VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1428892
Sex: F
Age: 11
State: WA

Vax Date: 06/25/2021
Onset Date: 06/25/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: NO KNOWN ALLERGY

Symptom List: Dysphagia, Epiglottitis

Symptoms: THE NURSE ACCIDENTALLY GAVE 1ST DOSE OF PFIZER VACCINE TO 11 YEAR OLD KID. PFIZER IS INDICATED FOR 12 YEARS AND UP. SO FAR, THE PATIENT DOESN'T HAVE ANY SIDE EFFECTS YET. WE NOTIFIED THE PATIENT'S MOM ABOUT THE INCIDENT AND NOT TO GET 2ND DOSE UNTIL THE PATIENT TURNS 12.

Other Meds: NO

Current Illness: NO

ID: 1428893
Sex: M
Age: 54
State: WA

Vax Date: 05/10/2021
Onset Date: 05/11/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: No

Symptom List: Anxiety, Dyspnoea

Symptoms: Extreme fatigue, brain fog, constricted chest, chest pain for 4 days after my second dose. Now, I've been experiencing continued ongoing fatigue for 6 weeks. My legs grow heavy each day. I pass out from exhaustion early each night. I have trouble concentrating. I'm experiencing ankle and wrist pain with a feeling of low circulation as my feet and hands fall asleep if I sit too long. I'm also having vivid nightmares on an ongoing basis. Other than a back injury, I was healthy and normal before this vaccine. I have not been to a doctor. I have been resting, focused on eating well and taking 3000mg of Vit C a day.

Other Meds: Vit C, Vit D

Current Illness: no

ID: 1428894
Sex: M
Age: 57
State: CA

Vax Date: 05/18/2021
Onset Date: 05/19/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: none

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Severe flu like reactions for 2.5 days. Fever, extreme fatigue, body muscle aches, chills, headache, loss of appetite, slight nausea.

Other Meds: Multivitamins, vitamin D, etc. Losartan 25mg Rosuvastatin 10mg Amlodipine 5mg

Current Illness: none

Date Died: 03/21/2021

ID: 1428895
Sex: M
Age: 92
State: CA

Vax Date: 02/08/2021
Onset Date: 02/09/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies: COQ10- nosebleeds Glycopyrrolate ? hives/Rash No Known food allergies

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Feb 8th 2nd vaccination. Next day lost consciousness, fell no injuries. Following day Feb 10th weak and could not stand, BP low, Dr sent him via ambulance. EMS identified him having a heart attack that started Feb 9th. He had no cardiac history He was hospitalized for a sudden blockage, had a vtach episode, did not lose consciousness, one stent placement, had a 2nd vtach episode and did lose consciousness. Placed on blood thinner, within a few days had uncontrolled urinary bleeding, catheter to irrigate, changed blood thinners and did not stop. Continued weakness and decline. Then developed pneumonia the following week. Placed on antibiotics, oxygen 2-7 L/nc. Went to rehab, back and forth to hospital. Came home twice, once Feb 14th for 24 hours, then 2nd time March 9 (his birthday) for his final 2 weeks t home where I cared for him until he passed March 21st. On 4L/NC, did not have catheter, bleeding had stopped.

Other Meds: Levothyroxine 0.075 mg 1 every morning 2 hours before a meal (also binds to coffee) Ecitalopram 5 mg 1 every morning Donepazil Hcl 5 mg 1 every morning Carbidopa/Levodopa 25/100 mg 4 times per day (7am-11am-3pm-7p) Benazapril 20 mg 1 every

Current Illness:

ID: 1428896
Sex: M
Age: 57
State: IL

Vax Date: 04/28/2021
Onset Date: 04/29/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: None

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: After and elevated heart rate for 15 hours.

Other Meds: Crestor, statin, vitamin D3, NP Thyroid

Current Illness: None

ID: 1428897
Sex: M
Age: 36
State: NY

Vax Date: 04/03/2021
Onset Date: 04/01/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies: None

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: All symptoms aligned with the reported Heart Inflammation reactions. Primary symptom showed as shortness of breath and noticeable heart "flutter"/pounding and heart rate spikes. that began a week or so after the 1st vaccination. The Emergency room was visited soon after these symptoms began but tests came back inconclusive. Symptoms gradually improved over 1-2 weeks but returned more significantly after the 2nd vaccination shot. These symptoms lasted for about a month.

Other Meds: Multivitamin

Current Illness: None

ID: 1428898
Sex: F
Age: 30
State: AZ

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Penicillin

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Late in the evening after receiving the shot, I felt hot, and uncomfortable. The entire next day I felt dizzy, slow, hot, and later in the evening I had what felt like heartburn. A gripping in my chest. By morning of the second day I felt 100% again.

Other Meds: None

Current Illness: None

ID: 1428899
Sex: M
Age: 63
State: HI

Vax Date: 01/16/2021
Onset Date: 06/18/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: None

Symptom List: Pharyngeal swelling

Symptoms: Blood Clot Left Leg

Other Meds: Vitamin C, B

Current Illness: None

ID: 1428900
Sex: F
Age: 34
State: MI

Vax Date: 05/23/2021
Onset Date: 05/31/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: None

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: 5 days afterwards i had a grandmal seizure for unknown cause. No history of seizures. No symptoms prior to this event.

Other Meds: Spironolactone, sertraline, trazodone, estradiol, progesterone, vitamin d.

Current Illness: None

ID: 1428901
Sex: F
Age: 46
State: CA

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Sulpha

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Immediately had Wrist pain, body felt off within 15 minutes, within two hours fever, body aches, injection site pain, fatigue, headache, heart racing 125bpm, chest/heart ache, after 6 hours nausea, severe arm pain, after 18 hours vomiting, body weakness, shortness of breath, almost passed out, severe bone pain, muscle aches, chills, ovary pain, break-through period . Feet hurt to walk on, severe weakness. Pain and fever did not go away with Tylenol or Advil. Fever lasted five days. Break-through period lasted 3.5 weeks. High blood pressure was marked a week after vaccine. Still have high heart rate, shortness of breath, high blood pressure, headache, fatigue, ovary pain, malaise, swollen abdomen 4 weeks later.

Other Meds: Montelukast, Trelegy, Armour, cyclobenzoprine, pirmella, loratidine, Vit D, zinc, biotin, slow Fe, selenium, magnesium, K2, methyl folate, B12

Current Illness: Sinus infection, long-haul Covid

ID: 1428902
Sex: F
Age: 27
State:

Vax Date: 06/01/2021
Onset Date: 06/25/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies: None

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Started on the morning of 6/25/2021. I received my second dose of Pfizer COVID vaccination after my menstrual period ended and this morning when I woke up, I noticed that there was blood on the toilet paper. There was no blood in the urine and throughout the day, there continues to be an increase in the amount of blood left on my pad and tissue paper. Haven't had issues with spotting in the past and this is a new occurrence. Also feel that my left posterior auricular lymph node is harder and more swollen and left sinus is more congested.

Other Meds: None

Current Illness: None

ID: 1428904
Sex: F
Age: 18
State: CO

Vax Date: 06/21/2021
Onset Date: 06/25/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies: No

Symptom List: Rash, Urticaria

Symptoms: Sudden sharp pain in the right leg under the knee. Making it difficult to walk and move. Noticed three small bruises in the same area appeared around 1 hour after the pain started. Also some swelling around the area. And the area around the bruises is pale (white) This happens today at 2:30 pm June 24 The vaccine was administered June 21 11:30 am

Other Meds: No

Current Illness: No

ID: 1428905
Sex: F
Age: 64
State: AZ

Vax Date: 04/21/2021
Onset Date: 05/24/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Metformin

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Patient went for a routine mammogram screening and was noted to have R axilla lymphadenopathy- likely reactive lymph nodes

Other Meds: Amlodipine, aspirin, Vitamin D, flexeril, gabapenitn, glipizide, lisinipril, metformin, omeprazole, simvastatin, ursodiol

Current Illness: None

ID: 1428906
Sex: F
Age: 23
State:

Vax Date: 05/07/2021
Onset Date: 05/09/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Sore arm, increased and loud heartbeat, shortness of breath, lightheaded, and tinnitus.

Other Meds:

Current Illness:

ID: 1428907
Sex: F
Age: 50
State: CA

Vax Date: 06/24/2021
Onset Date: 06/24/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: none

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Severe aches and pains, felt like my skin was on fire, horrible headache, exhaustion, and extreme pain in my arm. I was very weak and dizzy. The next day my arm was huge and had red welts all over it. The doctor told me to take an antihistamine and ice it. I was on back to back ibuprofin and tylenol, however it barely helped. Symptoms have lasted 17 hours so far. If my arm is still sore, red, and huge I will go in tomorrow to urgent care.

Other Meds: lexipro, hormone patch, progesterone, thyroid suppliment

Current Illness: none

ID: 1428908
Sex: M
Age: 36
State: CA

Vax Date: 05/15/2021
Onset Date: 05/20/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Penicillin

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Genital ulcer

Other Meds: None

Current Illness:

ID: 1428909
Sex: F
Age: 15
State: CA

Vax Date: 06/19/2021
Onset Date: 06/21/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies: No

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Chest pain, heart beat around 100 for few hours. Took Motrin.

Other Meds: No

Current Illness: No

ID: 1428910
Sex: M
Age: 76
State: WA

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies: Amoxicillin

Symptom List: Ear pain, Hypoaesthesia

Symptoms: 7-8 hours after injection slight soreness at shot location; 20 hours after injection sudden wave nausea & possible need to vomit, defecate, urinate, & dizziness; sat on toilet & collapsed forward onto floor into stack of towels remaining semi-conscious for a several minutes trying to determine location; worked way upright, got to bedroom, and tried to sleep but severe chills; chills subsided and slept 6 hours; felt feverish and in period of 2 hours had temperatures of: 99.6; 100; 100.4; 101.5; 101.8; 98.8 & went back to bed for night; awoke feeling relatively normal 03/13/2021; thereafter to the present time of 04/04/2021 days of feeling relatively normal, but often waves of feeling light-headed; blood pressure Continuing description of events after second Moderna vaccination: my blood pressure taken at home on Omron wrist device has been highly variable from 136/74/58 down to 101/64/72 with prior normal being about 115/65 to 130/70 at home and as taken at the eye doctor's office on 03/01/2021 the week prior to cataract surgery on 03/08/2021 it was 128/70, but is commonly higher at doctors office exams likely due to stress of driving to the doctor's office and on day of surgery was up to 158/80; on those days of being light-headed the blood pressure was commonly in the 101/64/72 to 114/65/61 range; my body temperatures remained in normal ranges of 97-98; beginning on 03/30/2021 there was some feeling of some throat or esophagus constriction and harder to swallow; this has continued & included acid reflux on 04/03/2021 and feeling very tired and went to bed about 05:00pm & slept to 08:00pm followed by going to bed at 11:00pm and unable to sleep the rest of night due to acid reflux in throat all night; but better on awakening this morning; it remains that there is the feeling of being light headed; a few times during this period after getting the Moderna vaccination the area of the injection has had a minor soreness, and/or itchiness. I have not yet seen a doctor about this reaction, but I did indicate to my eye doctor prior to the cataract surgery on 03/08/2021 that I would be getting my second Moderna vaccination 3 days after. He felt it should be okay. Similarly at the time of my first Moderna vaccination, I told the nurse practitioner that I would be having cataract surgery 3 days prior to the scheduled second vaccination. She also felt it should be okay, as well as having had a reaction to Amoxicillin for the first time about 11 months earlier. That reaction was hives all over the body that kept recurring for 3 weeks and thereafter at places on the body for another month. I am otherwise in excellent health for my age and the only medication taken is Timolol for glaucoma. I am active and frequently walk several or more miles several days per week. My reaction seems unusual. I have only now ceased taking the last of the cataract surgery eye medications, that being Prednisolone eye drops. If the symptoms persist after seeing my eye doctor tomorrow, and after elimination of the eye drop medication as of today, I will be scheduling an appointment with my regular doctor for a checkup. Additional information as of May 24, 2021: I had an examination by Dr., Care Center on April 14, 2021. After discussing the reaction and symptoms that occurred thereafter an EKG indicated a slight heart beat abnormality. Combined with the continuing lightheaded symptoms that periodically recurred he considered the potential that the Timolol that I have used since my late 30s to reduce eye pressure from glaucoma could potentially have reacted with the Moderna shot. As such he later called my opthalmologist, Dr., at Eye Clinic in to discuss this possibility. Dr. also scheduled for me to have an echocardiagram to determine if there has been a resulting heart problem from the Moderna shot. Subsequently after discussing this with Dr. I discontinued taking Timolol for about 3 weeks with a subsequent eye exam to determine the pressure in my right eye to see if a new prescription may be necessary or other alternatives. This was on May 19, 2021. I had been taking my blood pressure daily, sometimes multiple times during the day since the collapse after the Moderna shot. Toward the end of the 3-week period of not using Timilol drops in my right eye the feeling of being lightheaded had become less frequent and blood pressure had become more consistently above 110/65. The feeling of being lightheaded had seemed to often correlate with blood pressure below that, but often my blood pressure was erratic going as low as 100/60 and upward to more normal areas of 120/68-130/75. However, it was not clear to me, or to Dr. if this was a result of having discontinued Timolol or if it was the needed period of time for the Moderna aftereffects to subside. He has me now using only 1-drop of Timolol per day, rather than 2-drops per day in my right eye as my eye pressure is just over borderline of concern for glaucoma in that eye. The cataract surgery on March 8, 2021, 3 days before the 2nd Moderna shot, had eliminated the need for taking Timolol in my left eye. As it stands, I continue to feel relatively normal. I had a second checkup with nurse practitioner at Unity Care Center on May 12, 2021 and she agreed that I should have the echocardiagram as scheduled on May 28, 2021 which is in 4 more days. Additional information as of June 25, 2021: I had an echocardiagram on May 28, 2021 and was provided the evaluation of the results on Jun 9, 2021 by nurse practitioner at Care Center. 1) overall results were good; 2) my ejection factor was 65% and normal; 3) the only abnormality is a mild resistance to ventricle heart relaxing when it is filling up with blood (she further indicated that in positions of some stress is when this was primarily occurring and could result in lower blood outflow and lower blood pressure potentially related to the feeling of being lightheaded and could possible pass out); 4) my heart valves look OK; 5) keep well hydrated to maintain a healthy blood pressure. At the time there was a period of several weeks of having felt relatively normal most of the time with few episodes of feeling lightheaded. However, during a period from June 11 to June 19 there reoccurred daily feeling of being lightheaded and at times the systolic blood pressure dropping to as little as 104 and often no more than 115. However, since that time the blood pressure has returned to the more normal range of 115-130 and feeling more normal. It remains unknown what part the second Moderna shot had to do with this, but there had not been these prior periods of feeling on the verge of passing out combined with lack of energy during these periods. However, the periods of feeling lightheaded seem to be shortening and the periods of feeling normal longer and whatever the causes are gradually subsiding.

Other Meds: Timolol Maleate Opth. Sol. 0.5%; Gatifloxacin 0.5% Opth. Sol; Prescription drugs at time continued: Ketorolac 0.4% Opth. Sol; Prednisolone AC 1% Opth. Sol.

Current Illness: cataract surgery 03/08/2021

ID: 1428912
Sex: M
Age: 50
State: GA

Vax Date: 06/23/2021
Onset Date: 06/25/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Pronounced lower back pain and left leg pain, commencing second day after vaccination. Experienced both in milder form at the same interval after first vaccination.

Other Meds: 240 MG Verapamil 30 MG Duloxetine 30 McG Avonex 2000 IU Vitamin D

Current Illness:

ID: 1428913
Sex: M
Age: 32
State: TX

Vax Date: 04/23/2021
Onset Date: 04/23/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies: No

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Very fast heart beating and shortness of breath (maybe related to heart inflammation side effect)

Other Meds: No

Current Illness: None

ID: 1428914
Sex: M
Age: 45
State: CA

Vax Date: 05/15/2021
Onset Date: 05/17/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: certain fruits and pollen.

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: No side effects after the 1st vaccine. No noticeable side effects until 58 hours after the 2nd vaccine. Fatigue most likely started until 48 hours after the shot. At hour 58 post-vaccine and for the next 36 hours: fever up to 102F, chills, cold sweat, muscle pain. Headache (pain level 4). At hour 96 post-vaccine and for the next 36 hours: urinary incontinence, cluster headaches (pain level 8, which required a tele visit and a Diclofenac prescription). An easy exercise outdoor (a walk) was attempted on day 6 after vaccine; abandoned after 0.25 of a mile due to chest tightness and a discomfort in the heart area. Slow return to easy exercises attempted again on day 8 after the vaccine. Max athletic output at 50% of capabilities prior to the vaccine. As of June 10th chest tightness and dull pain in the center/right side of the chest still experienced, which was reported to the primary physician during the annual checkup. As of June 21th chest tightness and dull pain in the center/right side of the chest still experienced; in addition ? a dull pain in the shoulder blade area when air was inhaled and held. As of June 25th max athletic output at 80% of capabilities prior to the vaccine.

Other Meds: N/A

Current Illness: N/A

ID: 1428915
Sex: M
Age: 21
State: IN

Vax Date: 06/25/2021
Onset Date: 06/25/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Latex, Fennel, Grass, Red Dye #40

Symptom List: Unevaluable event

Symptoms: About an hour after getting the shot, the skin on my right arm was flushing before going numb. Then my shoulder went partially numb and it's still numb/frozen as of 2:20 am 26/June/2021. Over the course of nine hours from when I got the shot, starting at around 1 hour after, I started to get symptoms, which as of right now are still here. After my skin started acting up, my blood pressure dropped and my heart was pounding extremely hard in my chest and felt tight. My muscles have been going between losing muscle tone and being locked up extremely hard. I've been dizzy since about 3:00 pm 25/June/21, and it has progressively gotten worse to where I feel like I am going to pass out if I stand up. I have chills that make my chest tighten up and cause angina. I have been feeling very faint since around 9:00pm. I've had a mild headache since around 2:30pm, and have been feeling like I am falling since about 1am. Breathing takes manual effort. I have been feeling dissociated and nauseous since about 6pm and cannot remember much from after 6pm. I am not sure whether it is a medical emergency or not but I can't afford to go to the er.

Other Meds: Vthrive daily multivitamin, Klonopin, Restoril

Current Illness: N/A

ID: 1428916
Sex: F
Age: 41
State: CA

Vax Date: 06/08/2021
Onset Date: 06/09/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: None

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: High fever 103 and diarrhea for 3 days Fatigue, strong headache, sensitivity to smell, sensitivity to light and nausea for 24 h Dizziness and brain fog for 1 week

Other Meds: Multi-vitamin

Current Illness: None

ID: 1428917
Sex: F
Age: 16
State: CA

Vax Date: 06/19/2021
Onset Date: 06/21/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: None

Symptom List: Injection site pain, Pain

Symptoms: 2d post receiving the second dose developed a nose bleed - lasted 10 minutes 2d post had headache all day 3d post started her menses (would not have been typically due at that time)

Other Meds: None

Current Illness: None known

ID: 1429230
Sex: U
Age:
State: MA

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: No additional AEs; a patient was inadvertently administered GARDASIL 9 today (14JUN2021) that was expired; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported. On 14-JUN-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, formulation, concentration, vaccination scheme frequency, route of administration, anatomical site of vaccination were not reported; lot number R009615 has been verified to be valid, expiration date reported and validated as 07-DEC-2020) (expired product administered). No additional adverse events (AEs) reported.

Other Meds:

Current Illness:

ID: 1429231
Sex: M
Age: 23
State: MT

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Customer reports that the finger flange has broken off and is separated from the barrel of the syringe; the patient did not experience any other AE; one of the GARDASIL 9 doses was administered to a patient before the defect was noticed; This spontaneous report was received from a consumer and refers to a 23-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-JUN-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered into left deltoid, lot # T024831, expiration date 18-NOV-2022 (exact dose and route of administration were not provided) for prophylaxis. The reporter stated that finger flange had broken off and was separated from the barrel of the syringe (poor quality device used, syringe issue). It was reported that there was another dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) with the same issue from the same box and tray but it was not administered. No adverse event was reported (with an outcome reported as recovered). 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: T024831; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1429233
Sex: U
Age:
State: MA

Vax Date: 06/15/2021
Onset Date: 04/01/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies was not provided. On an unspecified date in April 2021, the reporter had a delivery of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) that did not arrive for more than 5 days (product distribution issue), when the product was received it was supposed to be returned to the wholesaler, instead it was placed in the refrigerator. Information about the temperature storage or a time frame was unknown by the reporter. There wasn't a previous temperature excursion. On 15-JUN-2021, the patient was vaccinated with a bad dose HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, 1 time dose as prophylaxis (lot number T026168 has been verified to be valid, expiration date reported and validated as 04-DEC-2022) (vaccination scheme frequency, route and anatomical location of administration were not provided) (product storage error) (poor quality product administered). No additional adverse events occurred. This is one of several reports received from the same reporter. 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: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments: US-009507513-2106USA005004: US-009507513-2106USA005005: US-009507513-2106USA005047: US-009507513-2106USA005081: US-009507513-2106USA005150:

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1429234
Sex: F
Age:
State: OH

Vax Date: 06/01/2019
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: No additional AEs reported; a patient received her first dose of GARDASIL 9 two years ago and did not receive the second or third dose recommended in the series; This spontaneous report was received from a pharmacy technician referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided. In June 2019 (reported as two years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. The patient did not receive the second or third dose recommended in the series (inappropriate schedule of product administration). No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1429238
Sex: F
Age:
State:

Vax Date: 05/02/2021
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: ATYPICAL PNEUMONIA; ALLERYGY SYMPTOMS WORSE; WHEN SHE FEEL LIKE SHE "STARTS HURTING; SHE DOES ENBREL INJECTION EVERY 7-10 DAYS; fever of 103; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASL2021091359), license party for etanercept (ENBREL). This serious solicited report (USASL2021091359) was reported to Amgen on 11/JUN/2021 by a consumer from a commercial program and involves a 33 year old, female patient who atypical pneumonia [PT: atypical pneumonia], allergy symptoms worse [PT: hypersensitivity], she does Enbrel injection every 7-10 days [PT: intentional product misuse], when she feel like she starts hurting [PT: pain], fever of 103 [PT: pyrexia], bad side effects [PT: adverse reaction] while receiving Enbrel, Reusable Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis. The patient's concomitant medications included ibuprofen. The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel on an unknown date in 2012. On an unknown date, the patient started using Reusable Autoinjector. The patient stated that she did her Enbrel injection every 7 to 10 days and that her HCP was aware, she takes it when she felt like she starts hurting. Additionally, the patient had atypical pneumonia. Subsequently, the patient had to stop Enbrel once before for about four to five weeks. On an unknown date, Enbrel therapy was resumed. The patient also stated that she felt like the injections made her allergy symptoms worse. On an unknown date in 2021, the patient stated that she skipped a week between each dose of covid-19 vaccine. On 02/MAY/2021, the patient just took second covid-19 vaccine. On an unknown date in 2021, the patient had really bad side effects after vaccine, she had a fever of 103 (unit was not provided) for about three days even after taking ibuprofen. No treatment information was received. The outcome of the events atypical pneumonia, hypersensitivity, intentional product misuse, pain, pyrexia, adverse reaction were reported as unknown. Action taken with Enbrel and Reusable Autoinjector was temporarily withheld for the event atypical pneumonia. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the events pain, hypersensitivity. The consumer reported that the event hypersensitivity was possibly related to Enbrel. The causal relationship between the events atypical pneumonia, intentional product misuse, pain, pyrexia, adverse reaction and Enbrel was not provided by the consumer. The causal relationship between the events atypical pneumonia, intentional product misuse, pain, hypersensitivity, pyrexia, adverse reaction and Reusable Autoinjector was not provided by the consumer. Follow up has been requested Amgen comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept caused or contributed to the adverse event reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual report does not change the safety profile of the product. Amgen Causality Assessment: event Atypical pneumonia; Allergy aggravated was related to etanercept; events Fever; Adverse reaction; Intentional misuse in dosing frequency; Pain were unrelated to etanercept. The reporter's assessment of the causal relationship of the events (except hypersensitivity) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available clinical data and known drug safety profile, a causal relation between events hypersensitivity, pain, pyrexia and vaccination with BNT162B2 cannot be excluded. The event atypical pneumonia was most likely an intercurrent medical condition not related to BNT162B2 vaccine. Based on the available clinical data and pharmacological properties of etanercept, a contributory role of etanercept to events atypical pneumonia, hypersensitivity, pyrexia cannot be 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: IBUPROFEN

Current Illness: Hypersensitivity; Psoriatic arthritis

ID: 1429239
Sex: M
Age:
State: MD

Vax Date: 02/23/2021
Onset Date: 02/26/2021
Rec V Date: 06/26/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Myocarditis; Heart rate increased; Chest pain; Inflammation; This case was received via VAERS on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased), CHEST PAIN (Chest pain) and INFLAMMATION (Inflammation) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and INFLAMMATION (Inflammation) (seriousness criterion hospitalization). 26-Feb-2021, the patient experienced HEART RATE INCREASED (Heart rate increased) (seriousness criterion hospitalization). The patient was treated with COLCHICINE for Inflammation, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased), CHEST PAIN (Chest pain) and INFLAMMATION (Inflammation) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Angiogram: not provided (Inconclusive) Not provided. On 26-Feb-2021, Chest X-ray: not provided (Inconclusive) Not provided. On 26-Feb-2021, Echocardiogram: not provided (Inconclusive) Not provided. On 26-Feb-2021, Heart rate: increased (Inconclusive) Increased. On 26-Feb-2021, Lipids: not provided (Inconclusive) Not provided. On 26-Feb-2021, Metabolic function test: not provided (Inconclusive) Not provided. On 26-Feb-2021, Troponin: not provided (Inconclusive) Not provided. On 26-Feb-2021, Urine analysis: not provided (Inconclusive) Not provided. On 27-Feb-2021, Full blood count: not provided (Inconclusive) Not provided. On 27-Feb-2021, Metabolic function test: not provided (Inconclusive) Not provided. On 27-Feb-2021, Troponin: not provided (Inconclusive) Not provided. On 01-Mar-2021, Echocardiogram: not provided (Inconclusive) Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Patient received treatment to Lower Heart rate and Inflammation. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

Date Died: 05/27/2021

ID: 1429240
Sex: F
Age:
State: TX

Vax Date: 05/19/2021
Onset Date: 05/27/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Death; Dysarthria; Lethargy; This case was received via FDA VAERS (Reference number: 1358542) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), DYSARTHRIA (Dysarthria) and LETHARGY (Lethargy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The patient's past medical history included Back surgery (History of multiple back surgeries including a rod placement.). On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), DYSARTHRIA (Dysarthria) (seriousness criterion death) and LETHARGY (Lethargy) (seriousness criterion death). The patient died on 27-May-2021. The cause of death was not reported. An autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not reported. On 27 May 2021, autopsy was performed. As per the spouse, the autopsy results were pending. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.Very limited information regarding the events have been provided at this time.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.Very limited information regarding the events have been provided at this time.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1429241
Sex: M
Age:
State: PA

Vax Date: 05/18/2021
Onset Date: 05/19/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Delirium; Syncope; Altered state of consciousness; Dehydration; Pyrexia; This case was received via VAERS (Reference number: 1358559) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DELIRIUM (Delirium), SYNCOPE (Syncope) and ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Hospitalized for 8-10 (No vent).) in February 2021. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced DELIRIUM (Delirium) (seriousness criterion medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) (seriousness criterion medically significant), DEHYDRATION (Dehydration) and PYREXIA (Pyrexia). At the time of the report, DELIRIUM (Delirium), SYNCOPE (Syncope), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness), DEHYDRATION (Dehydration) and PYREXIA (Pyrexia) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was treated with IV fluid and condition improved after that. Physician did not recommend dose 2. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1429242
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Deep vein thrombosis; Pulmonary embolism; This case was received via VAERS (Reference number: 1358680) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Parkinson's disease and Latex allergy. Concomitant products included CARBIDOPA, LEVODOPA (CARBIDOPA LEVODOPA), TAMSULOSIN, DROXIDOPA (NORTHERA), MELATONIN, CYANOCOBALAMIN (B-12), FINASTERIDE, POTASSIUM, CITALOPRAM and ROSUVASTATIN for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion medically significant) and PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication information was not provided. Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.

Other Meds: CARBIDOPA LEVODOPA; TAMSULOSIN; NORTHERA; MELATONIN; B-12; FINASTERIDE; POTASSIUM; CITALOPRAM; ROSUVASTATIN

Current Illness: Latex allergy; Parkinson's disease

ID: 1429243
Sex: F
Age:
State:

Vax Date: 04/06/2021
Onset Date: 04/18/2021
Rec V Date: 06/26/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Muscular weakness; Swelling; Tenderness; This case was received via VAERS (Reference number: 1358802) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MUSCULAR WEAKNESS (Muscular weakness), SWELLING (Swelling) and TENDERNESS (Tenderness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Muscular weakness) (seriousness criterion hospitalization), SWELLING (Swelling) (seriousness criterion hospitalization) and TENDERNESS (Tenderness) (seriousness criterion hospitalization). At the time of the report, MUSCULAR WEAKNESS (Muscular weakness), SWELLING (Swelling) and TENDERNESS (Tenderness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug information was provided. No treatment information was provided. Limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.

Other Meds:

Current Illness:

ID: 1429244
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: showed mild irritation / and reflux; stomach pain; stomach pain and burning; chills; sweating; dry heaves; nausea; a sensation that she had to urinate all the time; inability to eat or drink; This case was reported by a consumer via call center representative and described the occurrence of gastric irritation in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis, acetylsalicylic acid (Aspirin) for product used for unknown indication and naproxen for product used for unknown indication. The patient's past medical history included esophageal disorder (unknown problem with esophagus and underwent a stomach wrap procedure several years ago.). Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2021131455). On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular), the 1st dose of COVID-19 VACCINE PFIZER, Aspirin at an unknown dose and frequency and naproxen at an unknown dose and frequency. On an unknown date, less than a week after receiving Shingrix and an unknown time after starting Aspirin, the patient experienced gastric irritation, stomach pain, stomach burning sensation of, chills, sweating, dry heaves, nausea, urinary tract disorder and unable to eat. The action taken with Aspirin was unknown. The action taken with naproxen was unknown. On an unknown date, the outcome of the gastric irritation, stomach burning sensation of and unable to eat were unknown and the outcome of the stomach pain, chills, sweating, dry heaves, nausea and urinary tract disorder were recovered/resolved. It was unknown if the reporter considered the gastric irritation, stomach pain, stomach burning sensation of, chills, sweating, dry heaves, nausea, urinary tract disorder and unable to eat to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient volunteers that she has an unknown problem with her esophagus and underwent a stomach wrap procedure several years ago. The patient received 2nd dose of Shingrix on left arm. One or two days after receiving 2nd dose of Shingrix, the patient experienced stomach pain and burning, chills, sweating, nausea, dry heaves and inability to eat or drink. The patient also experienced a sensation that she had to urinate all the time. The patient experienced a similar reaction following the first Pfizer COVID-19 vaccine (date of administration unknown). On 2nd June 2021, the patient underwent an endoscopy that showed mild irritation that may be related to use of Aspirin, Naproxen, NSAIDs, or alcohol and reflux. It was unknown if the reporter considered the gastric irritation, stomach pain, stomach burning sensation of, chills, sweating, dry heaves, nausea, urinary tract disorder and unable to eat to be related to Covid-19 vaccine Pfizer. The reporter considered the gastric irritation, stomach pain, stomach burning sensation of, chills, sweating, dry heaves, nausea, urinary tract disorder and unable to eat to be related to Naproxen and NSAIDs or alcohol and reflux. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021131455:Same reporter

Other Meds:

Current Illness:

ID: 1429246
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: Suspected vaccination failure; I've got shingles after the 2 dose vaccination.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional details were provided as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient reported that he/she received 2nd dose of Shingrix and experienced shingles. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting. No other information was provided.

Other Meds:

Current Illness:

ID: 1429249
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: temp excursion; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Herpes zoster (Shingrix) for prophylaxis and pneumococcal 13 valent conjugate vaccine (Prevenar13) for prophylaxis. On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Shingrix and Prevenar13 at an unknown dose and frequency. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. 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 age at vaccination was not reported. Health care professional reported that the Shingrix and Bexsero were stored other than recommended temperature, which led to incorrect storage of drug. Also temperature excursion was reported for Prevenar13. Over the phone call there was no mention that the medication was given to any patients after the temperature excursion. No other information was provided. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1429250
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Suspected vaccination failure; I got my shot. I year later I had a mild case.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the Shingles vaccine and 1 year later patient experienced shingles. The patient stated that it was mild case and patient had all the systems described above. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1429251
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: had the shot and got shingles, but was very mild; got shingles, but was very mild; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (Family History) ( to mother ) and pain (Family History) ( to mother ). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient's mother had shingles twice and worst pain ever. The patient received Shingles vaccine and experienced shingles, but was very mild. The reporter stated that get the shots. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1429252
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: Got it again AFTER the vax / Got the shot, still get it; Got it. Got the shot, still get it; Hurts; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got shingles again after vaccination and hurts. This case was considered as suspected vaccination failure, since completeion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1429253
Sex: U
Age: 56
State: PA

Vax Date: 04/19/2021
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Enlargement of lymph nodes on both sides / in his chest also; Lymph nodes turned fire red; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 56-year-old patient who received Herpes zoster (Shingrix) (batch number 59LK9, expiry date 18th December 2022) for prophylaxis. On 19th April 2021, the patient received the 2nd dose of Shingrix (intramuscular). In April 2021, less than a week after receiving Shingrix, the patient experienced enlargement of lymph nodes and localized erythema. On an unknown date, the outcome of the enlargement of lymph nodes and localized erythema were recovered/resolved. It was unknown if the reporter considered the enlargement of lymph nodes and localized erythema to be related to Shingrix. Additional details were provided as follows: The patient received 2nd dose of Shingrix in left arm intramuscularly and approximately seven days after experienced an enlargement of lymph nodes on both sides and lymph nodes turned fire red. Also the patient experienced swollen lymph node in his chest. The reaction got subsided after about a week. The reporter consented permission to follow up with health care professional.

Other Meds:

Current Illness:

ID: 1429254
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: felt like his lungs were burning; This case was reported by a physician via sales rep and described the occurrence of lung irritation in a 54-year-old male 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 lung irritation. On an unknown date, the outcome of the lung irritation was unknown. It was unknown if the reporter considered the lung irritation to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and he felt like his lungs was burning. No other information was reported.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR136715:Same reporter

Other Meds:

Current Illness:

ID: 1429255
Sex: U
Age:
State:

Vax Date: 06/21/2021
Onset Date: 06/01/2021
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Feeling tired; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 21st June 2021, the patient received the 1st dose of Shingrix. In June 2021, less than a week after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to Shingrix. Additional details were provided as follows: The patient reported the case for himself/herself. The age at vaccination was not reported. On the day before reporting date, the patient had received first dose of Shingrix and was feeling tired. The patient inquired that was this normal. No other information was reported.

Other Meds:

Current Illness:

ID: 1429256
Sex: U
Age:
State: OK

Vax Date:
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Gave the diluent for Shingrix rather than the mixed dose; Gave the diluent for Shingrix rather than the mixed dose; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned that, someone in his/her office gave the diluent for Shingrix rather than the mixed dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter mentioned that, the patient had to return to the office to get the full dose of Shingrix. No other information was reported.

Other Meds:

Current Illness:

ID: 1429257
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: shinghles is i got that from shinghles shots; shinghles is i got that; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. The reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, got shingles shots and experienced shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1429258
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: suspected vaccination failure; had the shingles and after I got the shot they came back with a vengeance; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had the shingles and after he/she got the shot, shingles came back with a vengeance This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided

Other Meds:

Current Illness:

ID: 1429259
Sex: M
Age: 74
State: FL

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: received the first dose of Shingrix on 2018 / have not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-years-old male patient who received Herpes zoster (Shingrix)(batch number 3PD3E, Expiry date 8th October 2022) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2018). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix on 2018 and came back on the day of reporting to receive the second one. Till the time of reporting, the patient did not receive 2nd dose, which led to in incomplete course of vaccination. This case has been linked with case US2020254931, reported by same reporter. The reporter consented to follow up. Follow up information received from pharmacist on 23rd June 2021: On 23rd December 2020, the patient received 2nd dose of Shingrix (0.5 ml) intramuscularly, which led to lengthening of vaccination schedule. Te batch number and expiry date was updated. The VAERS details were updated.; Sender's Comments: US-GLAXOSMITHKLINE-US2020254931:same reporter

Other Meds:

Current Illness:

ID: 1429260
Sex: U
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: reconstitution was mix in the same syringe with the Pfizer covid vaccines; reconstitution was mix in the same syringe with the Pfizer covid vaccines; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID 19 VACCINE PFIZER for prophylaxis. On an unknown date, the patient received Shingrix and COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and underdose. On an unknown date, the outcome of the inappropriate reconstitution technique and underdose were unknown. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that Shingrix final reconstitution was mix in the same syringe with the Pfizer covid vaccines, which led to inappropriate reconstitution technique. It was stated that the pharmacist realized that, they leak 0.3ml of the vaccine and administrated to the patient, which led to underdose. No adverse event was reported. The reporter consented to follow up. No vaccination date provided.

Other Meds:

Current Illness:

ID: 1429262
Sex: M
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Patient immunocompromised had Shingrix first dose 3 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received 3 years ago). Concurrent medical conditions included immunocompromised. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the patient received first dose of Shingrix and did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The patient was immunocompromised and the pharmacist inquired if she needs to restart the series. The patient was taking steroids medication. The reporter consented to follow up by fax.

Other Meds:

Current Illness: Immunocompromised

ID: 1429265
Sex: F
Age:
State: TX

Vax Date: 04/19/2021
Onset Date:
Rec V Date: 06/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Patient takes allergy shots 3 times a week and she wants to received Shingrix second dose./ first dose was on April 19th 2021; This case was reported by a pharmacist via call center representative and described the occurrence of allergy in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On 19th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced allergy. The patient was treated with allergens (nos) (Allergy Shots). On an unknown date, the outcome of the allergy was not recovered/not resolved. It was unknown if the reporter considered the allergy to be related to Shingrix. Additional details were provided as follows: The age of the patient was over 50 years old. The age at vaccination was not reported. Pharmacist was looking for information about Shinrgix second dose for the patient who took allergy shots 3 times a week and she wanted to receive Shingrix second dose. No information was provided about allergy product type or brand name. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm