VAERS 2021 Database www.vaers.hhs.gov

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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: 1634849
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 03/30/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: DOES NOT HEAL WELL; SCARS ON FACE; WORSENING OF NEUROPATHY; FOLLICULITIS; TIRED FOR 2 DAYS; This spontaneous report received from a patient concerned a 46 year old white (Not Hispanic Latino) male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic for 30 years, herniated disk in neck, and neuropathy in hands and feet. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered at left arm on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included gabapentin for worsening of neuropathy. On 30-MAR-2021 after vaccination, the patient experienced tired for 2 days. On 14-APR-2021, 2 weeks after vaccination, he started getting big bumps which spread on his face. He visited dermatologist in physician's office and was diagnosed with folliculitis. The folliculitis was spreading like the ivy poison, the dermatologist prescribed a cream that did not help. He was put on antibiotic course which helped a little in subsiding the effects. Later, he had rash on upper chest, upper left shoulder and neck for about a week. Rashes were located on collar that could break out, top of shoulder where he had shot and across his chest. He had spots on face, back, chest and head that looked like chicken pox and the rashes were itchy. The folliculitis continued for 1.5 to 2 months, the back had started getting better but still had few spots on chest. He visited 5 dermatologists, but the cream prescribed by last dermatologist helped. On 14-MAY-2021, his neuropathic condition in hands and feet got worsened. After vaccination for 3 to 4 weeks, his right hand was shaky, could not even hold a drink. His gabapentin dose was increased from 300 to 600 mg and his condition got better, later the dose was further increased to 800 mg. His right hand remained week and he had to use left hand over his right even after being right handed (might have had a little problem before because he uses it more). He had tremors in the right hand mostly along with left hand and feet. His hands were shaky and was difficult for him for picking up stuffs or putting it down. The condition improved but there were certain things he was not able to do currently. He was not sure it was due to vaccine and thought that the problems he had were intensified by his autoimmune disease. His neuropathy excelled quickly for about 2 months and had stopped. On 14-JUL-2021, his condition was stable with increased dose of gabapentin. He was not able to shave as few spots on face was still there. The rash appeared around the same time of day (midday to 8pm) which continued off and on for about a month and a half. In JUL-2021 (a month prior reporting), the folliculitis had stopped spreading. On unspecified date, he had scars on face and he was not healing well anymore because of diabetes. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from worsening of neuropathy on 14-JUL-2021, and tired for 2 days on 01-APR-2021, was recovering from folliculitis, and the outcome of scars on face and does not heal well was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210837531-Covid-19 vaccine ad26.cov2.s-Worsening neuropathy. 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: UNDERLYING DISEASE

Other Meds: Gabapentin

Current Illness: Diabetes (For 30 years.); Herniated disc; Neuropathy peripheral.

ID: 1634850
Sex: M
Age:
State: KY

Vax Date:
Onset Date: 07/30/2021
Rec V Date: 08/26/2021
Hospital: Y

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

Lab Data: Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: 99.2 F; Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 170/110 mmHg; Test Date: 20210731; Test Name: COVID-19 virus test; Result Unstructured Data: Negative; Test Date: 202108; Test Name: Antiphospholipid antibodies; Result Unstructured Data: Positive; Test Date: 20210803; Test Name: Platelet count; Result Unstructured Data: 37,000; Test Date: 20210813; Test Name: Nuclear magnetic resonance imaging; Result Unstructured Data: The bowel lining was compromised by the blood clot and was sloughing.; Test Date: 20210816; Test Name: CT scan; Result Unstructured Data: Various locations of clots as per report; Comments: major clots in portal vein.; Test Date: 20210819; Test Name: Platelet count; Result Unstructured Data: 230,000; Test Name: X-ray; Result Unstructured Data: unspecified; Test Name: Diagnostic ultrasound; Result Unstructured Data: not reported.

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: BILATERAL CLOTS IN THE LEFT AND PROXIMAL MAIN PORTAL VEIN/ MULTIPLE BILATERAL CLOTS IN THE LUNGS; CLOTS IN SPLENIC VEIN; BOWEL LINING COMPROMISED BY THE BLOOD CLOT; BLEEDING (SLOUGHING OFF); MULTIPLE DVTS RIGHT LEG; MULTIPLE BILATERAL CLOTS IN LUNGS/ BILATERAL PULMONARY EMBOLISM; SMALL CLOTS WITHIN THE SMV (SUPERIOR MESENTERIC VEIN); ABDOMINAL MESENTERIC ISCHEMIA; PLATELET COUNT DECREASED 37 000; POST THROMBOTIC SYNDROME; BLOOD PRESSURE INCREASED; WEIGHT LOSS (15 LBS); CHILLS/ SHAKING; VOMITING/THREW UP; LETHARGIC; FELT SICK; FEVER OF 99.2; SEVERE HEADACHE; EXTREMELY TIRED; APPETITE IMPAIRED (NEVER ATE, COULD NOT KEEP ANYTHING DOWN); This spontaneous report received from a consumer concerned a 54 year old, not Hispanic or Latino, white male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension. The patient was previously treated with lisinopril for hypertension. 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, 1 total administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 around 05:30 a:m, the patient experienced severe shaking/chills, felt terrible and sick, vomiting/threw up, lower back pain, fever of 99.2 F, blood pressure increased, lethargic, severe headache, appetite impaired (never ate, could not keep anything down), extremely tired, felt sick. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg. On 31-JUL-2021, the patient felt horrible and saw a teledoc. Teledoc said to get the antibodies done, Laboratory data included: COVID-19 virus test (NR: not provided) Negative, Antiphospholipid antibodies (NR: not provided) Positive. On 03-AUG-2021, the patient experienced platelet count decreased 37000 unspecified units. On AUG-2021, the patient experienced post thrombotic syndrome. On 09-AUG-2021, the patient experienced abdominal mesenteric ischemia, multiple bilateral clots in lungs/ bilateral pulmonary embolism, small clots within the SMV (superior mesenteric vein), thrombosis pulmonary, severe abdominal pain and for that visited emergency department, flank pain, dry heaves in ICU (Intensive Care Units). The patient was hospitalized. On 10-AUG-2021, the patient experienced multiple deep vein thrombosis right leg and bleeding (sloughing off). On 13-AUG-2021, the patient experienced bowel lining compromised by the blood clot. Would take 2-3 weeks to heal. Laboratory data included: Nuclear magnetic resonance imaging (NR: not provided) The bowel lining was compromised by the blood clot and was sloughing. On 16-AUG-2021, Laboratory data included: Computed tomography (CT) scan (NR: not provided) Various locations of clots as per report. His clots were still there but some had improved. On 17-AUG-2021, the patient experienced bilateral clots in the left and proximal main portal vein/ multiple bilateral clots in the lungs and clots in splenic vein. On 19-AUG-2021, the patient experienced weight loss (15 lbs.). Laboratory data included: Platelet count (NR: not provided) 230, 000 unspecified units. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) not reported, and X-ray (NR: not provided) unspecified. Other diagnostic data included PT and PTT. On 20-AUG-2021, the patient was still hospitalized. Blood pressure was still not under control and had fluctuated in hospital due to pain. At the time of report patient was on blood thinners which his wife indicated he would likely be on for the rest of his life. He was being followed by hematology. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from dry heaves in ICU, and chills/ shaking, and fever of 99.2 on 30-JUL-2021, was recovering from vomiting/threw up, feels terrible/felt horrible, lethargic, severe headache, flank pain, extremely tired, bowel lining compromised by the blood clot, small clots within the SMV (superior mesenteric vein), bilateral clots in the left and proximal main portal vein/ multiple bilateral clots in the lungs, clots in splenic vein, multiple bilateral clots in lungs/ bilateral pulmonary embolism, severe abdominal pain, low back pain, blood pressure increased, and platelet count decreased 37000, had not recovered from appetite impaired (never ate, could not keep anything down), multiple DVTS right leg, and felt sick, and the outcome of weight loss (15 lbs.), bleeding (sloughing off), post thrombotic syndrome and abdominal mesenteric ischemia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from a consumer concerned a 54-year-old white man who experienced thrombocytopenia (day 11) and multiple sites of thrombosis in pulmonary, intra-abdominal, and peripheral sites (day 17) after vaccine. Medical history included hypertension treated with lisinopril. On day 7, the patient experienced severe shaking/chills, felt terrible and sick, vomiting, lower back pain, blood pressure increased, lethargic, severe headache, appetite, extremely tired. On day 8: COVID-19 virus test Negative, Antiphospholipid antibodies Positive. On day 11, platelets were 37,000. On day 17, the patient experienced abdominal mesenteric ischemia, multiple bilateral pulmonary emboli, small clots within the SMV (superior mesenteric vein), thrombosis pulmonary, severe abdominal pain and was admitted to intensive care. On day 18, the patient experienced multiple deep vein thrombosis right leg and bleeding. On day 21, the patient experienced bowel lining compromised by the blood clot with sloughing. On day 22, CT scan confirmed many clots. On day 23, the patient experienced bilateral clots in the left and proximal main portal vein/ multiple bilateral clots in the lungs and clots in splenic vein. On day 24, the patient experienced weight loss (15 lbs.). Laboratory data included: Platelet count improved to 230,000. On day 25, the patient was still hospitalized. Blood pressure was still not under control and had fluctuated in hospital due to pain. At the time of report patient was on blood thinners which his wife indicated he would likely be on for the rest of his life and he was being followed by hematology. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from-BC), the low platelet count and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination. Additional information is requested.

Other Meds:

Current Illness: Hypertension

ID: 1634851
Sex: M
Age:
State:

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

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

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

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; GOT COVID; This spontaneous report received from a male patient of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown, expiry: unknown) 1 total, frequency, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient tested positive to Covid-19 (got Covid and suspected clinical vaccination failure). No further information provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got covid and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210841128-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

Other Meds:

Current Illness:

ID: 1634852
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 08/26/2021
Hospital: Y

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

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

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: COMA; GANGRENE ON HANDS AND FEET; YELLOW WELTS AROUND EYES; BODY WAS WILTING OUT; BLEEDING LUNGS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer who reported that he heard of a friend's cousin, a 6 decade old male (52-54 years old) of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 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 on MAY-2021, after vaccination the patient was diagnosed with Covid-19 (suspected covid-19 infection) and had suspected clinical vaccination failure. He was hospitalized (date unspecified). On an unspecified date on AUG-2021, the patient's lungs were bleeding and had been doing worse. On an unspecified date, the patient was unconscious and in a coma and also had gangrene on hands and feet which needs to be amputated and his body was wilting out. The patient had yellow welts all around eyes. Reporter was not clear on if these afflictions were induced by the vaccine or from being infected with the coronavirus after vaccination. Number of days hospitalized was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and bleeding lungs, and the outcome of coma, gangrene on hands and feet, yellow welts around eyes, suspected clinical vaccination failure, and body was wilting out was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210841428-COVID-19 VACCINE AD26.COV2.S.- Coma, Bleeding lungs, Gangrene on hands and feet, Suspected clinical vaccine failure, Suspected covid-19 infection, Yellow welts around eyes, Body was wilting out. This events is considered unassessable. The events has a 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: 1634856
Sex: F
Age:
State: IN

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: INSOMNIA; NECK PAIN; HEADACHE; COULD NOT USE ARM; ARM WEAKNESS; PINCHED NERVE; FROZEN SHOULDER; THROBBING AND PULSATING PAIN IN RIGHT ARM; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included: mastectomy, radiation, and surgery, and concurrent conditions included: diabetes, high blood pressure, high cholesterol, high blood sugar, non-smoker, non-alcohol user, lymphedema in left arm, breast cancer, sciatic nerve pain, lumbar disease five discs in back deteriorated, and chemotherapy, and other pre-existing medical conditions included: The patient had no history of illicit drug use/abuse. The patient was also prescribed a muscle relaxer and takes at night and also used a massager for relief. The patient experienced drug allergy when treated with amitriptyline, and atorvastatin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. Concomitant medications included anastrozole for breast cancer, insulin for diabetes, linagliptin for diabetes, diclofenac for left arm burning sensation, gabapentin, paracetamol, and pravastatin. On 01-JUL-2021, the patient experienced throbbing and pulsating pain in right arm. On 05-JUL-2021, the patient experienced pinched nerve. On 05-JUL-2021, the patient experienced frozen shoulder. On 05-JUL-2021, the patient experienced arm weakness. On 10-JUL-2021, the patient experienced could not use arm. On an unspecified date, the patient experienced insomnia, neck pain, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, had not recovered from pinched nerve, frozen shoulder, insomnia, throbbing and pulsating pain in right arm, arm weakness, and neck pain, and the outcome of could not use arm was not reported. This report was non-serious.

Other Meds: ANASTROZOLE; INSULIN; TRAJENTA; VOLTAREN [DICLOFENAC]; GABAPENTIN; TYLENOL; PRAVASTATIN

Current Illness: Abstains from alcohol; Blood pressure high; Blood sugar increased; Breast cancer; Chemotherapy; Diabetes; High cholesterol; Lymphedema; Non-smoker; Sciatic neuralgia; Spinal disorder

ID: 1634857
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 06/17/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: FELT ILL FROM THE VACCINE; HEAD SPASMS; TREMORS; RAPID HEARTBEAT; FELT LIKE STROKE/FELT LIKE LEANING TO RIGHT; WEAKNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight was 140 pounds, and height was 65 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: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 16-JUN-2021 16:30 for prophylactic vaccination. Concomitant medications included butalbital, methocarbamol, naproxen, paracetamol, prednisone, and venlafaxine. On 17-JUN-2021, the patient experienced felt like stroke/felt like leaning to right. On 17-JUN-2021, the patient experienced weakness. On 23-JUN-2021, the patient experienced tremors. On 23-JUN-2021, the patient experienced rapid heartbeat. On 26-JUN-2021, the patient experienced head spasms. On an unspecified date, the patient experienced felt ill from the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tremors, rapid heartbeat, head spasms, felt like stroke/felt like leaning to right, and weakness, and the outcome of felt ill from the vaccine was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds: PREDNISONE; VENLAFAXINE; NAPROXEN; METHOCARBAMOL; BUTALBITAL; ACETAMINOPHEN

Current Illness:

ID: 1634858
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/26/2021
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: BLURRED VISION; POTENTIAL BRUISE; CONCERNED ABOUT A BLOOD CLOT; BODY PAIN IN DIFFERENT AREAS; RIGHT UPPER LEG MORE SENSITIVE; POTENTIAL REDNESS ON SKIN OF LEG; LOT OF PAIN BEHIND RIGHT LEG MOSTLY FROM THE KNEE UP BUT LITTLE BELOW THE KNEE ALMOST TO THE TOP OF THE LEG (MOSTLY IN THE MIDDLE OF THE UPPER LEG); CHILLS, SHIVERING; HEADACHE; MUSCLE AND BODY ACHES; SWEATY; LOW GRADE FEVER; VARICOSE VEINS AT BACK OF LEG TURNED MORE BLUE AND MIGHT BE LITTLE RED; HOT ON AND OFF; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non smoker. The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient had no medical history to share and was generally in good health. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 20-AUG-2021 15:50 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, twelve hours after vaccination, like clockwork, the patient woke up at 3 AM shivering and had various body pain in different areas. By morning time, when she got up she felt that area (right upper leg) was more sensitive and then on the morning of 22-AUG-2021, it was much worse instead of getting better. On 21-AUG-2021, the patient had a headache, muscle and body aches, lot of pain behind right leg, mostly from the knee up but starting a little below the knee almost to the top of the leg, mostly in the middle of the upper leg and potential redness on skin of leg. The pain was like a bruise, it felt like she was touching a bruise when she was not (potential bruise). She was unable to confirm the appearance of the back of leg when questioned if there was a visible bruise. She was also unable to confirm if there was any swelling or heat present in the affected area. When she tried to see the back of leg she had varicose veins which had turned more blue and it might turned a little red back there. She was concerned about a blood clot as she read about that being a potential with the Janssen COVID-19 vaccine. She had chills and got sweaty. In AUG-2021, the patient felt like she had a low grade fever in general but she did not have a thermometer to measure. The patient was hot on and off. Her usual or expected side effects such as shivering, fever, various pains in other areas and headache went away. On 22-AUG-2021, her vision was blurred, she couldn't drive without glasses and usually she did not bother putting them on. The patient visited emergency room and physician's office. She did not know if this was related to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty, body pain in different areas, chills, shivering, low grade fever, and headache on AUG-2021, had not recovered from lot of pain behind right leg mostly from the knee up but little below the knee almost to the top of the leg (mostly in the middle of the upper leg), muscle and body aches, right upper leg more sensitive, and concerned about a blood clot, and the outcome of blurred vision, potential bruise, hot on and off, potential redness on skin of leg and varicose veins at back of leg turned more blue and might be little red was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

Date Died:

ID: 1634859
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: DEATH; This spontaneous report received from a consumer via a company representative from social media concerned an 8 decade old of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) 1 total, 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 died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210844359.; Sender's Comments: V0: 20210845181-covid-19 vaccine ad26.cov2.s- Death.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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1634860
Sex: U
Age:
State: NH

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: SEVERE ARM SORENESS THAT CONTINUED AFTER RECEIVING VACCINE; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 severe arm soreness that continued after receiving vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe arm soreness that continued after receiving vaccine. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634861
Sex: F
Age:
State:

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

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

Lab Data: Test Date: 20210810; Test Name: Body temperature; Result Unstructured Data: 39 C

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: TINGLING PRICKLY FEELING IN HANDS; SHIVERS; DIDN'T FEEL TOO WELL; FEVER OF 39 DEGREES; WEAK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-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 weak. On 10-AUG-2021, the patient experienced tingling prickly feeling in hands. On 10-AUG-2021, the patient experienced shivers. On 10-AUG-2021, the patient experienced didn't feel too well. On 10-AUG-2021, the patient experienced fever of 39 degrees. Laboratory data included: Body temperature (NR: not provided) 39 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weak, and the outcome of tingling prickly feeling in hands, fever of 39 degrees, shivers and didn't feel too well was not reported. This report was non-serious. This case, from the same reporter is linked to 20210850476.

Other Meds:

Current Illness:

ID: 1634862
Sex: F
Age:
State: TN

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

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

Lab Data: Test Name: Blood test; Result Unstructured Data: lack of immunity.

Allergies:

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

Symptoms: THIS VACCINE IS THE LEAST LIKELY TO WORK ON ANYTHING, IT'S THE WORST OF THE WORST/BLOOD TESTS SHOW THAT I DONT HAVE AN IMMUNITY; This spontaneous report received from a patient concerned a female of unspecified age with unspecified race & ethinicity. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 Total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient reported that the vaccine was the least likely to work on anything, it was the worst of the worst, every time patient turns on the computer somebody was dying from a blood clot. Laboratory data (dates unspecified) included: Blood test (NR: not provided) lack of immunity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of this vaccine was the least likely to work on anything, it was the worst of the worst/blood tests show that patient did not have an immunity was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190591.; Sender's Comments: V0: 20210846262- covid-19 vaccine ad26.cov2.s-this vaccine was the least likely to work on anything, it was the worst of the worst/blood tests show that patient did not have an immunity (Drug ineffective). This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness: Disability

ID: 1634863
Sex: F
Age:
State: FL

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

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

Lab Data: Test Date: 20210822; Test Name: COVID-19 virus test; Result Unstructured Data: Positive.

Allergies:

Symptom List: Rash, Urticaria

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 50 year old white not Hispanic or Latino female. Initial information was processed along with the additional information received on 24-AUG-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 18-SEP-2021) dose was not reported, 1 total administered to the left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced symptoms of Covid (headache, congestion, exhausted, things taste funny, runny nose). On 22-AUG-2021, patient received a result of COVID-19 virus test positive. The symptoms started last week but patient did not realize she had been infected (suspected covid-19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190597.; Sender's Comments: V0 20210846287- 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

Other Meds:

Current Illness:

ID: 1634864
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: HALF CONSCIOUS; BODY HURT; HEAD FELT SPLITTING OPEN; SKIN FELT LIKE MELTING OFF; PRESSURE BEHIND EYES; SHAKING; COULD NOT SLEEP; BAD FEVER; This spontaneous report received from a patient via a company representative through social media concerned a patient of an unspecified age, sex, 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, start therapy date were not reported, 1 total administered 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, for about 22 hours straight the patient experienced half conscious, shaking uncontrollably with a really bad fever, every cubic centimeter of body hurt, and their skin felt like melting off. The patient also felt pressure behind eyes and head felt splitting open. The patient genuinely wanted to die as it hurt so much and could not fall asleep or anything to at least help pass through the day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the half conscious, shaking, bad fever, body hurt, skin felt like melting off, head felt splitting open, pressure behind eyes, and could not sleep was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210846352-JANSSEN COVID-19 VACCINE Ad26.COV2.S- half conscious-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: 1634865
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 08/17/2021
Rec V Date: 08/26/2021
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: COVID-19 antibody test; Result Unstructured Data: Negative; Comments: Antibody test came back negative today (8/23/2021); Test Date: 20210816; Test Name: SARS-CoV-2 test; Result Unstructured Data: negative antibody test; Comments: detects antibodies to spike protein, including receptor binding domain RBD

Allergies:

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

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a pharmacist concerned a 69 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: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, SARS-CoV-2 test was done to detect spike protein and result came as negative antibody test on 17-AUG -2021 (Confirmed immunological vaccination failure). On unspecified date in AUG-2021, again covid-19 antibody test was done which came negative on 23-AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000190644.; Sender's Comments: V0. 20210846353-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: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1634866
Sex: F
Age:
State: FL

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

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

Lab Data: Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: 99-100 Fahrenheit

Allergies:

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

Symptoms: ACHY; SWEATY; BURNING BEHIND THE EYES; LOW GRADE FEVER; SORE AT INJECTION SITE; FATIGUE; 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 concurrent conditions included: sinusitis, penicillin allergy, hashimoto's, epstein barr, minor palpitations, non alcohol user, non smoker, and thyroid nodule, and other pre-existing medical conditions included: The patient had no drug abuse or illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. Concomitant medications included loratadine. On AUG-2021, the patient experienced achy. On AUG-2021, the patient experienced sweaty. On AUG-2021, the patient experienced burning behind the eyes. On AUG-2021, the patient experienced low grade fever. On AUG-2021, the patient experienced sore at injection site. On AUG-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99-100 Fahrenheit. Treatment medications (dates unspecified) included: vitamins nos, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore at injection site, and had not recovered from low grade fever, fatigue, burning behind the eyes, sweaty, and achy. This report was non-serious.

Other Meds: LORTAB [LORATADINE]

Current Illness: Abstains from alcohol; Epstein-Barr virus infection; Hashimoto's disease; Non-smoker; Palpitations; Penicillin allergy; Sinusitis; Thyroid nodule

ID: 1634868
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 08/21/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SYMPTOMS OF COVID-19; This spontaneous report received from a consumer concerned a 29 year old female. The patient's weight was 165 pounds, and height was 65 inches. The patient's concurrent conditions included: alcohol non-user, and non smoker, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with amoxicillin, and clarithromycin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, the patient experienced symptoms of covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from symptoms of covid-19. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1634869
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 08/21/2021
Rec V Date: 08/26/2021
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: 20210822; Test Name: CT scan; Result Unstructured Data: Negative for blood clot; Test Date: 20210822; Test Name: CBC; Result Unstructured Data: Normal; Test Date: 20210822; Test Name: Blood pressure; Result Unstructured Data: 220/110 mmHg; Test Date: 20210822; Test Name: Blood pressure; Result Unstructured Data: 168/98 mmHg; Test Date: 20210822; Test Name: Ultrasound scan; Result Unstructured Data: Lymphatic mass in the left axilla

Allergies:

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

Symptoms: TINGLING SENSATION/ PINS AND NEEDLES IN THE FINGERS OF LEFT ARM; JOINT ACHES; EYES HURTED; BODY ACHES; ARM SORE; CHILLS; A BASE BALL SIZE LYMPHATIC MASS IN THE LEFT AXILLA; SLIGHT HEADACHE; PAINFUL INJECTION; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included: lymph node swelling of both armpits, and concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient was previously 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: 0421A21, expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, the patient experienced painful injection. On 22-AUG-2021, the patient experienced eyes hurted. On 22-AUG-2021, the patient experienced body aches. On 22-AUG-2021, the patient experienced arm sore. On 22-AUG-2021, the patient experienced chills. On 22-AUG-2021, the patient experienced a base ball size lymphatic mass in the left axilla. On 22-AUG-2021, the patient experienced slight headache. Laboratory data included: Blood pressure (NR: not provided) 220/110 mmHg, 168/98 mmHg, CBC (NR: not provided) Normal, CT scan (NR: not provided) Negative for blood clot, and Ultrasound scan (NR: not provided) Lymphatic mass in the left axilla. On 23-AUG-2021, the patient experienced tingling sensation/ pins and needles in the fingers of left arm. On 23-AUG-2021, the patient experienced joint aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 22-AUG-2021, was recovering from painful injection, and arm sore, had not recovered from body aches, slight headache, eyes hurted, a base ball size lymphatic mass in the left axilla, and joint aches, and the outcome of tingling sensation/ pins and needles in the fingers of left arm was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1634870
Sex: F
Age:
State: FL

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

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Raised

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: RISE IN TEMPERATURE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 rise in temperature. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Raised. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rise in temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210847388.

Other Meds:

Current Illness:

ID: 1634871
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/23/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Date: 20210823; Test Name: IgM; Result Unstructured Data: Negative; Test Date: 20210823; Test Name: IgG; Result Unstructured Data: Negative

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, unknown race, and ethnic origin. 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-AUG-2021, the patient had just come back from the doctor and the doctor had drawn the patient's blood to see where the patient's antibodies level was to see if the patient needed a booster. The patient's IgG (Immunoglobulin G), and IgM (Immunoglobulin M) were both negative. When the patient told the doctor that the patient received the Johnson and Johnson vaccine, the doctor said that he was prohibited from giving the patient a booster and that they had to wait to see what the CDC (Centers for Disease Control and Prevention) said. The patient asked about getting another brand of vaccine and the doctor said said that he would have done it, but he needed orders from a Johnson and Johnson doctor sent to him. The patient did not know how to get that. The patient stated that he was walking around without any immunity and he was told that the protection would last 8 months. The patient was planning to get a vaccine in November again, but without any antibodies, the patient felt that he needed a vaccine. 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 number: 90000190615.; Sender's Comments: V0: 20210846539-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: 1634872
Sex: F
Age:
State: OH

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

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

Lab Data: Test Date: 202108; Test Name: SARS-CoV-2 rapid diagnostic test; Result Unstructured Data: negative; Test Date: 202108; Test Name: Troponin; Result Unstructured Data: negative; Test Date: 202108; Test Name: CT scan; Result Unstructured Data: negative; Comments: 2 times; Test Date: 202108; Test Name: EKG; Result Unstructured Data: negative; Comments: 5 times; Test Date: 202108; Test Name: Fibrin D dimer; Result Unstructured Data: negative; Test Date: 202108; Test Name: Chest X-ray; Result Unstructured Data: negative; Comments: 2 times; Test Date: 202108; Test Name: Stress test; Result Unstructured Data: negative; Test Date: 202108; Test Name: Oxygen saturation; Result Unstructured Data: 100 but with movement it goes down to 70-80%; Test Date: 202108; Test Name: Heart rate; Result Unstructured Data: 100; Test Date: 202108; Test Name: Diagnostic ultrasound; Result Unstructured Data: negative; Comments: Did ultrasound for the possibility of fluid around the lung which was negative.

Allergies:

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

Symptoms: CHRONIC CHEST TIGHTNESS; LABORED BREATHING UPON MOVEMENT; WITH MOVEMENT OXYGEN LEVEL WENT DOWN TO 70 TO 80 PERCENTAGE; SWEATS; CHILLS; SORE ARM FOR 1 WEEK; BURNED INTENSELY AT THE TIME OF INJECTION; HEADACHE; MUSCLE ACHES ALL OVER THE BODY; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 155 pounds, and height was 67 inches. The patient's past medical history included chest infection and ended up with bronchitis in her late 30s. When the patient was a teenager and was active in sports sometimes would get short of breath. The patient's concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included no known prior history and did not have any drug abuse/illicit drug use. The patient was previously treated with salbutamol for bronchitis and with nebulizer for short of breath. The patient experienced hives all over body when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 09-AUG-2021 at around 15:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced intense burning at the time of injection and had sore arms for one week. Half an hour later the patient had a headache and 2 hours later had muscle aches all over her body, low grade fever, chills and sweating which all were resolved in morning after 48 hours. The next morning on 10-AUG-2021 the patient felt tight chest, something that had not gone away and she had chronic chest tightness and labored breathing. The patient visited ER (emergency room) twice. On 14-AUG-2021, the patient visited ER for second time and got admitted. The patient underwent lab tests such as blood clots (negative for pulmonary embolism), troponin, D-Dimer, COVID (rapid tests), 5 times EKGs (electrocardiogram), 2 times CT (computerised tomogram) scans, 2 times chest X-Rays, Stress test with lexiscan (because the patient could not perform on treadmill) and they all were negative. They ruled out myocarditis or pericarditis and did ultrasound for the possibility of fluid around the lung which was negative. They found mitral valve thickening which were told it was not significant. They also pointed out to anxiety but the reporter said that she knew that was not anxiety. The patient's main concern was that she had labored breathing with any movement or positioning and she had chronic chest tightness that she said she had been in intermittent ambulatory distress. The patient's oxygen level at rest was 100 but with movement oxygen level went down to 70 to 80 percentage and her heart rate went up to 100. They treated her with IV (intravenous) saline drip on the first day in the hospital and nothing was given orally for the tests. They offered heparin and steroids but the patient declined. She will also be seen by a pulmonary specialist. At the time of reporting the patient was in the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweats, chills, headache, muscle aches all over the body, and low grade fever on 11-AUG-2021, and sore arm for 1 week, and burned intensely at the time of injection on 16-AUG-2021, had not recovered from chronic chest tightness, and labored breathing upon movement, and the outcome of with movement oxygen level went down to 70 to 80 percentage was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210846641 -covid-19 vaccine ad26.cov2.s- chronic chest tightness, labored breathing upon movement, with movement oxygen level went down to 70 to 80 percentage. 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: Abstains from alcohol; Non-smoker

ID: 1634873
Sex: U
Age:
State: ID

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Test Name: PCR; Result Unstructured Data: positive

Allergies:

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

Symptoms: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned 2 patients of unspecified sex, age, race and ethnicity. No past medical histories or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A, expiry: unknown) dose was not reported, 1 total administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. It was reported that the 2 patients had a polymerase chain reaction (PCR) based corona virus disease (COVID) test which came back positive. Both had fever, headaches, nasal congestion, and diarrhea. The patients experienced confirmed COVID-19 infection, and confirmed clinical vaccination failure. The patients were still recovering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed COVID-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846435.; Sender's Comments: V0. 20210846649-covid-19 vaccine ad26.cov2.s -confirmed 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

Other Meds:

Current Illness:

ID: 1634874
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/26/2021
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: 20210814; Test Name: Body temperature; Result Unstructured Data: 100.8 F

Allergies:

Symptom List: Unevaluable event

Symptoms: FATIGUE(TIREDNESS); PAIN AT INJECTION SITE/ARM; NAUSEA; FEVER/CHILLS,FEVER OF 100.8F; SEVERE HEADACHE; FEELS BLOATED WITH ABDOMINAL DISTENTION; SHAKING/TREMBLING; FEELING COLD; FEELING SICK ,UNWELL,DID NOT FEEL WELL, GENERAL MALAISE; VOMITING,RETCHING; ARM WAS VERY PAINFUL; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 120 pounds, and height was 65 inches. The patient's concurrent conditions included: occasional migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 14-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced arm was very painful. On 14-AUG-2021, the patient experienced feels bloated with abdominal distention. On 14-AUG-2021, the patient experienced shaking/trembling. On 14-AUG-2021, the patient experienced feeling cold. On 14-AUG-2021, the patient experienced feeling sick, unwell, did not feel well, general malaise. On 14-AUG-2021, the patient experienced vomiting, retching. On 14-AUG-2021, the patient experienced nausea. On 14-AUG-2021, the patient experienced fever/chills, fever of 100.8f. On 14-AUG-2021, the patient experienced severe headache. On 14-AUG-2021, the patient experienced pain at injection site/arm. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 15-AUG-2021, the patient experienced fatigue (tiredness). Treatment medications (dates unspecified) included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking/trembling, feeling cold, vomiting,retching, nausea, fever/chills,fever of 100.8f, and severe headache on 15-AUG-2021, and arm was very painful, and pain at injection site/arm on AUG-2021, and had not recovered from fatigue(tiredness), feeling sick ,unwell,did not feel well, general malaise, and feels bloated with abdominal distention. This report was non-serious.

Other Meds:

Current Illness: Migraine

ID: 1634875
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: DIARRHEA; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 61.4 kilograms, and height was not reported. The patient's concurrent conditions included: primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included sildenafil citrate. On an unspecified date, the patient experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea. This report was non-serious. This case, involving the same patient is linked to 20210818697.

Other Meds: SILDENAFIL CITRATE

Current Illness: Primary pulmonary hypertension

ID: 1634876
Sex: F
Age:
State: NH

Vax Date:
Onset Date: 03/02/2021
Rec V Date: 08/26/2021
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: VISION TROUBLE; UNCOMFORTABLE SLEEP; I THOUGHT I WAS HAVING A STROKE/FELT VERY BAD JUST ODD AND STRANGE; SMELLING SMOKE; PAIN AT THE TOP OF HER HEAD/INSTANT WORSE MIGRAINE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stroke. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-MAR-2021, the patient experienced pain at the top of her head/instant worse migraine. On an unspecified date, the patient experienced vision trouble, uncomfortable sleep, i thought i was having a stroke/felt very bad just odd and strange, and smelling smoke. The action taken with covid-19 vaccine was not applicable. The patient recovered from pain at the top of her head/instant worse migraine, vision trouble, uncomfortable sleep, and smelling smoke, and the outcome of i thought i was having a stroke/felt very bad just odd and strange was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634877
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 08/18/2021
Rec V Date: 08/26/2021
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: 20210818; Test Name: SARS-CoV-2 rapid antibody 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 male. The patient's height, and weight were not reported. The patient's concurrent conditions included: insulin dependent. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 in right arm in the morning for prophylactic vaccination. No concomitant medications were reported. On 18-AUG-2021, the patient experienced confirmed immunological vaccine failure. The patient underwent a Immunoglobulin G/Immunoglobulin M (IgG/IgM) COVID-19 combination antibody test, which resulted into negative antibodies (Ab). 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).; Sender's Comments: V0: 20210847388-covid-19 vaccine ad26.cov2.s-Confirmed Immunological Vaccine 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:

Current Illness: Insulin dependent diabetic

ID: 1634878
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/27/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: HEAVY FEELING IN CHEST; FLU-LIKE SYMPTOMS(FELT FEVERISH, HACKING COUGH, SUDDEN TIREDNESS, HEADACHES, MUSCLE ACHES); 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 27-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-JUL-2021, the patient experienced heavy feeling in chest. On 27-JUL-2021, the patient experienced flu-like symptoms (felt feverish, hacking cough, sudden tiredness, headaches, muscle aches). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy feeling in chest, and flu-like symptoms (felt feverish, hacking cough, sudden tiredness, headaches, muscle aches). This report was non-serious.

Other Meds:

Current Illness:

ID: 1634879
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: RASH; 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 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 rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash. This report was non-serious. This case, from the same reporter is linked to 20210846321.

Other Meds:

Current Illness:

ID: 1634880
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 08/17/2021
Rec V Date: 08/26/2021
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: NIGHTMARES; WAKING UP EVERY HOUR IN PAIN; EXTREME MUSCLE CRAMPS; STOMACH PAIN; DIARRHEA; HEADACHE; This spontaneous report received from a patient concerned a 58 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 16-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, treatment medications included: acetylsalicylic acid, and ibuprofen. On 17-AUG-2021, the patient experienced nightmares. On 17-AUG-2021, the patient experienced waking up every hour in pain. On 17-AUG-2021, the patient experienced extreme muscle cramps. On 17-AUG-2021, the patient experienced stomach pain. On 17-AUG-2021, the patient experienced diarrhea. On 17-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, diarrhea, nightmares, waking up every hour in pain, extreme muscle cramps, and stomach pain. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634881
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 07/30/2021
Rec V Date: 08/26/2021
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: PARANOID THAT PATIENT HAD SARS SYNDROME; MUSCLE SPASMS IN FINGERS, TOES, AND BUTTOCKS; DISTURBING DREAMS AS IF PATIENT WAS IN A BARBER CHAIR AND SOMEONE WAS SPINNING PATIENT; SPINNING SENSATION DURING DREAMS AND WHEN AWAKE; FELT OFF/FELT LIKE HIT BY A TRUCK; FELT ILL; FEELING SUPER DUPER TIRED AND FATIGUE; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies, no known previous medical conditions, and no current medication usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced felt off/felt like hit by a truck. On 30-JUL-2021, the patient experienced felt ill. On 30-JUL-2021, the patient experienced feeling super duper tired and fatigue. On 30-JUL-2021, the patient experienced fever. On 30-JUL-2021, the patient experienced nausea. On 30-JUL-2021, the patient experienced headache. On 01-AUG-2021, the patient experienced disturbing dreams as if patient was in a barber chair and someone was spinning patient. On 01-AUG-2021, the patient experienced spinning sensation during dreams and when awake. On 08-AUG-2021, the patient experienced muscle spasms in fingers, toes, and buttocks. On an unspecified date, the patient experienced paranoid that patient had sars syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt off/felt like hit by a truck, felt ill, feeling super duper tired and fatigue, fever, nausea, and headache, and disturbing dreams as if patient was in a barber chair and someone was spinning patient, spinning sensation during dreams and when awake, and muscle spasms in fingers, toes, and buttocks on AUG-2021, and the outcome of paranoid that patient had sars syndrome was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634882
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 08/24/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: CRAMPS IN BOTH LEGS FROM KNEE TO ANKLE; SEVERE ARM PAIN THAT RADIATES FROM SHOULDER TO ELBOW LIKE HAD SURGERY ON IT; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight was not reported and height was 61 inches. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no any seasonal allergies, medications and previous medical history, no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 23-AUG-2021 11:30 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 24-AUG-2021, the patient experienced cramps in both legs from knee to ankle. On 24-AUG-2021, the patient experienced severe arm pain that radiates from shoulder to elbow like had surgery on it. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe arm pain that radiates from shoulder to elbow like had surgery on it, and cramps in both legs from knee to ankle. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1634883
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: THE FOLLOWING WEEK HAD ABOUT TEN DIME SIZE BRUISES ON ARMS AND LEGS; SEVERE CHILLS; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes( controlled with diet), hashimoto, sjogrens, celiac, and crohns. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced the following week had about ten dime size bruises on arms and legs, severe chills, sore arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills, and sore arm, and the outcome of headache and the following week had about ten dime size bruises on arms and legs was not reported. This report was non-serious.

Other Meds:

Current Illness: Celiac disease; Crohn's disease; Diabetes; Hashimoto's disease; Sjogren's syndrome

ID: 1634884
Sex: F
Age:
State: MA

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

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

Lab Data: Test Name: Echocardiogram; Result Unstructured Data: Not reported; Test Name: Body temperature; Result Unstructured Data: 97-98 (normal)

Allergies:

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

Symptoms: BODY IS ON FIRE, HEAD TO TOE/SKIN IS ON FIRE; BLOOD PROBLEM/HEMATOLOGY PROBLEM; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sinus infections. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced body is on fire, head to toe/skin is on fire, and blood problem/hematology problem. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97-98 (normal), and Echocardiogram (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body is on fire, head to toe/skin is on fire and blood problem/hematology problem was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634885
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 08/24/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: 101.1 F

Allergies:

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

Symptoms: BODY ACHES; SORE ARM; HEADACHES; FEVER OF 101.1F; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 23-AUG-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced body aches. On 24-AUG-2021, the patient experienced sore arm. On 24-AUG-2021, the patient experienced headaches. On 24-AUG-2021, the patient experienced fever of 101.1f. Laboratory data included: Body temperature (NR: not provided) 101.1 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 24-AUG-2021, and was recovering from headaches, sore arm, and fever of 101.1f. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634886
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Name: Blood test; Result Unstructured Data: No significant findings

Allergies:

Symptom List: Tremor

Symptoms: FIBROMYALGIA; This spontaneous report received from a patient concerned a 51 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced fibromyalgia. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No significant findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fibromyalgia. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634887
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 08/23/2021
Rec V Date: 08/26/2021
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: VOICE SOUNDS LIKE A FROG; STUFFED UP IN NOSE AREA; BODY ACHES FROM HEAD TO TOE; CHILLS; HEADACHE; SORENESS IN ARM; This spontaneous report received from a patient concerned a 58 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: 204B21A, and expiry: UNKNOWN) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-AUG-2021, the patient experienced soreness in arm. On 24-AUG-2021, the patient experienced voice sounds like a frog. On 24-AUG-2021, the patient experienced stuffed up in nose area. On 24-AUG-2021, the patient experienced body aches from head to toe. On 24-AUG-2021, the patient experienced chills. On 24-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in arm, was recovering from chills, and had not recovered from body aches from head to toe, stuffed up in nose area, voice sounds like a frog, and headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634888
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 08/19/2021
Rec V Date: 08/26/2021
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: Test Date: 20210820; Test Name: Body temperature; Result Unstructured Data: 100.5 F

Allergies:

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

Symptoms: HEAVINESS IN HEAD; FELT DISORIENTED; CHILLS; NOT FEELING GOOD; FEVER; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's past medical history included: mild covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 02-OCT-2021) dose was not reported, administered on 18-AUG-2021 19:00 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced heaviness in head. On 19-AUG-2021, the patient experienced felt disoriented. On 19-AUG-2021, the patient experienced chills. On 19-AUG-2021, the patient experienced not feeling good. On 19-AUG-2021, the patient experienced fever. On 20-AUG-2021, Laboratory data included: Body temperature (NR: not provided) 100.5 F. Treatment medications included: ibuprofen. On 21-AUG-2021, treatment medications included: paracetamol. On 23-AUG-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 20-AUG-2021, had not recovered from heaviness in head, and felt disoriented, and the outcome of not feeling good was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634889
Sex: M
Age:
State: ID

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 08/26/2021
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: LOSS/ALTERED SENSE OF TASTE; LOSS/ALTERED SENSE OF SMELL; EVERYTHING TASTE LIKE NICKELS; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced loss/altered sense of taste. On 13-MAR-2021, the patient experienced loss/altered sense of smell. On 13-MAR-2021, the patient experienced everything taste like nickels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss/altered sense of taste, loss/altered sense of smell, and everything taste like nickels. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634890
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 08/26/2021
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: KNEES HURTED; SWOLLEN ANKLES; SWOLLEN KNEES; SWOLLEN FEET; This spontaneous report received from a patient concerned a 57 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced swollen ankles. On APR-2021, the patient experienced swollen knees. On APR-2021, the patient experienced swollen feet. On an unspecified date, the patient experienced knees hurted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen ankles, swollen knees, knees hurted and swollen feet was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634891
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: PROBABLE STOMACH FLU; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced probable stomach flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of probable stomach flu was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634892
Sex: F
Age:
State: TN

Vax Date:
Onset Date: 06/07/2021
Rec V Date: 08/26/2021
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 Date: 20210607; Test Name: Pulse rate; Result Unstructured Data: over 150 bpm; Test Date: 20210702; Test Name: X-ray; Result Unstructured Data: Unknown; Test Name: Blood test; Result Unstructured Data: exact tests and results were not accessible; Test Name: Diagnostic ultrasound; Result Unstructured Data: could not see anything

Allergies:

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

Symptoms: MENSTRUAL CHANGES; ACNE; NUMBNESS IN LEGS; ACHINESS AND PAIN IN HER LEGS; FATIGUE; MIGRAINES; HIGH PULSE RATE; SWEATING; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's past medical history included: reaction to flu vaccine, and concurrent conditions included: low pulse rate, non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known 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: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cyanocobalamin. On 07-JUN-2021, the patient experienced high pulse rate. Laboratory data included: Pulse rate (NR: not provided) over 150 bpm. On 07-JUN-2021, the patient experienced sweating. On 07-JUN-2021, the patient experienced migraines. On 07-JUN-2021, the patient experienced fatigue. On 08-JUN-2021, the patient experienced numbness in legs. On 08-JUN-2021, the patient experienced achiness and pain in her legs. On 24-JUN-2021, the patient experienced menstrual changes. On 24-JUN-2021, the patient experienced acne. On 02-JUL-2021, Laboratory data included: X-ray (NR: not provided) Unknown. Laboratory data (dates unspecified) included: Blood test (NR: not provided) exact tests and results were not accessible, and Diagnostic ultrasound (NR: not provided) could not see anything. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraines on 11-JUL-2021, was recovering from fatigue, high pulse rate, and menstrual changes, and the outcome of sweating, numbness in legs, acne and achiness and pain in her legs was not reported. This report was non-serious.

Other Meds: VITAMIN C [ASCORBIC ACID]; VITAMIN B12 [CYANOCOBALAMIN]

Current Illness: Abstains from alcohol; Low pulse rate; Non-smoker

ID: 1634893
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 03/17/2021
Rec V Date: 08/26/2021
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: DIFFICULTY WALKING DUE TO THE PAIN; TINGLING IN LEG THAT GOES UP AND DOWN SOMETIMES INVOLVES TOES; DULL ACHE/PAIN IN LEFT LEG; HEAVINESS IN LEFT LEG; This spontaneous report received from a patient concerned a 55 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: 1805022, and expiry: 23-AUG-2021) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient experienced heaviness in left leg. On 17-MAR-2021, the patient experienced dull ache/pain in left leg. On 20-JUN-2021, the patient experienced difficulty walking due to the pain. On 20-JUN-2021, the patient experienced tingling in leg that goes up and down sometimes involves toes. Treatment medications (dates unspecified) included: diclofenac sodium, and meloxicam. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dull ache/pain in left leg, and the outcome of tingling in leg that goes up and down sometimes involves toes, heaviness in left leg and difficulty walking due to the pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634894
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: SWOLLEN FACE; This spontaneous report received from a consumer concerned a 56 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: 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 swollen face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swollen face was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634895
Sex: M
Age:
State: IN

Vax Date:
Onset Date: 08/24/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SWELLING IN RIGHT HAND/SWELLING IN THE PALM AND BACK OF RIGHT HAND; ITCHING IN RIGHT HAND/ ITCHINESS IN THE PALM AND BACK OF RIGHT HAND; HAVING A LITTLE HEAT TO IT AS WELL; MILD INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, ragweed allergy, pet dander allergy, molds allergy, and environmental allergy. The patient experienced drug allergy when treated with cefalexin, and cefixime. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18200096,and expiry: UNKNOWN) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced swelling in right hand/swelling in the palm and back of right hand. On 24-AUG-2021, the patient experienced itching in right hand/ itchiness in the palm and back of right hand. On 24-AUG-2021, the patient experienced having a little heat to it as well. On 24-AUG-2021, the patient experienced mild injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in right hand/swelling in the palm and back of right hand, mild injection site pain, itching in right hand/ itchiness in the palm and back of right hand, and having a little heat to it as well. This report was non-serious.

Other Meds:

Current Illness: Allergy to animal dander; Allergy to molds; Environmental allergy; Ragweed allergy; Sulfonamide allergy

ID: 1634896
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: ASTHMA; This spontaneous report received from a patient 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced asthma, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asthma was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210849243-Covid-19 vaccine ad26.cov2.s-Asthma. 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: 1634897
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 06/07/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Date: 20210821; Test Name: COVID-19 antigen test; Result Unstructured Data: positive for Covid-19 antibodies

Allergies:

Symptom List: Vomiting

Symptoms: ACHING JOINTS; COUGHING; STOMACH SWOLLEN UP; DIARRHEA; ARM SORENESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, smoker, and blood pressure, and other pre-existing medical conditions included: The patient had no known allergies and 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: Unk) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUN-2021, the patient experienced arm soreness. On 20-AUG-2021, the patient experienced coughing. On 20-AUG-2021, the patient experienced stomach swollen up. On 20-AUG-2021, the patient experienced diarrhea. On 21-AUG-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) positive for Covid-19 antibodies. On 22-AUG-2021, the patient experienced aching joints. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, stomach swollen up, diarrhea, and aching joints on AUG-2021, and arm soreness on 08-JUN-2021. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (occasionally); Blood pressure; Smoker (Daily basis)

ID: 1634898
Sex: M
Age:
State: MS

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: RAN A LOW GRADE FEVER FOR THE FIRST 24 HOURS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, and hyperlipidemia. 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 ran a low grade fever for the first 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ran a low grade fever for the first 24 hours. This report was non-serious.

Other Meds:

Current Illness: Hyperlipidemia; Hypertension

ID: 1634899
Sex: F
Age:
State: IN

Vax Date:
Onset Date: 08/22/2021
Rec V Date: 08/26/2021
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: PAINFUL AND ITCHING BLISTERS ON BOTH HANDS; SPOTS ON LEGS ANKLES ARMS STOMACH WAIST AREA CHEST BACK UP TOWARD THE NECK; ITCHY SPOT; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included: blister. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-AUG-2021, the patient experienced spots on legs ankles arms stomach waist area chest back up toward the neck. On 22-AUG-2021, the patient experienced itchy spot. On 23-AUG-2021, the patient experienced painful and itching blisters on both hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spots on legs ankles arms stomach waist area chest back up toward the neck, and itchy spot, and the outcome of painful and itching blisters on both hands was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634900
Sex: U
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: BLOOD CLOT; This spontaneous report received from a consumer concerned multiple patients. No past medical histories or concurrent conditions were reported. The patients 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, 1 total administered for prophylactic vaccination. The batch number were not reported and have been requested. No concomitant medications were reported. On an unspecified dates, multiple patient developed blood clots. As per the reporter," I am worried about the Janssen vaccine because I heard that 2 or 3 patient had blood clots ranging from ages 18 to 49." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcomes for the multiple patients with blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210829146.; Sender's Comments: V0: 20210849364-COVID-19 VACCINE AD26.COV2.S-blood clot. 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: 1634901
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: SORE SHOULDER; 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: not reported) 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 sore shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore shoulder. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634902
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 08/24/2021
Rec V Date: 08/26/2021
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: DRY HEAVING; VOMITING; This spontaneous report received from a consumer concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced dry heaving. On 24-AUG-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, and dry heaving. This report was non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am