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: 0937681
Sex: F
Age: 29
State: CA

Vax Date: 01/10/2021
Onset Date: 01/11/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Low grade temp, tired, headache. Resolved.

Other Meds:

Current Illness:

ID: 0937682
Sex: F
Age: 38
State: MI

Vax Date: 12/30/2020
Onset Date: 01/07/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: See prior description

Allergies: NKDA

Symptoms: See prior description

Other Meds: Azelaic acid 15% gel; Vit D 50,000 IU weekly, ciclopirox 8% topical, clotrimazole-betamethasone topical cream, cyclobenzaprine prn, benadryl prn, fluticasone nasal spray, glucosamine-chondroitin, phentermine 37.5mg, proair HFA, tizanidine p

Current Illness: None acute prior to vaccination. Patient had COVID vaccination #1 (Moderna, Lot 011L20A) on 12/30/2020. On Jan 4, 2021, she had a nexplanon contraceptive device placed SQ in her left upper arm (medial side). On Jan 5, she developed pruritis of her left lateral deltoid and subsequently developed erythema at the injection site. She was initially treated with bactrim with continued worsening of erythema and pruritis and was hospitalized Jan 9-10 for IV abx (3 doses of vancomycin) with symptom improvement. In the hospital, she was noted to have elevated lactate (2.1) and tachycardia but no fever and negative blood cultures. US was done of her upper arm but showed no abscess. She was discharged on bactrim but when I saw her on Jan 11 I switched her to keflex (as she had previously failed bactrim). Suspected co-morbidities include morbid obesity with BMI=50 and pre-diabetes.

ID: 0937684
Sex: F
Age: 57
State: DE

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

Lab Data: Follow up care received at Hospital.

Allergies: Zantac, Demerol, Amoxicillin, Paxil, Gluten

Symptoms: Patient received vaccine around 10 am. She waited 30 minutes in the clinic with staff due to history of numerous allergies (zantac, demerol, amoxicillin, paxil, gluten). After patient left the site, she returned around 11:18am reporting she was feeling poorly (specifically with nausea, headache, and itchy/sore throat). No lip swelling , shortness of breath, hives noted. Vital signs were monitored and were stable. Diphenhydramine 50mg given orally and EMS notified as per our company protocol. Patient left via ambulance at 11:32 in stable condition to Hospital .

Other Meds: Aspirin, Effexor, Plaquenil, Verapamil, Sulfasalazine, Pravastatin, Klonopin, Calcium, Vitamin D, Ambien, Tylenol

Current Illness: None reported

ID: 0937685
Sex: F
Age: 65
State: CA

Vax Date: 12/28/2020
Onset Date: 12/30/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data: CBC and Chemistry panel was normal, my SED rate was only slightly elevated. Still waiting for other lab results.

Allergies: none Seasonal hay fever allergies

Symptoms: 48 hours after the injection I began to notice a sore throat before bedtime on Dec 30, but slept well. The next morning, Dec 31, I had acute allergic symptoms that never start so suddenly. I was having constant Post-nasal Drip, nasal congestion and beginning of cough due to PND. That night I had a severe sore throat similar to my typical allergic pattern. I coughed all night and awoke on the morning of Jan 1st with clear severe onset allergies and could not talk without coughing. That persisted for 4 days, then my allergist prescribed inhaled steroids BID which reduced the nighttime cough, but I persisted with symptoms for 10 days when they slowly resolved and my sense of well-being returned. I missed 7 days of work, which is atypical for my allergies when I catch them early. This was an acute flare of typical allergic symptoms that seems to have been triggered by the timing of the immune change from the vaccine at day #2-3 after the vaccine #1 was given. I am worried about getting vaccine #2 in 2 weeks and don't want to go through another flare up of dialing allergies again.

Other Meds: progesterone, estradiol

Current Illness: none

ID: 0937686
Sex: F
Age: 39
State:

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: acute shoulder pain

Other Meds:

Current Illness:

ID: 0937687
Sex: F
Age: 33
State: MD

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

Lab Data:

Allergies: Bactrim Clindamycin Percocet Vicadin

Symptoms: itchy arms, back, head, chest and legs and light headed Sat for 1 hour, itching and dizziness resolved

Other Meds: Zyrtec Candesartan Singulair Prozac Cartia Pantoprazole Pristiq Lithium Adderal XR 20

Current Illness:

ID: 0937689
Sex: M
Age: 56
State: MO

Vax Date: 01/05/2021
Onset Date: 01/10/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Ringing / buzzing in the ears and light headache beginning on 1/10.

Other Meds:

Current Illness:

ID: 0937690
Sex: F
Age: 36
State: CA

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

Lab Data: CBC, CMP, Troponin, CXR, EKG

Allergies: sulfa, lovenox

Symptoms: Vaccine administered at approx. 9 am. At 1000am , began feeling very tired, dizzy. S/sx increased over the next 2 hours. - began vomiting, felt very "slow motion". At approx. 1 pm, went back to vaccine area; felt like there was more effort to breath (heaviness); given epi-pen in ED, S/sx improved, Hydration started.

Other Meds: Tylenol, Levothyroxine, Protonix, Paxil, Gabapentin

Current Illness: had strep throat 1 week ago

ID: 0937691
Sex: F
Age: 27
State: ME

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

Lab Data: 12/29/20 Blood glucose at 0710-360, at 0820 -236, at 0915-165 serum sodium 134 Total bili 2.2 All other tests within normal limits including TSH, CBC, and the rest of the COMP Chest XR - normal EKG - no acute ischemia, NSR, 78.

Allergies: Adhesives Latex Penicillin Sulfonamides

Symptoms: Patient presented to the emergency department 12/29/20 7 AM, reporting hyperglycemia since receiving COVID vaccine one day earlier. Had been 140 at time of immunization. Highest reported was "high 300's". At time of presentation glucose 360 and accompanied by nausea, shakes and sweating. Also reporting fatigue. Patient reporting having felt like this when she is in DKA

Other Meds: none reported

Current Illness:

ID: 0937692
Sex: M
Age: 25
State: NC

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Stated developed slight dizziness, "the feeling you get before you become severely sick". Then developed a hoarse voice for 3.5 days & slight cough to clear throat often.

Other Meds:

Current Illness:

ID: 0937695
Sex: F
Age: 33
State: MA

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies: N/a

Symptoms: Left upper extremity (injection arm) dysfunction x ~50 hours. Unable to use left arm; unable to lift with no resistance.

Other Meds: Oral contraceptives

Current Illness: N/a

ID: 0937696
Sex: F
Age:
State: MA

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

Lab Data: She reached out to her PCP

Allergies: nka

Symptoms: PAIN BEHIND EYES, HEAD TO EXPLODE DOWN BAck OF HEAD

Other Meds: Rizatriptan

Current Illness:

ID: 0937697
Sex: F
Age: 22
State: KS

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: 1/12/2021 CBC, sed rate pending

Allergies: PCN G

Symptoms: Developed fever on day of vaccine. 1 day later fever continued and erythematous patch to left upper outer breast appeared. Tender, firm, has progressively spread. Currently rash is 2.5x2.5 in. Seen in clinic 1/12/2021 as a new patient for wellness exam

Other Meds: none

Current Illness: none

ID: 0937698
Sex: F
Age: 36
State: PA

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

Lab Data:

Allergies: Augmentin= hives

Symptoms: Pfizer-biotentech covid 19 vaccine EUA Body aches fatigued started at 3pm1/11. By 12am 1/12 unable to sleep due to Such severe pain all over head to toe, chills/shaking , vomiting and sweats. As of now today 1/12 1pm still very achey and fatigued with waves of nausea.

Other Meds: Losartan 50 mg po daily Synthroid 112mcg po daily

Current Illness:

ID: 0937699
Sex: F
Age: 73
State: TN

Vax Date: 01/07/2021
Onset Date: 01/09/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: none

Allergies: sulfa

Symptoms: Pt woke up on Saturday with headache. Pt broke out in shingles on Monday and was diagnosed today with Herpes Zoster

Other Meds: famotidine 40mg bid duloxetine 30mg synthroid 125mcg omeprazole 40mg bid Ziac 10-6.25 qd asa 81mg qd rosuvastatin 20mg qd metformin 500mg qd meloxicam 15mg qd wellbutrin sr 150mg bid

Current Illness: none

ID: 0937701
Sex: F
Age: 63
State: MD

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: none

Allergies: Allergic to Latex, adhesives and allergy medications, anti-itch meds,

Symptoms: I had an allergic reaction at the site of injection on my left arm. I applied alcohol and a new bandaid at 10:30 pm and went to bed. I woke up at 3 am with my left arm in serious pain. I removed the bandaid and the top skin was removed at the site of the bandaid. The area was swollen and inflamed red with a large circle on my upper left arm.

Other Meds: Atenolol, Triamterene, Fish Oil, Vitamin C, Mutivitamin for Women 50+

Current Illness: none

ID: 0937703
Sex: F
Age: 82
State: NJ

Vax Date: 01/09/2021
Onset Date: 01/10/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: none

Allergies: shell fish acute

Symptoms: Rash at site of injection, red and itchy following am date of injection . Also generated out break of eczema on right shoulder. Still evident 24 hours after shot. Applying RXfor exzema

Other Meds: Myrbetriq 50mg daily Atorvastatin tab 20mg weekly Pregabalin 25 mg daily Estradiol 0.01% nightly Fluoxetine cap 20 mg daily Alendro9nate Sodium Tab 70mg weekly

Current Illness: None

ID: 0937704
Sex: F
Age: 35
State: MA

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

Lab Data:

Allergies: NKA

Symptoms: Patient received vaccine 12/30, on 1/11 patient noted a circular rash around injection site that is tender and warm to touch

Other Meds:

Current Illness:

ID: 0937705
Sex: M
Age: 37
State: CT

Vax Date: 12/22/2020
Onset Date: 01/07/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: Unknown

Allergies: Sulfa

Symptoms: Patient developed lesion inner arm near elbow of (L) hand. Reports that his skin is painful when touched. Saw his PCP, being treated as Shingles.

Other Meds: Lexapro, Seroquel, Zyrtec

Current Illness: None identified

ID: 0937706
Sex: F
Age: 46
State: NC

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Developed rash with itching and irritation.

Other Meds:

Current Illness:

ID: 0937707
Sex: F
Age: 36
State: VA

Vax Date: 01/02/2021
Onset Date: 01/08/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: Negative rapid COVID on 1/10/21. Negative PCR COVID on 1/10/21. Pending CBC and iron studies drawn today 1/12/2021.

Allergies: Vigamoxx, iodinated contrast

Symptoms: Had fatigue, headache and L arm pain on Day 1 and 2. No sxs on Day 2. Had shaking chills beginning evening of Day 3. Night of Day 4 and ongoing have been having feverish, sweating, and chills several times per night, which continue. Woke up on Day 7 (1/8/2021) with pain in L axilla, which continues. On Day 9, I had red, slightly itchy, rash at site of injection approx 6x5cm. Had neg rapid COVID test on Day 9 and PCR, which was negative as well. Saw my provider on Day 10 and requested labs to be checked (cbc, iron also checked as needed to follow up those incidentally). Requested an esr but provider did not think it was necessary but did encourage me to report to Health Department or Moderna but found this website instead. Please let me know if I need to notify anyone else.

Other Meds: B12, D3, iron, miralax, and probiotic (all chewable or liquid)

Current Illness: Iron deficiency

ID: 0937708
Sex: F
Age: 44
State: CO

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

Lab Data: urgent care 1/11/21 - only abnormal lab was lower potassium 3.5 I was given a liter of IV fluids

Allergies: penicillin, nickel, gluten

Symptoms: 1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a couple hours. Took ibuprofen which helped. Low grade fever 99.8, EXTREME weakness and fatigue, body aches devloped evening with profuse watery diarrhea 1/7-1/10, poor appetite (NO nausea, NO vomiting) also had mild symptoms of intermittent runny nose, itchy eyes, mild cough. Symptoms improved 1/11/21 with decr freq diarrhea, improvement energy level. I pushed fluids in home and ate soup. Visit to urgent care 1/11/21 for IV hydration after receiving covid testing req for job d/t symptoms. 1/12/21 feeling improvement in symptoms but not fully recovered at this time-monitoring symptoms in home

Other Meds: bupropion

Current Illness: none

ID: 0937709
Sex: F
Age: 46
State: MA

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

Lab Data: none

Allergies: NKA

Symptoms: Left arm numbness /tingling all the way down to fingers.

Other Meds: Multivitamins and Minerals

Current Illness: None

ID: 0937710
Sex: F
Age: 35
State: MA

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

Lab Data:

Allergies: None

Symptoms: patient received vaccine on 12/30, yesterday 1/11, patient noted a big circular rash around the injection site that is warm and tender to touch. patient temperature was 100.4 F when reported to ED to inquire about rash.

Other Meds: None

Current Illness:

ID: 0937711
Sex: F
Age: 42
State: KY

Vax Date: 01/10/2021
Onset Date: 01/11/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies: Ceclor

Symptoms: The day after the 2nd dose, I experienced mild side effects of chills, body aches and fatigue that lasted approximately 4 hours.

Other Meds: Birth control pills

Current Illness: None

ID: 0937712
Sex: F
Age: 33
State: IL

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies: NKA

Symptoms: Injection site reaction that was 3 inches by 3 inches, the site was red, warm to the touch, swollen and sore. This is the same reaction that she had during the first dose and reported it when receiving her second dose. She stated that the first time it lasted 6 days.

Other Meds: unknown

Current Illness:

ID: 0937713
Sex: M
Age: 25
State: MN

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

Lab Data: None

Allergies: NKA

Symptoms: Low-grade fever, headache, muscle soreness, injection site pain, chills (despite not feeling cold).

Other Meds: None

Current Illness: None

ID: 0937714
Sex: F
Age: 32
State: SC

Vax Date: 01/07/2021
Onset Date: 01/09/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: I received the 2nd covid vaccine on thursday evening at 6:40pm. On the following Saturday I developed a red raised rash on the right side of my body, mostly arm and neck. I took 25mg benadryl. Rash lasted about 6h.

Other Meds: None

Current Illness: None

ID: 0937715
Sex: F
Age: 33
State: KY

Vax Date: 01/10/2021
Onset Date: 01/10/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies: Septra, Guardacil vaccine

Symptoms: Debilitating fever as high as 102, chills, sweating, weakness (unable to pick up 3 month old baby), significant joint pain, headache for days

Other Meds:

Current Illness:

ID: 0937738
Sex: F
Age: 25
State: MA

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

Lab Data:

Allergies:

Symptoms: She received GARDASIL 9 while pregnant; This spontaneous prospective pregnancy report was received from a 25-year-old female patient regarding herself. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. It was mentioned that she had no allergies. On 16-DEC-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular for prophylaxis (lot# and additional dosage regimen information was not reported), while she was pregnant. The patient explained that at the time of vaccination on 16-DEC-2020, she did not know she was pregnant, therefore she answered "no" when she was asked that question. Then, on 02-JAN-2021, she found out she was pregnant, but she was told by a healthcare professional that she likely became pregnant back in November 2020. The date of her last menstrual period was reported as November 2020.

Other Meds:

Current Illness:

ID: 0937739
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: cellulitis in her upper chest area; pain at the injection site all the way up to her jaw; redness all over her right shoulder; pain at the injection site; This spontaneous report was received from a female patient in her 60's, referring to herself. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (formulation, exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis and subsequently experienced pain at the injection site all the way up to her jaw and redness all over her right shoulder. After a few days, she developed cellulitis in her upper chest area and had to go to urgent care for treatment. It was unknown whether any lab diagnostics/studies were performed. The outcome of the events was unknown. The relatedness between the suspect therapy and the events was not provided Upon internal review, the event of cellulitis was considered medically significant.

Other Meds:

Current Illness:

ID: 0937740
Sex: U
Age:
State: NM

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

Lab Data:

Allergies:

Symptoms: PATIENT RECEIVED AN EXPIRED FLUMIST QUADRIVALENT; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin. No medical history was reported. No concomitant products were reported. The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number MH2201) 0.2 ml once/single administration, via nasal route, on an unknown date. The report described a medication error for Flumist Quadrivalent. The reported term was "patient received an expired flumist quadrivalent" (Preferred term: Expired product administered). Treatment with Flumist Quadrivalent (influenza virus vaccine live, intranasal) was not changed. The outcome of the event was unknown. The event was considered non-serious. Device Information: Product As Reported: FLUMIST QUADRIVALENT Product Role: Suspect Operator of device: Health Professional

Other Meds:

Current Illness:

ID: 0937741
Sex: F
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: granuloma on the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site granuloma in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 47CX9, expiry date 29th May 2002) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 1st December 2020, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 1st December 2020, less than a day after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced injection site granuloma. On an unknown date, the outcome of the injection site granuloma was not recovered/not resolved. It was unknown if the reporter considered the injection site granuloma to be related to Pediarix and Pediarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient administered Pediarix to left thigh and developed a granuloma on the injection site on on same day. The Vaccine Administration Facility is the same as Primary Reporter. No patient initials provided. The reporter consent to follow up. Error correction was performed on 12th January 2021: The classification Exclude from Regulatory Authority was removed from general tab.

Other Meds:

Current Illness:

ID: 0937742
Sex: M
Age: 72
State: FL

Vax Date: 09/16/2020
Onset Date:
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: cramping in the arm / arm cramps; sore arm; This case was reported by a consumer via call center representative and described the occurrence of cramp of limb in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 16th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced cramp of limb and pain in arm. On an unknown date, the outcome of the cramp of limb was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the cramp of limb and pain in arm to be related to Shingrix. Additional details were reported as follows: The patient experinced sore arm after receiving the first dose that lasted approximately 3 days. Also reported experiencing cramping in the arm after receiving the first dose, which was ongoing. The patient stated that their arm cramps when they put it in an unusual position (such as stretching it behind them). The patient stated that not experiencing any cramping in the arm prior to receiving Shingrix.

Other Meds:

Current Illness:

ID: 0937743
Sex: F
Age:
State:

Vax Date: 11/20/2020
Onset Date:
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hip pain; This case was reported by a consumer via call center representative and described the occurrence of pain in hip in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in hip. On an unknown date, the outcome of the pain in hip was unknown. It was unknown if the reporter considered the pain in hip to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient experinced hip pain after receiving her second shot of Shingrix on The reporter did not consent to follow-up. This case is one of the 3 cases reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021002009:Same reporter US-GLAXOSMITHKLINE-US2021AMR002842:same reporter

Other Meds:

Current Illness:

ID: 0937744
Sex: M
Age: 15
State: MI

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: administration of FLUBLOK to patients under 18 years of age with no adverse event; Initial information received on 04-Jan-2021 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 15 years old male patient who was administered with 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ509AA and expiry date : 10-May-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 22-Dec-2020, under 18 years of age with no adverse event (product administered to patient of inappropriate age) . Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. This was an actual medication error due to inappropriate age at vaccine administration [latency was same day]. No laboratory data reported. At the time of reporting, no adverse event was reported to the patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 0937745
Sex: M
Age: 14
State: MI

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

Lab Data:

Allergies:

Symptoms: FLUBLOK was administered to 14 years old patient with no adverse event; Initial information received on 04-Jan-2021 regarding an unsolicited valid non-serious case from other health professional. This case is linked to case 2021SA002575 (Same reporter). This case involves a 14 year old male patient who was administered with a 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot number: UJ509AA, expiry date:10-May-2021) via intramuscular route at the right deltoid for prophylactic vaccination on 30-Dec-2020 (Product administered to patient of inappropriate age). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration (latency-same day). Reporter stated that FLUBLOK had been administered to 11 pediatric patients and would like to know if patients were covered for influenza vaccination for the season. At the time of reporting, no adverse event reported (reported as none). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 0937746
Sex: F
Age:
State:

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

Lab Data: Test Name: Bone-marrow biopsy; Result Unstructured Data: Revealed intracytoplasmic kappa-restricted monoclonal plasma cells that occupied 40% of the marrow.; Test Name: Serum calcium; Test Name: Serum calcium; Result Unstructured Data: above 22; Test Name: Serum calcium; Test Name: IgA; Result Unstructured Data: IgA elevated; Test Name: PTH; Result Unstructured Data: Low; Test Name: Peripheral blood smear; Result Unstructured Data: Revealed rouleaux formation; Test Name: Viscosity levels; Result Unstructured Data: Elevated; Test Name: SPEP; Result Unstructured Data: IgA-Kappa MM; Test Name: Serum immunofixation; Result Unstructured Data: IgA-Kappa MM; Test Name: Quantitative serum light chain Kappa:Lambda ratio; Result Unstructured Data: Normal levels of kappa and lambda, with an elevated Kappa:Lambda ratio of 2:1.; Test Name: PTHrP; Result Unstructured Data: Elevated; Test Name: 24-hour urine collection; Test Result: 550 {DF}; Test Name: UPEP; Result Unstructured Data: IgA-Kappa MM; Test Name: 1, 25-(OH)2-Vitamin D3; Result Unstructured Data: Low

Allergies:

Symptoms: Vaccination induced cytokine storm; IgA-Kappa MM; Severe-symptomatic hypercalcemia; Flu-like symptoms; This literature case was received on 04-Jan-2021, concerning a 65-year-old female patient. The patient's concurrent conditions included multiple myeloma (MM). The patient's concomitant medications were not reported. On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; anatomical location, dose, route of administration and indication: not reported). The batch number was not reported. On an unspecified date, 5 days after receiving influenza virus vaccine polyvalent, the patient presented with subjective myalgias lasting two days. Vital signs were stable, complete blood count (CBC) and basic metabolic panel (BMP) were unremarkable and serum calcium was 10.8 mg/dl. The patient was discharged on supportive therapy. On an unspecified date, the day later, the patient presented with persistent flu-like symptoms. Labs revealed serum calcium being above 22 mg/dl; normal renal function, total protein, albumin, angiotensin converting enzyme (ACE) levels; clear urine analysis (UA) with no albuminuria; low parathyroid hormone (PTH) and 1, 25-(OH)2-Vitamin D3 levels; elevated parathyroid hormone-related protein (PTHrP) and viscosity levels. 24-hour urine collection revealed proteinuria (550 mg). Peripheral blood smear revealed rouleaux formation. Computerized tomography (CT) scans of the chest, abdomen and pelvis revealed no obvious malignancy. Quantitative immunoglobulins (Ig) revealed elevated IgA (2415 mg/dl), and concurrent suppression of IgG and IgM levels. Quantitative serum light chain measurement revealed normal levels of kappa and lambda, with an elevated Kappa: Lambda ratio of 2:1. Serum protein electrophoresis (SPEP), urine protein electro-phoresis (UPEP) and serum immunofixation revealed IgA-Kappa MM. The patient developed severe-symptomatic hypercalcemia, she was treated with aggressive intravenous crystalloids, loop diuretics, calcitonin, Pamidronate (pamidronate disodium), and hemodialysis. The patient's calcium subsequently normalized to 10.1 mg/dl. Bone-marrow biopsy revealed intracytoplasmic kappa-restricted monoclonal plasma cells that occupied 40% of the marrow. Bone survey was negative for lytic lesions. The patient was started on bortezomib, lenalidomide, dexamethasone and monthly zoledronic acid, and she has not attained remission from myeloma yet. On an unknown date, the patient recovered from the event 'hypercalcemia'. At the time of initial report, the patient had not recovered from 'multiple myeloma'. The outcome of all the rest events was not reported. The reporters assessed the event of 'cytokine storm' as related to the influenza virus vaccine polyvalent. It was theorized that the inactivated influenza vaccine given prior to presentation unmasked an atypical presentation of MM. This may be attributed to a vaccination induced cytokine storm, especially IL-6 mediated that may be the key in the pathophysiology of hypercalcemia related to MM. The reporter did not provide a causality assessment for other events. The events of 'cytokine storm' and 'multiple myeloma' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. Company comment: A 65-year-old female patient experienced cytokine storm, plasma cell myeloma, hypercalcemia and influenza like illness. Symptoms of the reported events started emerging one day after administration of influenza virus vaccine polyvalent. Very detail laboratory and diagnostic findings were provided in the report. Causality is assessed as possibly related for influenza like illness and for cytokine storm due to biological plausibility and presented information and unrelated for plasma cell myeloma due to biological and temporal implausibility. Hypercalcemia is more likely related to myeloma however the reporter's rationale points to vaccine as well, therefore assessed as unlikely related. (''unlikely related'' defaults to ''related'' in the safety database for reporting purposes); Reporter's Comments: It was theorized that the inactivated influenza vaccine given prior to presentation unmasked an atypical presentation of MM. This may be attributed to a vaccination induced cytokine storm, especially IL-6 mediated, that may be the key in the pathophysiology of hypercalcemia related to MM.; Sender's Comments: A 65-year-old female patient experienced cytokine storm, plasma cell myeloma, hypercalcemia and influenza like illness. Symptoms of the reported events started emerging one day after administration of influenza virus vaccine polyvalent. Very detail laboratory and diagnostic findings were provided in the report. Causality is assessed as possibly related for influenza like illness and for cytokine storm due to biological plausibility and presented information and unrelated for plasma cell myeloma due to biological and temporal implausibility. Hypercalcemia is more likely related to myeloma however the reporter's rationale points to vaccine as well, therefore assessed as unlikely related. (''unlikely related'' defaults to ''related'' in the safety database for reporting purposes)

Other Meds:

Current Illness:

ID: 0937748
Sex: M
Age: 40
State: MI

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

Lab Data: none

Allergies: penicillin, sulfa

Symptoms: Patient received the Maderna Covid-19 vaccine. Was sitting in observation for 10 minutes post vaccine and got up to "make a call." I was called to the conference room at 0815. Caregivers heard a loud noise and found patient on the ground in the hallway right outside the observation room. Patient states "I got dizzy and started getting tunnel vision" also states that this happens at times with needles/ blood draws since he was a kid. Patient set up on his own, denies head/neck pain. Denies any injury. Stood on his own and guided into observation for more time- set in chair. 0832 checked with patient , still denies injury, denies anymore dizziness. Encouraged him to go to the ED to get checked out. Patient denies head/neck pain or any S/S at this time. Declines ED. 0847- Patient denies dizziness, s/s and declines going to ED. Walked out, gait steady.

Other Meds: unknown

Current Illness: No

ID: 0937749
Sex: M
Age: 38
State: IN

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

Lab Data: None

Allergies: Penicillin

Symptoms: 48 hours of rigors and headache followed by lack of appetite as well as neuropathic pain over the thorax. No treatment except over the counter medications for symptoms. All symptoms except lack of appetite have resolved.

Other Meds: N/A

Current Illness: None

ID: 0937750
Sex: F
Age: 57
State: OH

Vax Date: 01/04/2021
Onset Date: 01/11/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: unknown

Allergies: none

Symptoms: Stated she had a sore, red arm on 1/4-1/6. Stated it went away but last night on 1/11 she noticed the injection site was swollen again, but now is red, warm and "bigger than the palm of my hand" stated is it not tender. Advised to reach out to PCP.

Other Meds: none

Current Illness: none

ID: 0937751
Sex: F
Age: 44
State: IN

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

Lab Data:

Allergies: Dairy, Phenergan, Codeine

Symptoms: 11hours 30min after vaccine administration, Pt. starts to experience fever 103.1, Chills, body aches, fatigue. 28 hrs. from vaccination Pt still experiencing fever 102.3 with the use of fever reducing medications. body aches, fatigue

Other Meds: Tylenol, Zinc, Vitamin C, Multivitamin

Current Illness:

ID: 0937752
Sex: F
Age: 43
State: MI

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

Lab Data:

Allergies: none

Symptoms: I woke up this morning with a lymph node in my neck shoulder area that was swollen and sore and affecting that shoulder on that side. Just alittle pain. I have had no treatment

Other Meds: Tylenol 8 hrs, Plaqinul 200 mgs but I did not take that a week prior to shot

Current Illness: none

ID: 0937753
Sex: F
Age: 58
State: WA

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Aprox. 12 hours after receiving the vaccine, I developed the following symptoms: headache, low-grade fever, chills, muscle/body aches, nausea, vertigo, primarily muscle/body aches. My symptoms resolved aprox. 36 hours later. Aprox. 60 hours later, I had a couple of episodes of diarrhea, and was just feeling a little "spacey" and slightly tender behind my eyes.

Other Meds: None

Current Illness: None

ID: 0937754
Sex: M
Age: 46
State:

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

Lab Data:

Allergies:

Symptoms: Covid Positive

Other Meds:

Current Illness:

ID: 0937755
Sex: F
Age: 67
State: NC

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Received vaccine on 1/4. Woke on 1/5 with cold sweats and painful diarrhea. Called Covi hotline. Instructed to stay home form work until symptoms improved.

Other Meds:

Current Illness:

ID: 0937756
Sex: F
Age: 25
State: IN

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

Lab Data: N/A

Allergies: Sulfa antibiotics

Symptoms: Fatigue and body aches 1/8/21 8:00 pm. Severe chills and body aches 1/8/20 11:00 pm continued for several hours. Muscle and body aches and fatigue continued until 1/10/21 7:00 am was gone. Swollen lymph nodes on neck (still experiencing this 1/12/21)

Other Meds: Zyrtec Thorne prenatal Tarina Fe 1/20

Current Illness: None

ID: 0937757
Sex: M
Age: 27
State: UT

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: Covid 19 by pcr- scheduled on 01/12/2021

Allergies:

Symptoms: Patient reports that the next morning he woke up with fever, body aches, headache, fatigue, shortness of breath, fatigue, congestion, dry throat and he feels his HR is elevated(never measured above 100BPM).

Other Meds:

Current Illness:

ID: 0937758
Sex: F
Age: 47
State: OR

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

Lab Data: COVID RAPID TEST ( NEGATIVE) MONDAY THE 11TH, SEEKED MEDICAL CARE FOR SYMPTOMS HAD GONE ON TO LONG

Allergies: Slight allergy to Amoxicillin at end of course ( rash ), walnuts and some nuts that are not roasted, lactose intolerant

Symptoms: RASH STARTED APPEARING AT CHEST AND NECK AND FACE WITH ITCHING, FATIGUE, PAIN AT INJECTION SITE, NUMBNESS AND TINGLING IN THE ARM SHOT GIVEN, HEADACHES, JOINT PAIN, BODY ACHES, CHILLS, FEVER OF 99.9 BY TUESDAY. STILL HAVING SEVERE JOINT AND BODY ACHES WITH HEADACHES AND LOW GRADE FEVER CURRENTLY.

Other Meds: Lisinopril

Current Illness: none

ID: 0937759
Sex: F
Age: 33
State: ID

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data: COVID test - PCR Nasal Midterminent Swab

Allergies: none

Symptoms: 24 hours later - arm got really swollen - 3 in by 2 inches - painful - still have a bump; didn't take anything; Started having a sore throat and body fatigue four days after Dec 28 about 10 am- tested positive for CoVID at 4:00 pm. I took vitamins for Covid - Zinc; baby aspirin; Calcium Magnesium supplement. Still have a few COVID symptoms. (Telemed appt with two of my doctors during the course of this.)

Other Meds: none

Current Illness: none

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm