VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer

Incidents per State

State Total
29,971
AK1,112
AL2,452
AR1,602
AS31
AZ7,527
CA29,178
CO5,606
CT3,846
DC758
DE778
FL15,968
FM3
GA6,338
GU48
HI1,050
IA2,372
ID1,302
IL9,505
IN14,463
KS2,379
KY3,142
LA2,178
MA6,906
MD5,949
ME1,545
MH5
MI8,608
MN5,829
MO4,579
MP10
MS1,250
MT1,288
NC7,647
ND686
NE1,523
NH1,597
NJ7,720
NM2,000
NV1,786
NY15,973
OH9,483
OK2,567
OR3,857
PA10,098
PR1,098
QM1
RI1,077
SC2,821
SD681
TN4,097
TX15,809
UT2,211
VA7,182
VI23
VT927
WA6,552
WI5,519
WV1,222
WY434
XB4
XL1
XV1

ID: 1249222
Sex: U
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: CHEST PAIN WHEN LYING; SHORTNESS OF BREATH; ARM PAIN; NOT DOING WELL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced chest pain when lying. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced not doing well. Laboratory data included: Pain scale (NR: not provided) 4 and a half. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain when lying, arm pain, shortness of breath and not doing well was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious

Other Meds:

Current Illness:

ID: 1249223
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: MIGRAINES; BODY ACHES; SPASMS; CHILLS; FEVERS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: acetylsalicylic acid/butalbital/caffeine, and ibuprofen. On 09-APR-2021, the subject experienced migraines. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced spasms. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fevers. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, migraines, body aches, chills, and fevers, and the outcome of spasms was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1249224
Sex: M
Age:
State: LA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BLOOD CLOT IN CORONARY REGION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the patient experienced blood clot in coronary region. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in coronary region was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a male, unspecified age, unspecified ethnicity, who experienced blood clot in coronary region after he received the COVID-19 vaccine ad26.cov2.s on an unspecified date. No other details given. The information provided precludes a meaningful medical assessment. Additional information requested.

Other Meds:

Current Illness:

ID: 1249225
Sex: U
Age:
State: GA

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BAD HEADACHE; DIZZINESS; This spontaneous report received from a patient concerned a 58 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medical history. 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced bad headache. On 13-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and bad headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious

Other Meds:

Current Illness:

ID: 1249226
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 04/10/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: CHEST PAIN; STOMACH PAIN; VOMITING; DIZZY; SWEATING; CHILLS; FEVER; This spontaneous report received from a parent concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chest pain. On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced dizzy. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 11-APR-2021, had not recovered from stomach pain, and dizzy, and the outcome of vomiting, chest pain and sweating was not reported. This report was non-serious.; Sender's Comments: v0-Medical assessment comment not required as case is assessed as per standard operating procedures.

Other Meds:

Current Illness:

ID: 1249227
Sex: M
Age:
State: WV

Vax Date:
Onset Date: 04/07/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: LEG PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included does not take blood thinner. patient's father lost legs to blood clot. 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-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On 07-APR-2021, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain on APR-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious

Other Meds:

Current Illness:

Date Died:

ID: 1249228
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: DEATH; This spontaneous report received from a physician via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once total, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, three days after vaccination, the patient died of unknown cause. It was unknown, whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1249229
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: DIARRHEA; THREW UP; NAUSEATED; HEADACHE; LUNG PAIN (FELT LIKE LUNGS GOING TO EXPLODE); LEFT ARM PAIN; FATIGUE AND FELT TIRED; LETHARGY; SICK; PAIN DOWN FROM LEFT BREAST TO ELBOW; 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 pre-existing medical conditions included the patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pain down from left breast to elbow. On 07-APR-2021, the subject experienced lethargy. On 07-APR-2021, the subject experienced sick. On 07-APR-2021, the subject experienced left arm pain. On 07-APR-2021, the subject experienced fatigue and felt tired. On 08-APR-2021, the subject experienced lung pain (felt like lungs going to explode). On 08-APR-2021, the subject experienced nauseated. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced threw up. On 11-APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: oxycodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from threw up, and diarrhea, had not recovered from fatigue and felt tired, lung pain (felt like lungs going to explode), nauseated, left arm pain, lethargy, headache, and pain down from left breast to elbow, and the outcome of sick was not reported. This report was non-serious.; Sender's Comments: V0: MAC comment not required for non serious cases as per standard protocol

Other Meds:

Current Illness:

ID: 1249230
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 04/08/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BAD DREAMS; NO APPETITE; FEVER; NAUSEA; HEADACHE; 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 no alcohol consumption, and non smoker, and other pre-existing medical conditions included no known allergies and 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: 206A21A and expiry: 16/AUG/2070) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced bad dreams. On 08-APR-2021, the subject experienced no appetite. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad dreams, no appetite, fever, and nausea on 10-APR-2021, and had not recovered from headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1249231
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 04/10/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: TINY BRUISE AT RIGHT ARM AT INJECTION SITE; RIGHT ARM AT INJECTION SITE HURTING AND IT IS HOT; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included overweight, and concurrent conditions included arthritis, penicillin allergy, and sulfa drug allergy. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced tiny bruise at right arm at injection site. On 10-APR-2021, the subject experienced right arm at injection site hurting and it is hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiny bruise at right arm at injection site, and right arm at injection site hurting and it is hot. This report was non-serious.

Other Meds:

Current Illness: Arthritis; Penicillin allergy; Sulfonamide allergy

ID: 1249232
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 04/11/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BLOOD IN STOOL; STOMACH PAIN LIKE A CUT INSIDE; FREQUENT BATHROOM VISITS THREE TIMES IN A ROW; This spontaneous report received from a patient concerned a 44 year old Hispanic or Latino male. 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: 1805018, expiry: 25-MAY-2021) dose was not reported, once total, administered on 27-MAR-2021 at Left Arm as prophylactic vaccination. No concomitant medications were reported. On 11-Apr-2021, the patient experienced blood in stool (bleeding in feces). It was reported that bleeding was almost like hemorrhage, a lot of blood came out and patient felt like patient was bleeding internally. Patient described pain like stomach was cut inside. The patient felt bad on the side of his stomach all over midsection. He mentioned that it started all of sudden, on same day an hour later he went to the restroom and went 3 times after in a row, on the day of report patient did not use the restroom and the pain was less. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from frequent bathroom visits three times in a row on 13-APR-2021, was recovering from stomach pain like a cut inside, and had not recovered from blood in stool. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210426962-covid-19 vaccine ad26.cov2.s-Blood in stool. 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: 1249233
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SKIN PEELING BETWEEN INSIDES OF FINGERS OF RIGHT HAND; HEADACHES; NAUSEA; BLURRY VISION; SORENESS OF KIDNEY/LOWER BACK AREA; MASSIVE BODY ACHES; DIZZINESS UPON STANDING (HYPOTENSION); CHEST TIGHTNESS; FOGGINESS; FATIGUE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies and 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: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6 out of 10. On 09-APR-2021, the subject experienced fogginess. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced blurry vision. On 10-APR-2021, the subject experienced soreness of kidney/lower back area. On 10-APR-2021, the subject experienced massive body aches. On 10-APR-2021, the subject experienced dizziness upon standing (hypotension). On 10-APR-2021, the subject experienced chest tightness. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced skin peeling between insides of fingers of right hand. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fogginess, blurry vision, fatigue, massive body aches, dizziness upon standing (hypotension), headaches, nausea, chest tightness, skin peeling between insides of fingers of right hand, and soreness of kidney/lower back area. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Other Meds:

Current Illness: Alcohol use (A few drinks a week); Non-smoker

ID: 1249234
Sex: U
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: FAINTING; NAUSEA; This spontaneous report received from a consumer concerned multiple patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose,1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On an unspecified date, the patient's experienced dizziness, nausea and fainting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and fainting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -covid-19 vaccine ad26.cov2.s-fainting. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1249235
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: DOUBLE VISION; SHORT TERM MEMORY LOSS; LACK OF ATTENTION; COGNITIVE DEFICIENCIES; HEADACHE; POSSIBLE INFARCTION DUE TO RECENT EVENT; This spontaneous report received from a health care professional concerned a 67 year old white and not Hispanic or Latino male. 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) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the patient experienced headache and dizziness. On 15-MAR-2021, patient had experienced double vision, trouble reading, lack of attention, short term memory loss and cognitive deficiency. One or two days later, (possibly on 16-MAR-2021), the patient visited emergency room and his computerized axial tomography (CAT) scan was normal. In MAR-2021 (a week after), the patient's symptoms got worsened and he consulted primary care physician. The patient underwent magnetic resonance imaging (MRI) scan which showed possible infarction due to recent event. It was reported that, the patient was yet to visit cardiologist and neurologist for follow up on the MRI scan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 18-MAR-2021, had not recovered from double vision, short term memory loss, lack of attention, and cognitive deficiencies, and the outcome of possible infarction due to recent event was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210427306-covid-19 vaccine ad26.cov2.s-possible infarction due to recent event. 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: 1249236
Sex: U
Age:
State: PA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: COLD SWEATING; NOT ABLE TO EAT; VOMITING; FEVER; NAUSEA; HEADACHE; MUSCLE ACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced cold sweating. On APR-2021, the subject experienced not able to eat. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, cold sweating, nausea, headache, muscle ache, not able to eat and vomiting was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1249237
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: STUFFY NOSE; FELT TO THROW UP BUT SHE DID NOT; DIZZY; LUNG CONGESTION, COUGH; This spontaneous report received from a patient concerned a 57 year old white, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies or drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A,expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 12:30 p.m. in right arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 03:00 a.m., the patient experienced lung congestion, cough. On 09-APR-2021 11:00 a.m., the patient experienced dizzy, felt to throw up but she did not. On 11-APR-2021, the patient experienced stuffy nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, and felt to throw up but she did not and was recovering from cough, lung congestion, and stuffy nose. This report was serious (Other Medically Important Condition).; Sender's Comments: V0--covid-19 vaccine ad26.cov2.s-Lung congestion. 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: 1249238
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: FAST HEARTBEAT; BLURRED VISION IN LEFT EYE; LIGHTHEADEDNESS; PRESSURE IN THE HEAD, HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced fast heartbeat. On 12-APR-2021, the subject experienced blurred vision in left eye. On 12-APR-2021, the subject experienced lightheadedness. On 12-APR-2021, the subject experienced pressure in the head, headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heartbeat, blurred vision in left eye, and lightheadedness on 12-APR-2021, and was recovering from pressure in the head, headache. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

Other Meds:

Current Illness:

ID: 1249239
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
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Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: BLOOD CLOTS; This spontaneous report received from a company representative via social media post and concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported, one total dose is administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested. No concomitant medications were reported. On an unspecified date, the subject experienced blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This patient reported via social media to have blood clots and to have received the COVID-19 vaccine ad26.cov2.s. No other information provided. There is insufficient information to make a meaningful assessment. Additional information will be requested.

Other Meds:

Current Illness:

ID: 1249240
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Lab Data:

Allergies:

Symptom List:

Symptoms: CHEST TIGHTNESS; INTERMITTENT HEADACHES; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included basilar artery thrombosis, and vertebral artery thrombosis, and concurrent conditions included non-smoker, and other pre-existing medical conditions included no illicit use of drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included . On 12-APR-2021, the subject experienced chest tightness. On 12-APR-2021, the subject experienced intermittent headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent headaches, and chest tightness. This report was non-serious.; Sender's Comments: V0; MAC Comment is not required for non serious case as per standard protocol.

Other Meds: CONTRACEPTIVES

Current Illness: Non-smoker

ID: 1249241
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 03/23/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: PNEUMONIA; ALLERGY-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, ten days later vaccination the subject experienced coughing, allergy-like symptoms and fatigue. On 01-APR-2021, the patient visited Healthcare Professional where she was diagnosed pneumonia and was prescribed antibiotics and nebulizer. On 06-APR-2021, Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergy-like symptoms and pneumonia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210427853-covid-19 vaccine ad26.cov2. s-pneumonia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness: Blood pressure high

ID: 1249243
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: TROUBLE BREATHING/WHEEZING; HANGOVER; HOT FLASHES; CHILLS; SWOLLEN ARM MUSCLE; INJECTION SITE RED SCAB; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 42 year old female. 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: 043a21a, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced trouble breathing/wheezing. On APR-2021, the subject experienced hangover. On APR-2021, the subject experienced hot flashes. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced swollen arm muscle. On APR-2021, the subject experienced injection site red scab. On APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hangover, hot flashes, trouble breathing/wheezing, chills, injection site pain, swollen arm muscle and injection site red scab 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:

Current Illness:

ID: 1249244
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/11/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
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Allergies:

Symptom List:

Symptoms: SORE THROAT; HIGH BLOOD PRESSURE; SEVERE DIZZINESS; WHOLE BODY MUSCLE PAIN; LITTLE FEVER; HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breastfeeding, and high blood pressure, and other pre-existing medical conditions included the patient did not have any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced whole body muscle pain. On 11-APR-2021, the subject experienced little fever. On 11-APR-2021, the subject experienced headache. On 12-APR-2021 06:30, treatment medications included: paracetamol. On 12-APR-2021 21:30, the subject experienced high blood pressure. On 12-APR-2021 21:30, the subject experienced severe dizziness. Laboratory data included: Blood pressure (NR: not provided) 152/102 mmHg. On 12-APR-2021 22:30, Laboratory data included: Blood pressure (NR: not provided) 152/102 mmHg. On 13-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 130/100 mmHg. On an unspecified date, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever, and headache on 12-APR-2021, was recovering from severe dizziness, and had not recovered from high blood pressure, whole body muscle pain, and sore throat. This report was non-serious. This parent/child case is linked to 20210432107.; Sender's Comments: V0;MAC is not required for non serious cases as per standard protocol

Other Meds:

Current Illness: Blood pressure high; Breast feeding (Child age- 2 years)

ID: 1249245
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/26/2021
Rec V Date: 04/23/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: PASSED OUT; COULD HARDLY GET UP; TROUBLE WITH LEFT HIP OR KNEE; LIGHT HEADED; NOT FEELING UP TO PAR; This spontaneous report received from a patient concerned an 85 year old male. 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: unknown, expiry: unknown) dose was not reported, 1 total administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021,(on the night of vaccination) patient could hardly get up while he was putting some beer in refrigerator. Since then patient had trouble with his left hip or knee. Few days before 10-APR-2021, patient was light headed and not felt up to par. On 10-APR-2021, the patient was passed out which he never experienced before. On the same day, the patient was hospitalized and checked everything including blood clots in his leg. They did not found anything that could be causing problem. The patient was admitted to the hospital for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could hardly get up, trouble with left hip or knee, not feeling up to par, light headed, passed out was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 85-year-old male patient of unknown ethnicity was admitted in a hospital after "passing out" 15 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. The patient noted difficulty standing up on h the day of vaccination but attributed it to his hip or knee "trouble". On the day of hospitalization, the patient complained of light headedness and was rushed to the hospital when he was found passed out. The patient reported that the hospital checked everything including clots in his leg but did not found anything that could cause the problem. No laboratory/diagnostic test results were reported; the treatment and outcome was not reported. Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information will be requested for further assessment once contact information is available.

Other Meds:

Current Illness:

ID: 1249246
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: HIGH BLOOD SUGAR READING; BLACK SPOTS ON BACK AND RIGHT LEG; BODY ACHES; THROAT TIGHTNESS; THROAT PAIN; SLIGHT HEADACHE; FATIGUE, TIREDNESS; This spontaneous report received from a consumer concerned a 57 year old Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high cholesterol, and she was a non-smoker, and non-alcoholic. The patient had no known drug or non-drug allergies and had no drug abuse or illicit use. The patient's normal fasting blood sugar was around 120. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 06-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced body aches, felt very fatigued, tired, throat pain/tightness, and slight headache after vaccination. On 08-APR-2021, the patient experienced high blood sugar with reading of 290 and 340. On 08-APR-2021, the patient noticed black spots on back and right leg (4 black dime-sized spots on her back and it spread to her right leg). The lowest blood sugar reading she had since post vaccination was on 13- APR-2021 morning which was 190 fasting. On unspecified date, Laboratory data included: Blood test (NR: not provided) normal, cholesterol was getting better, blood sugar was under control. She was advised to continue with her dietary restrictions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 10-APR-2021, was recovering from throat tightness, and throat pain, and had not recovered from high blood sugar reading, black spots on back and right leg, fatigue, tiredness, and body aches. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood sugar increased. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.

Other Meds:

Current Illness: Abstains from alcohol; Diabetes; High cholesterol; Non-smoker

ID: 1249247
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 04/23/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: BROKE OUT IN HIVES; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was 61.8 kilograms, and height was not reported. The patient's concurrent conditions included terrible seasonal allergies. 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 patient received macitentan (tablet, oral, batch number: ZE019B0101 expiry: 31-JUL-2024) 10 mg, frequency, and therapy dates were not reported for primary pulmonary hypertension. The batch number was not reported. As per procedure, no follow-up will be requested for this case. Concomitant medications included tadalafil. On an unspecified date, the subject experienced broke out in hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of broke out in hives was not reported. This report was non-serious. This case, involving the same patient is linked.

Other Meds: ADCIRCA

Current Illness: Seasonal allergy

ID: 1249249
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 03/08/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: DIVERTICULITIS; HEADACHE; This spontaneous report received from a patient concerned a 53 year old African American and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient was non alcohol user, non-smoker, and the patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 at unspecified time to left arm for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of this report. On 08-MAR-2021, the patient experienced headache. On 04-APR-2021 patient experienced unbearable abdominal cramps and went to emergency room on 08-APR-2021 where lab test of CAT scan was done and the patient diagnosed with diverticulitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 10-MAR-2021, and had not recovered from diverticulitis. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210428413-covid-19 vaccine ad26.cov2.s-Diverticulitis. 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: 1249250
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 03/09/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: SHINGLES; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included shingles, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on 10-MAR-2021, and had not recovered from shingles. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1249251
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: CLITORIS THE SIZE OF A PINEAPPLE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. he 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 MAR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers."No concomitant medications were reported. On APR-2021, the subject experienced clitoris the size of a pineapple. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clitoris the size of a pineapple. 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:

Current Illness:

ID: 1249252
Sex: M
Age:
State: WA

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: PASSING OUT/FAINTING; LOW HEART RATE (30 BEATS PER MINUTE); DECREASED BLOOD PRESSURE (60/50); SHAKING; This spontaneous report received from a patient concerned a 42 year old white, not Hispanic or Latino male. The patient's height and weight were not reported. The patient's concurrent conditions included seasonal allergy, non alcoholic and non smoker. The patient did not had drug abuse or illicit drug use. The patient did not had reactions before with any other vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 12-APR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021 after vaccination, the patient immediately experienced low heart rate (30 beats per minute), decreased blood pressure (60/50), profuse sweating and shaking and as the result he passed out immediately. The patient reported that he was under care of the medical staff at the facility and both his heart rate and blood pressure were reassessed multiple times within the hour of observation. The patient reported that vaccination provider advised him that his reaction was not related to the Janssen Covid-19 vaccine and that he fainted only because he was afraid of the needle but the patient denied and stated that he was not afraid of the needle. Laboratory data included: Blood pressure (NR: not provided) 60/50 mmHg and heart rate (NR: not provided) 30 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out/fainting on 12-APR-2021, and low heart rate (30 beats per minute), decreased blood pressure (60/50) and shaking on unspecified date APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428755 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passing out/fainted, low heart rate, Decreased blood pressure. 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; Seasonal allergy

ID: 1249253
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: INCREASED SEIZURES; THREW UP; INCREASED PHLEGM / INCREASED COUGHING; This spontaneous report received from a parent concerned a 43 years old white Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included cerebral palsy, mental retardation, and epilepsy, and concurrent conditions included seizures, cough, and phlegm. Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced increased phlegm / increased coughing. On 07-APR-2021, the patient experienced increased seizures. On the same day, he experienced threw up. The patient usually had a cough and phlegm. On the following day of vaccination, the patient's amount of phlegm and cough was increased and he throw-up and had 2 seizures. On 08-Apr-2021, the patient had 10 seizures. The patient regularly had seizures but the number per day increased after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased seizures on 09-APR-2021, and threw up on 07-APR-2021, and had not recovered from increased phlegm / increased coughing. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428761-covid-19 vaccine ad26.cov2.s-increased seizures. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

Other Meds:

Current Illness: Cough; Phlegm; Seizures

ID: 1249254
Sex: M
Age: 32
State: CA

Vax Date: 03/28/2021
Onset Date: 04/13/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: BODY PAIN; SORE AT INJECTION SITE; HEADACHE; CHEST PAIN; This spontaneous report received from a patient concerned a 32 year old male. 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced chest pain. Laboratory data included: Blood test (NR: not provided) unknown, ECG (NR: not provided) UNKNOWN, and X-ray (NR: not provided) UNKNOWN. On an unspecified date, the subject experienced body pain, sore at injection site, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, body pain, and sore at injection site, and had not recovered from headache. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Other Meds:

Current Illness:

Date Died:

ID: 1249255
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/23/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: DIED IN SLEEP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. Patient had children. 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 for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the patient died in her sleep from an unknown cause of death. It was unknown 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 20210429895.; Sender's Comments: V0: 20210428967-COVID-19 VACCINE AD26.COV2.S- Died in sleep. 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: 1249256
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 03/30/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List:

Symptoms: HAD PERIOD AGAIN; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hormone replacement therapy, menopause, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, 1 total administered on 30-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included estradiol, progesterone, and testosterone. On 30-MAR-2021, the subject experienced flu-like symptoms. On 30-MAR-2021, on the same day of vaccination the patient experienced symptoms such as flu-like symptoms, headache, extreme fatigue and runny nose that had lasted for 2 days. On 11-APR-2021, the patient started having period again. The last time she had period was 20 years ago. She was on natural hormone replacement therapy, a mixture of estrogen, progesterone and testosterone for the last six months from the time of this report and the patient was not sure if the period was side effect from the vaccination or from her hormone replacement therapy. The patient had notified her hormone replacement therapy physician and would be going for an ultrasound scan the day after this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 01-APR-2021, and had not recovered from menstruation. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 -Covid-19 vaccine ad26.cov2.s -Post menopausal bleeding. 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: CONMEDS-OTHER SUSPECT DRUGS

Other Meds: ESTROGEN; PROGESTERONE; TESTOSTERONE

Current Illness: Abstains from alcohol; Hormone replacement therapy (Estrogen, Progesterone and Testosterone for the last 6 months.); Menopause (20years ago.); Non-smoker

ID: 1249257
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: TIGHTNESS OF THROAT; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and no alcohol consumption, and other pre-existing medical conditions included the patient had no known allergies, not on any chronic medications and is not allergic to any medications. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced allergic reaction. On APR-2021, the subject experienced tightness of throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction and tightness of throat 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:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1249258
Sex: U
Age:
State: MI

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: POOPING BLOOD; REALLY BAD STOMACH PAIN; SHORTNESS OF BREATH; TIRED; This spontaneous report received from a consumer concerned a white patient of unspecified age and sex. 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: 043A21A, and expiry: UNKNOWN) dose was not reported, once total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient felt tired. On 10-APR-2021, the patient experienced really bad stomach pain. On 10-APR-2021, the patient experienced shortness of breath. On 13-APR-2021, the patient experienced pooping blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 11-APR-2021, and had not recovered from really bad stomach pain, shortness of breath, and pooping blood. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210429185-covid-19 vaccine ad26.cov2.s-pooping blood. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1249259
Sex: M
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: NOSEBLEED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced nosebleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nosebleed 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:

Current Illness:

Date Died: 04/14/2021

ID: 1249260
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/14/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: DIED; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 14-APR-2021, the patient died due to unknown cause. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210429218 - COVID-19 VACCINE AD26.COV2.S- Died. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1249261
Sex: M
Age:
State: AZ

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SHORTNESS OF BREATH; HEADACHE; This spontaneous report received from a consumer concerned a 24 year old male. 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: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0: As per standard protocol, non-serious cases does not require comment

Other Meds:

Current Illness:

ID: 1249262
Sex: U
Age:
State: FL

Vax Date:
Onset Date: 04/07/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BLOWS THE NOSE; SORE THROAT; LIKE I HAVE A COLD; WATER GETS OUT FROM EYES; LEG FELT ICKY; LEG HURTS ALL THE TIME; DIARRHEA; COUGH WAS WITH SPUTUM AND BLOOD COMES; HEADACHE; FEVER; CHILLS; This spontaneous report received from a patient concerned a 73 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included CHF, heart surgery, hospitalized for gall bladder issue, heart surgery for chronic AIFB, circulation problem, stomach issue, seasonal allergy, strawberry allergy, non-alcoholic, and non-smoker, and other pre-existing medical conditions included no drug abuse/illicit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. Laboratory data included: Headache (NR: not provided). On 09-APR-2021, treatment medications included: guaifenesin. On 12-APR-2021, the subject experienced cough was with sputum and blood comes. On 14-APR-2021, Laboratory data included: Headache (NR: not provided) SCALE 2. On an unspecified date, the subject experienced diarrhea, blows the nose, sore throat, like I have a cold, water gets out from eyes, leg felt icky, and leg hurts all the time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, and the outcome of diarrhea, headache, cough was with sputum and blood comes, blows the nose, sore throat, like i have a cold, water gets out from eyes, leg felt icky and leg hurts all the time was not reported. This report was non-serious.

Other Meds:

Current Illness: Cardiac operation (Heart surgery 10 years ago.); Chronic atrial fibrillation (In jan 2021); Congestive heart failure; Disorder circulatory system; Gallbladder disorder; Gastric disorder; Seasonal allergy (SEASONAL POLLEN ALLERGY)

ID: 1249263
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SHORTNESS OF BREATH; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. On 13-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 14-APR-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1249264
Sex: F
Age:
State: OK

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: RECTAL BLEEDING; FELT REALLY BAD; JOINT PAIN; CHILLS; WEAKNESS; RASH ON FACE; HEADACHE; FEVER; PAIN TO RIGHT LUNG; COULDNT SLEEP; BODY ACHES; THROAT PAIN; EAR PAIN; KNEES TO BOTTOM FELT HOT FOR SIX DAYS; FEELS LIKE LEG IS ASLEEP; LOCALIZED HEAT TO RIGHT INNER KNEE; This spontaneous report received from a patient concerned a 45 year old Hispanic or Latino female. The patient's weight was 185 pounds, and height was 63 inches. The patient's past medical history included hypothyroidism, and concurrent conditions included pollen allergy, alcohol user twice a year, and non smoker, and other pre-existing medical conditions included the patient had mecroabenola hitosesiario (in Spanish). The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25/MAY/2021) dose was not reported, 1 total, administered on 25-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced weakness and rash on face. On 25-MAR-2021 patient felt really bad On 27-MAR-2021, patient was menstruating but at the same time she had rectal bleeding but was not sure. That Saturday (27-MAR-2021) she though had abundant rectal bleeding twice. The second episode came two hours after the first one. She also had bleeding on Sunday (28-MAR-2021) but it was mild. Patient had fever, chills, pain to her right lung, joint pain, she could not sleep, She had body aches, throat pain, ear pain, headaches, (took Tylenol as treatment drug with specified dose) and her knees to the bottom felt hot for six days. Now that has resolved except she had localized heat to the right inner knee. It felt like spiders, like her leg was asleep. Lung pain was on and off, can be mild sometimes stronger. The rest of the side effects resolved The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rectal bleeding, could not sleep, body aches, throat pain, ear pain, knees to bottom felt hot for six days, joint pain, chills, rash on face, headache, fever, and weakness on 2021, had not recovered from pain to right lung, localized heat to right inner knee, and feels like leg is asleep, and the outcome of felt really bad was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- Covid-19 vaccine ad26.cov2.s-rectal bleeding. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness: Non-smoker; Pollen allergy; Social alcohol drinker

ID: 1249265
Sex: F
Age:
State: MN

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 04/23/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: ANEMIA SECONDARY TO MENSTRUATION; TINGLING OF TONGUE; SORE THROAT; MUSCLE ACHES; FEVER; HEADACHE; This spontaneous report received from a physician concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included anemia secondary to menstruation. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021 (same day after vaccination), the patient experienced tingling of tongue, sore throat, muscle ache, fever, headache and was hospitalized. On the same day, the patient experienced anemia secondary to menstruation as her hemoglobin was 6.2 (unit not specified) and was transfused. On 13-APR-2021, the patient had a mild headache at night and labile temperatures (her maximum temperature was 101.1 F in 24 hours prior to this report). On 14-APR-2021, the patient symptoms were improved and she had no thrombocytopenia to date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling of tongue, headache, muscle aches, sore throat, fever, and anemia secondary to menstruation. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210429348-covid-19 vaccine ad26.cov2.s- anemia secondary to menstruation. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE 20210429348-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Tingling of tongue, Sore throat. This event(s) are 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). 20210429348-covid-19 vaccine ad26.cov2.s - headache, muscle aches, fever. This event(s) are labeled per and is therefore considered potentially related.

Other Meds:

Current Illness:

ID: 1249266
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: DIZZINESS; CHILLS; JOINT PAIN; MUSCLE PAIN; NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, chills, joint pain, muscle pain, nausea, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, muscle pain, joint pain, nausea, fatigue, headache and dizziness was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1249267
Sex: U
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: HEART ATTACK; KNOT ON LEG(SORE); This spontaneous report received from a patient and concerned a patient of unspecified age and sex. 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: 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 heart attack, and had a knot on leg which was sore for over 3 weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack, knot on leg(sore) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: covid-19 vaccine ad26.cov2.s-heart attack. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1249268
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 03/19/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SHORTNESS OF BREATH WHILE WALKING; FEELING LIKE HE WAS GOING TO DIE; HIGH BLOOD PRESSURE; SEVERE CHEST PAIN/ON AND OFF CHEST PAIN; SEVERE BACK PAIN; DIFFICULTY SLEEPING; TIREDNESS; NUMBNESS IN LEFT ARM; WEAKNESS; CRAZY JOINT PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, no alcohol use, and smoker (smokes cigarettes twice a day), and other pre-existing medical conditions included patient had no known allergies. patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced crazy joint pain in left arm. On 21-MAR-2021, the subject experienced weakness. On 23-MAR-2021, the subject experienced numbness in left arm. On 28-MAR-2021, the subject experienced tiredness. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) up, Blood test (NR: not provided) negative, CBC (NR: not provided) negative, ECG (NR: not provided) unknown, Imaging procedure (NR: not provided) negative, Troponin (NR: not provided) negative, and X-ray NOS (NR: not provided) unknown. On 04-APR-2021, the subject experienced shortness of breath while walking. On 04-APR-2021, the subject experienced feeling like he was going to die. On 04-APR-2021, the subject experienced high blood pressure. On 04-APR-2021, the subject experienced severe chest pain/on and off chest pain. On 04-APR-2021, the subject experienced severe back pain. On 04-APR-2021, the subject experienced difficulty sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in left arm on 26-MAR-2021, and difficulty sleeping on 06-APR-2021, was recovering from shortness of breath while walking, and severe back pain, had not recovered from weakness, tiredness, severe chest pain/on and off chest pain, and crazy joint pain in left arm, and the outcome of high blood pressure and feeling like he was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Diabetes; Smoker

Date Died: 04/04/2021

ID: 1249269
Sex: M
Age:
State:

Vax Date:
Onset Date: 04/04/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: DIED IN SLEEP; This spontaneous report received from a consumer via social media concerned a 42-year-old male. 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: Unknown, expiry date: unknown) with unknown dose, on unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up required for this case. No concomitant medications were reported. On 04-APR-2021, the patient died in his sleep and the cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This case was linked to 20210428967 (same reporter) This report was serious (Death).; Sender's Comments: V0:20210429895-COVID-19 VACCINE AD26.COV2.S- Died in sleep. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1249270
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 04/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: D DIMER POSITIVE; DIZZY; FEELS TERRIBLE; This spontaneous report received from a company representative via media post and concerned an adult female (age approximately 30). 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: unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in APR-2021, the patient reported dizzy and felt terrible. On an unspecified date, the patient went to urgent care and tested positive for D-Dimer (PT of Fibrin D dimer increased). The patient went to emergency room for full body ultrasound to look for clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, feels terrible and d dimer positive was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1249271
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 03/14/2021
Rec V Date: 04/23/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: FAST HEART RATE; BLOOD CLOT IN BOTH LUNGS; ACHY; LOW ENERGY; VERY WEAK; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on left arm on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included pregabalin(Lyrica) for fibromyalgia and bad back. The patient reported pregabalin makes her gait off. On 13-MAR-2021, the patient felt okay. On 14-MAR-2021, the patient experienced achy, low energy, very weak, headache, fever of 100 degrees fahrenheit. Laboratory data included: Body temperature (NR: not provided) 100 F. On 13-APR-2021, she had wellness visit. The patient had a fast heart rate. Laboratory data included: Heart rate (NR: not provided) 144 (units unspecified). So immediately her electrocardiogram was taken and she was hospitalized for 2 days in emergency room by ambulance and started running tests. The patient had a computer tomography with dye contrast and it showed blood clots in both lungs. She had many tests, echocardiogram and X-rays. Treatment medications (dates unspecified) included: continuous oxygen via nasal prong (3.2 litre down to 2 litre), warfarin sodium(Coumadin), blood, whole, and rivaroxaban(Xarelto). The patient stated once she had rivaroxaban she felt "free". Currently also had 2 intravenous and taking blood regular. She was also on physical therapy. The therapist came in and made her walk across her room twice according to therapist she did not need oxygen. The patient currently had 2 IV's and taking blood regular. The patient will be discharged with or without the oxygen. The patient has machine on her chest with all kinds of wires. She don't know about her oxygen saturation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, low energy, very weak, headache, and fever on 15-MAR-2021, had not recovered from fast heart rate, and the outcome of blood clot in both lungs was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).; Sender's Comments: V0: This is a 72 year old female, unspecified ethnicity, who experienced tachycardia and was noted to have blood clots in both lungs 32 days (around 1 month) after receiving the COVID-19 vaccine ad26.cov2.s on the left arm. Patient had Fibromyalgia and is maintained on Pregabalin (Lyrica). Patient's height and weight were not reported as well as history of smoking, allergies or drug abuse. One day after receiving the vaccine, the patient experienced fever, headache, weakness and pain, which resolved. During a wellness visit after a month from the vaccine, tachycardia was noted and an EKG was done. Patient was immediately brought to the ER, where the CT Scan (with contrast) showed blood clots in both lungs (detailed result not reported). Other tests done were also not reported. Patient was subsequently admitted in the hospital and was discharged after 2 days. The information provided is insufficient to show that the vaccine is causing the event; hence, this is assessed as indeterminate per WHO causality classification of adverse event following immunization. Additional information requested.

Other Meds: LYRICA

Current Illness: Back disorder; Fibromyalgia

ID: 1249273
Sex: M
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Vax Date:
Onset Date: 04/08/2021
Rec V Date: 04/23/2021
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Symptoms: BILATERAL BLOOD CLOTS IN LEFT AND RIGHT LOWER LUNGS; This spontaneous report received from a patient via a company representative concerned a 46 year old male. 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: unknown, expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 08-APR-2021, the patient experienced mild chest pain and dyspnea. On 14-APR-2021, the patient visited to emergency room and diagnosed with bilateral blood clots in left and right lower lungs. The patient had no prior medical history of blood clot and pulmonary issues. On 14-MAR-2021, treatment medications included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral blood clots in left and right lower lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a 46 male patient, unspecified ethnicity who was noted, at the emergency room (ER), to have bilateral blood clots in left and right lower lungs 9 days after receiving the covid-19 vaccine ad26.cov2.s. Weight and height were not reported. Medical history, smoking history and concomitant medications were not reported. Six (6) days prior to the visit to the emergency room, the patient experienced mild chest pains and dyspnea. Patient was sent home from the ER with Rivaroxaban. Based on the available information and considering the temporal causality, this is assessed as indeterminate per WHO causality classification of adverse reaction following immunization.

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ID: 1249274
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 04/08/2021
Rec V Date: 04/23/2021
Hospital: Y

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Symptoms: BLOOD CLOT IN LEFT LUNG; SHORTNESS OF BREATH; DIARRHEA; LEG PAIN; INJECTION SITE PAIN; HEADACHE; SWEATING; DIZZINESS/FEELING FAINT; This spontaneous self-report was received from a patient and concerned a 29 year Black Mexican, White (Hispanic or Latino) old female. The patient's height and weight were not reported. The patient's concurrent conditions included hypertension, latex allergy, allergic to banana, and non smoker. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total dose on left arm administered on 08-APR-2021 (Thursday) for prophylactic vaccination. Concomitant medications included labetalol and nifedipine for hypertension. On 08-APR-2021, when patient received a vaccination it hurt at the time of injection. Later, she developed a headache. At night, she woke up with sweating. She went down to the kitchen and felt shortness of breath and felt faint. On 09-Apr-2021 (Friday), after she woke up, she developed diarrhea all day. On 10-APR-2021 (Saturday), her symptoms were continuing included diarrhea, sweating, dizziness, legs hurting, headache, and feeling shortness of breath. On 11-APR-2021 (Sunday), she felt better, however headache was ongoing. At night, she started feeling bad again. On 12-APR-2021, she woke up with diarrhea and sweating, no symptoms have resolved. On 13-APR-2021, her legs continued to be in pain. At night, she went to emergency room (ER) and have blood work done, showing it was positive for a blood clot. Her computerized axial tomography (CAT) was performed and blood clot in left lung was found. Her doctor said that all other blood work came back normal, and he did not see anything else wrong with her, and that the blood clot was related to the vaccine. He wanted to put her on a blood thinner and prescribed Eliquis (apixaban). Doctor mentioned that if she felt shortness of breath or started feeling dizzy, she must go to the hospital. It was reported that she was hospitalized for 1 day, and both admission and discharge dates were reported 13-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in left lung, injection site pain, headache, sweating, shortness of breath, dizziness/feeling faint, leg pain, and diarrhea. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: This is a 29 year old male patient, who experienced leg pain and noted to have blood clot in the left lung 1 day and 5 days, respectively, after receiving the COVID-19 vaccine ad26.cov2.s on the left arm. Height and weight not reported. Patient has hypertension and is taking Labetalol and Nifedipine. Patient has history of allergy to latex and banana. Patient is not a smoker. Few hours after receiving the vaccine, patient developed headache, sweating, dizziness and shortness of breath. The following day, patient had diarrhea and experienced leg pain, laterality not reported. The symptoms were persistent and, 5 days after the vaccine, patient sought consult at the Emergency Room (ER) where the CAT scan showed blood clot in left lung. Patient was prescribed with Apaxiban. The information provided precludes a meaningful medical assessment. Additional information requested.

Other Meds: NIFEDIPINE; LABETALOL

Current Illness: Fruit allergy; Hypertension (Labetalol, Nifedipine); Latex allergy; Non-smoker

Total 2021 VAERS Injuries: 292,192

Page last modified: 03 October 2021 5:28pm