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: 0996590
Sex: F
Age: 49
State:

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

Lab Data:

Allergies: None

Symptoms: Chills, fever 101.9. Headache. Pain at site of injection

Other Meds: Flonase

Current Illness: None

Date Died: 01/30/2021

ID: 0996591
Sex: F
Age: 85
State: CA

Vax Date: 01/23/2021
Onset Date: 01/25/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: None

Allergies: Codeine Penicillin simvastatin

Symptoms: patient received vaccine on Jan 23, 2021. developed weakness on Jan 25, 2021. Sent to ED on Jan 27, 2021 with hypoxia requiring 6 L O2, low Bp, declining mental status. Per family request transitioned to hospice and passed away on Jan 30, 2021

Other Meds: citalopram, Wellbutrin, docusate, Seroquel, acetaminophen, senna, may have received hospice medications

Current Illness: Dementia, depression, arthritis, IBS, atherosclerosis of aorta, hyperlipidemia, osteoporosis

ID: 0996592
Sex: M
Age: 89
State: UT

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: I received a Moderna vaccine injection on January 19, 2021 at approximately 3:15 p.m. Later that evening at about 7:40 p.m, I was suddenly hit with pain in my back like someone had hit me with a board. The pain continued to surround the midsection in a swath of about 15 inches. I felt like my muscles were failing me. I made it to my bed where I started shivering and shaking uncontrollably feeling like I was having a seizure. The shaking was sporadic, lasting about an hour. I was covered with a blanket and continued with liquids for dehydration and was given an Xanax to calm nerves. Later that night while attempting to sleep, I was perspiring and my heart was beating 90 to 100 beats hindering sleep. Through the night I attempted to go to the bathroom but with absolutely no control over my arms and legs I was unable to stand. Rolling off the bed and unable to pull myself back, I lay on the floor and pulled a cover over me. At about 4:30 a.m. (Wednesday morning.) I was covered with another blanket and a pillow was put under my head. I slept until awakened at about 11 a.m My heart rate and oxygen level was chedked and appeared to be within normal range. I was greatly fatigued, and light-headed. Continuing a regimen of liquids, I was fed a small amount of soup and some fruit. I ate nothing the rest of the day. I slept most of the day. In the evening, I was fatigued and nauseated and spent 2-3 hours through the night on my knees in the bathroom attempting to vomit. Thursday morning I was awakened around 11.a.m. and was barely able to lift my head. I slept more until needing to use the bathroom and receiving more liquids. Two hours later I was able to eat only a half a piece of toast ? the first and only thing I was able to eat that day. Early evening having no control of my legs, I attempted to walk. It was difficult getting legs out of the covers, but I got up and walked a few feet with the help of a walker. However, an hour later (about 8:30) I went to the bathroom and was unable to pull myself up from the toilet and fell to the floor and crawl flat on my stomach to my bed. I had no strength in my legs and arms and needed assistance from two people to put me on my bed. Periodic rapid heartbeat and fatigue caused restless sleep. Some strength began to return on Friday and with caution over the weekend, and support from a loving family, I appear to be making a slow recovery. Checking with several family medical people working in hospitals, my experience with the serum seemed more extreme than most. Therefore, it was felt that I should report some information on how the Moderna injection affected me that it may be of help to others. (Some of the above information was related to me as I was not always cognizant of conditions at particular times.) I am still puzzled, as members of my family are, as to what happened to me. We would be grateful for any information that might be helpful for us to understand my situation as it relates to others that may have had similar experiences with the Moderna serum.

Other Meds: None

Current Illness: None

ID: 0996593
Sex: F
Age: 69
State: WA

Vax Date: 01/23/2021
Onset Date: 01/29/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: I did not seek medical attention. Took Tylenol for headaches and used Neosporin for swelling and itchiness.

Allergies: none

Symptoms: 1/29/2021 headaches all day, felt fatigued 1/30 diarreaha for 4 hrs, 1/31 diarreaha for 4 hrs., 1/31 injection site2 " swollen and itchy and felt fatigued, I applied Neosporin, 2/1 injection site 2" swollen and itchy I then applied Neosporin.

Other Meds: oxybutunin 10mg

Current Illness: none

ID: 0996594
Sex: F
Age: 30
State:

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

Lab Data:

Allergies: None

Symptoms: Nosebleed night of fascination and night after

Other Meds: Multi vitamin

Current Illness: None

ID: 0996595
Sex: F
Age: 24
State: CA

Vax Date: 01/11/2021
Onset Date: 01/15/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: Echogram, heart monitor, blood work.

Allergies: Allergy or amoxicillin

Symptoms: 4 days after the vaccine, heart palpitations began. I had no prior history of these palpitations. They were so frequent to the point where I had to go to my doctor. He heard them with his stethoscope and believed they were Premature ventricular contractions. (PVCs). After almost 3 weeks, they slowly diminished. I just got my 2nd shot today, and I am hoping it does not continue.

Other Meds: None.

Current Illness: None.

ID: 0996596
Sex: F
Age: 25
State: IA

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: None. Never went anywhere to have them checked out. I have, on occasion, used triamcinolone cream or hydrocortisone cream on the area to try to get it to stop itching though. I've contemplated going to my PCP about this, or maybe go straight to a dermatologist to get to the root of 'all' of these issues figured out and taken care of.

Allergies: One time I had hives all over my body that just came and went again within the day. I'm unsure if it was an allergic reaction to something new like a laundry detergent of some sort maybe. As I've gotten older though, I do notice that my skin is a lot more sensitive and more easily susceptible to getting hives at that. Sometimes I think it's my makeup, but sometimes I won't have any makeup on and it'll do it then too. Specifically around my eyelids, only. Not sure why this happens. And it only really happens at night time too, thankfully, cause it rarely happens in the middle of the day when I'm out and about- thankfully. Otherwise though I have NKDA.

Symptoms: Very itchy arm that has persisted, this far, to a month after getting the vaccine. At the injection site and around that general portion of my upper arm. Sometimes it's perfectly fine, sometimes it's red or pink and either will or will not be itchy as well. If I scratch at it too much, which I try really hard not to but it's really hard not to, and then the little rash-looking areas turns into a small area of mini skin hives. Still redish/pink and itchy. Then I try not to mess with it for the most part, but it's just consisted since then. Idk if this is a me problem, specifically cause I got some weird skin hive stuff going on actually on my eyes at night (randomly) that randomly occur. And that started way before I got the vaccine. With the hives on my arms, it will persist for a while at a time and go away before coming right back again as itchy as ever. It's been basically every single day since I got my vaccine that these side effects have been going on. #StillSupportIt lol. (:

Other Meds: Buproprione 300mg Escitalopram (1.5 tab) = 30mg per dose Jasmiel (birth control pills) Ambien 5mg Hydroxyzine 25-50mg PRN for anxiety Melatonin (OTC) - 10MG before bed as needed. Adderall 15mg tab PRN

Current Illness: Nothing much. I never had a fever or temp or anything like that. Sometimes I'd get a cough, but I also think that could just be my terrible lungs after years of smoking cigarettes unfortunately. No other real symptoms really.

ID: 0996597
Sex: F
Age: 19
State: CA

Vax Date: 01/27/2021
Onset Date: 01/30/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: Facial and forehead strength test - indicated diminished forehead strength Neuro exam - indicated Bell?s palsy

Allergies: Chlorohexadine - surgical prep wipes

Symptoms: 3 days after second dose of Pfizer vaccine, (01/30/2021), went to emergency room for facial droopiness and numbness on the left side. Was diagnosed with Bell?s palsy in the ED. Currently taking prednisone (60 mg - once a day). Valtrax (1mg - 3x a day), Erythromyocin eye ointment (.5% - 4x daily)

Other Meds: 1. Gabapentin 2. Prazosin 3. Vitamin D supplement 4. Allergic medication (allertec) 5. Depo Provera injection - birth control

Current Illness: N/A

ID: 0996598
Sex: M
Age: 33
State: PA

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: None

Allergies: Pencillins, Sulfas

Symptoms: Moderna COVID-19 Vaccine EUA 1.) Diffuse muscle pain/stiffness over entire body (most notably in neck and back) 2.) Severe lethargy/fatigue 3.) Intermittent nausea Symptoms lasted 48 hours and required no medical intervention aside from an OTC NSAID which only mildly improved symptoms.

Other Meds: Amphetamine/dextroamphetamine

Current Illness: None

ID: 0996599
Sex: F
Age: 37
State: IL

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies: Seasonal allergies, mold

Symptoms: 24 hours after vaccine, my legs became mottled. My doctor confirmed Livedo Reticularis. No pain swelling or issues, just discolored. It has been visible majority of the day (I am not ?cold? and i wear warm clothes). It has been a week, and has not gone away yet. I also started to get swelling / redness and a lump on my arm exactly 7 days after vaccine was given.

Other Meds: Euthyrox, Vyvance

Current Illness: Chronic ulticaria

ID: 0996600
Sex: M
Age: 32
State:

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

Lab Data:

Allergies: anapyhylaxis to amoxicillin/sulfa drugs, rash/hives to penicil

Symptoms: Tolerated first vaccine one month prior without incident. Today, developed 10/10 headache with photophobia starting five minutes after recieving the injection. Developed a cough and then crushing chest pain. Initial blood pressure and heart rate were within normal limits, and continuous pulse oximetry showed consistent Oxygenation of 98%. Patient was able to speak in full sentences although unable to take a deep breath. Pain was physically limiting, and patient was transported to ER, for immediate evaluation and treatment. At the ER, pateint was normotensive and nontachycardic. He received IV epinephrine and dexamethsasone. Per paramedic report while in ER, patient shortly afterward developed hypotension with left

Other Meds: motrin, tylenol

Current Illness: none

ID: 0996601
Sex: M
Age: 40
State: NV

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

Lab Data: None

Allergies: None

Symptoms: Left arm hurts, head hurts and stomach hurts

Other Meds: None

Current Illness: None

ID: 0996602
Sex: M
Age: 83
State: CA

Vax Date: 01/25/2021
Onset Date: 02/03/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Developed itchy rash on upper arm just below vaccination site. Treated with cortisone cream. I have photo

Other Meds: Ripatha-finesteride-Lisinopril-Vit C-Vit D-calcium

Current Illness: None

ID: 0996603
Sex: F
Age: 43
State: OR

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

Lab Data: Was observed by convention COVID19 event volunteer physician and nurse, and next by my PCP who works in same office as my practice. Did not choose to go to ED. Blood pressure: as noted above Pulse: as noted above No temperature. No labs. No EKG.

Allergies: Dairy, coconut, spearmint family, sesame

Symptoms: I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sided chest pain at around 8 minutes after administration. Then flagged down a nurse. They checked my blood pressure at 196/110 (first one may have been 210/110)- I was sort of disoriented. Sat there for about an hour with repeated blood pressure checks, until my pulse went from 118 down to 90. They let me go home at 170/100. I do t have hypertension. Then went and laid down in my office nearby and my left upper arm turned bright red and became painful and slightly swollen. Took five hours for my blood pressure to drop to 118/80- my normal is 114/78. Still have weird chest pain and some SOB with exertion (not normal for me).

Other Meds: Levothyroxine Cytomel Vit C Vit D Nattokinase Vit A

Current Illness: Hypothyroid

ID: 0996604
Sex: F
Age: 23
State: CA

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies: Dust mites, pollen, pet dander

Symptoms: Itchy raised bumps on left arm the day after the vaccine and hives as well as increased itchiness throughout my body as the days progressed

Other Meds: Zovia 28day, lexapro 10mg

Current Illness: None

ID: 0996605
Sex: F
Age: 34
State: CA

Vax Date: 01/07/2021
Onset Date: 01/14/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Red rash below injection site, size of a quarter, warm to touch, itchy, no pain, started 7 days after injection was received, grew in size daily. Resolved after 1 week.

Other Meds: Vitamin C

Current Illness:

ID: 0996606
Sex: F
Age: 26
State: CO

Vax Date: 01/26/2021
Onset Date: 02/02/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies: just outside pollens and down feathers.

Symptoms: Extreme itchy arm, huge red spot at injection site, hard, hot, painful to the touch

Other Meds: none

Current Illness: none

ID: 0996607
Sex: M
Age: 31
State: OH

Vax Date: 01/22/2021
Onset Date: 01/27/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: Tingling in lower extremities from the waist down, which began 4-5 days after receiving my 1st dose of the Moderna COVID vaccination.

Other Meds: none

Current Illness: none

ID: 0996608
Sex: F
Age: 28
State: MD

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

Lab Data:

Allergies: Cats Dogs Seasonal Mold Non-Seasonal Mold Orchard Grass Timothy Grass Plantago Tobacco Feathers Nickel

Symptoms: Fever Chills Headache Body Ache Nausea Tiredness Insomnia

Other Meds: Citalopram Cetirizine Montelukast Estradiol Vitamin D3 Supplement Vitamin B12 Supplement Magnesium Supplement

Current Illness: None

ID: 0996609
Sex: F
Age: 68
State: CA

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: none

Allergies: penicillin, IM progesterone in oil

Symptoms: Approximately 24 hours after first Moderna vaccination, malaise, slight headache, generally feeling unwell. Took 1 baby aspirin. Symptoms lasted 8-12 hours and resolved after good night's sleep.

Other Meds: Rosuvastatin, Vitamin C, Vitamin D

Current Illness: none

ID: 0996704
Sex: U
Age:
State: IL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: an improperly stored vaccine was administered on 25JAN202 l.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On On 25-JAN-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T013546 was confirmed to be valid, expiration date was reported as 27-OCT-2021, but upon internal validation, it was established as 28-OCT-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The temperature excursion was above 9 Celsius degrees (C) (13.4 C) for 2 hours and 9 minutes. There were no previous excursions reported. The digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-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: 0996705
Sex: U
Age:
State: IL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: improperly stored vaccine was administered on 25JAN2021; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, prefilled syringe, lot # T026954, expiration date 13-APR-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine was stored in the temperature of above 9 degrees Celsius (13.4 degrees Celsius) for 2 hours and 9 minutes. There were no previous temperature excursions reported. The improper storage was recorded by digital data logger. There was no additional adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026954; expirationdate: 13-APR-2022; 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: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 0996706
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: strongest reaction/ had fairly bad flue like symptoms, but only where I have sports injuries, back, hips, knees, ankles, etc; not feeling well; have had more than two or three days of painless; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included anterior cruciate ligament reconstruction (twice) and sports injury. Previously administered products included Plague vaccine, encephalitis vaccine and Yellow fever vaccine. Concurrent medical conditions included knee pain (probably 20 years or more). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms, feeling unwell and unexpected therapeutic effect. On an unknown date, the outcome of the influenza-like symptoms, feeling unwell and unexpected therapeutic effect were unknown. It was unknown if the reporter considered the influenza-like symptoms, feeling unwell and unexpected therapeutic effect 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 patient had a very positive side effect from Shingrix vaccination after he/she received first round shot. The patient had discussed it with the physician and explained that the patient should contact about this, as there was a positive side effect that could allow some component of the vaccination to be used for other purposes. The patient was warned when the shot was received that he/she might have some flu like symptoms. When it was given to the patient, the patient did indeed had the strongest reaction he/she ever had from any vaccination in their life and the patient had traveled all over the world, getting plague, encephalitis, yellow fever, etc. vaccinations. Interestingly, the patient had fairly bad flue like symptoms, but only where he/she had sports injuries, back, hips, knees, ankles, etc. However, after two days of not feeling well, the patient's left knee, which the patient had anterior cruciate ligament (ACL) reconstruction surgery on twice, had no pain for about the last month, which led to unexpected therapeutic effect. The pain was starting to come back just in the last couple of days from time of reporting. This was the first time in probably 20 years or more the patient had more than two or three days of painless time with the knee. The patient stated it was quiet remarkable. The patient agreed to provide more information and hoped there was a benefit in this for all people with chronic joint pain.

Other Meds:

Current Illness: Knee pain (probably 20 years or more)

ID: 0996707
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: body aches; exhaustion; chills; This case was reported by a consumer and described the occurrence of chills 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. On 4th December 2020, 1 days after receiving Shingrix, the patient experienced general body pain and exhaustion. In December 2020, the patient experienced chills. On an unknown date, the outcome of the chills, general body pain and exhaustion were unknown. It was unknown if the reporter considered the chills, general body pain and exhaustion 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 2nd dose of Shingrix and had chills at night. On the day of reporting, the patient went to work and had to leave early because of body aches and exhaustion. The patient asked was that a normal side effect.

Other Meds:

Current Illness:

ID: 0996708
Sex: F
Age: 65
State: AR

Vax Date: 12/12/2019
Onset Date:
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: received her first dose / on 12/12/2019 / experienced a sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 12th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: This case was reported by patient for herself. The patient experienced a sore arm. The reporter consented to follow up. For further tolerance after 2nd and 3rd dose of Shingrix refer linked cases US2020AMR248212 and US2020247551 respectively.; Sender's Comments: US-GLAXOSMITHKLINE-US2020247551:3rd dose US-GLAXOSMITHKLINE-US2020AMR248212:2nd dose

Other Meds:

Current Illness:

ID: 0996709
Sex: F
Age: 65
State: AR

Vax Date: 02/11/2020
Onset Date:
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: second dose on 02/11/2020 / experienced a sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 12th December 2019, refer linked case US2020AMR248211). On 11th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: This case was reported by patient for herself. The patient experienced a sore arm. The reporter consented to follow up. For further tolerance after 3rd dose of Shingrix refer linked cases US2020247551.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR248211:1st dose US-GLAXOSMITHKLINE-US2020247551:3rd dose

Other Meds:

Current Illness:

ID: 0996710
Sex: U
Age:
State: MA

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

Lab Data:

Allergies:

Symptoms: arm became significantly inflamed; large welts; lymph nodes by my clavicle were huge; fever; chills; ACHES; HEADACHE; Nausea; This case was reported by a consumer and described the occurrence of inflammation localized in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inflammation localized, welts, enlargement of lymph nodes, fever, chills, pain, headache and nausea. On an unknown date, the outcome of the inflammation localized, welts, enlargement of lymph nodes, fever, chills, pain, headache and nausea were unknown. It was unknown if the reporter considered the inflammation localized, welts, enlargement of lymph nodes, fever, chills, pain, headache and nausea to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. After receiving Shingrix, the patient's arm became significantly inflamed with large welts, lymph nodes by clavicle were huge, had a fever, chills, aches, headache and nausea. The patient was looking for the ingredients that were in the Shingrix shingles vaccine and want to know if the patient was allergic to this to prepare for 2nd dose and any other vaccines that might contain similar ingredients.

Other Meds:

Current Illness:

ID: 0996711
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: injection site pain; aches; fever; This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in an unspecified number of patients who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site pain, pain and fever. On an unknown date, the outcome of the injection site pain, pain and fever were unknown. It was unknown if the reporter considered the injection site pain, pain and fever to be related to Flu vaccine. Additional details were reported as follows: The age at vaccination was not applicable for this report. The common flu shots caused injection site pain, aches and fever. This case has been linked with the case US2020AMR248144, reported by same reporter.

Other Meds:

Current Illness:

ID: 0996712
Sex: U
Age:
State:

Vax Date: 12/12/2020
Onset Date: 12/14/2020
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I wake up with a rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 12th December 2020, the patient received Shingrix. On 14th December 2020, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash 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 Saturday, the patient received Shingrix and on the day of reporting the patient woke up with a rash.

Other Meds:

Current Illness:

ID: 0996713
Sex: U
Age:
State: AR

Vax Date: 12/14/2020
Onset Date: 12/14/2020
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 14th December 2020, the patient received the 2nd dose of Shingrix. On 14th December 2020, less than a day after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the chills to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experiencing chills, but not fever. It was 5 day later and reporter asked how long would these side effects continue. The reporter considering a COVID test but had no fever nor any of the common symptoms of COVID.

Other Meds:

Current Illness:

ID: 0996714
Sex: U
Age:
State:

Vax Date: 12/16/2020
Onset Date: 12/01/2020
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: GOT THE 1ST VACCINE / I SWEAR I HAVE THE SHINGLES NOW / FEELING ON MY LOWER BACK; This case was reported by a pharmacist and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 16th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not repored. The age group of the patient was not reported but selcted as an adult as per vaccine indication. The reporter stated that, received 1st dose on wednesday and had shingles on the lower back. The reporter asked if should receive acyclovir.

Other Meds:

Current Illness:

ID: 0996715
Sex: U
Age:
State:

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

Lab Data: Test Date: 2020; Test Name: body temperature; Result Unstructured Data: (Test Result:102.8,Unit:degree F,Normal Low:,Normal High:)

Allergies:

Symptoms: I have 102.8 fever after vaccine; This case was reported by a consumer and described the occurrence of fever 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 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 age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had fever (102.8 degree F).

Other Meds:

Current Illness:

ID: 0996716
Sex: F
Age: 65
State: CA

Vax Date: 11/19/2020
Onset Date: 11/01/2020
Rec V Date: 02/03/2021
Hospital:

Lab Data: Test Name: Body temperature; Result Unstructured Data: (Test Result:96.8,Unit:degree F,Normal Low:,Normal High:); Test Date: 202011; Test Name: Body temperature; Result Unstructured Data: (Test Result:99.2,Unit:degree F,Normal Low:,Normal High:); Test Date: 20201130; Test Name: COVID test; Test Result: Negative

Allergies:

Symptoms: Headache / migraine medicine did not help; Chest pain; Pain at the injection site; Chest congestion / better but would come and go; Sore throat; Runny nose; Fever of 99.2 / her temperture normally runs low; Sinus pressure / Sinus issues; Sinus pain / Sinus issues; Scratchy throat; This case was reported by a consumer via call center representative and described the occurrence of lung congestion in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included migraine and allergy. On 19th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced lung congestion (serious criteria GSK medically significant), sore throat, runny nose, fever, sinus pressure, sinus pain and throat irritation. On 20th November 2020, the patient experienced chest pain and injection site pain. On 22nd November 2020, the patient experienced headache. The patient was treated with antimigraine preparations (Generic Migraine Medicine (Name Unknown)). On 10th December 2020, the outcome of the lung congestion, sinus pressure, sinus pain and throat irritation were recovered/resolved. On an unknown date, the outcome of the chest pain, injection site pain, headache, sore throat, runny nose and fever were unknown. It was unknown if the reporter considered the lung congestion, chest pain, injection site pain, headache, sore throat, runny nose, fever, sinus pressure, sinus pain and throat irritation to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in right arm. Next day after receiving Shingrix, the patient had chest pain and pain at the injection site. The patient also had a headache that her migraine medicine did not help. The patient also experienced sore throat, runny nose, fever of 99.2-degree F, sinus pressure and sinus pain and chest congestion. The patient had as covid test which was negative. On 04th December 2020, scratchy throat, sinus issues and chest congestion better but would come and go. The events lasted until 10th December 2020. The patient mentioned that her temperature normally ran low at 96.8-degree F. The reporter provided permission to follow up with healthcare professional. For the tolerance of 2nd dose, refer linked case US2021AMR019262.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR019262:Same reporter.

Other Meds:

Current Illness: Allergy; Migraine

ID: 0996717
Sex: F
Age: 66
State:

Vax Date: 09/24/2020
Onset Date: 01/13/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: burning sensation on her arm; redness on her arm / growing larger toward her chest; This case was reported by a consumer and described the occurrence of extremities burning sensation of in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included venetoclax (Venclexta) tablet for chronic lymphocytic leukemia. Concurrent medical conditions included chronic lymphocytic leukemia and drug allergy (allergic to Lipitor, Oxycodone and Penicillins). Concomitant products included allopurinol, metformin, sitagliptin (Januvia), paracetamol (Tylenol) and obinutuzumab (Gazyva). On an unknown date, the patient received Shingrix. On 24th September 2020, the patient started Venclexta (oral) 100 mg 3 times daily (400 mg daily). On 13th January 2021, less than 4 months after receiving Shingrix and an unknown time after starting allopurinol, the patient experienced extremities burning sensation of and erythema of extremities. Venclexta was continued with no change. On an unknown date, the outcome of the extremities burning sensation of and erythema of extremities were unknown. It was unknown if the reporter considered the extremities burning sensation of and erythema of extremities to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported, but could be 65 or 66 years. The patient had a response to Shingrix vaccine while being on Venclexta. The 13th January 2021, 3 months and 20 days after receiving Venclexta and less than 4 months after receiving Shingrix, the patient experienced a redness and a burning sensation on the arm that was growing larger towards the chest. It was unknown if the reporter considered the extremities burning sensation of and erythema of extremities to be related to Venclexta.

Other Meds: Allopurinol; METFORMIN; JANUVIA; TYLENOL; GAZYVA

Current Illness: Chronic lymphocytic leukemia; Drug allergy (allergic to Lipitor, Oxycodone and Penicillins)

ID: 0996718
Sex: F
Age: 70
State: SC

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

Lab Data:

Allergies:

Symptoms: Vertigo; Pain / Sore arm; Redness / red whelp at the injection site; Vomiting; Shivering; Sweats; This case was reported by a consumer and described the occurrence of vertigo in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included meniere's disease. On 2nd December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 36 hrs after receiving Shingrix, the patient experienced vertigo, vomiting, shivering, sweating, pain in arm and injection site erythema. On an unknown date, the outcome of the vertigo, pain in arm and injection site erythema were unknown and the outcome of the vomiting, shivering and sweating were recovered/resolved. It was unknown if the reporter considered the vertigo, vomiting, shivering, sweating, pain in arm and injection site erythema to be related to Shingrix. Additional details were provided as follows: The patient received first dose of Shingrix and approximately thirty six hours later, she had severe Vertigo and Vomiting for three hours, and then it resolved. The patient stated she then had Shivering and Sweats for one hour. She reported that she had pain as in a sore arm and redness or a red whelp at the injection site The reporter consented to follow up.

Other Meds:

Current Illness: Meniere's disease

ID: 0996719
Sex: M
Age: 79
State: OH

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

Lab Data:

Allergies:

Symptoms: first dose of Shingrix on 23Oct2020 and 2nd dose on 02Dec2020.; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) (batch number LN399, expiry date 9th October 2022) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On 2nd December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, less than recommended interval which led to shortening of vaccination schedule.

Other Meds: Shingrix

Current Illness:

ID: 0996720
Sex: M
Age: 65
State: OH

Vax Date: 07/28/2020
Onset Date: 07/29/2020
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Breakout on his face / shingles/chickenpox virus; Lesions themselves are not painful / the postherpetic pain is; Redness (from top of left shoulder to the elbow); Chills; Headache; This case was reported by a consumer and described the occurrence of shingles in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 28th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2020, 1 days after receiving Shingrix, the patient experienced erythema, chills and headache. On an unknown date, the patient experienced shingles and post herpetic neuralgia. The patient was treated with valaciclovir hydrochloride (Valtrex). On 31st July 2020, the outcome of the erythema, chills and headache were recovered/resolved. On an unknown date, the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved. It was unknown if the reporter considered the shingles, post herpetic neuralgia, erythema, chills and headache to be related to Shingrix. Additional details were reported as follows: The patient received Shingrix on upper left arm. The day after getting Shingrix, the patient experienced redness (from top of left shoulder to the elbow), chills, and headache which lasted two days. Less than 6 months after receiving Shingrix, the patient experienced a breakout on his face that he describes as the shingles or chickenpox virus. The patient initially thought it was adult onset acne, but it spread from the right side of his face to the left side. He reports that the lesions themselves were not painful, but the postherpetic pain was. The patient had seen his HCP and was advised to not get the 2nd dose of the vaccine until the outbreaks stops. HCP prescribed Valtrex that he was still currently taking (day of reporting was his fourth day on Valtrex). On the day of reporting, the patient noticed that there were spots on his left arm, left inner elbow, and on his stomach as well. However, he stated the outbreak was primarily isolated to his face. Not all information was available. The reporter consented to follow up. The patient gave permission to follow-up with their HCP and provided the contact information. The patient was unable to provide HCP's email or fax at the time of report.

Other Meds:

Current Illness:

ID: 0996721
Sex: F
Age:
State: IL

Vax Date: 01/18/2020
Onset Date: 01/18/2020
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fatigue; Fever; Itchy body; Chills; Lower back pain; This case was reported by a pharmacist and described the occurrence of fatigue in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9H524, expiry date unknown) for prophylaxis. On 18th January 2020, the patient received the 1st dose of Shingrix. On 18th January 2020, less than a day after receiving Shingrix, the patient experienced fatigue, fever, generalized pruritus, chills and low back pain. On an unknown date, the outcome of the fatigue, fever, generalized pruritus, chills and low back pain were recovered/resolved. It was unknown if the reporter considered the fatigue, fever, generalized pruritus, chills and low back pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix, and experienced fatigue, chills, itchy body, fever and lower back pain. This case was linked with US2020AMR242120, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR242120:Same reporter. Case for dose 2

Other Meds:

Current Illness:

ID: 0996723
Sex: M
Age:
State: MA

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

Lab Data:

Allergies:

Symptoms: severe reaction that culminated in transverse myelitis; This case was reported by a consumer via call center representative and described the occurrence of myelitis transverse in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myelitis transverse (serious criteria GSK medically significant). On an unknown date, the outcome of the myelitis transverse was recovered/resolved. It was unknown if the reporter considered the myelitis transverse to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received the dose approximately 2 years ago from the date of reporting. The reporter reported a severe reaction that culminated in transverse myelitis. The reporter stated that a detailed account had been reported via a vaccine website and by their neurologist. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 0996724
Sex: M
Age:
State: MI

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 72-year-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3249, expiry date unknown) via an unspecified route of administration on the left arm on 15Jan2021, 11:30AM at a single dose for COVID-19 immunization. The patient's medical history included being overweight. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 15Jan2021 22:00, the patient experienced injection spot was a little sore, was very tired that night, and had some chills. No treatment was received in response to the events. Outcome of the events at the time of last observation was recovered. The events were considered non-serious.

Other Meds:

Current Illness:

ID: 0996725
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: felt like a cramp in face on one side of her cheek and it felt like her face was not working right; arm and legs were tired; tingling in her forehead and in nose/tingling in arms and in legs and her feet felt the worst; numbness; Muscle weakness; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK9231, unknown expiration), via an unspecified route of administration in left arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient reported that she had some things happened just after receiving the COVID-19 vaccine on Tuesday morning (12Jan2021). The patient later on experienced tingling in her forehead and in nose on 13Jan2021. The next day (14Jan2021), it started like tingling in arms and in legs and her feet felt the worst. On 14Jan2021, two days after (Thursday), she felt like her arm and legs were tired. On Friday (15Jan2021), she woke up and felt like a cramp in face on one side of her cheek and it felt like her face was not working right. Three days later (Friday), she still feels that it is better than it was. The patient also experienced numbness and muscle weakness (both in Jan2021). She don't know what she should do or if she should get the next shot, she almost felt like it was the worst and need to go to the hospital but her body was not so fatigued, she felt her muscle worked hard, described as weak. The patient haven't seen by her doctor or visited in emergency room. The patient did not receive treatment for the events. Outcome of the events was unknown. The events were assessed as non-serious.

Other Meds:

Current Illness:

ID: 0996726
Sex: U
Age:
State: MS

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 02/03/2021
Hospital:

Lab Data: Test Name: COVID-19; Test Result: Positive

Allergies:

Symptoms: tested positive for COVID-19; tested positive for COVID-19; patient already has missed the second dose on schedule; This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 29Dec2020 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient tested positive for COVID-19 on unspecified date. The patient already has missed the second dose on schedule. Outcome of the events was unknown. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.

Other Meds:

Current Illness:

ID: 0996727
Sex: F
Age:
State: LA

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

Lab Data: Test Date: 20210114; Test Name: Nasal Swab; Test Result: Positive

Allergies:

Symptoms: Pt +covid test 14Jan2021; Pt +covid test 14Jan2021; Tachycardia; Facial flushing; Fatigue; arm pain and swelling; arm pain and swelling; This is a spontaneous report from a contactable Other HCP. A 32-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 12Jan2021 at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included attention deficit hyperactivity disorder (ADD), hypothyroidism and anxiety. Past drug history included allergy to cefprozil (CEFZIL). Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN XL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and levothyroxine sodium (SYNTHROID). On 12Jan2021, the patient had tachycardia, facial flushing, fatigue, arm pain and swelling. The events required a physician office visit. Therapeutic measures taken as result of the events included levocetirizine dihydrochloride (XYZAL) and diphenhydramine hydrochloride (BENADRYL). On 14Jan2021, the patient underwent a COVID-19 virus test (nasal swab) which resulted positive. The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 12Jan2021, and COVID-19 test positive on 14Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.

Other Meds: WELLBUTRIN XL; ADDERALL; SYNTHROID

Current Illness:

ID: 0996728
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: big lumps on both sides of his neck; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age (reported as 62, no unit provided, pending clarification) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Jan2021 (reported as two weeks ago), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that he received the first dose two weeks ago (Jan2021) and the morning after, he experienced big lumps on both sides of his neck, in which he still has at the time of the report. The patient stated that he called his HCP, in which they want to perform a biopsy. The patient wanted to know if having big lumps on the sides of his neck was a common side effect after receiving the COVID vaccine. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0996729
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a non-contactable consumer (patient). This male patient received first dose of of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection)at SINGLE DOSE for covid-19 immunisation . His physician recommended him to not be administered with the second dose of the vaccine because he was going to start with a cancer treatment just before the administration of the second dose.Outcome of the events was unknown.. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.

Other Meds:

Current Illness:

ID: 0996730
Sex: F
Age:
State: CA

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 02/03/2021
Hospital:

Lab Data: Test Name: Covid; Test Result: Negative ; Test Name: Covid; Test Result: Negative ; Test Name: Weight; Result Unstructured Data: Test Result:lost a lot of weight

Allergies:

Symptoms: This is a spontaneous report from a contactable consumer reporting for self. This 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 29Dec2020 around 10AM at left arm at single dose for COVID-19 immunization. Medical history included allergic to penicillin. She also had an allergy to anesthesia but was told this was irrelevant to the shot, this allergy was over 20 years ago. Ongoing acid reflux, she had a problem with acid reflux for a year (it was controlled on medication) but they made changes to her medication and started to come back. She stated it was not real bad and that this wasn't a side effect because she has been dealing with it for a year. Concomitant medications were none. No other vaccinations within 4 weeks. The patient stated she received her first dose of the vaccine and didn't have any problem with it, just that her arm was sore and ached but by the next morning it was gone. The arm soreness happened maybe 12 hours later after she took the shot. She didn't experience it immediately after getting the injection. The soreness lasted overnight and by mid morning of 30Dec2020, she recovered completely. She stated this morning (18Jan2021) she woke up with a sore throat and her ear started to throb and she asked if it is safe for someone to receive the second dose if they are not feeling their very best? She is scheduled for her next dose tomorrow. The events did not require a visit to emergency room or physician office. Patient stated she was not sure about her weight because she lost a lot of weight dealing with the acid reflux she had had lately. Lab data included she had two COVID tests because of work previously, but these were negative. The outcome of arm soreness was recovered on 30Dec2020, outcome of other events was unknown. Information on the LOT/Batch number has been requested.

Other Meds:

Current Illness: Acid reflux (oesophageal)

ID: 0996731
Sex: F
Age:
State: FL

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: urine issues/kept going to the bathroom to urinate; upset stomach; diarrhea; felt like she was going to faint, pass out at any second; dizziness; Had a funny taste in her mouth; felt very weird, strange; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for two patients (one is patient self). This is the first of two reports. This 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration to right arm on 13Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included allergies to Sulfas, Penicilins, and Avelox, Sulfa or Penicillin allergies since she was a child and had the Avelox allergies about 15-16 years ago. None concomitant medications. Patient did not receive any other vaccines that day or 4 weeks prior. Did get the original Shingles vaccine about 3 years ago and then they came out with the new one and she got the first dose of that and believes she had a reaction to that one, thinks it was a rash. Also had the flu shot and she usually gets sick with it, but didn't with this last one. Thinks her body is just delicate. No vaccines administered on same date. Patient had the Pfizer BioNTech vaccine on 13Jan2021 15:00 and she was fine. She had a reaction the following day (on 14Jan2021). At 11am the next day she got very dizzy and felt like she was going to faint, pass out at any second. Used cold compresses and drank water and took deep breaths, but she didn't pass out. She had a funny taste in her mouth. Then from that time until about 7pm she had urine issues and kept going to the bathroom to urinate and had diarrhea and upset stomach. Patient felt like she was out of her body, felt very weird, strange. Doctor stated she maybe had a reaction to the vaccine and recommended for her to take Tylenol. She didn't take it until right before going to bed. She was able to sleep on 14th night. Woke up the next morning and was fine. She didn't see any of these reactions listed and that happened. Patient explained to a friend of the reactions and the friend mentions that she also had a friend who had the vaccine and had the same exact reactions, everything. Everything improved and stopped the next morning she was fine, on the 15th. No Emergency Room or Physician Office visit. The events outcome was recovered on 15Jan2021. It was just a span of time and she has to assume that it was the vaccine since she has never had that before. Patient does not know if she should blame the vaccine because she also has a lot of allergies to a lot of antibiotics and does not know what caused her reactions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021065869 Same reporter/ vaccine/ AEs, different patient

Other Meds:

Current Illness:

ID: 0996732
Sex: F
Age:
State: AL

Vax Date: 01/06/2021
Onset Date: 01/12/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: Test Date: 20210113; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Diagnosed with Bell's Palsy six days after receiving the vaccine; This is a spontaneous report from a contactable other HCP (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in the right arm on 06Jan2021 14:30 at first single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. On 12Jan2021, the patient was diagnosed with bell's palsy six days after receiving the vaccine. COVID was tested post vaccination: Nasal Swab: negative on 13Jan2021. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Event treatment included oral steroids. Outcome of the event was not recovered.; Sender's Comments: Based on the temporal relationship, the association between the event Bell's palsy with BNT162b2 can not be fully excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0996733
Sex: F
Age:
State: FL

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: hearing test; Result Unstructured Data: Test Result:sensory neuro bilateral hearing loss; Comments: worse on one side at 11:00; Test Name: Weight; Result Unstructured Data: Test Result:175-180 lbs

Allergies:

Symptoms: sensory neuro bilateral hearing loss worse on one side; tinnitus; This is a spontaneous report from a contactable physician (patient). A 46-years-old female patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular into right arm on 05Jan2021 at 0.3 mL, single for covid-19 immunization. Time the vaccination was reported as 10:00-10:30. Medical history included food and environmental allergies. The patient had a history of autoimmune antibodies to thyroid but with normal thyroid numbers. No medication was needed, but autoimmune antibodies was found in the past. She had a propensity for autoimmune disease, it was just not active. She was diagnosed the first time she found auto antibodies 12 years before 19Jan2021 (2009) and checks her thyroid yearly and they had been normal. She still had antibodies, but thyroid hormone levels are normal without intervention. The patient's concomitant medications included Vitamin C and Vitamin D. Historical vaccine included Pneumovax 30 days before getting the COVID vaccine (06Dec2020, 46-years-old). Her pneumonia titers were low. Historical vaccine also included flu shot, she felt sick but like everyone else, she did not consider that abnormal. She thought most people felt kind of down and it did not have long term effects. It did not require any doctor visits. She did not have a rash or anaphylaxis. The patient was a physician and well versed in terms of symptoms. By evening of 05Jan2021, she developed tinnitus, which she had never had and has been there ever since. She was on day 13 post vaccine and still having bilaterally, every day and it never went away. She had a physician visit on 12Jan2021 and hearing test performed that day. They did find sensory neuro bilateral hearing loss worse on one side, her test confirmed bilateral hearing loss at 11:00 on 12Jan2021. It was mild so far in the high frequency ranges. So, they gave option to start 14 day course of high dose steroids with steroid injections into the ear, because in some cases of acute hearing loss, it can curb or reduce it. She decided to do that. Now she was going to be on steroids. She would be temporarily immunosuppressed. She did not know if that will affect the vaccine. She had not decided if she will get second shot. It is due next week, but she was a little nervous. She was considering delaying the booster a couple months out to see if more information develops. She provided her weight as between 175 to 180lb. Right now, the hearing loss was mild and it won't be that bad, but normally, it was permanent, which would be disabling hearing loss. She was going 20Jan2021, for the steroid injection in the ear canal. That would be the first injection. She was taking oral steroids now. They would see if this limits the progression. The events outcome was not recovered.; Sender's Comments: The possible causality between the reported tinnitus/sensory neuro bilateral hearing loss and the administration of COVID-19 vaccine, BNT162B2, cannot be fully denied based on the reasonable temporal association. 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 RA, IEC, as appropriate.

Other Meds: VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS

Current Illness:

ID: 0996734
Sex: F
Age:
State: MA

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: Test Name: shrunk; Result Unstructured Data: Test Result:5'5-1/2"; Comments: Patient Height: reported her mother shrunk, and is 5'5-1/2"; Test Name: lung x-ray; Result Unstructured Data: Test Result:Unknown results; Test Date: 20200423; Test Name: COVID-19; Test Result: Positive ; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Test Name: Weight; Result Unstructured Data: Test Result:gained

Allergies:

Symptoms: Congestive cough; Weakness; didn't have an appetite; legs felt stiff, or almost frozen; Severe muscle weakness/extreme weakness was only in her mother's lower body; tremendous fatigue/Tiredness; Couldn't walk; This is a spontaneous report from contactable consumers. An 86-year-old female patient (mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) for years; COVID-19 Virus from 23Apr2020 to an unknown date, patient was not on a vent or in the ICU but did receive plasma as part of her COVID-19 Virus treatment; ongoing cough. Caller's grandmother had Multiple Sclerosis. There were no concomitant medications. The patient received her first Pfizer COVID-19 Vaccine dose, and had significant side effects. Patient weight was 175 lbs as provided by caller, who stated her mother recently moved into an independent living facility, and gained weight because the facility has a really good pastry chef. Patient height, reported her mother shrunk, and was 5'5-1/2". Reported her mother couldn't walk after receiving the first dose. She said her mother was not able to walk the next morning, 13Jan2021. The caller stated she had to spend 3 days with her mother, after her mother received her first COVID-19 Vaccine dose on 12Jan2021. Reported she thought initially what her mother was experiencing was either neurological or muscular. She said it was like her mother's brain wanted her to move, but her mother's legs wouldn't move. She said her mother needed to use a walker and have someone hold her from behind. She said now, at a week later, her mother still was not back to normal. She clarified her mother needed a walker to maneuver around, but didn't need someone holding her from behind. Reported she assumed her mother may have had tiredness, weakness, severe muscle weakness from receiving the first COVID-19 Vaccine dose. She clarified if her mother wasn't able to walk after receiving the first COVID-19 Vaccine dose, then what her mother had was the epitome of weakness, and the weakness was only in her mother's lower body. She said her mother had tremendous fatigue on days 2, 3, and 4 after receiving the first dose. She said her mother was able to function as of 19Jan2021, but her mother couldn't keep her eyes open during that time period. Reported her mother developed a congestive cough. She said her mother's cough was not continual, but persisting. She stated her mother said the cough was there before she had her first dose of the COVID-19 Vaccine. The caller stated she disagreed with her mother. She said her mother has COPD, but her mother was not a cougher. She said her mother's cough now, reminded her of the cough her mother had when her mother had the COVID-19 Virus in 2020. She clarified her mother was tested on 23Apr2020 for the COVID-19 Virus, and diagnosed positive for the virus on 24Apr2020. The caller said she was perplexed by her mother's cough, and her mother will be seeing her doctor this Thursday, 21Jan2021. She said she gave her mother some Robitussin for the cough. She said her mother's cough was not persistent, but the cough was still there. She said her mother's cough was not constant, but her mother's cough was congested. She said she didn't know when her mother's cough started. She said she thought giving her mother the Robitussin doses was kind of insignificant, because her mother did not have a constant cough, where she needed to take the Robitussin. She said her mother didn't even use half of a normal sized Robitussin bottle. Caller stated she did not have the Robitussin UPC, Lot, and Expiration Date. Reported her mother has an annual lung x-ray and MRI, clarifying she believed her mother had both within the past 3 months. Reported her mother was concerned about receiving the second COVID-19 Vaccine dose. She said she told her mother that it was better to get the second dose of the COVID-19 Vaccine than to get the COVID-19 Virus again. Reported her mother had asked her primary care doctor if she should get the COVID-19 Vaccine, and her doctor told her absolutely. She said her doctor told her she needed to take the COVID-19 Vaccine even if she had the plasma treatment with the COVID-19 Virus in Apr2020. Reported she planned to stay with her mother after her mother received the second COVID-19 Vaccine dose. She said she didn't anticipate her mother having a reaction after the first COVID-19 Vaccine dose because people said most reactions are happening after getting the second COVID-19 Vaccine dose. She said now people are reporting having reactions after the first COVID-19 Vaccine dose. Reported she thought her mother's side effect after having the COVID-19 Vaccine to be unusual, since most people say it feels like they have the flu, or they are tired, or they have a headache. Reported her mother not to be able to walk wasn't that her mother was not walking, but that her mother's foot wouldn't move. She said mother not walking was either neurologic or muscular, unless that is what extreme weakness is. She said she wondered if others have experienced what her mother has. She said if her mother was experiencing just extreme weakness, the extreme weakness was only in her mother's lower body, not in her upper body. She said her mother didn't have an appetite, but her mother was not too weak to put a spoon to her mouth. She said her mother couldn't move her legs, and her mother said her legs felt stiff, or almost frozen. She said if her mother had extreme weakness, and couldn't walk, what did that mean. She said if a person is really tired, the person can still move and get out of bed. She said her mother said she was really, really tired, and couldn't move. The caller said her mother said she couldn't move, and it took her mother 20 minutes to get her legs over the side of the bed. She said her mother not being able to move her legs could be extreme weakness, but observing her mother first hand, she said it looked like her mother not being able to move her legs was neurologic. She said her mother was strong in character and body, and her mother would do everything she could in her body to move, but it was like her mother's brain said "go", and her body said "not now". The outcome of the event Congestive cough was not recovered, of the other events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness: COPD (for years); Cough

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm