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: 0938058
Sex: F
Age:
State: FL

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hellucinogenic visions of monsters and violent events; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 05Jan2021 at 14:30 on Right arm at single dose for COVID-19 immunization in hospital. The patient medical history included Hypertension, Hypothyroid. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (LEVOXYL); Olmesartan; aluminium hydroxide gel, dried, magnesium carbonate (PEPCID); bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC); ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took and had known allergies with bacitracin zinc;neomycin sulfate;polymyxin b sulfate (NEOSPORIN) and bacitracin zinc;neomycin sulfate;polymyxin b sulfate (POLYSPORIN). The patient experienced hellucinogenic visions of monsters and violent events on 06Jan2021 at 02:00 AM. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.

Other Meds: LEVOXYL; ; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]; PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDO; CENTRUM MULTIGUMMIES

Current Illness:

ID: 0938060
Sex: F
Age:
State: MO

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

Lab Data: Test Date: 20201204; Test Name: Potassium; Result Unstructured Data: Test Result:low; Comments: little down; Test Date: 20201204; Test Name: blood work; Result Unstructured Data: Test Result:verything was kind of normal; Test Name: body temperature; Result Unstructured Data: Test Result:98; Comments: degrees, her normal body temperature is 96.7

Allergies:

Symptoms: immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really sweaty, so much so, that she had sweat under her eyes; thyroid problems; feels shaky inside; Numbness facial; Exhaustion; Foggy feeling in head/feeling rundown; felt exasperated; sweating like crazy and then gets chills; felt yucky/she didn't feel good at all; Joint pain; Nausea; Chills; after receiving the COVID-19 Vaccine on (Dated), she had left upper shoulder pain.; She clarified she had some injection site pain; and the injection site was a little itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration on 02Jan2021 14:30 at single dose in the left upper arm for COVID-19 immunization. Medical history included Pernicious anaemia from 2006 and ongoing, Hashimoto's disease ongoing, stated she was diagnosed with Hashimoto's disease in either 1994 or 1995. Psoriatic arthritis from Nov2020 and ongoing. Potassium low ongoing, reported she has had low potassium off and on for years. She said she can't remember when she didn't have low potassium. She said she normally finds out her potassium is low when she has blood work done. She stated she has had low potassium most of her adult life. IgA deficiency from Feb2019 and ongoing, Psoriasis ongoing, paralysis in her left trapezius muscle. Concomitant medication included B-12 for pernicious anemia. She said she had the typical reactions that one might get with a vaccine. She clarified she had some injection site pain and the injection site was a little itchy on 02Jan2021. She stated on the second day (03Jan2021) she had joint pain, felt yucky, had nausea, and chills. She said the next day (04Jan2021) she felt a little better, but still had chills. She said yesterday (05Jan2021) she thought she was feeling better, but by yesterday, clarified as late afternoon and evening, she crashed. She said she has a lot of autoimmune issues and immune deficiencies, saying she has pernicious anemia and Hashimoto's disease. She said yesterday evening she experienced extreme body temperature issues. She said she was really sweaty, so much so, that she had sweat under her eyes. She said she would get really hot and had chills. She said she was feeling really bad and was feeling shaky inside. She said she thought it was important that she report what she was experiencing to Pfizer. She stated she has psoriatic arthritis, too. Reported after receiving the COVID-19 Vaccine on 02Jan2021, she had left upper shoulder pain. She clarified that she had a previous history of paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder. She said she had a weird feeling that went around where her scar was from the surgery on the back of her left shoulder. She said maybe the left shoulder pain had to do with how she held her left shoulder. She said on Monday, 04Jan2021, she had a little bit of pain in her left shoulder and by yesterday night, 05Jan2021, there was not much pain at all. Clarified her joint pain was in her ankles, wrists, hips, neck, back, and knees. She said the joint pain felt like "flu" joint pain. She stated she normally has joint pain with the other issues she has, but this joint pain felt different. She said the joint pain she experienced after taking the COVID-19 Vaccine was all over her body. She said yesterday (05Jan2021) her joint pain felt so much better, but later in the afternoon she didn't feel right. She said she has pernicious anemia, and thought maybe she needs her B-12 shot. She said yesterday (05Jan2021) she experienced a lot more symptoms. She said she had numbness in her face, felt extremely exhausted, had a foggy feeling, and felt exasperated. She said the symptoms didn't start until late in the afternoon into the evening of 05Jan2021. She said she did not feel well and went to bed at 8:45PM, which is early for her. She said she did give herself a B-12 1mcg/ml shot intramuscularly yesterday. She provided the B-12 1mcg/ml NDC Number: 7006900510, Lot Number: C0495, and Expiration Date: Aug2022. She said the name (company name) was listed on the B-12 1mcg/ml packaging. She said she gives herself a B-12 shot every 10 days. She said she still has some joint pain, but the joint pain is not like it was on 03Jan2021. She said she still has a tiny bit of heaviness in her joints with a constant throbbing pain, which is a different joint pain from her normal. Reported last night (05Jan2021) she didn't feel good at all. She said she felt horrible, and had to go to bed. She said she felt shaky inside all night, and still feels that way now. She said she was sweating like crazy, and then would get chills. She clarified she is used to being hot and cold in her normal life because of her thyroid problems, but stated what she experienced last night was beyond that. She said her hot and cold issue was bumped up several levels last night. She said she was chilled or sweating all the time last night, but did not have a temperature. She clarified her normal body temperature is 96.7, and when she checked her temperature at one point, her temperature was 98 degrees. Reported the hot and cold with sweating and chills, and nausea come and go. She said if she has nausea, it is a mild feeling of nausea. Clarified if Sunday, 03Jan2021. was a work day, she would have called out sick. She said Monday (04Jan2021) and Tuesday (05Jan2021) she did go to work. Reported she has low potassium and made herself an electrolyte cocktail. Reported if her system feels off, she said her electrolytes maybe off. She said her heart felt like it may be shaky, so she ate a banana to get potassium in her system. She said she does her little routine before she would call her doctor to get blood work done. She said she had her blood work done not too long ago. She said she wasn't feeling this way before she had the COVID-19 Vaccine, and is feeling rundown now. She said she was feeling good before she had the COVID-19 Vaccine. She said she feels like something is going on with her body now. Reported her last blood work was done on 04Dec2020 and everything was kind of normal. She clarified her thyroid was a little off, and her doctor adjusted her medication. She said her potassium was a little down. Reported she was told when she got the COVID-19 Vaccine shot she has to be a little more careful, and she might not be as protected as some people. She said she was told there have not been enough studies on the COVID-19 Vaccine. She clarified she was told that information by a person at the site where she received the COVID-19 Vaccination, saying the person was helping her with the COVID-19 Vaccination authorization form. Reported she thought she was doing OK after she received the COVID-19 Vaccine, until after last night and yesterday afternoon. She said if she continues feeling the way she is, she will see her doctor. She said her system seems off. She said she normally tries everything she knows first, like drinking a lot of water, and drinking electrolytes, and will take potassium to see if that is the issue. She said those are her own things that she does before she calls her doctor. Clarified sometimes she has numbness in her face due to not having her B-12. She said she still has a little numbness in face. She said on 05Jan2021, the numbness went across her face from the bridge of her nose down through to her mouth. She said the numbness was nothing like paralysis in her face, but her face was really hot at the same time she had the numbness. Reported she took Tylenol (clarified as (company) brand Tylenol, stating she doesn't have the UPC, Lot and Expiration Date). She said the Tylenol wasn't kicking in, so she took Ibuprofen (clarified as (company)brand Ibuprofen, and she doesn't have the Ibuprofen NDC, Lot and Expiration date). She said she took her normal medications. Outcome of events "She clarified she had some injection site pain" "and the injection site was a little itchy" and Shoulder pain were recovered on an unspecified date,

Other Meds: B-12

Current Illness: Hashimoto's disease (Stated she was diagnosed with Hashimoto's disease in either 1994 or 1995); IgA deficiency (she has IgA deficiency - selective, according to her patient chart. No further details provided.); Pernicious anemia (Verbatim: Pernicious anemia); Potassium low; Psoriasis (Reported she has had psoriasis forever, saying since she was a kid. No further details provided.); Psoriatic arthritis (Reported she has had psoriasis for a long time, but was just diagnosed with psoriatic arthritis.)

ID: 0938061
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bell's Palsy; This is spontaneous report from a contactable Other Health Professional. This reporter reported similar events for 6 patients. This is a 6th of 6 reports. A patient of unspecified age and gender 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's medical history and concomitant medications were not reported. The patient experienced bell's palsy on an unspecified date with outcome of unknown. Since the use of modified RNA in COVID vaccines, the reporter aware of 6 cases of Bell's Palsy by the companies making these vaccines. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis 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.,Linked Report(s) : US-PFIZER INC-2021007605 Different patient, same drug/event.

Other Meds:

Current Illness:

ID: 0938062
Sex: F
Age:
State: LA

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

Lab Data:

Allergies:

Symptoms: The numbness began to intensify and I could not feel myself blinking or smiling on the left side of my face; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; This is a spontaneous report from a contactable nurse reported for herself. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142) via an unspecified route of administration on 07Jan2021 07:00 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was Workplace Clinic. Medical history included food allergy at shrimp. Concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 07:15 AM the patient notice pain and numbness to her left ear and left jaw that began to spread down left jaw and upward across left cheek, left eye, and left temple, and above left eyebrow. The numbness began to intensify and patient could not feel herself blinking or smiling on the left side of my face. The numbness slowly began improving over the next hour in the same order that it began, but she still have mild left ear and jaw pain and mild numbness. Events outcome are recovering. No treatment was received. The action taken was not applicable.; Sender's Comments: Based on the compatible time association, the facial palsy is possibly related to suspect BNT162B2 administration. 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: 0938063
Sex: M
Age:
State: AZ

Vax Date: 12/21/2020
Onset Date: 12/22/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Burst blood vessel in left eye 24 hours after vaccine was given.; This is a spontaneous report from a contactable other-HCP. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number not available, via an unspecified route of administration on 21Dec2020 07:45 AM at single dose for covid-19 immunization. Vaccine location was left deltoid. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included morbid obesity and blood pressure high. No known allergies. Patient didn't do relevant test. Concomitant medication included amlodipine (AMLODIPINE) at 5mg daily. The patient experienced burst blood vessel in left eye 24 hours after vaccine was given (eye haemorrhage) on 22Dec2020 08:30 with outcome of recovered. No treatment received. The action taken in response to the event for BNT162B2 was not applicable. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, the company considers that a causal relationship between the eye haemorrhage and vaccination with BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 0938064
Sex: M
Age:
State: MT

Vax Date: 12/17/2020
Onset Date: 12/18/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Had ruptured blood vessels x 2 spontaneously in eyes; This is a spontaneous report from a contactable nurse reported for herself. A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 17Dec2020 03:00 P.M at single dose for covid-19 immunization. The facility type vaccine was: workplace clinic. Medical history included manifesting carrier BMD (Becker's muscular dystrophy). Allergies to medication: allergies rash on Sulfa. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included pregabalin (LYRICA), duloxetine hydrochloride (DULOXETINE [DULOXETINE HYDROCHLORIDE]). The patient experienced ruptured blood vessels x 2 spontaneously in eyes (eye haemorrhage) on 18Dec2020 with outcome of recovered. No treatment received. The action taken in response to the event for BNT162B2 was not applicable.; Sender's Comments: Based on the available information, the company considers that a causal relationship between the eye haemorrhage and vaccination with BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: LYRICA; DULOXETINE [DULOXETINE HYDROCHLORIDE]

Current Illness:

ID: 0938065
Sex: F
Age:
State: LA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: some congestion that just came on; her arm was really aching after the injection; she started coughing; voice was hoarse; light wheeze; soles of her feet were hurting; pressure in bilateral groin; aching all over; very tired; balance issues; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) intramuscularly in left upper arm on 05Jan2021 at single dose for covid-19 immunisation. The patient got her Covid vaccine yesterday (05Jan2021) around 11 or 11:30 am in her left upper arm. She had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right, so she got the vaccine in the left arm. She also had some skin cancers removed, one would not heal properly on her left arm and formed a blister, and her dermatologist popped it and put a band aid on it. The vaccine was given 3 inches above it. The patient's concomitant medications were not reported. The patient experienced pressure in bilateral groin, aching all over, very tired and balance issues on 05Jan2021; light wheeze on 06Jan2021. Seriousness for these events was medically significant. The patient stated she had some congestion that just came on. She felt fine yesterday (05Jan2021) right after getting the vaccine, that at work she did notice that there was something different feeling in the left side of her groin. She was not in direct patient care. She noticed on her left side in the groin, something felt different, then yesterday evening (05Jan2021) after work she was really tired in the evening, aching all over last night, even the soles of her feet were hurting, woke up like her balance was off, she would walk one way and go another, states it is not like an orthostatic issue, that she knows what that feels like. She stated that in her inguinal area she could feel pressure, bilaterally. Her arm was really aching after the injection. Her breathing, heard a light wheezing, was clearing her voice, and then she started coughing, voice was hoarse. The outcome of events pressure in bilateral groin, very tired and light wheeze was not recovered; of events aching all over and balance issues was recovering; of other events was unknown.; Sender's Comments: The reported events bilateral groin, aching all over, very tired, balance issues and light wheeze were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. 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.

Other Meds:

Current Illness:

ID: 0938066
Sex: F
Age:
State: MD

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

Lab Data:

Allergies:

Symptoms: Severe respiratory distress; This is a spontaneous report from a contactable pharmacist. A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection),Lot# lot number: EL1284, intramuscular at right arm on 07Jan2021 12:00 PM, at SINGLE DOSE for COVID-19 immunization. No known allergy , no other medical history.No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility .No any other vaccines within 4 weeks prior to the COVID vaccine. No Concomitant medications (received within 2 weeks of vaccination) . On 07Jan2021 the patient experienced Severe respiratory distress that resulted in Emergency room/department or urgent care.It was unknown if treatment was received for the event. The patient had not been tested for COVID post vaccination. The outcome of the event was unknown.; Sender's Comments: A possible causal relationship between Severe respiratory distress and BNT162B2 cannot be completely ruled out considering the temporal relationship. However, more information would allow for a full medically meaningful assessment, especially medical history, concomitant medications, concurrent illness and event details. 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: 0938067
Sex: F
Age:
State: FL

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/12/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; This is a spontaneous report from a contactable nurse. A 95-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), Lot# EH9899 Exipration on 06Jan2021 at 15:00 at SINGLE DOSE at deltoid for COVID-19 immunization. The patient received first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), Lot# EH9899 Exipration date : 31Mar20221, on 16Dec2020. Medical history included : cardiac failure congestive, hypertension, cardiac murmur .There were no concomitant medications. The patient previously took cymbalta , vasotec and zocor and experienced drug hypersensitivity. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.This nurse,worker at a skilled nursing facility, reported that this patient with a history of heart failure, received her second dose of the Pfizer-BioNTech Covid-19 vaccine yesterday, 06Jan2021, at 3pm. At 7am on 07Jan2021 she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive. Patient was stable prior to vaccination, but will now be transferred to hospice care. The nurse added the patient had the second COVID vaccine on 06Jan2021 yesterday and has now been transport to hospital due to a drastic decline after the shot. It was explained that this morning around 7 am she was transferred to the hospital. She was experiencing tachycardia, shortness of breath, and congestion. The events started this morning around 6-6:30am. The patient was admitted to the hospital. The shot was given at the facility. She received it at 3pm on 06Jan2021, First dose was on 16Dec2020.The caller relays she didn't know how aggressive the hospital will be for the patient. She was a full code when left and now a DNR and is unresponsive. The patient will be going on hospice care. The causality was reported as related. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tachycardia, shortness of breath, congestion, unresponsive, and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The patient's pre-existing medical condition of cardiac failure congestive, hypertension, cardiac murmur are confounding factors. 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: 0938068
Sex: M
Age:
State: CA

Vax Date: 12/18/2020
Onset Date: 12/23/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Date: 20201223; Test Name: MRI; Result Unstructured Data: Test Result:T2 hyperintensity; Comments: Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation; Test Name: COVID-19; Result Unstructured Data: Test Result:Negative

Allergies:

Symptoms: patient developed acute onset of right-sided facial palsy and pain; patient developed acute onset of right-sided facial palsy and pain; Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation; This is a spontaneous report from a contactable physician. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 18Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included psoriasis. No COVID prior vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine.No known allergies. Concomitant medications (received within 2 weeks of vaccination) included fluoxetine. days following vaccination,on 23Dec2020,the patient developed acute onset of right-sided facial palsy and pain. Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation. Work-up is ongoing. AE Resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage].It was unknown if the event was treated. The event was assessed as serious for Disabling/Incapacitating. The patient had been tested for COVID post vaccination (covid test result-Negative). The outcome of the events werenot recovered Information about lot/batch number has been requested.; Sender's Comments: A possible causal relationship between acute onset of right-sided facial palsy and pain with MRI findings suspicious for brain inflammation and BNT162B2 cannot be completely ruled out considering the 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: 0938069
Sex: M
Age:
State: NY

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

Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:showed myositis

Allergies:

Symptoms: myositis; This is a spontaneous report from a contactable physician. A 43-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date in Dec2020 reported as around the end of December, at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date after he received the vaccine he had right arm pain and swelling (states it was in his bicep brachial radialis in the muscle) which is the opposite arm of the injection site. He had an MRI done on an unknown date that showed myositis. He thinks could be due to the vaccine since it started two days after he received the vaccine. His pain peaked at about a week and a half and now the pain was improving and the swelling was down. He still had function in the right arm but when he strained it would hurt. His concern was that the reaction may be an autoimmune reaction and the first response was muted. He was worried the second dose may elicit a larger response. At the time of the reporting the patient was recovering from the events. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the available information, the company considers that a causal relationship between the myositis and vaccination with BNT162B2 cannot be excluded. Additional information regarding onset latency, relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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: 0938070
Sex: F
Age: 24
State: PA

Vax Date: 12/30/2020
Onset Date: 01/05/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: none

Allergies: UNKNOWN

Symptoms: On 1/5/21 arm became swollen, red and hard. She saw her PCP on 1/7/21 and she was started on Prednisone 40 mg for 5 days. Arm is improving today, 1/12/21

Other Meds: UNKNOWN

Current Illness: UNKNOWN

ID: 0938071
Sex: F
Age:
State: IL

Vax Date: 12/21/2020
Onset Date: 12/22/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Name: EKG; Result Unstructured Data: Test Result:Atrial fibrillation

Allergies:

Symptoms: Atrial fibrillation; Was not feeling well; Warm sensation in chest; This is a spontaneous report from a contactable nurse (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EJ 1685), intramuscular, on 21Dec2020 at 09:30 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 62-years-old. The patient received also varicella zoster vaccine RGE (CHO) (SHINGRIX) on 19Nov2020. Medical history included gastrooesophageal reflux disease (GERD) and high cholesterol. Concomitant medications included omeprazole, colestyramine (QUESTRAN), and vitamins. On 22Dec2020, the patient was not feeling well intermittently starting the day after the injection with warm sensation in chest that would go away until 31Dec2020 when the warm sensation of chest would not go away. The patient was sent for EKG that showed atrial fibrillation that she is now being treated for. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. Outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported atrial fibrillation and the administration of COVID 19 vaccine, BNT162B2. More information regarding the clinical course, the patient's underlying concurrent medical condition are required for the Company to make a more meaningful causality 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 RA, Agency, as appropriate.

Other Meds: ; QUESTRAN;

Current Illness:

ID: 0938072
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:fevers

Allergies:

Symptoms: blood in the stool; fevers; night sweats; chills; aches; This is a spontaneous report from a contactable Physician reporting for herself. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She experienced chills and aches after 24 hours (on 31Dec2020) and experienced significant fevers that wouldn't break and cycles of chills and fevers that would last for 2 hours each cycle over the next 24 hours. She also experienced night sweats and blood in the stool and mentioned it was the first time that happened to a healthy 30 year old like her. She is asking for reports of these side effects, especially blood in the stool and for recommendations regarding taking the 2nd dose as she is still not sure on whether to take it due to hearing that the 2nd dose side effects were worse. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of blood in the stool. 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: 0938073
Sex: F
Age: 32
State: NY

Vax Date: 12/28/2020
Onset Date: 01/11/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sore arm; rash at site of vaccine injection 12/28 for soreness; 1/11/21 for rash (appearance of rash 2 weeks after injection)

Other Meds:

Current Illness:

ID: 0938074
Sex: M
Age:
State: AL

Vax Date: 12/17/2020
Onset Date: 12/18/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:Down to 76/50; Test Date: 202012; Test Name: CT of the lungs; Result Unstructured Data: Test Result:second showed a 10-15% increase; Comments: in filtrates in his lungs; Test Date: 20201221; Test Name: CT of the lungs; Result Unstructured Data: Test Result:is ok; Test Date: 20210105; Test Name: CT of the lungs; Result Unstructured Data: Test Result:resolution of the infiltrates; Comments: most of the lesions are gone. CT results have improved significantly; Test Name: COVID-19 test; Test Result: Positive ; Test Date: 20201220; Test Name: COVID-19 test; Test Result: Positive ; Test Date: 20210106; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: Tested positive for COVID-19; CT showed increased infiltrates 10-15%; Dehydration/Dehydrated; Chills; Tested positive for COVID-19; Hypotensive; Achy; Severe achy cramps/Severe cramps all over body; This is a spontaneous report from a contactable nephrologist (patient himself). This 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via an unknown route, on 17Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 78-year-old. The patient was diabetic and hypertensive. Additional medical history included hyperlipidaemia. No relevant concomitant medications were provided. On 18Dec2020, the patient developed severe achy cramps/severe cramps all over body. On 19Dec2020, the patient developed achy. On 20Dec2020, the patient was dehydrated and hypotensive, he had also chills. On unknown date, blood pressure was down to 76/50. His symptoms for COVID were severe achy cramps, hypotension, and dehydration. On 20Dec2020, COVID-19 test was positive. On 21Dec2020, the patient was given monoclonal antibodies. A computerized tomogram (CT) of the lungs was performed on 21Dec2020 and it was ok. A week later (Dec2020), he had a repeat CT which showed increased infiltrates of 10 to 15%. He then started on dexamethasone, apixaban (ELIQUIS) and the rest of the things. He had a repeat CT on 05Jan2021 which showed resolution of the infiltrates; most of the lesions went gone. CT results had improved significantly. The patient underwent a second COVID test a week ago which was still positive. He had a third COVID on 06Jan2021, but results were not available yet. The patient queried if he can proceed with second dose planned on 07Jan2021 or if he should wait. The clinical outcome was recovered for the event 'severe achy cramps/severe cramps all over body' on 19Dec2020, for 'dehydration/dehydrated' on 20Dec2020, for 'chills' on unknown date in Dec2020, for 'achy' on 30Dec2020, for 'hypotensive' on 20Dec2020; the outcome of the event 'CT showed increased infiltrates 10-15%' was recovering; the outcome for 'Tested positive for COVID-19' was unknown. The reporter considered the events 'achy' and 'severe achy cramps/severe cramps all over body' serious because causing disability; the events 'tested positive for COVID-19', 'dehydration/dehydrated', 'chills' and 'hypotensive' were considered medically significant. The reporter considered the events 'Tested positive for COVID-19', 'CT showed increased infiltrates 10-15%' and 'dehydrated/dehydration' unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. Case will be reassessed when new information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0938075
Sex: F
Age:
State: PA

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Date: 20210105; Test Name: Nasal Swab; Test Result: Negative ; Comments: COVID test name post vaccination=Abbott BinaxNOW; Test Date: 20210107; Test Name: Nasal Swab; Test Result: Negative ; Comments: COVID test name post vaccination=Abbott BinaxNOW

Allergies:

Symptoms: Possible cellulitis; slight redness in left upper within 24 hours; severe redness and swelling and warmth of entire upper left arm and half of lower arm; severe redness and swelling and warmth of entire upper left arm and half of lower arm; Some pain; This is a spontaneous report from a contactable Physician. A 94-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140) on 30Dec2020 at 12.00 pm at single dose Intramuscular on left arm for COVID-19 immunization. Relevant medical history included COVID 19 infection, on 19Jul2020, post COVID left femoral DVT oral anticoagulation, Alzheimer dementia, Osteoarthritis, Spinal Stenosis, Gait Dysfunction and Constipation. Known allergies included acetazolamide, penicillin and sulfa. Concomitant medications included apixban (ELIQUIS ) 5 mg twice a day, colecalciferol (VIT D3) 1000u once a day. On 31Dec2020 at 12:00 pm patient experienced slight redness in left upper within 24 hours. The patient also experienced possible cellulitis, severe redness and swelling and warmth of entire upper left arm and half of lower arm. Some pain. No fever. It was also informed that patient underwent nasal Swab test for Coronavirus (Abbott BinaxNOW) on 05Jan2021 and on 07Jan2021 and resulted negative, for both. Treatment received for cellulitis included Cefuroxime. Outcome for the event possible cellulitis was unknown. Outcome of other reported events was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to temporal association. However patient old age and other underlying conditions cannot be excluded for a contributory role 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: ELIQUIS; VIT D3

Current Illness:

ID: 0938076
Sex: F
Age: 51
State: MN

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

Lab Data: na

Allergies: Amoxicillin, Cefprozil, Codeine NA Benzoate-Sulfamethoxazole-Trimethoprim

Symptoms: Extreme chills lasted approx 6 hrs. Muscle & joint pain, fatigue, headache lasting approx. 36hrs.

Other Meds: multivitamin

Current Illness: na

ID: 0938078
Sex: F
Age:
State: AR

Vax Date: 12/17/2020
Onset Date: 12/17/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Facial paralysis; This is a spontaneous report from a contactable Pharmacist. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899, Expiration Date 30Mar2021), via intramuscular, on 17Dec2020 (at 15:35), at single dose of 0.3 mL for COVID-19 immunisation. The patient was vaccinated at hospital, age at vaccination was 70-year-old. Vaccine location was deltoid but unsure which deltoid. The patient did not have a relevant medical history and concomitant medications. Pharmacist said that after vaccination, she waited to be monitored the standard 15 minutes at hospital and then when she got in the car and was on the way home like 20 minutes later she had brief episode of what the patient described as facial paralysis. It was like the side of her face in one area felt funny, it felt numb and it was not anywhere else on her face. It lasted the 20 minutes and then went away. The patient had recovered from the events on 17Dec2020. The pharmacist queried if the patient can proceed with the 2nd dose of the vaccine. The reporting pharmacist considered the event 'facial paralysis' as non-serious.; Sender's Comments: A possible causal relationship between acute onset of facial paralysis and BNT162B2 cannot be completely ruled out considering the temporal relationship and the known adverse event profile of the suspect vaccine. 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: 0938079
Sex: M
Age: 39
State: TX

Vax Date: 01/06/2021
Onset Date: 01/08/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: none

Allergies: pennacillin

Symptoms: Moderna Covid - 19 Vaccine EUA I received the vaccine on Wednesday January 6th. EARLY Friday morning around 30 minutes after midnight - I noticed pain on my left shoulder / neck area (tenderness). I began to feel around and found a swollen lymph node at the base of my neck just inside my left collar bone. Seems to be the supraclavical lymphnodes. I also noticed tenderness under my left arm in the arm pit region. I received the injection on the left side.

Other Meds: none

Current Illness: none

ID: 0938080
Sex: M
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; Left arm was extremely painful; This is a spontaneous report from a contactable Other-HCP. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EL1284) on 02Jan2021 at 10:00 AM at single dose via intramuscular on left arm for COVID-19 immunization. Medical history included allergy to codeine hypertension and asymptomatic HIV infection. Concomitant medications were not reported. Patient got home from the shot on 02Jan2021 at 11: 45 am. Fell asleep until 930p:m. During sleep was told by family that He was angry, cursing and yelling in his sleep. He didn't remember any of it, He felt delirious and out of control. Left arm was extremely painful. At the time of the reporting had recovered from the events without any treatment.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event delirious 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: 0938081
Sex: F
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: lymph node swelling and lymphedema in the right forearm side and the right upper arm; lymph node swelling and lymphedema in the right forearm side and the right upper arm; cold blister on lip; significant swelling on the right side of the base of her neck near her clavicles; slightly itchy scalp; redness, swelling, tenderness at injection site; redness, swelling, tenderness at injection site; redness, swelling, tenderness at injection site; This is a spontaneous report from a contactable Registered nurse reporting for herself. A 58-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Batch/lot number: EL0140), in Hospital, by intramuscular route in right upper arm on 23Dec2020 at 08:30, at 58-year-old of age, at single dose for COVID-19 immunization. The patient had no relevant medical history. She didn't receive any prior vaccinations within 4 weeks. There were no concomitant medications. The patient reported that it has been 2 weeks since she received the COVID-19 Vaccine now and she still has a considerable amount of lymph node swelling and lymphedema in the right forearm side and the right upper arm. The nodes on the right side of her neck around the clavicle have been quite swollen for about 2 weeks. She has the list of side effects so she was not concerned, as this was listed but now she's not sure. When she got the vaccine she had the expected redness, swelling and tenderness at injection site (onset reported as 23Dec2020). On the evening of the 24Dec2020 she had an itchy scalp but she didn't see any rash and that only lasted a short time. On 29Dec2020 the patient had a significant swelling on the right side of the base of her neck near her clavicles that wrapped around to the posterior of her neck and was assessed as medically significant. She treated it by putting ice on it in the evening. On 30Dec2020 the swelling seemed to be slightly decreased but it is still a visible lump, the nodes are firm and there is swelling around those and it has not improved since the 30Dec2020. On 30Dec2020 she noticed a little cold blister or hive on the center of her lower lip and that was resolved by 03Jan2021, she did not have fever and did not feel sick, but her main problem is the swollen lymph nodes around base of neck around clavicle and it is considerably swollen there. The patient reported that last night (06Jan2021) it looked like her right arm was swollen, she thinks she is having lymphedema on the right arm, her right forearm is half an inch circumference larger than her left arm and was measured at her work. The patient reported she is seeing her new primary care doctor on 26Jan2021 and will follow up with the doctor. The patient wanted to know if she should get the second dose scheduled for the next week or should wait until the swelling resolves. Moreover the patient asked how long do the side effects usually last (specifically systemic side effects). The events "redness, swelling and tenderness at injection site" and "slightly itchy scalp" resolved on 25Dec2020, the event "Cold blister on lip" resolved on 03Jan2021. The event "Swelling on the right side of the base of her neck near her clavicles" had not resolved yet at the time of the report. All the reported events were assessed as related to the COVID-19 Vaccine by the Primary Source Reporter (Method of assessment:Agency).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events swelling and lymphadenopathy 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: 0938082
Sex: F
Age:
State: TX

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: kidney infection; urine turning a different color/urine was an orange color/urine was a tea color; This is a spontaneous report from a contactable Nurse reporting for herself. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated earlier this afternoon (07Jan2021) urine turning a different color, her urine was an orange color, and this afternoon her urine was a tea color. She had no other symptoms as if she had a kidney infection. The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the event kidney infection 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: 0938083
Sex: F
Age: 81
State: AS

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

Lab Data: n/a

Allergies: none

Symptoms: none

Other Meds: n/a

Current Illness: none

ID: 0938084
Sex: F
Age:
State: NY

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any attention; sleeping a lot; sick; Headache; body aches; This is a spontaneous report from a contactable nurse. A 62-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 05Jan2021 08:15 at single dose for COVID-19 immunisation. Anatomical location of administration of vaccine was right deltoid. Medical history was not reported. The patient previously took omeprazole (PRILOSEC) and experienced drug hypersensitivity and lip swelling. Concomitant medication included atorvastatin (LIPITOR). The patient experienced headache on Jan2021, body aches on Jan2021, nausea on 06Jan2021, diarrhea on Jan2021, jitteriness on Jan2021, foggy head or brain on Jan2021, sleeping a lot on Jan2021, sick on Jan2021, she can't concentrate /she didn't pay it any attention on Jan2021. The outcome of headache and she can't concentrate /she didn't pay it any attention was recovering, of pain, jitteriness, foggy head or brain was not recovered, of sleeping a lot and sick was unknown. Nausea, and diarrhea recovered on 07Jan2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events headache, pain, nausea, diarrhea, feeling jittery, feeling abnormal, disturbance in attention and hypersomnia 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: LIPITOR [ATORVASTATIN]

Current Illness:

ID: 0938085
Sex: M
Age:
State: MD

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Date: 20210106; Test Name: fever; Result Unstructured Data: Test Result:High

Allergies:

Symptoms: High fever; Vomiting; Severe fatigue; Weakness; This is a spontaneous report from a contactable physician (patient himself). This 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1442), via intramuscular, on 05Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 61-year-old. Vaccine location was deltoid left. The subject did not have a relevant medical history and concomitant medications. On 06Jan2021, the patient developed high fever, vomiting, severe fatigue and weakness. He did not experience anaphylaxis. The events were considered serious as medically significant. The patient stated that side effects mentioned lasted 3 hours and he felt much better now. However, the final clinical outcome was unknown. The patient is not sure if he should get the shot again in 3 weeks since he was really sick. The reporting physician considered the events 'high fever', 'vomiting', 'severe fatigue' and 'weakness' related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, vomiting, fatigue and asthenia 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: 0938086
Sex: F
Age: 41
State: MS

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: WILL BE SKIN PRICK TESTED FOR VACCINE ALLERGY ON 01/21/21

Allergies: METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE

Symptoms: 1. ASTHMA ATTACK- 10 MINUTES POST VACCINATION, SUBSIDED WITHIN AN ADDITIONAL 10 MINUTES WITH USE OF EMERGENCY INHALER AND OTC ALLERGY MEDICATION. 2. ITCHING - FULL BODY ITCHING BEGAN WITHIN 1 HOUR POST VACCINATION. ITCHING WAS UNCONTROLLABLE BY EITHER OVER THE COUNTER ALLERGY MEDS OR MY REGULAR PRESCRIBED ALLERGY MEDS. NO RASH OR WHELPING. ZYRTEC DOSAGE DOUBLED BY ALLERGIST MD 48 HOURS AFTER REACTION BEGAN, NEGLIGIBLE EFFECT UPON SYMPTOMS. ITCHING REACTION LASTED FOR 72 HOURS (TUE AFTERNOON - FRI AFTERNOON) BEFORE SUBSIDING. 3. INJECTION SITE ITCHING - ITCHING AT INJECTION POINT IN ADDITION TO THE EXPECTED INJECTION SITE PAIN, REDNESS, & SWELLING. BEGAN WITHIN 1 HOUR POST VACCINATION & LASTED 72 HOURS

Other Meds: SINGULAIR , ZYRTEC, AMITRIPTYLINE, BENADRYL, CLARATIN

Current Illness: STREP THROAT 12/25/20 - 12/28/20

ID: 0938087
Sex: F
Age:
State: FL

Vax Date: 12/16/2020
Onset Date: 12/17/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Name: Hearing test; Result Unstructured Data: Test Result:Moderate hearing loss and speech clarity of 96%; Comments: in her left ear compared to 52% in the right ear; Test Date: 20201217; Test Name: COVID-19 PCR test; Test Result: Negative

Allergies:

Symptoms: feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy. Concomitant medications included fluticasone propionate for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral 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: FLONASE [FLUTICASONE PROPIONATE]

Current Illness:

ID: 0938088
Sex: M
Age: 73
State: LA

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: Second day had rapid rise and fall of my heart rate 68 to 115 in seconds and then back whether I was sitting, lying down or walking. this continued through the day until Jan 8 morning then it went back to nornal

Other Meds: atorvastatin dorzolamide timolol malate latanoprost ophthalmic

Current Illness: none

ID: 0938089
Sex: F
Age:
State: FL

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

Lab Data: Test Name: hearing test; Result Unstructured Data: Test Result:moderate hearing loss and speech clarity of 96%; Comments: % in her left ear compared to 52% in the right ear. They don't know if it is permanent; Test Date: 20201217; Test Name: COVID-19 PCR test; Test Result: Negative

Allergies:

Symptoms: constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine administered; hearing loss that worsened from before; hearing loss that worsened from before; This is a spontaneous report from a contactable physician (patient). This 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH9899), via an unspecified route of administration, on 04Jan2021 at 08:00AM at single dose for COVID-19 immunisation. The first dose was received on 16Dec2020 at 7:40 AM at single dose. Vaccine location was in the left arm. The patient was vaccinated at hospital, age at vaccination was 34-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included ongoing fluticasone proprionate (FLONASE) for seasonal allergy taking for two years. On 17Dec2020, COVID-19 PCR test was negative. On 04Jan2021 at night, she experienced myalgia, fever, chills, back pain and started with a constant ringing in her right ear and the hearing loss that worsened from before (started on 18Dec2020 after first dose, see AER # 2021012126). Start date of constant ringing in right ear was 05Jan2021. The events resulted in Physician Office visit. Hearing loss in right ear worsened and constant ringing in right ear were reported serious as medically significant while the other events were reported as non-serious. She went to see an ENT doctor and get a hearing test. The hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She is currently being treated with 80mg of Prednisone daily by mouth and getting dexamethasone injections to her middle eardrum. All of these effects have resolved except the hearing loss and ringing in her ear. All the events were considered related to the vaccine per reporter.; Sender's Comments: A causal association between BNT162B2 and the reported events 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: FLONASE [FLUTICASONE PROPIONATE]

Current Illness:

ID: 0938090
Sex: F
Age:
State: CO

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Date: 20210107; Test Name: fever; Result Unstructured Data: Test Result:103.7 Fahrenheit; Test Date: 20201113; Test Name: Covid; Result Unstructured Data: Test Result:she had Covid

Allergies:

Symptoms: fever of 103.7; Cough; body aches; Joint pain; chills; This is a spontaneous report from a contactable Nurse reporting for herself. A 54-year-old female patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose in left deltoid for COVID-19 immunisation at the age of 54-year-old. Lot number was EL1284. Medical history included Asthma since 1991 and ongoing, high blood pressure since 2020 (6 months before the report) and ongoing. Concomitant medications were unknown. On 07Jan2021, the patient experienced fever of 103.7 at 1:30PM, chills at 9:00AM, body aches at 11:00AM, Joint pain at 09:00AM, cough at 1:00PM; the events were considered medically significant. The patient was not treated for the events. On 13Nov2020, test showed she had COVID-19. On 07Jan2021, body temperature was 103.7 Fahrenheit. The patient did not recover from the events. The nurse considered the events were related to suspect vaccine.; Sender's Comments: A causal association between BNT162B2 and the reported events 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:

Current Illness: Asthma; Blood pressure high (Diagnosed 6 months before the report)

ID: 0938091
Sex: F
Age:
State: IL

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

Lab Data: Test Date: 20201218; Test Name: Calcium; Result Unstructured Data: Test Result:5.7; Test Date: 20210104; Test Name: Calcium; Result Unstructured Data: Test Result:9.5 (normal); Test Date: 20201218; Test Name: Magnesium; Result Unstructured Data: Test Result:1.2; Test Date: 20201221; Test Name: Magnesium; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201223; Test Name: Magnesium; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201226; Test Name: Magnesium; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201228; Test Name: Magnesium; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201230; Test Name: Magnesium; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210104; Test Name: Magnesium; Result Unstructured Data: Test Result:2.1 (normal); Test Date: 20201218; Test Name: Potassium; Result Unstructured Data: Test Result:2.6; Test Date: 20210104; Test Name: Potassium; Result Unstructured Data: Test Result:4.2 (normal); Test Date: 20201218; Test Name: CBC; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201221; Test Name: CBC; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201223; Test Name: CBC; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201226; Test Name: CBC; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201228; Test Name: CBC; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201230; Test Name: CBC; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210104; Test Name: CBC; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201218; Test Name: hemoglobin; Result Unstructured Data: Test Result:10.2; Comments: (at normal for her); Test Date: 20210104; Test Name: hemoglobin; Result Unstructured Data: Test Result:14.5 (normal); Test Date: 20201218; Test Name: CMP; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201221; Test Name: CMP; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201223; Test Name: CMP; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201226; Test Name: CMP; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201228; Test Name: CMP; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201230; Test Name: CMP; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210104; Test Name: CMP; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: Hypokalemia; Hypomagnesemia; Hypocalcemia; Hemoglobin dropped little bit; Tetany; Muscle cramps; This is a spontaneous report from a contactable healthcare professional, a physician assistant. A 50-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included tachycardia, tension headache, and glucose tolerance impaired. Concomitant medications included rosuvastatin calcium (CRESTOR), gabapentin (MANUFACTURER UNKNOWN), and metoprolol (MANUFACTURER UNKNOWN). On 18Dec2020, the patient experienced hypokalemia, hypomagnesemia, hypocalcemia, tetany, muscle cramps, and hemoglobin dropped little bit. The clinical course was as follows: The patient received the vaccine and about 30 minutes later she started to "feel bad". She went to the urgent care and about an hour after they took her to the emergency room (also reported as hospital). She had a complete blood count, complete metabolic panel, and magnesium level done on the 18th, 21th, 23rd, 26th, 28th, 30th of Dec2020 and then again on 04Jan2021. On 18Dec2020, her initial lab test showed potassium: 2.6, hemoglobin: 10.2, magnesium: 1.2, and calcium: 5.7. The physician assistant reported that a potassium of 2.6 was critically low and a hemoglobin was 10.2 was about normal for the patient. She received oral medications of potassium 20 mEq twice a day and calcium and magnesium supplements once a day. On 04Jan2021, lab data showed: potassium: 4.2, magnesium: 2.1, calcium: 9.5 and hemoglobin: 14.5. Per the reporting physician assistant, the above levels went back to normal but stated she had to be supplemented to get back to that point. The clinical outcomes of the hypokalemia, hypomagnesemia, hypocalcemia, and hemoglobin dropped little bit were recovered on 04Jan2021; while that of the tetany and muscle cramps, were unknown. The physician assistant assessed the events as related to the suspect vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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: CRESTOR; ;

Current Illness:

ID: 0938092
Sex: F
Age: 29
State: CO

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

Lab Data: None known

Allergies: Unknown

Symptoms: Person called to ask about COVID vaccines reactions. Is having tingling on one side of the body along with fever, fatigue, flushing, nausea, and a rash

Other Meds: Unknown

Current Illness: Unknown

ID: 0938093
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient felt tingling in their neck, arms and hand and then few days later it went to their feet; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: unknown), 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. On an unspecified date, the patient felt tingling in their neck, arms and hand and then few days later it went to their feet (medically significant). The clinical outcome of the event was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events 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:

Current Illness:

ID: 0938094
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bell's palsy; Flu like symptoms; This is a spontaneous report from a non-contactable consumer reported that a female patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. It was reported that the patient got Bell's palsy four days after the vaccine and had flu-like symptoms for two weeks. Added that patient is completely symptom free at the time of report. The outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0938095
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Name: lab work; Result Unstructured Data: Test Result:Unknown Results

Allergies:

Symptoms: Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; My whole body was as if I was sun burnt; My heart started to race; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2, (Pfizer COVID Vaccine, lot number: EK9231, expiry date: Apr2021) intramuscular on an unspecified date at single dose on right arm for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included nortriptyline for migraine, botulinum toxin type a (BOTOX) for migraine and birth control medication. The patient stated that, "I was wondering if this was a reaction to the vaccination I had today. So I ended up 3 hours after I received the vaccine, I got very hot and clammy but at the same time had the goosebumps and then my whole body was as if I was sun burnt and my heart started to race. And then my whole body was red as if I had a sunburn. Actually I went to the ER today and they just did lab work because of the way I was feeling. All they gave me in the emergency room is IV fluids." Therapeutic measures taken as a result of the events included IV fluids. The outcome of the events was unknown.

Other Meds: ; BOTOX

Current Illness:

ID: 0938096
Sex: F
Age: 65
State: NC

Vax Date: 10/27/2020
Onset Date: 10/28/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data: none

Allergies: NKA

Symptoms: Patient woke up the morning after her vaccines with extreme muscle pain and weakness from her neck to her lower legs . Had difficulty walking . No respiratory symptoms. patient had a telemed appointment with Dr. and was diagnosed with moderate Guillain-Barre' Syndrome. Patient did require cane for stability when walking . Patient has improved but still having some pain and weakness.

Other Meds: Paxil, Xanax, ,Levothyroxine, Zinc, Calcium

Current Illness: None

Date Died:

ID: 0938097
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: died; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported the patient was a doctor, died after the vaccine with no apparent disease. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 0938099
Sex: M
Age: 32
State:

Vax Date: 12/22/2020
Onset Date: 12/31/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Covid Positive

Other Meds:

Current Illness:

ID: 0938101
Sex: F
Age: 37
State: GA

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

Lab Data:

Allergies: none

Symptoms: rash initially has resolved, fever 100.1F, chills,headache, heart rate 120, fatigue SOB states symptoms occur in afternoon advised to see PCP

Other Meds: Nortriptalion, Nurtez, Novaring, Morana, Ibuproten, magnesium, Topamax

Current Illness: none

ID: 0938102
Sex: F
Age: 77
State: OK

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

Lab Data: no

Allergies: Shell fish, Derma bond, Demerol

Symptoms: Chills, was shaking. high temp 103 over the night, then 101, 99. Sore arm.

Other Meds: Amlodipine

Current Illness: 12/29 Positive COViD test

ID: 0938103
Sex: M
Age: 26
State: OR

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

Lab Data:

Allergies: none

Symptoms: Ran fever of unknown level. Ran in the middle of the night and broke at approximately 8:00 am January 12, 2021. No other adverse effects have been noted thus far. Treated with acetametaphine.

Other Meds: multi vitamin, metformin, gilipizide.

Current Illness: none

ID: 0938104
Sex: M
Age: 70
State:

Vax Date: 12/22/2020
Onset Date: 12/28/2020
Rec V Date: 01/12/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: COVID-19 positive and admitted to hospital 6 days post-vaccination

Other Meds:

Current Illness:

ID: 0938105
Sex: M
Age: 44
State:

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

Lab Data:

Allergies: none

Symptoms: muscle aches and stiffness on non vaccinated area

Other Meds: none

Current Illness: none

ID: 0938106
Sex: F
Age: 43
State: TX

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies: Client reported an allergic reaction after receiving the pneumococcal vaccination, redness and swelling at the injection site. Client reported going to the ER after a wasp sting, was treated with steroids.

Symptoms: Approximately 30 minutes after the injection clients voice became raspy. She reported 1-2 seconds of blurred vision, that resolved. No breathing difficulty or wheezing, no dizziness. B/P 128/88 Pulse 59. No other complaints from client. No swelling or redness at injection site. Waited X 60 minutes, no changes. Instructed client to closely monitor and seek emergency care if needed.

Other Meds: unknown

Current Illness: unknown

ID: 0938107
Sex: F
Age: 40
State: AZ

Vax Date: 01/04/2021
Onset Date: 01/11/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies: NKDA

Symptoms: One week after IM injection pain redness and swelling noted at site of injection. Applied ice on 20 min and off 20 min for 1 hour, took 600mg of ibuprofen with noted increased swelling, redness, and warmth at injection site. Called clinic and received prescription for Bactrim to treat cellulitis with instructions to follow up with PCP in 2 days if symptoms do not improve.

Other Meds: Wellbutrin albuterol

Current Illness: None

ID: 0938108
Sex: F
Age: 28
State: VA

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

Lab Data:

Allergies: NKDA, none

Symptoms: Noticed pain to my L axilla ~4 days after vaccine administration and then palpated a mass under my armpit.

Other Meds: Zyrtec and Ibuprofen

Current Illness: N/A

ID: 0938109
Sex: M
Age: 43
State: IA

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

Lab Data: COVID swab positive 1/1/2021 Hospital admission 1/11/2021 not sure what tests are being performed

Allergies:

Symptoms: Received first dose Moderna COVID vaccine on 12/28/2020; on that same day 12/28 he noticed a dry cough; on 1/1/2021 he reported fever, chills, body aches, Headache, sinus congestion. On 1/1/2021 he tested positive for COVID-19, he reported being with a family member on Christmas who had COVID symptoms. On 1/11/2021 he required hospitalization for COVID-19 pneumonia

Other Meds:

Current Illness:

ID: 0938110
Sex: F
Age: 64
State:

Vax Date: 01/03/2021
Onset Date: 01/03/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies: Sulfa, ciprofloxacin, augmentin

Symptoms: Within several minutes after injection, I felt flushed, strange feeling in head and chest as if I was going to pass out, and heart started pounding. These symptoms subsided within 2 minutes with no treatment needed. I sat for 15 more minutes with no further problems.

Other Meds: 50mg metoprolol, 20 mg atorvastatin, 2000IU Vit D,multivitamin, calcium citrate plus D,Eye Omega Advantage, 200 mg cimetidine

Current Illness:

ID: 0938111
Sex: F
Age: 29
State: MA

Vax Date: 01/10/2021
Onset Date: 01/12/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: N/A

Allergies: Sulfa

Symptoms: Congestion, nausea, fatigue, body aches

Other Meds: N/A

Current Illness: N/A

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm