-Aug-2021: Follow up information contains Patient demographics, medical history ,concomitant medicine, new event (rising blood pressure, painful muscle in chest and felt awful), outcome and causality of events updated.

Other Meds: CANDESARTAN; HYDROCHLOROTHIAZIDE; ESOMEPRAZOLE MAGNESIUM; ATORVASTATIN; CO Q-10; LIDOCAINE.

Current Illness: Blood pressure high; Drug allergy; GERD; Irritable bowel syndrome.

ID: 1661018
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Patients were administered the vaccine that undergone 2 temperature excursions; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered the vaccine that undergone 2 temperature excursions) 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 EXPIRED PRODUCT ADMINISTERED (Patients were administered the vaccine that undergone 2 temperature excursions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered the vaccine that undergone 2 temperature excursions) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported. Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up report contain No New Information

Other Meds:

Current Illness:

ID: 1661019
Sex: M
Age: 50
State: CA

Vax Date: 03/06/2021
Onset Date: 04/04/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Stiffness; Locking of the joint; My thumb kept getting worse and lead to tendinitis; Constant waking up in the night due to the pain; Joint pain, tendinitis in left hand; Started like freezing like with tendinitis, tendinitis in left hand; Second knuckle on the left hand became inflamed, not the big knuckle but the joint right after, Joint pain; A lot of pain; At first all five fingers were inflammed, inflamation in fingers of left hand after second shot; This spontaneous case was reported by a physician and describes the occurrence of ARTHRITIS (Second knuckle on the left hand became inflamed, not the big knuckle but the joint right after, Joint pain), TENDONITIS (Started like freezing like with tendinitis, tendinitis in left hand), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (A lot of pain) and INFLAMMATION (At first all five fingers were inflammed, inflamation in fingers of left hand after second shot) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced ARTHRITIS (Second knuckle on the left hand became inflamed, not the big knuckle but the joint right after, Joint pain), PAIN (A lot of pain) and INFLAMMATION (At first all five fingers were inflammed, inflamation in fingers of left hand after second shot). On 05-Apr-2021, the patient experienced TENDONITIS (Started like freezing like with tendinitis, tendinitis in left hand) and ARTHRALGIA (Joint pain, tendinitis in left hand). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), JOINT LOCK (Locking of the joint), CONDITION AGGRAVATED (My thumb kept getting worse and lead to tendinitis) and INSOMNIA (Constant waking up in the night due to the pain). The patient was treated with CORTISONE at a dose of Shot a month ago. At the time of the report, ARTHRITIS (Second knuckle on the left hand became inflamed, not the big knuckle but the joint right after, Joint pain), TENDONITIS (Started like freezing like with tendinitis, tendinitis in left hand), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (A lot of pain), INFLAMMATION (At first all five fingers were inflammed, inflamation in fingers of left hand after second shot), JOINT LOCK (Locking of the joint), CONDITION AGGRAVATED (My thumb kept getting worse and lead to tendinitis), INSOMNIA (Constant waking up in the night due to the pain) and ARTHRALGIA (Joint pain, tendinitis in left hand) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ARTHRITIS (Second knuckle on the left hand became inflamed, not the big knuckle but the joint right after, Joint pain) to be possibly related. No further causality assessments were provided for TENDONITIS (Started like freezing like with tendinitis, tendinitis in left hand), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (A lot of pain), INFLAMMATION (At first all five fingers were inflammed, inflamation in fingers of left hand after second shot), JOINT LOCK (Locking of the joint), CONDITION AGGRAVATED (My thumb kept getting worse and lead to tendinitis), INSOMNIA (Constant waking up in the night due to the pain) and ARTHRALGIA (Joint pain, tendinitis in left hand). The patient stated that he experienced joint pain, stiffness and inflamation in fingers of left hand post second shot. Patient has never diagnosed with COVID-19. The patient stated that, after a month post second dose, his little finger through his index finger became better, but his thumb kept getting worse and lead to tendinitis and locking of the joint. He also stated that it caused him a lot of pain, minimal use of his left hand as he is a left-hander and constant wake up in the night due to the pain and popping of his thumb joint. The hand specialist saaid that it is usually caused by inflamation and in this case, probably from the vaccine. The patient stated that he received a very painful cortisone injection in his thumb joint. He also stated that his physician told him it might lead to surgery if tendons do not release. No concomitant medications were reported Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: New adverse events- Musculoskeletal stiffness, arthralgia, joint lock, condition aggravated, insomnia and outcomes included. Start dates for events updated. Patient information, Vaccine information, dose start dates and Vaccine Facility Information updated. Causality for event Arthritis was updated.

Other Meds:

Current Illness:

ID: 1661020
Sex: F
Age:
State: AR

Vax Date: 07/20/2021
Onset Date: 07/26/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: very weird and annoying bumps at the back of her tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (very weird and annoying bumps at the back of her tongue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced TONGUE DISORDER (very weird and annoying bumps at the back of her tongue). At the time of the report, TONGUE DISORDER (very weird and annoying bumps at the back of her tongue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported. No treatment information provided. Caller advised she went to an urgent care, but was not seen.

Other Meds:

Current Illness:

ID: 1661021
Sex: F
Age: 84
State: OH

Vax Date: 07/29/2021
Onset Date: 07/30/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: injection site is sore if she pushes on it; I'm not going to get the follow-up shot; itchy pinkish-red rash which started on her legs and went up all over her body,rash started in both my legs,This rash...went to both arms,This rash...went to my mid section,This rash...went to the left, middle & right side of my neck.; itching/intermittently itchy pinkish-red rash which started on her legs and went up all over her body; itching & redness; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itching/intermittently itchy pinkish-red rash which started on her legs and went up all over her body), RASH ERYTHEMATOUS (itching & redness), INTENTIONAL DOSE OMISSION (I'm not going to get the follow-up shot), RASH (itchy pinkish-red rash which started on her legs and went up all over her body,rash started in both my legs,This rash...went to both arms,This rash...went to my mid section,This rash...went to the left, middle & right side of my neck.) and VACCINATION SITE PAIN (injection site is sore if she pushes on it) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. Concurrent medical conditions included Cancer, Allergy to wool, Atrial fibrillation and Glaucoma. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) for Rash, FLECAINIDE, WARFARIN, ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE and CEPHALEXIN [CEFALEXIN] for an unknown indication. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced RASH PRURITIC (itching/intermittently itchy pinkish-red rash which started on her legs and went up all over her body), RASH ERYTHEMATOUS (itching & redness) and RASH (itchy pinkish-red rash which started on her legs and went up all over her body,rash started in both my legs,This rash...went to both arms,This rash...went to my mid section,This rash...went to the left, middle & right side of my neck.). On 05-Aug-2021, the patient experienced INTENTIONAL DOSE OMISSION (I'm not going to get the follow-up shot). On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site is sore if she pushes on it). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) for Rash, at an unspecified dose and frequency. On 05-Aug-2021, INTENTIONAL DOSE OMISSION (I'm not going to get the follow-up shot) had resolved. At the time of the report, RASH PRURITIC (itching/intermittently itchy pinkish-red rash which started on her legs and went up all over her body), RASH ERYTHEMATOUS (itching & redness) and RASH (itchy pinkish-red rash which started on her legs and went up all over her body,rash started in both my legs,This rash..went to both arms,This rash..went to my mid section,This rash..went to the left, middle & right side of my neck.) was resolving and VACCINATION SITE PAIN (injection site is sore if she pushes on it) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received had updated medical history, batch number of the suspect, concomitant and treatment details. Additional events of rash erythematous, vaccination site pain and Intentional dose omission were added. On 16-Aug-2021: Follow up information received on contains Significant information i.e concomitant medications addition, treatment information was updated. On 25-Aug-2021: Follow up received contains no new information

Other Meds: FLECAINIDE; WARFARIN; LIPITOR; AMLODIPINE; BANOPHEN; CEPHALEXIN [CEFALEXIN.]

Current Illness: Allergy to wool; Atrial fibrillation; Cancer; Glaucoma.

ID: 1661022
Sex: F
Age:
State: FL

Vax Date: 03/19/2021
Onset Date: 08/09/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Arm hurt after 1st dose, hurting inside it shoots down my leg, pain in the arm, it hurts; Not doing so great; Very sick; Burning hot from the inside, like there is heat irradiating into my bone; I feel like swollen; Very hard ball in the area where they gave me the shot; Rash; Rash around injection area; Fever after 1 dose; Whole left side is reacting, it shoots down my leg, it hurts; Arm is going completely numb, it's going up to my neck, it goes all the way to my hand, not feeling my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt after 1st dose, hurting inside it shoots down my leg, pain in the arm, it hurts), MALAISE (Not doing so great), ILLNESS (Very sick), BURNING SENSATION (Burning hot from the inside, like there is heat irradiating into my bone) and HYPOAESTHESIA (Arm is going completely numb, it's going up to my neck, it goes all the way to my hand, not feeling my arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced HYPOAESTHESIA (Arm is going completely numb, it's going up to my neck, it goes all the way to my hand, not feeling my arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt after 1st dose, hurting inside it shoots down my leg, pain in the arm, it hurts), MALAISE (Not doing so great), ILLNESS (Very sick), BURNING SENSATION (Burning hot from the inside, like there is heat irradiating into my bone), SWELLING (I feel like swollen), VACCINATION SITE INDURATION (Very hard ball in the area where they gave me the shot), RASH (Rash), VACCINATION SITE RASH (Rash around injection area), PYREXIA (Fever after 1 dose) and MYALGIA (Whole left side is reacting, it shoots down my leg, it hurts). At the time of the report, PAIN IN EXTREMITY (Arm hurt after 1st dose, hurting inside it shoots down my leg, pain in the arm, it hurts), MALAISE (Not doing so great), ILLNESS (Very sick), BURNING SENSATION (Burning hot from the inside, like there is heat irradiating into my bone), HYPOAESTHESIA (Arm is going completely numb, it's going up to my neck, it goes all the way to my hand, not feeling my arm), SWELLING (I feel like swollen), VACCINATION SITE INDURATION (Very hard ball in the area where they gave me the shot), RASH (Rash), VACCINATION SITE RASH (Rash around injection area), PYREXIA (Fever after 1 dose) and MYALGIA (Whole left side is reacting, it shoots down my leg, it hurts) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Patient stated to have a ball, not a bump. Concomitant and treatment medication was not provided. This case was linked to MOD-2021-281322 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received contains additional events of feeling unwell, sickness, burning sensation, numbness, swelling, vaccination site induration, rash, vaccination site rash and myalgia. Updated second dose details and action taken from Unknown to No Change.

Other Meds:

Current Illness:

ID: 1661023
Sex: F
Age:
State: FL

Vax Date: 03/19/2021
Onset Date: 08/09/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Hot, injected arm; Not doing so great; Very sick; Burning hot from inside/like there is heat irradiating into my bone, it was hot; I feel like swollen; Rash; Burning deep to the bones, injected arm; Bump on the injection area/very hard ball in the area where they gave me the shot; Rasharound injection area; Whole left side is reacting; Pain from the hand to neck; Pain from the hand to neck/it shoots down my leg/pain in the arm/Hurting from inside/not feeling my arm/ it hurts; Arm numbness/arm is going completely numb/its going to my neck/it goes all the way to my hand; Can't move her arm; She can't sleep, patient states last night wasn't able to sleep; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain from the hand to neck), PAIN IN EXTREMITY (Pain from the hand to neck/it shoots down my leg/pain in the arm/Hurting from inside/not feeling my arm/ it hurts), HYPOAESTHESIA (Arm numbness/arm is going completely numb/its going to my neck/it goes all the way to my hand), MOBILITY DECREASED (Can't move her arm) and INSOMNIA (She can't sleep, patient states last night wasn't able to sleep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced INSOMNIA (She can't sleep, patient states last night wasn't able to sleep). On an unknown date, the patient experienced NECK PAIN (Pain from the hand to neck), PAIN IN EXTREMITY (Pain from the hand to neck/it shoots down my leg/pain in the arm/Hurting from inside/not feeling my arm/ it hurts), HYPOAESTHESIA (Arm numbness/arm is going completely numb/its going to my neck/it goes all the way to my hand), MOBILITY DECREASED (Can't move her arm), VACCINATION SITE WARMTH (Hot, injected arm), MALAISE (Not doing so great), ILLNESS (Very sick), BURNING SENSATION (Burning hot from inside/like there is heat irradiating into my bone, it was hot), SWELLING (I feel like swollen), RASH (Rash), VACCINATION SITE PAIN (Burning deep to the bones, injected arm), VACCINATION SITE SWELLING (Bump on the injection area/very hard ball in the area where they gave me the shot), VACCINATION SITE RASH (Rasharound injection area) and MYALGIA (Whole left side is reacting). At the time of the report, NECK PAIN (Pain from the hand to neck), PAIN IN EXTREMITY (Pain from the hand to neck/it shoots down my leg/pain in the arm/Hurting from inside/not feeling my arm/ it hurts), HYPOAESTHESIA (Arm numbness/arm is going completely numb/its going to my neck/it goes all the way to my hand), MOBILITY DECREASED (Can't move her arm), INSOMNIA (She can't sleep, patient states last night wasn't able to sleep), VACCINATION SITE WARMTH (Hot, injected arm), MALAISE (Not doing so great), ILLNESS (Very sick), BURNING SENSATION (Burning hot from inside/like there is heat irradiating into my bone, it was hot), SWELLING (I feel like swollen), RASH (Rash), VACCINATION SITE PAIN (Burning deep to the bones, injected arm), VACCINATION SITE SWELLING (Bump on the injection area/very hard ball in the area where they gave me the shot), VACCINATION SITE RASH (Rasharound injection area) and MYALGIA (Whole left side is reacting) had not resolved. No relevant concomitant medications reported. No treatment medications reported. This case was linked to MOD-2021-281314 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received contains additional events and outcome of events was updated.

Other Meds:

Current Illness:

ID: 1661024
Sex: F
Age: 73
State: NV

Vax Date: 08/06/2021
Onset Date: 08/08/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: felt drugged-out; it feels like she is coming down with flu; sore throat; joint aches; headache/severe headaches; chills; body aches/more body aches; feeling tired/tired/extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (felt drugged-out), INFLUENZA LIKE ILLNESS (it feels like she is coming down with flu), OROPHARYNGEAL PAIN (sore throat), ARTHRALGIA (joint aches) and HEADACHE (headache/severe headaches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced FATIGUE (feeling tired/tired/extremely fatigued). On 09-Aug-2021, the patient experienced MYALGIA (body aches/more body aches). On 10-Aug-2021, the patient experienced CHILLS (chills). On 11-Aug-2021, the patient experienced HEADACHE (headache/severe headaches). On an unknown date, the patient experienced EUPHORIC MOOD (felt drugged-out), INFLUENZA LIKE ILLNESS (it feels like she is coming down with flu), OROPHARYNGEAL PAIN (sore throat) and ARTHRALGIA (joint aches). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 13-Aug-2021, CHILLS (chills), MYALGIA (body aches/more body aches) and FATIGUE (feeling tired/tired/extremely fatigued) had resolved. At the time of the report, EUPHORIC MOOD (felt drugged-out), INFLUENZA LIKE ILLNESS (it feels like she is coming down with flu), OROPHARYNGEAL PAIN (sore throat), ARTHRALGIA (joint aches) and HEADACHE (headache/severe headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication of the patient was not reported. On 09-Aug-2021, the patient felt extremely fatigued and tired. On 10-Aug-2021, the patient had more body aches. The patient received her vaccination in her right arm shoulder deltoid muscle. Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: New reporter demographic details; date of birth of the patient; vaccination date, route and anatomical location; corrective treatment and new events were added.

Other Meds:

Current Illness:

ID: 1661025
Sex: F
Age: 60
State: NJ

Vax Date: 08/09/2021
Onset Date: 08/10/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: She had a cough during the call; headaches; fatigue; Thought she had fever but does not know if she had; difficulty breathing; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), DIZZINESS, COUGH, HEADACHE, and FATIGUE in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced DYSPNOEA (difficulty breathing), DIZZINESS (dizziness), HEADACHE, FATIGUE, and PYREXIA. On an unknown date, the patient experienced COUGH. At the time of the report, DYSPNOEA, DIZZINESS, HEADACHE, and FATIGUE had not resolved and COUGH and PYREXIA outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications and no treatment medications were reported. Patient query was how to treat symptoms.

Other Meds:

Current Illness:

ID: 1661026
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/08/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: In bed sick; Runny nose; Fever; Aches; Headache; Fatigue; 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 ILLNESS (In bed sick), RHINORRHOEA (Runny nose), PYREXIA (Fever), MYALGIA (Aches) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced ILLNESS (In bed sick), RHINORRHOEA (Runny nose), PYREXIA (Fever), MYALGIA (Aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, ILLNESS (In bed sick), RHINORRHOEA (Runny nose), PYREXIA (Fever), MYALGIA (Aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment medications were not provided by the reporter.

Other Meds:

Current Illness:

ID: 1661027
Sex: M
Age: 77
State: TX

Vax Date: 01/08/2021
Onset Date: 02/05/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Felt lousy; Minor symptoms; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt lousy), VACCINATION COMPLICATION (Minor symptoms) and ARTHRALGIA (Shoulder pain) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. Concurrent medical conditions included Heart attack (Reported as heart condition and he had two heart attacks and a stent placed.) and Diabetic. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced MALAISE (Felt lousy), VACCINATION COMPLICATION (Minor symptoms) and ARTHRALGIA (Shoulder pain). At the time of the report, MALAISE (Felt lousy), VACCINATION COMPLICATION (Minor symptoms) and ARTHRALGIA (Shoulder pain) outcome was unknown. It was reported that the patient had two heart attacks and a stent placed. No concomitant medications information were reported. No treatment medications were provided.

Other Meds:

Current Illness: Diabetic; Heart attack (Reported as heart condition and he had two heart attacks and a stent placed.)

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am