VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1692135
Sex: M
Age:
State: MT

Vax Date: 08/06/2021
Onset Date: 08/07/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210807; Test Name: Blood pressure; Result Unstructured Data: Test Result:low; Test Date: 202108; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown result; Test Date: 202108; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown result; Test Date: 202108; Test Name: EKGs; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210807; Test Name: heart rate; Result Unstructured Data: Test Result:high; Test Date: 202108; Test Name: X-rays; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Fainted; high heart rate; low blood pressure; This is a spontaneous report from a contactable consumer (patient). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0196), via an unspecified route of administration, in right arm on 06Aug2021 12:45 (at the age of 14-years-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 and allergy to amoxicillin. Concomitant medication included fish oil (OMEGA 3) and multivitamins. The patient experienced high heart rate, fainted and had low blood pressure on 07Aug2021 11:45. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures taken as a result of fainted, high heart rate and low blood pressure included fluids. The patient underwent lab tests and procedures which included x rays, blood work, EKG and CT scan in Aug2021. The outcome of the events was recovered in Aug2021.

Other Meds: OMEGA 3 FISH OIL [FISH OIL]

Current Illness:

ID: 1692136
Sex: M
Age:
State: TX

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: The caller did not clarify if the caller was diagnosed with diabetes before or after receiving the vaccine; This is a spontaneous report. A contactable consumer (patient) reported for himself. A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Apr2021 as dose number unknown, single for COVID-19 immunization. The patient medical history included diabetes mellitus (The patient mentioned that he also has diabetes). Concomitant medication was not reported. Other Products, patient history and investigation assessment: not provided. The patient did not clarify if the patient was diagnosed with diabetes before or after receiving the vaccine in 2021. Reporter seriousness of the case was unspecified. The outcome of the event was unknown. The lot number was not provided. Information on lot number has been requested during follow up.

Other Meds:

Current Illness:

ID: 1692137
Sex: F
Age:
State: MN

Vax Date: 07/10/2021
Onset Date: 07/29/2021
Rec V Date: 09/11/2021
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: Test Date: 2021; Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 202108; Test Name: echo; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: EKG; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: Holter monitor; Result Unstructured Data: Test Result:15% of the time was with PVCs; Comments: After second dose - I had a relatively normal set of data (2% of the time with PVCs); Test Date: 202108; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210801; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210807; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210728; Test Name: Saliva test-PCR; Test Result: Negative ; Comments: Other

Allergies:

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

Symptoms: About 2.5 weeks after my second vaccine, I started to have chest pains; returned with intense palpitations; The palpitations and pain decreased, I had a relatively normal set of data (2% of the time with PVCs)/recently the chest pains returned with intense palpitations; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 44-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number FA6780, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 10Jul2021 15:00 (at a age of 44-year-old) as dose 2, single for COVID-19 immunisation. The patient previously took bnt162b2 (BNT162B2, Lot number: EW0181, Expiry: Unknown) via an unspecified route of administration, administered in Left arm on 19Jun2021 at 02:00 PM as dose 1 single, for COVID-19 immunisation. The patient medical history included bee sting allergy, Known allergies was with sulfa from an unknown date and unknown if ongoing. The patient was not positive for COVID-19 prior to vaccination and had been tested post vaccination. Patient did not receive any other vaccines within 4 weeks and other medications 2 weeks include women's daily multi vitamin prior to the COVID vaccine. It was reported that, about 2.5 weeks after her second vaccine, she started to have chest pains. After a week of intermittent chest pain, the pain was concentrated on her left side and she went to the ER where an EKG was done and blood work was done. She just moved when the chest pains were starting and since she didn't have her Holter data, they asked her to do another Holter monitor. In the meantime, the palpitations and pain decreased, she had a relatively normal set of data (2% of the time with PVCs) and felt back to normal for about 2 weeks. Then, recently the chest pains returned with intense palpitations. Patient just had an echo and an MRI done and awaiting results. On an unspecified date in 2021 the patient underwent lab tests and procedures which included blood test: unknown results, echocardiogram: unknown results, electrocardiogram: unknown results, electrocardiogram ambulatory: 15% of the time was with PVCs, after second dose she had a relatively normal set of data (2% of the time with PVCs), magnetic resonance imaging: unknown results on Aug2021, SARs-cov-2 test: negative on 01Aug2021 Nasal Swab, sars-cov-2 test: negative on 07Aug2021 Nasal Swab , sars-cov-2 test: negative on 28Jul2021 Other. No treatment was taken for the events. The outcome of the events were not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692138
Sex: F
Age:
State: WY

Vax Date: 01/08/2021
Onset Date: 01/01/2021
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/100; Test Date: 20210622; Test Name: EKG; Result Unstructured Data: Test Result:abnormal; Comments: inverted T wave; Test Date: 20210622; Test Name: Troponin; Result Unstructured Data: Test Result:7.5 or something

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: myocarditis; pericarditis; troponin and did an EKG. From there she was life flighted/troponin levels, and they 7.5 or something/She was hospitalized; chest pain; heart attack; fainted; haven't been able to return to work; BP going high; heart pounding; didn't feel good; dizziness; disoriented feeling; uncomfortable; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1284), dose 2 via an unspecified route of administration on 08Jan2021, single for COVID-19 immunization. Medical history included, blood pressure measurement from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took carvedilol, BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EK5730), dose 1 via an unspecified route of administration on left arm 18Dec2020 7:00 to 8:00 am as single for COVID-19 immunization and experienced myocarditis and pericarditis. On an unspecified date, patient received both doses of Pfizer covid 19 vaccine, the first dose on 18Dec2021 and second dose 08Jan2021, she was 66 years old at the time. Reporting that after the first dosage of Pfizer covid vaccine she was diagnosed with myocarditis and pericarditis and after the second dose in Jul she had the heart attack after both doses. The patient stated that "she was diagnosed with myocarditis and pericarditis in Jun after hospitalization, but struggling all through the spring with heart pounding, BP going high, dizziness, just dizzy funny disoriented feeling started first week of Jan." This week has to have proof of vaccination which she has. Her concern is as she understands it, there is never going to be 100% proof of how she got myocarditis. She states she has been living in (Withheld) for 3 years and never sick. The only thing was she had this vaccine. She doesn't know what to do about Booster. What about some point, they want to see proof of booster? I want to be protected. I don't know what to think about getting the booster. The cardiologist said you don't get it he also works with Pediatric doctor with a different opinion. What do I do? Caller states, "As a patient I am trying to get all of my information, I get so many opinions one for one and another from another. DSU - I just thought my blood pressure medications wasn't working anymore. then the cardiologist asked me questions. I had chest pain and didn't feel good. I would be hiking and I couldn't do it felt dizzy, not feeling safe, heart started pounding, it wouldn't slow down. I started with these symptoms till it progressed to this heart attack. My symptoms started and I began writing down my blood pressures, I started doing that on 04Jan. I Hiked and experienced dizziness and disoriented feeling. This whole summer since the heart attack, I haven't been able to return to work. She explains she got her first dose on 18Dec2020 and her second on 08Jan2021. She began having symptoms the first week of Jan2021. She was diagnosed with myocardia and pericarditis. She experienced further symptoms in 21Jun2021 and went to urgent care on 22Jun2021 where it was found she had a heart attack. Caller remarks her employer wants proof of vaccination and she is unsure about the booster shot. The symptoms started in Jan2021, before the second dose and continued through the spring. She explains that she didn't relate this to the vaccine, the cardiologist suspected it was due to vaccine as he has seen with others. She reported she had been on carvedilol since early 2006, and her blood pressure was controlled. Suddenly she noticed she was not feeling right but not sure of the date this started. This made her started tracking her blood pressure and she was getting high readings of 150/100 where her normal was 130's/80-90. She tracked this through the spring and started going to primary care to get checked. She visited her primary care related to this on 19Jan2021, 03Feb2021, 17Mar2021, 31Mar2021, and 01Jun2021. She had her heart attack in Jun2021. Late in the afternoon 21Jun2021 she started having chest pain but didn't go to urgent care until 22Jun2021 where they checked her troponin and did an EKG. From there she was life flighted to a different hospital. She was hospitalized from 22Jun2021-24Jun2021.She was hospitalized again in mid-Jul2021 where she spent the night for observation, this was around 14Jul2021. Her cardiologist had discussed this and said he felt like he had seen other similar cases. The symptoms mentioned that started in Jan2021 were, with high blood pressure, dizziness which she described as a kind of disoriented feeling and her heart would pound and be really uncomfortable when she would do anything. It would take a long time to slow down too. Her primary care changed blood pressure medication several times during the spring while she was following up related to the symptoms. Caller has no other product names other than the carvedilol mentioned and no NDC, Lot, or Expiry to provide for any of those products. She notes they are in pharmacy bottles and she doubts there are any lot numbers for the products. When she went to urgent care in Jun2021 with her heart attack, she noted they did an EKG that showed it was abnormal with inverted T wave and checked her troponin levels, and they 7.5 or something. This is why they sent her to the hospital. When asked how the event is since starting the caller relays she has not been to work since the event. She feels like there has been improvement but doesn't think she could go back to work. It is reported she fainted Tuesday afternoon and felt she felt like fainting before she called us. She is still having chest pain and her heart pounds. The caller did say she was told her EKG has improved. She went to the ER again 23Aug2021 with chest pain and was checked and discharged. They looked at her EKG, troponin level and blood pressure. Her troponin is normal and that is why she was sent home; she saw cardiologist the next morning. No treatment was received. The patient underwent lab tests blood pressure measurement was 150/100 on an unspecified date, electrocardiogram was abnormal so the inverted T wave, troponin was 7.5 or something as reported on 22Jun2021. The outcome of events myocarditis, pericarditis recovered on 23Aug2021. The outcome of events troponin a did an EKG, From there she was life flighted/troponin levels, and they 7.5 or something/She was hospitalized was recovered on 24Jun2021 and rest all other outcome of events were unknown.

Other Meds:

Current Illness:

ID: 1692139
Sex: F
Age:
State: CA

Vax Date: 08/08/2021
Onset Date: 08/24/2021
Rec V Date: 09/11/2021
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: Facial paralysis; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 32-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 08Aug2021 13:30 (at the age of 32-yearsold) as dose 1, single for COVID-19 immunization. Medical history included hepatitis c from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient had no Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In Health Clinic facility patient received vaccine. The patient experienced facial paralysis on 24Aug2021 at 20:00. The events assessed as serious (medically significant). Patient visited Emergency room/department or urgent care. No treatment was received for the event. The outcome of the events was reported as not recovered. The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1692140
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Name: SARS-CoV-2 spike antibody test; Result Unstructured Data: Test Result:none; Test Name: SARS-CoV-2 test; Test Result: Positive

Allergies:

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

Symptoms: kidney transplant recipients who developed COVID-19 more than 14 days after receipt of 2 doses of SARSCoV- 2 mRNA vaccine, administered at the recommended dosing interval; kidney transplant recipients who developed COVID-19 more than 14 days after receipt of 2 doses of SARSCoV- 2 mRNA vaccine, administered at the recommended dosing interval; This author reported similar events in four patients. This is second of four reports. A 71-year-old male subject received two doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included renal transplant and calcineurin inhibitor-based immunosuppression. Time from transplant to 1st vaccine was 248 months. Thymoglobulin was not received 6 months prior to 1st vaccine dose. The subject's concomitant medications included prednisone and tacrolimus for maintenance immunosuppression. No MMF/ Aza was stopped or reduced. The subject developed COVID-19 more than 14 days after receipt of 2 doses of vaccine, administered at the recommended dosing interval. Symptoms started after 58 days from 2nd dose, including weakness, cough. SARSCOV-2 test was performed after 62 days from 2nd dose and was positive. Casirivimab and imdevimab were not given. The subject was hospitalized for 4 days, was not admitted to ICU, not requiring mechanical ventilation, no O2 supplement on discharge. Disposition was at home. Duration of follow-up was 79 days. The subject was still alive at time of last follow-up. The outcome of events was unknown. Recently, a study showed that only 54% of organ transplant recipients developed a positive antibody response after 2 doses of SARS-CoV-2 mRNA vaccine and, among kidney transplant recipients, only 48% had an antibody response 4. At our center the seropositivity rate in organ transplant recipients was 37.2% 5.This suggests that a significant proportion of transplant recipients remain at risk for COVID-19 despite completing the vaccination series. Our center encourages COVID-19 vaccination for all transplant recipients. We estimate an active follow-up of approximately 1,680 fully vaccinated kidney transplant recipients. We had 8 kidney transplant recipients who developed COVID-19 more than 14 days after receipt of 2 doses of SARSCoV- 2 mRNA vaccine, administered at the recommended dosing interval (table). All patients were symptomatic, most commonly with fatigue and cough. The median age was 65 years old (range 36-73), 50% had received a previous transplant, the median time from the most recent transplant to the first dose of mRNA vaccine was 31 months (range 3 - 248), and 3 out of 8 patients had received thymoglobulin for induction in the 6 months preceding vaccination. All patients were on calcineurin inhibitor (CNI)-based immunosuppression and 7 of the 8 were on mycophenolate mofetil. CNI level goals were not changed during illness, anti-metabolite doses were reduced or held based on symptoms and severity, at the discretion of the nephrologist. Symptom onset and SARS-CoV-2 testing occurred at a median of 56 days (range 18-77) and 59 days (range 20-77) after the second dose of the vaccine, respectively. Three patients received casirivimab/imdevimab as outpatient and did not require hospital admission. Three patients were hospitalized and had a length of stay of 3 to 5 days, without requiring ICU admission or mechanical ventilation. All were discharged to home without oxygen. None of the patients had anti-SARS-CoV-2 spike protein antibody checked after vaccination or disease and viruses were not sequenced. Data on the COVID-19 vaccine effectiveness is emerging, however, vaccine effectiveness in the immunocompromised population is lacking. It is encouraging that our breakthrough cases of COVID-19 after vaccination were mild and associated with good outcomes. However, we should continue to encourage our patients to be vaccinated and also encourage vaccination of household members and close contacts. Recent guidance allowing fully vaccinated individuals to resume prepandemic activities probably should not apply to transplant recipients. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 towards the breakthrough COVID-19 infection following vaccination in this patient cannot be completely excluded.,Linked Report(s) :PFIZER INC-202101115297 Same article/ drug/event and different patient:

Other Meds: TACROLIMUS; PREDNISONE

Current Illness:

ID: 1692141
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: sars-cov-2 test; Test Result: Positive ; Comments: 62 days after the second dose

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: kidney transplant recipients who developed COVID-19 more than 14 days after receipt of 2 doses of SARSCoV- 2 mRNA vaccine, administered at the recommended dosing interval; kidney transplant recipients who developed COVID-19 more than 14 days after receipt of 2 doses of SARSCoV- 2 mRNA vaccine, administered at the recommended dosing interval; This is a literature report. This author reported similar events in four patients. This is forth of four reports Recently, a study showed that only 54% of organ transplant recipients developed a positive antibody response after 2 doses of SARS-CoV-2 mRNA vaccine and, among kidney transplant recipients, only 48% had an antibody response 4. At our center the seropositivity rate in organ transplant recipients was 37.2% 5.This suggests that a significant proportion of transplant recipients remain at risk for COVID-19 despite completing the vaccination series. Our center encourages COVID-19 vaccination for all transplant recipients. We estimate an active follow-up of approximately 1,680 fully vaccinated kidney transplant recipients. We had 8 kidney transplant recipients who developed COVID-19 more than 14 days after receipt of 2 doses of SARSCoV- 2 mRNA vaccine, administered at the recommended dosing interval (table). All patients were symptomatic, most commonly with fatigue and cough. The median age was 65 years old (range 36-73), 50% had received a previous transplant, the median time from the most recent transplant to the first dose of mRNA vaccine was 31 months (range 3 - 248), and 3 out of 8 patients had received thymoglobulin for induction in the 6 months preceding vaccination. All patients were on calcineurin inhibitor (CNI)-based immunosuppression and 7 of the 8 were on mycophenolate mofetil. CNI level goals were not changed during illness, anti-metabolite doses were reduced or held based on symptoms and severity, at the discretion of the nephrologist. Symptom onset and SARS-CoV-2 testing occurred at a median of 56 days (range 18-77) and 59 days (range 20-77) after the second dose of the vaccine, respectively. Three patients received casirivimab/imdevimab as outpatient and did not require hospital admission. Three patients were hospitalized and had a length of stay of 3 to 5 days, without requiring ICU admission or mechanical ventilation. All were discharged to home without oxygen. None of the patients had anti-SARS-CoV-2 spike protein antibody checked after vaccination or disease and viruses were not sequenced. Data on the COVID-19 vaccine effectiveness is emerging, however, vaccine effectiveness in the immunocompromised population is lacking. It is encouraging that our breakthrough cases of COVID-19 after vaccination were mild and associated with good outcomes. However, we should continue to encourage our patients to be vaccinated and also encourage vaccination of household members and close contacts. Recent guidance allowing fully vaccinated individuals to resume prepandemic activities probably should not apply to transplant recipients. A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as Dose 1, single and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as Dose 2, single, both for covid-19 immunisation. Medical history included renal transplant from an unknown date (Time from transplant to 1st vaccine dose was 151 months). The patient's concomitant medications were not reported. Ongoing concomitant drug included Tacrolimus, MMF(mycophenolate mofetil) and prednisone. The patient was kidney transplant recipients who developed covid-19 more than 14 days after receipt of 2 doses of sarscov- 2 mrna vaccine, administered at the recommended dosing interval on an unspecified date. The symptoms of covid-19 included Cough, congestion and fever was occurred 60 days after the second dose. The events of covid-19 was without requiring hospitalization, ICU, Mechanical ventilation and O2 supplement. The patient underwent lab tests and procedures which included sars-cov-2 test: positive 62 days after the second dose. The outcome of covid-19 was unknown after 3 days home stay. Patient was alive on the latest follow up. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 towards the breakthrough COVID-19 infection following vaccination in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202101115297 Same article/ drug/event and different patient:

Other Meds: TACROLIMUS; MYCOPHENOLATE MOFETIL; PREDNISONE

Current Illness:

ID: 1692142
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Name: anti-SARS-CoV-2 spike protein antibody; Result Unstructured Data: Test Result:None of the patients had anti-SARS-CoV-2 spike pro; Comments: None of the patients had anti-SARS-CoV-2 spike protein antibody checked after vaccination; Test Name: SARSCOV-2 test; Test Result: Positive

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: kidney transplant recipients who developed COVID-19 more than 14 days after receipt of 2 doses of SARSCoV- 2 mRNA vaccine, administered at the recommended dosing interval; kidney transplant recipients who developed COVID-19 more than 14 days after receipt of 2 doses of SARSCoV- 2 mRNA vaccine, administered at the recommended dosing interval; This is a literature report. This author reported similar events in four patients. This is third of four reports. Recently, a study showed that only 54% of organ transplant recipients developed a positive antibody response after 2 doses of SARS-CoV-2 mRNA vaccine and, among kidney transplant recipients, only 48% had an antibody response. At the center the seropositivity rate in organ transplant recipients was 37.2% .This suggests that a significant proportion of transplant recipients remain at risk for COVID-19 despite completing the vaccination series. The center encourages COVID-19 vaccination for all transplant recipients. Authors estimate an active follow-up of approximately 1,680 fully vaccinated kidney transplant recipients. Authors had 8 kidney transplant recipients who developed COVID-19 more than 14 days after receipt of 2 doses of SARSCoV- 2 mRNA vaccine, administered at the recommended dosing interval. All patients were symptomatic, most commonly with fatigue and cough. The median age was 65 years old (range 36-73), 50% had received a previous transplant, the median time from the most recent transplant to the first dose of mRNA vaccine was 31 months (range 3 - 248), and 3 out of 8 patients had received thymoglobulin for induction in the 6 months preceding vaccination. All patients were on calcineurin inhibitor (CNI)-based immunosuppression and 7 of the 8 were on mycophenolate mofetil. CNI level goals were not changed during illness, anti-metabolite doses were reduced or held based on symptoms and severity, at the discretion of the nephrologist. Symptom onset and SARS-CoV-2 testing occurred at a median of 56 days (range 18-77) and 59 days (range 20-77) after the second dose of the vaccine, respectively. Three patients received casirivimab/imdevimab as outpatient and did not require hospital admission. Three patients were hospitalized and had a length of stay of 3 to 5 days, without requiring ICU admission or mechanical ventilation. All were discharged to home without oxygen. None of the patients had anti-SARS-CoV-2 spike protein antibody checked after vaccination or disease and viruses were not sequenced. Data on the COVID-19 vaccine effectiveness is emerging, however, vaccine effectiveness in the immunocompromised population is lacking. It is encouraging that breakthrough cases of COVID-19 after vaccination were mild and associated with good outcomes. However, authors should continue to encourage patients to be vaccinated and also encourage vaccination of household members and close contacts. Recent guidance allowing fully vaccinated individuals to resume prepandemic activities probably should not apply to transplant recipients. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 and dose 2 both via an unspecified route of administration on an unspecified dates (Batch/Lot number was not reported) as single doses for covid-19 immunisation. Medical history included kidney transplant and immunosuppression. The patient's concomitant medications included Tacrolimus and azathioprine as immunosuppression. The patient previously took thymoglobulin. It was reported kidney transplant recipients who developed covid-19 more than 14 days after receipt of 2 doses of sarscov- 2 mrna vaccine, administered at the recommended dosing interval on an unspecified date with outcome of unknown. Characteristics of the kidney transplant recipient who developed COVID-19 after two doses of mRNA vaccines were reported as follows: Time from transplant to 1st vaccine dose was 3 months. Type of vaccine was BNT162b2. Thymoglobulin 6 months prior to 1st vaccine dose. Maintenance IS (immunosuppression) -Tacrolimus, Aza (azathioprine). MMF (mycophenolate mofetil)/ Aza stopped or reduced was Yes. Symptoms were Dyspnea, weakness, fatigue, cough. 18 Days from 2nd dose to symptoms. 20 Days from 2nd dose to SARSCOV-2 test (Positive). Casirivimab and imdevimab was No. Hospitalization was Yes. ICU was No. Mechanical ventilation was No. Disposition Home. Length of stay was 3 days. O2 supplement on discharge was No. Previous transplant was Yes. Duration of follow-up was 70 days. Status at last f/u was Alive. The patient underwent lab tests and procedures which included anti-SARS-CoV-2 spike protein antibody: positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 towards the breakthrough COVID-19 infection following vaccination in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202101115297 Same article/ drug/event and different patient

Other Meds: TACROLIMUS; AZATHIOPRINE

Current Illness:

ID: 1692143
Sex: F
Age:
State: RI

Vax Date: 08/25/2021
Onset Date: 08/26/2021
Rec V Date: 09/11/2021
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: High fever; chest pain; back pain; This is a spontaneous report from a contactable consumer. A 35-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: FC3182 and expiration date was not reported), dose 2 via intramuscular route of administration in left arm on 25Aug2021 at 15:00 (age at vaccination 35-years-old) as single dose for COVID-19 immunization. The patient medical history included Anorexia. The patient's concomitant medications were not reported. The historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: FA7484 and expiration dates were not reported), dose 1 via an intramuscular route of administration in left arm on 04Aug2021 at 15:00 pm as single dose for COVID-19 immunization. No other vaccine in four weeks and no other medications in two weeks. On 26Aug2021 at 02:30 PM the patient experienced high fever, chest pain and back pain. The Adverse event resulted in Emergency room/department or urgent care. The patient treated with the Tylenol for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as withheld. The outcome of the events was recovering. Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692144
Sex: F
Age:
State: CA

Vax Date: 05/11/2021
Onset Date: 05/01/2021
Rec V Date: 09/11/2021
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: I started to break out in the hives and I still do every single day; I have been getting the severe allergic reaction with the food that I have been okay with eating; When probed for the event is worsened, improved or persisting, Consumer stated, " Worse, but it's kind of goes up and down, like sometimes it's better and sometimes it's bad."; This is a spontaneous report from a contactable consumer. This contactable 18-year-old female consumer (patient) reported that: An 18-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration, administered in Arm Right on 11May2021 (at the age of 18-year-old) as single dose for covid-19 immunisation. Patient medical history reported as none. Medical condition related to adverse event reported as none. Family history related to adverse event It's kind of unknown because I am adopted. There were no concomitant medications. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Left arm on 20Apr2021 (at the age of 18-year-old) as single dose for covid-19 immunisation. Patient was not received any other vaccine four weeks prior vaccination. Patient reported I was told to call if I had like lingering side effect of the vaccine (Covid-19 Vaccine). I got my first dose on 20Apr and second on 11May. Two weeks after on unspecified date in May2021, my second dose I started to break out in the hives and I still do every single day and I have been getting the severe allergic reaction with the food that I have been okay with eating. Patient reported when probed for the event is worsened, improved or persisting, patient stated, it was worse, but it's kind of goes up and down, like sometimes it's better and sometimes it's bad. Still experiencing the problem. Therapeutic measures were taken as a result of the events with Prednisone and Hydroxyzine. The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692145
Sex: F
Age:
State: NY

Vax Date: 07/19/2021
Onset Date:
Rec V Date: 09/11/2021
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: After 1st shot I had heart pain; After receiving my first Pfizer covid shot. I developed three very distinct mosquito like bites on my left arm. They were not going away, were very scratchy and developed a black dot within them; After receiving my first Pfizer covid shot. I developed three very distinct mosquito like bites on my left arm. They were not going away, were very scratchy and developed a black dot within them; Concurrently my gums swelled and were leaking blood/puss for unknown reasons; Concurrently my gums swelled and were leaking blood/puss for unknown reasons; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FA6780), via an unspecified route of administration, administered in left arm on 19Jul2021 at 05:00 (at the age of 45-years-old) as single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unknown date and unknown if ongoing. The patient had no known allergies. There were no concomitant medications. The patient after receiving first Pfizer COVID shot on an unspecified date developed heart pain, three very distinct mosquito like bites on left arm. They were not going away, were very scratchy and developed a black dot within them and concurrently the patient's gums swelled and were leaking blood/puss for unknown reasons. The patient had no other vaccine in four weeks; no other medications in two weeks. The patient received no treatment for the adverse events. The patient had COVID prior to vaccination and had not tested post vaccination. The clinical outcome for the events was unknown. Follow-up (27Aug2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Response: Dear Colleagues, please find translated form. Follow-Up (03Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692146
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Temperature; Result Unstructured Data: Test Result:98; Test Date: 2021; Test Name: Temperature; Result Unstructured Data: Test Result:100.1

Allergies:

Symptom List: Rash, Urticaria

Symptoms: This is a spontaneous report from a contactable consumer or other non-health care professional. A 47-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On unspecified date 2021, The patient experienced, after the first dose of the Pfizer COVID-19 vaccine 3 weeks ago and was due to get his second shot today but he had been "deathly ill", so bad that it was like flu like symptoms, she checked his temp every day, he had no energy/fatigue, kept a bucket next to him to throw up in, he was eating fine until 3 days ago, his breathing sounds was good. His temperature was 98. but yesterday it went to 100.1, she was not sure if he were dehydrated or not. She wanted to know what to do for him and if he should get the second shot or not today. These symptoms started one and a half weeks after getting the vaccine. My fiance had his shot. Three weeks ago and he started developing the flu like symptoms and that was a like symptoms because I was taking his temperature every hour and he was stayed at 98 all week so, I knew. It's side effect from the shot. I mean throwing up, fatigue but he also have no energy at all. It's hard for him to get up and go to bathroom. I am not finish. I know that, There are some side effects, That few people get but yesterday. He often loss his appetite and he losses appetite from three days and he haven't appetite. All week during all this because, I was eating three or four times a day and he was not eating and he was drinking lot of water and all sudden, Had already started again and now his temperature, It went from 98 to 100.1 and now he is due for his 2nd shot today and I am scared to taking with. I don't know, What to do about it. He doesn't have a doctor. He doesn't have a servant. I don't know, What to do." The patient underwent lab tests and procedures which included body temperature: 98 on 2021, body temperature: 100.1 on 2021. The outcome of events was unknown. Follow up attempt completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692147
Sex: F
Age:
State: MI

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
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: I had a 15 day heavy menstrual cycle- which is very abnormal for me. Heavy bleeding and very painful.; I had a 15 day heavy menstrual cycle- which is very abnormal for me. Heavy bleeding and very painful.; I had a 15 day heavy menstrual cycle- which is very abnormal for me. Heavy bleeding and very painful.; I had a 15 day heavy menstrual cycle- which is very abnormal for me. Heavy bleeding and very painful.; This is a spontaneous report from a contactable other hcp. A 31-years-old non pregnancy female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0179) dose number unknown via an unspecified route of administration on Aug2021 (age at vaccination 31years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and Other medications in 2 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced I had a 15-day heavy menstrual cycle- which is very abnormal for me. heavy bleeding and very painful on unspecified date in Aug2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1692148
Sex: F
Age:
State: OH

Vax Date: 04/07/2021
Onset Date: 03/01/2021
Rec V Date: 09/11/2021
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: Test Name: autonomic test; Result Unstructured Data: Test Result:Unknown; Test Name: bloodwork; Result Unstructured Data: Test Result:Unknown; Test Name: CT scan with contrast/CT without contrast; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: neurological issues/She states she is in the traumatic brain injury category; fatigue level increasing; difficulty concentrating; migraine; postural dizziness; visual disturbances; extreme sensitivity to any type of light, light was intolerable to her in May2021; extreme sensitivity in her ears, she didn't hear sounds, she felt the vibrations that the sounds made; paresthesia; numbness has been more on her right side than her left side; shooting pain primarily in her head; foot now is rather painful and tender; Her right leg doesn't work exactly as it should; worsening headache; hematuria; acute urinary tract infection; sinusitis; yeast infection; increased urinary frequency; allergic reaction to insect bites; neurological issues; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EP7534, expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in arm right on 17Mar2021 as dose 1, single and dose 2 via an unspecified route of administration, administered in arm right on 07Apr2021 (lot number: ER8734, expiration date: 31Jul2021) as dose 2, single for (at the age of 52-years-old) covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took flu vaccine about 3 weeks prior to the first Covid 19 vaccine. On an unknown date in Mar2021, the patient had difficulty concentrating, migraine, postural dizziness, visual disturbances, extreme sensitivity to any type of light, light was intolerable to her in May2021, and extreme sensitivity in her ears, she didn't hear sounds, she felt the vibrations that the sounds made. She also had paresthesia. She reports the numbness has been more on her right side than her left side. She also has shooting pain primarily in her head. She states she had injured a nerve in her left foot prior to receiving either Covid 19 vaccine and that foot now is rather painful and tender in the morning. Her right leg did not work exactly as it should. She was not dragging her right leg but from the time she got the first Covid 19 vaccine her right leg was not working properly. The patient experienced the worsening headaches, hematuria, acute urinary tract infection, sinusitis, yeast infection, allergic reaction to insect bites, and increased urinary frequency. The patient was in the traumatic brain injury category and her fatigue level was increasing. The patient was seen by her primary care doctor and went to and Urgent Care on 07Apr2021 after getting the second dose and the emergency department on 08Apr2021. She was not hospitalized. The bright side is, she's still alive. Her sister was the one who wheeled her in to the emergency department after her reaction but she is equally satisfied that she received the second Covid 19 vaccine. On an unknown date, bloodwork, CT scan without contrast, CT scan with contrast and autonomic test was performed but results were not reported. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1692149
Sex: M
Age:
State: FL

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:200/92; Comments: blood pressure was 200/92, constant; Test Date: 2021; Test Name: stress test; Result Unstructured Data: Test Result:UNKNOWN; Test Date: 2021; Test Name: EKG; Result Unstructured Data: Test Result:abnormal; Test Date: 2021; Test Name: heartrate; Result Unstructured Data: Test Result:140

Allergies:

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

Symptoms: blood pressure was 200/92 constant; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness. For 3 weeks following the vaccine, my heartrate was in the constant 140s; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness. For 3 weeks following the vaccine, my heartrate was in the constant 140s; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness. For 3 weeks following the vaccine, my heartrate was in the constant 140s; short of breath; He also had abnormal EKG; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: PFR; EM9810 via an unspecified route, administered in left arm on 09Feb2021 at 11:30 (31-year-old at vaccination) as a dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications within two weeks of vaccination. Vaccination facility type was reported as Hospital. The patient had not received any other vaccine in four weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with Covid. On 09Feb2021 at 11:30, immediately following the 1st vaccine of Pfizer, he started receiving heart palpitations and extreme dizziness/lightheadedness. For 3 weeks following the vaccine, his heartrate was in the constant 140s and his blood pressure was 200/92, constant. Every day he was very lightheaded, dizzy and short of breath. He also had abnormal EKG. These adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: 200/92, stress test: unknown result, Echocardiogram: abnormal on an unknow date in 2021. Post vaccination the patient was not tested for Covid. Treatment medication such as Metoprolol was taken as result of events. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1692150
Sex: F
Age:
State: AZ

Vax Date: 08/26/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
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: Administered subcutaneously; Pain in injection site; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program. A 39-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), subcutaneously on 26Aug2021 (Morning with unknown time) at vaccination age 39 years old (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunization. Vaccination Facility Type Doctor's office. The patient's medical history included asplenic and concomitant medications was not reported. The patient experienced administered subcutaneously as opposed to IM (intramuscularly) (medically significant) on 26Aug2021 with outcome of unknown, pain in injection site (medically significant), having a lot of pain in the arm which patient believed was because of the placement being incorrect in Aug2021 with outcome of not recovered. The events were not requiring emergency room, physician office and hospitalization. The lot number for pneumococcal 13-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.; Sender's Comments: A contributory role of PREVNAR 13 with incorrectly subcutaneous administration triggering the onset of vaccination site pain cannot be fully 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: 1692151
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: Covid; Result Unstructured Data: Test Result:negative

Allergies:

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

Symptoms: sore throat; stomach is bothering him; This is a spontaneous report from a Pfizer-sponsored program. A contactable Consumer reported for a male Patient (Reporter son) A 13-years-old male patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore throat and stomach is bothering him on an unspecified date. The reporter considered the events as non-serious. The clinical course reported as follows Consumer said her 13-year-old son already received the 1st dose and was supposed to get the 2nd dose today. However, he was feeling a little bit under the weather. He has sore throat, and his stomach was bothering him. Consumer would like to know if he can push with getting the 2nd dose next week, which would be 4 weeks after his 1st dose, and if it would still work. Consumer said she is not sure if her son was exposed to someone who has Covid. For this, she will have him tested. She wants to know if she should postpone his 2nd dose until he is feeling well and has tested negative for Covid. The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1692152
Sex: M
Age:
State:

Vax Date: 02/19/2021
Onset Date: 08/26/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210826; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Patient tested positive for COVID-19 after completing full vaccination series.; Patient tested positive for COVID-19 after completing full vaccination series.; This is a spontaneous report from a non-contactable other hcp. A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/lot number: EN5318) via an unspecified route of administration on 29Jan2021 (age at vaccination 53-years-old) as single dose, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN5318) via an unspecified route of administration on 19Feb2021 (age at vaccination 53years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 26Aug2021, the patient experienced patient tested positive for covid-19 after completing full vaccination series. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Aug2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on information in the case, a possible causal association between the event Covid 19 and the suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 1692153
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: covid_test_result = Positive; Test Result: Positive

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: They both later tested positive for COVID at around the same time; They both later tested positive for COVID at around the same time; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. Covid prior vaccination was unknown. Covid was tested positive post vaccination. The patient reported that they both later tested positive for covid at around the same time, coughing, sneezing on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101120179 Same reporter/drug/event for different patients.

Other Meds:

Current Illness:

ID: 1692154
Sex: M
Age:
State: NC

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: his temperature got up; Result Unstructured Data: Test Result:102.8

Allergies:

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

Symptoms: Off label use; shingles; feeling bad; wasn't' feeling well; Sweat, last night he had to change his pajamas 2 times because he was so wet from the sweat; Had broken out in some kind of bumps on his shoulder and his abdomen/bumps break out over night; Running a fever; Slight fever; Had a fever of 102; Had really bad chills; he is in the bed sleeping a lot; Extra dose administered; This is a spontaneous report from a contactable consumer or other non-health care professional. This consumer (patient's wife) reported for a 72-year-old male patient (reporter's husband). A 72-year-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: So-lution for injection, Lot number: FC3181), via an unspecified route of administration (at the age of 72-years), administered in arm left on 25Aug2021 as dose 3, single for COVID-19 immunization. Medical history included , chronic lymphocytic leukaemia , blood pressure and he was immunocompromised from an unknown date and unknown if ongoing. The patient historical vaccine included first dose and second dose an unspecified date in Feb2021 (at the age of 72-years), on of BNT162B2 for COVID-19 immunization. Concomitant medications included losartan potassium (LOSARTAN POTASSIUM) taken as 100mg, once a day and amlodipine besilate (AMLODIPINE BESILATE) taken for blood pressure measurement as 5mg, 1 tablet a day , start and stop date were not reported. On 26Aug2021, the pa-tient experienced shingles. On 25Aug2021, experienced feeling bad, wasn't' feeling well, sweat, last night he had to change his pajamas 2 times because he was so wet from the sweat, had broken out in some kind of bumps on his shoulder and his abdomen/bumps break out over night, running a fever; slight fever; had a fever of 102, had really bad chills, he is in the bed sleeping a lot. On an unspecified date, experienced off label use. It was further stated that caller was a consumer, calling on behalf of her 72-year-old husband, asking what kind of side effect she should expect due to the circumstances of his vaccination. Caller reported that her husband had both Pfizer vac-cine doses in Feb, which he did not have any reaction to, and then the booster dose of the vaccine on Wednesday the 25th because he has the type of Leukemia, CLL. Caller reports that on Tuesday her husband noticed that he had a couple of spots or bumps on him that they suspected were mosquito bites. He decided to go and get his booster dose on Wednesday. Caller reports that about 30 minutes after getting the booster dose her husband started feeling bad reporting that he was fine during the 15 minutes he was supposed to wait after getting the dose but then we had to make another stop at the bank and were there for about 20 minutes and by the time we got out he said he was not feeling well. Now he feels really bad, he is in the bed sleeping a lot and had a temperature about an hour ago, his temperature got up to 102.8. Caller also reports that her husband had a lot of sweats during the night and had to change his pajamas a couple of times because he was so wet. She also reports that he also had some more bumps break out over night last night. Caller reports that her husband saw his PCP yesterday, who said that they Suspect its shingles but it was not acting normally like shingles her hus-band has never had the shingles vaccine. Also reports that they are still waiting for a call back from his Oncologist because he is a leukemia patient although he has not yet started to receive treatment. Caller asked, if you could tell me if because he was already possibly sick with the shingles virus and did not know it would that have caused his reaction. I do not know about an expiration date on the card. I do not see anything, they did not write that down. I only have the expiration date when he had the first 2 shots in Feb but go ahead. Well he started having these issues after the vaccine on the took on (25Aug2021). When confirmed if patient started experiencing the side effects on the same day of ad-ministration. Right, that when he started having, feeling bad, slight fever and chills. The treatment was received for the adverse events running a fever; slight fever; had a fever of 102 (pyrexia). He took 2 Ibuprofen yesterday because he had a fever of 102. Ibuprofen he took, he took 2 of them and they are 200mg each. It was further stated that he does take any treatment for his leukemia yet. He was waiting for a phone call from his, the cancer center today but so far he has not had to take any treat-ment. The adverse events, shingles feeling bad, was not feeling well, sweat, last night he had to change his pajamas 2 times because he was so wet from the sweat, had broken out in some kind of bumps on his shoulder and his abdomen/bumps break out over night, running a fever; slight fever; had a fever of 102, had really bad chills, he is in the bed sleeping a lot, resulted in physician office visit. The patient underwent lab tests and procedures which included body temperature: 102.8 on an unknown date in Aug2021. The clinical outcome for all the events was reported as unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: LOSARTAN POTASSIUM; AMLODIPINE BESILATE

Current Illness:

ID: 1692155
Sex: F
Age:
State: MS

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: itching and swelling of her lips; itching and swelling of her lips; soreness and arm pain; felt the tightness in her lips; itching on her face and cheeks; itching on the lips; rosy cheeks; entire face swollen; Swelling of lips; sore arm; headache; This is a Follow up spontaneous report from a Pfizer sponsored program Support. A contactable nurse (patient) reported that: A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 24Aug2021 at 11:30 (At the age of 61-year-old, Batch/Lot Number: FC3181; Expiration Date: 31Oct2021) as dose 1, single for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing, atopic dermatitis from an unknown date and unknown if ongoing, seborrhoeic dermatitis from an unknown date and unknown if ongoing (was not active. It was dormant, she has not had any problems or reactions), food allergy from an unknown date and unknown if ongoing, medication allergies from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing, angioedema from an unknown date and unknown if ongoing, rag weeds allergy from an unknown date and unknown if ongoing (seasonal stuff), allergy to nuts, eggs, peanuts, pecans, fresh strawberries, shellfish from an unknown date and unknown if ongoing (with these she experiences rashes and itching). The patient was allergic to penicillin products. Concomitant medications included clindamycin taken for an unspecified indication from an unspecified start date to 21Aug2021. The patient previously took lidocaine and experienced drug allergy (It causes heart palpitations, and she cannot breathe. She cannot take that stuff now. She found out when she went to the dentist. They gave her some Lidocaine to get numb. She felt like an elephant was sitting on her chest and she could not breathe. They had to give her Narcan to reverse it. She could not figure out why it felt like something was sitting on her chest and could not breathe. It was one of the newer ones.), codeine, demerol, verapamil, lisinopril, lortab, ultram and experienced rash, hives, and itching. The patient was taken epipen for previous history allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that first dose on 24Aug2021, it was before 11:00. Her appointment was at 10:00, they gave it to her about 11:30, she had to stay for 30 minutes. The most significant side effect was the soreness and arm pain and headache, but last night, she noticed a sensation and looked at herself in the mirror and discovered swelling and she felt itching around her lips. When she looked in the mirror, it was slight swelling to her upper and lower lip as well. She thought it was nothing and went to sleep, but she felt the tightness in her lips. This morning, her lips are more swollen, and she has itching on her face and cheeks. She took some Loratadine and still has it but, not as bad, it was improving. The only thing she had introduced new to herself was the vaccine. She knows there are delayed reactions like rash after receiving the Pfizer COVID-19 vaccine. She does not have any shortness of breath or anything like that. She has a lot of allergies and there may be something in the vaccine that could have caused her to experience this sensitivity to it. She thinks she was good, and it is all calming down, but the itching in her lip remains. She knows to go to the emergency department if her symptoms worsen or to see her health care professional if things do not improve. The caller was a health care professional reporting that upon getting the first dose of the Pfizer Covid-19 vaccine on 24Aug2021, last Tuesday, she experienced a sore arm. Last night, she experienced itching on her lips, and they got swollen. She took Loratadine and she noticed her face got itchy. Clarified with the caller that she took the Loratadine because of the itchiness and the swelling, that was why she took the Loratadine. It has now been 30 minutes. The reason she took the Loratadine was that she started to feel itching in the cheeks, closer to her nose. That was why she went ahead and took the Loratadine, to calm it down. She did not have any Benadryl in the house. She usually keeps liquid Benadryl but apparently there was none. It was reported that about an hour after the injection on 24Aug2021. It was still sore now, well, it was not sore, but she has pain in that left arm. It was better. She would expect soreness with any other type of vaccine. She feels it a little more now than she did last night. There was swelling too. When she looked this morning, she took a selfie of her lips before she went to bed. When she looked this morning and compared it, it was a little more swollen, just in the upper lips. The upper lip was more, and she could tell it was in the lower lips but not as bad as the upper lip. She can tell more and can also feel underneath and inside the lips. She can tell that it was swollen. She would not say that it was severe but enough that it was significant, no. Put it this way, it was somewhat significant. The sensation was there and in her facial area, like her cheeks and around the nose area and the lips. Noticing it before she took the Loratadine, it was kind of all over her face. It was significant at one point. She took the Loratadine and it kind of calmed down. Now, it was just in the area of the nose, and mouth and under the eyes. It was itching and swelling, and she did not have any shortness of breath. Just the Loratadine. She applied warm compress to the arm. She did take Tylenol as they told her to take after the injection. Caller states she does not have her glasses on. It was hard to see when you get older, and they do not want to give them contacts. She still has to use readers. She wanted to be vaccinated to protect herself and her entire family. They had already been vaccinated. She went to one of the drives through sites and they would not let her get it there. They told her to go a professional site because of all of her allergies. She also has an epi Pen. She agreed with that. She did not want to go through that in a drive through. She would think they would be at this point. She has had nothing new introduced, no new medications and no new anything. That was the only thing she had taken that was different. She did get a headache immediately after and she does not generally get headaches. She had it for a couple of days. It went away but it was not that bad. It was probably a couple of hours later. It was once she got home. She does not have headaches. She thought it was odd to have a headache. She basically had the COVID shot, and everything was good. She was on an antibiotic that she finished taking Saturday. It was before the Pfizer. She thinks it was for an ear infection, or it was the sinuses. No, caller was just wanting to know, she mentioned delayed reactions. She was trying to see if this was one of them. If she was allergic to something, it happens within the first 15 to 20 minutes, or an hour. She had not had a reaction then, last night, when she noticed it, it was still there. This morning, and it was yesterday, she had rosy cheeks and had swelling in her entire face. She took Loratadine and her entire face has calmed down. She is still itching right underneath the nose and around the lip and mouth area. With the Lisinopril, she did have angioedema and it did make her lip swell. She does not take Lisinopril because she was allergic to it. She took the first dose of Lisinopril and went to bed. She woke up that morning and had a reaction that she had when she was sleeping. Being that the onset was almost 48 hours, she was wondering if there was anything else that would be delayed and if she would have any other reactions. The adverse events were not resulted in visit to emergency room and physician office. No, she called their office and left a message. They have not called back yet. The events were reported as non-serious. There was no laboratory tests or diagnostic st

Other Meds: CLINDAMYCIN.

Current Illness:

ID: 1692156
Sex: F
Age:
State: NY

Vax Date: 07/29/2021
Onset Date:
Rec V Date: 09/11/2021
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: Unevaluable event

Symptoms: she has an infection employee; This is a spontaneous report from a contactable other HCP (director of patient services) reported for a 58-year-old female patient. A 58-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/lot number: EW0196, Expiry date: unknown), via an intramuscular route unknown site on 29Jul2021 (age at vaccination: 58-year-old), 0.3 ml as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced infection. The patient was scheduled to receive second dose on 09Sep2021 (over 4 weeks after the first dose). The clinical outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692157
Sex: F
Age:
State:

Vax Date: 08/09/2021
Onset Date: 08/15/2021
Rec V Date: 09/11/2021
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: Test Date: 20210815; Test Name: COVID-19 test; Test Result: Positive

Allergies:

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

Symptoms: received the first dose of the Pfizer covid vaccine on Aug 9 and she was diagnosed with covid on august 15; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 09Aug2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she received the first dose of the Pfizer COVID vaccine on 09Aug2021 and she was diagnosed with COVID on 15Aug2021. The patient underwent lab test which included COVID-19 test (Sars-cov-2 test): positive on 15Aug2021. The patient wanted to know when she will be eligible to get the second dose of the Pfizer COVID vaccine. Her doctor told her not to take the second dose and she did not need it. The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1692158
Sex: F
Age:
State: AL

Vax Date: 07/30/2021
Onset Date: 08/12/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210817; Test Name: Covid 19 Test; Result Unstructured Data: Test Result:Positive

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: on 12Aug2021 she had first symptoms of the Covid19 virus, and on 17Aug2021 she was tested positive with the virus; on 12Aug2021 she had first symptoms of the Covid19 virus, and on 17Aug2021 she was tested positive with the virus; This is a spontaneous report from a contactable consumer(patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration, in Right Arm on 30Jul2021 (at the age of 69-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Aug2021, the patient had experienced first symptoms of the covid19 virus, and on 17Aug2021 she was tested positive with the virus. She added that she was feeling better, and she wanted to know how to proceed with the 2nd dose. The events does not require a visit to emergency room and physician office. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 17Aug2021. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692159
Sex: F
Age:
State: MA

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 09/11/2021
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: Start feeling like bugs crawling all over; About 4 hrs after shot tongue swelled up to fill inside her mouth; This is a spontaneous report from a non-contactable consumer (patient). A 45-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in the right arm, on 09Aug2021 at 02.15 PM, at single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included allergy from an unspecified date. The patient had not experienced Covid-19 prior vaccination. Concomitant medications were unknown. On 09Aug2021, at 04:00 PM, about 2 hrs after the vaccination, the patient experienced crawling sensation of skin described as "start feeling like bugs crawling all over". On 09Aug2021, about 4 hrs after the shot, tongue swelled up to fill inside her mouth. The patient was treated with Benadryl and 1hr or so later it started going down. The patient recovered from the adverse events on an unspecified date. Post the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1692160
Sex: M
Age:
State: GA

Vax Date: 08/08/2021
Onset Date: 08/19/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210819; Test Name: tested positive; Test Result: Positive

Allergies:

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

Symptoms: Son received first dose 08Aug2021, tested positive 19Aug2021; This is a spontaneous report from a contactable consumer (Patient). An unspecified age male patient received received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: not provided), via an unspecified route of administration on 08Aug2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not provided. On 19Aug2021, the patient tested positive. Recovered no symptoms gone through isolation, even though antibodies don't make sense why.- Declined to complete a report at this time. Unable to obtain further details. Provided caller with phone number (withheld), and the hours of operation prior to the transfer. Warm transfer from agent (withheld). The outcome of the event was recovered on an unknown date Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692161
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: flares; flares; This is a spontaneous report from a contactable other hcp and a contactable consumer (patient). A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had blood draws every few months. The patient previously took unspecified drug (DRUG, UNSPECIFIED) and experienced adverse event of leukopenia. Patient advised to back off dose to once daily or every other day. Patient also reported COVID vaccine caused flares on an unspecified date. Clinical outcome of event was unknown. Information about lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events (Leukopenia, Condition aggravated) and the BNT162B2 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: 1692162
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Diabetes; heart disease; Asthma; This is a spontaneous report received from a contactable nurse (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 intramuscular on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 1, 0.3 ml single, dose 2 intramuscular on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 2, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient asked about the Pfizer Covid 19 booster shot if she could get it 6 months rather than 8 months. She was diagnosed with heart disease, diabetes and asthma on an unspecified date in 2021. Added that she was already done with her two doses of the vaccine last February. The Pfizer BioNTech COVID-19 Vaccine was administered intramuscularly as a series of two doses (0.3 mL each) three weeks apart. A third dose of the Pfizer-BioNTech COVID-19 vaccine (0.3 mL) administered at least 28 days following the first two doses of this vaccine. Patient wanted to know if the booster shot had the same dose compared to her first two doses. The clinical outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events diabetes mellitus and suspect drug BNT162B2 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: 1692163
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Covid; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: Consumer states that she may have gotten COVID after getting the 1st dose of the Pfizer COVID vaccine.; Consumer states that she may have gotten COVID after getting the 1st dose of the Pfizer COVID vaccine.; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced consumer states that she may have gotten covid after getting the 1st dose of the pfizer covid vaccine on an unspecified date in 2021. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on an unspecified date in 2021. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692165
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: Covid; Result Unstructured Data: Test Result:got Covid; Comments: got a vaccine for covid 19 and got Covid from them.

Allergies:

Symptom List: Nausea

Symptoms: he got a vaccine for covid 19 and got Covid from them; he got a vaccine for covid 19 and got Covid from them; got sick; This is a spontaneous report from a contactable consumer or other non-health professional (reported for nephew) via a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced he got a vaccine for covid 19 and got covid from them and got sick. Reporter stated all he hearing was how safe this vaccine was, and now it was getting mandated. It seems like it was going to be forced on us. Maybe nothing sinister. Reporter questioned can Pfizer Guarantee that if he, his wife and two children receive the vaccine there will be no side effects or adverse reactions. He wanted a guarantee that this was not going to kill or harm anyone in my family. It was being forced from the top down. There seems to be a lot of misinformation about the vaccine, how many people have died and how many had taken it repoter questioned. List of lawsuits involving Pfizer, tons of them that Pfizer has had to pay out. A huge list he was looking at. This information, makes it look like there was a lot of corruption, and kick backs. The amount of censorship and a lot of red flags. Reporter asked how does the vaccine work. Reporter stated he was hearing about a lot of side effects from the vaccine. The patient underwent lab tests and procedures which included Covid: got covid on an unspecified date. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up

Other Meds:

Current Illness:

ID: 1692166
Sex: F
Age:
State: PA

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 09/11/2021
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: rash; her lips got bigger/lips were tingling and thick, bigger; tingling and itching; Itching; This is a spontaneous report from a contactable other health care professional nurse reported for herself. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection. Batch/Lot Number: FA7484) via an unspecified route of administration, administered in left arm on 09Aug2021 at 09:00 (at the age of 33-years-old) as Dose 1, Single for COVID-19 immunization. Medical history included hypersensitivity (e.g., rash, pruritus, urticaria, angioedema) from an unknown date and unknown if ongoing. Concomitant medication was not reported. Patient history and investigation assessment: no. No other vaccines given the same day or 4 weeks prior and no problems with vaccines in past. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): none. Additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. No adverse events following prior vaccination. Patient medical History (including any illness at time of vaccination): none. Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: None. Illness/Adverse event: None. Family Medical History Relevant to adverse events: none. Relevant tests: None. Vaccination facility type at physician Office. The patient was vaccinated with the Pfizer COVID vaccine almost 3 weeks ago, (09Aug2021) and within an hour the patient got tingling and itching and lips were tingling and thick, bigger. Then she broke out in a rash later that afternoon and still has the rash now and it's been 18 days and it keeps getting worse and nothing was helping. Has already sought medical attention and been on steroids. She wants to know if anything has been reported like this or other people reporting this or if there was anything else patient can do. Feels events were serious/medically significant due to the duration and daily occurrence. Treatment was given with steroids for the itching, tingling, and rash and clarifies steroid as Prednisone. No further details provided. Patient visited to physician office. The outcome of the events were not recovered.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the event Rash, Lip swelling, Paraesthesia, Pruritus and the suspect drug BNT162B2 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: 1692167
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: One of them can't even use the left side of her face; This is a spontaneous report from a non-contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced can't even use the left side of her face. Reporter stated that she had friends who had suffered because of this vaccine. They have had major complications. One of them can't even use the left side of her face and the other one lost her baby. She lost her baby. The doctors say that can't prove it was from the vaccine but they say they are pretty darn sure it is because of the vaccine. The outcome of the event was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1692168
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:165 IU/l; Test Name: Aldolase; Result Unstructured Data: Test Result:97.8 IU/l; Test Name: Anti-aminoacyl-tRNA synthetase antibodies; Test Result: Negative ; Comments: (ab) (includes anti- Jo-1, anti-PL-7, anti-PL-12, anti-EJ, anti-OJ), anti-SRP ab, anti-MI-2 ab, anti-TIF1-gamma ab, anti-MDA5 ab, anti-NXP2 ab, anti-PM/ Scl-100 ab, anti-U3 RNP ab, U2 snRNP Ab, ANTI-U1-RNP AB, anti- Ku antibodies, antieSSeA 52 KD ab IgG, ANA, and HIV antibodies were all negative.; Test Name: ANA; Test Result: Negative ; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:675 IU/l; Test Name: AST levels; Result Unstructured Data: Test Result:down-trending; Test Name: bicarbonate; Result Unstructured Data: Test Result:normal; Test Name: cortisol; Result Unstructured Data: Test Result:in the normal range; Comments: in the normal range; Test Name: CPK; Result Unstructured Data: Test Result:down-trending; Test Name: Creatinine Phosphokinase; Result Unstructured Data: Test Result:more than 22,000 IU/l; Test Name: creatinine level; Result Unstructured Data: Test Result:normal; Test Name: Electrolyte level; Result Unstructured Data: Test Result:within normal limits; Comments: been within normal limits throughout the hospitalization; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:1525 IU/l; Test Name: potassium; Result Unstructured Data: Test Result:normal; Test Name: blood pressure; Result Unstructured Data: Test Result:Transient elevated; Comments: at the beginning of the hospitalization; Test Name: TSH; Result Unstructured Data: Test Result:in the normal range; Comments: in the normal range; Test Name: Blood Urea Nitrogen; Result Unstructured Data: Test Result:normal; Test Name: Total and free carnitine levels; Result Unstructured Data: Test Result:weere within the normal limits; Test Name: CT scan/lumbar spine; Result Unstructured Data: Test Result:No musculoskeletal abnormalities were found; Test Name: CT scan of the thoracic; Result Unstructured Data: Test Result:No musculoskeletal abnormalities were found; Test Name: high sensitive C-reactive protein; Result Unstructured Data: Test Result:6.4 mg/l; Test Name: haptoglobin; Result Unstructured Data: Test Result:in the normal range; Comments: in the normal range; Test Name: HIV antibodies; Test Result: Negative ; Test Name: straight leg test; Test Result: Negative ; Test Name: lab results; Result Unstructured Data: Test Result:down-trending CPK and AST levels.; Test Name: Basic Metabolic Panel; Result Unstructured Data: Test Result:showed normal potassium, bicarbonate, Blood Urea N; Comments: showed normal potassium, bicarbonate, Blood Urea Nitrogen, and creatinine levels; Test Name: Hepatitis B panel; Result Unstructured Data: Test Result:negative except for hepatitis B surface antigen.; Test Name: Hepatitis C panel; Result Unstructured Data: Test Result:negative except for hepatitis B surface antigen.; Test Name: pain; Result Unstructured Data: Test Resul

Allergies:

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

Symptoms: COVID-19 vaccine induced rhabdomyolysis; This is a literature report from the Diabetes & Metabolic Syndrome, 2021, volume 15(4), pages: 102170, DOI: 10.1016/j.dsx.2021.06.007, entitled COVID-19 vaccine induced rhabdomyolysis: Case report with literature review. Herein the authors present the first case of COVID-19 vaccine-induced rhabdomyolysis to help clinicians easily identify such a problem in newly vaccinated patients. 1.1. Case presentation: The authors present a 21-year-old male patient with a past medical history of asthma who presented to the emergency department for progressively worsening pain and swelling in the lower back for one day after his first Pfizer/BioNTech COVID-19 vaccine injection. He described it as a 5 to 10 out of 10 sharp pain located at his mid to lower back with radiation to his left lateral thigh. The pain worsened with body movement. The patient tried over-the-counter pain medication with limited relief. He also noticed a darkened urine color before he came to the hospital. The patient did not use any medication regularly. He denied excessive exercise, heavy weightlifting or body trauma after vaccination. He had no family history of autoimmune or musculoskeletal diseases, and surgical history was only significant for an uncomplicated appendectomy. Patient endorsed social marijuana use but denied other drug, alcohol, or tobacco use. Transient elevated blood pressure was noticed at the beginning of the hospitalization, but other vital signs were unremarkable. Physical examination was positive for tenderness to the paraspinal lumbar area upon palpation. The straight leg test was negative. Pertinent lab results included Creatinine Phosphokinase (CPK) level more than 22,000 U/L (normal range 20-190 U/L), Aldolase 97.8 U/L (normal range 3.3-10.3 U/L), alanine aminotransferase 165 U/L (normal range 0 to 41 U/L), aspartate aminotransferase 675 U/L (normal range 5-40 U/L), high sensitive C-reactive protein 6.4 mg/L (normal range < 5.0 mg/L) and Lactate dehydrogenase 1525 U/L (normal range 135-225U/L). Urinalysis revealed clear yellow urine with positivity for blood and protein but negativity for Red Blood Cells (RBCs). Basic Metabolic Panel (BMP) showed normal potassium, bicarbonate, Blood Urea Nitrogen, and creatinine levels. Hepatitis B and C panels were negative except for hepatitis B surface antigen. Total and free carnitine levels were within the normal range. SARS-CoV-2 PCR was negative. Anti-aminoacyl-tRNA synthetase antibodies (ab) (includes anti- Jo-1, anti-PL-7, anti-PL-12, anti-EJ, anti-OJ), anti-SRP ab, anti-MI-2 ab, anti-TIF1-gamma ab, anti-MDA5 ab, anti-NXP2 ab, anti-PM/ Scl-100 ab, anti-U3 RNP ab, U2 snRNP Ab, ANTI-U1-RNP AB, anti- Ku antibodies, antieSSeA 52 KD ab IgG, ANA, and HIV antibodies were all negative. ESR, haptoglobin, TSH, and cortisol were in the normal range. No musculoskeletal abnormalities were found on CT scan of the thoracic and lumbar spine. The right upper quadrant sonogram showed no abnormality in the liver, biliary tracts, gallbladder, or pancreas. The patient had been hydrated with high volume IV normal saline for rhabdomyolysis. Morphine was given as needed for muscle pain. Follow-up lab results showed down-trending CPK and AST levels. Electrolyte level and renal functions have been within normal limits throughout the hospitalization. No change of urine color or urine output volume was noticed. The patient felt pain improved after treatments and was discharged after five days of hospital stay. In the patient, rhabdomyolysis was evident by clinical picture with muscular pain and laboratory confirmation showing markedly elevated CPK levels. He was treated adequately with fluids and discharged safely. All possible etiologies for rhabdomyolysis were searched for and were negative. Intake of Marijuana might have shared this problem, although patients have been using it daily and temporal correlation in favor of the vaccine. Also, Hepatitis B was reported in one case report to cause rhabdomyolysis, but the timing of the vaccine just one day before disease onset favors vaccine side effects as the cause of such a problem. Conclusion Although COVID-19 vaccines are generally safe and encouraged for everyone, side effects can happen. Rhabdomyolysis has been documented with COVID-19, but clinicians should be vigilant about the possibility of rhabdomyolysis following COVID-19 vaccination as early diagnosis and treatment carry an excellent prognosis.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1692169
Sex: F
Age:
State: CA

Vax Date: 08/05/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
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: the patient was presenting with Guillain-Barre syndrome; numbness in her extremities bilaterally, mid-arm that extended distally to her lower extremities, and mid-thigh bilaterally that extended distally.; Difficulty walking/gait changes; Cool extremities; weakness; This is a spontaneous report from a contactable Physician reporting for a patient. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, time the vaccination was given, anatomical location of administration, Batch/lot number, NDC number and Expiry date were unknown), via an unspecified route of administration on 05Aug2021 at the age of 38-years-old as dose 1, single for covid-19 immunisation. Patient's medical History including any illness at time of vaccination was none. Family medical history relevant to AE(s) included maternal aunt had a history of Gillian-Barre. There were no concomitant medications. Relevant Tests were none. Vaccination facility type was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): this was the patient's first dose. Additional vaccines administered on same date of the pfizer suspect if applicable, list all vaccines administered on same date with the pfizer vaccine considered as suspect were none. Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine were none. AE(s) following prior vaccinations were none. There was no investigation assessment. The Reporter was calling in regard to Pfizer's COVID vaccine. The reporter stated that she had a patient, a 38-year-old female, who had numbness in her extremities bilaterally, mid-arm that extended distally to her lower extremities, and mid-thigh bilaterally that extended distally on an unspecified date in Aug2021. She stated that the patient received their first dose on 05Aug2021, and her symptoms started 10 days later. The reporter wanted to gain clarification in regard to the incidences of this type of reaction occurring with the Pfizer COVID-19 vaccine. Her symptoms presented for 3 days and were self-limiting, but because of her weakness and gait changes on an unspecified date in Aug2021, the vaccine facility where she received her first dose had concerns the patient was presenting with Guillain-Barre syndrome on an unspecified date in Aug2021. The reporter explains the patient was never formally assessed when she was symptomatic. The symptoms began 10 days after receiving her first dose and presented for 3 days. The reporter confirmed the patient was not assessed by any provider while she was symptomatic. The reporter confirms the patient had said she had some weakness on an unspecified date in Aug2021, but this cannot be confirmed objectively. Per the patient, the patient had difficulty walking the first day she became symptomatic on an unspecified date in Aug2021, but this was unverified in terms of any cooperation with a medical professional. The reporter confirms the symptoms resolved after 3 days but the diagnosis were unverified. She said the vaccine facility from where she the patient received the vaccine believes it may be GBS. The patient also reported cool extremes of her extremities at the time she was symptomatic on an unspecified date in Aug2021. The Reporter stated that the patient had a physical before her appointment and no new medications were initiated for the patient. The patient did no test after this episode but mentioned her maternal aunt had a history of (name). The reporter states the patient was asymptomatic when they discussed her symptoms today. She is setting the patient up to see neurology for further assessment, however the patient didn't have any acute symptoms at the time she was assessed today. There were no initial diagnoses other than an exam. Adverse events did not require a visit to Emergency Room or Physician Office. The patient didn't seek any acute care. HCP wanted to know if there have been reports of numbness after receiving the 1st dose. Physician wanted to know if they should still give the patient a 2nd dose after having a reaction with the 1st dose. The reporter was a healthcare provider and would like to discuss how to treat an adverse event that occurred in one of her patients. Reporter assessed seriousness for numbness in her extremities bilaterally, mid-arm that extended distally to her lower extremities, and mid-thigh bilaterally that extended distally, cool extremities and difficulty walking as medically significant. Causality: Due to the time frame (the patient having symptoms within 10 days of the vaccine), the reporter believes the symptoms are related. Relatedness of drug to reaction(s)/event(s): Reactions assessed: numbness in her extremities bilaterally, mid-arm that extended distally to her lower extremities, and midthigh bilaterally that extended distally and cool extremities. Drug result: Related. The outcome of the events was recovered on an unspecified date in Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship there is reasonable possibility of causal association between the reported events Gullian Barre Syndrome, Hypoaesthesia, gait disturbance, peripheral coldness, asthenia, and the suspect drug BNT162B2. 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: 1692170
Sex: F
Age:
State: PA

Vax Date: 04/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Date: 202108; Test Name: Biopsy today or Monday; Result Unstructured Data: Test Result:unknown results; Test Date: 202108; Test Name: Bloodwork; Result Unstructured Data: Test Result:unknown results; Test Date: 202108; Test Name: Liver enzyme abnormal; Result Unstructured Data: Test Result:abnormal; Test Date: 202108; Test Name: MRI; Result Unstructured Data: Test Result:Blockage in the Liver; Test Date: 202108; Test Name: Urine Sample; Result Unstructured Data: Test Result:UTI

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: liver damage; liver damage; Jaundice; Jaundice; Liver Blockage; Eyes are Yellow; UTI; Liver Enzymes are Worse than when she took Tylenol; This is a spontaneous report from a contactable consumer (spouse). A 42-year-old female patient (Reporter's Wife) received bnt162b2 (COMIRNATY, Covid 19 Vaccine, mRNA), dose 2 via an unspecified route of administration at the end of Apr2021 (Batch/Lot number was not reported) as dose 2, single at the age of 41-year-old for COVID-19 immunisation. No medical history. Concomitant medications were not reported. Historic vaccine was bnt162b2 received via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 1, single at the age of 41-year-old for COVID-19 immunisation. The patient previously took tylenol in 2019 and not ongoing for blood clot and experienced liver damage with jaundice. No additional vaccines administered on same date of the Pfizer suspect. This report is not related to a study or programme. No prior vaccinations (within 4 weeks). Family medical history relevant to AEs: Not that they are aware of. The patient experienced liver damage, liver blockage, jaundice, eyes are yellow, urinary tract infection, liver enzymes were worse than when she took Tylenol in Aug2021. The patient was hospitalized for the events from 26Aug2021 and ongoing. Events resulted in emergency room and physician office visit. 2 years ago the patient had blood clot and had taken Tylenol. She had liver damage with jaundice. She stopped taking Tylenol and so the jaundice went away and she was back to normal. The patient was now in the ER with the same symptoms as when she took Tylenol. Stated that she was back in the hospital because liver damage again. Her husband was trying to figure out why her liver had been damaged, the last thing that she took was only the Pfizer Covid 19 vaccine. Asking if in Pfizer Covid 19 vaccine has an ingredient that Tylenol has. The patient took second shot at the end of April2021. She had a reaction to Tylenol sometime back and it attacked her liver and she was doing okay and then after the second shot her enzymes are worse than when she took the Tylenol. Caller was wondering if she took some type of Tylenol that was in the vaccine or something that triggered her reaction? Caller stated it was a long shot but he wasn't sure if there was something that is in Tylenol that is in the ingredients of the Covid vaccine? Caller stated the doctors automatically said no but he can't rule it out until he checks it out. Lab tests on Aug2021: bloodwork, MRI last night, biopsy today or Monday, urine sample found out UTI. Caller stated the MRI showed the blockage in her liver. The patient got her blood results and went to the ER immediately. The patient felt fine and she did the last time. This is the same as when the said to quit taking Tylenol. It was extra strength Tylenol for a blood clot in 2019. UPC, Lot, Expiration: Unknown. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1692171
Sex: U
Age:
State: HI

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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: heart attacks; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's cousin). This case is for reporter's first cousin. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. On an unspecified date, the patient had heart attack and was hospitalized. No product quality compliant was reported. The outcome of the event was reported as unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1692172
Sex: M
Age:
State: CA

Vax Date: 05/18/2021
Onset Date: 06/25/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210625; Test Name: Alanine Transminase (ALT); Result Unstructured Data: Test Result:204 U/L; Test Date: 202108; Test Name: Alanine Transminase (ALT); Result Unstructured Data: Test Result:67 U/L; Comments: without taking medication; Test Date: 20210625; Test Name: Aspartate Transaminase; Result Unstructured Data: Test Result:82 U/L; Test Date: 202108; Test Name: Aspartate Transaminase; Result Unstructured Data: Test Result:42 U/L; Comments: without taking medication; Test Date: 20210527; Test Name: RT-PCR; Test Result: Negative

Allergies:

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

Symptoms: suspected liver damage; Patterns of diagonal grid-like blood vessels inflammation (similar to livedo reticularis) appeared on left front leg. Faded on its own gradually after two months; elevated level of Alanine Transminase (ALT) at 204 U/L; Aspartate Transaminase (AST) 82 U/L; This is a spontaneous report from a contactable consumer (patient). A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in left arm on 18May2021 at 04:30 hours as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. On an unspecified date, the patient experienced suspected liver damage, patterns of diagonal grid-like blood vessels inflammation (similar to livedo reticularis) appeared on left front leg. Faded on its own gradually after two months. On 25Jun2021, the patient experienced elevated level of alanine transminase (ALT) at 204 U/L and aspartate transaminase (AST) 82 U/L, 5 weeks after receiving second dose of Pfizer COVID vaccine. No personal history of drinking or other suspected cause could be determined that could attribute to this symptom. The patient underwent lab tests and procedures which included alanine aminotransferase: 204 U/L on 25Jun2021, aspartate aminotransferase: 82 U/L on 25Jun2021, alanine aminotransferase: 67 U/L on an unspecified date in Aug2021 without taking medication, aspartate aminotransferase: 42 U/L on an unspecified date in Aug2021 without taking medication, and RT-PCR: negative on 27May2021. The patient did not receive any other vaccine in four weeks. The patient did not receive any treatment for the adverse events. The patient was recovering from the events.

Other Meds:

Current Illness:

ID: 1692173
Sex: F
Age:
State: GA

Vax Date: 08/17/2021
Onset Date: 08/18/2021
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Date: 20210818; Test Name: Low sodium; Result Unstructured Data: Test Result:Low; Test Date: 20210818; Test Name: Heart rate; Result Unstructured Data: Test Result:High; Test Date: 20210818; Test Name: Fever; Result Unstructured Data: Test Result:104.7; Test Date: 20210818; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Fever 104.7; loss of consciousness; high heart rate; cardiac ischemia; low sodium; This is a spontaneous report from a contactable consumer (patient). An 81-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3180, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 17Aug2021 18:00 as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included pyridostigmine (PYRIDOSTIGMINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Pyridostigmine medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever104.7, loss of consciousness, high heart rate, cardiac ischemia, low sodium on 18Aug2021. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included heart rate: high, pyrexia: 104.7, sars-cov-2 test: negative on 28Aug2021 and blood sodium: low, Ct, MRI, ekgs, echocardiogram, blood tests. The patient received treatment for the events with IVs. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: PYRIDOSTIGMINE

Current Illness:

ID: 1692174
Sex: M
Age:
State: CA

Vax Date: 08/16/2021
Onset Date: 08/18/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: EKG; Result Unstructured Data: Test Result:Unknown; Test Name: Nasal sawb; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab

Allergies:

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

Symptoms: heart irregularities; severe tightness in chest; chest pain; shortness of breath; could not move neck much, barely could get out of bed; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A 20-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 16Aug2021, at 12:00 (at the age of 20-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Past drug included augmentin and had allergy to it. Patient was tested for covid prior and post vaccination. On 18Aug2021, Less than 48 hours after injection patient woke up Wednesday morning and experienced heart irregularities, severe tight-ness in chest, chest pain, shortness of breath, could not move neck much, barely could get out of bed. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. There they did electrocardiogram and asked the patient to go straight to ER for heart irregularities. The patient underwent lab tests and procedures which included electrocardiogram and results was unknown and sars-cov-2 Nasal Swab test which showed negative results on an unspecified date. Therapeutic measures were taken as a result of heart irregularities and received Medications for heart inflammation, severe tightness in chest, chest pain, shortness of breath, could not move neck much, barely could get out of bed. At the time of this report, the outcome of events was not recovered. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692175
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: blood clots; Long-lasting menstrual cramping (greater than 8 hours & still going); heavy period; cervical discomfort/pain; fatigue; This is a spontaneous report from a non-contactable other health care professional (patient). A non pregnant 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 1, single and via an unspecified route of administration on an unspecified date at dose 2, single for COVID-19 immunization. Medical history included penicillin allergy. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient had long-lasting menstrual cramping (greater than 8 hours & still going), heavy period, cervical discomfort/pain, blood clots, fatigue on an unspecified date. No treatment was given for the events. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Thrombosis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 1692176
Sex: F
Age:
State: NY

Vax Date: 08/11/2021
Onset Date: 08/13/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210826; Test Name: Nasal Swab; Test Result: Negative .

Allergies:

Symptom List: Pain in extremity

Symptoms: Nausea; increased sensitivity to smell, (like pregnant); vertigo; blurry vision; hot flashes; (never had before) vaginal spotting; This is a spontaneous report from a contactable consumer. This 46-year-old non-pregnant female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0185) via an unspecified route of administration on 11Aug2021 at 10: 00 AM (at 45-year-old) in left arm as dose 1, single for COVID-19 immunization. The patient had history of Hashimotos Disease and POTS and had no allergies. It was mentioned that no other vaccine was received in four weeks. The patient received Synthroid Prozac in two weeks. It was reported that patient did not have COVID prior vaccination. On 12Aug2021 at 02:00 Pm the patient experienced nausea, increased sensitivity to smell, (like pregnant) vertigo blurry vision, hot flashes (never had before) vaginal spotting. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received vertigo medicine as treatment and had not recovered. On 26Aug2021 the patient had a nasal swab rapid test for which result was negative. Follow-up attempts were completed. No further information was expected.

Other Meds: SYNTHROID; PROZAC.

Current Illness:

ID: 1692177
Sex: M
Age:
State: CT

Vax Date:
Onset Date: 07/15/2021
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: seizures; stroke; kidney failure; diabetes onset when never had prior; Altered mental status; This is a spontaneous report from a contactable other HCP. A 66-year-old male patient received an unknown dose of BNT162B2 (PFIZER COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included high blood pressure. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergy was unknown. The patient didn't received other vaccine in four weeks. Concomitant medication include regular prescriptions of high blood pressure medication and water pills. On 15Jul2021, the patient experienced altered mental status, seizures, stroke, kidney failure and diabetes onset when never had prior. The events caused in hospitalization 7 days. Treatment was received . The outcome of events was not recovered. The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition(hypertension) which is not related to the suspected drug. The case will be reassessed if additional information becomes available.

Other Meds:

Current Illness:

ID: 1692178
Sex: F
Age:
State: WI

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 09/11/2021
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: lower face felt funny especially right; tingling/numbness around lower face; tingling/numbness around lower face; ER agreed Bell's Palsy mild case; This is a spontaneous report from a contactable consumer (patient). A 51-years-old Non pregnant female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FD8448), via an unspecified route of administration, administered in arm left on 25Aug2021 at 02:30 PM (age at vaccinattion was 51-years-old) as DOSE 1, SINGLE for covid-19 immunisation. No other vaccines were received within four weeks. The patient was not pregnant at the time of vaccination. Medical history included bell's palsy from 2002 and ongoing, blood clot to eye from 1997 to an unknown date, protein s diagnose from 2010 to an unknown date (Protein S diagnose after DVT Right calf from broken foot), hypothyroidism from 2010 to an unknown date, LPR acid Reflex from 2021 to an unknown date, deep vein thrombosis (DVT) right calf from 2010 to an unknown date (2010 Protein S diagnose after DVT Right calf from broken foot), broken foot from 2010 to an unknown date (2010 Protein S diagnose after DVT Right calf from broken foot). No known allergies were reported. Concomitant medications included omeprazole 20 mg and levothyroxine, liothyronine 45 mg (NP THYROID); both taken for an unspecified indication, start and stop date were not reported. On 25Aug2021 at 02:50 PM, the patient experienced tingling/numbness around lower face which subsided at 03:30 PM. On 26Aug2021 at 05:00 AM, the patient's lower face felt funny especially right. On the same day at 07:20 AM, the patient decided to go to urgent care and was sent to ER. ER agreed Bell's Palsy mild case. Therapeutic measures were taken as a result of the events. Treatment included prescribed steroid (unspecified) but the patient did not take it. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events tingling/numbness around lower face was recovered and other events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: OMEPRAZOLE; NP THYROID

Current Illness: Bell's palsy

ID: 1692179
Sex: M
Age:
State: TX

Vax Date: 08/29/2021
Onset Date: 08/29/2021
Rec V Date: 09/11/2021
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: Loss of consciousness; sweating; chills; nausea; numb tongue; shortness of breath; confusion; odd taste sensations; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 18-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3181), via unspecified route of administration in arm left on 29Aug2021 at 04:00 PM (at the age of 18-years-old) as dose 1, single for COVID-19 immunisation. The patient had no known allergies. No other medical history and no other medications (in two weeks) were not reported. Facility type vaccine was Pharmacy or Drug store where the patient took vaccine, the patient took no other vaccine in four weeks. The patient did not take COVID prior vaccination and was not COVID tested post vaccination. On 29Aug2021 at 04:15 PM, the patient experienced Loss of consciousness, sweating, chills, nausea, numb tongue, shortness of breath, confusion, odd taste sensations. The patient took treatment with Vitals being checked by EMS for the events. The outcome of the events was not recovered. Follow-up attempts were completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1692180
Sex: F
Age:
State: TX

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Pain at the injection site; Her arm felt feverish after both vaccines; This is a spontaneous report from a contactable consumer (patient), from a Pfizer Sponsored Program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on Jun2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date of 2021 (It was the end of Apr or the Middle of May 2021) as dose 1, single for covid-19 immunization and experienced flu symptoms for a week after the first vaccine, sore arm, her arm felt feverish after both vaccines. It was reported that, for the second dose she pain at the injection site. Her arm felt feverish after both vaccines. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101119257 same reporter/SD/AE,different patient

Other Meds:

Current Illness:

ID: 1692181
Sex: F
Age:
State:

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Sudden onset of chronic migraine (30 migraine days/month) beginning 2/20/21. Inpatient hospitalization to manage pain. Currently 20 migraine days/month; received the second dose of BNT162B2 via an unspecified route of administration on 12Jan2021; received the second dose of BNT162B2 via an unspecified route of administration on 12Jan2021; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID 19) via an unspecified route of administration on 12Jan2021 (Lot Number: EL8982) at the age of 26-year-old as single dose for COVID-19 immunization. Medical history included Anxiety. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergies included sulfa. The patient didn't received other vaccine in four weeks. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING) and escitalopram. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 12Jan2021 (Lot Number: EL3246) at the age of 26-year-old as single dose for COVID-19 immunization. The patient sudden onset of chronic migraine (30 migraine days/month) beginning 20Feb2021. Inpatient hospitalization to manage pain. Currently 20 migraine days/month. migraine treatment with DHE The outcome of migraine was not recovered. The outcome of other events was unknown.; Sender's Comments: Based on current information available, the event migraine mostly represented intercurrent condition in this patient unrelated to Bnt162b2. Given information is too limited for medically meaningful assessment. 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 RAs, Ethics Committees, and Investigators, as appropriate

Other Meds: NUVARING; ESCITALOPRAM

Current Illness:

ID: 1692182
Sex: F
Age:
State: FL

Vax Date: 08/03/2021
Onset Date: 08/05/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: had never had diarrhea in her 39 years of life; was a little achy in her arm; States she was still eating and drinking and feeling fine and had stomach pains and that was the only thing coming out of her body; Anxiety; had gelatinous clear and bloody stools every single day for about 5-6 days; This is a spontaneous report from a contactable other hcp (patient). A 39-years-old female patient received BNT162B2 (Pfizer COVID19 vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Aug2021 08:00 (age at vaccination 39-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pneumonia and stated she had pneumonia twice in 3 years / had pneumonia but did not receive the pneumonia shot then and in 2017 she had pneumonia so bad that she was in the hospital for two weeks and when she recovered at 100 percent the HCP recommended, she got the pneumonia vaccine, so she got the pneumonia vaccine at that point in 2017 or 2018 and has no lots, expiry dates or name of the vaccine to provide. No concomitant medications were reported. Relevant Tests, Prior Vaccinations and family Medical History Relevant to adverse event was reported as none. It was reported that after the first dose on that Tuesday morning she had a little anxiety with the vaccine so she did it at 8:00am and by Tuesday night she was a little achy in her arm and she had that before with other vaccines she had in order to prevent the flu or pneumonia but it was not a big deal and by Thursday morning on 05Aug2021 she knew this sounds disgusting but she had gelatinous clear and bloody stools every single day for about 5-6 days (medically significant) after that and called her primary doctor and they stated that it was highly unlikely and was not due to the Pfizer COVID19 vaccine but she was a crazy person and had never had diarrhoea in her 39 years of life and she assumed it was the way she reacted to the vaccine. It was reported that she was still eating and drinking and feeling fine and had stomach pains on an unspecified date and that was the only thing coming out of her body. She stated her HCP told her she needed to wait another day or two and if it persisted to see a GI specialist and she was getting better and this resolved by the 9th or 10th day. At the time of this report, the outcome of events had gelatinous clear and bloody stools every single day for about 5-6 days and States she was still eating and drinking and feeling fine and had stomach pains and that was the only thing coming out of her body was recovered on an unknown date in 2021 while the outcome for other events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events haematochezia and diarrhoea the suspect drug BNT162B2. 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: 1692183
Sex: F
Age:
State: FL

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: she had the swelling in her left armpit; HCP said this was soft tissue swelling; she was unable to move her arm up and couldn't move it because it was so completely swollen; a lot of soft tissue swelling in her left breast and it is very painful.; a lot of soft tissue swelling in her left breast and it is very painful.; This is a spontaneous report from a contactable Nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 24Aug2021 08:00 (at the age of 39 years old) as dose 2, single for COVID-19 immunisation. Medical history included pneumonia from an unknown date and unknown if ongoing (she had pneumonia twice in 3 years), abscess from an unknown date and unknown if ongoing (she had had an abscess before in a lymph node when she was much younger and that had been cut open). There were no concomitant medications. Patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 03Aug2021 08:00 (at the age of 39 years old) as dose 1, single for COVID-19 immunisation and experienced had gelatinous clear and bloody stools every single day for about 5-6 days, was a little achy in her arm, had never had diarrhea in her 39 years of life; Stated she was still eating and drinking and feeling fine and had stomach pains and that was the only thing coming out of her body. Historical vaccine also included pneumonia vaccine on 2017 for immunisation and experienced achy in her arm; flu vaccine on an unspecified date for immunisation and experienced arm soreness with the flu vaccine. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The patient experienced she had the swelling in her left armpit, health care professional said this was soft tissue swelling. She received 2nd dose of the vaccine and had reactions to after the 2nd dose that she got on Tuesday 24Aug2021, she had armpit swelling and her lymph nodes was super swollen and a lot of soft tissue swelling in her left breast and it was very painful (on 24Aug2021). Other vaccines she has had in order to prevent the flu or pneumonia but it was not a big deal. Stated after the 2nd dose of the Pfizer COVID Vaccine, she had the swelling in her left armpit and had gotten the 2nd dose at 08:00 and by Tuesday night (24Aug2021), she realized she was unable to move her arm up and couldn't move it because it was so completely swollen and she went to work and asked the health care professional she worked with to take a look at it to make sure she was not missing anything because she had had an abscess before in a lymph node when she was much younger and that had been cut open; stated the health care professional said this was soft tissue swelling and to contact her primary care physician. She went today (unspecified) to see her primary care physician and he agreed it was a reaction to the Pfizer COVID vaccine and it was a known reaction to have happen and he put her on steroids over the weekend and said to touch base on Monday or Tuesday and she started taking the steroid Prednisone this morning and it was 20mg and she had to take one tablet twice per day for 5 days. She had arm soreness last year and had pneumonia but did not received the pneumonia shot then and in 2017 she had pneumonia so bad that she was in the hospital for two weeks and when she recovered at 100 percent the health care professional recommended she get the pneumonia vaccine so she got the pneumonia vaccine at that point in 2017 or 2018 and has no lots, expiry dates or NDC or name of the vaccine to provided. Adverse event resulted in physician office visit. Therapeutic measures were taken as a result of she had the swelling in her left armpit, soft tissue swelling. Outcome of the events were unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1692184
Sex: F
Age:
State: MI

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 202102; Test Name: X rays; Result Unstructured Data: Test Result:blood clots (60%-80%)

Allergies:

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

Symptoms: blood clots; life threatening blood clots/ had blood clots that were 60% blockage from the brain/ The clot is in her neck was reported as worsened.; minor strokes; This is a spontaneous report from a contactable consumer or other non hcp. An 8 decade elderly (late 70's; unit: not provided) old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration on Feb2021 as dose number unknown, single for covid-19 immunisation. Unable to provide patient's date of birth or current weight. Patient took vaccine as she was elderly, wanted to protect herself from COVID virus, first was avail, and want to be first protected. Reporter unsure if patient had both shots. Medical history included high cholesterol and heart murmur from an unknown date and unknown if ongoing in the past, but caller does not know if it corrected itself in the past. Family Medical History Relevant to AE was none. Prior Vaccinations within 4 weeks was unknown. AE following prior vaccinations was None. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as none. The patient's concomitant medications were not reported. On unspecified date in Feb2021 the patient experienced blood clots, life threatening blood clots/ had blood clots that were 60% blockage from the brain/ the clot is in her neck was reported as worsened and minor strokes. On unspecified date in Feb2021 the patient underwent lab tests and procedures which included x-ray result with blood clots (60%-80%). The doctor wanted to schedule her for immediate surgery, but they were trying to get her booked and they were all booked up. They said they can put her on a blood thinner medication, but she was already on a blood thinner. They had wanted to switch her from the current blood thinner she was on for another illness (not sure if it's for her age or cholesterol), to another one. Patient was on a blood thinner prior to getting the COVID shot, and she didn't want to switch up the blood thinners. Therapeutic measures were taken. The outcome of the event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692185
Sex: M
Age:
State: PA

Vax Date: 08/20/2021
Onset Date: 08/26/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210826; Test Name: blood work; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: Bell's palsy; This is a spontaneous report from a contactable consumer (wife) reporting for patient (Reporters Husband). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Left arm, upper arm on 20Aug2021 (Batch/Lot Number: FC3181, at the age of 49-year-old) as single dose for COVID-19 immunisation. The patient's relevant medical history and concurrent conditions included high blood pressure from an unknown date. Concomitant medication included lisinopril taken for blood pressure high, start and stop date were not reported. There was investigation assessment, prior vaccinations were none. Reporter stated that they received their vaccine on Friday, last Friday and her husband. Well, they took him to the doctor the previous day, on 26Aug2021, he got Bell's palsy, so she had called the pharmacy, they told her to report it to Pfizer too. Treatment for AE included reporter stated that they put him on steroid pack Prednisone. The patient underwent lab tests and procedures which included blood work (blood test): result unknown on Thursday, 26Aug2021 at the doctor's office. The Reporter asked, how did they know if he was supposed to get the second shot and asked whether she supposed to wait for the side effect to clear up. Reporter also asked what she do there. Reporter seriousness for Bell's palsy was unspecified. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: LISINOPRIL

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am