VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 1038209
Sex: M
Age: 70
State: CT

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data: blood work,

Allergies: Penicillin, bananas

Symptoms: when i first got the shot i could feel a difference in my body immediately. i started hurt on my left side of my throat, then started getting puffy face and eyes. was given some Benadryl pulse 45 blood pressure 90/54 and did an EKG , then medic didn't like what he was seeing and called 911 . Medic gave him an epi pen because his throat started swelling. Went to the hospital where he was there for 5 hrs.

Other Meds:

Current Illness:

ID: 1038210
Sex: F
Age: 89
State: NC

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: U/a CBC, CMP, Troponin CT head, Chest xray.

Allergies: none

Symptoms: difficulty with balance, lethargy, elevated BP, fell in the floor, on 2/16 could not walk and was poorly responsive had to report to the ER, had two seperate ER visits due to lethargy and unable to walk. on 2/17 patient returned to baseline.

Other Meds: Fluoxetine, Losartan, risperidone, melatonin, vitamin B12.

Current Illness: noe

ID: 1038211
Sex: F
Age: 69
State: CA

Vax Date: 02/04/2021
Onset Date: 02/13/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: "Covid Arm" redness and itching around the injection site (about 3-4 inches diameter)

Other Meds: magnesium, montelukast sodium, Pepcid, Biotin, Blink eye drops

Current Illness: None

ID: 1038212
Sex: F
Age: 72
State: IN

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Rapid result test

Allergies: None

Symptoms: Chills, fever and achy

Other Meds: None

Current Illness: None

ID: 1038213
Sex: F
Age: 73
State: MI

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: I had been positive for a COVID 19 test in late November and hardly had any symptoms and when I got the vaccine I has body aches headache my skin hurt I couldn?t sleep.

Other Meds: Atorvastatin 10mg, Losartan 100mg, Hydralazine 25mg, Levothyroxine 75mcg, pantoprazole 40mg

Current Illness: None

ID: 1038214
Sex: M
Age: 68
State: GA

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: none, got rx for itching scalp.

Allergies: aspirin, penicilin

Symptoms: Very bad itching scalp and very dry mouth. shakes.

Other Meds: no

Current Illness: none

ID: 1038215
Sex: F
Age: 24
State: IN

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Nausea and throwing up. Migraine. Body aches(sore arm). Fever 102.4 at peak. Swollen lymph node on same side as injection. Swollen arm.

Other Meds: None

Current Illness: None

ID: 1038216
Sex: F
Age: 77
State: GA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: unknown

Symptoms: Itching/hives bilateral axilla. Sensation of lump in throat/itching tingling in throat. EMS on site. Patient's Epi-pen used left thigh. EMS started IV in left AC gave fluids and gave 25 mg Benadryl IV. Vitals monitored. Symptoms improved shortly after medication administration. Med unit transported patient to hospital for further evaluation.

Other Meds: unknown

Current Illness: unknown

ID: 1038217
Sex: F
Age: 42
State: TX

Vax Date: 02/14/2021
Onset Date: 02/16/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: Had a massive headache for 2 days, then a rash for the past 3 days on injection rate that felt hot to touch and soreness. Rash has slowly gone away.

Other Meds: none

Current Illness: none

ID: 1038218
Sex: F
Age: 52
State: FL

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: NOne

Allergies: None

Symptoms: left arm pain and soreness

Other Meds: None

Current Illness: NOne

ID: 1038219
Sex: M
Age: 85
State: NY

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: EKG was performed, which was normal.

Allergies: NKDA

Symptoms: ound patient in sitting position in elevator s/p 2nd dose of vaccine. Patient awake, opening eyes, mumbling, incoherent speech, noted to be pale. As per patient's wife, "He felt dizzy and used walker to assist himself into a sitting position on elevator floor. He did not hit his head, I do not think he lost consciousness. He waited in the waiting room for more than 15 minutes and drank 2 cups of juice before we left." No obvious injuries noted. Palpated weak, thready pulse. Patient tachypneic w/ shallow respirations. Called for assistance. Vital signs: B/P 98/34, HR 121, RR 23, unappreciated O2 sat. Fingers cool to touch. FS = 139. Attempted to re-orient patient, given small sip of apple juice. 911 activated. Patient transported to ER with wife. Noted patient to be more alert, responsive with clearer speech upon arrival to ER. After monitored in the ER, the patient was cleared for discharge.

Other Meds: Risperidone 0.5 mg 1 tablet PO twice daily Docusate 100 mg once daily Vitamin D2 50,000 units PO once a week Gabapentin 100 mg PO 3 times a day Losartan 50 mg 1 tablet PO once a day Brimonidine 0.2 % ophthalmic solution 1 drop into both e

Current Illness: NA

ID: 1038220
Sex: F
Age: 70
State: CO

Vax Date: 01/28/2021
Onset Date: 02/05/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: None

Allergies: Erhtyamicin

Symptoms: Exactly 8 days after first vaccine an approx 3? red circle rash appeared around the injection site. It didn?t hurt but was tender to the touch and itched non stop. I took Benadryl by mouth and bought topical Benadryl to help control the itching. After 1 day after a week the rash was totally gone.

Other Meds: Lottel and atorvastatin

Current Illness: None

ID: 1038221
Sex: F
Age: 74
State: AZ

Vax Date: 02/09/2021
Onset Date: 02/16/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: None

Allergies: Possible sulfa allergy, reacted to Sulamyd eye drops. Caffeine causes PVCs.

Symptoms: Developed red itchy rash at injection site one week after injection. Started as diffuse area 5x7cm and by the following day area was circumscribed 8x10cm and edematous. No medical visit as research showed this to be a documented side effect in some patients. Used Benadryl oral and OTC cortizone cream topically.

Other Meds: Zetia, Prolia injections every 6 mos, B comp+C, glucosamine/chondroitin/msm joint supplement, Celadrin, Biotin 5000mcg, Lutein 6mg, CoQ-10 100mg, Niacin 1000mg, Vit D 2000 iu, Folate 800mg,Calcium 600mg, Magnesium 500mg, Black Cherry 1000mg

Current Illness: None

ID: 1038222
Sex: F
Age: 60
State: WV

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: none

Allergies: no

Symptoms: The morning after my vaccine, I drank a half of cup of coffee and started feeling funny, went to the restroom and threw up and than I had this weird feeling kind of like a numbness that went from my arms down to my legs and my hands turned in like they were going to cramp up, I started breathing slowly and it all went away, I was fine after that. My left arm stayed sore for about 3 days, also when they gave me the shot I bled a little.

Other Meds: Vitamins: Calcium 400 mg, One a day 50 plus, B12 1,000 mcg, D3 25mcg, Cherry Fruit 1,000 mg

Current Illness: no

ID: 1038223
Sex: F
Age: 23
State: KY

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: Allergic to strawberries and coconut

Symptoms: Ever since I received the vaccine, my arm has been extremely sore. Over the next few days, I became incredibly itchy and developed a rash on both of my arms. I now have what I think is considered, "COVID Arm". There is a red circle around the injection site that is swollen, red, and tender. I then noticed the inside of my mouth was sore and I had blisters developing on the roof of my mouth near my gums. My throat is super sore and swollen and has a yellow pocket on the back of my throat. I am also having body aches under my arms near my ribs and back.

Other Meds: None

Current Illness: None

ID: 1038224
Sex: M
Age: 96
State: MD

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: NKDA

Symptoms: No adverse event suffered. Due to improper record keeping upon the facility, the patient received a 3rd dose of a vaccine that only requires 2 doses. Followed up with the facility to check on the patient after one day and after one week. no adverse events reported. Facility does not believe the patient received a third dose.

Other Meds: information unavailable

Current Illness: information not available

Date Died: 02/17/2021

ID: 1038225
Sex: M
Age: 83
State: AK

Vax Date: 01/11/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: Tomato, cheese

Symptoms: Death, 2-17-21 at 1802 hours

Other Meds: Metoprolol, Pramipexole, Furosemide, Aspirin, Haloperidol, Lorazepam, Morphine

Current Illness: G60.9, D72.1,

ID: 1038226
Sex: F
Age: 15
State: WI

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccination was administered without adverse event at COVID-19 clinic. Individual was noted to be a healthcare volunteer. Upon logging person into tracking process for scheduling a second dose appointment, it was identified that this recipient was under the age of 16, not in the correct age range for vaccination with the Pfizer BioNtech COVID19 vaccine.

Other Meds:

Current Illness:

ID: 1038227
Sex: F
Age: 62
State: AZ

Vax Date: 02/14/2021
Onset Date: 02/15/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: No tests to date

Allergies: Penecilin

Symptoms: Initial Events - started morning 2/15/21 - dizziness, lightheadedness, fatigue, nausea, chills - resolved by 6pm 2/16/21. Subsequent Event - started morning 2/16/21 - leg pain in calf area and formation of lump in armpit of right arm. Leg pain migrating to upper rear of legs and into lower back from 2/16/21 to 2/18/21. These events are ongoing and unresolved.

Other Meds: levothroxine - .137mg vitamin D - 2000 IU Probiotic Baby Aspirin - .81 mg

Current Illness: None

ID: 1038228
Sex: F
Age: 38
State: FL

Vax Date: 02/08/2021
Onset Date: 02/11/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data: MRI scan of the brain and C spine showed multiple, bilateral white matter, nonenhancing lesions. Similar lesion on C spine 02/16 and 17/2021

Allergies: Levaquin

Symptoms: 3 days after the second Moderna vaccine patient developed right arm and leg weakness, tingling over the whole body

Other Meds: N/A

Current Illness: None

ID: 1038229
Sex: M
Age: 75
State: NY

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: Penicillin, shell fish

Symptoms: 26 hours after receiving the injection, I became very nauseous and had diarrhea. At one time I passed out and when I woke up I was covered in feces and vomit. The symptoms remained until about 3:00 a.m. on the 18th of this month. Today, the 18th, the vomiting and diarrhea subsided; but I remain very weak; and I have no appetite.

Other Meds: Xarelto, Atorvastatin, fenofibrate, Silodosin Dutasteride, Tums

Current Illness:

ID: 1038230
Sex: U
Age: 63
State: MA

Vax Date: 01/11/2021
Onset Date: 01/13/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: 1/14:Covid and influenza test- negative 1/19: Ova, PTrichrome stain, C- difficile- negative 1/29: Norovirus: negative, Elevated LFTs, Stool calprotectin elevated

Allergies: NKA

Symptoms: Received 2nd vaccine dose 1/11 and started with GI symptoms 1/13. 1/14 had covid and flu test, tested negative for both. She had stool culture ? normal flora, negative for c-diff, camphobacter, shigella, echoli and salmonella. Was started on flaggyl 1/20 and taking prescription strength probiotics. Other than diarrhea having no symptoms. Had 5-6 episodes in a day, slowly reducing. Feels little bit weak and tired from the diarrhea ? has been doing BRAT diet. Rx viral gastroenteritis, babesiosis (likely latent). Travelled to upper Midwest in 2020. Energy and strength better + back to work on modified schedule with restrictions. Being treated currently for babesiosis.

Other Meds: Daily vitamins, aspirin, Advair BID

Current Illness:

ID: 1038231
Sex: F
Age: 80
State: NY

Vax Date: 02/16/2021
Onset Date: 02/18/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: EKG- normal (2/16/2021)

Allergies: NKDA

Symptoms: 80 y/o F presents for tingling sensation to B/L hands and high blood pressure after receiving the 2nd dose of the Covid-19. Patient was taken to the ED for monitoring; she denied any allergic reaction, CP, fever, chills, lightheadedness, dizziness, N/V/D/C, abdominal pain or other symptoms aside from tingling of all fingers. Her blood pressure was 197/92 at the time. EKG was performed, which was normal. No medications were administered. After 2 hours, the blood pressure normalized to 140/80 and patient was discharged.

Other Meds: Unknown

Current Illness: NA

ID: 1038232
Sex: F
Age: 65
State: GA

Vax Date: 02/12/2021
Onset Date: 02/25/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: None

Allergies: Aspirin , Bactrim erthromycin macrobid tetanus injection crabs shrimps

Symptoms: Generalized itchiness that started on the day after the shot. It?s almost 6 days now and the itchiness did not go away. I have been alternating Benadryl , Zyrtec and Pepcid Ac. Find relief from itchiness but did not completely went away. I only had one elevated rash on my shoulder but went away next day. I also experienced diarrhea but it stopped after two days. The one that concerns me the most is the prolonged itchiness .

Other Meds: Tylenol Benadryl metformin atenalol hydrochlorothiazide

Current Illness: None

ID: 1038233
Sex: F
Age: 70
State: WI

Vax Date: 02/10/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Itchy, swollen injection site with surrounding rash.,

Other Meds: Lisinopril, Hydrochlorot

Current Illness: None

Date Died: 02/13/2021

ID: 1038234
Sex: F
Age: 84
State: MA

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: Sulfa, Aricept

Symptoms: First dose Pfizer given at assisted living on 1/14/21 she was subsequently admitted to hospital and got her second dose but Moderna was given instead of Pfizer on 2/8/21. She had been improving but in the days following the Moderna vaccine she developed fever and then her mental status declined. She was discharged back to assisted living. Suspected UTI, and moderate dementia, placed on hospice (2/12/21). Died on 2/13/21.

Other Meds: Cephalexin Spiriva, Nitro, Probiotic, Albuterol, Vitamin D3, Multivitamin Aspirin, Glucosamine, Metamucil, Tylenol, Cranberry, Claritin, Quetiapine

Current Illness: Dementia with mental status change Urinary tract infection

ID: 1038239
Sex: U
Age: 1
State: TX

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-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; Sender's Comments: US-009507513-2102USA004059:

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1038240
Sex: U
Age: 4
State: TX

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 07-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T013204; expirationdate: 03-DEC-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; Sender's Comments: US-009507513-2102USA004059:

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1038241
Sex: U
Age: 1
State: TX

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 17-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 secundes. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-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; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1038242
Sex: U
Age:
State: CA

Vax Date: 12/07/2020
Onset Date: 12/07/2020
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; was improperly stored and administered/ BELOW 36 Farenheit degrees/ ABOVE 47 Farenheit degrees; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 07-DEC-2020, the patient was vaccinated with incorrectly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot # T011167 with expiration date on 27-MAY-2022 (route of administration was unknown) for prophylaxis. The vaccine underwent an excursion of 35.7 degrees Fahrenheit for 1 hour and 30 minutes and 64.36 degrees Fahrenheit for 3 hours. Digital data logger was involved. No adverse event was reported.

Other Meds:

Current Illness:

ID: 1038243
Sex: F
Age: 61
State: NC

Vax Date: 06/02/2020
Onset Date: 06/03/2020
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she felt run down; This case was reported by a consumer and described the occurrence of unwell in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 2nd June 2020, the patient received the 1st dose of Shingrix. On 3rd June 2020, 1 days after receiving Shingrix, the patient experienced unwell. On 4th June 2020, the outcome of the unwell was recovered/resolved. It was unknown if the reporter considered the unwell to be related to Shingrix. Additional information was provided as follows: The next day of receiving vaccine, the patient felt run down but resolved after one day. The reporter did not consent to follow up. For tolerance of 2nd dose, refer case US2020252523.; Sender's Comments: US-GLAXOSMITHKLINE-US2020252523:same reporter

Other Meds:

Current Illness:

ID: 1038244
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Acute upper respiratory infection; asthma attack; flu like sympthoms; malaise; This case was reported by a physician via other manufacturer and described the occurrence of acute upper respiratory tract infection in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included asthma. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced acute upper respiratory tract infection, asthmatic attack, influenza-like symptoms and malaise. On an unknown date, the outcome of the acute upper respiratory tract infection, asthmatic attack, influenza-like symptoms and malaise were unknown. It was unknown if the reporter considered the acute upper respiratory tract infection, asthmatic attack, influenza-like symptoms and malaise to be related to Shingrix. Additional details were provided as follows: The patient received dose of shingrix and experienced acute upper respiratory tract infection, asthmatic attack, influenza-like symptoms and malaise. The information regarding consent to follow up was not reported.

Other Meds:

Current Illness: Asthma

ID: 1038245
Sex: M
Age: 54
State: NC

Vax Date: 12/16/2020
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fever; chills; muscle pain; extreme fatigue; felt like someone punched him and threw him down the street; This case was reported by a consumer and described the occurrence of fever in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 23rd September 2020 and also had fatigue, muscle pain and chills, refer case US2021013449). On 16th December 2020, the patient received the 2nd dose of Shingrix. In January 2021, less than 2 months after receiving Shingrix, the patient experienced fever, chills, muscle pain, fatigue and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, chills, muscle pain, fatigue and feeling unwell were recovered/resolved. It was unknown if the reporter considered the fever, chills, muscle pain, fatigue and feeling unwell to be related to Shingrix. Additional details were provided as follows: The case was reported by patient himself. The patient experienced the same side effects fever, chills, muscle pain, fatigue with greater intensity. The patient had to put on an electric blanket with heat and he felt like someone punched him and threw him down the street. All the adverse events were recovered after 3 days. The reporter consented to follow up. This case was linked with case US2021013454, reported by the same reporter; Sender's Comments: US-GLAXOSMITHKLINE-US2021013454:same reporter US-GLAXOSMITHKLINE-US2021013454:same reporter

Other Meds:

Current Illness:

ID: 1038246
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Face is still sore; This case was reported by a consumer via interactive digital media and described the occurrence of facial pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced facial pain. On an unknown date, the outcome of the facial pain was unknown. It was unknown if the reporter considered the facial pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of shingrix and experienced face was still sore. The age group was not reported but it was selected as adult as per vaccine indication. The patient received shot of clovis, had no side effects. The information regarding consent to follow was not reported.

Other Meds:

Current Illness:

ID: 1038247
Sex: F
Age: 56
State: NY

Vax Date: 07/01/2020
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 202008; Test Name: CT brain/face; Result Unstructured Data: (Test Result:Negative for masses or other anatomical explanatio,Unit:unknown,Normal Low:,Normal High:)

Allergies:

Symptoms: preseptal cellulitis/left facial cellulitis; facial asymmetry; sagging of left upper lid; This case was reported by a physician via call center representative and described the occurrence of preseptal cellulitis in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of periorbital cellulitis (1st dose received in December 2019, refer case US2021018328). In July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 1 week after receiving Shingrix, the patient experienced preseptal cellulitis (serious criteria GSK medically significant). On an unknown date, the patient experienced facial asymmetry and sagging eyelid skin. The patient was treated with amoxicillin sodium, potassium clavulanate (Augmentin) and sulfamethoxazole + trimethoprim (Bactrim). Rechallenge with Shingrix was positive. In August 2020, the outcome of the preseptal cellulitis was resolved with sequelae. On an unknown date, the outcome of the facial asymmetry and sagging eyelid skin were not recovered/not resolved. The reporter considered the preseptal cellulitis to be almost certainly related to Shingrix. It was unknown if the reporter considered the facial asymmetry and sagging eyelid skin to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported but could be 54 or 55 years. The physician stated that because of COVID epidemics the delivery of the 2nd dose was delayed till July 2020/ some 6 months later. The patient about 1 week later of vaccination, developed preseptal cellulitis and was treated successfully with combination of oral Bactrim and Augmentin for 10 days. The physician stated that less than 9 months after receiving Shingrix, some facial asymmetry and sagging of left upper lid persisted. In August 2020, CT brain done had not revealed any significant abnormalities. The physician stated that the patient never suffered preseptal cellulitis before or after these two episodes. The reporter consented to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021018328:Same reporter

Other Meds:

Current Illness:

ID: 1038248
Sex: F
Age: 88
State: WY

Vax Date: 07/17/2018
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Shingles after dose one; This case was reported by a pharmacist and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) (batch number B334Y, expiry date unknown) for prophylaxis. The patient's past medical history included cancer and shingles. On 17th July 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced shingles. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR013246.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR013246:Same reporter.

Other Meds:

Current Illness:

ID: 1038249
Sex: F
Age: 56
State: KY

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20201229; Test Name: oxygen stat; Result Unstructured Data: Oxygen stat fluctuated from 97 to 86

Allergies:

Symptoms: Moderate allergic reaction; Felt light headed and dizzy; Cough; dry throat; Scratchy throat; Nose Tingling; did not sleep well; O2 saturation levels fluctuating from 97-86; A spontaneous report was received from nurse concerning a 56-year-old female patient who felt lightheaded and dizzy and experienced moderate allergic reaction, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuations. The patient has past medical history of Chronic obstructive pulmonary disease (COPD) and emphysema. No relevant concomitant medications were reported. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273, for prophylaxis of COVID-19 infection. On 29 Dec 2020, immediately after the vaccine shot, she felt lightheaded and dizzy. She experienced nose tingling, cough and her throat was dry and scratchy. Her symptoms were considered severe by clinic staff and the patient was taken to the emergency Room (ER). Her oxygen levels were reported to be fluctuating from 97-86. The reaction was considered a moderate allergic reaction. Treatment with diphenhydramine and steroid shot was given. The patient condition improved and was discharged from the ER with prescription for steroid taper. The patient did not sleep well and did not contact the provider about any symptoms. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, moderate allergic reaction, felt lightheaded and dizzy, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuation was unknown. The causality assessment for the events, moderate allergic reaction, felt lightheaded and dizzy, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuation was not provided.; Reporter's Comments: This case concerns a 56-year-old female patient with a relevant medical history of COPD and emphysema who received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient experienced the serious unlisted event of Hypersensitivity, and non--serious unlisted event of Dizziness, Cough, Dry throat, Throat irritation, Poor quality sleep, and Oxygen saturation decreased. The events occurred on the same day after first dose of mRNA-1273, lot # unknown. Treatment for the events included diphenhydramine and steroid shot. Based on the temporal association between the use of the product and the events occurring after receiving the vaccine, a causal relationship cannot be excluded and the events are considered possibly related to the product.

Other Meds:

Current Illness:

ID: 1038250
Sex: F
Age: 73
State: NY

Vax Date: 12/24/2020
Onset Date: 12/25/2020
Rec V Date: 02/18/2021
Hospital: Y

Lab Data: Test Date: 20210108; Test Name: cat scan; Test Result: Positive ; Result Unstructured Data: Blood clots in both lungs, saddle embolism; Test Date: 20201225; Test Name: O2 sat; Result Unstructured Data: low; Test Date: 20201226; Test Name: O2 sat; Test Result: Inconclusive 89 %; Result Unstructured Data: Inconclusive; Test Date: 20201228; Test Name: O2 sat; Test Result: Inconclusive 83 %; Result Unstructured Data: Inconclusive; Test Date: 20201231; Test Name: O2 sat; Test Result: Inconclusive 90 %; Result Unstructured Data: Inconclusive; Test Date: 20201228; Test Name: covid-19 test; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20201230; Test Name: covid-19 test; Test Result: Negative ; Result Unstructured Data: negative

Allergies:

Symptoms: Sadle embolism in lungs; DVT in left leg; Slight fever; Extreme fatigue; Shortness of breath,struggling for every breath; Low o2 sat; A spontaneous report was received from a health care professional, who was a 73-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced shortness of breath, slight fever, extreme fatigue, left leg deep vein thrombosis (DVT), and saddle pulmonary embolism (PE). The patients' medical history was not provided. No concomitant medications list was provided. On 24 Dec 2020, prior to the onset of symptoms, patient received the first of two planned doses of mRNA-1273 (Batch number 011J20A) for the prophylaxis of COVID -19 infection. On 25 Dec 2020, patient experienced shortness of breath with low oxygen saturation levels. On 26 Dec 2020, the patient's oxygen saturation levels were down to 89% with slight fever and extreme fatigue. On 27 Dec 2020, patient's energy was back to normal. On 28 Dec 2020, the patient woke up in the morning with symptoms of almost could not breathe, could not walk across the room. The patient's vital signs included oxygen saturation 83%. The patient was struggling for every breath. The patient tested negative for COVID-19. On 30 Dec 2020, another COVID-19 test was negative. On 31 Dec 2020, patient's vital signs included oxygen saturation closer to 90%, and she reported getting better. Symptoms remained the same for about a week. On 08 Jan 2021, the patient experienced left ankle and foot swollen. The patient was seen by physician and then sent to emergency room where it was determined that the patient had DVT in the left leg. A computerized tomogram (CT) scan found clots in the left lung, or saddle PE. On 09 Jan 2021, the patient was discharged from the hospital. Treatment for the events experienced included intravenous heparin and blood thinners. Action taken with planned second dose of mRNA-1273 in response to the events was not provided. The event, extreme fatigue, was considered resolved on 27 Dec 2020. The outcome of the events, shortness of breath, slight fever, DVT and saddle PE were not provided. Follow-up received on 19 Jan 2021 included updated events (DVT and saddle PE), updated event details, treatment, and hospitalization details.; Reporter's Comments: This spontaneous report refers to a case of 73- year-old female patient who experienced serious event of pulmonary embolism and deep vein thrombosis and non-serious events of shortness of breath, oxygen saturation levels were down to 89% with slight fever and extreme fatigue the next day after administration of the first dose of mRNA-1273, lot # 011J20A, expiration date-unknown. Based on temporal information provided and the known safety profile of the vaccine and the absence of any other etiology factors, a causal association between the vents of shortness of breath, oxygen saturation levels were down to 89% with slight fever and extreme fatigue and the administration of mRNA-1273 vaccine cannot be excluded. Fever and fatigue are consistent with the known safety profile of mRNA-1273 vaccine. There is no enough information t clinically assess the causal association between the events of pulmonary embolism and deep vein thrombosis as the patient's medical history and list of concomitant medications were lacking. Main field defaults to ?possibly related'

Other Meds:

Current Illness:

ID: 1038251
Sex: F
Age: 63
State: NC

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hyperpigmentation; Sloughed skin; Bullous eruption eventually peeled off with "sloughed skin"; Redness down to side of the arm and demarcation, looks like a burn; Constant burning sensation; Bullous eruption on her arm; Bruising; Discoloration; Blisters; Vesicular pustules; Significant pruritus; Arm felt warm; Significant tenderness and pain on arm/significant tenderness and pain; Her arm felt warm, painful and was red; Swelling extended down to her arm; A spontaneous report was received from a physician, who was also a 63-year old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, bullous eruption on her arm, bruising, discoloration, blisters, vesicular pustules, significant pruritus, hyperpigmentation, constant burning sensation, sloughed skin, arm felt warm, bullous eruption eventually peeled off with "sloughed skin," redness down to side of the arm and demarcation, looks like a burn, significant tenderness and pain on arm/significant tenderness and pain, her arm felt warm, painful and was red, and swelling extended down to her arm. The patient's medical history, as provided by the reporter, included hypertension, sulfonamide drug allergy, and penicillin drug allergy. Concomitant medications reported included bisoprolol, telmisartan, vitamin D, vitamin C, and zinc. On 30 Dec 2020, approximately four hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, after receiving the vaccine, the patient experienced warmth, redness, and pain in the arm which she treated with ice and diphenhydramine. On 31st Dec 2020, 14 hours after vaccine administration, the patient started to experience bullous eruption on her arm, pruritis and constant burning sensation in the arm. She reported having swelling extended down to her arm, bruising, discoloration, blisters, small vesicular pustules, erythema down to the side of the arm, and demarcation. She spoke to her primary care provider as her rash continued to evolve. She was started on a methylprednisolone pack but only took two doses for concern it would blunt the immune response to the vaccine. Additionally, she was treated with triamcinolone ointment. On 03 Jan 2021, the bullous eruptions peeled off with sloughed skin, she had an excoriated area underneath the skin. She also had tenderness and pain in the arm which resolved spontaneously. The patient self-treated the events with benzethonium chloride and vitamin E oil. On 28th Jan 2021, the patient had hyperpigmentation of her posterior arm with an excoriated area. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, bullous eruption on her arm, bruising, discoloration, blisters, vesicular pustules, significant pruritus, hyperpigmentation, constant burning sensation, arm felt warm, bullous eruption eventually peeled off with "sloughed skin", redness down to side of the arm and demarcation, looks like a burn, her arm felt warm, painful and was red, and swelling extended down to her arm, was not reported. The outcome of the event, sloughed skin, was considered recovering. The outcome of the events, significant tenderness and pain on arm/significant tenderness and pain and swelling extended down to her arm, was considered resolved.; Reporter's Comments: This case concerns a 63 year old female patient with medical history of hypertension, sulfonamide drug allergy, and penicillin drug allergy, who experienced a serious unexpected event of Dermatitis bullous and NS unexpected events of bruising, discoloration, blisters, vesicular pustules, significant pruritus, hyperpigmentation, constant burning sensation, sloughed skin and arm felt warm. The events occurred 14 hours after first dose of the study medication administration. She was started with a methylprednisolone pack and triamcinolone ointment. 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: BISPROLOL COMP; TELMISARTAN; VITAMIN D 2000; VITAMIN C;VITAMIN D NOS;VITAMIN E; ZINC

Current Illness:

ID: 1038252
Sex: F
Age:
State: IN

Vax Date: 01/04/2021
Onset Date: 01/07/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nervous system disorder NOS; Severe uncontrollable body movements, my tongue was also affected; Allegedly having an adverse reaction with seizures; A spontaneous report was received from a consumer who was a 42-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced attack on nervous system, severe uncontrollable body movements, and allegedly having an adverse reaction with seizures. The patient's medical history, as provided by the reporter, included hysterectomy. No concomitant medications were provided. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 011L20A) for prophylaxis of COVID-19 infection. On 07 Jan 2021, the patient's tongue began to spasm. On 08 Jan 2021, the patient's whole body had been convulsing all day. The patient reported that it was attacking her nervous system on an undisclosed date. She visited four hospitals in two days; all blood work was normal. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, attack on nervous system, severe uncontrollable body movements, and allegedly having an adverse reaction with seizures, was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 42-year-old, female patient with medical history of hysterectomy, who experienced serious, unexpected event of seizures and non-serious, unexpected event of dyskinesia and nervous system disorder NOS. The events occurred 4 days after the first dose of mRNA-1273 (Lot Number: 011L20A) administration. Very limited information regarding this event has been provided at this time. Based on 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:

Date Died: 01/13/2021

ID: 1038253
Sex: M
Age:
State: FL

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Died the next day; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died the next day. The patient's medical history was not provided. Concomitant medication use was not provided by the reporter. On 12 Jan 2021, approximately one day prior to the event, the patient received one of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021 the patient died. No additional information was provided in regards to the event. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 13 Jan 2021. The cause of death was unknown.; Reporter's Comments: This case concerns a male patient of unknown age. The medical history and concomitant medication were not provided. The patient died approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1038254
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Name: body temperature; Test Result: 104 {DF}; Result Unstructured Data: High; Test Name: Heart rate; Result Unstructured Data: 145 beats per minute; Test Name: Urine analysis; Result Unstructured Data: no additional details provided

Allergies:

Symptoms: Heart rate 145 beats per min; Shortness of breath; Panic attack; Severe dehydration; Cannot quench thirst; Numb tongue and mouth; Fever of 104 F; Aches; Chills; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart rate 145 beats per min (bpm), fever of 104F, shortness of breath, panic attack, severe dehydration, cannot quench his thirst, numb tongue, numb mouth, aches and chills. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced a fever of 104 F, elevated heart rate of 145 bpm, severe dehydration, cannot quench his thirst, numb tongue and moth for 3 days and aches and chills for 3 days. He sought medical attention at his doctor's office. A urinalysis was completed which resulted normal. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events, heart rate 145 beats per min, fever of 104F, shortness of breath, panic attack, severe dehydration, cannot quench his thirst, numb tongue, numb mouth, aches and chills, were considered resolved on an unknown date.; Reporter'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:

Current Illness:

ID: 1038255
Sex: F
Age: 78
State: NY

Vax Date: 01/09/2021
Onset Date: 01/11/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Viral encephalitis; Short term memory loss; Combative behavior; Significant cognitive deficit; Not remembering words; Completely incoherent; A spontaneous report was received from a consumer concerning a 78-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced short term memory loss, combative behavior, viral encephalitis, significant cognitive deficit, not remembering words, and completely incoherent. The patient's medical history, as provided by the reporter, included an unspecified thyroid disorder. Concomitant medications reported included levothyroxine and levothyroxine sodium. On 09 Jan 2021, approximately two days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient began exhibiting short term memory loss and combative behavior. She was completely incoherent, not remembering words, could not name colors or shapes, and her short term memory was gone. On 15 Jan 2021, the patient saw a neurologist and tests ordered included a doppler and air being blown into her ear. On 18 Jan 2021, the patient had unspecified bloodwork done. No results were provided. On 21 Jan 2021, three magnetic resonance imaging (MRI) exams were conducted as well. No results were reported. On 21 Jan 2021, it was reported the patient's symptoms had not resolved and the patient had since been hospitalized. Her doctors believed she developed viral encephalitis brought on by the COVID vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events, short term memory loss, combative behavior, viral encephalitis, significant cognitive deficit, not remembering words, and completely incoherent, were considered not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Other Meds: LEVOTHYROXINE; LEVOXINE [LEVOTHYROXINE SODIUM]

Current Illness: Thyroid disorder NOS

ID: 1038256
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccine was incorrectly administered into fat (subcutaneous) and not in muscle; They want to give her the third dose; A spontaneous report was received from a consumer, concerning a female patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), which resulted in events, vaccine was incorrectly administered into fat (subcutaneous) and not in muscle/incorrect route of product administration and they want to give her the third dose/prescribed overdose. The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, prior to the onset of events, the patient received their first dose of mRNA-1273 (Lot number: unknown), subcutaneous in the back of her arm for prophylaxis of COVID-19 infection. The nurse didn't administer the vaccine to the patient in her deltoid muscle but administered it in the back of her arm. The nurse at the clinic stated that it wasn't administered correctly and was administered into her fat (subcutaneous) and not in her muscle. The patient's arm was not sore, and they want to give her the third dose. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, "vaccine was incorrectly administered into fat (subcutaneous) and not in muscle and they want to give her the third dose", were reported as resolved on an unknown date.; Reporter's Comments: This report refers to a case of a female consumer who received Moderna's COVID 19 vaccine subcutaneously, (instead of intramuscularly (IM)), and they want to give her the third dose/prescribed overdose. The vaccine lot number was not reported. There were no reported AEs associated with this case of female consumer who received Moderna's COVID-19 vaccine subcutaneously, and want to give her a third dose.

Other Meds:

Current Illness:

Date Died: 01/18/2021

ID: 1038257
Sex: M
Age: 63
State: NM

Vax Date: 01/14/2021
Onset Date: 01/16/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210113; Test Name: COVID test; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210118; Test Name: COVID test; Test Result: Positive ; Result Unstructured Data: per coroner

Allergies:

Symptoms: Passed away; tired; nonresponsive; cold; difficulty breathing; swelling; sore arm; feeling weird and funny; A spontaneous report (United States) was received from a consumer concerning a 63 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal and the patient passed away . Medical history included treatment for tuberculosis and dialysis. Concomitant medication included calcium acetate, Renvela, glipizide, omeprazole, aspirin, vitamin D, losartan, furosemide, rifampin, and Sensipar. On 14 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 030L20A) for prophylaxis of COVID-19 infection. On 13 Jan2021, the patient tested negative for COVID-19). On 16 Jan 2021, the patient experienced a sore arm, and feeling weird/funny. On 17Jan2021, the patient experienced difficulty breathing and swelling. On 18 Jan 2021, the patient declined dialysis, was tired and wanted to lay down. At 8 am, the patient was found nonresponsive and cold and is believed to have passed away around 4 am. The coroner tested the deceased for COVID-19 and the test was positive. No autopsy was reported. No death certificate was issued at the time of the report but the reporter believes it will list cause of death as COVID complications. Action taken with the mRNA-1273 was not applicable. The outcome of the events of limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal, was fatal. On 18 Jan 2021, the patient was died. Cause of death was COVID-19. Autopsy details were not provided.; Reporter's Comments: The events developed on four days after first dose of mRNA-1372. Dyspnea, unresponsive to stimuli, and death were consistent with infection in pandemic set up confounded by age of patient and refusal of dialysis Cause of death was reported as COVID-19. Autopsy details were not provided. Based on reporter's causality the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19

Other Meds: CALCIUM ACETATE; RENVELA; GLIPIZIDE; OMEPRAZOLE; ASPIRIN (E.C.); VITAMIN D NOS; LOSARTAN; FUROSEMIDE; RIFAMPIN; SENSIPAR

Current Illness: Dialysis; TB

ID: 1038258
Sex: F
Age:
State: NC

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Woke up on the floor, not sure if passed out or was unconscious; Cramps in hand; Hands shook; Dry heaving; Voice kind of changed; Urine was very bright; Chills; A spontaneous report was received from a female (age unknown) consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cramps in hand, hands shook/shaking of hands, dry heaving/dry heaves, voice kind of changed/distorted voice, urine was very bright/urine color abnormal, chills and woke up on the floor, not sure if passed out or unconscious. The patient's medical history was not reported. No relevant concomitant medications were reported. On 28 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On unknown date, patient started to experience cramps in hand, shaking of hands, dry heaving, voice kind of changed, urine was very bright, chills and woke up on the floor, not sure if passed out or unconscious. Treatment for the events were not provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, cramps in hand, hands shook/shaking of hands, dry heaving/dry heaves, voice kind of changed/distorted voice, urine was very bright/urine color abnormal, chills and woke up on the floor, not sure if passed out or unconscious was Unknown.; Reporter's Comments: The events developed after first dose of mRNA-1372. Very limited information regarding this events has been provided at this time. 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:

Current Illness:

ID: 1038259
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 02/18/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: pneumonia (felt cold, fever, difficulty breathing, body aches); A spontaneous report was received from a healthcare professional concerning an 88-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia. Medical history included atrial fibrillation. No relevant concomitant medication was reported. On an unspecified date, the patient received a dose of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced being cold at night, felt fever in the morning, had difficulty breathing, body aches, and was diagnosed with pneumonia at the hospital. The patient was treated while in the hospital (treatment was unknown). Action taken with the mRNA-1273 in response to the event was not reported. The event, pneumonia, was considered resolved.

Other Meds:

Current Illness: AFib

ID: 1038260
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 17-year-old patient received the 1st dose of the vaccine; A spontaneous report was received from a health care professional, concerning a 17-year-old, patient who received the first dose of Moderna's COVID-19 vaccine (mRNA-1273). 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 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, it was reported that one of the pharmacies administered a 17-year-old patient the first dose of the vaccine. No treatment information was reported. The outcome of the event, 17-year-old patient received the 1st dose of the vaccine, was resolved.; Reporter's Comments: This case concerns a 17 year old patient of unknown gender who received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events in this case of product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 1038261
Sex: F
Age: 36
State: NJ

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 36 year old female patient inadvertently received an expired dose of Tenivac, no AE; Initial information received on 09-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 36 years old female patient who was vaccinated with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation. On 08-Feb-2021, the patient received a 0.5 ml booster dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot C5578AA and expiry date: 28-Jan-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency on same day). It was also reported that the caller stated a patient was administered Tenivac on 08-FEB-2021. The caller stated that it was discovered that the vaccine was expired as of 28 JAN 2021. The caller would like to know the efficacy of the vaccine at this time and how to proceed to care for the patient. Event Information for further details. Additional description of event adverse events: Patient inadvertently received an expired dose of Tenivac intramuscularly yesterday (08 Feb 2021), Dose was intended to be the booster dose. Reported did not know where on the body the dose was given. Reporter relationship: health care professional (HCP) Product used: used first time product used: yes still using product: no At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1038263
Sex: F
Age: 29
State: NH

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: concerned about some focal bruising, erythema and soreness at the site of injection (L deltoid). Patient states she did not have any reaction to the first dose aside from some muscle tenderness. Denies fever, chills, seizure, headache, arthralgias, N/V, abdominal pain, diarrhea, urticaria, dyspnea, wheezing.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm