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: 1025653
Sex: F
Age: 28
State: MN

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
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: tropical fruits Cipro seasonal allergies

Symptom List: Dysphagia, Epiglottitis

Symptoms: Within minutes of pt receiving injection, pt verbalized feeling butterflies in the stomach, lightheadedness and tightening of the throat. Epi-pen and Benadryl 50mg were given 5 minutes after symptoms were reported. Pt was transported via EMS to ED

Other Meds: Vitamin D Lexapro 10mg Famotidine 20mg Mirena Lorazepam 0.5mg

Current Illness: none

ID: 1025654
Sex: F
Age: 82
State: FL

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 02/12/2021
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: None

Symptom List: Anxiety, Dyspnoea

Symptoms: Hard, itchy, red circle around injection site about the size of a silver dollar since the morning following shot and continues still today

Other Meds: Advil

Current Illness: None

ID: 1025657
Sex: F
Age: 29
State: IN

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/12/2021
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 Right Arm Pain Diagnosed as Nerve Damage due to Injection Sharp Pain Limb Weakness Burning Sensation Throbbing Aching Muscle Stiffness

Other Meds: Depression (SER), Anxiety (BUS), and Mood Stab. (LAM)

Current Illness: None

ID: 1025658
Sex: M
Age: 41
State: WI

Vax Date: 01/13/2021
Onset Date: 01/15/2021
Rec V Date: 02/12/2021
Hospital:

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

Lab Data:

Allergies: none

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Moderate constant Left ankle joint pain. Worsens while walking and in certain ankle positions. Symptoms started 48 hours after injection and had not improved.

Other Meds: none

Current Illness: none

ID: 1025659
Sex: M
Age: 56
State: IN

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/12/2021
Hospital:

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

Lab Data:

Allergies: MSG

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

Symptoms: Started out with both shots 1 & 2 with lite headedness and nausea. Sore arm on both shots for 48 hours. 2nd shot started with a tingling burning sensation in legs up to stomach for the first 12 hours. 2nd shot had lack of energy and chills after 24 hours.

Other Meds:

Current Illness:

ID: 1025661
Sex: F
Age: 74
State: MS

Vax Date: 02/03/2021
Onset Date: 02/10/2021
Rec V Date: 02/12/2021
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: Amoxicillin, any form of Tetracycline,

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

Symptoms: One week after shot my arm has a big circular red warm spot. after reading it is evidently Covid arm. Can only receive injections on right due to cancer lymph nodes in left arm.

Other Meds: ArmorThyroid, Flecainide acetate, B12 injections weekly, potassium, Folbic, multi vitamin, super b?s, calcium, magnesium, vitamin D, daily aspirin.

Current Illness: Thalassemia

ID: 1025662
Sex: F
Age: 59
State: WI

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 02/12/2021
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: Pyrexia, White blood cell count decreased

Symptoms: CHILLS, BODY/JOINT ACHES, HEADACHE

Other Meds:

Current Illness:

ID: 1025664
Sex: F
Age: 45
State: CA

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
Hospital:

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

Lab Data:

Allergies: Acetaminophen with codeine, Lorazepam, Ziprasidone Mesylate, Azithromycin, Carbamazepine, Ketorolac, Risperdal, Chlorpromazine Hcl , APAP, Benadryl, Hydrocodone, PCN

Symptom List: Pharyngeal swelling

Symptoms: Patient received 3rd dose of vaccine due to documentation error. 1st dose given on 1/13/21, 2nd dose on 2/8/2021, and 3rd dose on 2/11/2021. No adverse effect noted at this time.

Other Meds: Atorvastatin tablet, Atropine Sulfate drops, Diltiazem HCL tablet, Docusate Sodium capsule, Furosemide tablet, Haloperidol tablet, Insulin Lispro, Ipratropium/Albuterol Sulfate, Levothyroxine Sodium tablet, Lithium Carbonate capsule, Mometa

Current Illness: Hospice, Comfort level care, End Stage Lung Disease

ID: 1025665
Sex: F
Age: 68
State: GA

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
Hospital:

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

Lab Data:

Allergies: Unknown

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: "My eyes feel strange" Calm and cooperative. 12:25pm. Lungs clear, symptoms absent. Patients reported eye strain has improved. Raspy voice that patient attributes to as Asthma symptoms. Pt. declined EMS services and was observed for 50 minutes prior to departure. Oral Diphenhydramine 1 ml. PO, 12.5mg/5ml given at 12:25pm. Disposition: Patient status stable, declined need for EMS, also no immediate need observed. Observed for 45min.

Other Meds: Unknown

Current Illness: Unknown

ID: 1025666
Sex: M
Age: 1
State: CT

Vax Date: 05/07/2004
Onset Date:
Rec V Date: 02/12/2021
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:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Fever, Rash, loud cry for hours. Glassy eyes and dazed. Sleeplessness. Doctor said this is normal. How can such serious side effects be normal??

Other Meds:

Current Illness:

ID: 1025667
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 02/12/2021
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: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: None

Other Meds:

Current Illness:

ID: 1025668
Sex: F
Age: 51
State: ID

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/12/2021
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: none

Symptom List: Rash, Urticaria

Symptoms: Chest tightness radiates to upper Back tender to palp. left of sternum

Other Meds: none

Current Illness: none

ID: 1025673
Sex: F
Age: 53
State: NY

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/12/2021
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: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: PATIENT REPORTED SYNCOPE TO CHILDHOOD IMM., BUT NOT RECENT FLU SHOT. PATIENT WAS OBSERVED TO BE FINE FOR 20 MINUTES POST-VACC. SHE WAS ON HER WAY HOME AT 50 MINS. POST-VAC WHEN SHE BECAME UNCONSCIOUS, UNRESPONSIVE, & PRESENTED W/HIVES. SHE WAS TREATED AT EMERG. DEPT. AFTER 90 MIN, SHE IS CONSCIOUS & IMPROVING.

Other Meds:

Current Illness:

ID: 1025674
Sex: M
Age: 17
State: MN

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 02/12/2021
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: Patient is 17 years old and received 1 Dose of Moderna COVID-19 vaccine

Other Meds: ___________________

Current Illness: _____________________________

ID: 1025675
Sex: F
Age: 61
State: NY

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 02/12/2021
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Patient states had 2nd vaccine on 2/9/21 - reports injection site red, warm, slightly swollen body aches, headache on/off, fatigue and states lymph nodes under L armpit was swollen.

Other Meds:

Current Illness: none

ID: 1025676
Sex: F
Age: 43
State: GA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/12/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: At 5:22 pm patient reported to nurse that she was feeling "sleepy", lightheaded, and "cold" after she recieved her first dose of Pfizer BioNTech COVID-19 vaccine EUA. Viitals taken every 5 minutes. Patient then reports that she is feeling heavyness in her body, nausea, and started to feel "warm coming from the inside." 5: 45pm Administered 50 mg of Benadryl by mouth. Patient initially declined meds. Monitored patient for one hour. Patient was alert and oriented and left clinic with her friend.

Other Meds: Amlodipine

Current Illness:

ID: 1025689
Sex: M
Age: 70
State: DE

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/12/2021
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:

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

Symptoms: Client sitting in his wheelchair after 1st COVID 19 vaccination, arrived in observation room 1:57pm. Client with complaint of headache. He reported rating as 5 and said headache usually followed by syncope. He then lost consciousness and aroused by a nurse present in the room. He was maintained in his wheelchair. He was breathing on his own and has a pulse. He noted headache still present, again lost consciousness and was aroused by a nurse in the room. EMS arrived and assisted client to the floor. He aroused. EMS assessed the client, and brought paramedic assessed EKG. Client was transferred to stretcher, awake responsive. Client

Other Meds:

Current Illness:

ID: 1025702
Sex: F
Age: 61
State: NC

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/12/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Pain& Swelling @ injection site

Other Meds: No regular medications

Current Illness: None

ID: 1025718
Sex: U
Age:
State: DE

Vax Date: 01/23/2021
Onset Date: 01/31/2021
Rec V Date: 02/12/2021
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: On January 31, 2021 I started to experience the following : Sweating. Headache. Rash on both lower legs. Night time lower leg cramping. On February 3, the rash was spreading upward on the legs. I saw the Emergency Room Doctor at the Medical Clinic. Prior to this visit the Sweating and Headaches had begun to subside. The Doctor prescribed Prednisone for the rash. I tried to email this to vaers,hhs.gov. but my email provider rejected your email address and would not send this, so this is why I am mailing this to you. I have tried to email you this thru 3 different email platforms and all reject this address you say to contact you at. My second concern is: at the time of the first dose I was told that I was automatically scheduled for the second dose and that I would be contacted sometime in between the 28 day waiting period. My wife has read that I will have to re-register and be put on a waiting list just like the first dose. Please advise as to which is correct. Lastly on behalf of myself and my family I would like to give you all a heartfelt thank you for your contributions to the COVID effort. You and your CDC family are my HEROES. God Bless you all and stay safe.

Other Meds:

Current Illness:

ID: 1025838
Sex: M
Age: 58
State: KS

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 02/12/2021
Hospital:

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

Lab Data:

Allergies: unknown

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

Symptoms: Patient he became short of breath, body aches, headache this am

Other Meds: None

Current Illness: No

ID: 1025912
Sex: F
Age: 39
State: GA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/12/2021
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:

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

Symptoms: Patient received first dose of Pfizer BioNTech Covid 19 vaccine EUA. Patient reported to nurse that she felt lightheaded, nausea, and dizzy. Vitals taken every 5 minutes. Monitored patient for 1 hour. Patient left clinic after observation period.

Other Meds: Levothyroxine, tropsium chloride, lexapro, murobectrate, vitam

Current Illness:

ID: 1025930
Sex: M
Age: 5
State: IN

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 02/12/2021
Hospital:

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

Lab Data:

Allergies: NKDA

Symptom List: Unevaluable event

Symptoms: Crying, not wanting to walk Left thigh, red, warm to touch 5x6 inches long

Other Meds: 0

Current Illness: 0

ID: 1026002
Sex: F
Age:
State: IL

Vax Date: 07/21/2020
Onset Date:
Rec V Date: 02/12/2021
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: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Sore arm; Red / arm; This case was reported by a pharmacist and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date 29th October 2021) and (batch number 9227H, expiry date 28th February 2022) for prophylaxis. On 21st July 2020, the patient received Shingrix (intramuscular). On an unknown date, the 1st dose was an unknown dose. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the erythema of extremities was unknown. It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced red arm and sore arm. The reaction lasted for 3 months. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1026003
Sex: U
Age:
State: WA

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

Symptom List: Injection site pain, Pain

Symptoms: due to COVID they had delayed patient's 2nd doses of Shingrix; This case was reported by a pharmacist and described the occurrence of social problem in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix due to covid-19 The reporter did not consent to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021007458:SAME REPORTER

Other Meds:

Current Illness:

ID: 1026004
Sex: F
Age: 54
State: PA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/12/2021
Hospital: Y

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: Fever; Severe vomiting; Chills; Headache; Arm was sore; Fatigue; A spontaneous report was received from a medical assistant, concerning herself, a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed sore arm, fever, severe vomiting, headache, chills and fatigue. The patient's medical history included COVID-19 at the end of Oct-2020. Concomitant product use was not provided by the reporter. On 25-Jan-2021 at 07:50 AM, the patient received their first of two planned doses of mRNA-1273 (Lot # 012L20A) in the left arm for prophylaxis of COVID-19 infection. On 25-Jan-2021, late in the afternoon, after the first dose of vaccine, the patient got headache and her arm was sore. The same evening, she experienced chills, fever of 100.7 Fahrenheit (was high in the hospital) and severe vomiting. Hence, she was hospitalized for two days from 25-Jan-2021 to 27 Jan 2021 and was treated with acetaminophen, fluids, ondansetron and potassium. On 28-Jan -2021, patient still had a little bit of headache and fatigued. Action taken with mRNA-1273 in response to the events were not provided. The outcome of the events, headache and fatigue were considered not resolved at the of this report. The outcome of the events, sore arm, fever, severe vomiting and chills were resolved on 27-Jan-2021. The reporter did not provide an assessment of the events, headache, sore arm, chills, fever, severe vomiting and fatigue.; Reporter'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. Further information will be requested.

Other Meds:

Current Illness:

ID: 1026005
Sex: M
Age: 59
State: MD

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 02/12/2021
Hospital: Y

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: Facial paralysis; Bradycardia; Weakness on his right arm and right leg; Difficulty talking; Can?t close eyes; Right leg is numb; Severe headache; Some eye issues, sees blurry; A spontaneous report was received from a paramedic, who was also a 59-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia. The patient's medical history was not provided. Concomitant product use reported included, insulin, statin, losartan, and metformin. On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 07 Jan 2021, after receiving the vaccine, the patient experienced eye issues and would see blurry and had a severe headache. On 23 Jan 2021, the patient was hospitalized for 36 hours because he thought he was having a stroke. Test results showed the patient did not have a stroke. The patient did, however, experience facial paralysis, couldn't close his eyes, bradycardia, weakness in the right arm and right leg, difficulty talking, and his right leg felt numb. Treatment for the events included prednisone, valaciclovir, and unspecified calming medication while at the hospital. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right am and right leg, right leg is numb, can't close eyes, and bradycardia, was considered not resolved.; Reporter's Comments: This case concerns a 59 year old male was hospitalized with a serious events of some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia after first dose to mRNA-1273 in the left arm. Comcomitant medications include insulin, metformin, atorvastatin, losartan. Hospital work-up showed ne did not have a stroke, and he was treated with prednisone, valaciclovir and a "calming medicine". b) Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. + b) Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: INSULIN; METFORMIN; STATIN [ATORVASTATIN CALCIUM]; LOSARTAN

Current Illness:

ID: 1026006
Sex: M
Age: 68
State: TX

Vax Date: 01/09/2021
Onset Date:
Rec V Date: 02/12/2021
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: Cellulitis; A spontaneous report was received from a consumer concerning a 68-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis. The patient's medical history was not provided. No relevant concomitant medications were reported. On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced cellulitis from the vaccine. No further details were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event cellulitis was unknown.; Reporter's Comments: This case concerns a 68 year-old, male patient, who experienced event of cellulitis. The event occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. Based on the current available limited information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.

Other Meds:

Current Illness:

ID: 1026007
Sex: M
Age:
State:

Vax Date: 01/17/2021
Onset Date:
Rec V Date: 02/12/2021
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: Had a syncopal event; A spontaneous report was received from a health care provider who is also the patient, a male of unreported age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a syncopal episode. The patient's medical history was not provided. No relevant concomitant medications were reported. On 17 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 17 Jan 2021, after receiving the vaccine, the patient had a syncopal episode. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the event, syncopal episode, was considered unknown.; Reporter's Comments: This case concerns a male patient of unknown age. The medical history is not provided. The patient experienced a medically significant and unexpected event of Syncope occurred one day (same day) after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 1026008
Sex: F
Age: 47
State: CT

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 02/12/2021
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: New sensitives to face cleansers; Anaphylactic shock; A spontaneous report was received from a consumer, concerning herself, a 47-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylactic shock and "newsensitives to face cleansers". The patient's medical history was not provided. Concomitant product use included face cleansers. On 08-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08-Jan-2021, approximately five minutes after receiving the vaccine, the patient experienced anaphylactic shock as evidenced by throat warm and tingling, arms was bright red and warm to touch, trouble breathing, felt like choking, and nausea. Hence, she was treated with "epinephrine quite a few times along with steroids and ranitidine". On 09-Jan-2021, the patient went to the hospital two more times for "breathing issues", however she was not admitted. On 10-Jan-2021, in the morning, the patient had "passed out" and was given another epinephrine injection as she went into anaphylaxis shock again. On-29 Jan-2021, the patient also reported her arm, legs and chest are "bright red" and "burns". The patient also experienced new sensitivities to the face cleansers she has used for over 12 years. Action taken with mRNA-1273 in response to the events were unknown. The events, anaphylactic shock, was considered newsensitives to face cleanser" were considered not resolved.; Reporter's Comments: This case concerns a 47-year-old female patient, who experienced serious event of anaphylactic shock and non-serious event of sensitive skin. The event of anaphylactic shock occurred on the same day and re-occurred again approximately 2 days after first dose of mRNA-1273, lot # unknown. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1026009
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/12/2021
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: Nausea

Symptoms: nosebleeds got worse where she was filling up towels with blood; sore throat; cough; A solicited report was received from a 61-year-old female patient, who who received Moderna's COVID-19 vaccine (mRNA-1273) developed significant nosebleeds where she was filling up towels full of blood, sore throat and coughing during and after her Tyvaso session. The patient's medical history included Secondary Pulmonary Arterial Hypertension. Products known to have been used by the patient within two weeks prior to the event was Sildenafil Citrate. Additional suspected products included Treprostinil Sodium, Plavix, and Aspirin. On an unknown date, the patient received one of two planned doses of mRNA-1273 (Lot: unknown) for prophylaxis of COVID-19 infection. On an unknown date, after receiving the vaccine, the patient experienced worsening of nosebleeds filling up towels full of blood, sore throat and coughing. Treatment for the events, nosebleed, sore throat and cough was not reported. Action taken with second dose of mRNA-1273 in response to the events was not reported. The event, worsening of nosebleeds filling up towels full of blood was considered not resolved and outcome of the events, sore throat and cough was not reported.; Reporter's Comments: This case concerns a 61 year old female patient with medical history of Secondary Pulmonary Arterial Hypertension, who experienced a serious unexpected event of Epistaxis and NS events of oropharyngeal pain and cough. The events occurred on an unknown date after first dose of the study medication administration. A causal relationship cannot be excluded. Noting the subject's underlying medical condition and concomitant medication could remain a confounder.

Other Meds: TREPROSTINIL SODIUM; PLAVIX; ASPIRIN [ACETYLSALICYLIC ACID]; SILDENAFIL CITRATE

Current Illness:

ID: 1026011
Sex: M
Age: 60
State: CA

Vax Date: 12/31/2020
Onset Date: 01/14/2021
Rec V Date: 02/12/2021
Hospital: Y

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: Bled Out 40% of blood from lower GI; Bloody diarrhea; Lightheaded; Sweating; Malaise; Fever; tachycardia; A spontaneous report was received from a pharmacist who is a 60-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal tract, tachycardia, sweating, lightheaded, malaise and fever. The patient's medical history was not provided. No concomitant product use was reported. On 31 Dec2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient reported 14 days after receiving the vaccine, he developed tachycardia with a heart rate of 120 and did not feel right. The patient stated was sweating and thought he was having a heart attack. On an unknown date, the patient saw his doctor who performed an electrocardiogram (EKG) ? results not provided. The patient also stated he had blood pressure issues but did not provide any further information. On an unknown date, the patient reported he was hospitalized with bloody diarrhea. He stated he bled out 40 percent of blood from his lower gastrointestinal track. He reported he had malaise and fever as well. The patient reported he had to have surgery to stop the bleeding. Treatment for the event included surgery. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal track, tachycardia, sweating, lightheaded, malaise and fever, were considered unknown.; Reporter's Comments: This case concerns a 60 year old male patient, who experienced a serious event of gastrointestinal haemorrhage, associated with other non-serious events after receiving first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1026012
Sex: F
Age: 21
State: CA

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 02/12/2021
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: Fainted; A spontaneous report was received from a 21-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainted (syncope). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received her first of two planned doses of mRNA-1273 (lot/batch number unknown) in the left arm in approximately January 2021 for prophylaxis of COVID-19 infection. In approximately January 2021 (a few days later after vaccination), the patient experienced fainted. Treatment information was not provided. The action taken with mRNA-in response to the event was unknown. The outcome of the event fainted was unknown.; Reporter's Comments: This case concerns a 21-year-old, female, patient, who experienced a serious unexpected event of syncope. The event occurred at unknown date, reported as few days later, after first dose of mRNA-1273, lot # unknown. Treatment information is not provided. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1026013
Sex: F
Age:
State:

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/12/2021
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: If it was administered wrong; injection site leaking clear, watery liquid; A spontaneous report (United States) was received from a consumer concerning a female patient, of unknown age, who was administered Moderna's COVID-19 vaccine and it was leaked out and administered wrong. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28-Jan-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration in the arm for prophylaxis of COVID-19 infection. On 28-Jan-2021 at 3:30 pm the patient had her first dose of the Moderna vaccine. She felt the needle go into her arm; however, when the person removed the needle, she said the patient was bleeding. The patient immediately put her hand over the area on her shoulder and then looked at it. Per the patient, her hand was wet, not a few drops, but her whole palm was wet with clear watery looking liquid, there was no blood. The patient tried to call the pharmacist same day at 6:30pm but the pharmacy was closed. On 30-Jan -2021 patient got a Covid nasal swab done for work and came negative. Patient asked doctor at the clinic if she should have had that much of leakage that filled her hand and doctor replied no. The patient spoke with the pharmacist on 31-Jan-2021 regarding this issue. Patient was concerned if she should get another vaccine or if okay to get 2nd dose on 25-Feb-2021. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, vaccine leaked out and administered wrong, was considered resolved on 28-Jan-2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Lot number: unknown) with no associated AEs.

Other Meds:

Current Illness:

ID: 1026014
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 02/12/2021
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: Tremor

Symptoms: Hypertensive crisis; Flushing in face, it became red, and swollen; Flushing in face, it became red, and swollen; Flushing in face, it became red, and swollen; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a hypertensive crisis, flushing in face, it became red and swollen. The patient's medical history was not provided. No concomitant product use was reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On the unknown date, approximately half an hour after receiving the Moderna COVID-19 vaccine, the patient had facial flushing, it was red and swollen. The patient was taken to the emergency room for hypertensive crisis. Her blood pressure was 250/150 mmHg. She was in the emergency room for four hours until her blood pressure came down. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, hypertensive crisis, flushing in face, it became red and swollen, was unknown.; Reporter's Comments: This spontaneous report (which concerns a female patient who experienced hypertensive crisis and flushing in face and it became red and swollen. The events occurred half hour after the administration of mRNA-1273 vaccine (Lot number: 041L20A, expiration date: unknown). Based on the information provided which shows a temporal association, a causal association between the reported events and the administration of mRNA-1273 vaccine cannot be excluded.

Other Meds:

Current Illness:

ID: 1026015
Sex: F
Age:
State: OR

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 02/12/2021
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: Had headache that was similar to migraine; Feeling foggy; Diarrhea; Episode of nausea; Extreme fatigue; Muscle ache; Rash inside armpit; Anaphylactic reaction; Tingling in arm; Itching; Rapid heartbeat; Started feeling hot; Petechia eye; Tiny broken vessel on both ankles; A spontaneous report was received from a consumer who was also a female patient over the age of 55 but under 60 years of age who received Moderna's Covid-19 vaccine (mRNA-1273) and who experienced anaphylactic reaction, tingling in arm, itching, rapid heartbeat, started feeling hot, rash inside of armpit, petechia eye, tiny broken vessel on both ankles, headache similar to migraine, nausea, extreme fatigue, feeling foggy, muscle ache, and diarrhea. The patient's medical history was significant for anaphylactic reaction to cephalosporin antibiotics. No other medical history was provided by the patient. Concomitant product use was not provided by the patient. On 24 Jan 2021, prior to the onset of symptoms, at the County Health Department, the patient received the first of two planned doses of mRNA-1273 intramuscularly into her upper left arm. Because of her past medical history, the patient was observed for 30 minutes at the facility for any adverse reaction. When the observation period ended the patient went to her car and sometime later began having a delayed reaction. She reported experiencing the following symptoms: "tingling in arm", "itching", "rapid heartbeat", "started feeling hot", "rash inside of armpit", "petechia eye", and "tiny broken vessel on both ankles". The patient went to an Urgent Care Clinic, where she was treated with an injection of diphenhydramine and an oral prednisone. She was given a prescription for diphenhydramine, and prednisone. The patient was informed that she had an anaphylactic reaction to the vaccine. On 25 Jan 2021, the patient stated she had a "headache similar to a migraine", "episode of nausea", "extreme fatigue", "feeling foggy", "muscle ache", and "diarrhea". She was being followed up by an allergist. Action taken with mRBA-1273 in response to the events was not provided. The outcome of the events, anaphylactic reaction, tingling in arm, itching, rapid heartbeat, started feeling hot, rash inside of armpit, petechia eye, and tiny broken vessel on both ankles, and headache similar to a migraine, episode of nausea, extreme fatigue, feeling foggy, muscle ache, and diarrhea, was considered unknown.; Reporter's Comments: This case concerns a 55-60 year old female who had a serious unexpected anaphylactic reaction, with NS unexpected paranesthesia, pruritus, HR increased, feeling hot, rash, petechia, telangiectasia, migraine, feeling abnormal, diarrhea, and NS expected nausea, fatigue, myalgia. Event onset 1 day after first dose mRNA-1273. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1026016
Sex: F
Age: 45
State: KY

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 02/12/2021
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: possible case of cellulitis; arm feeling heavy; hot to touch; swelling; rash developed that was 3-4 inches diagonal that appear to spread to upper arm in couple of days; redness; shower with itchiness at the site of injection that was round in shape; thrust from antibiotics bactrim and Amo/Clav; on and off adverse event with feeling left ear on fire; A spontaneous report was received from a healthcare facility staff member concerning a 45-years-old, female patient who experienced possible case of cellulitis, on and off adverse event with feeling left ear on fire, hot to touch, redness, swelling, arm feeling heavy, thrust from antibiotics, rash developed that was 3-4 inches diagonal that appear to spread to upper arm in couple of days and shower with itchiness at the site of injection that was round in shape. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 06-Jan-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 012L20A] intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. On 06 Jan 2021, the patient started experiencing on and off adverse event with "feeling left ear on fire". Eight days later the patient noticed itchiness at the site of the injection that was round in shape. Rash developed that was 3-4 inches diagonal that appeared to spread to upper arm. The injection site was hot to touch, redness, swelling and arm feeling heavy. On 13 Jan 2021 or 14 Jan 2021, the patient was recommended Bactrim (sulfamethoxazole, trimethoprim), amox/Clav (amoxicillin, clavulanic acid) and clotrimazole lozenges because the primary care physician (PCP) was believing she possible has a case of cellulitis. The patient went to the emergency room (ER) on 17 Jan 2021, in which an ultrasound was performed and did not suspect any blood clot or cellulitis. Upon discharge, the patient experienced thrust from antibiotics. Treatment for the event included Bactrim (sulfamethoxazole, trimethoprim), amox/clav (amoxicillin, clavulanic acid), clotrimazole lozenges and Benadryl (diphenhydramine hydrochloride). Patient informed that the symptoms are on-going where the swelling and redness comes and goes. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events possible case of cellulitis, on and off adverse event with feeling left ear on fire, hot to touch, arm feeling heavy, thrust from antibiotics, rash developed that was 3-4 inches diagonal that appear to spread to upper arm in couple of days and shower with itchiness at the site of injection that was round in shape was considered as not recovered and for redness and swelling outcome is considered as unknown.; Reporter's Comments: This case concerns a 45 year old female subject with a serious unexpected cellulitis, with NS unexpected burning sensation, feeling hot, limb discomfort, thrush, and NS expected Vaccination site events of erythema, swelling, pruritus, and rash. Event onset same day as first dose mRNA-1273. US without blood clot or cellulitis. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1026018
Sex: F
Age:
State: NC

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/12/2021
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: Lightheadedness within 5 minutes; weakness of muscles; rapid heart rate; This is a spontaneous report from a contactable other HCP reporting for herself. A 28-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , intramuscular on 25Jan2021 09:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medicatons were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient experienced lightheadedness, weakness of muscles and rapid heart rate on 25Jan2021 09:15 with outcome of recovering. The patient was treated in Emergency Room with steroids and anxiety medications. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1026019
Sex: F
Age:
State: TX

Vax Date: 01/26/2021
Onset Date: 01/01/2021
Rec V Date: 02/12/2021
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: I got a strange vision/hallucination; rapid and hard heartbeat; shortness of breath; nausea; headache; had nightmares all night; stiff, sore arm; stiff, sore arm; my arm has a bumpy, red mild rash at and around injection site; my arm has a bumpy, red mild rash at and around injection site; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), via an unspecified route of administration on 26Jan2021 at 14:45 (at the age of 39 years) as a single dose in the right arm for COVID-19 vaccination. Medical history included fatty liver. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications were not reported. The patient reported that on 27Jan2021 at 12:30 AM, approximately ten hours after the vaccine, the patient experienced a rapid and hard heartbeat, shortness of breath, nausea and headache. These lasted for one and one half hours. As she lay down falling asleep she got a strange vision/hallucination (this had never happened to her before) of her eyes turning lightning blue and her body rising up in the bed. She stated that she does not take medications or drugs and does not have a history of mental illness. She could not shake the vision. She fell asleep and had nightmares all night and nightmares are rare for her. One day two she woke up fine just a stiff, sore arm. On day three her arm has a bumpy, red mild rash at and around injection site. The patient did not receive any treatment for the events. Lab data included a COVID SARS CoV-2 positive test on an unspecified date. The clinical outcomes of hallucination, heart rate increased, shortness of breath, nausea, headache, nightmares, pain in arm, limb stiffness and vaccination site rash were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1026020
Sex: M
Age:
State: FL

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 02/12/2021
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: looked like pancreatitis; developed increased LFTs; This is a spontaneous report from a contactable physician (patient). A 53-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, saoluion ), via an unspecified route of administration on the left arm on 07Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia and benign prostatic hyperplasia (BPH). The patient has no known drug allergy (NKDA) and no known food allergy (NKFA). Concomitant medications included duloxetine hydrochloride (CYMBALTA), acetylsalicylic acid (ASPIRIN 81), diphenhydramine hydrochloride (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]), multivitamins [vitamins NOS] (MULTIVITAMINS [VITAMINS NOS]). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number: eh9899, expiration date: unknown), at the age of 53 years old, on the left arm on 17Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed increased liver function tests (LFTs) that looked like pancreatitis on 08Jan2021 at 12:00. Treatment received for the adverse event include addition of PPI. The events resolved with sequel. Information on the lot/batch number has been requested.

Other Meds: CYMBALTA; ASPIRIN 81; BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

Date Died:

ID: 1026021
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 02/12/2021
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: a male patient received the pneumonia shot 12 days after the first dose of the vaccine; he had died; This is a spontaneous report from a contactable consumer or other non hcp. A 76 years old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID 19 immunisation and received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date 12 days after bnt162b2 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities. Information on lot and batch number has been requested. Follow-up: (08Feb2021): Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: a male patient received the pneumonia shot 12 days after the first dose of the vaccine; he had died

Other Meds:

Current Illness:

ID: 1026022
Sex: F
Age:
State:

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/12/2021
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: she felt so tired; her breathing was heavy and felt tight; This is a spontaneous report from a contactable nurse. A 67-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9262), at age 67 years, injection into the left upper arm/deltoid, first dose on 27Jan2021 14:00 at single dose, for COVID-19 vaccination. Ongoing medical history included diabetes diagnosed more than 10 years ago and high cholesterol diagnosed around 10 years ago, maybe longer. The patient's concomitant medications were unspecified maintenance medications because she is diabetic and has high cholesterol. She said that she has been taking these medications for a long time though already. Patient was a retired registered nurse that was calling about the COVID-19 vaccine and reported that she had the first dose injection on 27Jan2021 at 14:00 and 2 hours after she got home, she felt so tired that she did not feel like moving and her breathing was heavy and felt tight. Patient said that her breathing feeling heavy and tight did not last too long, maybe an hour then went away. Her tiredness, felt so tired lasted through the day and whole night and she was fine and completely recovered after waking up in the morning. For breathing feeling heavy and tight: She clarified that it lasted from like 14:00-17:00 yesterday 27Jan2021. Patient wanted to know with the symptoms she had is it contraindicated to get the second dose? She was reading the information about the injection and seemed like the symptoms are part of it. The outcome of the events was recovered, for felt so tired was on 28Jan2021 and for breathing was heavy and felt tight was on 27Jan2021. Case was reported as serious with other medically important condition as seriousness criteria. The reporter assessed the events she felt so tired and her breathing was heavy and felt tight as related to the suspect drug COVID-19 Vaccine. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness: Diabetes; High cholesterol

ID: 1026023
Sex: M
Age:
State: MO

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 02/12/2021
Hospital: Y

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: Was in the hospital for his heart condition; he had something around his chest area, some kind of pressure on his chest area; Chills; He ran a temperature of 100.4/running a temperature of 100.8; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9261), via an unspecified route of administration on the left arm on 27Jan2021, at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter (patient's wife) stated that both (patient and patient's wife) had the Vaccine shot on Wednesday, 27Jan2021. After that she was okay but he was not, he had something around his chest area, some kind of pressure on his chest area on Thursday (28Jan2021), he was in the hospital for his heart condition. Patient was done with stress test was good, had another test (unspecified) and he was okay. He had some temperature on Thursday while he was in hospital, next day on Friday (29Jan2021) he was relieved, then he was doing fine. He came home on 29Jan2021, and he started getting aspirin (given in hospital) and took cardiac medicine (unspecified). Everything was okay until few hours later, around 7 o'clock he started getting chills with running a temperature of 100.8 and then by 8 o'clock he ran a temperature of 100.4 (on 29Jan2021). Then call to nurse and the doctor, nurse said to give him the Extra Tylenol which was given at 9 o'clock and then patient's wife took his temperature again last at 11 o'clock, it was 99.55. Then this morning (30Jan2021) at 8 am it was 99.5 and patient had Tylenol and then also at 11 o'clock this morning it was 98.2, this afternoon at 2:45 it was back up to 99. At then at 3:53 it went up to 100.2, so at that point at 4 o'clock, given him Tylenol. He had some chills with it (Clarification unknown), chills were going back and forth. Seriousness of the events heart condition and chest pressure was reported as hospitalization. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1026024
Sex: F
Age:
State: MO

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/12/2021
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: passed out and almost broke her arm; started salivating really bad/it's lot of drool; Heart rate started pounding; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261, expiration date May2021), via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunisation. Medical history included: Allergy. Concomitant medication included drospirenone, ethinylestradiol (YASMIN) for Birth control, chlorphenamine maleate (PIRITON) for Allergy. The patient was perfectly fine up until about the 3 hours after the vaccine, she started salivating really bad, she was not throwing up or nauseas or anything, it's just that it's lot of drool, like she even had just go over sink as just salivating so much it was weird, and her heart rate started pounding and she passed out and almost broke her arm, so and then she kind of like blacked out and don't remember anything for rest of the evening. The events onset date was on 26Jan2021 08:30. No treatment was received. The outcome of events was recovered in Jan2021.

Other Meds: YASMIN; PIRITON

Current Illness:

ID: 1026025
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 01/04/2021
Rec V Date: 02/12/2021
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: cold extremities; fever; chills; fatigue; rheumatoid arthritis; This is a spontaneous report from a non-contactable physician. A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. Historical Vaccine included received first dose of BNT162B2 intramuscular at the age of 39-year-old on 16Dec2020 at single dose for COVID-19 immunization and did fine. The patient did fine after first dose, after second dose had 36 hours of fever and chills. Covid test negative. Several weeks later she developed fatigue and cold extremities. She was found to have elevated CCP (Cyclic Citrullinated Peptide) antibodies, dx (diagnosis) rheumatoid arthritis. All events occurred on 04Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received for the events included medication for pain, specialist referral. There was no other vaccine received in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. Covid test (Nasal Swab) post vaccination was Negative. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the time association and drug's safety profile, the events fever, chills, fatigue, and cold extremities are possibly related to suspect vaccine BNT162B2 administration. The event rheumatoid arthritis is more likely underlying/intercurrent condition, unrelated to suspect vaccine BNT162B2 injection given the product's safety profile and the pathophysiology of rheumatoid arthritis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1026030
Sex: F
Age: 59
State: CA

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 02/12/2021
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: Headache and chills, missed one day of work

Other Meds:

Current Illness:

ID: 1026031
Sex: M
Age: 72
State: NJ

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/12/2021
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: I experienced the following side effects 45 minutes to 1 hour after I received the 1st administration of the Pfizer Covid19 vaccine. The side effects ended 24 hours after I received the injection. 1- Sneezing 2- Excessive Running Nose 3- Watery Eyes

Other Meds:

Current Illness:

ID: 1026032
Sex: F
Age: 50
State: NE

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/12/2021
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: Morphine/Hydrocodone, sulfa, omnicef

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

Symptoms: I am an LPN and received my 1st dose of Moderna vaccine 2/5/21. Immediately after I experienced episodes of dizziness and request to have blood pressure checked which was 160's/100's and did not seems to come down after 10 minutes. Started to develop shortness of breath at about 20 minutes post shot and was immediately taken to ER in which I started to become hoarse and losing voice and heaviness in chest. I was given solu-medrol, Benadryl, Pepcid and neb treatment due to wheezing also. Chest xray , EKG done which remained normal. D-dimer was slightly elevated so did do CT chest which was also normal. Was in ER under observation for about 4 hours before discharge. I continued to have shortness of breath and difficulty breathing with exertion/activity and blood pressure remained high over next few days. I saw my PCP on 2/10/21 and was instructed to continue with albuterol inhalers and neb treatments as needed, and added Amlodipine for elevated blood pressures.

Other Meds: Stelara, Plaquenil, Telmisartan, Spironolactone, Celebrex, Wellbutrin, Diethylpropion, Trazadone, Tramadol, Flexeril, Dexilant, zinc, Vitamin D, Vitamin C, quercertin

Current Illness: Crohn's, spondyloarthritis, connective tissue disorder, fibromyalgia, hypertension, vitamin D def, osteoarthritis, elevated BMI, depression. Did have GI illness earlier in the week.

ID: 1026033
Sex: F
Age: 83
State: IN

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/12/2021
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: Chills, slight headache, muscle aches, much fatigue.. Took Tylenol.

Other Meds: Pravastatin, Tylenol, Levothyroxine

Current Illness:

ID: 1026034
Sex: F
Age: 58
State: AZ

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/12/2021
Hospital:

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

Lab Data:

Allergies: none

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

Symptoms: About 1/2 hour after injection my fingers were tingling, then about 45 minutes after injection my heart started beating fast and felt like it was going to burst out of my chest. My blood pressure went up to 170/95. I was at work (dental practice) so continued t monitor the blood pressure. The symptoms slowly subsided but continued through the afternoon till 5pm. My blood pressure returned to normal the next morning.

Other Meds: Losartan HCTZ 50 mg 1 daily at 7AM

Current Illness: Edema from Breast Cancer on the left side. Injection given in the right arm.

ID: 1026035
Sex: F
Age: 66
State: OH

Vax Date: 01/31/2021
Onset Date: 02/06/2021
Rec V Date: 02/12/2021
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: IV Dye

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

Symptoms: Six days post injection the injection site began to itch. The itching was followed by a four inch in diameter hot, hard, welt which continued to increase in size. Benadryl, Bactrim & Zyrtec were ordered by the GP.

Other Meds: Baclophen 10mg. BID Elioquist 5 mg. BID Metropolol 25mg. BID Vit. D 2000 IU BID Culturelle 1 daily

Current Illness: Primary Progressive MS

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm