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: 1349930
Sex: M
Age: 91
State:

Vax Date: 01/11/2020
Onset Date: 01/13/2020
Rec V Date: 01/14/2021
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: N/A

Other Meds:

Current Illness:

ID: 1349931
Sex: M
Age: 75
State:

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Patient received COVID-19 vaccine at assisted living facility. Had myalgia symptoms from 01/08/21-01/21/21. Has resolved since.

Other Meds:

Current Illness:

ID: 1349932
Sex: M
Age: 90
State:

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient reported feeling dizzy 10 minutes after receiving the vaccination. His vital signs were taken at 1100: BP 11760, HR 49, 02Sat 94%, T 98.6 which is consistent with his baseline. Patient wife stated "he has a vascular problem in his brain and he gets dizzy spells like this at home." Veteran was instructed to remain seated for a few more minutes. Patient reported feeling shaky and was given 4oz of orange juice. His vital signs were retaken at 1125: BP 138/63, HR 54, 02Sat 96%, Blood glucose 164. Provider consulted. After symptoms resolve and pt. history reviews, patient was sent home at 1130.

Other Meds:

Current Illness:

ID: 1349933
Sex: F
Age: 67
State:

Vax Date: 01/11/2021
Onset Date: 01/13/2021
Rec V Date: 01/14/2021
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: Myalgia, SkinRash, developed skin rash over neck/left clavicle about 48 hours post vaccine; Had myalgia/fatigue about 24 hours post vaccine Narrative:

Other Meds:

Current Illness:

ID: 1349934
Sex: M
Age: 98
State: IL

Vax Date: 01/05/2021
Onset Date: 01/11/2021
Rec V Date: 01/14/2021
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: Patient was hospitalized at an outside hospital and treated for cellulitis. Rash & ErythemaMultiform

Other Meds:

Current Illness:

ID: 1349936
Sex: F
Age: 36
State:

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 01/14/2021
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: Headache, Myalgia, Diarrhea, NauseaVomiting, chills, fatigue Narrative: within 48 hours of vaccine employee reported vomiting and diarrhea, self resolved; then 7 days after vaccine developed fever to 103.8, headache, chills, fatigue, body aches. Testing for COVID was recommended, employee tested negative for COVID on 01/11/21.

Other Meds:

Current Illness:

ID: 1349937
Sex: F
Age: 65
State:

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 01/14/2021
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: Myalgia, Nausea Vomiting, Fatigue Missed work following second dose secondary to above symptoms

Other Meds:

Current Illness:

ID: 1349938
Sex: F
Age: 40
State:

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/14/2021
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: Narrative: PATIENT VACCINATED ON 12/23/2020, PRESENTED TODAY (01/13/2021) FOR 2ND VACCINE. SHE REPORTED SYMPTOMS OF CONFUSION, DISORIENTATION, AND TASK WERE HARD TO COMPLETE, STATED SHE FELT LIKE SHE WAS DRUGGED. THESE ISSUES STARTED 2 HOURS AFTER SHE RECEIVED VACCINE.

Other Meds:

Current Illness:

ID: 1349939
Sex: M
Age: 43
State:

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/14/2021
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: Sedation diaphoresis Per ER report, effects were most likely not due to his vaccine, other causes.

Other Meds:

Current Illness:

ID: 1349940
Sex: M
Age: 37
State:

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/14/2021
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: Headache Pt experienced throbbing frontal headache 30 minutes after receiving 2nd dose of covid vaccine leading to ED visit. Given APAP and ibuprofen.

Other Meds:

Current Illness:

ID: 1349941
Sex: M
Age: 41
State:

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/14/2021
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: Myalgia sweating, chills and moderate to severe pain at the site Narrative:

Other Meds:

Current Illness:

ID: 1349942
Sex: F
Age: 32
State:

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/14/2021
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: Dizziness Narrative: After second dose of covid vaccine, pt felt dizzy, flushed, sweaty, and racing heartbeat, leading to ED visit. Given IM Benadryl.

Other Meds:

Current Illness:

ID: 1349943
Sex: M
Age: 62
State:

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 01/14/2021
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: Myalgia left axilla swelling, enlarged lymph nodes Narrative:

Other Meds:

Current Illness:

ID: 1349944
Sex: F
Age: 65
State:

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/14/2021
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: Localized reaction Narrative:

Other Meds:

Current Illness:

ID: 1349945
Sex: F
Age: 58
State:

Vax Date: 12/31/2020
Onset Date: 01/05/2021
Rec V Date: 01/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Headache, Diarrhea, NauseaVomiting, congestion, chills Narrative:

Other Meds:

Current Illness:

ID: 1349946
Sex: F
Age: 41
State:

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/14/2021
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: Headache, Myalgia, Fever, Fatigue, Chills Narrative:

Other Meds:

Current Illness:

ID: 1349969
Sex: F
Age: 50
State:

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/14/2021
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: Headache, Fever, Chills Narrative:

Other Meds:

Current Illness:

ID: 1416796
Sex: M
Age: 79
State:

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/14/2021
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: Headache and Myalgia Treatment:IBUPROFEN BID

Other Meds:

Current Illness:

ID: 1416847
Sex: M
Age: 75
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/14/2021
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: Myalgia & right arm pain x5 days

Other Meds:

Current Illness:

ID: 1416851
Sex: M
Age: 78
State:

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/14/2021
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: Myalgia

Other Meds:

Current Illness:

ID: 1416852
Sex: M
Age: 49
State:

Vax Date: 01/08/2021
Onset Date: 01/11/2021
Rec V Date: 01/14/2021
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: Myalgia, Arthralgia, Nausea Vomiting, SEVERE ABDOMINAL CRAMPING AND PAIN Narrative:

Other Meds:

Current Illness:

ID: 1416854
Sex: M
Age: 76
State:

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/14/2021
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: Narrative: Symptoms: Myalgia Treatment:

Other Meds:

Current Illness:

ID: 1416916
Sex: M
Age: 75
State:

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Headache & SkinRash

Other Meds:

Current Illness:

ID: 1416920
Sex: M
Age: 78
State:

Vax Date: 12/30/2020
Onset Date: 01/02/2021
Rec V Date: 01/14/2021
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: Narrative: Symptoms: UrticariaPruritus & itching to right face remains Treatment:

Other Meds:

Current Illness:

ID: 1416923
Sex: M
Age: 80
State:

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 01/14/2021
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: Symptoms: & Pain in injection arm remains

Other Meds:

Current Illness:

ID: 0945738
Sex: U
Age:
State: PR

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Chills; fever; This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received her second dose of bnt162b2 (BNT162B2 reported as Covid 19 vaccine/ Covid Vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient had the first dose on an unspecified date for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced chills and fever after second dose of Covid 19 vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 0945747
Sex: M
Age:
State: UT

Vax Date:
Onset Date: 10/01/2019
Rec V Date: 01/15/2021
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: red itchy rash on anterloposterior torso, upper inner arms, neck groin, all apparent in a.m.; This spontaneous report was received from healthcare professional and refers to a male patient of an unknown age. The patient had no known allergy, no other illness at the time of vaccination and no chronic or long-standing health conditions. At the time of vaccination, the patient was taken unspecified herbal remedies. There was no information about the patient's medical history provided. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (reported as HPV vaccine of Merck & Co but lot # S008154 has been verified to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), expiration date was not provided but upon internal validation established as 20-NOV-2021), in the deltoid, intramuscularly for prophylaxis (exact dose was not provided) and influenza virus split virion 3v vaccine inactivated (FLUARIX) lot number: TAR35, intramuscularly in the deltoid, for prophylaxis (exact dose and expiration date were not provided) (age at vaccination was provided as 15years and 11 months). On 01-OCT-2019 at 07:00 am, the patient awoke with red itchy rash on anterioposterior torso, upper inner arms, neck groin, all apparent in the morning. As treatment prednisone and methylprednisolon (MEDROL) dose pack were given. The patient had to follow prednisone dosing and cetirizine (ZYRTEC). The outcome of the event was not recovered. The causality assessement was not provided. Follow-up information was received from a medical assisstant on 04-JAN-2021. Additional information has been requested. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S008154; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness: Prophylaxis

ID: 0945748
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
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: severe adverse reaction; This spontaneous report was received from a health care professional via Pfizer and refers to a 64 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On approximately 2015 (reported as 5 to 7 years ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number was reported as unknown; strength, dose, frequency, route of administration and expiration date were not reported) for prophylaxis. On an unknown date, the patient reacted severely to vaccination (vaccination complication). The outcome of vaccination complication was unknown. The causal relationship between the event and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.

Other Meds:

Current Illness:

ID: 0945749
Sex: U
Age:
State: NY

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/15/2021
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: No additional AE; doses were administered following the excursion; This spontaneous report was received from a physician referring to a 13-month-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 23-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) lot # T021642, expiration date 21-DEC-2021, at a dose of 0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No additional adverse event reported. The vaccine was stored in a temperature of max 16.2 degree Fahrenheit (?F) for 2 hours 28 minutes as recorded by a data logger. There was no previous temperature excursion reported.

Other Meds:

Current Illness:

ID: 0945750
Sex: U
Age:
State: SC

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/15/2021
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: temperature excursion ROTATEQ/one dose of ROTATEQ being administered to a patient; This spontaneous report was received from a medical assistant referring to a 6-month-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 04-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1691141, expiration date 01-NOV-2021, at a dose of 2 milliliter, orally for prophylaxis. The vaccine was stored in a temperature of 8.6 degree Celsius (C) for 11 hours, 15 minutes and 8.7 C for 59 minutes, as recorded by a data logger. There was no previous temperature excursion reported.

Other Meds:

Current Illness:

ID: 0945751
Sex: U
Age:
State: WV

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/15/2021
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: No additional ae reported; PROQUAD was administered to a patient post-expiry; This spontaneous report was received from a nurse referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. The nurse reported that one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) lot # S021326 was administered to a patient post-expiry (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The administration was performed by a medical assistant with the practice, not the reporting nurse. She was calling to determine the "integrity" of the vaccine and if the dose needed to be repeated. The involved measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (rha) (PROQUAD) expired on 05-JAN-2021 and was administered on 06-JAN-2021. No additional adverse event reported, and no further information provided.

Other Meds:

Current Illness:

ID: 0945752
Sex: U
Age:
State: CA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/15/2021
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: No adverse event reported; Gardasil 9 had been stored in the freezer rathen than the refrigerator. It was administered one time this morning; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's, pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported. On 11-JAN-2021 (also reported as: this morning), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (route of administration, anatomical location and vaccine scheme were not provided), lot number: R036913 has been verified to be a valid lot number, expiration date was on 23-SEP-2021 as prophylaxis. On the same date (reported as "when we came in today"), it was realized that HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) had been stored in the freezer rather than the refrigerator (product storage error ) and it was administered one time this morning. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -11 Fahrenheit (?F), for a time frame of 24 hours 0 minutes. A digital data logger was involved. There were no previous temperature excursions reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp and Dohme Corp.; devicelotnumber: R036913; expirationdate: 23-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 0945753
Sex: F
Age:
State: NY

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/15/2021
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: No adverse event; expired PNEUMOVAX administered; This spontaneous report was received from a nurse practitioner referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications. On 12-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter for prophylaxis, which had expired on 03-DEC-2020 (dose, route and site of administration and lot number were not reported). No adverse events were reported.

Other Meds:

Current Illness:

ID: 0945754
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
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: suspected vaccination failure; HBV; Cytomegalovirus; Aspergillus fumigatus; cough; wheezing; shortness of breath; intermittent chills; Possible bronchitis; influenza A; fever; productive cough/progressive cough; brain abscesses; brain lesions; nausea; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 54-year-old male patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included maraviroc unknown (batch number UNK, expiry date unknown) for hiv infection, dolutegravir unknown (batch number UNK, expiry date unknown) for hiv infection, darunavir unknown (batch number UNK, expiry date unknown) for hiv infection and ritonavir unknown (batch number UNK, expiry date unknown) for hiv infection. The patient's past medical history included smoker. Concurrent medical conditions included acquired immunodeficiency syndrome (HIV-1 approximately 25 years prior, his CD4 count was 12 cells/mm3). On an unknown date, the patient received Hepatitis B vaccine, maraviroc at an unknown dose and frequency, dolutegravir at an unknown dose and frequency, darunavir at an unknown dose and frequency and ritonavir at an unknown dose and frequency. On an unknown date, unknown after receiving Hepatitis B vaccine and not applicable after starting maraviroc and dolutegravir, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), hepatitis b (serious criteria hospitalization and GSK medically significant), cytomegalovirus infection (serious criteria hospitalization and GSK medically significant), aspergillus fumigatus infection (serious criteria hospitalization and GSK medically significant), cough (serious criteria hospitalization), wheezing (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), chills (serious criteria hospitalization), bronchitis (serious criteria hospitalization), influenza a virus infection (serious criteria hospitalization), fever (serious criteria hospitalization), productive cough (serious criteria hospitalization), brain abscess (serious criteria GSK medically significant), brain lesion and nausea. The patient was treated with levofloxacin, sulfamethoxazole + trimethoprim (Trimethoprim-Sulfamethoxazole), prednisone, piperacillin + tazobactam (Piperacillin-Tazobactam), vancomycin, voriconazole, micafungin and emtricitabine + tenofovir. The action taken with maraviroc was unknown. The action taken with dolutegravir was unknown. The action taken with darunavir was unknown. The action taken with ritonavir was unknown. On an unknown date, the outcome of the vaccination failure, hepatitis b, cytomegalovirus infection, aspergillus fumigatus infection, cough, wheezing, shortness of breath, chills, bronchitis, influenza a virus infection, fever, productive cough, brain abscess, brain lesion and nausea were unknown. It was unknown if the reporter considered the vaccination failure, hepatitis b, cytomegalovirus infection, aspergillus fumigatus infection, cough, wheezing, shortness of breath, chills, bronchitis, influenza a virus infection, fever, productive cough, brain abscess and brain lesion to be related to Hepatitis B vaccine. The reporter considered the nausea to be related to maraviroc and dolutegravir. Additional details were provided as follows: This was reported in a literature article and described the suspected vaccination failure, in a male patient aged 54-year-old, who was vaccinated with unspecified Hepatitis B vaccine (manufacturer unknown) for prophylaxis. The patient was a man with a history of acquired immunodeficiency syndrome (AIDS). At the time of initial diagnosis of HIV-1 approximately 25 years prior, his CD4 count was 12 cells/mm3. The patient had poor adherence to antiretroviral therapy (ART). The patient reported stopping his ART (maraviroc, dolutegravir, darunavir, and ritonavir) for approximately 4 months prior to presentation due to nausea, but he had restarted again two months prior to admission. Social history was significant for smoking. The patient worked as a nurse in a prison facility for several years. The patient was in a monogamous relationship with 1 male partner. The patient had 4 dogs and 1 pet cat. No information on patient family history was reported. On an unknown date, the patient received unspecified hepatitis B vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age at vaccination was not reported. Since 2009, the patient had positive surface antibody titers noted. On an unknown date, an unknown time after vaccination, the patient experienced cough, wheezing, shortness of breath, and intermittent chills. The patient was evaluated in the emergency department and was given trimethoprim-sulfamethoxazole for possible bronchitis. The patient symptoms did not improve, and presented again after 1 week at which time he was tested positive for influenza A. When symptoms still persisted, the patient was then started on prednisone and levofloxacin 1 week later. The patient had some relief from his symptoms but soon after his fevers recurred with productive cough and shortness of breath. The patient was therefore admitted and noted to have a fever of 102F. Piperacillin-tazobactam and vancomycin were started in addition to trimethoprim-sulfamethoxazole for broad empiric treatment. The patient left against medical advice on day 3, only to be readmitted to the hospital after cell free DNA (cfDNA) testing of plasma returned positive for Aspergillus fumigatus, HBV, and Cytomegalovirus (CMV) within 72 hours of specimen collection. On an unknown date, the patient presented with progressive cough, wheezing, shortness of breath, and intermittent chills for 1 month. Computed tomography (CT) of the chest was done which showed a left lower lobe 4 centimeter necrotic cavitary mass-like consolidation with thickened irregular walls, shaggy inner linings and septations, ground glass halo, as well as pericavitary irregular nodules and consolidations. The appearance of the cavity was consistent with angioinvasive aspergillosis. cfDNA next generation sequencing (NGS) was sent and revealed the presence of Aspergillus fumigatus, HBV, and cytomegalovirus (CMV). Aspergillus fumigatus was detected at 242 DNA molecules per microliter (MPM; reference level less than 10) and CMV level was 378 MPM. DNA sequencing detected HBV, but MPM was not reported as there is no environmental control for this virus. A sputum fungal culture eventually returned positive for heavy Aspergillus fumigatus after approximately 2 weeks, with a voriconazole MIC of 0.5 ug/mL. Levels of Serum Tests at presentation Aspergillus Galactomannan was 0.660 (ref range less than 0.5), Beta-d Glucan was more than 500 pg/mL ref range less than 80 pg/ml). Histoplasma urine antigen testing was negative. Serum CMV PCR testing showed a low-level viremia of 256 IU/ml. Repeat HBV testing demonstrated positive surface antigen, loss of surface antibody, positive core antibody, and positive E antigen. Hep B DNA was more than 1000,000,000 IU/mL, which along with elevated liver enzymes (aspartate aminotransferase (AST) of 55 U/L; alanine amino transferase (ALT) was 73 U/L) suggested active infection. The patient was admitted and during this admission, the patient was noted to have a CD4 count of 76 cells/mm3 with undetectable HIV viral load. Four months prior, the patient CD4 count was 379 cells/mm3. A magnetic resonance imaging (MRI) of the brain was done due to concern for central nervous system involvement. It showed 8, scattered, small nodular rim-enhancing lesions in bilateral cerebral and cerebellar hemisphere. Lumbar puncture was performed that showed total nucleated cell count of 2 with 88% neutrophils on differential. Cerebro-spinal fluid (CSF) glucose was 42 mg/dl, protein level was 28.9 mg/dl, and no growth of fungus was noted from CSF culture. Toxoplasma IgG and IgM were negative. Given the overall clinical picture, these brain lesions were consistent with brain abscesses due to disseminated aspergillosis from the lungs. CMV infection

Other Meds: Maraviroc; Dolutegravir; Darunavir; Ritonavir

Current Illness: Acquired immunodeficiency syndrome (HIV-1 approximately 25 years prior, his CD4 count was 12 cells/mm3)

ID: 0945755
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
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: Stiff Person Syndrome; right internuclear ophthalmoplegia; dysmetria in left more than right hands; Stiff Person Syndrome Phenotype as Progressive Encephalomyelitis with Rigidity and Myoclonus; horizontal double vision; upper back tightness and spams; upper back tightness and spams; left shoulder/arm stiffness; dysarthria; impaired saccades on right gaze; downbeat nystagmus; torso rigidity; spasticity in the hands and arms; bradykinesia; hyperreflexia; impaired fine finger movements and foot tapping; Stiff Person Syndrome Phenotype as Progressive Encephalomyelitis with Rigidity and Myoclonus; This case was reported in a literature article and described the occurrence of stiff person syndrome in a 14-year-old female patient who received HPV 16-18 (HPV vaccine) for prophylaxis. Concurrent medical conditions included autoimmune thyroiditis and type i diabetes mellitus. On an unknown date, the patient received HPV vaccine. On an unknown date, 3 months after receiving HPV vaccine, the patient experienced stiff person syndrome (serious criteria GSK medically significant), ophthalmoplegia (serious criteria GSK medically significant), dysmetria (serious criteria GSK medically significant), encephalomyelitis (serious criteria GSK medically significant), double vision, tightness of back muscles, spasms, limbs stiffness, dysarthria, saccadic eye movement, nystagmus, rigidity, spasticity, bradykinesia, hyperreflexia, movement disorder and myoclonus. The subject was treated with immunoglobulins nos (Intravenous Immunoglobulin), baclofen and benzodiazepine, nos (Benzodiazepines). On an unknown date, the outcome of the stiff person syndrome, ophthalmoplegia, dysmetria, encephalomyelitis, double vision, tightness of back muscles, spasms, limbs stiffness, dysarthria, saccadic eye movement, nystagmus, rigidity, spasticity, bradykinesia, hyperreflexia, movement disorder and myoclonus were unknown. It was unknown if the reporter considered the stiff person syndrome, ophthalmoplegia, dysmetria, encephalomyelitis, double vision, tightness of back muscles, spasms, limbs stiffness, dysarthria, saccadic eye movement, nystagmus, rigidity, spasticity, bradykinesia, hyperreflexia, movement disorder and myoclonus to be related to HPV vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of Stiff Person Syndrome in a 14.8 years old female patient, who was vaccinated with unspecified Human Papillomavirus (HPV) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of the study that aimed was to characterize the spectrum of clinical features and examination findings in pediatric-onset stiff person syndrome. [In this study, medical records were reviewed for all patients treated for stiff person syndrome with symptom onset in childhood at a tertiary medical center between March 2001 and February 2019. Cases were included if they met clinical criteria for stiff person syndrome (SPS) based on an adapted Dalakas Criteria and if SPS symptom onset occurred before age 18 years]. The patient was woman. The patient had personal history of autoimmunity as autoimmune thyroiditis, Diabetes mellitus type 1. The patient had no family History of autoimmunity. No information on patient's concurrent condition or concomitant medication was provided. On an unspecified date, 3 months before symptom onset, the patient received unspecified Human Papillomavirus (HPV) vaccine (administration route and site unspecified, dosage unknown; batch number not provided). On an unspecified date, between March 2001 and February 2019, an unknown period after the vaccination, the patient had initial presentation to center as horizontal double vision; upper back tightness and spasms; left shoulder/arm stiffness. Time to diagnosis from Symptom Onset was 6.5 years. Exam findings at initial presentation to center was dysarthria; right internuclear ophthalmoplegia; impaired saccades on right gaze; downbeat nystagmus; torso rigidity; spasticity in the hands and arms; bradykinesia; hyperreflexia; dysmetria in left more than right hands; impaired fine finger movements and foot tapping. At the age of 21.3 years, the patient was diagnosed to Stiff Person Syndrome Phenotype as Progressive Encephalomyelitis with Rigidity and Myoclonus. Serum Anti-glutamate decarboxylase 65 (GAD65) antibody titers was 89856 IU/ml (normal less than or equal to 1 IU/ml). Serum anti-amphiphysin antibodies was negative. Serum Anti-Glycine receptor (GlyR) Antibodies was not performed. CSF white blood cell count was unknown (normal 6-7/uL). CSF Protein was unknown (normal 15-60 mg/dL). More than 2 oligoclonal bands unique to CSF was unknown. CSF Anti-GAD65 antibody titers was positive (titer unknown) (normal less than 0.02 nmol/L). Electromyography (EMG) was normal. Immunotherapy received or currently receiving was intravenous immunoglobulin. Relevant symptomatic treatments received or currently receiving was Baclofen, benzodiazepines. Modified Rankin Scale (mRS) score at Most Recent Visit was 4. Timed 25 foot walk test at most recent visit was wheel-chair bound. [Within the study period, 186 patients with SPS were seen. Fifteen patients (8%) had symptom onset in childhood, of whom 11 (73%) were female and 13 (87%) were a specific ethnicity. The median age of symptom onset was 14.8 years (range 8.4 to 16.9 years), and the median latency from symptom onset to diagnosis was 6.2 years (range 0.4 to 15.0 years). Nine individuals (60%) were not diagnosed until adulthood, despite symptom onset occurring during childhood. Twelve individuals met criteria for classic SPS and three for progressive encephalomyelitis with rigidity and myoclonus (PERM). Individuals had a median total of four of the 12 symptoms and examination findings assessed (range 2 to 8), and 13 individuals (87%) had three or more reported features. Of the 15 individuals who met inclusion criteria, 11 (73%) were female and 13 (87%) were a specific ethnicity. Median age at symptom onset was 14.8 years (range 8.4 to 16.9), and median latency from symptom onset to diagnosis was 6.2 years (range 0.4 to 15.0). Nine individuals (60%) were not diagnosed until adulthood. The most common presenting features were painful spasms (n = 12, 80%), hyper-reflexia (n = 11, 73%), axial rigidity (n = 9, 60%), lower extremity rigidity or spasticity (n = 8, 53%), gait abnormalities (n = 6, 40%), and hyperlordosis (n = 6, 40%). Other noted features included anxiety (n = 5, 33%), dysautonomia (n = 3, 20%), and cranial neuropathies (n = 3, 20%; e.g., ptosis, double vision, nystagmus, and eye movement abnormalities). Personal (n = 9, 60%) and family history (n = 9, 60%) of autoimmune conditions was common. Serum antiglutamate decarboxylase 65 antibodies were found in 13 individuals (87%). Nearly all individuals received immunotherapy (n = 14, 93%), symptomatic medications (n = 15, 100%), and non-pharmacologic therapies (n = 14, 93%). However, most had persistent physical limitations, particularly impaired walking (n = 7, 47%) and inability to carry out previous activities (n = 14, 93%). Eight individuals (53%) reported having possible triggering events within one to three months of symptom onset. These events included a preceding infection (Ehrlichia along with Lyme disease-related Bell's Palsy and mononucleosis in one individual each), vaccination against human papillomavirus (in two individuals), concussion (in one individual), head trauma related to a motor vehicle accident (in one individual), and stressful life event (parents' divorce and familial financial stress in one individual each). Personal history (n = 9, 60%) and first-degree relative family history (n = 9, 60%) of autoimmune disease were commonly seen. Thirteen individuals (87%) had positive serum anti-GAD65 antibody titers (median 3183 IU/mL, range 1.2 to 184,320 IU/mL; normal less than or equal to 1 IU/mL) at the time of first evaluation in center, three of whom were on immunotherapy for concurrent autoimmune disease at that time. No individual had detected anti-amphiphysin antibodies, one individual had anti-GlyR antibodies, and

Other Meds:

Current Illness: Autoimmune thyroiditis; Type I diabetes mellitus

ID: 0945756
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
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: Stiff Person Syndrome; thoracic and lumbar paravertebral muscle spasms/upper back spasms; right hand pain; dysarthria; right hand/arm spasticity; This case was reported in a literature article and described the occurrence of stiff person syndrome in a 16-year-old female patient who received HPV 16-18 (HPV vaccine) for prophylaxis. Concurrent medical conditions included autoimmune thyroiditis. On an unknown date, the patient received HPV vaccine. On an unknown date, 1 month after receiving HPV vaccine, the patient experienced stiff person syndrome (serious criteria GSK medically significant), spasms, pain in hand, dysarthria and spasticity. The subject was treated with dantrolene sodium (Dantrolene), levetiracetam, botulinum toxin type a (Botulinum Toxin), immunoglobulins nos (Intravenous Immunoglobulin), operations and procedures (Plasma Exchange), rituximab, benzodiazepine, nos (Benzodiazepines), baclofen, tizanidine and methocarbamol. On an unknown date, the outcome of the stiff person syndrome, spasms, pain in hand, dysarthria and spasticity were unknown. It was unknown if the reporter considered the stiff person syndrome, spasms, pain in hand, dysarthria and spasticity to be related to HPV vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of Stiff Person Syndrome in a 16.9 years old female patient, who was vaccinated with unspecified Human Papillomavirus (HPV) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of the study that aimed was to characterize the spectrum of clinical features and examination findings in pediatric-onset stiff person syndrome. [In this study, medical records were reviewed for all patients treated for stiff person syndrome with symptom onset in childhood at a tertiary medical center between March 2001 and February 2019. Cases were included if they met clinical criteria for stiff person syndrome (SPS) based on an adapted Dalakas Criteria and if SPS symptom onset occurred before age 18 years]. The patient was woman. The patient had personal history of autoimmunity as autoimmune thyroiditis. The patient had no family History of autoimmunity. No information on patient's concurrent condition or concomitant medication was provided. On an unspecified date, 1 month before symptom onset, the patient received unspecified Human Papillomavirus (HPV) vaccine (administration route and site unspecified, dosage unknown; batch number not provided). On an unspecified date, between March 2001 and February 2019, an unknown period after the vaccination, the patient had initial presentation to center as upper back spasms; right hand pain. Time to diagnosis from symptom onset was 2.5 years. Exam findings at initial presentation to center was dysarthria; right hand/arm spasticity; thoracic and lumbar paravertebral muscle spasms; feet spasms. At the age of 19.4 years, the patient was diagnosed to Stiff Person Syndrome Phenotype as classic. Serum Anti-glutamate decarboxylase 65 (GAD65) antibody titers was 3183 IU/ml (normal less than or equal to 1 IU/ml). Serum anti-amphiphysin antibodies was negative. Serum Anti-Glycine receptor (GlyR) antibodies was negative. CSF white blood cell count was 1/uL (normal 6-7/uL). CSF Protein was 47 mg/dl (normal 15-60 mg/dL). More than 2 oligoclonal bands unique to CSF was unknown. CSF Anti-GAD65 antibody titers was 0.05 nmol/L (normal less than 0.02 nmol/L). Electromyography (EMG) was continuous muscle fiber activity and co-contraction of agonist and antagonist muscles (tibialis anterior and gastrocnemius muscles). Immunotherapy received or currently receiving was intravenous immunoglobulin, plasma exchange, rituximab. Relevant symptomatic treatments received or currently receiving was benzodiazepines, baclofen, dantrolene, tizanidine, methocarbamol, levetiracetam, and botulinum toxin. Modified Rankin Scale (mRS) score at Most Recent Visit was 4. Timed 25 foot walk test at most recent visit was wheel-chair bound. [Within the study period, 186 patients with SPS were seen. Fifteen patients (8%) had symptom onset in childhood, of whom 11 (73%) were female and 13 (87%). The median age of symptom onset was 14.8 years (range 8.4 to 16.9 years), and the median latency from symptom onset to diagnosis was 6.2 years (range 0.4 to 15.0 years). Nine individuals (60%) were not diagnosed until adulthood, despite symptom onset occurring during childhood. Twelve individuals met criteria for classic SPS and three for progressive encephalomyelitis with rigidity and myoclonus (PERM). Individuals had a median total of four of the 12 symptoms and examination findings assessed (range 2 to 8), and 13 individuals (87%) had three or more reported features. Of the 15 individuals who met inclusion criteria, 11 (73%) were female and 13 (87%). Median age at symptom onset was 14.8 years (range 8.4 to 16.9), and median latency from symptom onset to diagnosis was 6.2 years (range 0.4 to 15.0). Nine individuals (60%) were not diagnosed until adulthood. The most common presenting features were painful spasms (n = 12, 80%), hyper-reflexia (n = 11, 73%), axial rigidity (n = 9, 60%), lower extremity rigidity or spasticity (n = 8, 53%), gait abnormalities (n = 6, 40%), and hyperlordosis (n = 6, 40%). Other noted features included anxiety (n = 5, 33%), dysautonomia (n = 3, 20%), and cranial neuropathies (n = 3, 20%; e.g., ptosis, double vision, nystagmus, and eye movement abnormalities). Personal (n = 9, 60%) and family history (n = 9, 60%) of autoimmune conditions was common. Serum antiglutamate decarboxylase 65 antibodies were found in 13 individuals (87%). Nearly all individuals received immunotherapy (n = 14, 93%), symptomatic medications (n = 15, 100%), and non-pharmacologic therapies (n = 14, 93%). However, most had persistent physical limitations, particularly impaired walking (n = 7, 47%) and inability to carry out previous activities (n = 14, 93%). Eight individuals (53%) reported having possible triggering events within one to three months of symptom onset. These events included a preceding infection (Ehrlichia along with Lyme disease-related Bell's Palsy and mononucleosis in one individual each), vaccination against human papillomavirus (in two individuals), concussion (in one individual), head trauma related to a motor vehicle accident (in one individual), and stressful life event (parents' divorce and familial financial stress in one individual each). Personal history (n = 9, 60%) and first-degree relative family history (n = 9, 60%) of autoimmune disease were commonly seen. Thirteen individuals (87%) had positive serum anti-GAD65 antibody titers (median 3183 IU/mL, range 1.2 to 184,320 IU/mL; normal less than or equal to 1 IU/mL) at the time of first evaluation in center, three of whom were on immunotherapy for concurrent autoimmune disease at that time. No individual had detected anti-amphiphysin antibodies, one individual had anti-GlyR antibodies, and one individual had both anti-GAD65 and anti-GlyR antibodies. Seven individuals (64%) underwent lumbar punctures; three individuals (43%) had pleocytosis (6 to 17/mL), one individual (14%) demonstrated oligoclonal bands unique to the cerebrospinal fluid, and all three individuals who had cerebrospinal fluid anti-GAD65 antibody testing were positive (more than 0.02 nmol/L). Cerebrospinal fluid (CSF) oligoclonal band testing was either unknown or not performed (n = 2) or not present (n = 1) in the three individuals with detected CSF anti-GAD65 antibodies. All individuals had electromyography, and five individuals (36%) had abnormal results: continuous muscle fiber activity at rest, or cocontraction of agonist and antagonist muscles, or combination of these findings. Nearly all individuals received immunotherapy (n = 14, 93%), symptomatic medications (n = 15, 100%), and a variety of non-pharmacologic therapies (n = 14, 93%), reporting most favorable responses to a combination of interventions. At the most recent clinic visit mRS score, which assigns scores to motor disability from 0 (no symptoms) to 6 (dead), was assessed (median 12.2 years from symptom onset, r

Other Meds:

Current Illness: Autoimmune thyroiditis

ID: 0945757
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Hypercalcemia; multiple myeloma; flu-like symptoms; myalgia; This case was reported in a literature article and described the occurrence of hypercalcemia in a 65-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a week after receiving Influenza vaccine, the patient experienced hypercalcemia (serious criteria hospitalization), multiple myeloma (serious criteria hospitalization and GSK medically significant), influenza-like symptoms (serious criteria hospitalization) and myalgia (serious criteria hospitalization). The patient was treated with rehydration fluid (nos) (Crystalloids), diuretics nos (Loop Diuretic (Nos)), calcitonin, pamidronic acid (Pamidronate), hemodialysis dialysate solution, bortezomib, lenalidomide, dexamethasone and zoledronic acid. On an unknown date, the outcome of the hypercalcemia, multiple myeloma, influenza-like symptoms and myalgia were recovered/resolved. The reporter considered the hypercalcemia, multiple myeloma, influenza-like symptoms and myalgia to be related to Influenza vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of hypercalcemia in a 65-years old female patient, who was vaccinated with unspecified inactivated influenza vaccine (manufacturer unknown) for prophylaxis. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, 5 days prior to presentation, the patient received unspecified inactivated influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided but it could be 64 years or 65 years. On an unspecified date, an unknown period after the vaccination, the patient presented with subjective myalgias lasting 2 days. Vital signs were stable. Complete Blood Count (CBC) and basic metabolic panel (BMP) were unremarkable. Serum calcium was 10.8 mg/dl. The patient was discharged on supportive therapy. The patient presented a day later with persistent flu-like symptoms. Labs revealed serum calcium being above 22 mg/dl, normal renal function, total protein, albumin, ACE levels; clear UA with no albuminuria; low PTH and 1, 25-(OH)2-Vitamin D3 levels; elevated PTHrP & viscosity levels. 24-hour urine collection revealed proteinuria (550 mg). Peripheral blood smear revealed rouleaux formation. Computed tomography (CT) scans of the chest, abdomen and pelvis revealed no obvious malignancy. Quantitative immunoglobulins revealed elevated IgA (2415 mg/dl), and concurrent suppression of IgG and IgM levels. Quantitative serum light chain measurement revealed normal levels of kappa and lambda, with an elevated Kappa: Lambda ratio of 2:1. Serum Protein Electrophoresis (SPEP), Urine Protein Electrophoresis (UPEP), and serum immunofixation revealed IgA-Kappa multiple myeloma (MM). Given her severe-symptomatic hypercalcemia, the patient was treated with aggressive intravenous crystalloids, loop diuretics, calcitonin, pamidronate, and hemodialysis. The patient's calcium subsequently normalized to 10.1 mg/dl. Bone-marrow biopsy revealed intracytoplasmic kappa-restricted monoclonal plasma cells that occupied 40% of the marrow. Bone survey was negative for lytic lesions. The patient was started on bortezomib, lenalidomide, dexamethasone and monthly zoledronic acid; and the patient had not attained remission from myeloma yet. This case has been considered as serious due to hospitalization. The author commented, "Multiple myeloma (MM) is characterized by the neoplastic proliferation of immunoglobulin-producing plasma cells. Several cytokines, including IL-1, IL-6 and TNF-beta, derived from myeloma cells are thought to accelerate osteoclastic bone resorption and cause hypercalcemia through a paracrine mechanism. Our case is unique in that the patient initially had a normal serum calcium level that had increased rapidly to over 22 mg/dl within a period of 24 hours, had no renal failure or any bone involvement; and had a normal quantitative serum light chain measurement. It is theorized that the inactivated influenza vaccine given prior to presentation unmasked an atypical presentation of MM. This may be attributed to a vaccination induced cytokine storm, especially IL-6 mediated, that may be the key in the pathophysiology of hypercalcemia related to MM." This article corresponding to this case is not available for regulatory submission due to copyright restriction.

Other Meds:

Current Illness:

ID: 0945758
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/15/2021
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: some of the liquid aerosolized and shot up and out; Syringe somewhat exploded; needle may not have been on all the way; A spontaneous report was received from a man concerning his wife, a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect dose administered, syringe issue, and product administration error. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. During the administration, the reporter stated that when the nurse pushed the needle into the patient's muscle, the syringe somewhat exploded and some of the liquid aerosolized and shot up and out. The reporter stated that the nurse and pharmacist present during vaccine administration thought the needle may not have been on all the way which caused the issue. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, incorrect dose administered, syringe issue, and product administration error were considered resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered, Syringe issue, and Product administration error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0945759
Sex: F
Age:
State:

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: COVID-19 vaccine to a 16 year old; A spontaneous report was received from a nurse concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, COVID-19 vaccine to a 16 year old. The patient's medical history was not provided. Concomitant medications were not reported. On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The reporter stated, the patient would like to receive dose two to complete the vaccine series. The event, COVID-19 vaccine to a 16 year old, was considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a 16-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of drug administered to patient of inappropriate age. The event is assessed as not related to Moderna COVID-19 Vaccine.

Other Meds:

Current Illness:

ID: 0945760
Sex: U
Age:
State: NM

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
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: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0945761
Sex: F
Age: 27
State:

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/15/2021
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: Redness and swelling at the injection site; Redness and swelling at the injection site; Given in her lower arm in her tricep area and possibly given subcutaneously; A spontaneous report was received from a nurse who was a 27-year old, female patient who received the Moderna COVID-19 vaccine and experienced given in her lower arm in her tricep area and possibly given subcutaneously and redness and swelling at the injection site. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 026L20A) subcutaneously in her lower arm tricep area for prophylaxis of COVID-19 infection. On 29 Dec 2020, during vaccine administration, the patient noticed the vaccine was not being administered in her deltoid, but instead possibly subcutaneously in her lower arm, in the tricep area. She was unsure of the needle size as she did not see if at the time of vaccination. She reported experiencing injection site redness and swelling, which she typically experiences when getting the flu vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event, given in her lower arm in her tricep area and possibly given subcutaneously, was considered resolved on 29 Dec 2020. The outcome of the events, redness and swelling at the injection site, was not reported. The reported assessed the events, redness and swelling at the injection site, as related to study drug.; Reporter's Comments: This case concerns a 27-year old, female subject, who experienced a non-serious event of injection site redness, injection site swelling, and wrong route of administration. The event of injection site redness, injection site swelling was expected, and wrong route of administration was unexpected. The events occurred one day after first dose of mRNA-1273, lot # 026L20a. 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:

Current Illness:

ID: 0945762
Sex: F
Age: 55
State: WA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/15/2021
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: vaccine leaked out of patient's arm after administration; A spontaneous report was received from a healthcare professional concerning a 55-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, vaccine leaked out of patient's arm after administration. The patient's medical history was not provided. Concomitant product use was not reported. On 30 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 30 Dec 2020 some of the vaccine went into the patient's arm and then leaked back out. The health care professional estimated the leakage amount to be about two drops or 0.1 mL. The patient had no other adverse events or reactions. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccine leaked out of patient's arm after administration, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # Lot #037K20A. There were no reported AEs associated with this case of incorrect dose administered.

Other Meds:

Current Illness:

ID: 0945763
Sex: U
Age:
State: SD

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/15/2021
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: Vaccination potentially administered below the deltoid muscle; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, vaccination potentially administered below the deltoid muscle. The patient's medical history was not provided. No relevant concomitant medications were reported On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot #025J20-2A) intramuscularly for prophylaxis of COVID-19 infection. On 28 Dec 2020, a nurse administered the vaccine to the patient. Later, the nurse questioned whether it was given in the deltoid, or inadvertently administered slightly below the deltoid muscle. The patient reported no symptoms and no treatment was provided for the event. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccine potentially administered below the deltoid muscle, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product administered at inappropriate site for mRNA-1273, Lot #025J20-2A. There were no reported AEs associated with this case of Product administered at inappropriate site.

Other Meds:

Current Illness:

ID: 0945764
Sex: F
Age: 44
State: MA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/15/2021
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: Product leaked out and dripped down her arm; Product leaked out and dripped down her arm; A spontaneous report was received from a healthcare facility staff member who was a 44-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the product leaked out and dripped down her arm. The patient's medical history was not provided. Concomitant product use was not provided. On 30 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 0011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, some of the product leaked out of the syringe and dripped down the patient's arm during vaccination. She denied experiencing any side effects. Treatment information was not provided. Action taken with mRNA-1273 in response to the events, product leaked out and dripped down her arm, was not provided. The outcome of the events, product leaked out and dripped down her arm, was considered recovered on 30 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect dose administered and exposure via skin contact for mRNA-1273 (Lot number: 0011J20A). There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0945765
Sex: U
Age:
State: VA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/15/2021
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: Syringe leaked and the patient did not receive full dose; Vaccine leaked on patient or nurse's skin; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, the syringe leaked and the patient did not receive full dose, and the vaccine leaked on the patient or nurse's skin. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, the pharmacist called to report that when they vaccinated the patient, the syringe leaked and the patient did not receive the full dose. The pharmacist stated that they are not sure if the vaccine leaked on the patient or on the nurse's skin. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events, the syringe leaked and the patient did not receive full dose and the vaccine leaked on the patient or nurse's skin, were considered resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered and Exposure via skin contact without any associated adverse events.

Other Meds:

Current Illness:

ID: 0945766
Sex: F
Age: 66
State: TN

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/15/2021
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: Some of the vaccine leaked out of the arm, like 2 drop; A spontaneous report was received from a non-health professional concerning a 66-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the vaccine leaked out of the arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (lot number: 011J20A) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, during vaccine administration, some of the vaccine leaked out of the patient's arm. She estimates leakage of approximately 2 drops. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, some of the vaccine leaked out of the arm, was considered resolved on 30 DEC 2020.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Incorrect dose administered without any associated adverse events.

Other Meds:

Current Illness:

ID: 0945767
Sex: F
Age: 60
State: IA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/15/2021
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: Vaccine leaked out while being administered; A spontaneous report was received from a 60-year-old, female nurse, who was also the patient, who received Moderna's COVID-19 vaccine and experienced vaccine leaked out while being administered. The patient's medical history was not provided. Concomitant product use was not reported. On 30 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, the vaccine leaked out while being administered. There was a puddle on the floor about the size of a quarter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown. The event, vaccine leaked out while being administered, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (Lot number: 025J20-2A). There were no reported adverse events associated with this case.

Other Meds:

Current Illness: No adverse event (No reported medical history)

ID: 0945768
Sex: U
Age:
State:

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/15/2021
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: Inadvertent administration of Moderna COVID-19 Vaccine to a 17 year old patient; A spontaneous report was received from a nurse concerning a 17-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inadvertent administration of Moderna COVID-19 vaccine to a 17 year old patient. The patient's medical history and concomitant product use were not provided. On 29-Dec-2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 29-Dec-2020, the 17-year-old patient received the vaccine. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, inadvertent administration of Moderna COVID-19 vaccine to a 17 year old patient, was considered recovered on 29 Dec 2020.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.

Other Meds:

Current Illness:

ID: 0945769
Sex: U
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/15/2021
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: Gave vaccine to a 17 year old; A spontaneous report was received from a healthcare facility staff member concerning a 17-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, gave vaccine to a 17 year old. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, the healthcare staff member reported the Moderna COVID vaccine was given to a 17 year old patient. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, gave vaccine to a 17 year old, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 0945770
Sex: F
Age:
State: NV

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/15/2021
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: Fainting; Dizziness; Body ache; Joint pain; A spontaneous report was received from a 22-year-old female consumer, who received Moderna's COVID-19 vaccine and experienced dizziness, fainting, joint pain, and body aches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 31 Dec 2020 at 13:30, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 31 Dec 2020, after vaccine administration, the patient experienced dizziness, fainting, joint pain, and body aches. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the events, dizziness, fainting, joint pain, and body aches, was not reported.; Reporter's Comments: This case concerns a 22 year-old, female patient, who experienced events of dizziness, fainting, joint pain, and body aches. The events occurred on the same day after the first dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm