VAERS 2021 Database www.vaers.hhs.gov

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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: 1182709
Sex: M
Age: 56
State: NC

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 04/08/2021
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: celebrex

Symptom List: Dysphagia, Epiglottitis

Symptoms: Autoimmune response involving all previous symptoms of PTLDS especially dizziness, multiple joint pain especially spine, shoulders and hands along with uncomfortable stomach pain and severe headache. Treatment -water, some pepto, and 2 ibuprofen. Started previous evening with fatigue and hands, woke up around two AM with tremors and cramping, all symotoms worsening to the mid afternoon. Unable to stand or walk with confidence or safely hold objects

Other Meds: several of each

Current Illness: post-treatment Lyme disease syndrome + complications

ID: 1182710
Sex: F
Age: 62
State:

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 04/08/2021
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:

Symptom List: Anxiety, Dyspnoea

Symptoms: Dizziness, increased heart rate. BPs 190/117 (pulse 95), 169/98 (pulse 79). O2 sats 100%, 99%. Juice x 2, crackers.

Other Meds:

Current Illness:

ID: 1182711
Sex: F
Age: 59
State: IL

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 04/08/2021
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: No allergies, but sensitivity to codeine, Sudafed, novacaine (heart palpitations)

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

Symptoms: By 5 pm on 4/6, soreness of left arm, fatigue, minor headache and slight nausea/dizziness. On 4/7, symptoms worsened throughout the day (headache, fatigue, nausea, dizziness) and included lack of appetite and hydration (not wanting water, etc.), overall achiness, with more extreme pain in the left arm, neck, low back and legs. I went to bed at 4:30 in the afternoon, feeling ill. On 4/8, I woke up feeling considerably better, however still a slight headache and achiness. I took Tylenol on 4/7 (twice).

Other Meds: Amlodipine Besylate 7.5 mg and Metropole 25 mg (1/2 tab per day)

Current Illness: None

ID: 1182712
Sex: F
Age: 67
State: IL

Vax Date: 02/01/2021
Onset Date: 04/06/2021
Rec V Date: 04/08/2021
Hospital: Y

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

Lab Data:

Allergies: PCN- unknown reaction

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: She had both doses of Moderna COVID vaccine and finished the series in mid February. She was admitted 4/5/21 with bilateral PE and popliteal vein thrombus in the left leg. She had been sedentary the week before with a "cold" and has morbid obesity.

Other Meds: Cacium/VitD 600mg/00mg 1 tab daily Uloric 40mg daily gabapenten 300mg, 2cap BID lisinopril 10mg PO daily multivitamin daily ultram 50mg daily B12 1000mc tab daily

Current Illness: "a cold" with temp 99F. likely mild viral URI

ID: 1182713
Sex: F
Age: 56
State: CA

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 04/08/2021
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 erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: pt called having a problem with the arm that was vaccinated still swollen and red itchy

Other Meds:

Current Illness:

ID: 1182714
Sex: M
Age: 66
State: DC

Vax Date: 03/02/2021
Onset Date: 03/16/2021
Rec V Date: 04/08/2021
Hospital: Y

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: Patient received vaccine 3/2/2021, second dose. Uneventful. On 3/16, patient was found unresponsive and sent to hospital. Hospital course: altered mental status, pneumonia, acute hypoxia, acute encephalopathy. Treated in hospital, recovered and returned to nursing home. Patient tested negative for Covid on 3/16/21 before transfer to hospital. Before sent to hospital vitals were: Temp 101.7, pulse 104, BP 130/78, blood sugar 172, oxygen on room air 95%.

Other Meds: amlodipine, aspirin, atorvastatin, calcium/vitamin D, carbamazepine, carvedilol, donepezil, finasteride, gabapentin, haloperidol, hydralazine, insulin, levetiracetam, lisinopril, oxybutynin, polyethylene glycol, senna, tamsulosin

Current Illness: epilepsy, dementia, hypertension, diabetes, BPH

ID: 1182715
Sex: M
Age: 0
State:

Vax Date: 04/08/2004
Onset Date: 04/08/2021
Rec V Date: 04/08/2021
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: After receiving vaccine client stated he was experinecing dizziness, having tremors. He was lowered to the ground by staff and mother, both legs elevated on chair. Mother stated " he has a way with needles and gets like this sometimes". MD on site and paramedics responded accordingly. Vitals taken by paramedics and assessment done by MD.Client is now verbally responsive , sitting in chair, hydration fluid given PO. Mother stated client has a hx of black out spells along with auto immune disease. Escorted to observation area in wheelchair with parents and MD. Last Vitals Bp 106/68 HR 73 O2 98% blood glucose 104

Other Meds:

Current Illness:

ID: 1182716
Sex: F
Age: 39
State: AK

Vax Date: 03/31/2021
Onset Date: 04/08/2021
Rec V Date: 04/08/2021
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: Pharyngeal swelling

Symptoms: Covid vaccine recieved 3/31/21. Dysport recieved 04/07/21. At approximately 430am, I awoke to full body tremors, fever, extremely hot face, inability to control body movements. Lasted approximately 2 hours.

Other Meds: Recieved 28 units of dysport on 04/07/2021 @ approximately 245pm.

Current Illness:

ID: 1182717
Sex: F
Age: 23
State:

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 04/08/2021
Hospital:

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

Lab Data:

Allergies: no

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Client received the COVID vaccine (Janssen, Lot# 1808980) complained of feeling dizzy at 1424, EMT and RN responded. The client was sitting in a chair with her head in her hands, stated that she felt dizzy and was having a "hot flash." The client stated that she is anxious around needles and has a history of syncope after blood draws. She also complained of experiencing tunnel vision and hearing. The client's vital signs were a temperature of 96.7, blood pressure of 122/82, heart rate of 92, and O2 of 99%. The client stated she did eat that morning, and refused a set of repeat vitals, but agreed to wait 30 minutes for observation after her symptom onset. Per the client, she has no allergies or medical conditions, and takes no medications. At 1435, the client accepted some water to drink. At 1440, the client stated that she no longer felt dizzy. The client's color had returned and she was no longer dizzy. She agreed to have repeat vital signs at this time: blood pressure of 118/82, heart rate of 90, respiratory rate of 16, and O2 99%. The client refused benadryl at this time. At 1454, the client's vital signs were as follows: blood pressure of 116/82, heart rate of 90, respiratory rate of 12, and O2 of 99%. The client stated that she felt "back to normal" and called her sister to drive her home. She was escorted to her car by the EMT, she ambulated with a steady gait. Education provided regarding emergency response, V-safe, and the importance of following up with a primary care provider.

Other Meds: no

Current Illness: no

ID: 1182718
Sex: F
Age: 62
State: OH

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 04/08/2021
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: None known

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Fever, muscle aches, muscle cramps, muscle fassiculations, lethargy, fever, chills, nausea, joint pain, weakness, rash, head/ nasal congestion. Started around 7:00pm day of the vaccine( given at 8:00am). Unable to sleep at all that night due to concerns over breathing and due to maladies and general body pain. Rash erupted ~4:00am.

Other Meds: Vitamin B12, magnesium citrate 200 mg

Current Illness: None

ID: 1182719
Sex: F
Age: 25
State: NJ

Vax Date: 04/05/2021
Onset Date: 04/06/2021
Rec V Date: 04/08/2021
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: Headache thats lasted 3 days. Nausea, hot flashes, swelling/pain in arm. Stiff joints.

Other Meds: Metoprolol Amlodapine Clonidine Strattera

Current Illness:

ID: 1182720
Sex: F
Age: 0
State:

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 04/08/2021
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:

Symptom List: Rash, Urticaria

Symptoms: Pt reports difficulty swallowing, numbness to lips and mouth area, sensation of eye swelling. Pt appears anxious. Medics on site for evaluation; VSS. Pt left AMA.

Other Meds:

Current Illness:

ID: 1182721
Sex: F
Age: 66
State:

Vax Date: 03/10/2021
Onset Date: 03/18/2021
Rec V Date: 04/08/2021
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 red, warm skin rash on arm vaccine was administered in. Said rash extended from around the elbow up to around the shoulder area. Rash was limited to that area only. Patient did not report any other adverse effects. Patient said rash appeared approximately 7-10 days after receiving first dose of Moderna.

Other Meds:

Current Illness:

ID: 1182722
Sex: M
Age: 28
State:

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 04/08/2021
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: None

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

Symptoms: Presyncope

Other Meds: Sertraline, adderall

Current Illness:

ID: 1182723
Sex: F
Age: 34
State: CA

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 04/08/2021
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: n/a

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

Symptoms: scratchy throat and tongue 45 min after injection

Other Meds: n/a

Current Illness: n/a

ID: 1182724
Sex: F
Age: 74
State: WA

Vax Date: 03/30/2021
Onset Date: 04/06/2021
Rec V Date: 04/08/2021
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: None

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

Symptoms: On Apr 7th at 11:30 Pm my wife went to hospital. not being able to breathe sufficiently. This started the day before on the 6th while out walking. She is in the hospital being treated for embolisms of the lungs on both sides with multiple blood clots.

Other Meds: zinc 50 mg.

Current Illness: None

ID: 1182725
Sex: M
Age: 29
State: OH

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 04/08/2021
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: none reported

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

Symptoms: Patient received vaccine. After about 5 minutes he slid off the chair onto the floor. He woke up after about 10 seconds, remained on the floor face up. Sat up with help and was given water and a granola bar, and a cold damp paper towel for his forehead. After 20 minutes he moved to a chair and sat upright for another 50 minutes. He was given more water and another granola bar. He was given the ok to leave about an hour after the incident, stating he felt good to go.

Other Meds: none reported

Current Illness: none reported

ID: 1182726
Sex: F
Age: 72
State:

Vax Date: 04/06/2021
Onset Date: 04/07/2021
Rec V Date: 04/08/2021
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: Patient complained the next day after her shot she had Charlie horse symptoms. could not get out of bed. Patient tried taking tylenol , but did not help. Has no fever or any other adverse effects. Patient was advised to check with her doctor if symptoms don't improve.

Other Meds:

Current Illness:

ID: 1182727
Sex: F
Age: 22
State:

Vax Date: 03/26/2021
Onset Date: 04/08/2021
Rec V Date: 04/08/2021
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: rash

Other Meds:

Current Illness:

ID: 1182728
Sex: F
Age: 31
State: NC

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

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

Lab Data:

Allergies: None

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

Symptoms: Large red rash & body felt heated 1 hour after. Headache & upset stomach started few hours after. Starting 8 hours after dose, severe body aches & chills - lasted 8 hours after until 30 hours after. Dizzy and nauseous started 36 hours after until 38 hours after. By 48 hours after, only sore and tender arm at injection site lasting until 4 days after.

Other Meds: Adderall IR 30mg

Current Illness: None

ID: 1182729
Sex: F
Age: 70
State: CT

Vax Date: 04/05/2021
Onset Date: 04/06/2021
Rec V Date: 04/08/2021
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: Allergic to demerol

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

Symptoms: Noticed a small rash under the injection site around 4:00 a.m. after initial injection. As the day progressed the rash became larger and still remains there today. Arm has been very sore as well. I've had severe headaches and body aches for the past three days. The headaches have subsided today and the body aches are much less, however, I still feel tired.

Other Meds: None

Current Illness: None

ID: 1182730
Sex: M
Age: 30
State: WI

Vax Date: 04/07/2021
Onset Date: 04/08/2021
Rec V Date: 04/08/2021
Hospital:

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

Lab Data:

Allergies: soy products

Symptom List: Unevaluable event

Symptoms: 1:22 AM: chest pain, abdominal cramps, chills, difficulty breathing, hyperpnea, bilateral upper extremity trembling VS: pulse 112, respirations 22, temperature 37.0 Celsius, BP 156/103, O2 sat 99% on room air has history of deep vein thrombosis, pulmonary embolism 1:30 AM sent to emergency room via ambulance 4:00 AM report from emergency room: patient is stable and reported feeling better and breathing easier shortly after arriving to ER. Patient received 500cc NS bolus IV. Labs findings unremarkable. INR 2.0, PT 21.3, PTT 31. Last taken VS -BP 127/71, P109, R20, O2 93%RA. Patient will be discharging with Dx: reaction to COVID vaccine.

Other Meds: acetaminophen 500 mg TID PRN pain; albuterol 90 mcg/inhalation 2 puffs QID PRN chlorhexidine topical 4% BID PRN folliculitis fluticasone-salmeterol 500 mcg-50 mcg inhalation 1 puff BID lisinopril 10 mg daily warfarin 5 mg daily warfarin 2 m

Current Illness: none

ID: 1182732
Sex: M
Age:
State:

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 04/08/2021
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: reduced attention to details, diminished alertness, being cloudy headed, and clouded headedness; he noticed his "mental acuity [was] reduced; reduced attention to details, diminished alertness, being cloudy headed, and clouded headedness; He said he also has "drowsiness" which is getting more significant; cut his thumb while chopping asparagus He added he bled terribly, therefore he grabbed a clean paper towel, stanched the bleeding, and had to "seal" the wound with all the white first aid tape he had.; ut his thumb while chopping asparagus He added he bled terribly; This is a spontaneous report from a contactable consumer reporting for himself. A 70-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Mar2021 (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer after the second vaccine doses noticed his "mental acuity [was] reduced". He also described/referred to it as: "reduced attention to details, diminished alertness, being cloudy headed, and clouded headedness". After the second dose, this experience was "worst, more significant and continues to get more significant". He explained he drives a large tracker truck for (Company name) and had to take days off work due to his symptoms. He specified the following details post-vaccination with his second dose: Monday night, he was preparing diner around 8 pm and cut his thumb while chopping asparagus. He added he bled terribly, therefore he grabbed a clean paper towel, stanched the bleeding, and had to "seal" the wound with all the white first aid tape he had. He then said he called his physician on Tuesday who returned his call around 5:30 that same day, and who recommended to go to the ER since stiches were needed. He added he resisted to go to the ER because of his symptoms affecting his driving but went upon his HCP's encouragement. He explained once at the ER, the doctor there said he wouldn't recommend stiches since this may seal in the bacteria from the improper dressing he had, which will affect the make the healing period and scaring. He added they cleaned and sealed his wound nicely then they offered a tetanus shot, which he got. He described his thumb as a "flap finger". He explained when driving back home he almost had an accident due to not paying attention to details, which he wouldn't have done in his 40 years of driving experience. He said he also has "drowsiness" which is getting more significant. Events outcome was unknown. Information about lot/batch has been requested.

Other Meds:

Current Illness:

ID: 1182733
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 04/08/2021
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: acute hearing loss in the left ear; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced acute hearing loss in the left ear about ten days after getting the vaccine. The physician was wondering how common this was and if there was any advice for re-treatment or further testing. Outcome of the event was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the event hearing loss 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:

Current Illness:

ID: 1182734
Sex: F
Age:
State: NY

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 04/08/2021
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: break in rash/rash in mouth and throat; sore throat; dizzy; weak; felt like sleeping all the time; pain in her arm; blood clot in right leg; couldn't walk; veins are swollen; right knee got swollen; ear ache; felt like burning/ sore in her mouth like she was burned; sore in her mouth like she was burned; nausea; headache; slight fever; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in right arm on 09Mar2021 (Lot Number: EL9266) at single dose for covid-19 immunization. Medical history included arthritis, respiratory issues, allergies, Eczema of the nipples and breast, arthroscopic surgeries, she lost her voice. Caller stated she exercised everyday, she did yoga. Caller reported the last 2 years she hadn't been able to climb the mountain on the stairs. Caller states she didn't catch a cold, she was fine, she was very active. She was good except arthritic conditions, she has had arthroscopic surgeries, that was a side effect of that. Caller reporting she was a first responder and had some respiratory issues. Caller stated she had some allergies, if with dust or smoke, her throat constricts, it was just small, like her throat. She cannot be around that. She got once in a while, when she got in a rush. Caller stated before the vaccine, she had eczema in her nipples, on her breast. Caller stated she never got sick, besides the rash she got once in a while. Caller states but she was very healthy otherwise, no medication, no smoking, no drinking. Caller stated she was from 9/11, this was what happened with her voice once in a while, she lost her voice. Caller stated she had had some respiratory issues and allergies and so on. Caller stated she was here for 56 years and her mother died of old age so she was not sure. There were no concomitant medications. The patient previously took advil. Caller stated she used to take Advil when she went to the gym and had problems but she hasn't taken Advil for a while. She didn't take meds. Caller stated she didn't drink or smoke because what it did was it gave you a release. Caller stated she was not taking none, she was pushing through and hoping it will heal itself. The patient experienced blood clot in right leg on 26Mar2021, break in rash on an unspecified date, headache on 09Mar2021, slight fever on 09Mar2021, veins are swollen on 12Mar2021, right knee got swollen on 12Mar2021, sore throat on an unspecified date, ear ache on 10Mar2021, nausea on 09Mar2021, rash in mouth and throat on an unspecified date, felt like burning/ sore in her mouth like she was burned on 10Mar2021, sore in her mouth like she was burned on 10Mar2021, dizzy on an unspecified date, weak on an unspecified date, felt like sleeping all the time on an unspecified date, couldn't walk on 12Mar2021, pain in her arm on an unspecified date. Was a first responder, sometimes break in rash once in a while. Got Pfizer 1st vaccine 09Mar, was scared to have difficulty breathing however had headache, slight fever, right knee and veins were swollen, sore throat, ear ache, nausea, rash in mouth and throat also felt like burning also was dizzy and weak and felt like sleeping all the time. Caller stated she was told by her doctor to take the shot on 09Mar2021. Caller stated she had headache, slight fever, then her head was ok the fever was gone but the headache persisted as of today. Caller stated she still had headache and ear ache and her knee got swollen, her right knee. Caller stated for a few days she couldn't walk. Caller reported she has arthritic conditions in knees, she exercises everyday and no problem, but she couldn't walk for a few days. Caller states now she is able to walk on something, but the veins in the knee were still there and she didn't know. Caller stated she was due for second next on Tuesday and she was wondering what to do. Caller stated she was honestly worried about this reaction after the first shot. Caller stated she was told the 2nd had a worse reaction, so she was really weary and worried. Caller stated she only slept 5 hours at night, but now she wanted to sleep all the time. Caller stated she had such a headache and earache. Caller stated it made her nauseous, like in a sea or something. She stated she didn't know how to explain. She didn't vomit like when you were nauseous, it wasn't that feeling. Caller stated it was just lingering like when you were in the ocean. Caller reported headache has gotten better. It has gotten worse and then gotten better. Caller stated the earache was so painful and was still there. Caller reported she got it during the day and when she lied down, but the severity had subsided. Caller stated she didn't measure fever. She wanted to say after that, her mouth was sore after fever from the heat or from the vaccination. Caller stated her mouth was still today, still sensitive. Caller reported it was like her throat and her mouth was so sore like a burn. Caller reported her headache was mostly on the left side, but went to the right side too. Caller reported she could feel it in her eye, it hurt and her ear hurt. Caller reported her sore throat, the upper part, was still sensitive. Caller stated she couldn't swallow, but it was clear, her mouth was clear, only the upper top she would say. Caller stated it's 99% gone, its healing. Nauseous, like in a sea, its not like she has it all day long- nauseous- maybe once a day, nothing severely like what she had for a few things. The patient had a pain in her arm and she had that symptom one night and the following day she had nothing. Her arm was cooperative. Since she had been diagnosed with a blood clot. She saw her doctor on Friday and was recommended that she took some medications. She continued to have headache which she reported, though not as bad. She also reported that she had a sore mouth and earache. She was still fighting symptoms and didn't know what to do with the blood clot. She was scared to take the blood thinner Eliquis and that she will have side effects that it will do her harm she felt Eliquis will do her harm if she received the second dose of the vaccine or takes Eliquis. She was supposed to 20mg daily which she felt will kill her given her body was not healed from receiving the first dose of the Covid-19 vaccine. There was no prior vaccinations within 4 weeks. She was prescribed Eliquis Film-coated tablet (Lot Number: ABN4449S, Expiry date: Feb2023) 20mg daily for blood clot but had not started because she felt it will kill her was scared to take the second dose of the vaccine. The patient underwent lab tests and procedures which included Sonogram: blood clot in right on 26Mar2021. Therapeutic measures were taken as a result of blood clot in right leg. There was Physician Office Visit for all events. The outcome of the event blood clot in right leg, veins are swollen, right knee got swollen, couldn't walk was not recovered, of event slight fever was recovered on 10Mar2021, pain in her arm was recovered, of event ear ache, nausea, felt like burning/ sore in her mouth like she was burned, sore in her mouth like she was burned was recovering, of other events was unknown.

Other Meds:

Current Illness:

ID: 1182735
Sex: M
Age:
State:

Vax Date: 03/21/2021
Onset Date: 03/01/2021
Rec V Date: 04/08/2021
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 on right side; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 33-year-old male patient (reporter's son) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on Mar2021, four hours after the vaccine was received, the patient experienced facial paralysis on the right side. The patient went to the hospital and the side effects subsided. The outcome of the event was unknown. Information about Lot/Batch number is requested.

Other Meds:

Current Illness:

ID: 1182736
Sex: F
Age:
State:

Vax Date: 02/23/2021
Onset Date: 02/25/2021
Rec V Date: 04/08/2021
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: tested positive for covid; body aches; not feeling well; weakness; low grade fever; This is a spontaneous report received from a contactable consumer. A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 23Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient received her first dose of the BNT162B2 vaccine on 23Feb2021 and day later she had symptoms of covid, body aches, not feeling well, weakness, low grade fever, tested positive for covid. In the second week she had to go to hospital for few days and was very week and still covid positive. Reporter wanted to know can patient take her second dose or if she needs to redo her series. The outcome of the events was unknown. information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1182737
Sex: F
Age:
State: GA

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 04/08/2021
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: Tongue started to enlarge; Throat tighten up; Strange metal taste; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 56-year-old female patient received the first dose of BNT162B2 (PFIZER -BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 24Mar2021 at 10:45 AM, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to sulfa. The patient's concomitant medication included clopidogrel. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 30 minutes after injection (24Mar2021 at 11:15 AM), the patient felt throat tighten up and tongue started to enlarge. Also, the patient had strange metal taste but never lost ability to breathe. After drinking some water and about 15 minutes, the symptoms went away. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 24Mar2021 at 11:30 AM.

Other Meds: CLOPIDOGREL

Current Illness:

ID: 1182738
Sex: F
Age:
State:

Vax Date: 03/12/2021
Onset Date: 03/01/2021
Rec V Date: 04/08/2021
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: sickle cell crisis; This is a spontaneous report received from a contactable consumer (patient herself). A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 12Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 6 or 7 days later after receiving the first dose of the Pfizer Covid vaccine, the patient started to experience a sickle cell crisis which was continuing and had not resolved. The patient wanted guidance and also wanted to know if she should get the second dose. Outcome of the event was not recovered. Information related to the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1182739
Sex: F
Age:
State: MN

Vax Date: 03/19/2021
Onset Date: 03/01/2021
Rec V Date: 04/08/2021
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: passed out; bad stomach ache; Tired; not normal; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), lot no. EN60207, via an unspecified route of administration (left arm) on 19Mar2021 10:15 at a single dose for COVID-19 immunisation. The patient had no relevant medical history. She had no known allergies. No covid prior vaccination. Concomitant medications included levothyroxine, simvastatin, calcium, and multivimi (as reported). Historical vaccine included first dose of BNT162B2 (brand=Pfizer, lot no EN6203) on 26Feb2021 10:15 AM, left arm at age of 59 years. No other vaccine in four weeks. On 20Mar2021, the patient got up to go to bathroom at 4:00am Saturday and passed out. Bad stomach ache Saturday (20Mar2021), Sunday (21Mar2021). On Mar2021, tired and not normal til Thursday. No treatment for the events. No covid test post vaccination. The patient recovered from bad stomach ache on 21Mar2021 and from other events on Mar2021.

Other Meds: LEVOTHYROXINE; SIMVASTATIN; CALCIUM

Current Illness:

ID: 1182740
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/08/2021
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: staph infection; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient is scheduled to get the second dose of the Pfizer COVID-19 vaccine tomorrow (26Mar2021). However, he had been on antibiotics for a month and a half and he wants to know if there would be any potential interaction with antibiotics and the vaccine. He said he had a staph infection (medically significant) and he had taken antibiotics intravenously for 3 weeks (on an IV line) and he is supposed to take oral antibiotics for 2 more weeks. The outcome of the event was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1182741
Sex: F
Age:
State: KY

Vax Date: 03/04/2021
Onset Date: 03/06/2021
Rec V Date: 04/08/2021
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: she got pretty sick/she did not feel good on Friday, but on Saturday it got really bad; The swelling in throat created an infection; throat feels dry; a lot of congestion in chest and in the lobes; a lot of congestion in chest and in the lobes; Lymph nodes in throat swelled up; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Lot Number: EN6198, NDC number: 59267100001, Expiry date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 65-year-old) at single dose for COVID-19 immunization. Medical history included ongoing asthma diagnosed about 40 years ago in 1981. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for asthma had for a number of years, keeps them on hand; and salbutamol sulfate (VENTOLIN CR) taken for asthma, had for a number of years. The patient got the first shot and she have asthma but forgot to tell them that she has asthma and no one asked her first. The patient got pretty sick on unspecified date and she is trying to figure out if this could be from the vaccine. On 06Mar2021, her lymph nodes in her throat swelled up and her throat was raw, painful, super red and she could hardly talk, it also created a lot of congestion in chest- the lobes. The swelling in throat created an infection on unspecified date. She wound up going to the doctor and they prescribed her an antibiotic which cleared the infection in her throat. Her symptoms started two days after she received the shot. She is supposed to get the second shot on Thursday 25Mar2021 and that's why she is calling to find out information on what other people reported as far as asthma patients. She is debating on getting the second shot. Initially caller states that for the most part, it cleared up and went away about three days ago, but then explains it is gradually getting better. Every once in a while, her throat feels dry and raw, but she drinks water and it feels better. At first, she did not want to really talk. She has asthma, the congestion never really goes away and it didn't really improve this time after prednisone like it usually does. She did not feel good on Friday, but on Saturday it got bad. Her side effects have improved from what they were then. The patient recovered from the event swelling in throat created an infection on unspecified date. The outcome of got pretty sick and throat feels dry was unknown and the outcome of the remaining events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: SYMBICORT; VENTOLIN CR

Current Illness: Asthma (Verbatim: Asthma)

ID: 1182742
Sex: M
Age:
State: OH

Vax Date: 03/23/2021
Onset Date: 03/25/2021
Rec V Date: 04/08/2021
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: tested positive for Covid; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer (wife) reported for a male patient reported that, A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 23Mar2021 at a SINGLE DOSE for covid-19 immunization. Patient had a medical history of cough and his ears were plugged and he was dizzy. The patient's concomitant medications were not reported. On 25Mar2021 patient visited urgent care and was performed COVID-19 virus test resulted as positive. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1182743
Sex: F
Age:
State: MI

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 04/08/2021
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: She experienced 3 strokes; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (lot number and expiry date not reported) as a single dose for COVID-19 immunization. The patient's medical history included severe Factor 7 deficiency. Concomitant medications were not reported. On 12Mar2021, 50 minutes following the injection, the patient experienced 3 strokes. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1182744
Sex: F
Age:
State: IL

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 04/08/2021
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: lost consciousness and fainted two times; lost consciousness and fainted two times; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 21-year-old female received bnt162b2, dose 1 via an unspecified route of administration, administered in right arm on 25Mar2021 15:00 (Lot Number: 10350) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history included asthma, attention deficit hyperactivity disorder (ADHD), Bipolar II and post-traumatic stress disorder (PTSD). Prior to vaccination, patient was diagnosed with COVID-19 on an unknown date. No allergies to medications, food, or other products. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE), methylphenidate hydrochloride (CONCERTA), aripiprazole (ABILIFY) and escitalopram oxalate (LEXAPRO). On 25Mar2021 15:00, the patient lost consciousness and fainted two times. Paramedics were called and she was released. The events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab: positive on 06Jan2021. The outcome of the events was recovered in Mar2021. The events lost consciousness and fainted occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.

Other Meds: BLISOVI 24 FE; CONCERTA; ABILIFY; LEXAPRO

Current Illness:

ID: 1182745
Sex: F
Age:
State: GA

Vax Date: 02/17/2021
Onset Date: 03/18/2021
Rec V Date: 04/08/2021
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: Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and muscles throughout body; aching joints and muscles throughout body; Chills; felt "heavy & on-fire" though cool to the touch (neuropathy); diarrhea; Headache; lower GI distress; muscle cramping all over body; Low-grade fever/temperature 100.9; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included osteoarthritis and upper gastrointestinal (GI) distress. Concomitant medications included omeprazole (PRILOSEC) taken for upper gastrointestinal (GI) distress, start and stop date were not reported; celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12) taken for an unspecified indication, start and stop date were not reported; calcium carbonate (CAL) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (lot number: EL3249) on 27Jan2021 04:30 PM at left arm. Other vaccine in four weeks reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergies to medications, food, or other products reported as no. These symptoms persisted for 24hours: on 18Mar2021 the patient was awoke midnight with chills, severe lower GI distress, diarrhea, head ache, muscle cramping all over body, legs felt heavy and on-fire though cool to the touch; temperature 100.9. Second 24 hours: the patient had low-grade fever, diarrhea, head ache, aching joints and muscles throughout body, continued lower GI distress. After 48 hours: the patient had temperature normal, sore achy body, head ache, fatigue. Consumed only water during first 72 hours then resumed liquids (broth, ginger ale) intake. Effectively treated diarrhea with loperamide hydrochloride (IMMODIUM); dicycloverine hydrochloride (BENTYL) for lower GI distress; resumed omeprazole (PRILOSEC) for upper GI distress. The patient returned to work on 23Mar2021 half-day, 24Mar2021 full-day still not feeling well. On 24Mar2021 during the night, legs were restless from hips down, felt "heavy and on-fire" though cool to the touch (Neuropathy) was similar to first night on 18Mar2021. On 26Mar2021, all symptoms have disappeared and the patient felt good, again she was in very good general health, active, appropriate weight, never ill. Events reported as non-serious. Events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event fever was recovered on 20Mar2021, of other events was recovered on 26Mar2021.

Other Meds: PRILOSEC [OMEPRAZOLE]; CELEBREX; D3; B12 [CYANOCOBALAMIN]; CAL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1182746
Sex: F
Age:
State: NC

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 04/08/2021
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: could not walk on her left foot; hot, painful patch on the inner left lower leg below the calf muscle; Left lower leg and foot bluer than right; vascular issue; pain and redness was present in the lower left calf/ a large red, hot, painful patch on the inner left lower leg below the calf muscle; pain and redness was present in the lower left calf/a large red, hot, painful patch on the inner left lower leg below the calf muscle/tenderness, pain on affected area; tightness, tenderness, pain on affected area; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6204), via an unspecified route of administration at the age of 43 years old, administered in arm right on 17Mar2021 19:45 at single dose for covid-19 immunisation. Medical history included diabetes, Hashimoto's, PCOS (Polycystic ovarian syndrome), allergies to medications, food, or other products: contrast dye. The patient's concomitant medications were not reported, the patient had received medications within 2 weeks of vaccination, but the patient did not provide the specified drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Thursday morning, 18Mar2021 07:00, after vaccine, pain and redness was present in the lower left calf. This progressed to a large red, hot, painful patch on the inner left lower leg below the calf muscle. This has progressed over the past eight days and the patient had gone to Urgent Care (Sat 20Mar2021) where they were concerned about a clot and sent the patient to the ER. An ultrasound in Mar2021 confirmed there was no clot, but the Dr. did not know what the issue was. The doctor started the patient on an antibiotic. This still progressed and 25Mar2021 it spread bilaterally and could not walk on her left foot. Dr. believed it to be a vascular issue with how it presented at her office 26Mar2021 and was closely monitoring the situation. Left lower leg and foot bluer than right, redness, tightness, tenderness, pain on affected area. Subsides at various points during the day, but always returns at night. The patient was told to keep elevated, try Benadryl, and Advil and keep doctor informed to determine referral vasc Dr. The outcome of the events was not recovered. Date of start of events was reported 18Mar2021 07:00. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Case was reported as non-serious by reporter: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1182747
Sex: F
Age:
State: MD

Vax Date: 09/01/2020
Onset Date: 03/25/2021
Rec V Date: 04/08/2021
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: stools that appear to be what she described as "coffee grounds; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age also reported 71 (unit of measurement not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on 24Mar2021, as SINGLE DOSE for covid-19 immunisation; apixaban (ELIQUIS), via an unspecified route of administration, from Sep2020 and ongoing, at 5 mg, 2x/day for an unspecified indication; iron via an unspecified route of administration, from an unspecified date, at unspecified dose and frequency, for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was concerned about the information she received to report if she was taking a blood thinner. The patient didn't read the information prior to receiving the vaccine to inform the clinic. She has been taking ELIQUIS 5mg twice daily since Sep2020. The patient experienced stools that appear to be what she described as "coffee grounds" on 25Mar2021 (the next day). Action taken with apixaban and iron was unknown. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds: ELIQUIS; iron

Current Illness:

ID: 1182748
Sex: F
Age:
State: MO

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 04/08/2021
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: Lyme disease; Patient has no appetite after 2nd shot; This is a spontaneous report received from a contactable Non-healthcare Professional on behalf of a patient. A non-pregnant adult female patient received bnt162b2 (Pfizer, Solution for injection), dose 2 via an unspecified route of administration on Mar2021 as single dose, via an unspecified route of administration on Mar2021 to Mar2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 for covid-19 immunisation first dose. The patient experienced lyme disease (Medically significant) and has no appetite after 2nd shot on Mar2021. Outcome of the events was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1182749
Sex: M
Age:
State:

Vax Date: 03/15/2021
Onset Date:
Rec V Date: 04/08/2021
Hospital: Y

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: very high blood pressure; shortness of breath; his arm redness; sweating; dizziness; his head was pounding; weakness in his legs; This is a spontaneous report received from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at an unspecified age on 15Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included allergic to penicillin and iodine, when he took what he was allergic to he broke out in rash, hives. Concomitant medications were not reported. The patient had side effects: shortness of breath, very high blood pressure, his arm redness, sweating, dizziness, his head was pounding, weakness in his legs and dizzy. The patient was treated and was taken to the hospital till his blood pressure went down and they gave him some diphenhydramine hydrochloride (BENADRYL) for his side effects. They were looking the answer for if he can take a second shot or not. Since he went through all of these side effects. The patient did not want to take a second shot after what he has experienced after the first shot. He was doing ok right now. The patient did not have COVID. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1182750
Sex: F
Age:
State: OR

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 04/08/2021
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: Woke up the following morning after the injection with Vertigo and dizziness. Attempted to get out of bed and the room was spinning. Have never had Vertigo before.; Woke up the following morning after the injection with Vertigo and dizziness. Attempted to get out of bed and the room was spinning. Have never had Vertigo before.; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 12:00 (Batch/Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation. Medical history included Diabetes, high blood pressure, tinnitus, drusen of the optic nerve. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.Concomitant medication(s) included insulin glargine (TOUJEO) taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported; pravastatin taken for an unspecified indication, start and stop date were not reported; carvedilol taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported. At 05:30 AM of 16Mar2021,Woke up the following morning after the injection with Vertigo and dizziness. Attempted to get out of bed and the room was spinning. Have never had Vertigo before. This side effect has now continued for close to 2 weeks now, however, it has subsided as time progresses. Outcome of events was not recovered. No treatment received.

Other Meds: TOUJEO; METFORMIN; PRAVASTATIN; CARVEDILOL; LISINOPRIL

Current Illness:

ID: 1182751
Sex: M
Age:
State: OK

Vax Date: 03/22/2021
Onset Date: 03/23/2021
Rec V Date: 04/08/2021
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 kind of nauseated/ nausea; Could not think/his mind was blank/ couldn't think to do anything; felt like he was in slow motion; This is a spontaneous report from a contactable consumer (patient). This 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 22Mar2021 probably around noon (at age of 65 years old; lot number: ER8730) as single dose for COVID-19 immunization. Medical history included high blood pressure diagnosed about 10 years ago and diabetes type 2 diagnosed about 10 years ago (as of 24Mar2021). He caught COVID a few months ago (as of 24Mar2021) and was sick for 3 weeks and then came out of that and at that time got a rash and came out of that and wanted to get the vaccine because he was age 65 and did not want this thing to kill him. Concomitant medication(s) included gabapentin 300mg, 1 capsule three times per day by mouth, taken for neuropathy in his hands and his hands hurt from 22Mar2021 and ongoing. He was given the gabapentin to stop his hands from hurting. He also had medications he took every day and had diabetes type 2, and also had high blood pressure that he took medication for. No additional vaccines were administered on same date of the Pfizer suspect. There were no prior vaccinations within 4 weeks of the Pfizer vaccine. The patient reported he saw his healthcare professional (HCP) for the first time the same day he got the Pfizer Vaccine on 22Mar2021 and saw the HCP that morning. When he left he felt fine that day 22Mar2021 and felt fine that night. That night he tore up his bedroom and cleaned it and felt fine. Then the next morning (23Mar2021) he went to work and felt fine for a while and then got to building. He started working and then felt like he was in slow motion and couldn't think and it was crazy and his mind was blank and he could not think and felt like he was in slow motion; couldn't think to do anything. The feeling like he was in slow motion and not being able to think began yesterday morning on 23Mar2021 and stopped yesterday 23Mar2021 also. Yesterday he came home because he runs saws at work and stuff like that and he couldn't think and couldn't be around stuff like that because he was cutting things and could get hurt. He had not had this happen before and the feeling as if he couldn't think and felt in slow motion was not ongoing today, 24Mar2021. Today he now has nausea and the nausea was ongoing and about the same as when it began. Also stated as today (24Mar2021) he felt kind of nauseated and couldn't do anything again today and thought he would stay home because of these small side effects of the vaccine that he wanted to report. He had no treatment for the reported events but just went home and laid down. The events did not require an emergency room visit. Regarding whether the events required a visit to physician office the patient replied "Yes", he saw his HCP the morning of the day he got the vaccine on 22Mar2021. Patient was going to call the HCP to see if the medication she gave him would have these side effects and he had not taken the Gabapentin before; stated the HCP issued him Gabapentin that he began taking on 22Mar2021. He was calling the HCP to see if the reported events were related to the gabapentin as he had not taken that before. "Feeling like he was in slow motion and not being able to think" was recovered on 23Mar2021 and patient had not recovered from nauseated.

Other Meds: GABAPENTIN

Current Illness:

ID: 1182752
Sex: M
Age:
State: MD

Vax Date: 03/02/2021
Onset Date: 03/01/2021
Rec V Date: 04/08/2021
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: ache in the arm with first dose; felt like mild tetanus; stiff arm for a couple of hours; s is a spontaneous report from a contactable consumer. A 68-years-old male patient received bnt162b2 (BNT162B2), at the age of 68 years old, dose 1 via an unspecified route of administration, in left arm on 02Mar2021 at 14:30 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation . Medical history included ongoing type 2 diabetes mellitus he was diagnosed almost 30 years ago , plague plague shot a long time ago the black plague shots, states it kicked the heck out of him, had a low grade case of the black plague and it made him feel pretty miserable. He got it over seas, when he went to Africa. It was so long ago, over 15 years ago. Concomitant medication(s) included insulin degludec (TRESIBA) taken for type 2 diabetes mellitus from 2015 and ongoing; semaglutide (OZEMPIC) taken for type 2 diabetes mellitus from 2017 and ongoing; dapagliflozin propanediol monohydrate (FARXIGA) taken for an unspecified indication from an unspecified start date about 5 years agoand ongoing. Patient states that after his first shot he felt pretty good, it didn't bother him, felt like mild tetanus and a stiff arm for a couple of hours. Ache in his arm with the first dose, patient confirms started the day after he got the first dose, but only lasted a few hours. Patient clarifies his muscles aches recovered 80-90%, states it is fading away, it is more like he is just worn out. Patient states that his hips were aching, but that is gone now. The outcome of the remaining events was unknown.

Other Meds: TRESIBA; OZEMPIC; FARXIGA

Current Illness: Type 2 diabetes mellitus (he was diagnosed almost 30 years ago)

ID: 1182753
Sex: F
Age:
State: NC

Vax Date: 03/10/2021
Onset Date: 03/01/2021
Rec V Date: 04/08/2021
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: anterior uveitis / can't see well enough; it was getting better, but it was not happy; This is a spontaneous report from a contactable physician reported for herself. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, deltoid right on 10Mar2021 (batch/lot number EN6208 and expiry date not reported) at 66 years of age as single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included some over the counter B12 (unspecified). The patient informed that she developed an anterior uveitis which started 2 days post her COVID injection (12Mar2021). The patient informed that she will be reporting online but she can't see well enough (Mar2021) to report online. The patient informed that "it was getting better, but it was not happy". The patient informed that in response to the vaccine she was on Prednisolone 1 percent ophthalmic eye drops. The patient confirmed that she was taking Prednisolone as a treatment (for the events) and was still on it. The outcome of the event anterior uveitis was not recovered, while unknown for the other event. The physician informed that causality was "yes".; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event iridocyclitis cannot be excluded. This case will be reassessed once additional information becomes available. 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: 1182754
Sex: M
Age:
State: OK

Vax Date: 01/29/2021
Onset Date: 02/05/2021
Rec V Date: 04/08/2021
Hospital: Y

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: he was taken by ambulance on February 10th to the local hospital ER/ said that it was COVID; This is a spontaneous report received from a contactable consumer (patient's son). A 71-year old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), parenteral in the arm on 29Jan2021 (at the age of 70-year-old) at single dose for COVID-19 immunization. The patient's medical history included type 2 diabetes, heart attack on unspecified date in 2000 and shingles turned into neuropathy. The patient's concomitant medications included clopidogrel bisulfate (PLAVIX). Reporter was calling on concern of her/his father (patient) actually who still on ventilator (vent) due to your Pfizer's vaccine. So, he/she was told by the FDA to call directly Pfizer since it was a Pfizer vaccine that was given the first dose. He/she had already it reported it to their but he/she was not sure what all you need but he/she still pretty confident that it had a lot to do with vaccine that was given to him the first dose. At the time of this report he was on vent, he had been on for 40 days. He had the shot on 29Jan2021, his very first dose and then his very first symptom was on 05Feb2021. He also got a heart attack. I believe it was a triple bypass done back in 2000 but he did not have any heart damage. But he was on PLAVIX and he/she did not know all of his medication he was on. He/she had tried to look that up but he/she did not want to tell any other just in case he/she said that wrong, he/she honestly could not say what he was and wasn't taking at the time. He was taking the product, but he/she did not know the dose. He/she know for sure that he was on PLAVIX but did not know the dose. The other medication, no he/she would not have the names and dosage because he/she did not want to tell you because it was not, he/she did not truly know. About the start date of PLAVIX reporter stated he would have been started that probably in 2000 after his heart attack as far as he/she know but he/she could not confirm that. That was his/her rough guess as far as he/she know. As per dose reporter stated he she did not. About route of administration reporter stated, he/she could not give any information, on his dosages, his medications or anything because he/she did not want to give any false information. So, he/she did not have any of that exact information. He/she just know he was and he was on PLAVIX, that was the only one he/she know for sure, he/she did not know any dosage, he/she did know he was on other medication but he/she did not know any name or dosage so he/she did not want to give any false information. He also had shingles and also it had turned into neuropathy that was another thing he was dealing with at the time of the vaccine. As per lab data reporter stated his first symptom was around 05Feb2021 he was taken by ambulance on 10Feb2021 to the local hospital emergency room (ER), he was diagnosed with the flu and then later they called him in evening and said that it was COVID and by then he was staying home. The 11Feb2021 to the 13Feb2021, progressively getting worst, began to get a high fever, was unable to walk, uncontrolled bowel, etc. more of a flu (reported as flue) issue. And he was rest again by ambulance on 13Feb2021, he was taken to a bigger hospital. He was admitted to the intensive care unit (ICU) on 13Feb2021, he had a multiple lab done daily since then. He was on vent since then. He was put on the vent on 15Feb2021. When confirmed if it was after vaccine administration, reporter stated, after the vaccine, he got his first symptom 7 days after the vaccine. His vaccine was on 29Jan2021, his very first symptom which was very mild was on 05Feb2021. He progressively got worst and was admitted to the ICU on 13Feb2021 and then was intubation endotracheal (ET) tube on 15Feb2021. As per outcome of the event reporter stated he was still on the vent, he was, reporter would say improving since they told that probably never went to, he was actually going to die, they were pretty much planning a funeral. But he was now on a tracheostomy and he was walking up. So, they could say he was improving but he was still on a vent. As per hospitalization date reporter stated his very first day he went to the hospital would have been 10Feb2021 and that was when he was diagnosed with the flu and then later that evening after he was already home they called and said that his test came back positive for COVID also. But then he went back to the hospital by the ambulance again when he started not being able to walk or anything on 13Feb2021. When confirmed if he was still in hospital, reporter stated, his/her father was still on vent. Fighting for his life. He was in a long-term acute care center at the time of this report, he was moved from ICU to a long-term acute care as of the day before the present report (23Mar2021). He had been on a ventilator breathing for him for 36 days. The outcome of the event was resolving.

Other Meds: PLAVIX

Current Illness:

ID: 1182755
Sex: M
Age:
State: AL

Vax Date: 03/11/2021
Onset Date: 03/18/2021
Rec V Date: 04/08/2021
Hospital: Y

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: weakness; diarrhea; Dizziness; Really Bad Tiredness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at 77-year-old on 11Mar2021 12:00 (lot number: EN6199) at single dose for COVID-19 immunization. Vaccine was received in pharmacy, not at military facility. The patient medical history was reported as none. Family medical history relevant to the events was none. The patient's concomitant medications were not reported. No history of all previous immunization with the BNT162B2 considered as suspect. No additional vaccines were administered on same date of BNT162B2. No other products. No prior vaccinations within 4 weeks. No events following prior vaccinations. The patient experienced diarrhea (hospitalization) on 18Mar2021, weakness (hospitalization) on 22Mar2021, swollen lymph nodes on 18Mar2021, really bad tiredness on 19Mar2021, dizziness on 26Mar2021. Dizziness occurred when he stood up. The patient was hospitalized for diarrhea and weakness from 22Mar2021 to 24Mar2021. The patient was getting weak and they got worried and went to the ER (Emergency Room); he was admitted on 22Mar2021, observed on 23Mar2021 and came out on 24Mar2021. He was "Out of It" and on that Monday he was feeling so tired and weak and he had problems all last year and they were alarmed so they went to be checked out and the patient was released without finding anything. The events resulted in emergency room visit on 22Mar2021. No visit to physician office. Therapeutic measures were taken as a result of events included loperamide hydrochloride (IMODIUM). The outcome of events diarrhea, weakness, swollen lymph nodes, really bad tiredness was recovering, outcome of event dizziness was recovered on 26Mar2021. No medications, medical conditions, or tests relevant to this report. Consumer mentioned that the patient has an appointment to get the second dose of the BNT162B2 on 01Apr2021 and wanted to know if there were reports about getting the second dose will make the side effects stronger.

Other Meds:

Current Illness:

ID: 1182756
Sex: F
Age:
State: CA

Vax Date: 03/08/2021
Onset Date: 03/01/2021
Rec V Date: 04/08/2021
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: She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My face went numb; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer, the patient reported for herself that a 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Mar2021 (at the age of 50-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included prednisone (MANUFACTURER UNKNOWN); valaciclovir hydrochloride (VALTREX) (MANUFACTURER UNKNOWN). On an unknown date, the patient experienced bell's palsy but upon contacting her physician she was prescribed an immunosuppressant which is Prednisone. She was asking if she can take the second dose. Patient stated, after about a week of first dose on an unspecified date in Mar2021, she got dizzy and started bleeding out of nose. On an unpecified date in Mar2021, 2 weeks in, she thought she had an earache. It started on Sunday, Monday and Tuesday. On an unspecified date in Mar2021 (Wednesday), the first thing she noticed while driving was eyes were kinda blurry and her face went numb and she couldn't close eye. Within 2 hours of numbness she saw the doctor who put her on Valtrex and later her doctor put her on prednisone. She has the 2nd dose scheduled for Monday 05Apr2021 and she is worried about taking it. The clinical outcomes of the she experienced bell's palsy, dizzy, bleeding out of my nose, earache, eyes are kinda blurry, my face went numb were unknown. Information about lot number has been requested.

Other Meds: PREDNISONE; VALTREX

Current Illness:

ID: 1182757
Sex: F
Age:
State: TX

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 04/08/2021
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: low grade fever; bad chills; Hallucinations through fever and chills all night; bad stomach pain; headache; horrible diahrrea; Dose Number: 1, Date of start of drug: 9-MAR-2021/Dose Number: 2, Date of start of drug: 23-MAR-2021; Dose Number: 1, Date of start of drug: 9-MAR-2021/Dose Number: 2, Date of start of drug: 23-MAR-2021; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Mar2021 09:00 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. Medical history included none. No allergies to medications, food, or other product. Concomitant medication included paracetamol (TYLENOL 8 HOUR) taken for an unspecified indication, start and stop date were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. The patient previously received dose 1 via an unspecified route of administration, administered in Arm Right on 09Mar2021 09:30 (Batch/Lot Number: unknown) as SINGLE DOSE for covid-19 immunization. The patient experienced bad stomach pain and 12 hours later low-grade fever bad chills on 24Mar2021 04:00, hallucinations through fever and chills all night, headache and horrible diarrhea. Adverse events start time was reported as 16:00 on 23Mar2021. It was unknown if the patient received treatment for the events stomach pain, fever, chills, Hallucinations, headache and diarrhea. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events stomach pain, fever, chills, Hallucinations, headache and diarrhea were recovering, of other event as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: TYLENOL 8 HOUR

Current Illness:

ID: 1182758
Sex: F
Age:
State: NC

Vax Date: 03/10/2017
Onset Date: 03/21/2021
Rec V Date: 04/08/2021
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: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: nausea; Vomiting; This is a spontaneous report from a contactable other health professional (also reported as a consumer; patient); via specialty pharmacy. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization; treprostinil sodium (REMODULIN 5 mg/ml), intravenously from 10Mar2017 (Batch/Lot number was not reported) to an unspecified date, at 0.094 ug/kg, continuous for primary pulmonary arterial hypertension. Medical history included primary pulmonary arterial hypertension from an unknown date and unknown if ongoing. Concomitant medications included macitentan (OPSUMIT) taken for an unspecified indication, start and stop date were not reported. On 21Mar2021, the patient experienced nausea and vomiting. The patient was hospitalized for nausea and vomiting from 21Mar2021 to an unknown date. The patient began therapy with treprostinil sodium (REMODULIN, concentration of 5 mg/ml), on 10Mar2017 for primary pulmonary arterial hypertension. The current dose was reported as 0.094 ug/kg, continuous via intravenous (IV) route. On 21Mar2021, the patient was hospitalized due to nausea and vomiting after getting the COVID vaccine. The action taken in response to the events for treprostinil sodium was unknown. The clinical outcome of the events was unknown. The reporter did not provide causality for the events of nausea and vomiting. Case Comment/Senders Comment: The company has assessed the serious adverse events of nausea and vomiting as possibly related to IV treprostinil based on the known safety profile of the suspect drug even though there was a lack of temporal relationship. The events could also have been caused by the recent administration of the COVID vaccine. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of nausea and vomiting due to temporal relationship and current known drug safety profile. Case will be re-assessed upon the additional information provided. 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: OPSUMIT

Current Illness:

ID: 1182759
Sex: F
Age:
State:

Vax Date: 02/23/2021
Onset Date: 02/25/2021
Rec V Date: 04/08/2021
Hospital: Y

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: COVID symptoms after first vaccine/had COVID tested and it was positive; was very weak, achy, and could not get out of bed on 16 MAR 2021 to get the second shot; could not get out of bed; was very weak, achy, and could not get out of bed on 16 MAR 2021 to get the second shot; This is a spontaneous report received from a contactable consumer. A 85-year-old female patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201), via an unspecified route of administration on 23Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 2 days after her first dose on 25Feb2021, the patient started with COVID symptoms, very weak, achy, and could not get out of bed and was hospitalized, and it was unsure if patient had COVID when she got the vaccine. On 01Mar2021 her mother tested positive for Covid. Patient experienced. The patient was scheduled to have her second dose on 16Mar2021. But patient tested positive again on 16Mar2021 and did not receive her second Pfizer Covid vaccine. Outcome of events was not reported. Additional information has been requested.; Sender's Comments: Linked Report(s) : PFIZER-2021347468 same reporter/ product, different patient

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm