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: 1349528
Sex: M
Age:
State: UT

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: slurred speech; Memory loss; loss of cognitive functions; increased appetite; nausea; headaches; weight gain; unable to stay focused; shortness of breath / difficulty breathing; chest pain near heart; This is a spontaneous report from a contactable consumer or other non hcp. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0162) unknown dose via an unspecified route of administration in deltoid left on 15Apr2021 at 01:45 (at the age 29 years) as single dose for COVID-19 immunization. Medical history included depression. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination: Allergy medicine, ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Apr2021 at 16:00, the patient experienced memory loss, loss of cognitive functions, increased appetite, nausea, slurred speech, headaches, weight gain, unable to stay focused, shortness of breath, difficulty breathing, chest pain near heart. Outcome of the events was recovered with sequelae. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1349529
Sex: M
Age:
State: WI

Vax Date: 02/11/2021
Onset Date: 03/01/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data: Test Date: 20210301; Test Name: biopsy; Result Unstructured Data: Test Result:leukocytoclastic vasculitis

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Biopsy confirmed leukocytoclastic vasculitis on legs; scratchy throat; This is a spontaneous report from a contactable physician. A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 14Jan2021 for covid-19 immunisation. It was reported that biopsy confirmed leukocytoclastic vasculitis on legs which started on 01Mar2021, two weeks after the second Covid vaccine dose. No other systemic cause of vasculitis found on workup in rheumatology. Prednisone started and transient improvement. An antibiotic (Augmentin) was added because the patient also had a scratchy throat. A second tapering prednisone course was restarted for a few weeks. Vasculitis totally improved by early May and prednisone was discontinued. The patient recovered from the events on an unspecified date. Information on the lot/ batch number has been requested.; Sender's Comments: Based on current information available, the event leukocytoclastic vasculitis on legs and throat irritation mostly represented intercurrent condition in this patient, unrelated to Bnt162b2. Relevant medical history and concurrent disease are missing for a 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:

Current Illness:

ID: 1349530
Sex: F
Age:
State: FL

Vax Date: 04/07/2021
Onset Date: 04/13/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Passing out POT syndrome has occurred 10 times since initial vaccine; Passing out POT syndrome has occurred 10 times since initial vaccine; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 15:15 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included history of migraines from an unknown date and unknown if ongoing. Concomitant medication included vitamin d3 taken for an unspecified indication, start and stop date were not reported. Passing out POT syndrome has occurred 10 times since initial vaccine worsening post second vaccine on 13Apr2021 12:00. The patient experienced "passing out POT syndrome has occurred 10 times since initial vaccine" and was reported as worsening post second vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Therapeutic measures taken as a result of the event included a Heart monitor (as reported). Outcome of events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: VITAMIN D3

Current Illness:

ID: 1349531
Sex: M
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Allergic reaction; Red blotches nose, spots inside hands/ some rashes inside hands, skin, inside hands like little dots, snow white dots surrounding red rashes, like hundreds of them white little circle dots; head rashes/nose too high to low, lowdots on nose rashes like rashes and on nose but they come and go and they went away but these look like buyers spots in my hands; This is a spontaneous report received from a contactable consumer. A male patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02May2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for Covid-19 immunisation (first dose, rash). On unknown date, the patient experienced allergic reaction. On unknown date the patient experienced red blotches on nose and spots inside his hands/ the patient had some rashes inside hands, skin, on inside hands like little dots, snow white dots surrounding red rashes or something they was like hundreds of them white little circle dots (they sometime were more, sometimes they went away, then they came back, they went away). On unknown date, the patient experienced head rashes/ nose too high to low, low dots on nose rashes like rashes and on nose but they came and went ,and they went away but these look like buyers spots in hands. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1349532
Sex: U
Age:
State:

Vax Date: 04/27/2021
Onset Date:
Rec V Date: 05/26/2021
Hospital:

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

Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: Feeling awkward like I am drunk; I had Dilantin toxicity/I went to the emergency room and they said my Dilantin level has; was too high, my Dilantin level was toxic.; I am tired; Medications have react with the vaccine; I feel like I have been weak today and then I am still not having energy for the day.; so taking 1 tablet twice a day instead of two tablets twice a day; the second dose is about to kill me, I haven't felt like it in 16 years, I am recovering alcoholic. I am on medication from 16 years; Dilantin toxicity; This is a spontaneous report received from a contactable consumer (Patient). Follow-up (08May2021) information was processed together with initial information. A 46-year-old unspecified gender patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number: EW0171 and expiration date were not reported) via an unspecified route of administration in left arm, on 27Apr2021 (at the age of 46-year-old) as single dose for COVID-19 immunization. The patient also administered a Dilantin because of 16 years back had epilepsy. The patient's medical history included epilepsy which had sixteen years back and for this taken Dilantin and Trokendi XR 200 mg. The concomitant medication included Keppra 500 mg 3 in the morning 3 in the night, Onfi 10 mg, 1 tablet twice a day, also take Trokendi 200 mg extender release XR once a day. The event was described as follows: Patient took the vaccine and Patient having awkward Patient don't even what but it was during when Patient took Dilantin always do have but when took the vaccine April 27th that was the last vaccine on the 27th (April)."Patient experiencing feel like I am drunk and Patient have been on it (Dilantin), 16 years back had epilepsy. Patient have epilepsy (History) and the medications (Dilantin and Trokendi XR 200 mg) that Patient taking would not. If vaccine would affect, the medicines (Dilantin and Trokendi XR 200 mg) that taking but think it has and take Trokendi XR 200 mg one capsule a day, Patient take the generic brand (unspecified medication) take "6" (not clarified) capsules a day but "3" (not clarified) capsules last day 500 mg and took Dilantin. Patient supposed to be taking 2 capsules twice a day and Patient went to the Hospital in night they said I had Dilantin toxicity (Hence, conservatively PC Filed) and told me to start taking 1 Dilantin twice a day and kept down and doing that but Patient tried. Patient got no clue, feel like are any of these medications are related to or the vaccine. Patient asked any of these medications have any kind of react with the vaccine". Patient had no problem with the first dose, the second dose is about to kill, Patient haven't felt like it in 16 years, Patient recovering alcoholic. Patient on medication from 16 years." Patient underwent lab test and procedures included Blood test. The outcome of event was Unknown.

Other Meds: KEPPRA; ONFI; TROKENDI XR

Current Illness:

ID: 1349533
Sex: M
Age:
State: CA

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

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

Lab Data: Test Name: ct of head; Result Unstructured Data: Test Result:unknown result; Test Name: ekg; Result Unstructured Data: Test Result:unknown result; Test Name: vital sign; Result Unstructured Data: Test Result:unknown result

Allergies:

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

Symptoms: BLE and BUE went into abnormal extension; facial tics; shaking of the BUE; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; nausea; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in right arm on 05May2021 13:50 (Batch/Lot Number: EW0167) as single dose for covid-19 immunisation. Medical history were none. Prescriptions, over the counter medications taken were none. Allergies to medication, Food or other products were none. Other illness at the time of vaccination and up to one month prior were none. Chronic or long-standing health conditions were none. The patient's concomitant medications were not reported. 5 minutes following the vaccination, patients BLE and BUE went into abnormal extension immediately followed by facial tics and shaking of the BUE patient was pale, diaphoretic, and verbalized iam ok three times in a row without being asked. patient stated that he was unaware of what had just happened then verbalized feelings of nausea. Airway breathing, circulation intact. patient was placed on gurney, side rails upx2, and transported to ED. The patient never had an adverse event following any previous vaccine. Event start date was 05May2021. Medical tests and laboratory results related to the adverse events included: Vital signs, EKG, CT of the head. Emergency room/department or urgent care visit. Outcome was recovered. Follow-up attempts are needed. further information is expected.

Other Meds:

Current Illness:

ID: 1349534
Sex: F
Age:
State: CA

Vax Date: 04/22/2021
Onset Date: 04/01/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: She was sore in the area where she got the injection, on her arm, after the first vaccine; This is a spontaneous report from a contactable consumer (patient). This female consumer of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Apr2021, in the arm, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Apr2021, after the first vaccine, the patient was sore in the area where she got the injection, in her arm. Event outcome was unknown. The second vaccine was scheduled on 17May2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1349535
Sex: F
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Panic attacks; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient, not pregnant, received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration administered in arm left on 06May2021 10:30 as 2nd dose, single for covid-19 immunisation. Medical history included ulcerative colitis, and hypothyroidism. Concomitant medications included adalimumab (HUMIRA); levothyroxine; and balsalazide disodium - all taken for unspecified indications, start and stop dates were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 15Apr2021 10:15 AM administered in the left arm for covid-19 immunisation. There were no other vaccines received within 4 weeks prior to the covid-19 vaccine. The patient was not diagnosed with covid-19 prior to the vaccination. Vaccination was done at a pharmacy or drug store. The patient experienced panic attacks on 07May2021 which resulted in emergency room/department or urgent care. The patient had not recovered from the adverse event at the time of the report. Since the vaccination the patient has not been tested for covid-19. No follow-up attempts are possible. No further information is expected.

Other Meds: HUMIRA; LEVOTHYROXINE; BALSALAZIDE DISODIUM

Current Illness:

ID: 1349536
Sex: M
Age:
State: VA

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: assuming it was an allergic reaction; slightly dizzy and a bit sick to my stomach (likely from the dizzy feeling).; slightly dizzy and a bit sick to my stomach (likely from the dizzy feeling).; This is a spontaneous report from a non contactable consumer (patient). A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01May2021 14:30 (Lot Number: EW0176) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included multiple sclerosis and known allergies: All mammalian meats (alpha gal protein), shellfish, and tree nuts. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 01May2021 02:45 PM, within a few minutes of receiving his first dose of the Pfizer vaccine, the patient became slightly dizzy and a bit sick to my stomach (likely from the dizzy feeling). Since it occurred within minutes, he was assuming it was an allergic reaction to the vaccine itself. He was obviously nervous about getting his second dose now. Often times anaphylaxis occurs the 2nd time you encounter a reaction inducing stimuli. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovered on May2021. This case was reported as not serious. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1349537
Sex: F
Age:
State: GA

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: injection site: redness, swelling, itchy, raised area, very similar to a bee sting/ with the 1st dose, she had a similar reaction and a red spot; injection site: redness, swelling, itchy, raised area, very similar to a bee sting/ with the 1st dose, she had a similar reaction and a red spot; injection site: redness, swelling, itchy, raised area, very similar to a bee sting/ with the 1st dose, she had a similar reaction and a red spot; mild allergic reaction; This is a spontaneous report from a non-contactable consumer (pateint). A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 07Apr2021 09:00 as 1st dose, single; then on 06May2021 18:00 as 2nd dose, single; the patient received both doses via an unspecified route of administration on the left arm at the age of 27 years old (Batch/Lot number was not reported) for COVID-19 immunisation. Medical history included mental illness, anxiety, moderate depression, bipolar depression, post-traumatic stress disorder (PTSD), migraines, polycystic ovarian syndrome (PCOS) and sulfa drugs allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL), cetirizine hydrochloride (ZYRTEC ALLERGY), rizatriptan benzoate (MAXALT); all for excendrine migraine. On 07May2021, the patient had injection site: redness, swelling, itchy, raised area, very similar to a bee sting. The patient stated that with the 1st dose, she had a similar reaction on an unspecified date and a red spot about 1 inch wide remained. The patient was treated with ice (as reported), diphenhydramine (BENADRYL) and ibuprofen for mild allergic reaction. The patient had no other vaccines in four weeks and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: PROZAC; LAMICTAL; ZYRTEC ALLERGY; MAXALT

Current Illness:

ID: 1349538
Sex: F
Age:
State: FL

Vax Date: 04/23/2021
Onset Date: 04/26/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data: Test Name: Creatine Kinase; Result Unstructured Data: Test Result:Normal; Test Name: CRP; Result Unstructured Data: Test Result:Normal; Comments: CRP levels came back normal; Test Name: reflex test; Result Unstructured Data: Test Result:Normal; Comments: neurological strength/reflex test presented normal.; Test Name: Lumbar X-Ray; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: all over fasciculations; paresthesia in right arm and leg; deep lower back pain/shoulder pain; deep lower back pain/shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 23Apr2021 11:00 (Batch/Lot Number: ER8731) as 2nd dose, single, at the age of 43-years-old for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included penicillin allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 10:30 lot number: EP7533, in the right arm. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After second vaccine on 23Apr2021, on 26Apr2021 she noticed delayed onset of symptoms which include all over fasciculations, paresthesia in right arm and leg, deep lower back pain/shoulder pain. These symptoms have not resolved and are undiagnosed. Lumbar X-Ray came back normal, Creatine Kinase and CRP levels came back normal, neurological strength/reflex test presented normal. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was not recovered. Follow up needed, further information has been requested.

Other Meds:

Current Illness:

ID: 1349539
Sex: F
Age:
State: WA

Vax Date: 03/07/2021
Onset Date: 03/08/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Oral lesions appeared all over inside my mouth, on my tongue, cheeks, behind my lower lip, and gums; It began with a few white-colored sores; my tongue never felt right. It felt as though the top layer was numb; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 07Mar2021 11:45 AM (Batch/Lot Number: EN6199) at the age of 48-years-old as 1st dose, single for COVID-19 immunization at urgent care center. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included asthma, arthritis, and allergies: sensitive to peppers. Concomitant medication included meloxicam taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). On 08Mar2021, oral lesions appeared all over inside her mouth, on her tongue, cheeks, behind her lower lip, and gums. It began with a few white-colored sores. They would heal and new ones would appear. They lasted for 2 weeks. While the sores were gone, her tongue never felt right. It felt as though the top layer was numb. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. A device date of 09May2021 was reported. Therapeutic measures were taken as a result of the events which included valacyclovir hydrochloride (VALTREX), chlorhexidine gluconate (PERIDEX), triamcinolone, and B12. The outcome of the events was recovered with sequelae (recovered with lasting effects).

Other Meds: MELOXICAM

Current Illness:

ID: 1349540
Sex: F
Age:
State:

Vax Date: 05/03/2021
Onset Date: 05/03/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data: Test Date: 20210503; Test Name: body temp; Result Unstructured Data: Test Result:fever; Test Date: 20210507; Test Name: body temp; Result Unstructured Data: Test Result:100

Allergies:

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

Symptoms: Sweating profusely; could not even move her body it was so sore; flushed/this is like a hot feeling in her face; tingling feeling on the side of her face, above the eye; tingling feeling on her lip; numb feeling on the side of her face, above the eye and on her lip; numb feeling on her lip; fever of 100; arm started hurting really bad; felt really tired/exhausted; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03May2021 (Lot Number: EW0171; Expiration Date: Aug2021) as 2nd dose, single for covid-19 immunisation. Medical history and concomitant drugs were reported as no. The patient previously received 1st dose, single of bnt162b2 on 12Apr2021 (Batch/lot number - ER8729, Expiry Date: Jul2021) for covid-19 immunisation, and she was fine but then the next day her arm was a little sore if she touched it. Caller stated she just needs to ask a question because she is getting concerned. Caller stated then she went Monday to get the second dose and right after the shot her arm started hurting really bad which is a common side effect and she felt really tired so when she got home she went to bed. Caller stated then she noticed on the side of her face felt like she had Novocaine where she had this tingling and numb feeling on the side of her face, above the eye and on her lip and she was also still sore on her arm on Tuesday. Caller stated then Wednesday she was still experiencing a little bit of this tingling and numb feeling, was exhausted, and her arm was killing her. Caller stated on Thursday she was like ok she is feeling really good and starting to get back to normal. Caller stated and she just wanted to let this DSU agent know she has not been sick with anything not even a cold for over three years so this is not common. Caller stated then last night (was early this morning on 07May2021) she woke up sweating profusely and she could not even move her body it was so sore like she got beat up as it was just like an ache from her head to toes (this was like she had exercised and was really sore like that type of soreness) and also her arm was killing her still and she had a fever of 100. Caller stated she was calling because she is not sure if this is common? By Thursday she started feeling better from tired and made it through the whole day until last night she got really tired again and is still tired now. Caller stated she is just flushed (like a hot feeling in her face) now since the sweating had stopped. Caller stated she had a fever the first day on 03May2021 and then went away on Tuesday and she had recovered completely. But then she and woke up early this morning in the middle of the night on 07May2021 and the fever had started back. Caller stated she still has a fever as of now and it has stayed the same since she first noticed it early this morning. Treatment included: Tylenol and Ibuprofen. The outcome of sweating was recovered. The outcome of arm started hurting really bad, could not even move her body it was so sore and flushed was not recovered. The outcome of fever was unknown. The outcome of others was recovering. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1349541
Sex: F
Age:
State: WA

Vax Date: 03/28/2021
Onset Date: 03/01/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: that oral lesions appeared all over inside her mouth, on her tongue, cheeks, behind my lower lip, and gumsbegan with a few white-colored sores; Now the sores are gone and she's pain-free, but still experiencing some numbness; lips and tongue swelled; lips and tongue swelled; Couldn't eat anything but soup or yogurt; lost 15 pounds; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 28Mar2021 11:30 (Batch/Lot Number: ER8732) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included asthma and arthritis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication(s) included meloxicam taken for an unspecified indication, start and stop date were not reported. It was reported that oral lesions appeared all over inside her mouth, on her tongue, cheeks, behind my lower lip, and gums. It began with a few white-colored sores. They would heal and new ones would appear. They lasted for 2 weeks. While the sores were gone, my tongue never felt right. It felt as though the top layer was numb. 8 days after my second dose, the sores reappeared. This time it was much worse. Twice, the entire right-half of the underside of my tongue was white. Sores would move around. She could feel them forming on her tongue at night. Her lips and tongue swelled. She couldn't eat anything but soup and yogurt. It hurt to talk. She lost 15 pounds. Now the sores are gone and she's pain-free, but still experiencing some numbness. The outcome of events was recovered with lasting effects. The outcome of event was reported as Recovered/Resolved with Sequel. The events resulted in emergency room/physician's office visit. Therapeutic measures taken as result of events. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: MELOXICAM

Current Illness:

ID: 1349542
Sex: F
Age:
State: CA

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Immediate extreme migraine; Severe neuralgia flare up; Can't sleep due to muscle pain; Can't sleep due to muscle pain; Breakthrough bleeding; Cramps; 1st dose : 15Apr2021, 2nd dose: 15Apr2021; 1st dose : 15Apr2021, 2nd dose: 15Apr2021; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 15Apr2021 09:30 (Batch/Lot Number: ER8735) as 1st dose, single, and via an unspecified route of administration, administered in right arm on 15Apr2021 (Batch/Lot Number: EW0176) as 2nd dose, single for COVID-19 immunization, in an urgent care center. Medical history included chronic migraine, occipital neuralgia, and Penicillin allergy from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL); and zonisamide, both taken for an unspecified indication. On 07May2021, the patient experienced immediate extreme migraine, severe neuralgia flare up, she can't sleep due to muscle pain, breakthrough bleeding, and cramps. The patient has not recovered from the events.

Other Meds: JUNEL; ZONISAMIDE

Current Illness:

ID: 1349543
Sex: F
Age:
State:

Vax Date: 04/29/2021
Onset Date: 05/03/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: acute DVT of left peroneal vein (in the left calf); This is a spontaneous report from a non-contactable consumer (patient). This 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route, on 29Apr2021 11:30 (at the age of 49-year-old) at single dose in the left arm for COVID-19 immunisation. No relevant medical history was provided. No other vaccine was received in four weeks. Relevant concomitant medications included ibuprofen (ADVIL 12 HOUR). From 03May2021, the patient developed sharp, piercing pain in my left calf over several days. The frequency increased the early morning (06:00-09:00) of 09May2021 so she contacted her primary care physician to discuss what she thought might be an indicator of deep vein thrombosis (DVT). She presented to the Emergency Room the morning of 09May2021 and was diagnosed with acute DVT of left peroneal vein (in the left calf). She was given blood thinner. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: ADVIL 12 HOUR

Current Illness:

ID: 1349544
Sex: M
Age:
State: NC

Vax Date: 04/28/2021
Onset Date: 04/29/2021
Rec V Date: 05/26/2021
Hospital: Y

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

Lab Data: Test Date: 20210429; Test Name: heart rate; Result Unstructured Data: Test Result:rapid heart rate; Test Date: 2021; Test Name: heart rate; Result Unstructured Data: Test Result:170+; Test Date: 2021; Test Name: heart rate; Result Unstructured Data: Test Result:near 60; Test Date: 20210502; Test Name: covid_test; Test Result: Negative ; Comments: Blood test

Allergies:

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

Symptoms: nausea; vomiting; diarrhea; rapid heart rate; severe dehydration; unable to eat or drink; Extremely fatigued all day; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 28Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included spinach allergy, UC (Ulcerative colitis). Concomitant medication included mesalamine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 07Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 29Apr2021 01:00, less than 24 hours of second vaccine there was nausea, vomiting, diarrhea and a rapid heart rate and severe dehydration. This progressed and led to hospitalization from Saturday 01May2021 to 04May2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient also experienced unable to eat or drink and extremely fatigued in 2021. As of this message (10May2021), still unable to eat or drink without vomiting and hear rate up to 170+. This was up from a normal resting heart rate of near 60. Extremely fatigued all day, vomit several times per day and loose stool to diarrhea multiple times per day. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19, covid-test (blood test) on 02May2021: negative. Treatment was received for all events. The outcome of the events was not recovered. Information about batch/ Lot number has been requested.

Other Meds: MESALAMINE

Current Illness:

ID: 1349545
Sex: F
Age:
State: NY

Vax Date: 04/20/2021
Onset Date: 04/01/2021
Rec V Date: 05/26/2021
Hospital: Y

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

Lab Data: Test Name: Colonoscopy; Result Unstructured Data: Test Result:Good; Test Name: EGD; Result Unstructured Data: Test Result:Good

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: When she went to the hospital for her stomach pain, the doctor told her she was dehydrated, and her small bowel had no water getting to it; She had a severe small bowel obstruction; She had a lot of stomach pain; Throwing up; she is ill/She is sick; She slept for most of the day the next day (after her first COVID-19 Vaccine dose); Flu-like symptoms; Headache; Her legs were hurting in the front (after her first COVID-19 Vaccine dose); This is a spontaneous report from a contactable consumer (patient) This consumer reported same event for 5 patients. This is the first of 5 reports. This 65-year-old female consumer reported for herself that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0158) on 20Apr2021 (at the age of 65-years-old) between 11:30 and 12:00 via an unspecified route in the left arm as a single dose for COVID-19 immunization. Medical history included small bowel obstruction, H. Pylori, acid reflux (esophageal), stomach problems with pains (ongoing), and doctor told her she was born with something that was stretched out on top of her stomach. She stated that her stomach pain comes and then goes away and that she has learned to work with her stomach pain. She said her doctor gave her some medicine that started with a "P" and it had worked really well. The patient also had a familial history of stomach cancer. Every year she had to go for an EGD and colonoscopy because of stomach cancer in her family. Her results have been so far, so good. There were no prior vaccinations received within 4 weeks of the COVID vaccine. There were no additional vaccines administered on the same date as the COVID vaccine. There were no concomitant medications. In Apr2021, after her first COVID-19 vaccine dose, the patient had flu-like symptoms which lasted for 2 days, headache, and her legs were hurting in the front. She also slept for most of the next day on 21Apr2021. She said the headache may have been her fault because she was told by the nurse who administered the COVID-19 vaccine to drink a lot of water. Patient stated she may have had the headache from being dehydrated. Treatment received for flu-like symptoms & headache included drank a lot of liquids and her headache went away. Patient didn't want to take Tylenol because she was afraid to. She said she walked herself through her flu-like symptoms for a few days. In two days she felt better. On 02May2021, she went to the emergency room because she had a lot of stomach pain. She was told she had a severe small bowel obstruction. Patient reported she started throwing up and had a tube put up her nose and down her throat. Patient added that she always had stomach problems with pain since she was a child, but "her heart didn't feel like take it could take the stomach pain", so she went to an urgent care. The urgent care sent her to the Emergency Room. Right when she got to the Emergency Room, she started throwing up. On 03May2021, she had major surgery where they went into her stomach with cameras and she had 3 dots made on her belly. She had the tube in her throat draining her stomach until 05May2021. She said when she went to the hospital (for her stomach pain), the doctor told her she was dehydrated and her small bowel had no water getting to it. She had the major surgery and can't drive. Her body was not up to par. The patient was hospitalized for severe small bowel obstruction, stomach pain, dehydrated, and throwing up from 02May2021 to 08May2021. It was also reported she had 4 more friends with flu-like symptoms. She clarified every woman she talked to about the COVID-19 vaccine all had the same type of symptoms after the first COVID-19 vaccine dose. Her brother and 2 male cousins had no symptoms after both doses of the Pfizer COVID-19 vaccine. Her doctor didn't want her to get the second COVID-19 vaccine dose until he sees her again. She said while she was in the hospital, she had asked the doctor and nurse to get the second COVID-19 vaccine, and both suggested that she wait on getting the second dose. Patient stated she can't get the second dose tomorrow (11May2021), because she states she is sick/ill. The clinical outcomes of flu-like symptoms, headache, and her legs were hurting in the front were recovered in Apr2021, while of small bowel obstruction, stomach pain, slept for most of the day the next day, throwing up, dehydrated, and sick/ill were unknown. The patient thought her stomach pain and small bowel obstruction had nothing to do with the COVID-19 vaccine.; Sender's Comments: The patient thought her stomach pain and small bowel obstruction had nothing to do with the COVID-19 vaccine. The company consider all the serious events small bowel obstruction, stomach pain, dehydration, and vomiting were unrelated to the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). The underlying small bowel obstruction, acid reflux (esophageal) and stomach problems with pains could explain the symptoms. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021531142 same reporter/SD/AE, different patient.;US-PFIZER INC-2021533619 same reporter/SD/AE, different patient.;US-PFIZER INC-2021533282 same reporter/SD/AE, different patient.;US-PFIZER INC-2021531607 same reporter/SD/AE, different patient.

Other Meds:

Current Illness: Stomach pain (she always had stomach problems with pain (since she was a child),)

ID: 1349546
Sex: M
Age:
State: FL

Vax Date: 05/05/2021
Onset Date: 05/01/2021
Rec V Date: 05/26/2021
Hospital: Y

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

Lab Data: Test Date: 20210506; Test Name: Fever; Result Unstructured Data: Test Result:102; Test Date: 202105; Test Name: laboratory test; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Bleeding; Shortness of breath; Chest pain; Fever of 102; Viral myocarditis; This is a spontaneous report from a contactable consumer (parent). A 22-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration assuming left arm, at age 22 years, on 05May2021 (Batch/Lot Number: EW0153) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history was reported as no. Concomitant medications were not reported. Patient historically took first dose of BNT162B2 at age 22 years on 14Apr2021 for COVID-19 immunization. Reporter's son unfortunately appeared was hospitalized for adverse reaction (bleeding) and the physician told reporter to report this. Patient had has viral myocarditis of heart on an unspecified date on May2021 after he got his second dose on 05May2021. On 06May2021, patient started having symptoms of shortness of breath, chest pain and fever of 102 (unit: unknown) after the second dose, so he went to emergency room. Then on Friday , 07May2021, he ended up with bleeding, so admission date is 07May2021 and he is still in the hospital at the time of reporting, they don't know how long. Patient also underwent lab test and procedure that includes laboratory test on May2021, 2 weeks before, patient was fine until the second dose. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1349547
Sex: U
Age:
State: WA

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

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

Lab Data:

Allergies:

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

Symptoms: Whole body swell and itching; Whole body swell and itching; Burning sensations every where on body; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 04May2021 13:30 (Lot Number: EW013) as single dose for COVID-19 immunisation. Medical history included anaemia and recovered from Anemia, known allergies as bee stings, mango skin allergy, swelling of face response. severe itching / swelling. Concomitant medications included: thyroid medicine and multi vitamins. Two hours after shot on 04May2021, patient's whole body swell and itching, burning sensations every where on body, took antihistamine at home and went to the ER room where they gave patient steroids and EPI pen as well as more antihistamines. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered. Information on lot/batch was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1349548
Sex: F
Age:
State: NY

Vax Date: 04/01/2021
Onset Date: 05/08/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bell's palsy after 2 weeks of my first dose of vaccine; Left half face feels numb and I am not able to control my left half of face.; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female non-pregnancy patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left in Apr2021 (Lot Number: EWO169, at age of 27 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included: Birth control pills. The patient experienced Bell's palsy after 2 weeks of first dose of vaccine, left half face felt numb and patient was not able to control her left half of face on 08May2021 10:00. Event resulted in: Doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. The patient received treatment as Prednisone 50 mg tablet. The outcome of events was not recovered.

Other Meds:

Current Illness:

ID: 1349549
Sex: F
Age:
State: NY

Vax Date: 04/16/2021
Onset Date: 05/07/2021
Rec V Date: 05/26/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: a history of high blood pressure and says she went to the hospital due to experiencing high blood pressure; dizziness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient received her first injection of the Pfizer covid 19 vaccine and was supposed to receive her second injection on 07May2021 but she missed the appointment because she was in the hospital. The patient reported a history of high blood pressure and says she went to the hospital due to experiencing high blood pressure and dizziness on 07May2021. She was kept overnight and treated with blood pressure medication and a medication for dizziness and a vitamin. She reports being fine now. The outcome of the event was recovered on 07May2021. The patient does not feel like her high blood pressure and dizziness were due to the Pfizer covid-19 vaccine. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events 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: 1349550
Sex: F
Age:
State: NM

Vax Date: 03/30/2021
Onset Date: 04/07/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Her feet turned into giant whelps; Hives/hives started out on her feet and arms, and now they are taking over her entire body; She was having a hard time walking; They are painful; This is a spontaneous report received from a contactable consumer (patient herself). A 45-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 30Mar2021 09:00 (Lot Number: ER8733, at age of 45 years old) as single dose for COVID-19 immunisation. Medical history included she had always had bad allergies. She thought it was just an immune, Compromised immune status, Respiratory illness, Chromosomal abnormalities, diabetes, obesity, Seasonal allergies diagnosed when she was 5 years old, interstitial cystitis diagnosed a few years ago. The patient's concomitant medications were not reported. The patient previously Intramuscularly received first dose of BNT162B2 on 09Mar2021 for Covid-19 immunization, lot: EN6206; anatomical location: Left arm; Time the vaccination was given: 09:00. The patient developed hives on 07Apr2021, 5 days after receiving the second dose of the Pfizer Covid 19 vaccine. They had been going on for 6 weeks and weren't going away despite being on prednisone. Her doctor said there was no life threatening issue. She said they were painful, annoying and she couldn't work out or participate with her family like she wanted. She developed hives and was put on 60 mg of Prednisone to control. They started 5 days after the second dose of the vaccine and have not gone away. There was no prescriber. Her family recommended she did something. She would be seeing an allergist. She said Prednisone was a hell of a drug to be on. After second dose, she was told to do light exercise to move her arm. She did not have any fatigue. She was working out and 5 days later, she got the hives. The hives started out on her feet and arms, and now they were taking over her entire body. She was having a hard time walking because the ones in her feet turned into giant whelps. She could not put on shoes. She had to go to the ER to try and control them. She was already on Prednisone and her time was up and they came back worse. They put her back on it. She might have to take a pill for the rest of her life. They were not going away. The first Prednisone was 20mg and she was taking it twice daily for 5 days. She did not have a lot or expiration as she had disposed of it and it was in a pharmacy vial. The start date of the current Prednisone was 02May2021. The current dose was 10mg. She was taking it 6 times a day and was now taking twice a day. It was in a pharmacy vial with no lot or expiration. The count size of the 20 mg was unknown. The count size of the 10 mg is 57. She would not be willing to send a sample. ER or physician's office required at the Urgent Care. She went to that urgent care twice. The first time they said to ride it out. The second time, they prescribed Prednisone. She finished it and was on vacation and got them again. She had to go to the ER to get more Prednisone because they covered her entire body. It was very scary to have a new thing and thinking body was attacking itself. The outcome of hives giant and hives was not recovered, the outcome of rest events was unknown. Information on Lot/Batch number was available. Additional information had been requested.

Other Meds:

Current Illness:

ID: 1349551
Sex: F
Age:
State: MD

Vax Date: 04/17/2021
Onset Date: 04/01/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data: Test Date: 20210417; Test Name: Peak flow; Result Unstructured Data: Test Result:over 550; Comments: peak flow meter and it was fine, over 550 More information available (Y/N): NO

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: the back of her tongue felt numb/developed a numb tongue; throat was itchy then sore/her throat was sore and itchy; throat was itchy then sore/her throat was sore and itchy; chest pain; not quite normal breathing/uncomfortable breathing/heavy breathing that was more of an irregular breathing; Fatigue; her lungs felt swollen; This is a spontaneous report from a Pfizer-sponsored program via a consumer reported for a patient (reporter's mother). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 17Apr2021 (Lot Number: EW0162) (at the age of 23-year-old) as single dose for covid-19 immunization. Medical history included asthma and diagnosed at age 2, allergy and allergy to bull dogs. Concomitant medications included budesonid taken for allergy, start and stop date were not reported; formoterol fumarate dihydrate taken for allergy, start and stop date were not reported. The patient experienced her lungs felt swollen in Apr2021, the back of her tongue felt numb/developed a numb tongue on 17Apr2021, throat was itchy then sore/her throat was sore and itchy on 17Apr2021, chest pain on 17Apr2021, not quite normal breathing/uncomfortable breathing/heavy breathing that was more of an irregular breathing/out of breath walking up the steps on 17Apr2021 and fatigue on 17Apr2021. A family member had some reaction to the first pfizer covid-19 vaccine. Wanted to know where can she find information to determine if the second vaccine shot is safe. 40 minutes from the time of the injection the back of her tongue felt numb and her throat was itchy then sore. About 40 minutes after that those symptoms went away. Later in the day she had chest pain and not quite normal breathing. After using her asthma inhaler twice in a short time this dissapated. Fatigue remained for about a week. Her daughter was prescribed Metronidazole 500mg (she initially thought it was penicillin) and the packaging information of the antibiotic says not to receive any vaccines. She was scheduled for her second dose next Tuesday (18May2021) and wanted to know if it would this be applicable to the Pfizer BioNTech Covid 19 vaccine. Mother calling on behalf of daughter who received the first dose of the Pfizer BioNTech Covid 19 vaccine on 17Apr2021. She was told to wait 30 minutes after the vaccine and was okay, however after 40 minutes after the vaccine she developed a numb tongue, her throat was sore and itchy. This subsided within about 30 minutes (also reported as 40 minutes). About 4 hours after the vaccine she developed chest pain and uncomfortable breathing. Her daughter states her lungs felt swollen, and was out of breath walking up the steps. She did use her AuviQ and albuterol inhaler and the first dose of AuviQ didn't work so she repeated it and it helped. She called the doctor and used her peak flow meter and the doctor on call stated that her reading was okay and did not need further medical attention. After that evening those side effects went away. Caller has a past medical history of asthma and allergies to bulldogs. If she was even around someone who has been near a bull dog she will develop chest symptoms. Mother spoke with CDC and they told her as long as her daughter didn't go to the ER it was okay for her to receive the vaccine and wanted to know if she get her second dose of the Pfizer BioNTech Covid 19 vaccine. She is scheduled to receive it next Tuesday (18May2021). Her doctor said that some people react to the polyethylene glycol and want to know if she could get tested for that. After the patient received the vaccine, her tongue was numb and her throat was sore and itchy but it went away. This started 40 minutes after the patient received the vaccine. 4 hours after the patient received the vaccine, she had chest pain and heavy breathing. The caller is nervous because the patient has only had this chest pain during a severe allergic reaction in the past. The patient do about the second dose. The patient was also prescribed an antibiotic this week and the antibiotic paperwork said not to have any vaccines while taking that product. The patient is due for the second dose of the vaccine this week, is it okay to get because she will still be on the penicillin. This event happened after receiving the first dose of the vaccine on 17Apr2021. The patient also had fatigue for a week. The patient had the heavy breathing that was more of an irregular breathing. The patient's lungs felt swollen, it felt like there was weight on her chest, it was uncomfortable breathing. The caller felt out of breath walking up the steps. The caller used her inhaler twice. The patient underwent lab test included investigations: the on call doctor had the patient do the peak flow meter and it was fine, over 550 on 17Apr2021. No more information was available. The doctor also had the patient press her chest to see if there was pain when she touched it and there was not so the on call doctor felt comfortable not making the patient go to the emergency room. Caller reports that her daughter received her first vaccine dose on 17Apr2021 and afterwards experienced a severe reaction with symptoms including, tongue swelling, sore throat, and Chest pain. Caller reported that it didn't getm severe enough for her to need an Epi pen. Caller reports that they have an appointment to see her doctor as well, for further discussion. She calls today to ask if symptoms with the second dose are expected to be worse than they were with the first shot and timing of the second dose. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID- 19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the event her lungs felt swollen was unknown, the event fatigue was recovered in Apr2021, the other events was recovered on 17Apr2021. Information on lot/batch is available; further information has been requested.

Other Meds: BUDESONID; FORMOTEROL FUMARATE DIHYDRATE

Current Illness:

ID: 1349552
Sex: F
Age:
State: WA

Vax Date: 04/30/2021
Onset Date:
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Fainting; Sore arm; Abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0164; Expiration date was not reported) on the left arm on 30Apr2021 (16:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date in 2021, the patient was fainting; had sore arm; and had abdominal pain. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date in 2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1349553
Sex: M
Age:
State: CA

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

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

Lab Data: Test Date: 20210506; Test Name: ALT; Result Unstructured Data: Test Result:81 IU/l; Test Date: 20210506; Test Name: AST; Result Unstructured Data: Test Result:392 IU/l; Test Date: 20210506; Test Name: bilirubin; Result Unstructured Data: Test Result:0.6; Comments: normal

Allergies:

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

Symptoms: Transaminitis; AST 392; ALT 81 IU/l; Fevers; Nausea; Vomiting; abdominal pain; dose 2 on 05May2021 and first dose on 24Apr2021; dose 2 on 05May2021 and first dose on 24Apr2021; This is a spontaneous report from a contactable physician. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 intramuscular, administered in arm right on 05May2021 16:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included bilateral cystic kidney disease, hypertension, allergies to amoxicillin, cephalexin, ceftriaxone. Concomitant medication received within 2 weeks of vaccination included propranolol 30 mg, 3x/day. The patient previously received first dose of BNT162B2 intramuscular in right arm on 24Apr2021 04:00 PM for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced transaminitis, AST 392 IU/l, ALT 81 IU/l; normal bilirubin 0.6 on 06May2021. Fevers starting on 06May2021 to 10May2021 and continued (current at time of reporting) with nausea, vomiting, abdominal pain. These events resulted in Emergency room/department or urgent care. Treatment received for the adverse events included ondansetron; IV bolus. The outcome of events transaminitis, AST 392 IU/l, ALT 81 IU/l, Fevers and abdominal pain was recovering and other events was unknown. Events were reported as non-serious and did not resulted in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect. Information on the batch/lot number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the reported events cannot be totally excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: PROPRANOLOL

Current Illness:

ID: 1349554
Sex: F
Age:
State: MN

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: felt pop in right eye; white light flashes; floaters in left eye; blurry vision; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 via an unspecified route of administration, administered in arm right on 05May2021 11:15 (Lot Number: EW0982) as 2nd dose, single for covid-19 immunisation. The patient medical history was none. Concomitant medication included metoprolol succinate ER tablet 25 mg. The patient was not pregnant. The patient previously received first dose of BNT162B2 (lot number EW0153) on 07Apr2021, 11:00 AM in Right arm. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. Within 24 hours of receiving vaccine on 06May2021 12:00 PM, the patient felt pop in right eye and experiencing white light flashes and floaters in left eye, blurry vision. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of events was not recovered.

Other Meds: METOPROLOL SUCCINATE

Current Illness:

ID: 1349555
Sex: F
Age:
State: PA

Vax Date: 04/15/2021
Onset Date: 04/17/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: ability to bleed and bruise more easily; Heavier than normally menstrual cycle with blood not clumping; ability to bleed and bruise more easily; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm right on 15Apr2021 12:30 at age of 26-year-old (Batch/Lot Number: EW0162) at single dose for COVID-19 immunization. Medical history included asthma, diabetes, polycystic ovary syndrome. The patient is not pregnant. The patient had known allergies to latex, berries and seasonal. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 at 12:00, the patient experienced heavier than normally menstrual cycle with blood not clumping, and ability to bleed and bruise more easily. The events were reported as non-serious. The events did not resulted in hospitalization prolonged. Treatment was received for the events which included tranexamic acid 650mg for 5 days. The patient received second dose on 08May2021 (Batch/lot number: EW0167) in arm right for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown. No follow-up attempts are needed. further information is expected

Other Meds:

Current Illness:

ID: 1349556
Sex: F
Age:
State: CO

Vax Date: 04/15/2021
Onset Date: 04/20/2021
Rec V Date: 05/26/2021
Hospital: Y

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

Lab Data: Test Date: 20210503; Test Name: hyperbilirubinemia; Result Unstructured Data: Test Result:hyperbilirubinemia; Test Date: 20210505; Test Name: CT A/P; Result Unstructured Data: Test Result:cholelithiasis; Comments: MRCP and CT A/P unrevealing except evidence of cholelithiasis with absence of pain.; Test Date: 20210505; Test Name: Viral Hep panel; Test Result: Negative ; Test Date: 20210505; Test Name: Serial output LFTs; Result Unstructured Data: Test Result:Pending; Comments: Serial output LFTs pending.; Test Date: 20210505; Test Name: MRCP; Result Unstructured Data: Test Result:cholelithiasis; Comments: MRCP and CT A/P unrevealing except evidence of cholelithiasis with absence of pain.; Test Date: 20210503; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210503; Test Name: transaminitis; Result Unstructured Data: Test Result:moderate transaminitis

Allergies:

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

Symptoms: jaundice; itchy skin; evidence of cholelithiasis with absence of pain; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first single dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 15Apr2021 13:00 (Batch/Lot Number: EW0151) for covid-19 immunisation. Medical history included obesity. Concomitant medication(s) included amoxicillin; duloxetine hydrochloride (CYMBALTA); vitamins nos (DAILY MULTIVITAMIN); biotin, all 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 experienced jaundice, itchy skin, and evidence of cholelithiasis with absence of pain on 20Apr2021. The patient was hospitalized for the events from 03May2021 to 05May2021. The patient checked herself into Emergency Room with jaundice and itchy skin on 03May2021. No previous history of liver issues or jaundice. Discharged on 05May2021. Diagnosis of hyperbilirubinemia and moderate transaminitis on 03May2021. Viral Hep panel neg; MRCP and CT A/P unrevealing except evidence of cholelithiasis with absence of pain; Autoimmune labs pending; Serial output LFTs pending on 05May2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 on 03May2021 with Nasal Swab, Result: Negative. No treatment received for the events. Outcome of reaction/events was unknown. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events "jaundice, pruritus and cholelithiasis" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: AMOXICILLIN; CYMBALTA; DAILY MULTIVITAMIN; BIOTIN

Current Illness:

ID: 1349557
Sex: M
Age:
State: MN

Vax Date: 04/12/2021
Onset Date: 05/02/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Sudden idiopathic hearing loss of the left ear; This is a spontaneous report from a contactable consumer.A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 12Apr2021 11:15 (Batch/Lot Number: ER8729) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Alcoholism, diverticulosis, allergies Penicillins. Patient previous received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) in Mar2021 in Right arm for covid-19 immunization. Concomitant medication(s) included naltrexone taken for an unspecified indication, start and stop date were not reported; folic acid taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VITAMIN B-12) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sudden idiopathic hearing loss of the left ear on 02May2021 12:00 with outcome of not recovered.Therapeutic measures were taken as a result of sudden idiopathic hearing loss of the left ear. Case was reported as serious as Disabling/Incapacitating. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: NALTREXONE; FOLIC ACID; VITAMIN B-12

Current Illness:

ID: 1349558
Sex: M
Age:
State: NJ

Vax Date: 04/18/2021
Onset Date: 04/18/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: A minute or so after the shot had mild headache and difficulty breathing for 20-30 seconds.; A minute or so after the shot had mild headache and difficulty breathing for 20-30 seconds.; This is a spontaneous report from a contactable consumer (patient). A 20-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in arm left on 18Apr2021 10:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history were none. No known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient experienced a minute or so after the shot had mild headache and difficulty breathing for 20-30 seconds on 18Apr2021 10:15 with outcome of recovered on 18Apr2021. No treatment received. Seriousness criteria of difficulty breathing was medically significant. Follow-up needed. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1349559
Sex: F
Age:
State: NJ

Vax Date: 04/16/2021
Onset Date: 05/06/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I had a miscarriage and they estimated the baby died at 16 weeks 5 days.; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 14:00 (Batch/Lot Number: EW0161) as single dose for COVID-19 immunization. Medical history included allergies penicillin and COVID-19. The patient's concomitant medications included bupropion hydrochloride (WELLBUTRIN) within 2 weeks of vaccination. Last menstrual period (LMP) was reported as 30Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 06May2021 16:00, the patient had a miscarriage and they estimated the baby died at 16 weeks 5 days. There were no genetic disorders detected, so the cause was unknown. Patient thought maybe the vaccine could have something to do with it. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included fetal demise removal. Outcome of the event was recovering. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: WELLBUTRIN

Current Illness:

ID: 1349560
Sex: M
Age:
State: IL

Vax Date: 04/20/2021
Onset Date: 05/09/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data: Test Date: 20200610; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Pinched middle finger, got a 1/4 diameter blood clot under skin.; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 20Apr2021 12:00 (Batch/Lot Number: er8735) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The most recent COVID-19 vaccine was administered in facility. The patient experienced pinched middle finger, got a 1/4 diameter blood clot under skin on 09May2021 13:00. Patient was scheduled to go there tomorrow for the second dose. Had an accident yesterday and pinched the right middle finger. Usually when that happens, he gets a boil and it fills with a clear liquid pus. This time, it turned into a giant blood clot, well not giant but about a quarter inch in diameter in the tip of his finger. He has never had that happen before. He may have never damaged his finger in that way before. That is why it turned into a blood clot and not clear fluid. Patient was worried a little with the blood clot because he knew it has been an issue. When he first got a little worried about the blood clot, he thought he would take 2 aspirin and it might thin the blood a little bit. Patient ate some pineapple because he heard that was a blood thinner too. No treatment received for event. The patient underwent lab tests and procedures which included nasal swab: negative on 10Jun2020. Outcome of the event was unknown. Information on lot/batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1349561
Sex: F
Age:
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Lots of systemic Sx- Mild H/A; myalgia pretty strong; injection site pain; Fatigue; Poor appetite; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 at 15:45 (at the age of 61-years-old) as unknown, single for COVID-19 immunisation. Medical history included hypertension (HTN), hypercholesterol, hypothyroidism and possibly cephalosporin allergy. The patient's concomitant medications were not reported. On 06May2021 at 11:00, patient experienced lots of systemic Sx (symptoms)- Mild H/A (headache), myalgia pretty strong, injection site pain (unlike from past vaccines like flu and TPD), fatigue and poor appetite which lasted nearly entire next day after 3:45 pm shot. Patient reported it prevented her from attending to normal activities. No treatment was given to the patient. Patient did not have COVID prior and post vaccination. Outcome of events was recovered on an unspecified date. Information on lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1349562
Sex: F
Age:
State:

Vax Date: 04/17/2021
Onset Date: 05/03/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: SOB; hives; axilla swelling; This is a spontaneous report from a non-contactable other health professional. This other HCP reported for specific patient that a 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN0161) at the age of 43-years, via an unspecified route of administration on 17Apr2021 at single dose for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 03May2021, the patient experienced hives, axilla swelling and SOB. The events result in emergency room/department or urgent care. The patient received steroids as treatment to the events. Outcome of the events was recovering/resolving. No follow-up attempts are possible. No further information expected.

Other Meds:

Current Illness:

ID: 1349563
Sex: F
Age:
State: SC

Vax Date: 02/19/2021
Onset Date: 04/02/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data: Test Name: COVID Test; Test Result: Positive ; Comments: COVID testing done before getting the doses of the Pfizer COVID-19 vaccine; Test Name: COVID Test; Test Result: Negative ; Comments: COVID testing done before getting the doses of the Pfizer COVID-19 vaccine; Test Name: weight; Result Unstructured Data: Test Result:177 lbs; Test Date: 202007; Test Name: weight; Result Unstructured Data: Test Result:196 lbs

Allergies:

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

Symptoms: She keeps losing more and more weight; Petite mal seizures/frequency of seizures increased; Grand mal convulsion/ One clonic tonic or grand mal seizure; This is a spontaneous report from a contactable Nurse (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 administered in Arm Left on 19Feb2021 08:45 (Lot Number: EN6198) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included epilepsy (diagnosed since age 6), guillain-barre syndrome (she cannot get the flu vaccine anymore because of her history of with Guillain-Barre Syndrome), she had COVID-19 in AUG2020 and has been having increased seizures since then as well, Seizures. She was positive on her COVID test, she forgets what was that it said when it came back, it didn't say positive, it said something else, she went back and forth after that first COVID test. She says it said detected, it didn't say anything else. She says after that she came home and self quarantined for 14 days, then went back for piece of mind to get a negative test, but they said positive, so then she quarantined 21 days that time. She says she went back and they tested her with the gold test which takes longer to her understanding to study that, and that came back negative. She says after 21 days she built up enough antibodies for it to be negative. She clarifies that she had COVID and COVID testing done before getting the doses of the Pfizer COVID-19 vaccine, before she got her her vaccinations. She had no other vaccinations on the dates she got her Pfizer COVID-19 vaccine doses or in the four weeks prior. She uses Lysol wipes and Clorox to clean her house and her door knobs. She says she uses hand sanitizer and wears 1-2 masks. She says in 1990 she had an airborne virus that put her in intensive care for 21 days and she was paralyzed, so she is thankful to be alive, and that she is no longer paralyzed. She says this came along, and it brought back a lot of horrible memories. Caller says she had to live with something, and her mask, and a lot of handwashing. Call handler attempted to clarify this statement with the caller. Concomitant medications included clobazam (Manufacturer: Microlabs. NDC: 4271-315-01, EXP: 09Aug2021) 10mg tablets, two twice a day taken for seizure; levetiracetam (LEVETIRACETAM 1A FARMA) 500mg, four tablets in the morning and four at night, taken for seizure. The patient previously received first doe of bnt162b2 administered in Arm Left on 22Jan2021 08:45AM (Lot Number: EL3249) for covid-19 immunisation . The patient would like to know if the COVID-19 infection increases seizure activity. She has a history of epilepsy and has received both dose of her vaccine. She states that she petite mal seizures and has One clonic tonic or grand mal seizure on 2APR2021 at 12:35AM. She also reports that she keeps losing more and more weight and does not know why. She states that in JUL2020 she was 196 pounds and today she weighs 177 pounds. About frequency of seizures increased, the patient says that her seizures had been pretty well been controlled, for 6 months. She says that there were a couple times she had months seizure free, but now can't get through the day without multiple seizures. She says they are petit mal, but she is also having grand mal seizures. She clarifies that her seizures increased last July, after she got out of rehab, they got worse during the month of August. She confirms that she was diagnosed with COVID-19 in August 2020. She clarifies her seizures increased before she got the doses of the vaccine this year. She says she had convulsions on 2Apr2021, a grand mal seizure, at 12:35 in the morning. She was just wondering if there was any connection between COVID-19 and increased seizure activity. She says her neurologist and she are both hitting their heads on the floor and trying to think of what combination of meds could stop her seizures and convulsions to get her down to where she is not having multiple petit mal every day. She says she used to see her neurologist every 2-3 months, now she sees him every month. She says every 2-3 months he changes her medication. She says he has her on two drugs now, and he increased them both, they are hoping to get answers, if her seizures have not calmed down and gone away he is going to take her off Keppra. She is taking the Keppra generic, named Levetiracetam, she takes 500mg, four tablets in the morning and four at night. She says the other anti seizure medication is Clobazam, she takes two pills a day. She says each time he puts her on a different drug it is another chemical change to her body and another expense to be constantly changing drugs. She says her neurologist might change her medications again when she goes back May 20th for her follow up. She says there could be drug interactions and stuff that her neurologist might not be aware of, she is not having a fun time. She says her neurologist tried to put her on two different drugs to good take care of the problem, one was Keppra and her insurance denied that one so he said let's try this one and put it thru her insurance for authorization and it was accepted but they said they don't carry it and get her private pharmacist. The outcome of Petite mal seizures and Grand mal seizure was not recovered, of other event was unknown.

Other Meds: CLOBAZAM; LEVETIRACETAM 1A FARMA

Current Illness:

ID: 1349564
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: I was suffering from it, I was not able to move my mouth so, I tell my husband I couldn't move; tired; had a chills; it also made my back (incomplete sentence), I have problem with my back; My back pain was worsen; I was getting out of breath too; I can hardly walk; Bell's Palsy/she can move the rest of her body except for her face; paralyzed; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 64-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 at 10:15 (Batch/Lot Number: ER8736) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. On 06May2021 night the patient woke up paralyzed which was what a little bit she can find out was Bell's palsy. The patient was not able to move her mouth so, she tell her husband she couldn't move. The patient was also tired and had a chills too and other than that it also made her back (incomplete sentence), the patient have problem with her back. Her back pain was worsen for some reason. The patient do not know if it was from the shot or what. She have concerns with paralysis. The patient can hardly walk and it was outside and it will take a little while. She got a bad back, a bad her and a bad shoulder. The patient was falling apart. Hopefully she can get a new her and a new shoulder. The patient was getting out of breath too. Other things are tiredness and my back hurting a lot. Yesterday she was like getting tired and out of breath, usually she do not get out of breath like this. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1349565
Sex: F
Age:
State:

Vax Date: 03/03/2021
Onset Date:
Rec V Date: 05/26/2021
Hospital:

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

Lab Data: Test Name: liver enzymes; Result Unstructured Data: Test Result:elevated liver enzymes; Comments: with previous medication

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: had an allergic reaction to the vaccine; hard to wrap my head around my body attacking itself; This is a spontaneous report from Pfizer sponsored program Caremark Specialty Pharmacy Sutent and Ibrance Program received from a contactable other HCP and a contactable consumer (Patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) on an unspecified date (at the age of 42-year-old) at single dose for COVID-19 immunization. The patient was receiving tofacitinib citrate (XELJANZ XR), oral from 03Mar2021 at 11 mg, daily for rheumatoid arthritis. Medical history of elevated liver enzymes with previous medications. Concomitant drugs were unknown. Patient reported missed 7 days of tofacitinib citrate after bnt162b2 vaccine administration per Doctor of Medicine instructions. She "had an allergic reaction to the vaccine." Medical director aware. Further she reported hard to wrap her head around her body attacking itself, she needed to be proactive. She reported "feeling really good," no symptoms of arthritis after started tofacitinib citrate. At the time of reporting tofacitinib citrate was ongoing and the outcome of the events was unknown. No follow- up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1349566
Sex: F
Age:
State:

Vax Date: 03/03/2021
Onset Date:
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I also have lupus and so I have some skin problems; itching on her back, bottom and back of her legs; dry skin; little chill bumps; This is a spontaneous report received from a contactable consumer (patient). This 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received two cortisone shots in ankle one on 12Jan2021 and the second was 08Feb2021 which was two days before she had first COVID shot. Patient previously received first dose on 10Feb2021 for COVID-19 immunization, and she did not have any immediately reactions and she sat at the clinic for 20 minutes and then went home. She was fine until the second day after the first dose she had a small amount of itching on her lower back when she went to shower, but it went away. After the second dose she started itching on her back, bottom and back of her legs and she showered and put lotion on because she had dry skin. That did not help so she took a diphenhydramine hydrochloride (BENADRYL), which helped and she was able to sleep. She reported that since then the had been having to take diphenhydramine hydrochloride nightly to be able to sleep because of the itching, she had to wake her husband up in the middle of the night to scratch back, its not too bad during the day but once she changed clothes or went to shower then it really started itching. She also had lupus and so she had some skin problems anyway. She called doctor and he sent her in some topical cream to put on itchy areas but it was three small tubes and its not enough to get to all the areas one to two times daily. It was Triamcinolone 0.1 ointment that he sent in. She didn't have a rash at all it just felt like a have little chill bumps but there was no redness or rash. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1349567
Sex: F
Age:
State: PA

Vax Date: 05/07/2021
Onset Date: 05/08/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fever of 103; chills; sweating; body ache; nausea; vomiting; diarrhea; headache; couch; chest pain; This is a spontaneous report from a contactable consumer for herself. A 17-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07May2021 17:00 (Lot Number: EW0176) at single dose for COVID-19 immunisation. Medical history was none. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (lot number=EW0153) in left arm on 15Apr2021 04:00 PM for COVID-19 immunisation. The patient experienced fever of 103, chills, sweating, body aches, nausea, vomiting, diarrhea, headache, couch, chest pain on 08May2021 13:00 with outcome of not recovered. Events were resulted in doctor or other healthcare professional office/clinic visit. No treatment received. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1349568
Sex: M
Age:
State:

Vax Date: 02/25/2021
Onset Date: 04/09/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: At the six week mark post 2nd vaccine, developed a severe case of Shingles; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 25Feb2021 00:45 (Batch/Lot Number: EN6202) as 2nd dose, single (at the age of 44 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 28Jan2021 07:30 PM (lot number:EL8982), on left arm at the age of 44 years old for COVID-19 immunisation. The patient experienced at the six-week mark post 2nd vaccine, developed a severe case of shingles. The patient had muscular adjustments as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1349569
Sex: M
Age:
State: MA

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

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

Lab Data: Test Name: Nasal Swab; Result Unstructured Data: Test Result:unknown result; Test Date: 20210201; Test Name: Nasal Swab; Test Result: Positive ; Test Date: 20210305; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Lightheaded and fainted within 3 minutes of the shot.; Lightheaded and fainted within 3 minutes of the shot.; This is a spontaneous report from a contactable consumer reported for himself. This 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10May2021 16:45 Right arm at 1st dose, single (lot: Ew0182) for covid-19 immunisation. Medical history included COVID-19 from 01Feb2021 to 05Mar2021. Prior to vaccination, the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. He experienced Lightheaded and fainted within 3 minutes of the shot on 10May2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Lab data included Nasal Swab on 01Feb2021: Positive, on 05Mar2021: Negative. Since the vaccination, the patient has been tested for COVID-19: unknown result. Cat skan was received for the events. Outcome of the events were recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1349570
Sex: M
Age:
State:

Vax Date: 05/08/2021
Onset Date: 05/08/2021
Rec V Date: 05/26/2021
Hospital: Y

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

Lab Data: Test Date: 20210509; Test Name: covid_test; Test Result: Negative

Allergies:

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

Symptoms: vomiting; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 08May2021 (at the age of 64-years-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced vomiting on 08May2021. But because he takes other essential medication, he needed to be admitted to the hospital. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 09May2021. Therapeutic measures were taken as a result of vomiting. The event was assessed as serious, hospitalization. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1349571
Sex: F
Age:
State: ID

Vax Date: 04/05/2021
Onset Date: 04/07/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data: Test Name: ECHO; Result Unstructured Data: Test Result:Pericarditis

Allergies:

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

Symptoms: Pericarditis found on echo; vestibular labyrinthitis with severe vertigo; vestibular labyrinthitis with severe vertigo; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 05Apr2021 11:00 (Lot Number: ER8734) at age of 55-years-old as 2nd dose, single for COVID-19 immunization. Medical history included Hypertrophic cardiomyopathy (HCM), Semicircular canal fistula (SSCD). There was known allergies. Concomitant medications included metoprolol (12.5mg); vitamin c [ascorbic acid]; vitamin d nos. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206,) on 15Mar2021 02:45 PM at age of 55-years-old in right arm for Covid-19 immunization. On 07Apr2021 11:00 AM, the patient experienced vestibular labyrinthitis with severe vertigo. It lasted for about a month. Pericarditis found on echo by cardiologist at Clinic. The events resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient underwent lab tests and procedures which included echocardiogram: pericarditis. Therapeutic measures were taken as a result of the events. Pericarditis: Advil, need another echo. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was recovering.

Other Meds: METOPROLOL; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS

Current Illness:

ID: 1349572
Sex: M
Age:
State: NJ

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 05/26/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: stabbing headache in left temple and ear starting 12 hours after vaccine - would last a few seconds and repeat every few minutes; This is a spontaneous report from a contactable consumer(patient). The 58-year-old male patient received BNT162B2, via an unspecified route of administration on 21Apr2021 15:30 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. Medical history included none. She had no known allergies. There was no covid tested post vaccination, no covid prior vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY). The patient experienced stabbing headache in left temple and ear starting 12 hours after vaccine - would last a few seconds and repeat every few minutes, ended up in emergency room and physician office on 22Apr2021 02:30, which also led to hospitalization for 1 day with outcome of recovering. Treatment received included pain medication infusion. Information on the lot/batch number has been requested.

Other Meds: ZYRTEC ALLERGY

Current Illness:

ID: 1349573
Sex: M
Age:
State: CT

Vax Date: 04/01/2021
Onset Date: 04/18/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Myocarditis; This is a spontaneous report from a contactable consumer(patient). The 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 01Apr2021 12:45 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADD).There was no known allergies, no Covid prior vaccination. The patient's concomitant medications were not reported. The patient experienced myocarditis on 18Apr2021 23:30 which led to emergency room with outcome of unknown. There was no treatment. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1349574
Sex: M
Age:
State: ME

Vax Date: 04/06/2021
Onset Date: 04/28/2021
Rec V Date: 05/26/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: weakness in the legs; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 06Apr2021 (Batch/Lot Number: ER8734) as 1st dose, single (at the age of 63 years old) for COVID-19 immunisation. Medical history included ongoing high blood pressure diagnosed 4 to 5 years ago, ongoing diabetes diagnosed 10 years ago and ongoing bone cancer diagnosed about 2 years ago. The patient's concomitant medications were not reported. The patient experienced was in and out for different things. He was hospitalized for weakness in the legs on 28Apr2021. Patient was supposed to get second COVID19 vaccine on 28Apr2021 but was hospitalized for unrelated issues. The patient wants to know where to get second dose. The outcome of the event was unknown.

Other Meds:

Current Illness: Blood pressure high (Diagnosed 4 to 5 years ago); Bone cancer (Diagnosed about 2 years ago); Diabetes (Diagnosed 10 years ago)

ID: 1349575
Sex: M
Age:
State: PA

Vax Date: 02/19/2021
Onset Date: 04/10/2021
Rec V Date: 05/26/2021
Hospital: Y

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

Lab Data: Test Date: 20210410; Test Name: Temperature; Result Unstructured Data: Test Result:100.3 Fahrenheit

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Chest pain; Shortness of breath; Shoulder pain; Temperature: 100.3 degrees Fahrenheit; Pericarditis; The diagnosis he has is acute Pericarditis, peritonitis; This is spontaneous report from a contactable consumer (patient). This 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EM9810) at single dose in left arm on 19Feb2021 11:00 for COVID-19 immunization. The first dose was on 28Jan2021 (Lot#: EL9261) at noon in left arm. Adverse events following prior vaccinations was none. Additional vaccines administered on same date of the pfizer suspect was no. Prior vaccinations (within 4 weeks) was no. Ongoing medical history included controlled high blood pressure diagnosed around 2000; heart beat irregularities, diagnosed in his 20s, in 1971, he had his first EKG at that time. Concomitant medication was not reported. On 10Apr2021, patient experienced chest pain, shoulder pain, shortness of breath and ended up in the hospital. Temperature was 100.3 degrees Fahrenheit on 10Apr2021. It took a while to find out what was wrong, it was pericarditis, an inflammation and probably a viral infection of the pericardium. Patient was hospitalized on 10Apr2021, in the evening and discharged in the middle of the afternoon the next day, 11Apr22021, less than one day. The chest pain ended on 12Apr2021, but he had a relapse, and it was ongoing and persisting. Shoulder pain basically lasted for 24 hours. He was put on medicine and it got better, but he had a relapse last week and it was persisting. Shortness of breath had a relapse last week. When he was put on medicine, he felt better, but when he got off the medicine, he relapsed and he didn't know if it was persisting or getting better. Pericarditis was diagnosed on 11Apr2021 and it was ongoing and improving. Temperature was resolved the next day, the 11Apr2021 with the medicine. Patient was put on medication when he went to the Emergency Room. The medication was provided to deal with the inflammation. Ibuprofen was taken 600 mg by mouth, 3 times daily for inflammation, he took it from 11Apr2021 to 18Apr2021. The dose was lowered to 1200 mg per day, then 600 mg per day. When he went off of it, the symptoms came back. Caller was taking 200 mg tabs by mouth 6 times a day. Caller had a prescription dose that was higher before, the big ones, but that's over with now. Patient was taking colchicine at 0.6 mg by mouth once a day. It was an anti-inflammatory. The ibuprofen was stopped and after 3 weeks, his symptoms came back and he was put back on the ibuprofen. The colchicine was a 30-day prescription. He would run out this week and would renew it for a 30-day supply. Patient added these medications tear up the stomach, so they put him on pantoprazole at 40 mg once per day. The ibuprofen was 600 mg tabs, NDC: 65162-0465-50, quantity 21 tabs, no refills, Rx: 6330005, it was just in a bottle, not a shrink-wrapped thing. The diagnosis he had was acute pericarditis, peritonitis and the cause was unknown, but was being treated as a viral infection. He was asked if he had a cold or upset stomach, which would then indicate the type of infection he had but he didn't have anything. These would help determine which type of virus it was. In his case it was unknown and unknowable. When the caller was weaned off the ibuprofen his symptoms came back with in a couple days. His temperature went up, he experienced shoulder pain and was short of breath. He was put back on the ibuprofen at that time. He was anticipating many more weeks of symptoms based of the way he was being treated by the doctor. The patient added the symptoms that presented were almost the same as a heart attack and he was concerned when he started to experience those symptoms. There was no clear evidence of what has caused his symptoms, he did not know if it was by Covid-19 or the Covid-19 vaccine but it was possibility. Patient hoped it was not the vaccine. All the adverse events required a visit to emergency room and physician office. Therapeutic measures were taken for all the adverse events. The outcome of event body temperature increased was recovered on 11Apr2021, the outcome of event pericarditis was recovering, the outcome of events shortness of breath and peritonitis was unknown. The outcome of rest events was not recovered. The information on the lot/batch number has been requested.

Other Meds:

Current Illness: Blood pressure high; Heartbeats irregular

ID: 1349576
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Swollen on one of the legs; swollen and hurt knee; swollen and hurt knee; This is a spontaneous report received from a contactable consumer (friend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen on one of the legs and swollen and hurt knee on an unspecified date. It was reported that the reporter's friend told her that she went to her doctor (at the hospital) about her knee and she said it was swollen and hurt on the side of her leg she was swollen. She did not know if she bumped into anything, but all of a sudden, the swelling came up on her leg. The clinical outcome of swollen on one of the legs and swollen and hurt knee was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1349577
Sex: F
Age:
State: MA

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

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:up and down; Test Name: Blood pressure; Result Unstructured Data: Test Result:goes up

Allergies:

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

Symptoms: Hypertension; Blood pressure is up and down; This is a spontaneous report from a contactable nurse (sister). A female patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has hypertension now. She is on medication now because of the hypertension. Patient called her doctor again and her cardiologist. Blood pressure is up and down. She has been put on statins and beta blockers. When she sits up her blood pressure goes up. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am