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: 0999441
Sex: M
Age: 47
State: NV

Vax Date: 09/22/2017
Onset Date: 01/28/2018
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: Latex, plastic gloves

Symptoms: Few weeks after shots, pain became unbearable so I needed to rest often. I visited a clinic nearby but they told me to wait as vaccines can cause temporary pain. However, three plus years later, I am in pain often and when such pain occurs, it is acute.

Other Meds: None

Current Illness: None

ID: 0999442
Sex: F
Age: 68
State: GA

Vax Date: 01/25/2021
Onset Date: 02/01/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient describes itchy rash on arm that she was shot in, but rash did not start until a week after her vaccine

Other Meds:

Current Illness:

ID: 0999443
Sex: F
Age: 25
State:

Vax Date: 01/28/2021
Onset Date: 02/03/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: No

Symptoms: Itchy, warm rash. Very swollen and sometimes painful lymph nodes under armpit. Same side as injection.

Other Meds: Birth Control

Current Illness: No

ID: 0999444
Sex: M
Age: 49
State: PA

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: Nka

Symptoms: Arm sore approx 1 hour after administration. The next days when I woke up I had absolutely no feeling in the same arm from the shoulder all the way down to the hand.

Other Meds: Calcium, vitamin c, vitamin d3, men?s multi vitamin

Current Illness: None

ID: 0999445
Sex: F
Age: 47
State: WA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: 1st visit- 2 epi injections, transport to hospital, IV fluids, Benadryl, observation 2nd set of symptoms- dizzy, lightheaded, high blood pressure , paramedics came out , ekg, 3rd visit (hospital) extremely high blood pressure, headache, dizzy, lightheaded, went to the ER, ekg, fluids, chest X-ray, labs, CT scan

Allergies: None

Symptoms: Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressure

Other Meds: Levothyroxine, Valacyclovir, hair vitamins, fiber supplement, Modere collagen

Current Illness: None

ID: 0999446
Sex: M
Age: 31
State: CA

Vax Date: 01/30/2021
Onset Date: 02/02/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: My friend has been experiencing new onset intermittent unilateral blepharospasm starting 3 days after dose #2 of the Pfizer COVID-19 vaccine. My colleague is also experiencing this...in her case beginning 1 wk after dose #1 (I encouraged her to report this too not sure if she has yet). I find it fascinating both people are experiencing this after the vaccine and as an NP I felt compelled to report to help aggregate such data. Both my friend and colleague obtained the vaccine around the same time at the same clinic. Thank you!

Other Meds: Travoprost

Current Illness:

ID: 0999447
Sex: M
Age: 22
State: WA

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: BN/A

Symptoms: Body aches (lower back and legs mostly), Sore arm, fatigue all for a little over a day the day after the second dose

Other Meds: N/A

Current Illness: N/A

ID: 0999448
Sex: F
Age: 33
State: NY

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

Lab Data: N/A

Allergies: N/A

Symptoms: The injection was administered in the left tricep versus deltoid. In the morning following the injection, the patient experienced generalized malaise, muscle pain at the site of injection and fever. This lasted for 2 days. In the night following the injection the patient experienced an injection site reaction - greater than 5 inches in diabetes area that is swollen, warm, red and painful to the touch. Following application of cold compress, some relief is notable not the area is still red, warm, swollen and tender to touch.

Other Meds: 1 dose of acetaminophen

Current Illness: N/A

ID: 0999449
Sex: F
Age: 76
State: WA

Vax Date: 01/22/2021
Onset Date: 01/30/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: none

Allergies: cats, dogs, lithium, prozac, Cymbalta, Lipitor. dust mites

Symptoms: 3" diameter round swelling and rash at injection site. Itching. I took Benadryl and put ice on the swelling on Sunday and Monday . It is less annoying today but still red and hot.

Other Meds: celexa, tamoxifen, over the counter eye drops, vitamin D 1000 tablets, Calcium 500, DMannose Flonase 1 spray each nostril once a day

Current Illness: none

ID: 0999450
Sex: F
Age: 34
State: AZ

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Significant body aches starting 12 hours after injection lasting about 4 hours Took Tylenol and went to sleep. Aches were gone by morning

Other Meds: Lexapro 10 mg Levothyroxine 125mcg Tizanadine 4mg

Current Illness: None

ID: 0999451
Sex: M
Age: 29
State: MA

Vax Date: 12/28/2020
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: NKA

Symptoms: Mild hives. About 10-12 visible spots, mostly on left hand (injection on right hand). Only one spot was itchy. Hives went away within a few days, but most spots are still kinda visible if you look at it.

Other Meds: Nature made iron supplements, 65 mg (half tablet per day)

Current Illness: None

ID: 0999452
Sex: F
Age: 51
State: TX

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: None

Allergies: Morphine, Codeine, wasp stings, horse dander, various grasses and weeds

Symptoms: The first Pfizer shot I was very fatigued and had sore, stiff muscles on my left side of body. The second dose: I did not experience fatigue or the soreness... however, I started itching about 6-7 after the injection. The itching was in random places, but the itching was more like a pinch - it was sharper, but not long lasting.

Other Meds: Vyvanse, Adderall, Intuniv

Current Illness: Cognitive deficit effecting multiple domains of cognitive function. Specific disorders of learning - mixed. Pervasive developmental disorder - Aspergers. ADD associated with specific developmental disorder, includes working memory cognitive deficit.

ID: 0999453
Sex: F
Age: 26
State:

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: NA

Symptoms: Restlessness, fatigue, headache, muscle aches, cold and hot sweats, exhaustion

Other Meds: Vitamin C, Zinc, Prenatals, Collagen, fish oil

Current Illness: NA

ID: 0999455
Sex: F
Age: 67
State: OK

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Chills, headache and muscle aches, lethargy

Other Meds: Euthrox Cosopt Latanaprost

Current Illness: None

ID: 0999456
Sex: F
Age: 35
State: NY

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Rash all over body. Started on stomach - is still spreading 5 days later. On most of body at this point, except face, hands, feet.

Other Meds: Aleve, vitamin C, D3, B12, omega3

Current Illness:

ID: 0999457
Sex: F
Age: 62
State:

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pt was given Influenza 6 days after receiving the Covid-19 Moderna vaccine. Pt did not experience any adverse reactions. Only issue was that pt had received vaccine before the 2 week window.

Other Meds:

Current Illness:

ID: 0999458
Sex: F
Age: 43
State: CA

Vax Date: 01/21/2021
Onset Date: 01/27/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Painful lump under ipsilateral arm (left arm)

Other Meds: None

Current Illness: None

ID: 0999459
Sex: F
Age: 27
State:

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

Lab Data:

Allergies:

Symptoms: Pt experienced no Adverse reactions. Only concern was that pt had been given the Covid-19 Moderna Vaccine 8 days after pts Tdap.

Other Meds:

Current Illness:

ID: 0999460
Sex: F
Age: 76
State: CA

Vax Date: 01/29/2021
Onset Date: 02/03/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: Codeine, Morphine

Symptoms: Vaccination site is raised, red and itchy. No treatment.

Other Meds: Levothyroxine Sodium Imodium (generic) Colestipol HCL B-12 Mature Multi Ultimate Omega Extra MaxiVision AREDS2 Bone Strength Take Care Magnesium (600 mg) Potassium (198 mg) Aspartate Vitamin C Vitamin D Zyflamend Bio Complete 3 Extra Streng

Current Illness:

ID: 0999461
Sex: F
Age: 36
State: TX

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

Lab Data: None

Allergies: Milk/dairy and soy, both mild

Symptoms: Immediately afterwards - increased heart rate, dizziness, and headache. About 7 hours later - low grade fever, severe headache, joint pain, nausea, diarrhea, sore throat, stiff neck, and swollen lymph nodes in neck. Improved about 30-36 hours after vaccine.

Other Meds: Gabapentin, aleve, pantaprozole, Allegra, and natazia

Current Illness: None

ID: 0999462
Sex: F
Age: 61
State: CA

Vax Date: 01/20/2021
Onset Date: 01/24/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: none

Allergies: SULFA

Symptoms: Extremely painful enlarged lymph nodes under right arm. Remain painful 11days later. It is about the size of a baseball.

Other Meds: ADVIL 200MG X 3 tab daily FAMOTADINE 20MG 1 tab daily MEGA FOOD ELDERBERRY IMMUNE SUPPORT 400 MG 2 gummies daily LOW DOSE ASPIRIN 81MG 1x daily AMLODIPINE 5MG 1x daily HYDRALAZINE 10MG 2x daily K-TAB 15 mEq 3tab daily ESTRADIOL 0.5MG 3 tab

Current Illness: NONE

ID: 0999463
Sex: F
Age: 75
State: CA

Vax Date: 02/01/2021
Onset Date: 02/03/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: penicillin, cipro, topical sulfa, sugar, garlic, heating spices, grass, turpentine, various pollens

Symptoms: Next morning: 1 1/4 " pink rash adjacent to the vacc site 2 days and a few hrs later: itching gone, rash less, but whole right arm feels weird, and the middle finger on that hand looked and felt injured, i.e. 3/4" below the tip to the bottom of the 2nd joint was bluish purplish and felt as if it had been in a vise but hadn't ( 8 hrs later both of these reactions had lessened)

Other Meds: Singulaire, Combivent, quercetin, bromelain, drshen's Sinus pills, Ling Zhi chinese herbal pills for the lungs, turmeric, nicotinamide, a chinese herbal special formula probably boosting immune support, multivitamin, glucosamine/chondro

Current Illness: none other than allergies

ID: 0999866
Sex: M
Age:
State: PR

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

Lab Data: Test Date: 20210104; Test Name: Fever; Result Unstructured Data: Test Result:40 Centigrade; Comments: Degree

Allergies:

Symptoms: dizziness; nausea; pain all over the body; severe headache; excessive flatulence; Fever 40 Degree C/severe fever; pain in knees, ankles and foot the first day; pain in knees, ankles and foot the first day; administration date= 04Jan2021, dose number=2/administration date=18Dec2020, dose number=1; This is a spontaneous report from a contactable healthcare professional. A 35-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ES1686), intramuscular on 04Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 (first dose). The patient experienced fever 40 Degree C, pain in knees, ankles and foot the first day (on 04Jan2021 21:00); second day (05Jan2021) dizziness, nausea, severe fever, pain all over the body, severe headache, excessive flatulence. Symptoms lasted a week. Treatment included Panadol every 4 hours. The patient went for an emergency visit for the events. The outcome of the event was recovered in Jan2021.

Other Meds:

Current Illness:

ID: 0999867
Sex: F
Age:
State: PR

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

Lab Data:

Allergies:

Symptoms: headaches; upset stomach; nausea; body aches; Administration date: dose 1: 16Dec2020, Dose 2: 18Jan2021; Administration date: dose 1: 16Dec2020, Dose 2: 18Jan2021; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 at 14:45, in left arm, at single dose, for Covid-19 immunization. Co-suspect drug included acetaminophen (unknown manufacturer) as preventive medication. The patient received the first dose of BNT162B2 vaccine on 16Jan2021 at 17:15, in left arm with preventive acetaminophen and she felt no effects. The patient had not been tested for COVID19 nor before neither since the vaccination. Concomitant medication taken within 2 weeks of vaccination included high pressure medication. On 19Jan2021 at 08:15 the patient experienced headaches, upset stomach, nausea and body aches. She forgot to take that morning her high pressure medication, she took it, but symptoms continued. She expressed that symptoms were mild but noticeable. No treatment was received. The action taken with acetaminophen was unknown. The events resolved on an unspecified date in Jan2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0999877
Sex: U
Age:
State: KS

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE details; Nurse called to report temperature excursion and states that the vaccine was administered to patient during the excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions/allergies was not provided. On 28-DEC-2020, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally (lot # 1660998, expiration date 03-MAY-2021) for prophylaxis. The improperly stored dose of the suspect vaccine experienced a temperature excursion of below 2 degree Celsius (1.3 degree Celsius) for 24 minutes recorded by a data logger. The previous temperature excursion was reported as below 2 degree Celsius (1.6 degree Celsius) for 24 minutes. No additional adverse event (AE) details. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2101USA001046: US-009507513-2101USA001003: US-009507513-2101USA001285: US-009507513-2101USA000963: US-009507513-2101USA000908:

Other Meds:

Current Illness:

ID: 0999878
Sex: U
Age:
State: KS

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE details; Nurse called to report temperature excursion and states that the vaccine was administered to patient during the excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions/allergies was not provided. On 23-DEC-2020, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally (lot # 1684157, expiration date 26-JUN-2021) for prophylaxis. The improperly stored dose of the suspect vaccine experienced a temperature excursion of below 2 degree Celsius (1.3 degree Celsius) for 24 minutes recorded by a data logger. The previous temperature excursion was reported as below 2 degree Celsius (1.6 degree Celsius) for 24 minutes. No additional adverse event (AE) details. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2101USA001046: US-009507513-2101USA001003: US-009507513-2101USA000963: US-009507513-2101USA000908: US-009507513-2101USA001280:

Other Meds:

Current Illness:

ID: 0999879
Sex: U
Age:
State: IA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE reported.; an expired VAQTA was administered to a patient.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided. On 12-JAN-2021, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) (0.5 ml, lot # S032359 has been verified to be a valid lot number, expiration date was 11-JAN-2021) via unknown route for prophylaxis (expired product administered). It was confirmed the hepatitis a vaccine, inactivated (VAQTA) had not had any temperature excursions. No additional AE reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 0999880
Sex: U
Age:
State: AR

Vax Date: 08/05/2015
Onset Date:
Rec V Date: 02/04/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: encephalitis; other zoster-related conditions; other zoster-related conditions; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 05-AUG-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration unknown) for the long-term prevention of shingles and/or zoster-related conditions at the medical office. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, on or about 05-AUG-2015, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for encephalitis and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of events was unknown. The events were considered related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of encephalitis was determined to be medically significant.

Other Meds:

Current Illness:

ID: 0999881
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 01/04/2021
Rec V Date: 02/04/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: after having the COVID-19 vaccine, she mentioned that she was very sick in the hospital and is now getting well; She had seizures after receiving the MMR vaccine; She described her adverse reaction by having stroke like symptoms which she described as she cannot speak; She described her adverse reaction by having stroke like symptoms which she described as having numbness in her hands, face and lips; She described her adverse reaction by having stroke like symptoms which she described as having numbness in her hands, face and lips; She also felt exhausted; she also has pain in her arm; She mentioned that she also has her vision affected/She couldn't drive/There were wavy lines all trough her eyes; She described her adverse raction by having intense headaches/She described her adverse reaction by having stroke like symptoms which she described as having headaches; She described her adverse reaction by having stroke like symptoms; She started to have hallucinations such as seeing people that weren't there, seeing snowstorms, and seeing things shipping throughout the wind.; This spontaneous report has been received from Pfizer Inc, and a nurse, referring to a 65-year-old female patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided. On unspecified date (reported as when the patient was younger), the patient was vaccinated with measles, mumps, and rubella virus vaccine (manufacturer unknown) (dose, vaccine scheme, route of administration, anatomical location, lot number and expiration date were not provided), as prophylaxis. On an unknown date, after received the measles, mumps, and rubella virus vaccine (manufacturer unknown), the patient had seizures. She mentioned that she did not have adverse event (AEs) with other immunizations but the measles, mumps, and rubella virus vaccine (manufacturer unknown). On 30-DEC-2020, the patient was vaccinated with the first dose of included SARS-CoV-2 spike protein mRNA vaccine (PFIZER BIONTECH COVID-19 VACCINE) (dose, route of administration and anatomical location were not provided), as prophylaxis. On an unknown date, after SARS-CoV-2 spike protein mRNA vaccine (PFIZER BIONTECH COVID-19 VACCINE) vaccination, she was very sick in the hospital. On 04-JAN-2021, she stated to experience an adverse reaction described as having intense headaches, having stroke-Iike symptoms (cerebrovascular accident), as she could not speak (speech disorder), having headaches, having numbness in her hands, face, and lips (hypoaesthesia and hypoaesthesia oral). The patient also felt exhausted (fatigue), had pain in her arm (but for that event she reported that she was not very concerned). Additionally, she mentioned that her vision was affected, she could not drive, and there were wavy lines all through her eyes (visual impairment). She also started to have hallucinations, such seeing people that weren't there, snowstorms, and things shipping throughout the wind. It was reported that the patient wanted to know recommendations about the second shot of the SARS-CoV-2 spike protein mRNA vaccine (PFIZER BIONTECH COVID-19 VACCINE) because with her experience, she was not comfortable having the second shot of that vaccine. At the reporting time, the patient was getting well from the event illness. The outcome of the cerebrovascular accident, headache, visual impairment, pain in extremity, fatigue, hypoaesthesia oral, hypoaesthesia, speech disorder, seizure and hallucination was not reported. The causality assessment between the event seizure and measles, mumps, and rubella virus vaccine (manufacturer unknown) was not provided. The causality assessment between the events illness, cerebrovascular accident, headache, visual impairment, pain in extremity, fatigue, hypoaesthesia oral, hypoaesthesia, speech disorder, seizure and hallucination and the suspect vaccine was not provided. Upon internal review, the events cerebrovascular accident, hallucination and seizure were determined to be medically significant.

Other Meds:

Current Illness: Prophylaxis

ID: 0999882
Sex: U
Age:
State: GA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nurse calling to report at temperature excursion involving PROQUAD / the PROQUAD was administered to one patient this morning; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported. On 27-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (strength, number of administered dose, vaccination scheme, frequency, anatomical site of vaccination and route of administration were not reported; lot number T028139, which has been verified as valid, expiration date reported and validated as 15-FEB-2022) as prophylaxis, that experienced a temperature excursion (product storage error). The vaccine underwent a temperature excursion of minus 13.8 degrees Celsius (C) for 12 minutes, as recorded by a data logger. There was no previous temperature excursion.

Other Meds:

Current Illness:

ID: 0999883
Sex: U
Age:
State: GA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nurse calling inquiring about a 4 year old receiving second dose ofMMR-11 but some of the medication was sprayed out (probably 0.025mL) before the dose was administered.; Nurse calling inquiring about a 4 year old receiving second dose ofMMR-11 but some of the medication was sprayed out (probably 0.025mL) before the dose was administered.; This spontaneous report was received from a nurse, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided. On 27-JAN-2021, the patient received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), administered at a dose of 0.025 milliliter (ml) due to some of the medication was sprayed out before the dose was administered (incorrect dose administered and product container issue) (formulation, strength, route of administration and anatomical site of vaccination were not reported; lot number T000892, which has been verified to be valid, expiration date reported and validated as 08-JAN-2022). No additional adverse event were reported.

Other Meds:

Current Illness:

ID: 0999884
Sex: M
Age:
State: CT

Vax Date: 10/30/2014
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: varicella type rashes; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or around 30-OCT-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered varicella type rashes. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX). The event of rash vesicular was considered to be disabling.

Other Meds:

Current Illness: Routine health maintenance

ID: 0999885
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Injection site pain; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The reporter stated injection site pain from Shingrix vaccination and asked for remedies.

Other Meds:

Current Illness:

ID: 0999886
Sex: U
Age:
State:

Vax Date: 12/04/2020
Onset Date: 12/01/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: My arm is very sore; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 4th December 2020, the patient received Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. A day before reporting, the patient received Shingrix vaccine and the patient's arm was very sore. The patient asked what they could recommend to help ease that pain.

Other Meds:

Current Illness:

ID: 0999887
Sex: U
Age:
State:

Vax Date: 12/03/2020
Onset Date: 12/01/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Swelling; Redness; Hard lump; Itching; This case was reported by a consumer and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On 3rd December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced swelling, erythema, induration and pruritus. On an unknown date, the outcome of the swelling, erythema, induration and pruritus were unknown. It was unknown if the reporter considered the swelling, erythema, induration and pruritus to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. On Thursday, the patient received the second dose of Shingrix. The patient had a reaction which were not with the first dose. The patient experienced swelling, redness, hard lump and itching.

Other Meds:

Current Illness:

ID: 0999888
Sex: M
Age:
State:

Vax Date: 12/02/2020
Onset Date: 12/01/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Uncle pain in neck; Uncle pain in / shoulders; This case was reported by a consumer and described the occurrence of neck pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 2nd December 2020, the patient received Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced neck pain and shoulder pain. On an unknown date, the outcome of the neck pain and shoulder pain were not recovered/not resolved. It was unknown if the reporter considered the neck pain and shoulder pain to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. Three days before the date of reporting, the patient received Shingrix and experienced pain in neck and shoulders which was persistent till the date of reporting.

Other Meds:

Current Illness:

ID: 0999889
Sex: F
Age:
State:

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Where she got the shot is very red; Where she got the shot is very / tender; This case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 1st December 2020, the patient received Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site erythema and injection site tenderness were unknown. It was unknown if the reporter considered the injection site erythema and injection site tenderness to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter said that a senior auntie got her shot about 4 days ago from the day of reporting, the spot where she got the shot was very red and tender.

Other Meds:

Current Illness:

ID: 0999890
Sex: F
Age:
State: AL

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

Lab Data:

Allergies:

Symptoms: eruptions / herpes rash- itchy, drying and crushing over/Burning rash in the groin; herpes rash- itchy; burning rash in the groin; Dry rash; This case was reported by a nurse and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced itchy rash, vesicular rash, burning sensation and rash. On an unknown date, the outcome of the itchy rash, vesicular rash, burning sensation and rash were unknown. It was unknown if the reporter considered the itchy rash, vesicular rash, burning sensation and rash to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The day after receiving the dose, the patient had burning rash in the groin area, eruptions, in the providers words, similar to a herpes rash- itchy, drying and crushing over. The reporter stated that there was no fever or systemic reaction to note. The reporter consented to follow-up.

Other Meds:

Current Illness:

ID: 0999891
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Second vaccine was worse / infected spread from shoulder to elbowarea / required antibiotics again; Second vaccine was worse/ Redness at the injection site; Second vaccine was worse/ Left her arm red; Second vaccine was worse/ fever; This case was reported by a consumer via other manufacturer and described the occurrence of infection aggravated in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced infection aggravated, injection site erythema, erythema of extremities and fever. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the infection aggravated, injection site erythema, erythema of extremities and fever were unknown. It was unknown if the reporter considered the infection aggravated, injection site erythema, erythema of extremities and fever to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter was calling on behalf of someone else (general public). There were no information on patient's history. The person received Shingrix from Pfizer on an unspecified date. The batch number was not provided. The reporter stated that, it was told on the news that if a person had an adverse event to other vaccines, that person should not receive Covid vaccine. The reporter was calling for information as to whether this person should receive the Covid vaccine. The reporter wanted to know how she would know if the ingredients in Covid-19 vaccine and Shingrix vaccine were similar. The representative informed the reporter that the ingredients in Covid-19 vaccine could be found in EUA fact sheet and she may compare those to the ingredients in the Shingrix vaccine. The reporter asked for link to EUA fact sheet by email. The reporter also wanted a list of Shingrix vaccine ingredients. The reporter was provided with telephone number. The reporter was inquiring if it was accurate that someone who had an adverse event to any other vaccine should not take the Shingrix vaccine. The reporter mentioned a reaction to a previous Shingrix vaccine, on 2nd dose, the reaction was worse and was infected from shoulder to elbow area and required antibiotics again like 1st dose. The reporter consented to follow up and provided her name and email address, but did not provide patient's details to protect privacy. For the tolerance of 1st dose, refer linked case US2020AMR249478.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR249478:1st shot,same patient, same reporter, same suspect

Other Meds:

Current Illness:

ID: 0999892
Sex: M
Age: 68
State: WI

Vax Date: 09/30/2020
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Date: 2020; Test Name: Coronavirus test; Test Result: Negative

Allergies:

Symptoms: joint pain is remaining; This case was reported by a consumer and described the occurrence of joint pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of lymphadenopathy (1st dose was received on 21st July 2020 and the patient experienced lymphadenopathy (see case US2020AMR252432)). On 30th September 2020, the patient received the 2nd dose of Shingrix. In 2020, less than 3 months after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved. It was unknown if the reporter considered the joint pain to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient for himself. After vaccination, the patient experienced joint pain. The patient clarified that he did experience joint pain and not muscle pain. It seemed to be getting better, but it had not resolved. The joint pain was remaining; it had been going on for a couple of months before the date of reporting.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR252432:Same patient

Other Meds:

Current Illness:

ID: 0999893
Sex: M
Age: 68
State: WI

Vax Date: 07/21/2020
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Date: 2020; Test Name: Coronavirus test; Test Result: Negative

Allergies:

Symptoms: lymph nodes in neck, groin and armpits / active not painful but throbbing.; This case was reported by a consumer and described the occurrence of lymphadenopathy in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 21st July 2020, the patient received the 1st dose of Shingrix. In 2020, less than 3 months after receiving Shingrix, the patient experienced lymphadenopathy. On an unknown date, the outcome of the lymphadenopathy was recovering/resolving. It was unknown if the reporter considered the lymphadenopathy to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient for himself. The patient experienced lymph nodes in neck, groin and armpits which were active not painful but throbbing. This had partially resolved or had started to subside. The lymph nodes of the groin and armpits were no longer active, but the lymph nodes of the neck were active till the time of reporting (going on a bit) despite the fact that the patient was not sick. The patient did not have a cold and had been tested a couple of times for COVID and was negative. For tolerance to the 2nd dose of Shingrix, refer case US2020AMR252391.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR252391:Same patient

Other Meds:

Current Illness:

ID: 0999894
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Allergic reaction; This case was reported by a other health professional and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 4th January 2021, the patient received Shingrix. In January 2021, less than 3 weeks after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was not recovered/not resolved. It was unknown if the reporter considered the allergic reaction to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient had received Shingrix vaccine and seemed to have had an allergic reaction. The reporter had questioned as how long should the reaction last and could the patient get a COVID vaccine.

Other Meds:

Current Illness:

ID: 0999895
Sex: U
Age:
State: GA

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

Lab Data:

Allergies:

Symptoms: Suspected vaccination failure; Have had shingles 7, yes SEVEN times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: Age at vaccination was not reported. The patient had received all the various shots for shingles and since the last 2 shots, the latest ones, the patient had shingles 7 times. This shot does not prevent shingles. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown

Other Meds:

Current Illness:

ID: 0999896
Sex: M
Age:
State: WI

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: gastrointestinal symptoms; fever; shivering; fatigue; headache; myalgia; This case was reported by a consumer and described the occurrence of gastrointestinal symptom nos in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 23rd December 2020, the patient received the 2nd dose of Shingrix. On 24th December 2020, 1 days after receiving Shingrix, the patient experienced gastrointestinal symptom nos, fever, shivering, fatigue, headache and myalgia. On an unknown date, the outcome of the gastrointestinal symptom nos, fever, shivering, fatigue, headache and myalgia were not recovered/not resolved. It was unknown if the reporter considered the gastrointestinal symptom nos, fever, shivering, fatigue, headache and myalgia to be related to Shingrix. Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. On the day of reporting, in morning the patient experienced gastrointestinal symptoms, fever, shivering, fatigue, headache and myalgia. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 0999897
Sex: F
Age:
State: NJ

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

Lab Data: Test Name: body temperature; Result Unstructured Data: (Test Result:102.5,Unit:degree F,Normal Low:,Normal High:); Comments: The patient did lab test on an unknown date.

Allergies:

Symptoms: her mother / experienced a fever of 102.5F; This case was reported by a pharmacist and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were provided as follows: The patient was reporter's mother. The age at vaccination was not reported. The patient received vaccine under the watch and experienced a fever of 102.5 degree Fahrenheit, 2 weeks following administration. The reporter consented to follow-up.

Other Meds:

Current Illness:

ID: 0999898
Sex: F
Age:
State: NC

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

Lab Data:

Allergies:

Symptoms: Sore arm after receiving a Shingrix shot; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The reporter was friend. The age at vaccination was not reported. The patient was in her 60's and had complained about having a sore arm (at injection site) after receiving a Shingrix shot. No further information was gathered such as the patient's initials or whether it was dose 1 or dose 2(or both). The reporter also stated that patient did not experience a fever after receiving the Shingrix shot. This is 1 of 5 linked cases, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021013457:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014254:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014253:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014110:Same reporter.

Other Meds:

Current Illness:

ID: 0999899
Sex: F
Age: 50
State: PA

Vax Date: 03/12/2012
Onset Date: 03/01/2012
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pain in her arms and legs; Fatigue; Arthritis in her thumbs; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received HBV (Engerix B adult) (batch number 1106AA ?, expiry date April 2014) for prophylaxis. On 12th March 2012, the patient received Engerix B adult (intramuscular). In March 2012, an unknown time after receiving Engerix B adult, the patient experienced pain in arm, fatigue and finger arthritis. On an unknown date, the outcome of the pain in arm and fatigue were recovered/resolved and the outcome of the finger arthritis was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, fatigue and finger arthritis to be related to Engerix B adult. Additional information was provided as follows: The patient received Engerix B adult and experienced pain in arms and legs, fatigue and arthritis in thumbs. The patient provided the batch number and expiration date, but the batch number was not available in the sales data sheet or lot locator. The reporter was asking for the list of ingredients in the Engerix B. The reporter did not consent to follow up. Note: The batch number was not available and hence, 1106AA ? was captured.

Other Meds:

Current Illness:

ID: 0999900
Sex: F
Age: 60
State: WA

Vax Date: 10/29/2020
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Diagnosed with 20 percent hearing loss in the left ear / significant difficult hearing phone calls through the left ear; Constant and ongoing ringing in the left ear; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included fluticasone propionate (Flonase), methylprednisolone (Medrol) and sulfamethoxazole + trimethoprim (Bactrim Ds). On 29th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant) and ringing in ears. On an unknown date, the outcome of the hearing loss and ringing in ears were not recovered/not resolved. It was unknown if the reporter considered the hearing loss and ringing in ears to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a constant and ongoing ringing in the left ear approximately 2 to 3 days after receiving Shingrix. The patient had significant difficulty in hearing phone calls through the left ear. The patient was diagnosed with 20 percent hearing loss in the left ear by audiologist. The reporter consented to follow up. For tolerance of 2nd dose refer case, US2021AMR022441.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR022441:Same reporter.

Other Meds: Flonase; MEDROL; BACTRIM DS

Current Illness:

ID: 0999901
Sex: F
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Had a horrible reaction / Admitted to the hospital 3 times with tachycardia; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tachycardia (serious criteria hospitalization). On an unknown date, the outcome of the tachycardia was recovered/resolved. It was unknown if the reporter considered the tachycardia to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient took the two vaccine series a year ago from date of reporting and had a horrible reaction. She was admitted to the hospital 3 times with tachycardia. Emergency room visit required. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 0999902
Sex: F
Age:
State: CA

Vax Date: 12/26/2020
Onset Date: 12/26/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Date: 20201226; Test Name: Blood pressure; Result Unstructured Data: 190/105 mmHg

Allergies:

Symptoms: Heart murmur; Increase in her blood pressure 190/105; Tightness in chest when breathing; Blurry vision; A spontaneous report was received concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an increase in blood pressure 190/105, blurry vision, tightness in the chest when breathing and a heart murmur. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Dec 2020, approximately 30 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Dec 2020, the patient received the Moderna vaccine and after 30 minutes, she experienced an increase in her blood pressure (190/105), blurry vision and tightness in the chest when breathing. She remained at the site for an hour for observation and then was brought to the urgent care. An electrocardiogram (EKG) was performed and treatment included oral lisinopril. She was sent home, and she also stated that she had a heart murmur. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, increase in blood pressure 190/105, blurry vision, tightness in the chest when breathing, and a heart murmur, were not reported.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of blood pressure increased, and non-serious unexpected event of chest discomfort, vision blurred, and cardiac murmur. The events occurred 1 day (15 min) after first dose of mRNA-1273, lot # 037K20A. Treatment included lisinopril. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm