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: 1299091
Sex: M
Age:
State: NJ

Vax Date: 04/17/2021
Onset Date: 04/01/2021
Rec V Date: 05/08/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: positive cardiac enzymes; myocarditis; hypotension 3 days post 2nd vaccination who was admitted; left-sided chest pain; sob; diaphoresis; dizziness; paresthesia's to his hands; transient fever; chills; headache; body aches; This is a spontaneous report from a contactable physician. A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 17Apr2021 (Batch/Lot Number: ER8731) (at the age of 22-years-old) as a single dose for COVID-19 immunisation as a single dose for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received the first dose of BNT162b2 on 22Mar2021ont at 08:45 in intramuscularly in the left arm (Lot Number: ER8727) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Apr2021, the patient developed transient fever, chills, headache, and body aches which resolved 24 hours after his 2nd Pfizer vaccine, followed by left-sided chest pain, shortness of breath (SOB), diaphoresis, dizziness, paresthesias to his hands; hypotension 3 days post 2nd vaccination, on 20Apr2021, patient was admitted to hospital with positive cardiac enzymes, initially troponin T baseline at 663, 1 hour follow-up troponin T at 943 with troponin T delta at 42%. A 3-hour troponin T at 1913 with a troponin T3HR delta at 189% and CPK >1000 with the diagnosis of myocarditis. Covid screen was negative, Covid antibody was negative, HIV was negative, drug screen negative and rest of work up for other causes so far negative. On 20Apr2021, he was transferred to another hospital for further cardiac care. Treatments for the events included pressor, cardiac medications, cath, etc. Patient remains hospitalized. In Apr2021, the patient recovered from the events, body aches, headache, chills, transient fever. The patient had not recovered from the events, positive cardiac enzymes, myocarditis, hypotension, left-sided chest pain, SOB, diaphoresis, dizziness, and paresthesias to his hands.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on temporal relationship and lack of alternate explanation at this time. Case will be reassessed if additional information is received. 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: 1299092
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/08/2021
Hospital: Y

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: administered dose 1 and then they got Covid; administered dose 1 and then they got Covid; This is a spontaneous report from a contactable Other HCP. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. A patient in a nursing home was administered dose 1 and then they got Covid and was admitted to the hospital. They were administered convalescent plasma and monoclonal antibodies. Outcome of the events, administered dose 1 and then they got Covid was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity between the first vaccine dose and the event onset. The case will be reevaluated should additional information become available.

Other Meds:

Current Illness:

ID: 1299093
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 05/08/2021
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:

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

Symptoms: I can't hear out of one ear,; I feel like I have a really bad cold; I'm very tired; I feel really sick; and I'm concerned that I may have covid now; This is a spontaneous report from a contactable consumer(Patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She had her first dose of the Pfizer BioNTech covid vaccine and concerned that she may have covid now. Since getting the shot she feels like having a really bad cold, can't hear out of one ear, she is very tired and feel really sick. She is not sure if these are side effects of getting the vaccine or if she has covid. The outcome of all the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299094
Sex: F
Age:
State: VA

Vax Date: 03/31/2021
Onset Date: 04/20/2021
Rec V Date: 05/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at vaccination age of 73-year-old via an unspecified route of administration in the left arm on 31Mar2021 [reported as 1:00 or 1:30 pm] (Lot Number: EW0150; Expiration Date: Jul2021) as a single dose for covid-19 immunisation (didn't want to get COVID again or the variants; also due to age group). The patient reported that she had Covid illness back in Jan2021 and she tested positive for antibodies afterward (2021) after the COVID infection. The patient had no family medical history relevant to the adverse events. The patient's concomitant medications were not reported. The patient did not receive additional vaccines administered on same date of the Pfizer suspect or history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive other vaccine within 4 weeks prior to vaccination. She has started her vaccine series with the Pfizer-Biontech Covid19 vaccine and was due for her second dose 27Apr2021. She recently took a rapid Covid test that came back positive on 20Apr2021. She inquired if she can still go for her second dose as scheduled. She states that she had a scheduled nuclear stress test that she had to reschedule because of her testing positive. She stated that she called her PCP and he stated that with all the antibodies she has, she shouldn't have to quarantine, and she would be able to get the second vaccine, but also to check with Pfizer. Her doctor doesn't think she is contagious or anything since she has the antibodies, so she was just trying to get a second opinion. She also stated that her symptoms were just the same as the first time she had COVID which are fatigue and headache which started the afternoon of 20Apr2021. She confirms these symptoms are still persisting. She's been treating the headache with Tylenol. She mentioned that the events did not require emergency room visit or physician's office visit. She made the comment she believes she can take the vaccine from what she gathered. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1299095
Sex: M
Age:
State:

Vax Date: 04/18/2021
Onset Date: 04/01/2021
Rec V Date: 05/08/2021
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: feeling like it takes a while to comprehend things; fatigue; congestion; ongoing redness at the injection site; he felt healthy and normal before getting the shot and now he feels terrible; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 19Mar2021 and had no adverse event. On an unspecified date in Apr2021, since the second dose he reports that he has had fatigue, congestion, feeling like it takes a while to comprehend things and ongoing redness at the injection site. The patient reported frustration because he felt healthy and normal before getting the shot and now, he feels terrible and doesn't know when he will feel better. The patient reported that he didn't want to get the shot, but his daughter coerced him into getting it. The outcome of the events ongoing redness at the injection site and he felt healthy and normal before getting the shot and now he feels terrible was not recovered and other events was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1299096
Sex: F
Age:
State: NC

Vax Date: 04/04/2021
Onset Date: 04/04/2021
Rec V Date: 05/08/2021
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:

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

Symptoms: Atrial Fibrillation for 4 1/2 hours; 1st dose was 31Mar2021, 2nd dose on 04Apr2021; 1st dose was 31Mar2021, 2nd dose on 04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 04Apr2021 13:00 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. The first dose was received on 31Mar2021 13:00 on the left arm. The patient medical history was not reported. Patient was not pregnant. Concomitant medications included flecainide, apixaban (ELIQUIS), atorvastatin and unspecified multivitamins. No other vaccines within four weeks. The patient experienced atrial fibrillation for 4 1/2 hours on 22Apr2021 07:30. Flecainide was given as treatment. Outcome of the event of atrial fibrillation was recovered on an unspecified date. Patient did not have covid prior to vaccination and had not been tested post-vaccination.

Other Meds: FLECAINIDE; ELIQUIS; ATORVASTATIN

Current Illness:

ID: 1299097
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/08/2021
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: blood clot; This is a spontaneous report received from a contactable pharmacist from a Pfizer-sponsored program. A 70-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist was asking if there have been any reports of blood clots associated with the COVID-19 vaccine as the patient developed blood clot 1.5 weeks after receiving his first Pfizer COVID vaccine on an unspecified date. The outcome of the event was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Blood clots 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: 1299098
Sex: M
Age:
State: FL

Vax Date: 04/01/2021
Onset Date: 04/12/2021
Rec V Date: 05/08/2021
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: Pharyngeal swelling

Symptoms: diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient wanted to know if he should receive the second dose of the Pfizer COVID-19 vaccine after he has been diagnosed with COVID-19. On 12Apr2021, he was diagnosed with COVID-19 and hospitalized, he improved and left the hospital yesterday (21Apr2021), his appointment for the second is today (22Apr2021). The patient was hospitalized for diagnosed with covid-19 from 12Apr2021 to 21Apr2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive (diagnosed with covid-19) on 12Apr2021. The outcome of the event was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299099
Sex: F
Age:
State:

Vax Date: 04/09/2021
Onset Date: 04/16/2021
Rec V Date: 05/08/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: her kidney function usually has been in a 55-57 range; GFR went down to 44; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 16Apr2021, she went to get blood work done and her GFR went down to 44. She stated that her kidney function usually has been in a 55-57 range. The patient wanted to consult if this is a known side effect. The patient would like to consult if she should get the second dose of the COVID-19 vaccine after presenting side effects from the first. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299100
Sex: M
Age:
State: NC

Vax Date: 04/18/2021
Onset Date: 04/19/2021
Rec V Date: 05/08/2021
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:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Bright red blood and blood clots in urine on 4 consecutive days; Bright red blood and blood clots in urine on 4 consecutive days; This is a spontaneous report from a contactable nurse (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 71 years of age), dose 2 via an unspecified route of administration, administered in arm left on 18Apr2021 10:30 (Batch/Lot Number: ER8733) as a single dose for COVID-19 immunisation. Medical history included hypertension and penicilline allergy, both from an unknown date and unknown if ongoing. Concomitant medication included bisoprolol taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2, dose 1 via an unspecified route of administration, administered in arm left on 22Mar2021 14:30 (Batch/Lot Number: ER8737) (at 70 years of age) for COVID-19 immunisation. The patient had no other vaccine in four weeks prior to covid vaccine. He had no covid prior vaccination. He had not been tested for covid post vaccination. It was reported that the patient experienced bright red blood and blood clots in urine on 4 consecutive days. The events started on 19Apr2021 10:30 AM with outcome of not recovered. The patient had not received any treatment for the events.

Other Meds: BISOPROLOL

Current Illness:

ID: 1299101
Sex: F
Age:
State: RI

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 05/08/2021
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: Loss of vision in left eye.; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), via an unspecified route of administration, administered in right arm on 13Apr2021, at 10:00 as single dose for covid-19 immunisation. Medical history included Lupus, Hashimotos, chronic obstructive pulmonary disease, asthma, non- alcoholic fatty liver disease, and allergy from unknown dates. The patient experienced loss of vision in left eye on 13Apr2021, at 10:00. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent other tests and magnetic resonance imaging in Apr2021 with unknown results. Therapeutic measures were taken as result of the event. No COVID prior to vaccination was noted. No COVID test was performed post vaccination. The outcome of loss of vision in left eye was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1299102
Sex: F
Age:
State:

Vax Date: 03/15/2021
Onset Date: 04/12/2021
Rec V Date: 05/08/2021
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: scheduled to receive the second dose on 12Apr2021 but tested positive for COVID that day; scheduled to receive the second dose on 12Apr2021 but tested positive for COVID that day; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was scheduled to receive the second dose on 12Apr2021 but tested positive for COVID that day. The patient wanted to know when to receive the second dose. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299103
Sex: U
Age:
State: NJ

Vax Date: 04/02/2021
Onset Date: 04/10/2021
Rec V Date: 05/08/2021
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: Blood clot in the calf; Swelling/pain behind the knee; Swelling/pain behind the knee; A 62-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included vitamin d3 (VITAMIN D3). The patient experienced blood clot in the calf and swelling/pain behind the knee on 10Apr2021. The events resulted in emergency room visit. The patient underwent lab tests and procedures which included nasal swab: negative on 17Apr2021. Therapeutic measures were taken as a result of thrombosis, joint swelling and arthralgia included anticoagulation medication. The patient did not have COVID prior vaccination. Outcome of the event was recovering. Information on the lot/batch number has been requested.

Other Meds: VITAMIN D3

Current Illness:

ID: 1299104
Sex: F
Age:
State: MI

Vax Date: 04/19/2021
Onset Date: 04/20/2021
Rec V Date: 05/08/2021
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:

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

Symptoms: Two large hot swollen areas on right leg Went to ER ultrasound detected superficial clot; This is a spontaneous report from a contactable consumer (patient). This 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 19Apr2021 12:15 (Batch/Lot Number: EWO164) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Patient is not pregnant at the time of vaccination. Concomitant medications included fluticasone propionate (FLONASE), fexofenadine hydrochloride (ALLEGRA), and ibuprofen. The patient previously took tobramycin and Wellbutrin and experienced allergies for both. Patient received the first dose of bnt162b2 for COVID-19 immunization on an unspecified date (lot number unknown). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 20Apr2021 18:30, patient had two large hot swollen areas on right leg. She went to the ER. Ultrasound detected superficial clot. AE resulted in emergency room/department or urgent care. Patient has not recovered from the event. Treatment included antibiotics and ibuprofen.

Other Meds: FLONASE [FLUTICASONE PROPIONATE]; ALLEGRA; IBUPROFEN

Current Illness:

ID: 1299105
Sex: M
Age:
State: CT

Vax Date: 04/04/2021
Onset Date: 04/10/2021
Rec V Date: 05/08/2021
Hospital: Y

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: Stroke; Dementia; Lost most of cognitive abilities; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 04Apr2021, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination). The patient's concomitant medications were not reported. On 10Apr2021, the patient experienced adverse events (AEs) including stroke, dementia, and lost most of cognitive abilities. The AEs resulted in doctor or other healthcare professional office or clinic visit, hospitalization from Apr2021, and disability or permanent damage. The outcome of the events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Other Meds:

Current Illness:

ID: 1299106
Sex: F
Age:
State: MA

Vax Date: 04/06/2021
Onset Date: 04/19/2021
Rec V Date: 05/08/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: 2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clot and other DVT clot found; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female consumer received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot ew0153 as single dose via unknown route at the left arm on 06Apr2021 11:30, at the age of 49 years, for COVID-19 immunization. The patient was not pregnant. Medical history included, in 1996 while on oral contraceptives had a blood clot in left leg. Prescribed Coumadin for year. Went off, bad leg swelling occurred. Prescribed compression stocking. Genetic test discovered Factor V Leiden mutation heterozygous. Since 1996-1998, have had bad swelling in left leg but no further clotting. Last time ultrasound was needed to confirm leg was just bad swelling was approximately 2007. No other clotting since around 1996-1998. Concomitant medications were not reported. On evening 20Apr2021, 2 weeks after vaccine, noticed pain, swelling, tenderness, redness and lump on left leg. Went to doctor on 21Apr2021. Ultrasound performed. Superficial clot and other DVT clot found. Prescribed Xarelto. The outcome of the events was reported as recovering. No covid prior vaccination and the patient was not tested for covid post vaccination.

Other Meds:

Current Illness:

ID: 1299108
Sex: F
Age: 44
State: CA

Vax Date: 05/01/2021
Onset Date: 05/05/2021
Rec V Date: 05/08/2021
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:

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

Symptoms: Neurological disorientation such as staggered motor function. It has been challenging to walk- extremely noticeable as if you are tipsy on new years eve - Headache in center of forehead that hasn't waned 24-48 hour period of visual abnormalities Extreme pain at injection site since shot and untol now although getting better Extreme Lethargy Shortness of Breath Plugged ears Congestion which went from clear mucus to bright green within an extreme short period of time Dr prescribed augmentin antibiotics ITS NOT COVID 19 I GOT A NEGATIVE TEST 5/5/2021 All over rolling from extreme to mild pains Muscle spasms in places all over the body. A part of my body is always twitching under the skin (not any jerking movements others report ) SEVERE CHEST PAIN Swollen arm at injection site A deep cough not severe and frequent but significant and persistent

Other Meds: Irbestatin Tylenol

Current Illness:

ID: 1299109
Sex: F
Age: 47
State: CA

Vax Date: 04/23/2021
Onset Date: 05/07/2021
Rec V Date: 05/08/2021
Hospital:

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

Lab Data:

Allergies: None known

Symptom List: Ear pain, Hypoaesthesia

Symptoms: After searching in Google it seems I have "Covid arm": site of vaccine is swelling, reddish and itchy. It's been 2 weeks I received the first Moderna dose.

Other Meds: Blood Pressure medicine

Current Illness: None

ID: 1299110
Sex: F
Age: 67
State: NY

Vax Date: 03/30/2021
Onset Date: 04/01/2021
Rec V Date: 05/08/2021
Hospital:

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

Lab Data:

Allergies: Latex

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Area of upper right arm feels painful, heavy and stiff, as if I just got the vaccine. I experienced the same symptoms with the first dose, but to a lesser degree. I have had these symptoms up to this very day.

Other Meds: Imbruvica 560mg, vitamin D3, Calcium, probiotic, vitamin B12, Magnesium, muti-vitamin

Current Illness: B cell Lymphoma

ID: 1299111
Sex: M
Age: 71
State: HI

Vax Date: 03/24/2021
Onset Date: 05/05/2021
Rec V Date: 05/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Viral symptoms developed on 5/5/21. Diagnosed with COVID on nasal swab on 5/6/2021, despite being fully vaccinated.

Other Meds:

Current Illness:

ID: 1299112
Sex: M
Age: 72
State: MI

Vax Date: 05/06/2021
Onset Date: 05/07/2021
Rec V Date: 05/08/2021
Hospital: Y

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: none

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

Symptoms: altered mental status. Pt was found sitting on lawn mower confused A o x 1-2.

Other Meds: coumadin, januvia, paxil, toprol xl, metformin, Vit D, Calcium Citrate, Aspirin, acetaminophen prn

Current Illness:

ID: 1299113
Sex: F
Age: 30
State: WA

Vax Date: 04/17/2021
Onset Date: 05/01/2021
Rec V Date: 05/08/2021
Hospital:

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

Lab Data:

Allergies: Shellfish

Symptom List: Unevaluable event

Symptoms: Left shoulder pain began 2 weeks after vaccine. 3 days after the pain, a rash began to form on my back. The rash got bigger and received Shingles diagnosis 19 days post vaccination. Blisters have spread from upper back, to shoulder, and down left arm. Currently dealing with shooting nerve pain.

Other Meds: Kyleena, prenatal vitamin

Current Illness:

ID: 1299114
Sex: F
Age: 67
State: TX

Vax Date: 03/29/2021
Onset Date: 04/24/2021
Rec V Date: 05/08/2021
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: Pollen, Smoke, Lemons, Grapefruit,

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

Symptoms: High Blood Sugars,

Other Meds: Both were manufactured by J&Johnson. Tremfyn and Covid Vaccine.. Metformin, Lantus solostar, Byetta, Ezetimbe, Quinapril, Cosoft PF Eye drops, Vitamin D3 2000, Advil for pain, Zinc.

Current Illness: Stroke, Diabetes II, Glaucoma, Macular Pucker, Astigmatism, Dry eyes, Psoriasis, Psoriatic Arthritis, Osteo Penia, porowsus, Arthritis, Eczema, A-topic Dermatosis, Dandruff, BPPV, HPV, ADHD, PTD, 47 XXy, Odd Mosiac, hermaphrodism, Female Klinefelters, and 165 other benigns issues & diseases.

ID: 1299115
Sex: F
Age:
State: MI

Vax Date: 03/06/2021
Onset Date: 03/27/2021
Rec V Date: 05/08/2021
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: a measles like rash on her chest, arms and midriff developed; itchy; a measles like rash on her chest, arms and midriff developed; rash on her chest, midriff, arms, and bottom of legs; She states that she experienced a headache and a sore arm; She states that she experienced a headache and a sore arm; This is a spontaneous report from a contactable consumer (the patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206; expiration date was not reported), via an unspecified route of administration Arm right on 06Mar2021 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER2613; expiration date was not reported), via an unspecified route of administration on 27Mar2021 (at the age of 74-years-old) as single dose for covid-19 immunization. The patient's medical history Included High Blood Pressure. Concomitant medications included diphenhydramine hydrochloride(BENADRYL) for rash; coal tar, dimeticone, zinc oxide(ECZEMA CREAM) for Itching; Metoprolol Tartrate; SIMVASTATIN; LOSARTAN; POTASSIUM CHLORIDE (KLOR CON) for potassium dropped; Amlodipine Besilate; hydrochlorothiazide for high blood pressure. On 11Apr2021, the patient noticed a measly like rash on her chest, midriff, arms, and bottom of legs, measles and it was very itchy, On 28Mar2021 Headache recovered on 2021, on 27Mar2021 a sore arm recovered on 28Mar2021. The patient instructed to took Benadryl for a week and if the rash persists to come in to the office for an examination and also eczema cream in addition to taking the Benadryl for the itching. Outcome of the events rash on her chest, arms and midriff developed (rash), itchy was not recovered, measles outcome was unknown, headache and a sore arm outcome was recovered. The patient received the second dose on 27 MAR 2021. She experienced a headache and a sore arm for day and a half after the vaccine. Then last week she also had a headache for two days in a row, but that could be due to the change in the weather, she doesn't know what that is. She said that a week and a half ago a rash, a measles like rash on her chest, arms and midriff developed. She wasn't sure if it was because she was working outside, or related to the vaccine. She did find a couple of ticks on her. She called the local farm bureau and they said no, it wasn't from the ticks because the ticks would of burrowed their head into the skin. It was probably because she was outside. The patient has been taking Benadryl do to the fact that she has been outside and she has been very itchy. Everything is in bloom right now, but she was wearing long pants and long sleeves with gloves. The patient's itching is horrible. The patient night before up all night took Benadryl. She got a cream her husband use to used for eczema, it was an anti-itch cream, and she also used Aveeno eczema cream that has calamine lotion in it. The patient hasn't gone and seen her doctor yet because she felt better two days later and thought it was subsiding. The patient might be because she takes a shower and then she is alright for a couple of hours because of all the creams she is using. The last night she was up till 3 am because of the itching. She stated that she knows you are not suppose to take other peoples medication but she had Prednisone 10 mg in the house, from her husband when he would have eczema flare ups, and she took that at 3 in the morning. She said that her doctor thought there has been too much time from when she got the vaccine for it to be related so she googled and it said that people can get a measles like rash, and read something about being on their toes, but hers wasn't on her toes. Her rash was just her chest, arm, part of her legs and midriff. She stated that she is nervous, and she lost her husband a year ago on 28 APR and she doesn't know, if it is just nerves/stress or if it due to the reaction. The patient when she went to go get the vaccine they had asked her if she ever had reaction to a vaccine and she said a year ago when she had the pneumonia shot, she got cellulitis 2 inches above and 2 inches below the injection site. Her doctor thought it was cellulitis and she had to take antibiotics for a week. She stated that she had to wait longer then the normal 15 minutes because of her previous reaction so they made he wait for 30 mins when she got the covid vaccine. The first shot did not hurt at all. She asked that because she said that the second vaccine hurt immediately, it was discomforting. She thought she hit a nerve. She said it was like someone ran a nail down all the way down to her elbow. She doesn't know if she hit a nerve or what, but it was very painful. Clarified her headache started Sunday night after the vaccine and went away Monday. The patient thought the rash might be shingles, but then she was like no, that is only suppose to be on one side of a body. She stated that she needs to get the new shingles shot because the one that she had years ago isn't good anymore. She hasn't had new shingles immunization yet because she had to get the COVID shot. She doesn't know if the itching started because she saw the ticks or not but it started immediately. She states that she got the ticks off of her and shook her hair out. She states that she took Benadryl, she didn't have the fast acting Benadryl she had the 24 hour relief Benadryl. She went to the store and got fast acting Benadryl and has been taking them ever since Monday. She took Benadryl 25mg two only at night. Lot S200513 exp. May 2023. The patients second dose received on 27Mar2021 on right arm with lot number ER2613. She was told to get the vaccine in the dominant arm which is her right arm. She used to always get vaccines in her left arm because you were suppose to get it in her nondominant arm because of the movement. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Follow-up #1(PRD 22Apr2021): This is a spontaneous report from a contactable consumer. This 74-year-old female consumer (patient) reported for herself that: updated new events Headache: (From: 28Mar2021 To: 2021), sore arm: (From: 27Mar2021 To: 28Mar2021), a measles like rash on her chest, arms and midriff developed. Updated Concomitant Products Metoprolol, hydrochlorothiazide, simvastatin, Losartan, Klor-Con, Amlodipine for high blood pressure, she states that the last bone density test she had her numbers were good but her doctor put her on this prophylactically. Critical Calcium supplement maximum plus for bone density. The patient's blood pressure medication and vitamins but they haven't changed since she has been going to her current doctor for 5 or 6 years. No follow-up attempts are needed. No further information is expected.

Other Meds: BENADRYL; ECZEMA CREAM; Metoprolol Tartrate; SIMVASTATIN; LOSARTAN; KLOR CON; Amlodipine Besilate; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1299116
Sex: F
Age:
State: PA

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 05/08/2021
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: patient was a breastfeeding mother and got a plugged duct resulting in mastitis; patient was a breastfeeding mother and got a plugged duct resulting in mastitis; patient was a breastfeeding mother and got a plugged duct resulting in mastitis; patient was a breastfeeding mother and got a plugged duct resulting in mastitis; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Apr2021 (lot number: ep 6955) at the age of 29 years old, as single dose for COVID-19 immunisation. Medical history included hypothyroidism and known allergies to sulfa drugs; both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccines received in four weeks. The patient was a breastfeeding mother and got a plugged duct resulting in mastitis on 18Apr2021 11:45 with outcome of recovering. Therapeutic measures were taken as a result of plugged duct resulting in mastitis and included unspecified antibiotics. The patient was not diagnosed with COVID prior to vaccination. The patient has not been tested for COVID post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021452792 same reporter/drug, different patient/event (baby case)

Other Meds:

Current Illness:

ID: 1299117
Sex: F
Age:
State: CA

Vax Date: 03/01/2021
Onset Date: 03/02/2021
Rec V Date: 05/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Neurological vocal and motor tics; Neurological vocal and motor tics; This is a spontaneous report from a contactable consumer. A 21-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 01Mar2021 16:00 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included ehlers-danlos syndrome from an unknown date. The patient previously took codeine, metoclopramide, prochlorperazine, vancomycin and experienced allergies. The patient experienced neurological vocal and motor tics on 02Mar2021 seriousness criteria was reported as disability and medically significant. Therapeutic measures were taken as a result of neurological vocal and motor tics. Outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1299118
Sex: M
Age:
State: NY

Vax Date: 02/18/2021
Onset Date:
Rec V Date: 05/08/2021
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: He received his first dose back on 18Feb2021 then, tested positive for Covid; He received his first dose back on 18Feb2021 then, tested positive for Covid; This is a spontaneous report from a contactable consumer (reporting for himself). A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced he received his first dose back on 18Feb2021 then, tested positive for COVID. The patient was treated "with and infusion". The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299119
Sex: F
Age:
State: TN

Vax Date: 03/30/2021
Onset Date: 04/22/2021
Rec V Date: 05/08/2021
Hospital: Y

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: stroke symptoms; vomiting; migraine; dizziness; sleeplessness; unilateral numbness; left side numbness to her face, fingers, toes, and calf; headache; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: ER8737; Expiration Date: Jul2021) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced stroke symptoms (hospitalization, medically significant), vomiting (hospitalization), migraine (hospitalization), dizziness (hospitalization), sleeplessness (hospitalization), unilateral numbness; left side numbness to her face, fingers, toes, and calf (non-serious). On 22Apr2021, the patient experienced headache (non-serious). The clinical course was reported as follows: The patient asked if she should get the second vaccine dose after her severe side effects. The patient reported that she received her first vaccine dose on 30Mar2021 (Lot number ER8737, exp Jul2021) and experienced "pretty bad side effects afterwards." The patient reported "I was not normal for a full week", reporting that she experienced vomiting, migraines, dizziness, sleeplessness and stroke symptoms. The patient went to the hospital and the patient underwent lab tests and procedures which included magnetic resonance imaging (MRI), Computerised tomogram (CT) scan, and Electroencephalogram (EEG), for which all came back negative and she was discharged after 7 hours. The patient reported that she spoke with her health care professional (HCP) who advised her to go to the emergency room (ER) when she reported having unilateral numbness. The patient reported: left side numbness to her face, fingers, toes, and calf. The patient also reported experiencing dizziness to the point that she couldn't turn around or lean over for 4-5 days. The patient reported that the symptoms started to improve 7 days later, however, she was now apprehensive about getting the second dose. The patient reported that her doctor said it was fine to get the second dose, but she asked if there was any additional guidance. The patient had spoken to many friends who only experienced a sore arm. On 22Apr2021, the patient woke up with a headache and threw up. The clinical outcome of the events: stroke symptoms, vomiting, migraine, dizziness, sleeplessness, unilateral numbness; left side numbness to her face, fingers, toes, and calf, was recovering. The clinical outcome of the event, headache, was unknown.

Other Meds:

Current Illness:

ID: 1299120
Sex: M
Age:
State: CA

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 05/08/2021
Hospital: Y

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: the neurologist agreed that the vaccine has attacked nervous system; developed signs of stroke, he can't stand up and walk up straight; feeling unwell and was unable to work for a few days; he had tingling on the left side that moved to his right side; he has difficulty speaking/ word finding/Slurring his speech; tinnitus; nausea; pain in the rear of his neck, between the neck and skull; His symptoms continue to be severe and is unable to work; he cannot coordinate his thoughts and fantasies; dizziness, he felt his head was spinning; He had some kind of palsy where his face was not reacting bilaterally; pressure in his brain; Got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms; This is a spontaneous report from a contactable consumer (patients wife). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 25Mar2021 (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 experienced the neurologist agreed that the vaccine has attacked nervous system (nervous system disorder) (hospitalization) on an unspecified date with outcome of unknown , developed signs of stroke, he can't stand up and walk up straight (cerebrovascular accident) (medically significant) on an unspecified date with outcome of unknown , feeling unwell and was unable to work for a few days (malaise) (medically significant) on an unspecified date with outcome of unknown , he had tingling on the left side that moved to his right side (paraesthesia) (medically significant) on an unspecified date with outcome of unknown , he has difficulty speaking/ word finding/slurring his speech (dysarthria) (medically significant) on an unspecified date with outcome of unknown , tinnitus (tinnitus) (non-serious) on an unspecified date with outcome of unknown , nausea (nausea) (non-serious) on an unspecified date with outcome of unknown , pain in the rear of his neck, between the neck and skull (neck pain) (non-serious) on an unspecified date with outcome of unknown , his symptoms continue to be severe and is unable to work (loss of personal independence in daily activities) (medically significant) on an unspecified date with outcome of unknown , he cannot coordinate his thoughts and fantasies (coordination abnormal) (medically significant) on an unspecified date with outcome of unknown , dizziness, he felt his head was spinning (dizziness) (medically significant) on an unspecified date with outcome of unknown , he had some kind of palsy where his face was not reacting bilaterally (paralysis) (medically significant) on an unspecified date with outcome of unknown , pressure in his brain (head discomfort) (non-serious) on an unspecified date with outcome of unknown , got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms (illness) (non-serious) on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299121
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/21/2021
Rec V Date: 05/08/2021
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: The patient was pregnant at the time of vaccination; The patient was pregnant at the time of vaccination; Miscarriage; This is a spontaneous report from a contactable consumer (patient, self-reported). The patient reported information for both herself and fetus/baby. This is a maternal report. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID, prior vaccination. The patient was not tested for COVID post vaccination. The patient was pregnant at the time of vaccination. The Patient's last menstrual date was 09Jan2021 and delivery date was 16Oct2021. The mother reported she became pregnant while taking BNT162B2. The mother was 14 weeks pregnant at the onset of the event. It was reported that on 21Apr2021, the pregnancy resulted in spontaneous abortion- miscarriage and resulted in emergency room and physician visit. Outcome of the event miscarriage was reported as not recovered and for all other events, it was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299122
Sex: F
Age:
State: MN

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 05/08/2021
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: everything began to swim in front of her/Felt her knees giving out. Woke up face down on floor.; BP it was quite high; Blood began to drip from head wound.; blood began to drip from head wound; limbs felt rubbery and out of sorts; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 08:30 (Lot Number: ER8732) (at the age of 69-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. The patient not tested positive to COVID-19 pre or post vaccination. The patient medical history was not reported. Concomitant medications included amlodipine; fluoxetine; metoprolol and omeprazole, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient reported that on 24Mar2021 at 9:15 everything began to swim in front of her, the sink, counter, coffee pot, etc. Grabbed edge of sink to steady herself. Felt her knees giving out. Woke up face down on floor. Her limbs felt rubbery and out of sorts. Blood began to drip from head wound. Grabbed counter edge and pulled herself upright. Grabbed paper towel for compress. Wobbled over to sofa. She laid down. Her husband came home measured her blood pressure (BP) it was quite high and would not go down. She went to ER immediately. At ER, they took blood, observed, did Echo on heart and sent her home. No therapeutic measures were taken as a result of the events. The patient outcome of the events was recovered.

Other Meds: AMLODIPINE; FLUOXETINE; METOPROLOL; OMEPRAZOLE

Current Illness:

ID: 1299123
Sex: F
Age:
State: FL

Vax Date: 04/12/2021
Onset Date: 04/12/2021
Rec V Date: 05/08/2021
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: had seizures; she fell; she was sleeping a lot; fever; fatigue; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 at 12:00 (Lot Number: ER2613) (at the age of 47-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing ulcerative colitis. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6208) for COVID-19 immunization. The patient experienced fever and fatigue (on 12Apr2021) but then got better. On Monday 19Apr2021 she was sleeping a lot, she fell and then had seizures. The patient was taken to the emergency room and a CT scan was performed; she was there for 5-6 hours. The patient confirmed that she was not admitted to the hospital. The patient outcome of fever and fatigue was recovering, the outcome of the other events was unknown.

Other Meds:

Current Illness: Ulcerative colitis

ID: 1299125
Sex: F
Age:
State: PA

Vax Date: 01/20/2021
Onset Date: 04/08/2021
Rec V Date: 05/08/2021
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: DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right shoulder; very warm; swelling rapidly; sever left arm pain; nausea; Floating Bruising; Charlie horses on right leg calf; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL 3249) as SINGLE DOSE for covid-19 immunisation, at 63 years old. Medical history included caesarean section from 1988, and allergy to animal (Cat and Dog dander) from an unknown date. Patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 30Dec2020 17:00 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunisation. There were no concomitant medications. The patient previously took tramadol and experienced drug hypersensitivity (allergies). On 08Apr2021, while patient was reclining in her chair, she felt a tingling feeling on her right leg. She pulled up her pants leg and found her leg was severely black and blue, very warm and swelling rapidly. She went to the ER they did a CT scan and Chest Xray (Apr2021). The ER Doctors (mostly Medical Students at a Teaching Hospital) suspected she had a DVT. Patient was also experiencing severe left arm pain, left hand tingling and severe nausea. They said patient was fine on all accounts and told to get rays of her right leg and for her to follow up with her primary Doctor who is an NP with Hospital. After doing everything as instructed by all the Physicians, 16 days of the bruising and ER visit, patient is still experiencing "Floating Bruising" appearing on her right leg, right ankles and Charlie horses on right leg calf. Today patient now have black and blue on her right shoulder. Patient commented "Someone help me please. This is scary". Events occurred on 08Apr2021 17:00. Treatment was received for the events and required emergency room and physician office visit. Outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1299126
Sex: F
Age:
State: WA

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 05/08/2021
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: deep vein thrombosis left leg/Vascular u/s showed clot from the ankle to the groin in left leg; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation, administered at the hospital. Medical history included prediabetes, relapsing polychondritis, obesity, intolerant to gluten and cow's milk protein, and penicillin allergy. The patient is not pregnant at the time of report and vaccination. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included fish oil; ergocalciferol (VIT D); methylfolate; metformin; and desvenlafaxine succinate (PRISTIQ). On 12Jan2021 at 19:00, the patient's left ankle swelled double normal size. On 13Jan2021, left leg swelled. On 14Jan2021, patient knew it was a deep vein thrombosis left leg based on pain and swelling and past experience but waited till her day off on 15Jan2021 to seek medical care. Vascular u/s (ultrasound) on 15Jan2021 showed clot from the ankle to the groin in left leg. Sent to emergency department and started on Zarelto x 6 months for long term anticoagulation. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the second dose on 01Feb2021 at 16:45. Outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event deep vein thrombosis and the suspect drug. 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 Committees, and Investigators, as appropriate.

Other Meds: FISH OIL; VIT D; METHYLFOLATE; METFORMIN; PRISTIQ

Current Illness:

ID: 1299127
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/08/2021
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: Reoccurrence of lung cancer; This is a spontaneous report from a contactable consumer (friend). A female patient of an unspecified age received BNT162B2 (Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history included lung cancer. Concomitant medications were not reported. The consumer reported that her friend (the patient) got the vaccine and had a reoccurrence of lung cancer on unspecified date, in which she was told would not happen. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299128
Sex: F
Age:
State: MA

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 05/08/2021
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: fainted twice shortly after waking up/diagnosis was vasovagal syncope; fainted twice shortly after waking up/diagnosis was vasovagal syncope; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Apr2021 (batch/lot number and expiration date were unknown) as a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) on 31Mar2021 for COVID-19 immunization. Relevant medical history included a history of fainting on an unknown date in the past. It was unknown if the patient had known allergies. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. It was unknown if the patient was tested for COVID-19 post vaccination. The morning after receiving the second vaccine dose, on 22Apr2021, the patient fainted twice shortly after waking up. The patient went to the emergency room (ER), and the diagnosis was vasovagal syncope. Vital signs were normal on an unspecified date. The adverse event (AE) resulted in an emergency room/department or urgent care. The patient did not receive any treatment for the AE. The patient recovered from the event on an unspecified date in 2021. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1299129
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/08/2021
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: Arm pain; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), first dose on an unspecified date and second dose on 08Apr2021 via an unspecified route of administration at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain on an unspecified date and took Tylenol (2x500mg) after the first dose. It was sore for two days. She had arm pain again after the second dose and took Tylenol (2x500mg) twice daily for the event after the second dose. Caller stated she was never told about not taking Tylenol after getting the COVID vaccine. 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: 1299130
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/08/2021
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: a woman who was paralyzed after getting her doses of the Pfizer vaccine.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical and concomitant medications were not reported. The reporter reported that they are doing a story with a woman who was paralyzed on an unspecified date after getting her doses of the Pfizer vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299131
Sex: F
Age:
State:

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 05/08/2021
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: incredibly horrible itching under her Fitbit; whelp; her lips had started swelling; her tongue was tingling; she thinks that it was the beginning of anaphylactic reaction; she was just tired; type 1 hypersensitivity; a little soreness; It was like heaviness on her chest; having trouble breathing; allergic contact dermatitis; This is a spontaneous report from a contactable consumer (patient) and a physician. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 10:00 (lot number: EP7533) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing nickel allergy for decades which was under control and panic attacks. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021, it was reported that the patient didn't have any of the normal side effects such as fevers or chills but she was just tired and went to sleep early that night. She woke up on 15Apr2021 at 05:00 with incredibly horrible itching under her Fitbit that she wears to bed. She has a history of nickel allergy and she bought this particular Fitbit on purpose because it doesn't have any nickel in it that touches her skin and she has had no problems all year with the Fitbit. The itching was unbelievably bad and when she took the Fitbit off she had a horrible whelp under a tiny piece of metal that isn't even supposed to touch her skin. She thought well if it has exacerbated her nickel allergy then maybe it is doing something else to her body. On that day (15Apr2021), she thought that she had a panic attack and upon reading some information online, she thinks that it was the beginning of anaphylactic reaction because the symptoms are the same. She was thinking that the vaccine is doing something with her nickel allergy. It had used to be bad until she got it under control and she had it under control for many years. But with the things under the Fitbit she was blaming or associating it with the COVID vaccine so she took it off and then finally fell asleep again. But when she woke up in the morning, just a few hours later (15Apr2021), the bad whelp was still there and then her lips had started swelling and her tongue was tingling so she decided to look some more on google and she thinks that this is another version to an allergic reaction. She has had panic attacks before and she knows what they are now and she has learned through a therapist on how to get past and manage them but this was different for her. It was like heaviness on her chest and it felt like something was on top of her chest and she was having trouble breathing; both on an unspecified date in 2021. Her husband knows when she has a panic attack but this one was different she can't really explain it. She asks, what is the difference between a panic attack breathing and this type of breathing and later mentioned that she also had a little soreness (2021). In addition, the physician also called to report that this patient was complaining about 2 types of symptoms. The first was more an allergic contact dermatitis (2021) which the physician is not worried about. The second was lip swelling and tongue tingling which could be a type 1 hypersensitivity (2021). The physician is more concerned about the latter and would like to know if it is okay to pre-medicate the patient with Benadryl before getting the second dose. The outcome of the event 'she was just tired' was recovered on 14Apr2021; incredibly horrible itching under her Fitbit; whelp was recovering; her lips had started swelling and her tongue was tingling was recovered on 15Apr2021. The outcome of the other events was unknown.

Other Meds:

Current Illness: Allergy to metals (for decades and it was under control)

ID: 1299132
Sex: F
Age:
State: IN

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 05/08/2021
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: feels like she's dying; flu like symptoms; low grade fever; aches; This is a spontaneous report from a contactable consumer (patient's mother). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 21Apr2021 11:30 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient's mother reported that her daughter was experiencing flu like symptoms. Her daughter felt like she's dying. She has a low grade fever and aches. Her symptoms started today (22Apr2021). The outcome of the events were not recovered. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1299133
Sex: F
Age:
State: PR

Vax Date: 04/15/2021
Onset Date: 04/01/2021
Rec V Date: 05/08/2021
Hospital: Y

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: I can't be standing for more than a few minutes; My legs begin to cramp up; Muscle aches; Sore throat; Couldn't get out of bed all weekend; White blood and platelets count abnormally low; White blood and platelets count abnormally low; Mononucleosis; Cough; Dizziness; Muscle weakness; Fever; Headache; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in left arm on 15Apr2021 10:00 as single dose for Covid-19 immunization. Medical history included gastritis and sensitive stomach from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. Concomitant medications included drospirenone, ethinylestradiol (NIKKI); pantoprazole sodium sesquihydrate (PROTONIX); and an unspecified vitamin, all taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for Covid-19 immunization. The patient received her second dose on 15Apr2021, Thursday, and on 16Apr2021, Friday night, she got a mild headache. Beginning 17Apr2021 09:00, Saturday, she got severe headache, dizziness, muscle weakness, and a fever. Symptoms worsened throughout the days. On 19Apr2021, Monday, she also got a sore throat. She couldn't get out of bed all weekend. She went to the hospital and they found that her white blood and platelets count were abnormally low, among other low things (white blood at 1.8). She was hospitalized until 20Apr2021, Tuesday, and was found to have mononucleosis. Cough developed and ended Tuesday, 20Apr2021. Beginning 20Apr2021 onward, the muscle aches were the biggest complaint, she can't be standing for more than a few minutes or her legs begin to cramp up. Headaches and dizziness continued. Sore throat stopped, and fever began to subside. On 19Apr2021, the patient underwent lab tests and procedures which included platelet count: abnormally low, Nasal Swab/PCR: negative, and white blood cell count: 1.8. The events resulted in Doctor or healthcare professional office/clinic visit, Emergency room/department or urgent care, and events from 19Apr2021 caused hospitalization until 20Apr2021. Treatment for the events included Tylenol and IV fluids. The outcome of sore throat recovered in Apr2021, cough resolved on 20Apr2021, fever was recovering and for other events was not recovered.

Other Meds: NIKKI birth control; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]

Current Illness:

ID: 1299134
Sex: F
Age:
State: FL

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 05/08/2021
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: Got really inflamed and everything again; Brown-Sequard syndrome; Brown-Sequard syndrome; Tingling in both legs; legs getting swollen; whole left side of body swelling only from under the breast down; muscles tightening on the whole left side of body only from under the breast down; continued discomfort in left leg; Swelling makes it to where her joints can't like she can't bend her knee really well; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Apr2021 at 10:15 (Lot Number: EN6201), as single dose, for COVID-19 immunisation. Medical history included ongoing Brown-Sequard syndrome, ongoing diabetes mellitus, COVID-19 from 14Feb2021 to 2021 (for about 3 weeks), ongoing immunodeficiency. Concomitant medication included semaglutide (OZEMPIC) for diabetes mellitus. The patient experienced Brown-Sequard syndrome exacerbation (medically significant) on 01Apr2021 with outcome of unknown, tingling in both legs (non-serious) on 01Apr2021 with outcome of unknown, legs getting swollen (non-serious) on 01Apr2021 with outcome of unknown, whole left side of body swelling only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, muscles tightening on the whole left side of body only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, continued discomfort in left leg (non-serious) on 01Apr2021 with outcome of unknown, swelling makes it to where her joints can't like she can't bend her knee really well (non-serious) on 01Apr2021 with outcome of unknown, got really inflamed and everything again (non-serious) on 21Apr2021 with outcome of unknown. Patient reported that had swelling in the areas that normally, like the left side of her back, her stomach, all the sites that basically the Brown-Sequard Syndrome that she has problems with, it just exacerbated it. Follow-up attempts are completed. No further information is expected.

Other Meds: OZEMPIC

Current Illness: Brown-Sequard syndrome; Diabetes; Immunocompromised

ID: 1299135
Sex: F
Age:
State: MO

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/08/2021
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: This is a spontaneous report from a contactable consumer reporting for the daughter. A 41-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose maybe the right arm (reporter was unsure) at the age of 41-year-old for COVID-19 immunisation, administered through hospital. Medical history was none. There were no concomitant medications. In Apr2201 the patient experienced she can't hear right now and it won't go away, ringing in ears, she is extremely stressed out and this is affecting her life, she was so upset. The course of events was as follows: She has had ringing in her ears from this, started some time after the shot. She was extremely stressed out and this was affecting her life. She can't live like this. She recently divorced with 2 kids and trying to work. Went to the doctor twice and they sent her to ENT department. This is destroying her life. It was very stressful. Patient was having a severe problem. She had been to the doctor twice, including this week in Apr2021 and once the end of last week in Apr2021. They looked at her medications and sent her to counseling, to therapy. She had definitely not gotten better, has been persistent. She did not know on like a graph scale where it was. She received no treatment for ringing in ears. She was trying to take something for stress because this was horrible. She cannot hear right now and it won't go away. This is a serious problem. Reporter did not want her daughter to go deaf. She received a message from hospital, regarding her being scheduled for the second vaccine on Saturday and she said she was not going for that she wished she had not gotten the first one. Reporter stated she has a good friend who's daughter was a PA whom she has been corresponding to about this and she sent them links of how the Covid vaccine is linked to tinnitus. She has never had anyone report this. She sent it to her daughter and her daughter said can't read this, there is blogs with responses and she just said she can't read this, she was so upset that she can't hear right because of this with this ringing that won't go away. She had gotten a call from the Hospital Department stating that she was ready for the second shot. She was not getting the second shot and was sorry that she got the first one. The outcome of events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299136
Sex: M
Age:
State: TX

Vax Date: 04/19/2021
Onset Date: 04/22/2021
Rec V Date: 05/08/2021
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: clogged ears, loss of hearing acuity. Sudden onset.; clogged ears, loss of hearing acuity. Sudden onset.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8735), via an unspecified route of administration, administered in left arm on 19Apr2021 14:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. On 22Apr2021 20:30, the patient experienced clogged ears and loss of hearing acuity, sudden onset. There was no therapy for the events. The patient had no Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.

Other Meds:

Current Illness:

ID: 1299137
Sex: F
Age:
State: NC

Vax Date: 02/06/2021
Onset Date: 02/14/2021
Rec V Date: 05/08/2021
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: having a heart attack; couldn't breath; lungs were filled-up with fluid; felt like a pin cushion; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN9581), via an unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization. Medical history included breast cancer/her breast cancer had came back in the same place from 2006, both breasts removed on 2006. Concomitant medication included palbociclib (IBRANCE) taken for breast cancer female from 24Jun2020 to 04Feb2021 then from 01Apr2021 and ongoing. The patient previously received the first dose of bnt162b2 (lot number: EL3248) on 17Jan2021 for COVID-19 immunization and experienced acute bronchitis. On 14Feb2021, the patient was taken by an ambulance and was hospitalized because she couldn't breath, they thought she was having a heart attack, her lungs were filled-up with fluid. The doctors had her on oxygen while she was in the hospital, and did heart and lung tests on her on an unspecified date in 2021. While in the hospital, the patient felt like a pin cushion on an unspecified date. The patient left the hospital on 17Feb2021. The patient was tested for COVID-19 three times on unspecified dates all with negative results. the patient was hospitalized again on 25Feb2021 to 01Mar2021 for reasons not reported. The outcome of the events she couldn't breath, thought she was having a heart attack, her lungs were filled-up with fluid was recovered on 17Feb2021, while for the event felt like a pin cushion was unknown.

Other Meds: IBRANCE

Current Illness:

ID: 1299138
Sex: M
Age:
State: FL

Vax Date: 04/02/2021
Onset Date: 04/14/2021
Rec V Date: 05/08/2021
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: Tested positive for Covid19 PCR test on 14Apr2021, after receiving the first dose of the Covid19 vaccine on 2Apr2021; symptoms started on 8Apr2021 with a negative Covid19 rapid test that day.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 02Apr2021 19:00 (Batch/Lot Number: ER8732) as single dose at the age of 47-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were none. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). No events following prior vaccinations. The patient he got COVID in between the two doses: COVID-19 symptoms started on 08Apr2021 with a negative COVID-19 rapid test on 08Apr2021 and was tested positive for COVID19 PCR test on 14apr2021, after receiving the first dose of the COVID-19 vaccine. The events did not require a visit to Emergency Room? Or Physician Office. He received treatment with Tylenol. On 20Apr2021 he stopped the medication and he was feeling better now. The events were considered medically significant. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 14Apr2021, Sars-cov-2 test negative: negative on 08Apr2021. The outcome of event was unknown. This report was note related to a study or program. His second dose was scheduled for 23Apr2021. Caller was asking if he was still safe to get the vaccine or should he wait. A Product Complaint was filed.

Other Meds:

Current Illness:

ID: 1299139
Sex: M
Age:
State: NC

Vax Date: 03/22/2021
Onset Date: 03/27/2021
Rec V Date: 05/08/2021
Hospital: Y

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: Stroke; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Mar2021 09:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure, bleeding ulcer and helicobacter pylori infection both from 15Feb2021, and ongoing tumor on his heart. Concomitant medication included lisinopril taken for high blood pressure. The patient previously took the first dose of bnt162b2 in the left arm on 26Feb2021 (lot number: EN6203) for COVID-19 immunisation. Right before he had his first shot, he was in the hospital on 15Feb2021 with a bleeding ulcer and a helicobacter pylori infection. He had been in the hospital and isn't sure what all they gave him then. The patient started lisinopril 4 or 5 years ago when he was diagnosed with high blood pressure. His blood pressure was under control with the lisinopril but the patient is no longer on it. The patient's father had a stroke when he was 42 but he had high blood pressure and didn't get it treated. The patient got up around 07:00 in the morning on 27Mar2021. The patient's wife got up at 08:30 when she realized something was wrong. The patient said when he got up around 07:00, he experienced his right side being numb. The patient went to the emergency room and was treated there. He had a stroke. The patient was hospitalized from 27Mar2021 to 30Mar2021. The patient's wife doesn't know if it has anything to do with the shot. After his stroke, they put him on "carvilo". When the patient was in the hospital for the stroke, they found other issues. He has a tumor in his heart that's a pretty good size and the doctor said it had been there for awhile. So, they put her husband on "carvilo" to help with his blood pressure and his heart. She doesn't think the tumor had anything to do with the shot because the doctor did say the size of the tumor was as big as it was because it had been there a while. They found the tumor while trying to find out why he had the stroke. They still haven't found a reason as to why he had the stroke. The tumor is on the right side of his heart and they said they didn't think that had anything to do with the stroke. The tumor was found on 28Mar2021. They did an MRI and a CT scan on his head when he was in the emergency room (ER) on 27Mar2021. They also did an ultrasound on his heart, chest, and abdomen. Since he's been out, they did an MRI on his heart. They also did X-rays on his lungs. He is getting ready to go back to the hospital for open heart surgery on 07May2021. Outcome of the event was unknown.

Other Meds: LISINOPRIL

Current Illness: Blood pressure high; Cardiac neoplasm unspecified

ID: 1299140
Sex: M
Age:
State:

Vax Date: 03/25/2021
Onset Date: 04/08/2021
Rec V Date: 05/08/2021
Hospital: Y

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: DVT and PE, 2 weeks after first vaccine; DVT and PE, 2 weeks after first vaccine; This is a spontaneous report from a contactable physician. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) at the age of 57-years-old as single dose for covid-19 immunisation. Medical history included hypertension and hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included lisinopril; levothyroxine; amlodipine all taken for an unspecified indication, start and stop date were not reported. The patient experienced DVT (deep vein thrombosis) and PE (pulmonary embolism), 2 weeks after first vaccine on 08Apr2021. The patient was hospitalized due to the events for 1 day. Therapeutic measures were taken as a result of the events. The patient recovered from the events on an unspecified date in Apr2021. Information on lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between events DVT (deep vein thrombosis) and PE (pulmonary embolism) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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: LISINOPRIL; LEVOTHYROXINE; AMLODIPINE

Current Illness:

ID: 1299141
Sex: F
Age:
State: PA

Vax Date: 04/07/2021
Onset Date: 04/08/2021
Rec V Date: 05/08/2021
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: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Fever 103; total and severe body ache; chills; vomiting; swelling of hands; dizziness; terrible and constant abdominal pain; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 15:00 (at the age of 50-years-old) (Batch/Lot Number: ew0169) as SINGLE DOSE for covid-19 immunisation. Medical history included weight abnormal, Pituitary tumor extracted, known allergies_PCN. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 for Covid-19 immunisation on 30Mar2021 at 50-years-old. (Product: Covid 19, Brand: Pfizer, Lot Number: ER8727, Lot unknown: False, Administration Date: 30Mar2021, Administration time: 01:00PM, Vaccine location: Left arm, Dose Number: 1). On 08Apr2021 16:45, the patient experienced Fever 103, total and severe body ache, chills, vomiting, swelling of hands, dizziness, terrible and constant, abdominal pain. I have O Negative Blood and high percentages of Neanderthal DNA (more than 97% of population). The events were assessed as serious (disability). The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included body temperature: normal on 08Apr2021 Fever 103. The outcome of the events was not recovered. The patient did not have COVID prior vaccination, and was not covid tested post vaccination.

Other Meds: OMEPRAZOLE

Current Illness:

ID: 1299142
Sex: F
Age:
State: MO

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 05/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: cardiac enzymes were extremely elevated; Weight from 223 pounds to 211 pounds in 2 months; No appetite; Sleep pattern is bad/she cannot fall asleep until 0400 and then wakes right back up around 0800; Feels rough with fine bumps at times; Feels rough with fine bumps at times; Itches at times; Rash on outer aspect of arm; Tightness, uneasiness in chest; Palpitations, Fluttering in Chest; Palpitations, Fluttering in Chest; Easily Winded; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose on 16Mar2021 (Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), then the second dose on 07Apr2021 (Batch/Lot Number: ER8730; Expiration Date: 31Jul2021), both via an unspecified route of administration, at the age of 67-years-old, administered in arm left as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from 2002 and ongoing, ongoing diabetes mellitus, penicillin allergy from an unknown date and unknown if ongoing, became really sick, really fast, uncertain if was Covid 19 from Feb2020 to an unknown date and chest discomfort from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), glyceryl trinitrate (NITROGLYCERIN), both taken for chest discomfort; dulaglutide (TRULICITY) taken for an unspecified indication, all from an unspecified start date and ongoing. The patient previously took morphine and codeine and experienced drug allergy. The patient was at her eye doctor on 02Apr2021 and decided afterwards to have her grandson take her to the Emergency Room (ER) for some tightening and uneasiness she had been having in her chest over the preceding days. She also felt some palpitations, they were fast, then slowed down; did not feel labored. She went to the ER and was there for 8 hours. They told her that her cardiac enzymes were extremely elevated. After the cardiologist reviewed her results she was allowed to go home. She went to her regular cardiologist on 05Apr2021. That cardiologist went over her tests results and said that while it was not normal results for her he didn't find them too worrisome. He stated that just because her enzymes are elevated does not mean she is in trouble. He scheduled her for a Dobutamine Stress Test on 07Apr2021. She has been trying to get the results of this stress test from the doctor's office but has not been successful in doing so. Says that once she completed the Stress Test on 07Apr2021 she went to get her second dose of the Covid Vaccine. She was still having her symptoms when she got her second vaccine and they have continued since. She saw her endocrinologist who went over blood work with her. The endocrinologist told her that her blood glucose level was very good and her A1c was a 5.5. The endocrinologist was concerned because usually the A1c is between 6 and 7. Patient was 5 foot 6- and one-half inches. Tightness, Uneasiness in chest: Stated it is not pain, just an uneasy, uncomfortable, fluttering feeling. Palpitations, Fluttering in chest: Not a labored feeling, goes fast, then slows down, not constant. Rash on outer aspect of arm: Extends from her wrist to about 2-3 inches below her elbow. Outside of arm, not on the inner part of her arm. Feels rough with fine bumps at times; then will feel smooth again. Itches at times. She uses calamine lotion, which does help to relieve the itching and smooth the skin. Stated it eventually does come back though. Easily Winded: She has had respiratory conditions all of her life. This winded feeling, she has been having is different than that she stated. She gets the fast heartbeat really quick, can almost hear it; becomes winded and sits down. The episodes last about 15 minutes. She has had no appetite; she has lost almost 15 pounds in 2 months. Her weight was 223 pounds 2 months ago and now weighs 211 pounds. She mentioned her sleep pattern is bad. Some days she cannot fall asleep until 0400 and then wakes right back up around 0800. The patient underwent lab tests and procedures which included blood glucose: 100 on 22Apr2021, blood pressure measurement: 128/62 on 21Apr2021, body temperature: 97 degrees fahrenheit on 21Apr2021, haemoglobin: 5.5 on Apr2021, heart rate: 78 on 21Apr2021, myocardial necrosis marker: extremely elevated on 02Apr2021, oxygen saturation: 98 % on 21Apr2021. Therapeutic measures were taken as a result of rash on outer aspect of arm, Feels rough with fine bumps at times and Itches at times. The outcome of the events Itches at times, Feels rough with fine bumps at times, Rash on outer aspect of arm, Easily Winded was not recovered; Palpitations, Fluttering in Chest and Tightness, uneasiness in chest was recovering, while of the rest was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: ASPIRIN (E.C.); NITROGLYCERIN; TRULICITY

Current Illness: COPD (Verbatim: COPD); Diabetes (Verbatim: Diabetes)

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm