VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 0929148
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: she has been itching for hours and the sensation keeps coming and going; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration and unspecified date at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient stated that she has been itching for hours and the sensation keeps coming and going. It worsens in the morning and not so much in the evening. She said that there was no rash, just itching. The patient was asking any information on itching as a side effect of the vaccine. Outcome of the event was not recovered. Information about Lot/Batch number is requested

Other Meds:

Current Illness:

ID: 0929149
Sex: F
Age:
State: UT

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

Lab Data:

Allergies:

Symptoms: Chills; Headache; Bad dreams; Excessive thirst; This is a spontaneous report from a contactable other hcp, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number EL3246), intramuscularly on 02Jan2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. Prior to the vaccination, the patient had been diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On 02Jan2021, the patient experienced headache, chills, bad dreams and excessive thirst. No therapeutic measures were taken as a result of the events. The clinical outcome of headache, chills, bad dreams and excessive thirst was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0929150
Sex: F
Age: 37
State: CT

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

Lab Data: none

Allergies: amoxicillin, erythromycin

Symptoms: extreme fatigue and extreme migraine starting 9 hours after vaccine and lasting 24 hours, slightly sore arm for 24 hours

Other Meds: labetolol, prilosec

Current Illness: no

ID: 0929151
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Body aches; Sweating; Loss of appetite; Weakness; Sleepiness; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had side effects symptoms for 8 days after receiving the COVID-19 vaccine. Side effects reported were body aches, sweating, loss of appetite, weakness and sleepiness, the patient is being treated for his symptoms. The patient wanted to know how long his symptoms will last, stated that 8 days is not normal. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0929152
Sex: F
Age:
State: MS

Vax Date: 12/29/2020
Onset Date: 12/31/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: increased new palpitations/an increase in the amount of chest palpitations; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EH9899), intramuscular on the left deltoid on 29Dec2020 at SINGLE DOSE as COVID prevention at the hospital. Medical history included ongoing hypothyroidism for about 3 or 4 years, sinus headache, and ear pressure. It was reported that the patient had palpitations in the past but has not had any recently. Concomitant medications included ongoing liothyronine sodium (CYTOMEL) for hypothyroidism and phenylephrine (PHENYLEPHRINE) from unknown date until 31Dec2020 for ear pressure and sinus headache. The patient had her first dose of the COVID vaccine on 29Dec2020 and she had no problems at first, but she stated that she was seeing an increase in the amount of chest palpitations that she was having since 31Dec2020. She knew it was cold and fly season (uncommon for her to have ear pressure and headaches with weather changes) and she had to take some sinus medicines, so she just blew the palpitations off as having come from those sinus medicines but she was no longer taking those medicines and the palpitations were still persisting. The patient also mentioned that she was watching her caffeine intake, and she even was not having any more caffeine than she normally does. She really noticed the palpitations over the holiday weekend, and it felt like it was getting worse, and then she started feeling like she needed to reset herself. Outcome of the event was not recovered. As per causality, the patient also mentioned that it was unknown if the palpitations were caused by the vaccine, but she feared that they were. She also mentioned that she had no other vaccines on the same day as the COVID Vaccine so she was not sure.

Other Meds: CYTOMEL;

Current Illness: Hypothyroidism (about 3 or 4 years.)

ID: 0929153
Sex: F
Age: 15
State: IA

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

Lab Data:

Allergies:

Symptoms: no a/e, pt is under the age limit

Other Meds:

Current Illness:

ID: 0929154
Sex: M
Age:
State: AZ

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:101.7; Test Name: Covid screening test; Result Unstructured Data: Test Result:Unknown result; Comments: I do not have the results yet. I just look a Covid screening test because I had Covid back on the 4th of December. So, I just took a Covid screening test; Test Name: Weight; Result Unstructured Data: Test Result:125 lbs; Comments: Maybe 125 pounds

Allergies:

Symptoms: I was pretty sick, I felt palsy; I was pretty sick, I felt palsy; I developed the fever for all about 30 hours after the vaccination; Headache; This is a spontaneous report from a contactable physician. This physician reported for himself that a 67-years-old male patient received BNT162B2 (BioNTech Covid 19 vaccine; Batch/lot number: EL1284), via an unspecified route of administration on 30Dec2020 at SINGLE DOSE for "Because I am a physician, a healthcare provider" (covid-19 immunization). Medical history included had Covid back on the 4th of December. There were no concomitant medications. Physician stated he was wondering he just took your Pfizer Covid vaccination, the first one. He took it couple of days ago. He took it on the 30th of this month, two days ago. Physician further stated he developed the fever for all about 30 hours after the vaccination. Just because he developed the fever with the first one, it was like a 101.7 that was about 36 hours. So the question was just because he developed the fever with the first one, he was pretty sick, he meant he felt palsy, you know headache and all that it was like probably developed the same with the second one? Patient weight was maybe 125 pounds. When probed if vaccine was prescribed by any Physician, Physician stated he went himself. Causality by physician stated as "he think so". Lab work reported as He did not have the results yet. He just look a Covid screening test because he had Covid back on the 04Dec. So, he just took a Covid screening test. Treatment received included aspirin. The outcome of all events was unknown.; Sender's Comments: The causal relationship between BNT162B2 and the event palsy cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0929155
Sex: M
Age:
State: NY

Vax Date: 12/28/2020
Onset Date: 01/04/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20210104; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptoms: had the COVID-19 vaccine on 28Dec2020 and was tested positive today (04Jan2021) for COVID-19; had the COVID-19 vaccine on 28Dec2020 and was tested positive today (04Jan2021) for COVID-19; This is a spontaneous report from a contactable other hcp via the Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the COVID-19 vaccine on 28Dec2020 and was tested positive today (04Jan2021) for COVID-19. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported positive with Covid 19 test after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.

Other Meds:

Current Illness:

ID: 0929156
Sex: M
Age: 37
State: MN

Vax Date: 12/29/2020
Onset Date: 01/08/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: Urgent care visit this AM (08Jan2021), no tests, I took photos around 0830 this morning and forwarded them to Doctor for immunology opinion. He did review the photos and case and stated that the rash is consistent with an amoxacillin non-allergic etiology. Other etiologies could not be excluded and he (immunologist) recommended proceeding with the second shot as planned and advised a VAERS report.

Allergies: No allergies noted

Symptoms: Patient developed an exanthem involving the trunk, arms, neck, legs within 12 hour of his last dose of 875mg Amoxacillin for tooth abscess on day ten post the first immunization for COVID-19 (Moderna). The rash was maculopapular and mildly itchy treated within a couple of hours post discovery (member awakened with rash this AM) with benadryl via urgent care, no major change after benadryl.

Other Meds: Amoxicillin, took final dose after a course provided for tooth abscess, last dose 7 PM yesterday.

Current Illness: Tooth abscess with localized tooth pain resolved on Amoxacillin

ID: 0929157
Sex: F
Age:
State: TN

Vax Date: 12/20/2020
Onset Date: 12/01/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: picture of her retina; Result Unstructured Data: Test Result:unknown results; Test Name: Visual field test; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptoms: blurriness on the right eye with consistent optic neuritis; read up on transverse myelitis that may be related to her condition; blurriness on the right eye with consistent optic neuritis; This is a spontaneous report from a contactable physician. This physician (patient) reported for self that the 31-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730), via an unspecified route of administration on Deltoid, Left on 20Dec2020 13:00 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. Reported she has a flu vaccine in Sep2020, and had no reaction to the flu vaccine. She clarified she has never had a reaction to a vaccination before. The patient received the vaccine last 20Dec2020 and has reported to have blurriness on the right eye with consistent optic neuritis since 24Dec2020. She has already consulted with an ophthalmologist who said her case was interesting and referred her to Pfizer. She is scheduled to have her second dose on 10Jan2021 and is asking if she should still take it. She also mentioned that she read up on transverse myelitis that may be related to her condition and is asking for any information we may have on this. Doctor reporting she is having a possible adverse event to the COVID-19 Vaccine. The patient clarified she received the COVID-19 Vaccine on Sunday, 20Dec2020 at approximately 1:00PM. Reported the COVID-19 Vaccine was administered at her employer. Doctor reported she is experiencing blurry vision in her right eye only, consistent with optic neuritis in Dec2020 (Medically significant). She said her right eye blurry vision gets worse after working out or showering. She said she has read some medical information that states some kind of autoimmune reaction, like transfer myelitis, may occur after receiving the COVID-19 Vaccine. The patient asked if she should get the second COVID-19 Vaccine, clarifying she is scheduled to receive her second dose on 10Jan2021. Clarified she started experiencing the right eye blurry vision on either 24Dec2020 or 25Dec2020. Treatment: Reported she saw an ophthalmologist, and the ophthalmologist said he didn't see anything concerning or not normal. She said the ophthalmologist referred her to see a neurologist, and to get a MRI of her head. She clarified her MRI appointment is on 19Jan2021. She clarified her ophthalmologist called her back 2 hours after she left her appointment. She said the ophthalmologist told her he found what she was experiencing to be interesting, as to when she received the COVID-19 Vaccine, and the start of her right eye blurry vision, and that he wanted her to get further evaluation. She said the ophthalmologist performed visual field testing, and took a fancy picture of her retina. No further details provided. Vaccination Facility Type was hospital. No Vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) required a visit to Emergency Room but AE(s) required a visit to Physician Office. Prior Vaccinations (within 4 weeks) was none. Patient's Medical History(including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was not provided. Relevant Tests included Visual field test, and picture of her retina. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events optic neuritis, vision blurred and myelitis transverse cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0929158
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: tinnitus; This is a spontaneous report from a contactable other hcp, the patient. This 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 vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tinnitus 3 days after getting the vaccine. She stated it was getting worse over time. The clinical outcome of tinnitus was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0929159
Sex: U
Age: 34
State: CA

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pt states palpitations. PT monitored, VS at released from observation area were normal for this patient.

Other Meds:

Current Illness:

ID: 0929160
Sex: F
Age:
State: PA

Vax Date: 12/27/2020
Onset Date: 12/27/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; numbness in extremities; numbness and tingling in extremities, tingling in extremities more so in left upper extremity then left foot, then right hand; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration (Left arm) on 27Dec2020 14:30 at single dose for Covid-19 immunization. The patient's medical history included connective tissue undifferentiated (disorder), cervical radiculopathy, and Covid-19. No known allergies. Concomitant medications were unspecified; the patient received other medications within 2 weeks of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported numbness and tingling in extremities more so in left upper extremity then left foot, then right hand on 27Dec2020 (16:00). The patient also noticed slightly on day of injection then on day 3 (30Dec2020) after injection the patient had severe pain in left arm, weakness, and unable to raise arm at shoulder. The adverse events resulted in Emergency room/department or urgent care. The patient was treated with prednisone. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.

Other Meds:

Current Illness:

ID: 0929161
Sex: F
Age:
State:

Vax Date: 12/24/2020
Onset Date: 12/26/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201222; Test Name: Covid-19; Test Result: Negative ; Test Date: 20201226; Test Name: Covid-19; Test Result: Positive

Allergies:

Symptoms: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 24Dec2020, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient tested negative for Covid-19 on 22Dec2020, received her first vaccine dose on 24Dec2020 and then tested positive for Covid-19 on 26Dec2020. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and SARS-CoV-2 test positive cannot be ruled out.

Other Meds:

Current Illness:

ID: 0929162
Sex: F
Age: 47
State: IN

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies: Avelox,tizanadine, shellfish, eggs, peanut butter, mold, dogs,cats, dust and other misc environmental allergies.

Symptoms: Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating joint pain continues now. Malaise.

Other Meds: Lexapro, Wellbutrin, synthroid, elequis, ambien,acyclovir

Current Illness: Environmental stress?

ID: 0929163
Sex: F
Age:
State: WI

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Chills; Headache; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm on 30Dec2020 14:45 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 20:00, the patient experienced injection site sore, red hot hard, chills, and headache. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious by the reporter.

Other Meds:

Current Illness:

ID: 0929164
Sex: F
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: itchy face; warm face; facial flushing; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (04Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other hcp and a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot: EK5730, expiry date: Mar2021, via an unspecified route of administration on 04Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. An intern called to see if there was any cholesterol in the Covid vaccine or the amount of cholesterol in the vaccine. The patient had itchy face and warm face after receiving the vaccine. It was clarified that there was cholesterol in the vaccine, she would just like to know the source, she also clarified that the patient had facial flushing. The 1st Dose was on 04Jan2021, she reported facial flushing a few minutes later went away, the patient has already left. The patient states that she is vegan and wanted to know the source of cholesterol and if that could cause the facial flushing. The outcome of the event facial flushing was recovered while other events were unknown.

Other Meds:

Current Illness:

ID: 0929165
Sex: M
Age: 52
State: PR

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

Lab Data: no

Allergies: Unknown

Symptoms: The Patient present Sore throat , cough ,hoarseness . the doctor gave him Benadryl 50 mg IM now

Other Meds: No

Current Illness: Unknown

ID: 0929166
Sex: F
Age:
State: MN

Vax Date: 12/26/2020
Onset Date: 12/28/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: electrolytes; Result Unstructured Data: Test Result:normal; Test Date: 20201228; Test Name: EKG; Result Unstructured Data: Test Result:normal; Test Date: 20201228; Test Name: troponin levels; Result Unstructured Data: Test Result:normal

Allergies:

Symptoms: full body rash; heart palpitations; reaction to drug excipient; This is a spontaneous report from a contactable nurse, the patient. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 26Dec2020 as a single dose for COVID-19 immunization. Medical history included several outdoor allergies, but no known food allergies. The patient's concomitant medications were not reported. On 28Dec2020, the patient experienced full body rash and heart palpitations. The clinical course was as follows: the patient developed a full body rash and heart palpitations on 28Dec2020 and went to the emergency room. The patient had a full work-up which included electrocardiogram, troponin levels, and electrolytes, and all were normal. She was instructed to take diphenhydramine hydrochloride (BENADRYL). She thought it may have been due to the polyethylene glycol; however, she did mention that she previously took macrogol 3350 (MIRALAX) on unknown dates for an unknown indication and was fine. The clinical outcomes of the full body rash, heart palpitations, and reaction to polyethylene glycol, were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported full body rash and the administration of the suspect, BNT162B2, based on the reasonable temporal association. While the possibility of allergic to polyethylene glycol (drug excipient) might have provided alternative explanations. 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 RA, IEC, as appropriate.

Other Meds: POLYETHYLENE GLYCOL [MACROGOL]

Current Illness:

ID: 0929167
Sex: F
Age: 26
State: MO

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies: Morphine and NSAIDS Zucchini

Symptoms: The night of the shot I got a headache, was throwing up, running a temp, chills, fever, felt dizzy and my arm was really swollen, red and hurt. Fast forward to 1-6-2021 I started getting a reaction at injection site which consisted of being swollen, red, a hard knot under the red area, really warm and sensitive to touch. I also have pain going up the left side of my neck and down my armpits/lymph nodes.

Other Meds:

Current Illness:

ID: 0929168
Sex: M
Age:
State: NJ

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

Lab Data:

Allergies:

Symptoms: neuropathy; This is a spontaneous report from a contactable Nurse. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter called about Covid vaccine and has a question connected to the AE he has reported. Wants to know if neuropathy is a side effect of the vaccine. Event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Very limited information was provided in this case, pending further details such as medical history, clinical course, specified event description, at this moment, the mentioned neuropathy is considered related to BNT162B2 for reporting purpose. 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 RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 0929169
Sex: F
Age:
State:

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Development of microemboli on distal, fourth right phalange on the ventral surface. Just past the DIP. Small blue hue below skin surface with mild tenderness on deep palpation.; This is a spontaneous report from a non-contactable Physician (patient). This adult female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 23Dec2020 09:30 at single dose on right arm for COVID-19 immunisation. Medical history included migraine with aura. Concomitant medication included propranolol, loratadine (CLARITINE) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefprozil (CEFZIL) and experienced allergies. The patient experienced development of microemboli on distal, fourth right phalange on the ventral surface. Just past the DIP. Small blue hue below skin surface with mild tenderness on deep palpation on 24Dec2020 12:00. The event was considered as non-serious. Treatment for the events was unknown. The outcome of the event was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event microemboli on distal phalange with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: ; CLARITINE

Current Illness:

ID: 0929170
Sex: F
Age: 67
State: MT

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: headache, nausea, light sensitivity, neck pain, general not feeling well, not sleeping well

Other Meds:

Current Illness:

ID: 0929171
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 02/19/2015
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: EKG; Result Unstructured Data: Test Result:near perfect

Allergies:

Symptoms: States the intermittent muscle pain, and pain in chest and arms is worse now; tightness come into his chest; started having pains in his muscles in his chest and arms and they would reach up into throat; pains in muscles, chest and arms; pains in muscles, chest and arms/it hit him in the chest; pains in muscles, chest and arms; AFib; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot/batch number and Expiration date were not provided), intramuscular at left arm on an unspecified date at single dose for immunization. Medical history included seasonal allergies (serious reaction to Mountain Cedar because he lives in the mountains). Concomitant medication included finasteride, testosterone; both from 2013 and ongoing. Patient stated when he first took the vaccine he had flu like symptoms (19Feb2015) for 2 weeks and AFib (19Feb2015) and other problems, states these issues resolved after 3 weeks, stated later he developed a situation, states when he started to use any energy or adrenaline he started having pains in his muscles in his chest and arms and they would reach up into throat (all from Nov2018), states this was intermittent, sometimes would have it and sometimes wouldn't have it, states this really came into play in Nov2018, states he was working out one day and it hit him in the chest and had to stop working out, did not understand what happening, states at that time, he has a serious reaction to Mountain Cedar because he lives in the mountains, and he had just started taking Claritin to cover the mountain cedar problem. Over time in the spring, he gets off of antihistamine and it still continues, recently in the last month it has really come into play and he can just walk across a room quickly an the can feel the tightness come into his chest, the physician that did administer the vaccine put him on an EKG two years after vaccine to check if he has a heart problem, states he has a near perfect EKG. Stated the intermittent muscle pain, and pain in chest and arms is worse now than it was when it first started. States that he will work through it and it will dissipate after about 15 minutes. The patient wanted to know if there is an antidote to the vaccine. The outcome of the events AFib and Flu like symptoms were recovered in 2015; events Muscle pain, Chest pain, Pain in arm and Condition worsened were not recovered; other events were unknown. Information on the lot/batch number has been requested.

Other Meds: ;

Current Illness:

ID: 0929172
Sex: F
Age: 49
State:

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: Blood pressure 220/120 which is abnormally high for this patient

Allergies: none known

Symptoms: Pt described tingling of face and body just at time of vaccination

Other Meds: none known

Current Illness: none known

ID: 0929173
Sex: M
Age:
State: AK

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: cat scan; Result Unstructured Data: Test Result:Unknown results; Test Name: test blood; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201231; Test Name: MRI; Result Unstructured Data: Test Result:he had stroke

Allergies:

Symptoms: Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), on 31Dec2020 11:00 AM via unknown route of administration at single dose for COVID-19 immunization. Medical history included high blood pressure, but went up and down and had to readjust. His BP was high and not sure how long it was that way. Concomitant medications included unspecified blood pressure medications. There were no known allergies. Patient went to ER left side of face sagging. They did MRI it showed he had stroke. It Happened before 4pm that same day as vaccine on 31Dec2020 02:00 PM. And it Happened between 2-4 pm. Patient received treatment. Patient had ER test blood, cat scan, MRI. 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 did not have been tested for COVID-19. The outcome of the events was recovering. This case was assessed non-serious by reporter. And the events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.

Other Meds:

Current Illness:

ID: 0929174
Sex: M
Age: 23
State:

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Chills and fever

Other Meds: None

Current Illness: None

ID: 0929175
Sex: M
Age:
State: OR

Vax Date: 12/21/2020
Onset Date: 01/02/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20210103; Test Name: MRA; Test Result: Negative ; Test Date: 20210103; Test Name: Head CT; Test Result: Negative ; Test Name: HDL; Result Unstructured Data: Test Result:Low; Test Date: 20210103; Test Name: Lab test; Test Result: Negative ; Test Date: 20210103; Test Name: COVID-19 PCR test negative; Test Result: Negative ; Comments: full viral count

Allergies:

Symptoms: occipital neuralgia; left-side Bells Palsy; bilateral headache; This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration at right deltoid on 21Dec2020 19:00 at single dose for covid-19 immunization. The patient's medical history included low high density lipoprotein (HDL). There were no concomitant medications. The patient previously took influenza vaccine (longer than 4 weeks ago, and he did not have any reaction), pravastatin for low HDL. Reported 2 days ago (02Jan2021) he developed a bilateral headache. He stated he was asymptomatic until then. He said he now has Bells Palsy on 02Jan2021, clarified he has left-side Bells Palsy. He said it is unknown to him if the bilateral headache and Bells Palsy are related to taking the COVID-19 Vaccine. He stated he started wearing a N95 mask for the past 2 weeks. He said the N95 mask is very tight on the back of his head. He said he believes he is experiencing occipital neuralgia caused by wearing the N95 mask. He said studies show that the N95 mask can cause Bells Palsy, and the N95 mask maybe a confounding factor. He stated he doesn't have any further information on the N95 mask he was using. Initially he had a severe headache and administered to himself a sphenopalatine block of Lidocaine 1% in his nose. He stated being an ER doctor, he knows how to administer the sphenopalatine block to a patient. He went to the ER on 03Jan2021 to make sure he did not have a tumor or a stroke. He said the hospital performed a CT of his head, a MRA, labs, and a COVID-19 test (clarified as a PCR COVID-19 test) with a full viral count. He said all the tests were negative. His wife noticed his Bells Palsy yesterday, 03Jan2021. He said he thinks the Bells Palsy started the night before on 02Jan2021. He said he noticed on the night of 02Jan2021 when he was brushing his teeth, he hit a tooth on that side (clarified as left side) of his mouth with his tooth brush. He hasn't started taking steroids yet, but will be starting steroids real soon. He clarified his doctor prescribed a Medrol dose pack and Valtrex for the Bells Palsy. He stated he has not started the Medrol dose pack and Valtrex. He is ordering Lidocaine 1% viscous for himself, so he can do an internasal sphenopalatine block on himself. He does not know if the bilateral headache and Bells Palsy were caused by taking the COVID-19 Vaccine. The events required Emergency Room visit. The outcome of the event Bell's palsy was not recovered, Headache was recovering, Occipital neuralgia was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162b2 and the onset of Bell's palsy/Headache might not be excluded, considering the plausible temporal relationship. 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: 0929176
Sex: F
Age:
State: NC

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:100.2; Comments: degrees; Test Date: 20210104; Test Name: Body temperature; Result Unstructured Data: Test Result:98.7; Comments: degrees; Test Date: 20210103; Test Name: Heart rate; Result Unstructured Data: Test Result:110's; Comments: real high heart rate that were in the 110's that last for lasted for hours; Test Date: 20210104; Test Name: Heart rate; Result Unstructured Data: Test Result:98

Allergies:

Symptoms: Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she started with kind of chills and shakes; she was not feeling too good; real high heart rate that were in the 110's that last for lasted for hours; Fever; This is a spontaneous report from a contactable nurse reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231 and expiration date unknown), via intramuscular on left deltoid on 03Jan2021 09:13 at single dose for COVID-19 prophylaxis. The patient medical history and concomitant medications reported as none. The reporter is a registered nurse that reported that she had the first Covid-19 vaccine yesterday morning on 03Jan2021 and she had side effects. She reported that she had a fever, headache, and a real high heart rate that was in the 110's that last for lasted for hours. She said that she started with kind of chills and shakes 11 hours and 40 minutes after receiving the vaccine. One minute she was fine and the next minute she was feeling chilled. By the time she got home from her mother's house, which is a hours drive, she was not feeling too good. Her fever broke today 04Jan2021 at around 04:00 and when she checked her temperature it was 98.7 degrees. She said that 100.2 degrees was the highest temperature she recorded. The patient said that it was a mild fever. Her headache started about 22:00 03Jan2021. The patient said that she still has the headache a little bit and she has been treating it with Tylenol and it has gotten better. She said that she wears a fit bit that tracks her heart rate and she can hear her heartbeat in her ears and she could hear it going fast. Caller said that her heart rate was down to 98 beats per minute at 06:30 this morning. She said that her current heart rate was Body temperature. Caller said that her high heart rate had her very concerned. She said that it is not normal. She is supposed to go back on 30Jan2021 to get her 2nd injection. Should she still plan on getting the second part of the vaccine? The reporter assessed event real high heart rate that were in the 110's that last for lasted for hours as serious with medically significant. Other events were assessed as non serious. The outcome of the events fever and real high heart rate that were in the 110's that last for lasted for hours was recovered on 04Jan2020, outcome of the event headache was recovering, outcome of the other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event high heart rate with BNT162b2 can not be completely excluded.

Other Meds:

Current Illness:

ID: 0929177
Sex: F
Age: 44
State: AZ

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

Lab Data: None. I went to urgent care and they told me to take ibuprofen. I need assistance in getting this looked at

Allergies: Minocycline

Symptoms: Swollen area under the skin on left hand that is causing numbness in the palm, thumb and first finger. Some swelling to the hand as well

Other Meds: None

Current Illness: None

ID: 0929178
Sex: F
Age:
State: UT

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:high

Allergies:

Symptoms: I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart rate agai; uncontrollable rigors; numb lips and hands; numb lips and hands; nausea; shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable Other Health Professional (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the left arm, on 30Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had her gall bladder and tonsils removed. Concomitant medication included rizatriptan and paracetamol (TYLENOL). The patient had no known allergies but mentioned that she cannot take the NSAIDs eventhough she was not allergic to them. She had no allergies to food or to other products. It was reported that within about 10 minutes of the injection of the vaccine, she had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea on 30Dec2020 at 09:30 AM. She was discharged from the ED (emergency department), went home and took a nap. Later that evening, she began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath and she was admitted to the emergency department again and given more IV medications. The onset of the events was reported to be 30Dec2020 at 09:30 AM with outcome of recovering. As a result of the events, the patient visited that Emergency room/department or urgent care. Treatment received with IV medications (unspecified), breathing treatment, and epinephrine injection. The patient had no covid prior vaccination. She had not had Covid test post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events throat tightness, heart rate increased, chills, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: ; TYLENOL

Current Illness:

ID: 0929179
Sex: M
Age: 34
State: IN

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

Lab Data: Covid- 19 rapid test was negative

Allergies: None

Symptoms: Fatigue, myalgia, arthralgia, bone pain, sore throat and pharyngitis.

Other Meds: None

Current Illness: None

ID: 0929181
Sex: M
Age:
State:

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

Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:100.7 Fahrenheit

Allergies:

Symptoms: fibromyalgia and neuropathy on the lower cervical/pain has exacerbated; fibromyalgia and neuropathy on the lower cervical/pain has exacerbated; headache; channeled body pain; fever at 100.7F; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date (reported as 31Jan2020) as a single dose for COVID-19 immunization. Medical history included fibromyalgia and neuropathy on the lower cervical. The patient's concomitant medications were not reported. The patient experienced fibromyalgia and neuropathy on the lower cervical/pain has exacerbated, headache, channeled body pain, and fever at 100.7 F on an unspecified date. It was reported that headache, channeled body pain, and fever at 100.7 F occurred 1 hour after vaccination. The patient underwent lab tests and procedure, which included: body temperature: 100.7 Fahrenheit on an unspecified date. The patient has been taking unspecified medications for the condition, in addition to acetaminophen (TYLENOL FOR ARTHRITIS). Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of fibromyalgia and neuropathy on the lower cervical/pain has exacerbated, headache, channeled body pain, and fever at 100.7 F was unknown.

Other Meds:

Current Illness:

ID: 0929182
Sex: F
Age:
State:

Vax Date: 12/23/2020
Onset Date: 12/31/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fainting; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported similar events for 02 patient. This is the 1st of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fainting on 31Dec2020. The patient went to the emergency department in regards to fainting and was told the fainting couldn't be related to the COVID-19 Vaccine. Then she heard about someone else fainting. Outcome of the event was unknown. No follow-up attempts are possible, information about lot/batch cannot be obtained. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006463 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 0929183
Sex: F
Age: 24
State: TX

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies: n/a

Symptoms: nausea, severe headaches, fever, body aches, chills

Other Meds: n/a

Current Illness: n/a

ID: 0929184
Sex: F
Age:
State: AZ

Vax Date: 12/29/2020
Onset Date: 01/01/2021
Rec V Date: 01/08/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: difficulty breathing/swallowing; difficulty breathing/swallowing; Hives/hives all over including in her mouth; This is a spontaneous report from a contactable consumer (spouse). A 46-year-old female patient (wife) received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, lot number: EH9899) via unspecified route of administration at arm right on 29Dec2020 at single dose for Covid-19 vaccine. Medical history included ongoing anxiety diagnosed 22 years ago. Concomitant medications were not none. Patient received the vaccine and was one big hive (01Jan2021). She went to the ER on sat and will have to go back. Caller is asking where she should go. patient went through the VAERS report 3 times. She did not have any sides effects. patient is a frontline worker. On 29Dec2020 she got the Covid vaccine. On Sat 02Jan2021 she went the ER with hives all over including in her mouth, stated she had difficulty breathing/swallowing, was given medication to take home and discharged. She was readmitted yesterday 05Jan2020 with worsening symptoms and needed to be given a prednisone nebulizer. they had two ER visits. No Investigation Assessment. patient was not recovered from the event hives/hives all over including in her mouth, the final outcome of other events was unknown.

Other Meds:

Current Illness: Anxiety (Diagnosed 22 years ago)

ID: 0929185
Sex: U
Age:
State:

Vax Date: 12/19/2020
Onset Date: 12/01/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: What I believe may have triggered this reaction is that in October I had a carpal and ulnar tunnel release in the same extremity/affected the nerves; my entire upper arm began aching-pain from my trapezius down to my elbow; my index and middle finger began tingling; I am noting pain in each of the major joints of my arm-shoulder, elbow and wrist; I am noting pain in each of the major joints of my arm-shoulder, elbow and wrist.; I am noting pain in each of the major joints of my arm-shoulder, elbow and wrist.; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on the arm on 19Dec2020 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced the following: " my entire upper arm began aching-pain from my trapezius down to my elbow " in Dec2020 with outcome of unknown; "my index and middle finger began tingling " in Dec2020 with outcome of unknown; " I am noting pain in each of the major joints of my arm-shoulder, elbow and wrist " in Dec2020 with outcome of unknown; " what I believe may have triggered this reaction is that in October I had a carpal and ulnar tunnel release in the same extremity " in Dec2020 with outcome of unknown. Therapeutic measures were taken as a result of the events. Details were as follows: The injection itself was without any issues. However, 6-7 hours later, the patient described the following: patients entire upper arm began aching-pain from trapezius down to the elbow. This continued throughout the weekend and then Monday, patients index and middle finger began tingling (as if asleep). This symptom never subsided. The patient noted pain in each of the major joints of the arm shoulder, elbow and wrist. The patient tried trigger injections in the trapezius, ibuprofen, muscle relaxers, heat, exercises, and a steroid burst-all without relief of symptoms. Patient was able to move arm and had strength in the extremity. Patient saw a specialist in physical medicine and rehabilitation. The patient believed that what triggered this reaction is that in October the patient had a carpal and ulnar tunnel release in the same extremity. The patient wondered whether the medication affected the nerves that had been manipulated during surgery. The events outcome was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the time association, the possible contribution of suspect BNT 162B2 injection to the event Neuropathy peripheral 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: 0929186
Sex: F
Age: 56
State: OK

Vax Date: 12/18/2020
Onset Date: 12/29/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: After the shot the next evening my arm was so sore and couldn't move my arm. After 8 days when I became sick.

Other Meds: Victoza injection, Mediform extend relief

Current Illness: None

ID: 0929187
Sex: M
Age: 51
State: IL

Vax Date: 12/29/2020
Onset Date: 12/31/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: None

Allergies: NKDA

Symptoms: Pt. had a COVID vaccine (Moderna) 12/29/2020, in left deltoid. - Pt. said on day 0, he had no symptoms or injection site reaction. - Day 2-5 pt. reports his injection site grew to a "tennis ball" size (~10 cm x 6 cm) and became purplish/red - Day 6-8 pt. reports it has grown slightly larger than that and is more red. -Day 9-current pt reports no change in size, but color is less red. Pt. reports he has mild itching but does not interfere with daily activity, denies pain, fever, headache, dizziness. Pt. reports area is warm to touch, and slightly swollen, but does not feel any "knots" in arm at injection site. Has been using topical hydrocortisone for mild itch. Pt has h/o muscular dystrophy. reports very little muscle tone in arms, particularly at vaccine injection site. Pt is currently not very mobile, and is wc bound, due to bimalleolar fracture of left ankle.

Other Meds: Chlorthalidone 25 mg daily. Dietary supplement containing Calcium and Vitamin D.

Current Illness: Bimalleoloar Fracture

ID: 0929188
Sex: M
Age: 27
State: NY

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Fever, muscle aches, headache

Other Meds: Claratin

Current Illness: None

ID: 0929189
Sex: F
Age: 45
State: NC

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

Lab Data: Covid tested on Jan. 6, 2021 results were negative

Allergies: Milk intolerance

Symptoms: Patient received vaccine on Jan. 5, 2021 at one o'clock and symptoms began when she got home at 5:30 pm. She experienced headache, nausea, vomiting, chills, night sweats, sore arm, dry mouth, mild fever 99.7 was the highest recorded temperature. Patient called our employee hotline and was told to have a Covid test seeing as the symptoms were the same. She tested negative and began to feel better by the third day with residual symptoms of nausea and fatigue.

Other Meds: Nuvaring Lexapro 10 mg Zyrtec 10 mg Flonase Nasal Rinse

Current Illness: Loss of hearing in my right ear Sinus issues

ID: 0929190
Sex: F
Age:
State: TN

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

Lab Data:

Allergies:

Symptoms: Rash; Itching at different spot at different time; Hives; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 02Jan2021 at single dose as reported for "Indication: Consumer stated, "Because I work in Covid testing, in healthcare." Medical history included hypertension and allergy. Concomitant medication included amlodipine, lisinopril, metoprolol, hydrochlorothiazide (HYDROCHLORZIDE), desloratadine and montelukast. The patient stated, "had the first dose of the Pfizer vaccine yesterday for the Covid 19, 2 hours after I started itching and it has been different places all over my body. I do not know has it anything to do with the way that it goes through the body, I do not know. I have had to take a lots of Benadryl. I have had to take some steroids that I had here at the house I never had started and I thought it was okay. Last night my husband put hydrocortisone cream (later clarified as treatment) on areas I was itching and had hives. I slept all night I did not have any problem since I got up this morning I started itching in other place. So, I have done the whole thing again. I am going to has to go. I did not want to go ER because I am not having trouble on breathing or anything like that but I have got various places it is like different places every time it starts. So, I need to I am going to go and have a probably a strong steroid shot and have strong steroid given to me, not for oral but I just want to let you know if that is a side effect and I do not know whether I am going to take the second one or not?" I have taken Benadryl and I have taken Methylprednisolone and I have used on the Cortisone Cream, the topical cream". The outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the events rash, pruritus and urticaria cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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: ; ; ; HYDROCHLORZIDE; ;

Current Illness:

ID: 0929191
Sex: F
Age: 53
State: OR

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

Lab Data:

Allergies: Shellfish and kiwi

Symptoms: Raspy voice, tightening of throat, sweating, flushed, tingling feeling in face, one elevated BP reading, shaking. Received Diphenhydramine 50 mg IM at 1:20 PM

Other Meds: None

Current Illness: None

ID: 0929192
Sex: F
Age:
State:

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

Lab Data: Test Name: FEVER; Result Unstructured Data: Test Result:fever

Allergies:

Symptoms: Coughing so hard; coughed during COVID but not like this; Hard to stand up; Pain/body wrecking pains; Fever; Started heaving; Dizzy; Nauseous; Throwing up; Chills; Draining; This is a spontaneous report from a contactable consumer. An adult female patient (consumer's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included covid-19 from Nov2020. The patient had COVID in the middle of Nov2020 and her father and reporter had it two weeks before and then about two weeks later, she got it. She took her 14 days quarantine, she coughed and had some tummy issues. She had fever, the aches and pains with Covid, a little bit of dry cough. She did not feel good for probably about 5 days, after that she started working again. She had COVID and did not have to be hospitalized, any IV drip or anything before vaccination. 6 weeks later, she got the vaccine shot. The patient's concomitant medications were not reported. The vaccine came out on Wednesday (30Dec2020), the patient signed up at work to take it. Within about 12 hours (unknown onset date), she did start to feel 'oily', and had started having aches, pains and very shortly after that she started running a fever, all of a sudden the cough came out of the blue, she started heaving, dizzy, nauseous and it's three days later, she was coughing so hard. She coughed during COVID but not like this, this was like COVID ten times over, same symptoms though, throwing up, throwing up, hard to stand up, aches, pains, fever, chills, body wrecking pains. The patient can hardly talk because she kept coughing and draining. The reporter asked that "Should her daughter be given vaccine? Does her antibodies, daughter was asked - Did you have any severe case, and she told - No, I was able to stay home and just stay in bed, they said - Okay we'll give it to you. Should she have gotten so close to the signs that she had COVID? Why her daughter be asked that question? What is going on regarding the symptoms. What should we do about it?" Consumer tried to get daughter to go to a COVID Clinic today (02Jan2021), and know she didn't have COVID, that's not how it worked, but normal doctors didn't want to see her daughter. Consumer called the COVID Clinic and they said "Yes, we could probably see her". The outcome of events was unknown. Information about lot/batch number has been requested; Sender's Comments: A causal association between BNT162B2 and the reported events cough and difficulty standing cannot be excluded based on temporal relation of vaccination and onset of events. 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: 0929193
Sex: F
Age: 50
State: ND

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

Lab Data:

Allergies: Floricet, imitrex, flu vaccine, Inderal, narcotics

Symptoms: Within 9 minutes hives began, face began to swell up, body felt hot, palpitations began and itching. Her neck was blotchy red. 10 minutes later her mouth began to itch

Other Meds: Ambien, Potassium Chloride, Losartan, Zanaflex, Hydrochlorothiazide, Crestor, Promethazine HCL, metoprolol Succinate, Levothyroxine sodium, Ketorolac Tromethamine, Xanaz

Current Illness: None

ID: 0929195
Sex: F
Age:
State: KS

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: expired Tenivac was gievn to the patient, no AE; Initial information was received on 05-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional, nurse via Global Medical Information (GMI) (Reference number- 00416851) in the United States. This case involves a female patient of an unknown age who received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6101AA, expiration date- 23-Oct-2020, strength-standard) once via unknown route in unknown administration site for prophylactic vaccination on 29-Dec-2020. Medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy or vaccination done. It was a case of an actual medication error due to expired vaccine used (latency-same day). At the time of report no adverse event was reported. Reporter wanted to know if vaccine needed to be re-administered and if so how long they should wait to give it. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 0929196
Sex: M
Age: 35
State: MO

Vax Date: 12/29/2020
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies: EGGS

Symptoms: Redness, heat to touch at injection site, burning/stinging, some arm ache

Other Meds:

Current Illness:

ID: 0929197
Sex: F
Age: 52
State: NY

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

Lab Data:

Allergies:

Symptoms: Reported fever of 104F, severe headache, bodyaches, nausea/ vomit x4, couldn't sleep. Symptoms resolved with Excedrin,Motrin, and Tylenol.

Other Meds:

Current Illness:

ID: 0929198
Sex: M
Age: 48
State: NJ

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

Lab Data: Yes In hospital.

Allergies: turkey, cilantro

Symptoms: Had COVID March 17, 2020 and was put on medication, Brovana, Budesonide, Wixela, for lungs. After shot arm is very sore, body aches, 99.9 temp. When he work up next day, pulse was 130. Stayed in bed that day until lunch. Then head started getting hot. Pulse was 130 still. At 5:00pm pulse was 146 laying down. Went to hospital because of dizziness, ER. Fever 103. Will see a cardiologist next.

Other Meds: Pantoprazole 40mg, Dexamethasone 4mg, aspirin 81mg.

Current Illness: no

ID: 0929199
Sex: M
Age: 39
State: CA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Digestion problems lost 15-20 lbs since the shot

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm