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: 0934418
Sex: F
Age: 33
State: IL

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: n/a

Allergies: n/a

Symptoms: after vaccine, pain in the arm and cramping in left arm, fatigue, tingling sensation in extremities when at rest, doesn't feel the tingling too much when active

Other Meds: n/a

Current Illness: n/a

ID: 0934419
Sex: M
Age: 77
State: LA

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: NKDA

Symptoms: BELL'S PALSY.

Other Meds:

Current Illness:

ID: 0934420
Sex: F
Age: 26
State: NC

Vax Date: 01/10/2021
Onset Date: 01/10/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Approximately 15 min after vaccination began to experience tingling sensation under tongue. It was not bothersome so I proceeded to go home. At 2:04 pm, approximately 40 minutes after vaccination was driving home and began to experience an elevated HR, shortness of breath/difficulty breathing and throat tightness. Proceeded to pull over to a gas station and felt extremely weak when trying to walk and a tingling sensation all over. Took 25 mg of Benadryl tablets and symptoms began to subside within about 10 minutes or so. Proceeded to continue driving home and had another episode at 2:49 pm, experienced significant shortness of breath and tingling sensation in mouth spread to back of tongue and it felt swollen. I bought liquid Benadryl instead and took ~20 mL. This episode resolved within 10-20 minutes as well and was okay for the rest of the evening.

Other Meds: None

Current Illness: None

ID: 0934421
Sex: M
Age: 47
State: RI

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: N/A

Allergies: NKA

Symptoms: Tingling/burning down L arm, similar sensation down L leg; urticaria noted on back of neck extending slightly to L side of neck. Tachycardia and hypertension upon exam.

Other Meds: Multivitamins

Current Illness: none

ID: 0934422
Sex: M
Age:
State:

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: arm pain soreness in arm lethargic

Other Meds:

Current Illness:

ID: 0934423
Sex: M
Age: 30
State: IL

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: cold sweats, shivering, mild nausea for a few hours. then fever and headache for another several hours. all occurring overnight from 11:30 or so to resolving by noon following day with just a headache and general fatigue remaining

Other Meds: zinc and calcium/vitamin D supplements

Current Illness: none

ID: 0934424
Sex: F
Age: 30
State: WI

Vax Date: 12/28/2020
Onset Date: 12/29/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Severe head ache; nausea/vomiting; chills; muscle aches; injection site pain and swelling

Other Meds:

Current Illness:

ID: 0934425
Sex: M
Age: 41
State: CA

Vax Date: 01/09/2021
Onset Date: 01/10/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Body aches, chills and headache.

Other Meds:

Current Illness:

ID: 0934426
Sex: F
Age: 36
State: NY

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: Burning and redness both ears, burning and itching posterior head, hive behind right ear, chest and back, mild rash chest and right forearm.

Other Meds: methylphenidate

Current Illness: none

ID: 0934427
Sex: F
Age: 36
State: NY

Vax Date: 01/04/2021
Onset Date: 01/11/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: none

Allergies: shellfish, latex tylenol

Symptoms: one week post vaccine dose 1, i have swelling and rash with hives on my left arm at injection site, it is itching terribly, applied Benadryl cream to help with itch. rash is spreading down my arm. and my arm feels very hot at injection site. i would also like to note that i have had extreme hyper episodes post injection as well.

Other Meds: synthroid 125

Current Illness: none

ID: 0934428
Sex: F
Age: 49
State:

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Reported heart racing was brought to lay down at 11:40 no further heart racing pulse 60, blood pressure 142/86. Client shaking. No signs or symptoms of distress. Respirations even and unlabored. Skin pink warm and dry. Continuing to monitor. 1201 reported no further shaking and feeling that her chest was heavy but stated i am ok. blood pressure 142/80 no signs of distress. 12:18 stated she is much better, no further signs or symptoms and no signs of distress. Informed to seek medical attention if further problems arise.

Other Meds:

Current Illness:

ID: 0934429
Sex: M
Age: 67
State: MI

Vax Date: 11/17/2020
Onset Date: 11/17/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Patient states he has some soreness in his upper right arm and states he noticed it after he had his flu vaccination 11/17/2020, he states its sore to lay on it and sometimes when he lifts his arm. He denies any pain down the arm. Denies redness and denies any knot. Just states it has just bothered him since then. States he has not reached out to his provider regarding his arm. I recommended he reach out to his provider to let them know what exactly he is experiencing in his arm. Patient received the FLUAD quad. recommended patient call their physician

Other Meds:

Current Illness:

ID: 0934430
Sex: F
Age: 46
State: OH

Vax Date: 12/31/2020
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: na

Allergies: none

Symptoms: one week post injection, injection site became red, swollen and itchy. Rash last approx 24 hours.

Other Meds: B vitamin complex

Current Illness: none

ID: 0934431
Sex: F
Age: 56
State: OH

Vax Date: 12/29/2020
Onset Date: 01/08/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: moderna covid 19 vaccine eua developed red rash around site 11 days after infection and a few red spots on face and torso

Other Meds: flonase, flovent, vitamin C, MVI

Current Illness: none

ID: 0934432
Sex: M
Age: 60
State: ID

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: IOP, retinal photos, high plus slit lamp retinoscopy

Allergies: none reported

Symptoms: 2 hours after receiving Pfizer COVID vaccine, vision in left eye presented with new floaters, flashes of light, and visual disturbance. Described as constant by patient, has not resolved 3 days s/p vaccination

Other Meds: none reported

Current Illness: none reported

ID: 0934433
Sex: F
Age: 38
State: ID

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

Lab Data: NA

Allergies: Morphine, Sulfa

Symptoms: Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for several hours, racing heart rate, sudden hot feeling, extreme headache, extreme fatigue, brain fog, irritability, pain at injection site.

Other Meds: Xolair, Cytomel, Levothyroxine

Current Illness: None

ID: 0934434
Sex: F
Age: 58
State: IA

Vax Date: 12/28/2020
Onset Date: 12/29/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: Had a fever of 101.2 for 24 hours. Difficulty getting fever down with both Tylenol and Ibuprofen. After 24 hours, fever was gone and no other symptoms.

Other Meds: Duloxetine, Lexapro, Synthroid, Meloxicam, Vit D, Gabapentin

Current Illness: none

ID: 0934435
Sex: F
Age: 44
State: FL

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: Penicillin

Symptoms: Friday night - Sore arm and sore throat. Saturday morning - Woke up sweaty. Swollen lymph node on right side of neck, close to collar bone. Very sore. As of today, Monday, 1/11, it is more swollen and hurts. And I'm still having night sweats plus am extremely hot but not having a fever.

Other Meds: Claritin

Current Illness:

ID: 0934436
Sex: F
Age: 52
State: IL

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: no

Allergies: no

Symptoms: Symptoms began about 45 mins after. Lower part of jawline was swollen. Not sure if it was the n95 mask. Throat got scratchy, sounding hoarse. Took Benadryl, extremely fast heart rate when moving around. SOB walking to and from the bathroom. Extreme pain in back. Took Tylenol. 6am, Sat, woke up with headache and back was a tremendous pain. Took Tylenol every 6-8 hours. Today muscles in back are sore. No fever. Very fatigue today.

Other Meds: Losartin25mg, Victoza,

Current Illness: no

ID: 0934437
Sex: F
Age: 33
State: SC

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: Redness, itching, swelling, hot to the touch at injection site 4days in a row, fever 102degrees F on 2nd day with chills and tingly/prickly feeling all over, weakness/dizziness

Other Meds: none

Current Illness: none

ID: 0934438
Sex: F
Age: 80
State: NE

Vax Date: 12/30/2020
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: None

Allergies: NKA

Symptoms: Volunteer received Moderna dose on 12/30 and then came in to receive 2nd dose on 1/6. Received Pfizer dose on the 6th. She states feels fine, no adverse side effects. Instructed NOT to come on 1/27, when her next appointment was scheduled.

Other Meds:

Current Illness:

ID: 0934439
Sex: F
Age: 56
State: TX

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: Shellfish Ibuprofen

Symptoms: Numbing of tongue, possibly mild Bell's Palsy, and occurred about 7 minutes after vaccination

Other Meds: Benadryl

Current Illness:

ID: 0934440
Sex: F
Age: 38
State: WI

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

Lab Data:

Allergies:

Symptoms: Sore throat for a few hours after the injection Painful body aches, body sweats and chills in the evening - Aleve worked temporarily and then the side effects got worse, took another Aleve and eventually was able to sleep it off Arm aches at site of injection - still tender t otouch

Other Meds:

Current Illness:

ID: 0934441
Sex: F
Age: 58
State: CA

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: High fever that lasted until yesterday up to 101.9 F Severe headache Chills Body ache Abdominal pelvic pain Patient reports having first dose of shingles vaccine 11/6/2020

Other Meds:

Current Illness:

ID: 0934442
Sex: F
Age: 29
State: MA

Vax Date: 01/10/2021
Onset Date: 01/10/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: benadryl

Symptoms: tightening of chest, shortness of breathe, numbness/tingling in fingers and lips

Other Meds: fluoxetine 60mg, women's daily multivitamin, Junel (birth control), occasional zyrtec

Current Illness: none

ID: 0934443
Sex: F
Age: 43
State: CA

Vax Date: 01/03/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Leg Rash Red rash and hot to touch on the injection site swollen around the injection site

Other Meds:

Current Illness:

ID: 0934444
Sex: F
Age: 42
State: WI

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: Clindamycin, sulfa, flu vaccines , environmental

Symptoms: lient's tongue became swollen within 20 min. of vaccination. Swelling did not resolve by 4:00pm, client seen at urgent care. Client treated with Prednisone 60 mg PO x1; client prescribed Benadryl Q 4-6 hrs. x2 days, Prednisone 20 mg PO BID x5 days. Client developed generalized pruritis and lip tingling approximately 12 hrs. post-vaccination. Tongue swelling improved but not fully resolved at this writing (72 hrs. post-vaccination).

Other Meds: DAILY MULTI-VITAMIN

Current Illness:

ID: 0934445
Sex: F
Age: 52
State: OK

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: NKDA

Symptoms: 52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions. Provider will follow up in a few days to check on the patient.

Other Meds:

Current Illness:

ID: 0934446
Sex: F
Age: 37
State: WA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: 8:10 p c/o numbness, tingling, no sob, no dizziness, 120/76, 92 98% given H2O, rechecked 8:25p no changes in symp or V/S. Stayed on site for 40 mins symptoms resolved.

Other Meds: none

Current Illness: none

ID: 0934448
Sex: F
Age: 34
State: NM

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: None

Allergies: Lidocaine, chlorahexidine

Symptoms: Chills, sweats, low grade fever, muscle aches, headache, fatigue, nausea. Symptoms started approximately 13 hours after vaccination and all resolved after almost 68 hours except for the muscle aches and fatigue.

Other Meds: Gabapentin, magnesium, blisolvi, propanalol, Nexium, Zyrtec, hydrocodone, Wellbutrin

Current Illness: None

ID: 0934449
Sex: F
Age: 41
State: NY

Vax Date: 01/05/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: Negative Covid swab PCR

Allergies: None

Symptoms: Thursday evening 8:00 PM 6 Hour migraine 10/10 pain Friday: General feeling unwell Saturday 6:00 PM sudden severe onset Nausea/ Diarrhea for 3 hours Sunday : General feeling of unease/disoriented Monday: No symptoms Missed work Saturday and Sunday

Other Meds: Concerta

Current Illness: None

ID: 0934450
Sex: M
Age: 55
State: IL

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: NSAIDs

Symptoms: C/O body aches, fatigue afternoon after vaccine. Following night had Fever 100.5, body aches. Fever decreased with tylenol.

Other Meds: Baclofen, Docusate, Finasteride, Omeprazole, Tamulosin, Vit D,

Current Illness:

ID: 0934451
Sex: F
Age: 42
State: NY

Vax Date: 12/28/2020
Onset Date: 01/08/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: None at this time. Awaiting medical direction

Allergies: allergy to bee stings

Symptoms: Begining approx. 1/8/21, 11 days after the vaccine injection, the injection site is randomly very itchy and has a large red circle/ ring surrounding it. The red ring around the injection site is very large in size, about 3- 4 inches long and wide across my arm.

Other Meds: Pantoprazole 20 mg, 1x daily mutli vitamin levothyroxine 25 mcg

Current Illness: none

ID: 0934452
Sex: F
Age: 67
State: FL

Vax Date: 01/07/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: sulfa

Symptoms: client was awaken early morning 2 days after covid vaccine with severe abdominal cramps and nausea. Called PCP and got prescription for meclizine that afternoon and that helped alleviate symptoms along with taking zofran, which client already had at home.

Other Meds: multiple

Current Illness:

ID: 0934454
Sex: F
Age: 29
State: NM

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: none

Allergies: Ceclor, Azithromycin, Sudafed

Symptoms: Fever, lethargy, headache, muscle + joint ache, skin sensitivity, hair sensitivity, swollen lymph nodes. 3 days out axillary lymph nodes still swollen with joint pain, all other symptoms subsided on day 2.

Other Meds: Sertraline 50mg SID

Current Illness: None

ID: 0934456
Sex: F
Age: 71
State: FL

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

Lab Data:

Allergies: Sensitivity to erythromycin

Symptoms: Itching and subsequent rash in the upper left arm around the inoculation site.

Other Meds: Valtrex Multi-Vitamins D3

Current Illness: None

ID: 0934457
Sex: F
Age: 48
State: CA

Vax Date: 01/10/2021
Onset Date: 01/10/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and fever, night sweats and spreading pain throughout the body. Also reporting weakness

Other Meds:

Current Illness:

ID: 0934459
Sex: F
Age: 65
State: CA

Vax Date: 01/08/2021
Onset Date: 01/11/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: None

Allergies: tomatoes, potatoes, egg plant, peppers

Symptoms: Headache, nausea, right Kidney pain

Other Meds: None

Current Illness: None

ID: 0934462
Sex: F
Age: 29
State: CA

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: none

Allergies: Penicillin

Symptoms: Migraine and redness on the injection site

Other Meds: Plaquenil 200 mg PO QD Prenatal vitamins with DHA+FOLATE Xyval PO QD Flonase one spray to each nostril ASA 81 mg PO QD Pepcid PRN

Current Illness: None

ID: 0934470
Sex: U
Age:
State: MI

Vax Date:
Onset Date: 12/28/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no adverse event; a 14 month old old was given PROQUAD and VARlVAX together yesterday on 12/28/20; This spontaneous was received from a medical assistant, concerning a 14 month old patient of unknown gender. No information was reported regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies. On 28-DEC-2020 (reported as yesterday), the patient was given measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) together for prophylaxis (strength, dose, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported) (duplicate therapy error). No further adverse event was reported.

Other Meds:

Current Illness:

ID: 0934471
Sex: U
Age:
State: NY

Vax Date: 12/11/2020
Onset Date: 12/11/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; Temperature excursion for VARlVAX; This spontaneous report has been received from a physician referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided. On 11-DEC-2020, the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) experienced a temperature excursion (product storage error). It was reported that on the same date, following the temperature excursion, the dose of the vaccine (also reported as: "the doses") was administered to the patient at a dose of 0.5 milliliter (mL) (formulation, route of administration, anatomical location and vaccination scheme were not provided; lot number T010315 has been verified to be a valid lot number, expiration date was reported and validated as 24-MAR-2022), as prophylaxis. The vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was a maximum temperature of 16.2 Fahrenheit degrees (F), for a time frame of 1 hour and 14 minutes, there was no previous temperature excursion. Additionally, a digital data logger was involved. No additional adverse events (AE) were reported.

Other Meds:

Current Illness:

ID: 0934473
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Labial herpes; Ocular headache; A spontaneous report was received from consumer on 16NOV2020. The consumer (unknown gender and age) experienced labial herpes (PT: Oral herpes) and ocular headache (PT: Headache) while being on therapy with Vivotif for immunisation. The consumer asked "is it possible that in the days following taking the three doses I experienced a labial herpes and an ocular headache?". Action taken with Vivotif with respect to the reported events was unknown. The outcome of reported events was unknown. Company Comment: A consumer had oral herpes and headache after a few days of taking three doses of Vivotif. Information on medical history, and further details of the event is limited. Oral herpes is a viral infection caused by herpes simplex virus, and the causality of oral herpes is assessed as not related to Vivotif. Considering the potential of Vivotif to cause headache, the causality of headache is assessed as possible.; Sender's Comments: A consumer had oral herpes and headache after a few days of taking three doses of Vivotif. Information on medical history, and further details of the event is limited. Oral herpes is a viral infection caused by herpes simplex virus, and the causality of oral herpes is assessed as not related to Vivotif. Considering the potential of Vivotif to cause headache, the causality of headache is assessed as possible.

Other Meds:

Current Illness:

ID: 0934474
Sex: M
Age: 70
State: CO

Vax Date: 11/02/2020
Onset Date: 11/02/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data: Test Date: 20201111; Test Name: COVID-19 test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:)

Allergies:

Symptoms: skin sensitivity / sensitive skin that felt like a large sunburn; skin sensitivity with pain on his scalp; Pain on his chest; Pain in his abdomen; Shakiness of his hands; Arthralgias in his fingers; Sore throat; Chills; MUscle aches; Fatigue; Headache; This case was reported by a nurse via sales rep and described the occurrence of headache in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included varicella vaccine (dose received in 2010). On 2nd November 2020, the patient received the 1st dose of Shingrix. On 2nd November 2020, less than a day after receiving Shingrix, the patient experienced headache. On 3rd November 2020, the patient experienced sore throat, chills, muscle pain and fatigue. On 12th November 2020, the patient experienced sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand. Shingrix was discontinued. On 4th November 2020, the outcome of the fatigue was recovered/resolved. In November 2020, the outcome of the headache was recovered/resolved. On 23rd November 2020, the outcome of the sore throat, chills, muscle pain, sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand were recovered/resolved. The reporter considered the headache, sore throat, chills, muscle pain, fatigue, sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand to be related to Shingrix. Additional details were provided as follows: The reporter stated that the patient received first dose of Shingrix from his pharmacy. After receiving Shingrix, he had a headache that resolved. The following day, he had a sore throat, chills, muscle aches and fatigue. The next day he felt well. However, on 10th November 2020 he developed a sore throat, chills, and muscle aches. He had a COVID test that was negative, collected 11th November 2020. On 12th November 2020, 10 days later the patient had skin sensitivity with pain on his scalp, chest and abdomen, but no rash. He also had myalgias, shakiness of his hands and arthralgias in his fingers. He did not have a fever. The patient's myalgias improved, but he continued to have painful, sensitive skin that felt like a large sunburn. The patient's symptoms resolved 23rd November 2020. The reporter had decided already not to give the patient second dose.; Sender's Comments: US-GLAXOSMITHKLINE-US2020255814:Duplicate case

Other Meds:

Current Illness:

ID: 0934475
Sex: F
Age:
State: MI

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/11/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled up; her hand and whole arm swelled up; Trouble breathing; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EK9231, exp date Apr2021), via an unspecified route of administration in the right arm, on 29Dec2020, at single dose, for COVID-19 immunization and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration, at unknown posology, on 29Dec2020 (20 minutes prior to taking bnt162b2), for anaphylactic reaction. Medical history included ongoing thyroid disorder. Concomitant medications included apixaban (ELIQUIS), diltiazem (unknown trade name), losartan (unknown manufacturer), rosuvastatin calcium (CRESTOR), levothyroxine (unknown trade name), ongoing levothyroxine sodium (SYNTHROID) for thyroid disorder and metformin (unknown trade name). Previously the patient received unspecified influenza vaccine (reported as flu shot) for immunisation, on unspecified date, and experienced anaphylactic reaction treated with Benadryl. On 29Dec2020, an hour after getting the vaccine, the patient experienced her voice became raspy, she could hardly talk, she could barely talk with outcome of unknown, her hand and whole arm swelled up with outcome of unknown, trouble breathing with outcome of unknown. The reporter stated that her voice and everything reacted and made her go to the emergency room on 29Dec2020. She reported that had adverse effect more than normal. The event "Her voice became raspy, she could hardly talk, she could barely talk" caused patient's hospitalization on unknown date. The action taken as a result of the events with diphenhydramine hydrochloride was post-therapy. Therapeutic measures were taken at the emergency room as a result of the events and included treatment with Topcid and Benadryl every 6 hours, 2x 40 mg of steroid. The information on the lot/batch number has been requested. Follow-up (02Jan2021): New information received from the same contactable healthcare professional reporting for herself includes: patient's details, medical history, events updated, vaccine lot# and exp date, concomitant, seriousness of event "Her voice became raspy, she could hardly talk, she could barely talk" added as hospitalization, historical vaccine, suspect Benadryl details, therapeutic measures updated.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: ELIQUIS; ; ; CRESTOR; ; SYNTHROID; BENADRYL

Current Illness: Thyroid disorder

ID: 0934477
Sex: F
Age:
State:

Vax Date: 10/29/2018
Onset Date: 10/29/2018
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: She was not feeling well and was very flush, weak, lightheaded; She was not feeling well and was very flush, weak, lightheaded; She was not feeling well and was very flush, weak, lightheaded; She was not feeling well and was very flush, weak, lightheaded; Felt the vaccine running through her body; This spontaneous case was received on 16-Dec-2020 with additional information received on the same day (being processed together) from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05804) and concerned an adult, female patient. At the time of this report, the patient was 63-year-old. The patient's medical history and concomitant medications were not reported. The patient was receiving the flu vaccine for 10 years and never had a problem. On 29-Oct-2018, the patient vaccinated with Afluria (TIV) (influenza vaccine; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 333332418107 and expiry date was 22-Jun-2019. On the same day, within two minutes after receiving Afluria (TIV), the patient was not feeling well and was very flush, weak, lightheaded and felt the vaccine running through her body. She went to the emergency room but began to feel better. There, she sat in the waiting room about a half hour and all symptoms resolved. On the same day, the patient recovered from the events. The reporter did not provide a causality assessment. Company comment: The patient developed all events on the same day after receiving the suspect product, Afluria (TIV). Chronology is suggestive.The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed all events on the same day after receiving the suspect product, Afluria (TIV). Chronology is suggestive.The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).

Other Meds:

Current Illness:

ID: 0934478
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Local reactions back to back; This spontaneous case was received on 17-Dec-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05827) and concerned a patient of unreported age and gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847, expiration date: 30-Jun-2021. On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed local reactions back to back. It was not reported whether the patient received any corrective treatment. The outcome of the event was unknown. The reporter did not provide causality assessment. The case is linked to the cases 202007727, 202007728 and 202007730 (the same reporter). Company comment:The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.; Sender's Comments: The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.

Other Meds:

Current Illness:

ID: 0934479
Sex: F
Age:
State: CA

Vax Date: 11/07/2020
Onset Date: 11/07/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data: Test Date: 20201108; Test Name: Body temperature; Test Result: 98 {DF}

Allergies:

Symptoms: Cellulitis; Hives; Welts at the injection area; Flu vaccination being given too low on the arm; This spontaneous case was retrieved on 21-Dec-2020 from VAERS (reference number: 896357-1), reported by other health professional and concerned a 74-year-old female patient. The patient's concurrent conditions included bladder infection, asthma, codeine and sulfa allergy. The patient's concomitant medications included Levaquin (levofloxacin), levothyroxine, folic acid, Coreg (carvedilol), Lasix (furosemide), KCl (potassium chloride), Cholestyramine light (colestyramine) and oxybutynin, all for unreported indication. The patient's historical vaccine included influenza virus vaccine in 2017 after which the patient developed severe flu symptoms and was under a lot of stress at the time (see case 202009088). On 07-Nov-2020, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, anatomical location: right arm, dose and indication: not reported). The batch number reported was 279796. On 08-Nov-2020, one day after receiving Fluad Quadrivalent, the patient experienced hives, welts at the injection area (red, sore, hot to touch area about size of a hand), pain from elbow to shoulder. She had no fever; body temperature was 98 degrees Fahrenheit. Size of redness increased over time and pain progressed to wrist and to top of the neck. On 10-Nov-2020 in the evening, the patient went to urgent care and was given a prescription for cephalexin for 10 days and told she had cellulitis from the flu vaccination being given too low on the arm (explicitly coded as 'Vaccine administered at inappropriate site'). On 11-Nov-2020, the next morning, the patient saw primary care physician (PCP) and would follow up with PCP after finishing course of antibiotics. At the time of initial reporting, the patient had not recovered from the events, as she had taken two doses of cephalexin and symptoms remained. The reporter did not provide a causality assessment, but the urgent care stated that the cellulitis was from flu vaccination. The event of 'cellulitis' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. The case is linked to the case 202009088 (the same patient). Company comment: A 74-year-old patient was administered Fluad Quadrivalent. One day after receiving Fluad Quadrivalent, the patient experienced hives, welts at the injection area (red, sore, hot to touch area about size of a hand), pain from elbow to shoulder. The patient went to urgent care and was given a prescription for cephalexin for 10 days and told she had cellulitis from the flu vaccination being given too low on the arm. Vaccine administered at inappropriate site is assessed as not related per company's conventions. Causality is assessed as possibly related for vaccination site urticaria, urticaria and cellulitis. Per Brighton collaboration criteria, presented information correspond to level 2 diagnostic certainty for cellulitis at injection site.; Reporter's Comments: The urgent care stated that the cellulitis was from flu vaccination.; Sender's Comments: A 74-year-old patient was administered Fluad Quadrivalent. One day after receiving Fluad Quadrivalent, the patient experienced hives, welts at the injection area (red, sore, hot to touch area about size of a hand), pain from elbow to shoulder. The patient went to urgent care and was given a prescription for cephalexin for 10 days and told she had cellulitis from the flu vaccination being given too low on the arm. Vaccine administered at inappropriate site is assessed as not related per company's conventions. Causality is assessed as possibly related for vaccination site urticaria, urticaria and cellulitis. Per Brighton collaboration criteria, presented information correspond to level 2 diagnostic certainty for cellulitis at injection site.

Other Meds: LEVAQUIN; LEVOTHYROXINE; FOLIC ACID; COREG; LASIX [FUROSEMIDE]; KCL; CHOLESTYRAMINE LIGHT; OXYBUTYNIN

Current Illness: Asthma; Bladder infection; Drug allergy

ID: 0934485
Sex: M
Age: 1
State: CA

Vax Date: 03/18/2019
Onset Date: 03/31/2019
Rec V Date: 01/11/2021
Hospital:

Lab Data: None

Allergies:

Symptoms: Fever, pussing rash all over front and back of legs, arms, hands, and feet, a few on the face

Other Meds:

Current Illness:

ID: 0934486
Sex: M
Age: 58
State: AK

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: none

Allergies: aspirin

Symptoms: fever, headache, swollen face and eyes, body aches, excessive urination

Other Meds: Vitamin B, Vitamin D, Ambien

Current Illness: none

ID: 0934487
Sex: F
Age: 41
State: OH

Vax Date: 12/28/2020
Onset Date: 01/05/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: NA

Symptoms: Eight days post vaccine I developed an itchy, hive like rash over the injection site. It was approximately the size of a baseball in diameter. Over the next two days the itching and hives disappeared but the redness expanded in size. By the third day all symptoms were gone.

Other Meds: NA

Current Illness: NA

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm