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: 1348882
Sex: F
Age: 21
State:

Vax Date: 05/17/2021
Onset Date: 05/18/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Breast tenderness, starting the day after the vaccine and continuing for over a week. Still ongoing

Other Meds: Vitamin C supplements, biotin and keratin supplement

Current Illness:

ID: 1348883
Sex: F
Age: 36
State: FL

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 05/26/2021
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: Bactrium, ceclore

Symptom List: Anxiety, Dyspnoea

Symptoms: Within 10 minutes after the vaccine I started to feel very faint and eyes became very blurry and couldn?t see. The pharmacy gave me water and kept making me drink water and kept checking on me. The vaccine spiked my blood sugar. After a little while my sugar went down and I was fine. That evening I had the worst migraine ever and it lasted 3 days. I also had body aches and chills for 3 days as well and fatigue.

Other Meds: Methtadone

Current Illness: None

ID: 1348884
Sex: F
Age: 20
State: KY

Vax Date: 03/30/2021
Onset Date: 03/31/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies: No

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

Symptoms: I developed hives and woke ip covered in them. I ended up in the ER a day after my second vaccine having a severe allergic reaction. I ended up having to visit a dermatologist through an emergency appointment a week after my second vaccine. She diagnosed my hives as a chronic result of my COVID vaccine.

Other Meds: Tydemy

Current Illness: None

ID: 1348885
Sex: F
Age: 36
State: OR

Vax Date: 05/24/2021
Onset Date: 05/25/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Swelling, rash, pain in injection site

Other Meds:

Current Illness:

ID: 1348892
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/12/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BRUISE ON RIGHT FOOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced bruise. The action taken with covid-19 vaccine was not applicable. The outcome of bruise was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1348901
Sex: F
Age:
State: PR

Vax Date: 03/30/2021
Onset Date: 04/20/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Abdominal pain; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:00 (Batch/Lot Number: EW0151), age at vaccination of 50-years-old, as single dose, for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Left (Batch/Lot Number: EN6206), for covid-19 immunisation. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced abdominal pain, nausea and diarrhea on 20Apr2021 at 13:00. No treatments were given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1348974
Sex: U
Age:
State: NV

Vax Date: 08/12/2020
Onset Date: 08/12/2020
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Nurse calling to request information on voluntary recall of PNEUMOV AX 23 / she had vaccines from the affected batch that were administered to 30 patients after 12Aug2020.; This spontaneous non-valid report was received from a registered nurse and refers to 30 unknown patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-AUG-2020 (also reported as after this date), voluntary recalled doses of pneumococcal vaccines, polyvalent (23-valent) (PNEUMOVAX 23) 0.5 ml (lot # S036495, expiration date not reported, but upon internal validation established as: 13-SEP-2021) (route of administration and anatomical location were not reported) were administered to 30 patients for prophylaxis. This case is considered non-valid due to no patients' identifiers. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: PNEUMOVAX 23 SYRINGE

Current Illness:

ID: 1348975
Sex: U
Age:
State: IN

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: No additional AE reported.; the vaccine was inadvertently administered after expiration.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported. On 11-MAY-2021, the patient was inadvertently vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) (0.5ml, lot # T014590, expiration date was 15-APR-2021, strength and route were not reported) for prophylaxis (Expired vaccine used). No additional adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds:

Current Illness:

ID: 1348976
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: no other AE/PQC reported; a dose of improperly stored Pedvax HIB and Rotateq were both given to a patient; This spontaneous report was received from a physician assistant and refers to a currently 2-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2021, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), lot # 1688825, expiry date: 24-NOV-2021 and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) T000885, expiry date: 29-MAY-2022 (for both: formulation, strength, dose, dose number, frequency, route of administration, anatomical location were not provided), both for prophylaxis. Administered dose of vaccines experienced the temperature excursion of 33.24 degrees Fahrenheit for 5 hours. There were no previous excursions related. Data logger was involved. No other adverse events were reported.

Other Meds:

Current Illness:

ID: 1348977
Sex: F
Age:
State: PA

Vax Date: 10/23/2017
Onset Date:
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: outbreak of shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 23-OCT-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving the vaccine, the pt suffered and outbreaks of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccine, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered to be not recovered. The reporter determined the event of shingles to be related to zoster vaccine live (ZOSTAVAX). The event of shingles was considered to be disabling.

Other Meds:

Current Illness: Routine health maintenance

ID: 1348980
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: The patient had a bad reaction to MMR; This spontaneous report was received from a consumer concerning a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient had a bad reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (ill-defined disorder). The outcome of ill-defined disorder was unknown. The causality assessment between the suspect vaccine and the event occurrence was related.

Other Meds:

Current Illness:

ID: 1348981
Sex: M
Age:
State: CA

Vax Date: 01/29/2021
Onset Date: 02/02/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Sudden hearing loss; This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN HEARING LOSS (Sudden hearing loss) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), MULTIVITAMIN & MINERAL and ANTIOXIDANTS NOS for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced SUDDEN HEARING LOSS (Sudden hearing loss) (seriousness criterion medically significant). At the time of the report, SUDDEN HEARING LOSS (Sudden hearing loss) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reported the hearing loss happen on left ear. No treatment information for the event was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: VALACYCLOVIR HCL; MULTIVITAMIN & MINERAL; ANTIOXIDANTS NOS

Current Illness: Hypothyroidism

ID: 1348982
Sex: M
Age:
State: MO

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Cerebrovascular accident; Hemiparesis; Neurological symptom; This case was received via VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) and HEMIPARESIS (Hemiparesis) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. There is no relevant medical history reported. Concurrent medical conditions included Penicillin allergy. Concomitant products included VENLAFAXINE, FINASTERIDE, TRAMADOL, PARACETAMOL (TYLENOL), ASA, CYCLOBENZAPRINE, ALPRAZOLAM, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), MULTIVITAMIN [VITAMINS NOS], FISH OIL, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), NAPROXEN SODIUM (ALEVE) and OMEPRAZOLE for an unknown indication. On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) (seriousness criterion medically significant), HEMIPARESIS (Hemiparesis) (seriousness criterion medically significant) and NEUROLOGICAL SYMPTOM (Neurological symptom). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebrovascular accident), HEMIPARESIS (Hemiparesis) and NEUROLOGICAL SYMPTOM (Neurological symptom) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Magnetic resonance imaging: light stroke but dissolved by itself.. On 24-Feb-2021, Ultrasound Doppler: unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable. Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.

Other Meds: VENLAFAXINE; FINASTERIDE; TRAMADOL; TYLENOL; ASA; CYCLOBENZAPRINE; ALPRAZOLAM; ADVAIR; FLOMAX [MORNIFLUMATE]; MULTIVITAMIN [VITAMINS NOS]; FISH OIL; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; ALEVE; OMEPRAZOLE

Current Illness: Penicillin allergy

ID: 1348983
Sex: M
Age:
State: FL

Vax Date: 02/27/2021
Onset Date: 02/27/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Syncope; Injection site pain; Injection site swelling; Nausea; Vomiting; This case was received (Reference number: 1063219) on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hyperlipidemia, Diabetes mellitus, GERD and Hypertension. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), METFORMIN, LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain), INJECTION SITE SWELLING (Injection site swelling), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Syncope), INJECTION SITE PAIN (Injection site pain), INJECTION SITE SWELLING (Injection site swelling), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: LIPITOR; FLONASE ALLERGY RELIEF; NEXIUM 1-2-3; METFORMIN; LISINOPRIL; ASPIRIN 81

Current Illness: Diabetes mellitus; GERD; Hyperlipidemia; Hypertension

ID: 1348984
Sex: F
Age:
State: NY

Vax Date: 03/03/2021
Onset Date: 03/19/2021
Rec V Date: 05/26/2021
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: loss of feeling on entire left side; Acute nonhemorrhagic right Thalamic lacunar infarct; Right Lacunar Stroke; This case was received via VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (loss of feeling on entire left side), LACUNAR INFARCTION (Acute nonhemorrhagic right Thalamic lacunar infarct) and LACUNAR STROKE (Right Lacunar Stroke) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 01UM20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy, Type 2 diabetes mellitus and Hypothyroidism. Concomitant products included METOPROLOL, LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HYPOAESTHESIA (loss of feeling on entire left side) (seriousness criteria hospitalization and disability), LACUNAR INFARCTION (Acute nonhemorrhagic right Thalamic lacunar infarct) (seriousness criteria hospitalization, disability and medically significant) and LACUNAR STROKE (Right Lacunar Stroke) (seriousness criteria hospitalization, disability and medically significant). At the time of the report, HYPOAESTHESIA (loss of feeling on entire left side), LACUNAR INFARCTION (Acute nonhemorrhagic right Thalamic lacunar infarct) and LACUNAR STROKE (Right Lacunar Stroke) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Computerised tomogram head: no hemorrhagic stroke evidence. On 19-Mar-2021, Magnetic resonance imaging head: (abnormal) Acute nonhemorrhagic right Thalamic lacunar infarc. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. The patient had right lacunar stroke causing loss of feeling on entire left side. Most feeling had returned except in left forearm and hand which has only partially recovered. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: METOPROLOL; NP THYROID; ASPRIN

Current Illness: Drug allergy; Hypothyroidism; Type 2 diabetes mellitus

ID: 1348986
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: I got the 2 vaccines and still ended up with a bad case of Shingles/ Suspected vaccination failure; Ended up with a bad case of Shingles; Now I have nerve damage; A lot of / pain; A lot of itching; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve damage, post herpetic neuralgia and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the nerve damage, post herpetic neuralgia and pruritus were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, nerve damage, post herpetic neuralgia and pruritus to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2 shingles vaccines and still ended up with a bad case of Shingles and at the time of reporting, the patient had nerve damage with a lot of itching and pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1348987
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Shingles shot and had shingles few years later / had another 2 shots for shinkles/Suspected vaccination failure; Had shingles few years later; Still have nerve pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and had shingles few years later and still had nerve pain. The patient stated that he/she had another 2 shots for shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1348992
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: had the vaccination / got shingles about a year later/suspected vaccination failure; got shingles about a year later; very painful!; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The patient got Shingles about a year after vaccination, which was very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1348993
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
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: Got my first shot, flared up; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles for 9 months). On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced shingles. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced flared up. The patient was treated with antibiotics. For tolerance of 2nd dose, refer case- US2021AMR111252, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR111252:Same reporter

Other Meds:

Current Illness:

ID: 1348994
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
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: Got my first shot, flared up / same thing with the second shot, but they cleared up quickly/Suspected vaccination failure; Got my first shot, flared up / same thing with the second shot, but they cleared up quickly; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with dermatologicals nos (Calamine Lotion). On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The age at vaccination and age group were not reported. The case was reported by the patient. The patient got 1st shot of Shingles vaccine and had them for 9 months last year, the events also flared up. The patient went on the antibiotics immediately. Same thing with the 2nd shot of Shingles vaccine, but they cleared up quickly calamine lotion was your best friend. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided. For tolerance in 1st dose refer case US2021AMR111243.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR111243:Same reporter

Other Meds:

Current Illness:

ID: 1348995
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: I have had them 4 times and I had the shot/Suspected vaccination failure; I have had them 4 times and I had the shot; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient have had Shingles vaccine and had them 4 times. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.

Other Meds:

Current Illness:

ID: 1348996
Sex: F
Age: 55
State: TX

Vax Date: 12/14/2020
Onset Date: 12/14/2020
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Received ENGERIX-B a total of 4 times / most recent doses where on 5/10/21 and 12/14/2020; The first two are historical / most recent doses where on 5/10/21 and 12/14/2020; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received HBV (Engerix B adult) for prophylaxis. Co-suspect products included HBV (Engerix B adult) for prophylaxis. Previously administered products included Engerix B (1st dose received on unknown date) and Engerix B (2nd dose received on unknown date). On 10th May 2021, the patient received the 4th dose of Engerix B adult. On 14th December 2020, the patient received the 3rd dose of Engerix B adult. On 14th December 2020, not applicable after receiving Engerix B adult and unknown after receiving Engerix B adult, the patient experienced drug dose administration interval too long. On 10th May 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown. Additional details were provided as follows: The patient received 2 doses as history in past. The patient received the 3rd dose of Engerix B later than recommended time interval, which led to lengthening of the schedule and received 4th dose apart from the schedule, which led to extra dose administered. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1348997
Sex: F
Age: 69
State: NY

Vax Date: 12/01/2020
Onset Date: 03/01/2021
Rec V Date: 05/26/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Diagnosed with GBS / Hospitalized her for 5 nights to undergo testing/ Gullian-Barre Syndrome; Tingling in her arms and legs / Hospitalized her for 5 nights to undergo testing; legs were weak / Hospitalized her for 5 nights to undergo testing; fell down / Hospitalized her for 5 nights to undergo testing; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 VACCINE MODERNA for prophylaxis and COVID-19 VACCINE MODERNA for prophylaxis. On 1st December 2020, the patient received Shingrix. On 15th January 2021, the patient received the 1st dose of COVID-19 VACCINE MODERNA .05 ml. On 12th February 2021, the patient received the 2nd dose of COVID-19 VACCINE MODERNA .05 ml. On 1st March 2021, 90 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization), lower extremities weakness of (serious criteria hospitalization) and fall (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and tingling of extremity were recovering/resolving and the outcome of the lower extremities weakness of and fall were recovered/resolved. It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall to be related to Shingrix. Additional details were provided as follows: The patient experienced tingling in her arms and legs. The patient went to the physician's office on 1st March 2021 and her legs were weak and she fell down. The patient went to the emergency room, and the neurologist on duty hospitalized her for 5 nights to undergo testing. The patient had a brain scan which was negative, lumbar puncture which was negative and X-Rays were negative. The patient then underwent an electroencephalogram and was diagnosed with guillain barre syndrome. Her symptoms at time of reporting were slightly improved. On 1st March 2021, 45 days after receiving 1st dose and 17 days after receiving 2nd dose of Covid-19 vaccine Moderna, the patient experienced guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall. It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall to be related to Covid-19 vaccine Moderna and Covid-19 vaccine Moderna. The emergency room visit was required. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1348999
Sex: U
Age:
State: IN

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: received Engerix-B pediatric dose instead of an adult dose; received Engerix-B pediatric dose instead of an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a patient who received HBV (Engerix B pediatric) for prophylaxis. On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist was looking for medical information because the reporter realized the someone received Engerix-B pediatric dose instead of an adult dose, which led to underdose and adult use of a child product. At the moment of the call there were any details about patient involved but was going to search them. The reporter also did not know if this error was for a first or second dose in patient?s vaccine schedule. The reporter consented to follow up by email.

Other Meds:

Current Illness:

ID: 1349006
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 05/21/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: received the first dose of Twinrix in November 2020 / patient had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 36-year-old male patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Twinrix (1st dose received in November 2020, batch number: 9RT94, expiry date: 24th May 2022). On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 21st May 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter called to report that, the patient was late for Twinrix second dose, between the first and second dose 6 months had passed. Till the time of the reporting the patient had not received the second dose, which led to incomplete course of vaccination. No further events were reported.

Other Meds:

Current Illness:

ID: 1349007
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/26/2021
Hospital: Y

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: MEDICATION INDUCED COLITIS; RECTAL BLEEDING; RENAL INSUFFICIENCY; MUSCLE TENDERNESS; HEADACHE; NAUSEA; REDNESS AT INJECTION SITE; FEVER; GENERALIZED ITCHY RASH; SWELLING AT INJECTION SITE; DIZZINESS; RINGING IN THE RIGHT EAR; INTENSE MUSCLE/JOINT CRAMPING; JOINT TIGHTNESS; LUMP AT INJECTION SITE; BLOATING; UNABLE TO EAT OR DRINK; HAD POLYP; SMALL INTERNAL HEMMORRHOID; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: unknown) dose was not reported, 1 total administered to left deltoid on 14-MAR-2021 for prophylactic vaccination. The patient received Benadryl unspecified (form of admin and route of admin were not reported, batch number: unknown expiry: unknown) dose and frequency were not reported from MAR-2021 for itchy rash. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, after eight hours of vaccination, the patient woke up with intense muscle cramping which she had anticipated but also had joint cramp. The patient had temperature of 103.5 (unit unspecified) and the patient's right side of face was itching down into under her ears which also started to swell. The patient had a rash on her legs, arms, face and everything was itchy for her. The patient took a diphenhydramine (Benadryl) and then she had headache, dizziness, ringing in the right ear, nausea, and her fever jumped to 104. The patient laid down her head into floor because the dizziness was so bad and she ended up in more muscle cramping. The patient's fever never went away but went down and did not go for about a week and three days; the fever was just hanging out at 100 (unit unspecified) the whole time. The patient's dizziness and ringing was going on and also had GI (gastrointestinal) problems and really bad headache. The patient called a healthcare company and ordered meclizine (Meclizine) but did not specified she administered it or not. On 26-MAR-2021, the patient could not take the stomach pain, cramping, diarrhea, high fever, rectal bleeding and mucusy and bloody stool. The patient had intense abdominal pain and GI (gastrointestinal) issues after three days of her fever and was taken to ER (emergency room) and was confirmed that the patient had renal insufficiency and medication induced colitis. The patient had colitis and was given with metronidazole (Flagyl), however she had low grade fever, dizziness, ringing in ears, really bad headache and was admitted to hospital on 28-MAR-2021. The patient's CRP (C-reactive protein) was up, lactic acid was elevated, hemoglobin went from 14 down to 12, WBC count elevated, occult blood was positive and also had rectal bleeding, a foggy headache and dizziness feeling. The patient felt something was way off in her body at the side, also had a small orange halo on arm at the injection site which got resolved after four days. The patient had undergone unspecified tests and the results was negative. The patient liver enzymes were too off which was hand in hand with medication induced colitis. The patient had a small internal hemorrhoid and removed a polyp. The patient's heart rate experienced some issues as well. The patient was hospitalized for 6 days. The patient was discharged on 02-APR-2021.The patient had a follow-up with her physician on the next day of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with Benadryl unspecified was not reported. The patient recovered from had polyp on MAR-2021, generalized itchy rash on 16-MAR-2021, muscle tenderness on 06-APR-2021, and redness at injection site on 18-MAR-2021, was recovering from ringing in the right ear, rectal bleeding, medication induced colitis, joint tightness, lump at injection site, bloating, swelling at injection site, and small internal hemorrhoid, had not recovered from fever, headache, and dizziness, and the outcome of intense muscle/joint cramping, nausea, unable to eat or drink and renal insufficiency was not reported. This report was serious (Hospitalization Caused/Prolonged, and Other Medically Important Condition). This case is associated with the product quality complaint number 90000176228. This case is a duplicate of 20210429754. Additional information was received from patient on 13-APR-2021. It was determined that Manufacturer Case Number 20210429754 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20210427282.; Sender's Comments: V0: 20210427282-covid-19 vaccine ad26.cov2.s- rectal bleeding, medication induced colitis, renal insufficiency and had polyp. 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: CONMEDS-OTHER SUSPECT DRUGS

Other Meds:

Current Illness:

ID: 1349008
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: STAGE 5 KIDNEY FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose once total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced stage 5 kidney failure. The action taken with covid-19 was not applicable. The outcome of stage 5 kidney failure was not reported. This report was serious (Disability Or Permanent Damage). This case, from the same reporter is linked to. Sender's Comments: COVID-19 VACCINE stage 5 kidney failure. 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: 1349009
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 05/15/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: CHEST PAIN; DIZZINESS; SHORTNESS OF BREATH; SHE WAS UNABLE TO MOVE FOR WHOLE DAY; CRAWL TO THE BATHROOM; CHILLS; HEADACHE; FATIGUE; BURNING ARM; BODY ACHE; CHEST TIGHTNESS; LEFT ARM PAIN; LEFT SIDE OF BODY OUT OF IT; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1806025, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced left side of body out of it. On 15-MAY-2021, the subject experienced chest tightness. On 15-MAY-2021, the subject experienced left arm pain. On 15-MAY-2021, the subject experienced burning arm. On 15-MAY-2021, the subject experienced body ache. On 16-MAY-2021, the subject experienced she was unable to move for whole day. On 16-MAY-2021, the subject experienced crawl to the bathroom. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced headache. On 16-MAY-2021, the subject experienced fatigue. On 18-MAY-2021, the subject experienced chest pain. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from she was unable to move for whole day, was recovering from crawl to the bathroom, had not recovered from fatigue, burning arm, headache, dizziness, shortness of breath, chills, left arm pain, and chest pain, and the outcome of left side of body out of it, chest tightness and body ache was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Other Meds:

Current Illness:

ID: 1349010
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: ORAL THRUSH; WHOLE BODY IS INFLAMED; EYE TWITCHING; LEG JERKING; PRESSURE UNDER HER RIB CAGE; HOT TO TOUCH; RASH ON UPPER ARM, CHEST, STOMACH; LEFT ARM SORE; UNEXPLAINED BLUE/PURPLE BRUISING ON FRONT AND BACK LEG; BAD TASTE; LOSING TASTE; BURNING IN THE MOUTH; SWOLLEN TONGUE; ITCHINESS ALL OVER THE BODY; SKIN FELT LIKE IT'S BURNING AND HOT TO TOUCH; LIPS NUMBING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known health condition and was taking supplements only. the patient never had allergy medications (never get seasonal allergies).The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin felt like it's burning and hot to touch. On APR-2021, the subject experienced lips numbing. On 08-APR-2021, the subject experienced itchiness all over the body. On 20-APR-2021, the subject experienced burning in the mouth. On 20-APR-2021, the subject experienced swollen tongue. On 20-APR-2021, the subject experienced bad taste. On 20-APR-2021, the subject experienced losing taste. On MAY-2021, the subject experienced unexplained blue/purple bruising on front and back leg. On MAY-2021, the subject experienced left arm sore. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) normal white blood cells and iron level low, Platelet count (NR: not provided) normal, Serum iron (NR: not provided) low, and White blood cells (NR: not provided) Normal. On an unspecified date, the subject experienced oral thrush, whole body is inflamed, eye twitching, leg jerking, pressure under her rib cage, hot to touch, and rash on upper arm, chest, stomach. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from skin felt like it's burning and hot to touch, and rash on upper arm, chest, stomach, was recovering from pressure under her rib cage, had not recovered from swollen tongue, and burning in the mouth, and the outcome of itchiness all over the body, unexplained blue/purple bruising on front and back leg, eye twitching, leg jerking, left arm sore, whole body is inflamed, bad taste, losing taste, lips numbing, hot to touch and oral thrush was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534998.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.

Other Meds:

Current Illness: Abstains from alcohol; Allergic reaction to antibiotics; Non-smoker

ID: 1349012
Sex: F
Age:
State: NV

Vax Date:
Onset Date: 05/17/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: SORE THROAT MORE ON THE LEFT SIDE OF THROAT; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced sore throat more on the left side of throat. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from sore throat more on the left side of throat. This report was non-serious.

Other Meds:

Current Illness:

ID: 1349014
Sex: M
Age:
State: CO

Vax Date:
Onset Date: 05/15/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: RESTLESS SLEEP; FELT COLD; INJECTION SITE SORENESS; TIRED; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced restless sleep. On 15-MAY-2021, the subject experienced felt cold. On 15-MAY-2021, the subject experienced injection site soreness. On 15-MAY-2021, the subject experienced tired. On 15-MAY-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.4 (unit unspecified). On 16-MAY-2021, Laboratory data included: Body temperature (NR: not provided) normal. The action taken with covid-19 vaccine was not applicable. The patient recovered from restless sleep, felt cold, and low grade fever on 16-MAY-2021, injection site soreness on 19-MAY-2021, and tired on 17-MAY-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1349015
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ITCH IN LEGS AND ARM; LITTLE POLKA DOTS /FLUID-FILLED BLISTERS (RASH ON ARMS AND LEGS AND LITTLE BIT ON STOMACH); SHARP PAINS FROM SHOULDER TO THE ELBOW/ SORE ARM; SHARP PAIN DOWN TO WRIST/JOINT PAIN; FLUID LEAKING; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included supraventricular tachycardia, low blood pressure, and osteoporosis, and other pre-existing medical conditions included the patient had taken a natural hormone medication from a compounding pharmacy and also osteonutrients and unspecified medication for osteoporosis. The patient experienced drug allergy when treated with cyclobenzaprine hydrochloride, and tetanus vaccine for drug used for unknown indication, drug allergy when treated with clarithromycin, diazepam, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 08:55 for prophylactic vaccination. Concomitant medications included atenolol for supraventricular tachycardia. On 13-MAY-2021, the subject experienced fluid leaking. On 13-MAY-2021, the subject experienced sharp pains from shoulder to the elbow/ sore arm. On 13-MAY-2021, the subject experienced sharp pain down to wrist/joint pain. On 14-MAY-2021, the subject experienced itch in legs and arm. On 14-MAY-2021, the subject experienced little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach). Treatment medications (dates unspecified) included: calamine/glycerol/zinc oxide, ibuprofen, charcoal, activated, triamcinolone acetonide, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from sharp pain down to wrist/joint pain on 14-MAY-2021, had not recovered from little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach), and itch in legs and arm, and the outcome of fluid leaking and sharp pains from shoulder to the elbow/ sore arm was not reported. This report was non-serious.

Other Meds: ATENOLOL

Current Illness: Low blood pressure; Osteoporosis; Supraventricular tachycardia

ID: 1349016
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: ACHES; This spontaneous report received from a patient via a company representative 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced aches. The action taken with covid-19 vaccine was not applicable. The outcome of aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210539064.

Other Meds:

Current Illness:

ID: 1349017
Sex: M
Age:
State: SC

Vax Date:
Onset Date: 05/19/2021
Rec V Date: 05/26/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: MULTIPLE PULMONARY EMBOLISM; MULTIPLE BLOOD CLOTS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose not reported, 1 total, on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient developed multiple pulmonary embolism included multiple blood clots. On 19-MAY-2021, after 4 week of vaccination, the patient was diagnosed with suspected covid-19 infection (suspected clinical vaccination failure) and was not doing well. The patient got hospitalized. Number of hospitalization days was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure, multiple pulmonary embolism and multiple blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This report was associated with product quality complaint number: 90000180239. The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210539965-covid-19 vaccine ad26.cov2.s - multiple pulmonary embolism,multiple blood clots,suspected covid 19 infection. 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). V0:20210539965 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: 1349018
Sex: F
Age:
State: NV

Vax Date:
Onset Date: 05/18/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: HOT SPOT SENSITIVE; ROUND BUMP RED CIRCLE ABOUT AN INCH ON ARM NEXT TO THE INJECTION SITE; FELT TIRED; MILD HEADACHE; 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 diabetes, fibromyalgia, non hodgkin's lymphoma, and sulfa allergy.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042172117 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced felt tired. On 18-MAY-2021, the subject experienced mild headache. On 19-MAY-2021, the subject experienced round bump red circle about an inch on arm next to the injection site. On an unspecified date, the subject experienced hot spot sensitive. The action taken with covid-19 vaccine was not applicable. The patient recovered from mild headache on 18-MAY-2021, was recovering from felt tired, had not recovered from round bump red circle about an inch on arm next to the injection site, and the outcome of hot spot sensitive was not reported. This report was non-serious. This parent/child case is linked to 20210540029.

Other Meds:

Current Illness: Diabetes; Fibromyalgia; Non-Hodgkin's lymphoma; Sulfonamide allergy

ID: 1349019
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient had no family or personal history of clots and no provoking factors. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 18-MAY-2021, the patient presented to the emergency department with one week of leg swelling and pain. The patient work up was notable for deep vein thrombosis ultrasound positive for deep venous thrombosis in the left lower extremity in distal femoral and popliteal and PE study showing filling defect in the lobar and interlobar pulmonary arteries extending to segmental and subsegmental pulmonary arteries, right greater than left. On MAY-2021, the subject experienced deep vein thrombosis and pulmonary embolism. The action taken with covid-19 vaccine was not applicable. The outcome of deep vein thrombosis and pulmonary embolism was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: COVID-19 VACCINE deep vein thrombosis, pulmonary embolism. 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: 1349020
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (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 subject experienced unspecified adverse event. The action taken with covid-19 vaccine was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1349021
Sex: M
Age:
State: IN

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: CHILLS; HEADACHE; POSSIBLE EXPIRED VACCINE ADMINISTERED; 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 (suspension for injection, route of admin not reported, batch number: 042801A expiry: 01-FEB-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced possible expired vaccine administered. On 17-MAY-2021, the subject experienced chills. On 17-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, had not recovered from headache, and the outcome of possible expired vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1349022
Sex: F
Age:
State: MN

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/26/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: FALL/SHE FELL OVER AGAIN; UPON DISCHARGE WENT HOME WITH WALKER/SENT HER HOME WITH A WALKER; HAVING TROUBLE WITH HER DAILY LIFE; RED POLKADOTS ON HANDS; DRY SKIN; SOMETHING IN THROAT/RASPY THROAT; LEGS COLLAPSED; HER LEGS TURNED TO RUBBER; SAT DOWN HARD ON HER RIGHT ASS; HIT HEAD ON THE PAVEMENT; IT HURT; GOT UP DURING THE NIGHT; This spontaneous report received from a patient concerned a 68 year old other race female. The patient's height, and weight were not reported. The patient's past medical history included has broken 3 bones in the top of the foot, stroke, and shattered her shoulders and arm, and concurrent conditions included seizure, hydrochlorothiazide allergy, and penicillin allergy. The patient taking blood pressure pills and pills for seizures (unspecified). The patient received Covid-19 (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) 1 total dose, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient hurts. Then the patient went home; and went to store for picked up some groceries. On the way back to car the patient's legs turned to rubber and she sat down. Her legs collapsed and sat on ass hit head on the pavement. On 25-MAR-2021 the patient got up during the night and same things happened again and she fell over again and spent the night on the floor and admitted to hospital (dates unspecified) for 4 days and the patient received blood thinner shots (unspecified) in her stomach. The patient discharged from hospital (dates unspecified) with walker. On an unspecified dates the patient had all kinds of tests and all came back normal. On an unknown date the patient having trouble with her daily life. The patient had a physical therapy and occupational therapy for a month. On 30-MAR-2021, the patient experienced dry skin and something in throat/raspy throat. On an unknown date the patient had red polkadots on hands. The action taken with covid-19 vaccine was not applicable. On an unknown date the patient was recovered from fall/she fell over again, and not recovered from dry skin, and something in throat/raspy throat and the outcome for and the outcome of red polkadots on hands, her legs turned to rubber, sat down hard on her right ass, legs collapsed, hit head on the pavement, got up during the night, it hurt, upon discharge went home with walker/sent her home with a walker and having trouble with her daily life was not reported This report was serious (Hospitalization Caused / Prolonged). FALL/SHE FELL OVER AGAIN. 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: Drug allergy; Penicillin allergy; Seizure (Takes a blood pressure pill and something for seizures.)

ID: 1349023
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; FALSE POSITIVE PCR TEST; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient underwent to SARS-CoV-2 PCR test and diagnosed with the false positive result and had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of false positive PCR test and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000180230, PQM001525200 and PQM001525259. The suspected product quality complaint has been confirmed to be this record indicates an adverse event. there is no product quality issue reported. Approval to void this record due to no PQC identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210541182-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccine failure . This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1349024
Sex: F
Age:
State: WA

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Head cold; Feeling Sick; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 72.7 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZE019B0101 expiry: 31-JUL-2024) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, and dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included tadalafil. On an unspecified date, the subject experienced head cold, and feeling sick. The action taken with covid-19 vaccine , and macitentan was not applicable. The outcome of the feeling sick and head cold was not reported. This report was non-serious.

Other Meds: ADCIRCA

Current Illness: Primary pulmonary hypertension

ID: 1349026
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: NECK PAIN; This spontaneous report received from a consumer received on 14-MAY-2021 and concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Batch number was not reported and has been requested. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced neck pain. The action taken with covid-19 vaccine was not applicable. The outcome of neck pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1349027
Sex: U
Age:
State: NM

Vax Date:
Onset Date: 05/12/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: INCORRECT STORAGE OF DRUG; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced incorrect storage of drug. On 12-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the incorrect storage of drug and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210540069 and 20210540338.

Other Meds:

Current Illness:

ID: 1349028
Sex: M
Age:
State: KY

Vax Date:
Onset Date: 04/02/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: COUGH; SLIGHT ARM SORENESS; WEAKNESS/REALLY WEAK; HEADACHES EXCRUCIATING AFTER THE VACCINE; FEVER; SORE THROAT; COVID EYES; POST NASAL DRIP; This spontaneous report received from a consumer concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced post nasal drip. On 02-APR-2021, the subject experienced sore throat. On 02-APR-2021, the subject experienced covid eyes. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced slight arm soreness. On 02-APR-2021, the subject experienced weakness/really weak. On 02-APR-2021, the subject experienced headaches excruciating after the vaccine. On 02-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore throat, covid eyes, cough, and fever on 06-APR-2021, and slight arm soreness on 04-APR-2021, was recovering from weakness/really weak, and headaches excruciating after the vaccine, and the outcome of post nasal drip was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545446.

Other Meds:

Current Illness:

ID: 1349029
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 05/15/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: WEAKNESS OF THE RIGHT SIDE OF THE BODY; NUMBNESS ON RIGHT SIDE OF THE BODY; PAIN ON THE RIGHT SIDE OF THE BODY; STIFFNESS OF BODY; FEELING OF HEAVINESS IN BODY; HEADACHE; MUSCLE PAIN THAT EXTENDS TO THE BONES; This spontaneous report received from a consumer concerned a 59 year old not Hispanic or Latino, Asian female. The patient's weight was 130 pounds, and height was 162 centimeters. The patient's past medical history included pain on the right side of the body but not similar to what she was experiencing now, and concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies and patient had no drug abuse or illicit drug usage. The patient was not pregnant at the time of report. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805029, expiry: unknown) frequency 1 total, dose was not reported, administered on 13-MAR-2021 at deltoid in left arm for prophylactic vaccination. No concomitant medications were reported. The reporter stated that on the 15-MAY-2021, his mother started to develop side effects of the vaccine such as headache, pain and numbness on her right side of the body which started from her head to her feet and weakness of the right side of the body. According to the reporter the pain scale varied from 6-10/10, she described the pain like a feeling of heaviness, stiffness and muscle pain that extends to her bones. The patient consulted her health care professional and Chiropractor 2 days before the date of report and they did not prescribe anything but recommended to do MRI which she will do moving forward. Patient was taking over the counter pain medication and had massage on the painful area but it only helped for a short period of time and according to her son it was really affecting her activity of daily living (subsumed under event weakness of the right side of the body) as the symptoms were getting worse. On an unspecified date in MAY-2021, Laboratory data included: Pain scale (NR: not provided) the pain scale varies from 6-10/10. On 01-MAY-2021, Laboratory data included: Colonoscopy (NR: not provided) Unknown. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from numbness on right side of the body, pain on the right side of the body, weakness of the right side of the body, headache, feeling of heaviness in body, stiffness of body, and muscle pain that extends to the bones. This report was serious (Other Medically Important Condition). covid-19 vaccine weakness of the right side of the body. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Abstains from alcohol; Blood pressure high; Non-smoker

ID: 1349030
Sex: F
Age:
State: WY

Vax Date:
Onset Date: 04/28/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: MILD HEADACHE; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 118 pounds, and height was not reported. The patient's concurrent conditions included hashimoto's hypothyroidism autoimmune disease, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) 98.4 to 99.9 Fahrenheit, 97.6 Fahrenheit, 100.0 Ferhenheit. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 94.5 Fahrenheit. On 28-APR-2021, the subject experienced mild headache. On 28-APR-2021, the subject experienced fever. On 29-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100 Fahrenheit. On 12-MAY-2021, treatment medications included: amoxicillin trihydrate/clavulanate potassium. On 17-MAY-2021, treatment medications included: doxycycline, and methylprednisolone. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from mild headache, and fever. 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: Hashimoto's disease

ID: 1349031
Sex: F
Age:
State: MA

Vax Date:
Onset Date: 05/12/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: LEG PAIN; TIREDNESS; SORE MUSCLES; SHAKINESS; SORE SHOULDER; This spontaneous report received from a consumer concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatic in leg, sulfa allergy, non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no other health conditions or current medication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced shakiness. On 12-MAY-2021, the subject experienced sore shoulder. On 12-MAY-2021, the subject experienced tiredness. On 12-MAY-2021, the subject experienced sore muscles. On 13-MAY-2021, the subject experienced leg pain. Laboratory data included: Screening test (NR: not provided) Unknown. On 18-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal (Platelet count was normal). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from shakiness, tiredness, sore shoulder, and sore muscles, and the outcome of leg pain was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Allergic reaction to antibiotics; Cigarette smoker (5 Cigarettes per day); Sciatica

ID: 1349032
Sex: M
Age:
State: RI

Vax Date:
Onset Date: 05/18/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: JANSSEN COVID-19 VACCINE ADMINISTERED AFTER BEING AT ROOM TEMPERATURE FOR OVER 2 HOURS; JANSSEN COVID-19 VACCINE BEING AT ROOM TEMPERATURE FOR OVER 2 HOURS; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced janssen covid-19 vaccine administered after being at room temperature for over 2 hours. On 18-MAY-2021, the subject experienced janssen covid-19 vaccine being at room temperature for over 2 hours. The action taken with covid-19 vaccine was not applicable. The outcome of the janssen covid-19 vaccine administered after being at room temperature for over 2 hours and janssen covid-19 vaccine being at room temperature for over 2 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545147.

Other Meds:

Current Illness:

ID: 1349033
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/21/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: MENSTRUAL BLEEDING (VAGINAL BLEEDING); SLIGHTLY SWEATY; ARM PAIN; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcohol use, and other pre-existing medical conditions included the patient have no known drug allergies and being healthy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 21-MAY-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced menstrual bleeding (vaginal bleeding). On 21-MAY-2021, the subject experienced slightly sweaty. On 21-MAY-2021, the subject experienced arm pain. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from menstrual bleeding (vaginal bleeding), slightly sweaty, and arm pain. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (very rarely); Non-smoker

ID: 1349034
Sex: M
Age:
State: MN

Vax Date:
Onset Date: 05/21/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: VOMITING; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seizure. 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 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levetiracetam for seizures. On 21-MAY-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vomiting was not reported. This report was non-serious.

Other Meds: LEVETIRACETAM

Current Illness: Seizure (Takes seizure medication.)

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm