VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1594335
Sex: M
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of an 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 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, the patient had suspected immunological vaccine failure (exposed to someone with Covid). Laboratory data included: antibody and COVID-19 virus test was negative. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210830362-covid-19 vaccine ad26.cov2.s-suspected 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:

ID: 1594336
Sex: M
Age:
State: KY

Vax Date:
Onset Date: 08/10/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a physician concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: feeling ill, felt weak, and tired. 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 10-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, Laboratory data included: Fever (NR: not provided) 100.5 degree Fahrenheit, and Vital signs measurement (NR: not provided) stable. On 10-AUG-2021, the patient experienced tested positive for covid-19. On 14-AUG-2021, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 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: Feelings of weakness; Ill feeling; Tiredness

ID: 1594337
Sex: F
Age:
State: CT

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

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

Lab Data:

Allergies:

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

Symptoms: MAGNET STICKING TO INJECTION SITE; This spontaneous report received from a consumer concerned a 30 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 magnet sticking to injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of magnet sticking to injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210830342 and 20210830364.

Other Meds:

Current Illness:

ID: 1594338
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 04/22/2021
Rec V Date: 08/21/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: WEAKNESS; UNABLE TO FUNCTION; NUMBNESS IN HANDS AND FEET; MIDSECTION (WAIST) WAS NUMB; LINGERING INFLAMMATION; GUILLAIN BARRE SYNDROME; Initial information was processed with additional information received on 16-AUG-2021 from the patient via a telephone communication log (TCL). This spontaneous report received from a patient concerned a 58 year old white male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use (once daily), non-smoker (occasional once a year, cigar celebration), and occasional cannabis edible consumption. He had a previously active lifestyle (exercise, played sports). Patient did not had any known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) on 03-APR-2021 11:00 into left arm, for prophylactic vaccination. No concomitant medications were reported. Patient reported that on 22-APR-2021, he developed Guillain Barre Syndrome (GBS) two weeks post-vaccination, and was hospitalized. His symptoms included numb mid-section of torso ("felt like wearing a tick and wide belt"), fingertip numbness, aching feeling all over the torso and legs, "ants under skin" feeling, and facial palsy. The symptoms gradually spread and worsened over time with bilateral weakness and urinary urgency. COVID-19 virus test on an unspecified date was negative. Patient went to the medical center to figure out the symptoms he was experiencing. He was admitted on 22-APR-2021. Did all the tests, magnetic resonance imaging (MRI) and lumbar puncture. Patient was diagnosed with Guillain Barre Syndrome (GBS). Patient was treated with 5 rounds of intravenous immunoglobulin (IV Ig) (fresh antibodies). Patient was discharged to rehabilitation hospital on 01-MAY-2021 for rehab and recovery. Patient was discharged to home on 15-MAY-2021. Patient developed weakness and unable to function again. Patient was sent back to medical center on 09-JUN-2021, and did another lumbar puncture with elevated proteins. Patient was admitted again and treated with plasmapheresis (transfusion of plasma for fresh antibodies to get immune system to stop attacking his peripheral nervous system). Patient was there for 10 days and discharged again to rehabilitation hospital. Patient went through physical and occupational therapy for 10 days. Patient developed weakness again, and transferred back to medical center and did an electromyogram (EMG) test (to see extent of prevalent damage in his left leg). Patient developed a lot of numbness in hands and feet. Mid-section (waist) was numb, felt like wearing a "wrestling belt". Patient required assistance of walker. Patient was admitted once again to medical center on 19-JUN-2021, treated with intravenous (IV) steroids then oral prednisone, which he continued to be on. This was intended to knock down the lingering inflammation and allow him to regain the strength to the rehab once again. Patient was transferred again to rehabilitation hospital, on 29-JUN-2021. Patient returned to medical center on 01-JUL-2021 for another intravenous (IV) steroid and second electromyogram (EMG) test, then back to rehabilitation hospital on 03-JUL-2021. Finally patient was discharged to home on 13-JUL-2021 and continued with physical and occupational therapy home visits since. After successfully completing rehab work at rehabilitation hospital, and has been convalescing ever since. At the time of this report, patient continued to improve but was taking a long time. Patient body was regenerating and repairing the damage to the myelin sheath surrounding his axon nerves. Patient understands it will take time for him to improve, and still walks with assistance of walker and goes through physical and occupational therapy to regain balance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Guillain Barre syndrome, weakness, numbness in hands and feet, unable to function, lingering inflammation, and midsection (waist) was numb. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from a patient concerned a 58-year-old white male who experienced Guillain Barre syndrome (GBS) 2 weeks after vaccine. No significant past medical history was reported. No concomitant medications were reported. Patient developed GBS two weeks post-vaccination and was hospitalized. His symptoms included numb mid-section of torso, fingertip numbness, aching feeling all over the torso and legs, "ants under skin" feeling, and facial palsy. The symptoms gradually spread and worsened over time with bilateral weakness and urinary urgency. COVID-19 virus test on an unspecified date was negative. Patient was admitted and underwent magnetic resonance imaging (MRI) and lumbar puncture and was diagnosed with GBS. Patient was treated with 5 rounds of intravenous immunoglobulin (IVIG). Patient was discharged to rehabilitation hospital on day 28 and discharged home on day 42. Patient developed weakness and was readmitted days 67-77, with another lumbar puncture with elevated proteins. Patient was treated with plasmapheresis and discharged to rehab. Patient developed weakness again, underwent electromyogram (EMG). Patient was admitted once again days 77-87, treated with intravenous (IV) steroids then oral prednisone, then returned to rehab. Patient returned to medical center on day 89 for another intravenous (IV) steroid and second electromyogram (EMG) test, then back to rehab on day 91. Finally, patient was discharged to home on day 101 and continued with physical and occupational therapy home visits since. At the time of this report, patient continued to improve, but slowly. Information regarding other potential etiologies was insufficient, and the occurrence of GBS could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.

Other Meds:

Current Illness:

ID: 1594339
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: VERTIGO; BODY ACHES AND PAINS; FEVER; FATIGUE; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. 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 30-JUL-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, the patient experienced vertigo, body aches and pains, fever, fatigue, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches and pains, fatigue, muscle pain, and vertigo. This report was non-serious.

Other Meds:

Current Illness:

ID: 1594340
Sex: U
Age:
State: MI

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 08/21/2021
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: FELL FOR NO REASON; CHEST IS SO TIGHT ALL THE TIME; RESPIRATORY ARREST; DIFFICULTY TAKING DEEP BREATHS; This spontaneous report received from a patient concerned a 67 year old of unspecified sex, unknown race, and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had severe immune IgG (Immunoglobulin G). 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, 1 total, 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 patient experienced a reaction within 1 hour of receiving the vaccination. Within 40 minutes, the patient went into respiratory arrest. The patient was finally able to breathe but with a lot of difficulty. The patient had an appointment with her Physician the next day (14-MAR-2021) and since then she had been on 3 Liter oxygen 24/7. When the patient did not realize what was going on, a couple of times the patient fell for no reason and that was because was not getting enough oxygen in her system. The patient still had difficulty taking deep breaths on the day of reporting, and her chest felt so tight all the time. The patient knew she needed the booster but did not know which one and where. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from respiratory arrest, chest is so tight all the time, and difficulty taking deep breaths, and the outcome of fell for no reason was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210830722-Covid-19 vaccine ad26.cov2.s -Respiratory arrest , Difficulty taking deep breaths. 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: 1594341
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 08/14/2021
Rec V Date: 08/21/2021
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: CHILLS; LOW GRADE TEMPERATURE (99.5F AND 100.8F); HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 21 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 14-AUG-2021, the patient experienced chills. On 14-AUG-2021, the patient experienced low grade temperature (99.5f and 100.8f). On 14-AUG-2021, the patient experienced headache. On 14-AUG-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99.5 F, 100.8 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, low grade temperature, headache, and fatigue on 15-AUG-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1594342
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: FELT LIKE ABSOLUTE SHIT THE DAY AFTER VACCINATION, LIKE DEADASS. BUT DEADASS IT FELT LIKE GETTING THE FLU SHOT; BODY ACHES; HEADACHE; NAUSEA; MILD FEVERS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced felt like absolute the day after vaccination, like. but it felt like getting the flu shot, body aches, headache, nausea, and mild fevers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, mild fevers, nausea, and headache, and the outcome of felt like absolute the day after vaccination, like deadass. but it felt like getting the flu shot was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1594343
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: DIAGNOSED BLOOD CLOT; This spontaneous report received from a patient via a company representative concerned a 51year 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, Expiry: Unknown) dose not reported, 1 total administered, 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 (within 30 days of vaccination), the patient was diagnosed with blood clot and was hospitalized (date unspecified). Duration of hospitalization was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of diagnosed blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210832291-Covid-19 vaccine ad26.cov2.s-Diagnosed 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: 1594344
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 08/15/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: HOT FLASHES; RUNNY NOSE; TINNITUS; JOINT PAIN; LIGHT HEADACHES; MORE TIRED; This spontaneous report received from a consumer concerned a 69 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, and batch number: 1820096 expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced hot flashes. On 15-AUG-2021, the patient experienced runny nose. On 15-AUG-2021, the patient experienced tinnitus. On 15-AUG-2021, the patient experienced joint pain. On 15-AUG-2021, the patient experienced light headaches. On 15-AUG-2021, the patient experienced more tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headaches, more tired, joint pain, tinnitus, runny nose and hot flashes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210832500.

Other Meds:

Current Illness:

ID: 1594345
Sex: M
Age:
State: AZ

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: HERNIA; PAIN IN THE LEFT ARM; DEBILITATING PAIN IN JOINTS PRIMARILY, THE LOWER TORSO LIKE HIPS AND BUTTOCKS; BLURRED VISION; UNCOMFORTABLE DRIVING; HEAVY FEELING IN THE EYEBALL; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate sleep apnea, alcohol use, non smoker, mild hypertension, elevated cholesterol, hernia, and gastrooesophageal reflux disease, and other pre-existing medical conditions included: The patient had 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included rosuvastatin for elevated cholesterol, pantoprazole for gastrooesophageal reflux disease, hydrochlorothiazide/losartan potassium for mild hypertension, and metoprolol for mild hypertension. On MAR-2021, the patient experienced blurred vision. On MAR-2021, the patient experienced uncomfortable driving. On MAR-2021, the patient experienced heavy feeling in the eyeball. On MAR-2021, the patient experienced pain in the left arm. On MAR-2021, the patient experienced debilitating pain in joints primarily, the lower torso like hips and buttocks. On an unspecified date, the patient experienced hernia. Laboratory data (dates unspecified) included: Visual acuity tests (NR: not provided) 20/20 (normal). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from debilitating pain in joints primarily, the lower torso like hips and buttocks, blurred vision, heavy feeling in the eyeball, pain in the left arm, and uncomfortable driving, and the outcome of hernia was not reported. This report was non-serious.

Other Meds: LOSARTAN/HCTZ; METOPROLOL; ROSUVASTATIN; PANTOPRAZOLE

Current Illness: Alcohol use (Wine and Beer. 1 or 2 glasses a day); Gastrooesophageal reflux disease; Hernia; Hypercholesterolaemia; Hypertension; Non-smoker; Sleep apnea

ID: 1594346
Sex: F
Age:
State: KS

Vax Date:
Onset Date: 08/12/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: LOWER BACK PAIN; GASTROINTESTINAL ISSUES; DIARRHEA; PAIN AT INJECTION SITE; NAUSEA; HEADACHE; FELT YUCKY; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: narcolepsy, heart issues, penicillin allergy, non alcohol user, non-smoker, and sulfonamide allergy, and other pre-existing medical conditions included: 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: 1820095, expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide for heart issues, lisinopril for heart issues, and pneumococcal vaccine polysacch 23v. On AUG-2021, treatment medications included: naproxen sodium. On 12-AUG-2021, the patient experienced felt yucky. On 12-AUG-2021, the patient experienced pain at injection site. On 12-AUG-2021, the patient experienced nausea. On 12-AUG-2021, the patient experienced headache. On 14-AUG-2021, the patient experienced gastrointestinal issues. On 14-AUG-2021, the patient experienced diarrhea. On 15-AUG-2021, the patient experienced lower back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gastrointestinal issues, diarrhea, pain at injection site, nausea, and headache on 15-AUG-2021, was recovering from felt yucky, and had not recovered from lower back pain. This report was non-serious.

Other Meds: PNEUMOVAX; LISINOPRIL; HYDROCHLOROTHIAZIDE

Current Illness: Abstains from alcohol; Heart disorder; Narcolepsy; Non-smoker; Penicillin allergy; Sulfonamide allergy

ID: 1594347
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 08/14/2021
Rec V Date: 08/21/2021
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: DIZZINESS AND LIGHT HEADNESS; LEG LOCK; BLURRED VISION; SLIGHT TO MEDIUM DIFFICULTY BREATHING; CHEMICAL AND METALLIC TASTE WITH FOOD AND DRINKS; INJECTION SITE ITCHING; HARDENING OF THE INJECTION SITE; CHEST PAIN; MODERATE SWELLING OF THE BOTTOM ROW OF GUMS WHICH WAS INFLAMED AND BRIGHT RED; CHILLS; RINGING OF THE RIGHT EAR; TEMPORARY ITCHY RASH ON FACE AND NECK; TINGLY SENSATIONS IN THE FACE (TEMPORARY LASTED ABOUT 3 HOURS); SWELLING AT INJECTION SITE (LEFT DELTOID AREA); PAIN AT INJECTION SITE (LEFT DELTOID AREA); WEAKNESS; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight was 236 pounds, and height was 67 inches. The patient's concurrent conditions included: penicillin allergy, tegaderm allergy, red onions allergy, no alcohol use, non-smoker, and birth control implant, and other pre-existing medical conditions included: Patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. Concomitant medications included etonogestrel for birth control. On 14-AUG-2021, the patient experienced dizziness and light headness. On 14-AUG-2021, the patient experienced leg lock. On 14-AUG-2021, the patient experienced blurred vision. On 14-AUG-2021, the patient experienced slight to medium difficulty breathing. On 14-AUG-2021, the patient experienced chemical and metallic taste with food and drinks. On 14-AUG-2021, the patient experienced injection site itching. On 14-AUG-2021, the patient experienced hardening of the injection site. On 14-AUG-2021, the patient experienced chest pain. On 14-AUG-2021, the patient experienced moderate swelling of the bottom row of gums which was inflamed and bright red. On 14-AUG-2021, the patient experienced chills. On 14-AUG-2021, the patient experienced ringing of the right ear. On 14-AUG-2021, the patient experienced temporary itchy rash on face and neck. On 14-AUG-2021, the patient experienced tingly sensations in the face (temporary lasted about 3 hours). On 14-AUG-2021, the patient experienced swelling at injection site (left deltoid area). On 14-AUG-2021, the patient experienced pain at injection site (left deltoid area). On 14-AUG-2021, the patient experienced weakness. On 14-AUG-2021, the patient experienced nausea. On 14-AUG-2021, the patient experienced fever. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg lock, chest pain, and tingly sensations in the face (temporary lasted about 3 hours) on 14-AUG-2021, and blurred vision, chemical and metallic taste with food and drinks, and temporary itchy rash on face and neck on 15-AUG-2021, and had not recovered from dizziness and light headness, ringing of the right ear, weakness, nausea, slight to medium difficulty breathing, injection site itching, hardening of the injection site, fever, moderate swelling of the bottom row of gums which was inflamed and bright red, swelling at injection site (left deltoid area), pain at injection site (left deltoid area), and chills. This report was non-serious.

Other Meds: NEXPLANON

Current Illness: Abstains from alcohol; Adhesive tape allergy; Contraceptive implant (implanted on the left arm.); Food allergy; Non-smoker; Penicillin allergy

ID: 1594348
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 08/13/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: FEVER WITH TEMPERATURE OF 100.4 DEGREE FAHRENHEIT; SLIGHT DIZZINESS; CHILLS; HEADACHE; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 19 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: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient experienced slight dizziness. On 13-AUG-2021, the patient experienced chills. On 13-AUG-2021, the patient experienced headache. On 13-AUG-2021, the patient experienced muscle aches. On 13-AUG-2021, the patient experienced fatigue. Treatment medications included: ibuprofen, and paracetamol. On 14-AUG-2021, the patient experienced fever with temperature of 100.4 degree fahrenheit. Laboratory data included: Body temperature (NR: not provided) 100.4 F, 99.5 F, and Pain scale (NR: not provided) 4/10. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever with temperature of 100.4 degree fahrenheit on 15-AUG-2021, and was recovering from headache, chills, muscle aches, slight dizziness, and fatigue. This report was non-serious.

Other Meds:

Current Illness:

ID: 1594349
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male patient 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: 1802072 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. In AUG-2021, the patient used the (IgG antibody test) to assess his IgG and the result was negative (confirmed immunological vaccine failure). He stated that other patients who received an mRNA vaccine get a positive test for IgG when this test was used. Laboratory data included: SARS-CoV-2 rapid antibody test (NR: not provided) Negative for IgM IgG. 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 20210832350-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:

ID: 1594350
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 08/04/2021
Rec V Date: 08/21/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: BLOOD CLOTS ON LUNGS; PAIN IN BACK; PAIN IN SHOULDERS; WASN'T FEELING WELL; This spontaneous report received from a parent concerned a 27 year old, male. The patient's weight was 200 pounds, and height was 70.5 inches. The patient's pre-existing medical conditions included: The 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, one total administered on right arm on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient wasn't feeling well and had pain in shoulders and pain in back. On 05-AUG-2021, the patient experienced chest pain that got worse with deep breath, and went to urgent care and was later on that day, the patient was sent to emergency room and ran a bunch of tests including a CT scan and found blood clots on his lungs. The patient was hospitalized on the same day and was kept on Heparin until 08-AUG-2021 On an unspecified date, laboratory test of hereditary disease was performed whose results were negative. On 08-AUG-2021, the patient was discharged with a prescription for a blood thinner, Eliquis, for an unknown amount of time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wasn't feeling well, pain in shoulders, pain in back and blood clots on lungs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210832359-covid-19 vaccine ad26.cov2.s-blood clots on lungs; pain in back. This case concerned to a concerned a 27 year old, male patient. 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). 20210832359-covid-19 vaccine ad26.cov2.s-pain in shoulders; wasn't feeling well. This event(s) is labeled and is therefore considered potentially related.

Other Meds:

Current Illness:

ID: 1594351
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: PAIN MOVED FROM CENTER OF BACK AND MOVED BACK AGAIN TO CENTER OF CHEST; PAIN GOT WORSE EVERY TIME WHILE BREATHING AND FEELS LIKE IT IS BETWEEN TOP LAYER OF SKIN AND RIBS; PAIN UNDER LEFT ARM; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: disabled, and other pre-existing medical conditions included: Patient took the product as directed. Patient had no marks or lesions on skin. Patient reports that she did not fall and there is no other reason for any pain being caused. Patient did not left her apartment in 5 or 6 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced pain moved from center of back and moved back again to center of chest, pain got worse every time while breathing and feels like it is between top layer of skin and ribs, and pain under left arm. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, Mammogram (NR: not provided) Normal, and Sonogram (NR: not provided) Normal. Treatment medications (dates unspecified) included: paracetamol/tramadol hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain under left arm, pain moved from center of back and moved back again to center of chest, and pain got worse every time while breathing and feels like it is between top layer of skin and ribs. This report was non-serious.

Other Meds:

Current Illness: Disability

ID: 1594352
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: COULD NOT STAND; FEEL CRAZY; CHILLS; LEG PAIN SO BAD; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced could not stand, feel crazy, chills, leg pain so bad, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not stand, and leg pain so bad, and the outcome of chills, fever and feel crazy was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1594353
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/10/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SEVERE CHILLS; BONE AND JOINT PAIN; FEVER; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 50 year old white female of unknown ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, alcohol use once every 3 months, and non-smoker, and other pre-existing medical conditions included: the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy (mild hives) when treated with omeprazole, and azithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, frequency one total administered on right arm on 10-APR-2021 at about 10:30 for prophylactic vaccination. No concomitant medications were reported. On the day of vaccination after 6 to 8 hours of taking vaccine, the patient experienced severe chills, fever for 12 hours, nausea and fatigue for 4 days, bone and joint pain relieved after 24 hours. On 13-AUG-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: IgG (Immunoglobulin G), Spike protein, semi-quantitative Antibody test (NR: not provided) Negative. On an unspecified date the patient took Tylenol and Advil for fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills, bone and joint pain, and fever on 11-APR-2021, and nausea, and fatigue on 14-APR-2021, and 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: 90000189749.; Sender's Comments: V0:20210832418- 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: Alcohol use (Once every 3 months); Blood pressure high; Non-smoker

ID: 1594354
Sex: M
Age:
State:

Vax Date:
Onset Date: 05/10/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SWEATING; RESTLESS SLEEP; JOINT ACHES; HEADACHE; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-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 10-MAY-2021, the patient experienced sweating. On 10-MAY-2021, the patient experienced restless sleep. On 10-MAY-2021, the patient experienced joint aches. On 10-MAY-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, restless sleep, joint aches, and headache on 11-MAY-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1594355
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: MORE ACID REFLEX; EXHAUSTION WAS A DIFFERENT TYPE OF TIREDNESS AS IF SHE WAS COMING FROM ILLNESS/ EXTREMELY TIRED; STINGING THROUGH THE KIDNEY, MAINLY THE RIGHT SIDE FOR 1-2 MINUTES; LOWER BACK PAIN; BURNING IN LEGS AND FEET (BURNING, HOTNESS, HEAT IN THE BACK OF LEGS IN THE CALF AREA) AND BOTHERED BY THE ACHENES FEELING, LEGS ARE BURNING HOT WHEN SHE TOUCHES HER LEGS, THEY ARE NOT HOT AND NO PAIN, FEELS THAT THEY ARE HOT (HOT SENSATION); DID NOT SLEEP GOOD WHICH LASTED FOR 3-4 NIGHTS; DRIVING HER CRAZY; IT IS JUST HOW SHE FEELS THAT THEY ARE HOT( HOT SENSATION); This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included: blood clots in the lungs, and concurrent conditions included: hypertension, stomach ulcer, and acid reflex. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced driving her crazy. On AUG-2021, the patient experienced it is just how she feels that they are hot ( hot sensation). On 10-AUG-2021, the patient experienced stinging through the kidney, mainly the right side for 1-2 minutes. On 10-AUG-2021, the patient experienced lower back pain. On 10-AUG-2021, the patient experienced burning in legs and feet (burning, hotness, heat in the back of legs in the calf area) and bothered by the achenes feeling, legs are burning hot when she touches her legs, they are not hot and no pain, feels that they are hot (hot sensation). On 10-AUG-2021, the patient experienced did not sleep good which lasted for 3-4 nights. On 10-AUG-2021, the patient experienced exhaustion was a different type of tiredness as if she was coming from illness/ extremely tired. On an unspecified date, the patient experienced more acid reflex. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not sleep good which lasted for 3-4 nights on 14-AUG-2021, had not recovered from burning in legs and feet (burning, hotness, heat in the back of legs in the calf area) and bothered by the achenes feeling, legs are burning hot when she touches her legs, they are not hot and no pain, feels that they are hot (hot sensation), and the outcome of stinging through the kidney, mainly the right side for 1-2 minutes, lower back pain, exhaustion was a different type of tiredness as if she was coming from illness/ extremely tired, more acid reflex, driving her crazy and it is just how she feels that they are hot( hot sensation) was not reported. This report was non-serious.

Other Meds:

Current Illness: Gastrooesophageal reflux disease (She started to have more acid reflex which came up again after being quiet before getting vaccination.); Hypertension; Stomach ulcer (Taking medication for that).

ID: 1594356
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: EYESIGHT WAS TOTALLY BLURRED (BOTH EYES SHE COULD NOT SEE) AND FAILED A DRIVING RENEWAL TEST DUE TO THIS; BOTH LEGS CRAMPED ALL THE TIME; PAINFUL BONE SPUR ON THE LEFT FOOT (SOMETHING HARD ON THE TOP OF HER FOOT AND IT WAS PAINFUL); This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient experienced both legs cramped all the time. On 01-AUG-2021, the patient experienced painful bone spur on the left foot (something hard on the top of her foot and it was painful). On 12-AUG-2021, the patient experienced eyesight was totally blurred (both eyes she could not see) and failed a driving renewal test due to this. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from eyesight was totally blurred (both eyes she could not see) and failed a driving renewal test due to this, and had not recovered from both legs cramped all the time, and painful bone spur on the left foot (something hard on the top of her foot and it was painful). This report was non-serious.

Other Meds:

Current Illness:

Date Died:

ID: 1594357
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: SUSPECTED HEART ATTACK; This spontaneous report received from a company representative concerned a 60 year old male patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was reported that, the patient was fit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknow) with frequency as 1 total for prophylactic vaccination. Dose and therapy start date were not reported. 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 was suspected with heart attack. On an unspecified date, the patient died from suspected heart attack. It was reported that, the patient died within 30 days of receiving vaccine and cause of death was unknown however suspected as heart attack. It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210832457- covid-19 vaccine ad26.cov2.s-suspected heart attack. 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: SUSPECTED HEART ATTACK

Other Meds:

Current Illness:

ID: 1594358
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: AUTOIMMUNE DISORDER; CRYING NON-STOP; FELT VERY COLD AND HOT; NOT BEEN FEELING WELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 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, after vaccination, the patient had been crying non-stop, was having bowel issues, was experiencing pain in stomach under ribs, and felt very cold and hot. The patient had generally not been feeling well. It was reported that the patient had an appointment with her doctor and was told that the results of her fecal sample showed that she had an autoimmune disorder. Laboratory data (dates unspecified) included: Stool analysis (NR: not provided) autoimmune disorder (unspecified). It was reported that the patient was feeling progressively unwell during the time of this report and stated that she needed to lie down and could not provide any further information at this time. The patient had a colonoscopy scheduled on Wednesday, 18-AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not been feeling well, and the outcome of crying non-stop, felt very cold and hot and autoimmune disorder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210832464--Autoimmune disorder. 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: 1594359
Sex: M
Age:
State: LA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: BLOOD CLOTS; HEART TROUBLE; HE WAS DYING; This spontaneous report received from a consumer concerned a male 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 admin not reported, batch number: Unknown) dose was not reported, frequency time 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, after vaccination the patient had blood clots, (heart trouble) his heart didn't want to work and he was dying. Heart had to be shocked- stimulated heart. It was reported that every couple of days tests was being ran. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots, heart trouble and he was dying was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210832975; Sender's Comments: 20210832472-Covid-19 vaccine ad26.cov2.s-Blood Clots, heart trouble. 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: 1594360
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 08/11/2021
Rec V Date: 08/21/2021
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: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 55 year old white Not Hispanic/Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: complex regional pain syndrome (RSD/CRPS), diabetes mellitus, lung disease, Reynold's syndrome, connective tissue disease, mild facial pain syndrome, psoriasis, degenerative disc disease, stenosis, non-alcohol user, smoker, and other pre-existing medical conditions included: the patient did not have any history of drug abuse or illicit drug use except marijuana. The patient was not pregnant at the time of vaccination. The patient has allergy to any medicine ends with zine. The patient experienced drug allergy when treated with morphine, Propofol, oxycontin, injectable Benadryl. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: unknown) dose was not reported, 1 total, administered on 14-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) negative, SARS-CoV-2 IgM antibody test (NR: not provided) negative, and SARS-CoV-2 IgA antibody test (NR: not provided) negative. The patient wanted an exemption letter to get a booster shot as her doctor recommended (she could not afford to get Covid-19). Her health care professional wanted her to get Pfizer Covid-19 Vaccine. She was frustrated at the time of report. 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: 90000189771; Sender's Comments: V0: 20210832576-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: Abstains from alcohol; Complex regional pain syndrome; Connective tissue disorder; Degenerative disc disease; Diabetes mellitus; Facial pain; Lung disease; Psoriasis; Reynold's syndrome; Smoker (Marijuana); Stenosis

ID: 1594361
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: ADVERSE REACTIONS; This spontaneous report received from a patient via a company representative 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1594362
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 08/09/2021
Rec V Date: 08/21/2021
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: LEFT SCAPULA GETS A INTENSE PAIN; SHIN SPLINTS; WEIRD SORENESS UNDER TONGUE; TINGLING IN LIPS/WEIRD TINGLING UNDER TONGUE; BELLS PALSY; SWOLLEN FEET; CALVE TIGHTNESS STARTED IN LEFT CALF BUT MOVED TO AFFECT THE RIGHT CALF TOO; FACE TIGHTENING; EXTREME FATIGUE/TIRED; EXTREME WEAKNESS IN QUADS/LEGS; BURNING RASH ON FACE MOSTLY ON RIGHT BUT ON LEFT SOME ON BOTH CHEEKS AND WORSE ON THE RIGHT; COLD CHILLS THAT COME AND GO; IMMEDIATE ALLERGIC REACTION; TINGLING UP AND DOWN LEFT ARMS AND LEGS; This spontaneous report received from a patient concerned a 53 year old female, unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 09-AUG-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced an immediate allergic reaction within 5 minutes. She got a shot benadryl and steroids. Tingling went left hand up left arm and down left leg and Cold chills that come go suddenly. On 10-AUG-2021, the patient experienced face tightening, calves feel really tight, extreme weakness in quads/legs, burning rash on face mostly on right but on left some on both cheeks and worse on the right and extreme fatigue/tired. On 11-AUG-2021, the patient experienced swollen feet. On 12-AUG-2021, the patient experienced bells palsy. On 13-AUG-2021, the patient experienced shin splints, weird soreness under tongue, tingling in lips/weird tingling under tongue. On 14-AUG-2021, the patient experienced left scapula gets a intense pain. Treatment medications (dates unspecified) included: valaciclovir hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen feet on 12-AUG-2021, and had not recovered from bells palsy, tingling up and down left arms and legs, extreme weakness in quads/legs, shin splints, burning rash on face mostly on right but on left some on both cheeks and worse on the right, extreme fatigue/tired, face tightening, weird soreness under tongue, cold chills that come and go, tingling in lips, left scapula gets a intense pain, immediate allergic reaction, and calves feel really tight. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210832652-covid-19 vaccine ad26.cov2.s -Bells palsy. 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: 1594363
Sex: U
Age:
State: CA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 08/21/2021
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: ELEVATED BLOOD PRESSURE; This spontaneous report received from a consumer concerned an adult of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: alopecia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was non-serious.

Other Meds:

Current Illness: Alopecia (a couple of years ago)

ID: 1594364
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 08/21/2021
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: JOINT ACHE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No significant medical history. 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 patient experienced joint ache. On 12-APR-2021, the patient experienced fever. On 12-APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint ache, fever, and headache on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210832866.

Other Meds:

Current Illness:

ID: 1594365
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: OFF LABEL USE; GIVE J&J VACCINE TO SOMEBODY THAT HAD EITHER MODERNA OR PFIZER VACCINE; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included covid-19 vaccine for prophylactic vaccination. On an unspecified date, the patient experienced off label use, and give j&j vaccine to somebody that had either moderna or pfizer vaccine. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) did not built antibodies (with Moderna or Pfizer). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and give j&j vaccine to somebody that had either moderna or pfizer vaccine was not reported. This report was non-serious.

Other Meds: COVID-19 VACCINE

Current Illness:

ID: 1594366
Sex: M
Age:
State: MN

Vax Date:
Onset Date: 03/15/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ATROPHY OF SHOULDER; BLOOD CLOT; FELT TWINGES IN THE RIGHT SHOULDER; SORENESS IN LEFT ARM; STRENGTH ISSUE WITH THE LEFT ARM AND CAN NOT MAKE A FIST /LOST STRENGTH IN ARM; LEFT SHOULDER STARTED BOTHERING HIM AND NOT HAVING A GOOD RANGE OF MOTION IN THE LEFT SHOULDER AND FEELING IT IN HIS PACK AND BICEPS; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: bicycle accident, covid-19, lost weight, fever, and tooth absorption, and concurrent conditions included: non-alcohol, and other pre-existing medical conditions included: The patient had no known allergies. There was no drug abuse or illicit drug usage. He only smokes herbs like basil and coriander. He does not smoke cigarettes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included oxycodone/paracetamol. On JAN-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. The patient felt fine and he had a good mobility with his shoulders but on On 15-MAR-2021, a week after vaccination the patient experienced left shoulder started bothering him and not having a good range of motion in the left shoulder and feeling it in his pack and biceps and soreness in left arm. The patient experienced strength issue with the left arm and can not make a fist /lost strength in arm. The patient mentioned that he felt the shot when the vaccine was injected and jumped and the injector asked him whether everything was okay. The left shoulder issues was not getting better and was not getting worse either. On 30-MAY-2021, the patient experienced felt twinges in the right shoulder. On JUN-2021, treatment medications included: apixaban. On 26-JUN-2021, the patient experienced blood clot. On 02-AUG-2021, the patient experienced atrophy of shoulder. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt twinges in the right shoulder, had not recovered from left shoulder started bothering him and not having a good range of motion in the left shoulder and feeling it in his pack and biceps, strength issue with the left arm and can not make a fist /lost strength in arm, atrophy of shoulder, and soreness in left arm, and the outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210832831 -covid-19 vaccine ad26.cov2.s- blood clots. 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: TYLENOL

Current Illness: Abstains from alcohol

ID: 1594367
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: THYROID WAS TOTALLY OUT OF RANGE/ IT WAS MESSING UP THE THYROID AND STUFF; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was taking unspecified medication for thyroid. 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. No concomitant medications were reported. On an unspecified date, the patient experienced thyroid was totally out of range/ it was messing up the thyroid and stuff. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thyroid was totally out of range/ it was messing up the thyroid and stuff was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1594368
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 04/11/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: JOINT ACHES; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned a 47 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: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: ibuprofen, and paracetamol. On 11-APR-2021, the patient experienced joint aches. On 11-APR-2021, the patient experienced low grade fever. On 11-APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint aches, low grade fever, and headache on 11-APR-2021. This report was non-serious. This case, involving the same patient is linked to 20111208304 and 20140118303. This case, from the same reporter is linked to 20210832767.

Other Meds:

Current Illness:

ID: 1594369
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 08/16/2021
Rec V Date: 08/21/2021
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: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned an 18 year old male. Initial information was processed along with the additional information received on 17-AUG-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: cigarette smoker, human immunodeficiency virus (HIV) positive, irritable bowel syndrome (IBS), immunocompromised, and non-alcohol user. The patient had no known allergies nor history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, 1 total administered to left deltoid on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient got tested for the antibody and the results came back as undetected or negative (coded as confirmed immunological vaccine failure). The patient was not sure if the vaccine was working or whether he would need a booster. 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). The case is associated with Product Quality Complaint number 90000189821.; Sender's Comments: V0:20210832913-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: Abstains from alcohol; Cigarette smoker (cigarettes occasionally); HIV infection; Immunocompromised; Irritable bowel syndrome

ID: 1594370
Sex: M
Age:
State: IL

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

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

Lab Data:

Allergies:

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

Symptoms: TOTAL ORGAN FAILURE; SUSPECTED COVID-19 INFECTION; CONTINUED TO DIE; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a male of an 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 admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date (after vaccination), the patient developed Covid-19 (suspected clinical vaccination failure) and total organ failure. He was admitted to the hospital. The doctors and nurses could not do anything except comforting him as he continued to die. At the time of this report, the patient was still in the hospital. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from total organ failure, suspected covid-19 infection, and continued to die, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210832919-covid-19 vaccine ad26.cov2.s-total organ failure, suspected covid-19 infection, continued to die (General physical health deterioration). 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). 20210832919-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: 1594371
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 08/21/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: BLOOD CLOTS IN LUNGS; SHOULDER AND LEFT BREAST LEFT SIDE FEELS PARALYZED/ ARMS AND LEGS FEEL PARALYZED; HANDS, ARMS GOT TINGLING SENSATION; SWOLLEN THROAT; INFECTIOUS STUFF THAT WAS COMING OUT OF HER MOUTH AND NOSE; This spontaneous report received from a patient concerned a 67 year old female of mixed race half white and half Indian and unknown ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcoholic, and non smoker, and the patient did not have known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) frequency one total, dose was not reported on right arm, administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine besilate (10mg), hydroxyzine hydrochloride (25mg), Tradjenta (5mg), losartan (100mg), and paracetamol (Tylenol). After three days of vaccination the patient could not breath, went to the hospital (emergency room) on 08-APRIL-2021. A radio dye was injected and the patient was diagnosed with blood clots in her lungs. The patient was coughing blood and had a swollen throat. The patient was treated with Antibiotics and Nasal Spray for infectious stuff that was coming out of her mouth and nose. She was released from the hospital on 08-Apr-2021. She was on Oxygen and cannot breath. The patient experienced shoulder and left breast -left side feels paralyzed / arms and legs feel paralyzed, hands, arms got tingling sensation. Treatment medications (dates unspecified) included: Xarelto (20mg) (rivaroxaban) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in lungs, coughing blood, can't breath, shoulder and left breast -left side feels paralyzed / arms and legs feel paralyzed, swollen throat, and hands, arms got tingling sensation, and the outcome of infectious stuff that was coming out of her mouth and nose was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210832472.; Sender's Comments: V0: 20210832975- covid-19 vaccine ad26.cov2.s-blood clots in lungs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: Hydroxyzine HCL; Losartan; Amlodipine; Tradjenta; Tylenol

Current Illness: Abstains from alcohol; Non-smoker.

ID: 1594372
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: BLOOD CLOT; SEVERE ADVERSE HEALTH COMPLICATIONS; This spontaneous report received from a patient via a company representative via social media concerned 39 patients with unknown race and ethnicity. 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, the patient experienced blood clot, and severe adverse health complications. The majority of the reports regarding the serious condition have been in adult women, who are younger than 50 years old. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe adverse health complications and blood clot was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210423023.; Sender's Comments: V0: 20210832980-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: 1594373
Sex: F
Age:
State: CT

Vax Date:
Onset Date: 08/12/2021
Rec V Date: 08/21/2021
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: METALS ARE STICKING TO THE ADMINISTRATION SITE; SORE ARM; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: opioid dependency disorder, and sleep disorder, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. Concomitant medications included buprenorphine for opioid dependency disorder, quetiapine fumarate for sleep disorder, and clonidine. On 12-AUG-2021, the patient experienced sore arm. On 14-AUG-2021, the patient experienced metals are sticking to the administration site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from metals are sticking to the administration site, and sore arm. This report was non-serious.

Other Meds: CLONIDINE; SEROQUEL; SUBLOCADE

Current Illness: Opioid use disorder; Sleep disorder

ID: 1594374
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: COMA; SOMETHING ABOUT THE SPINE OCCUR; This spontaneous report received from a consumer and concerned a 5 decade old (in her forties) 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 and expiry were unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient went into a coma and something about the spine occurred. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the coma and something about the spine occur was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210833221-Covid-19 vaccine ad26.cov2. s Coma. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1594375
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: HAD STUFF GOING ON; 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. Concomitant medications included ergocalciferol. On an unspecified date, the patient experienced had stuff going on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had stuff going on was not reported. This report was non-serious.

Other Meds: VITAMIN D [ERGOCALCIFEROL]

Current Illness:

ID: 1594376
Sex: M
Age:
State: CT

Vax Date:
Onset Date: 03/06/2021
Rec V Date: 08/21/2021
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: LYING ALL THE TIME; SEVER HEADACHE (FELT LIKE HEAD IS GOING TO EXPLODE AND BLOOD VESSELS WERE BREAKING IN HEAD); This spontaneous report received from a patient concerned a 61 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: 1802072, expiry: 23-AUG-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced lying all the time. On 06-MAR-2021, the patient experienced sever headache (felt like head is going to explode and blood vessels were breaking in head). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lying all the time, and sever headache (felt like head is going to explode and blood vessels were breaking in head) on 09-MAR-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1594377
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 08/21/2021
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: CANNOT LIVE WITH THESE SYMPTOMS IN ANY FUNCTIONAL CAPACITY; RELAPSE OF HASHIMOTO'S AUTOIMMUNE DISEASE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto's autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in MAY-2021, since the day patient received vaccine, the patient was extremely symptomatic, experienced relapse of hashimoto's autoimmune disease. The patient had been in remission for over 10 years until she received the vaccination. On an unspecified date, the patient cannot live with these symptoms in any functional capacity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from relapse of hashimoto's autoimmune disease, and cannot live with these symptoms in any functional capacity. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210833873-COVID-19 VACCINE AD26.COV2.S-Relapse of Hashimoto's Auto-immune Disease- This event(s) is considered un-assessable. 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: Hashimoto's disease (The patient's disease have been in remission for over 10 years, until received the vaccine.)

ID: 1594378
Sex: U
Age:
State: ME

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced out of specification product use, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1594379
Sex: M
Age:
State: IN

Vax Date:
Onset Date: 07/14/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: FEELS LIKE BURNING UP; WAKING UP IN SWEAT; RUNNY NOSE; SINUS PRESSURE; SNEEZING; WET COUGHING YELLOW MUCUS; SLEPT FOR 18 HOURS STRAIGHT; DRAINAGE WONT STOP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies, and other pre-existing medical conditions included: Patient takes medication for allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the patient experienced feels like burning up. On 14-JUL-2021, the patient experienced waking up in sweat. On 14-JUL-2021, the patient experienced runny nose. On 14-JUL-2021, the patient experienced sinus pressure. On 14-JUL-2021, the patient experienced sneezing. On 14-JUL-2021, the patient experienced wet coughing yellow mucus. On 14-JUL-2021, the patient experienced slept for 18 hours straight. On 14-JUL-2021, the patient experienced drainage wont stop. On 17-JUL-2021, Laboratory data included: Body temperature (NR: not provided) 97.8 F, 91.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feels like burning up, waking up in sweat, runny nose, sinus pressure, sneezing, slept for 18 hours straight, and drainage wont stop, and the outcome of wet coughing yellow mucus was not reported. This report was non-serious.

Other Meds:

Current Illness: Allergy multiple (The patient was out due to allergies a few weeks ago.)

ID: 1594380
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/21/2021
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: ITCHY RASH ON ARMS; RASH; RASH/HIVES ON BOTH ARMS FROM WRIST TO SHOULDER; SCRATCH EYES OUT; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816024, and expiry: 29-SEP-2021) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate for heart disorder. On AUG-2021, the patient experienced scratch eyes out. On AUG-2021, the patient experienced rash. On AUG-2021, the patient experienced rash/hives on both arms from wrist to shoulder. On 06-AUG-2021, the patient experienced itchy rash on arms. Treatment medications (dates unspecified) included: camphor/diphenhydramine hydrochloride/zinc oxide, prednisone, betamethasone valerate, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy rash on arms, and rash, had not recovered from rash/hives on both arms from wrist to shoulder, and the outcome of scratch eyes out was not reported. This report was non-serious.

Other Meds: PLAVIX

Current Illness: Heart disorder

ID: 1594381
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: FAINTING (SYNCOPE) EPISODE; This spontaneous report received from a consumer concerned a 3 decade (approximately 23 year) old female of unknown 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 not reported, batch number: Unknown, expiry: Unknown) 1 total, dose and 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 fainting (syncope) episode. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting (syncope) episode. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210834926.; Sender's Comments: V0:20210834795-COVID-19 VACCINE AD26.COV2.S-Fainting (syncope) episode. 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: 1594382
Sex: M
Age:
State: NM

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 08/21/2021
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: CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: prostate cancer. 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021. This report was non-serious.

Other Meds:

Current Illness: Prostate cancer

ID: 1594383
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/21/2021
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: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 60 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: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date patient had no complaints except fatigue. On 01-AUG-2021, the patient had COVID-19 antigen test which resulted in positive (suspected clinical vaccination failure and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000189953.; Sender's Comments: V0- 20210834806- 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: 1594385
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: SMALL AMOUNT OF DISCOMFORT AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced small amount of discomfort at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small amount of discomfort at injection site. This report was non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm