VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer
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: 1068224
Sex: F
Age:
State: FL

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: CN5318, via an unspecified route of administration at right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. Medical history was not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date. There were no concomitant medications. On 29Jan2021, at 7 pm, the patient was nauseous and weak. At 9 pm, the patient was really unwell, tired, headache, muscle aches and nausea. She slept all Friday night, all day Saturday. Late around Sunday was finally able to get out of bed. Asked if she should see a doctor. The patient was still nauseous and weak. The outcome of the events nausea and weak was not recovered. The outcome of other events was unknown.

Other Meds:

Current Illness:

ID: 1068225
Sex: F
Age:
State: FL

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea; Dizziness; she feels like the whole house is turning around; slight headache; Chills; overall tiredness; overall not feeling good; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiration date: May2021), via an unspecified route of administration on the left arm on 29Jan2021 09:49 at single dose for COVID-19 prophylaxis. Medical history included ongoing hypertension (Stated that it is under control with her medication), prevent heart attack, high cholesterol, hepatitis B in 1996, Rubella/measles in 1996. Concomitant medication included ongoing acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) to prevent heart attack, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), simvastatin for high cholesterol. The patient previously took Flu shot for flu vaccination. She stated that she has had adverse events to previous vaccines. She stated that she had a rash and feeling bad. Profuse bleeding with her menses and stated that it lasted a week. Whenever she takes the Flu shot it disrupts her system for a while. Patient also previously took Hepatitis B in 1996 and a booster in 1997, Rubella/measles in 1996 and a booster in 1997, Tdap in 1996, OPV in 1996, Polio in 1996, TD 0.5mg in 2006. The patient experienced chills and overall tiredness on 29Jan2021; slight headache on 30Jan2021; nausea, dizziness and she feels like the whole house is turning around on 31Jan2021. Patient reported that she received the vaccine on Friday 29Jan2021 and said that she has had most of the events that were reported. Patient reported that she had chills, overall tiredness, nausea, slight headache, and overall not feeling good, like unwell feeling. She said that she had dizziness too. She said that she was wondering if she should call the doctor also. She was hoping her symptoms would go away. She said that she feels awful. She said that she feels like the whole house was turning around. She said that she cannot even drive. She said that she had a little bit of soup for lunch and she was nauseous. She said that she took Benadryl after she got home from getting the injection because she was not feeling good. She stated that she went to bed and slept and felt good when she woke up and said that feeling good was short lived. Chills: She said that she had to sleep with 2 layers of clothes. Noticed the chills at 9-10 pm that evening. She stated that she is still feeling chilly, but reported that the temperature is chilly outside. Tiredness: Started that evening after she received the vaccine. She said that she can still work, but she can hardly concentrate. She has to use a lot of focus to get the tasks done. Nausea: She noticed the nausea on Sunday. Slight Headache: She noticed the headache on Saturday 30Jan2021 and said that last night she had to take a Advil for her headache. Overall not feeling good: She thought it would have improved, but it is still there as of today. She said that she just wants to rest and she feels tired. Dizziness: Dizziness started yesterday 31Jan2021 and stated that it was awful yesterday. Patient said that it has slightly improved. The patient was recovering from chills and dizziness; not recovered from slight headache and nausea; unknown outcome for she feels like the whole house is turning around.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]; LOSARTAN/HCTZ; SIMVASTATIN

Current Illness: Hypertension

ID: 1068226
Sex: F
Age:
State: MS

Vax Date: 01/13/2021
Onset Date: 01/01/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Name: COVID; Result Unstructured Data: Test Result:did not have it

Allergies:

Symptoms: sick; Ached all over; felt really bad; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that three and a half days later (Jan2021) she got really sick. The patient ached all over on Jan2021, and for two days felt really bad on Jan2021. She did not seem to have the typical COVID symptoms. She got tested for COVID and did not have it. Over the next few days she gradually felt better, and then 10 days later she felt fine. She was due to have the second shot this Wednesday (03Feb2021). She was unsure if she should take it or not. The outcome of the events was recovered on Jan2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1068227
Sex: F
Age:
State:

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:low grade fever

Allergies:

Symptoms: a lot of the same symptoms from the covid virus; chills; low grade fever; everything hurt, muscles, head; everything hurt, muscles, head; everything hurt, muscles, head; tired; weak; feeling lousy; also had the breathing problem with the virus; This is a spontaneous report from a non-contactable Consumer. A female patient of an unspecified age receive 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 was not reported. The patient's concomitant medications were not reported. The patient experienced a lot of the same symptoms from the covid virus, chills, low grade fever, everything hurt, muscles, head, tired, weak, feeling lousy, also had the breathing problem with the virus on an unspecified date. The outcome of events was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101407 same reporter/drug/events, different patients

Other Meds:

Current Illness:

ID: 1068228
Sex: M
Age:
State: NJ

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: slight soreness; This is a spontaneous report from a contactable healthcare professional (patient). This 24-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 19Jan2021 at 19:00 (at the age of 24-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (lot number EK9231) intramuscularly in the right arm on 29Dec2020 at 18:45. On 20Jan2021 the patient experienced slight soreness. No treatment was provided for the event. The clinical outcome of slight soreness was recovered on an unspecified date. It was also reported the patient was not tested for COVID-19 post vaccination.

Other Meds:

Current Illness:

ID: 1068229
Sex: F
Age:
State: TX

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

Lab Data: Test Date: 2021; Test Name: covid-19; Test Result: Positive

Allergies:

Symptoms: tested positive after taking the vaccine; tested positive after taking the vaccine; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was tested positive after taking the vaccine on an unspecified date in 2021. She wanted to know if she will continue with the second dose which is on 24Feb2021. Lab data included: COVID-19 tested positive in 2021. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1068230
Sex: F
Age:
State: NJ

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

Lab Data:

Allergies:

Symptoms: severe chills; fever; body aches; fatigue; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El9266/expiration date: not provided), via an unspecified route of administration, on 11Feb2021 at 09:00 as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included aortic aneurysm on an unspecified date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El8982/expiration date: not provided), via an unspecified route of administration, on 22Jan2021 as a single dose for COVID-19 IMMUNIZATION. The patient did not have any known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Vitamin D, atorvastatin, metoprolol, and omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Feb2021 at 09:40 (40 minutes after receiving the vaccine, the patient experienced headache but reported that it was manageable and gone after a few hours. Later that evening on 11Feb2021 at 19:00, the patient experienced severe chills, fever, body aches, headache, fatigue. Symptoms lasted for over 48 hours. The patient started to feel some relief Saturday evening but still had annoyance headache on one side. The patient did not receive any treatment for these events. The outcome of the events severe chills, fever, body aches, headache, fatigue was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds: ATORVASTATIN; METOPROLOL; OMEPRAZOLE; VITAMIN D NOS

Current Illness:

ID: 1068231
Sex: F
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: wrist pain; wrist pain and it locked up.; little bumps on the back of her hand; Headache; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EJ1686) on 03Jan2021 in the morning before 12:00 pm (at 70 years) at single dose in right arm for COVID-19 immunization.Medical history included hypertension from 2002. Concomitant medication included enalapril for hypertension from 2002 (she tried several things- unspecified-before enalapril, took a number of months before she found something to tolerate). The patient on 24Aug2015 (at 65 years) took varicella zoster vaccine live (oka/merck) (ZOSTAVAX) for immunization and experienced shingles (it started a couple months after the shot, she had skin discoloration, black spots over the skin, caused by her bathing suit and the pool water, and it stayed for about 1.5 years, she was using a cream. It was maybe 2 years before it disappeared). Patient received first dose of the vaccine on 03Jan2021, after in Jan2021, she had a headache, a week and half later pain in wrist and wrists locked up, pain floated up to the back of her hand, continued since, locking of wrist stopped, pain continued, little bumps came on the back of hand.Patient added she may have had headache the second day (as reported), it came and went, she didn't pay attention, she had a headache morning and it gone as of 15Feb2021, but still came and went. Wrists locking up recovered before 24Jan2021. Bumps on back of hand started the same time, it came and went, stayed most of last week, still had it this week, about the same.No blood tests done since this happened.Final outcome of headache was unknown. Wrists locking up recovered in Jan2021. Bumps on back not recovered. wrist pain was recovering.Patient took the second dose of the vaccine (lot EN5318) on 24Jan2021 in the afternoon (maybe 2 or 3:00PM) at single dose in left arm for COVID-19 immunization. On 12Feb2021 patient lost part of mobility in the small finger of the right hand, can't lift it all the way above. Patient was scheduled to go to the doctor on 15Feb2021 in the afternoon. Patient saw joint pain listed on contraindications, would like to know the nature of the joint pain described from side effects of the covid vaccine. She was concerned of a blood clot, unsure what happened or what can cause it, was unsure if it was muscular or something. Patient would like to know whether blood clots and muscle pain have been reported as a side effect of the covid vaccine.

Other Meds: ENALAPRIL

Current Illness:

ID: 1068232
Sex: F
Age:
State: FL

Vax Date: 02/04/2021
Onset Date: 02/01/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL; developed a bad rash, hives, all over her body; developed a bad rash, hives, all over her body; itching; a few bumps kept increasing up to 3 days later; her feet were incredibly hot over the next 3 days; arm soreness; She was unable to sleep from being so itchy; Allergic reaction; This is a spontaneous report from a contactable consumer herself. A 61-year-old female patient received bnt162b2 (, Solution for injection, Batch/lot no: EN5318), via an unspecified route of administration on 04Feb2021 15:00 in the left arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously did get a flu shot in Nov or Dec2020. The patient developed a bad rash, hives, all over her body and itching on 10Feb2021. She reports, her feet were incredibly hot over the next 3 days on 07Feb2021. What started off as a few bumps kept increasing up to 3 days later. She was unable to sleep from being so itchy. Her doctor said it was an allergic reaction and prescribed an antihistamine after which it left in Feb2021. She was due for the 2nd dose of the vaccine on 25Feb2021. The patient did not had any investigation assessment. The patient states that there was little information out there to compare the experience she had. Wanted to call to make Pfizer aware of that and maybe get some more information out there. Has printed out the fact sheet and assumes she should not get the second vaccine because of what happened the first time. Wants to clarify what happened and share with Pfizer this information since she can't find much information for people who have had a delayed reaction. Went to get the vaccine on 04Feb and doesn't consider herself an allergic type person. Has no allergy to foods, medicines, only gets poison ivy and bug bites like most people. By Monday, the 4th day (08Feb2021) after getting the vaccine, noticed a couple of bumps on the wrist and does not know where else and didn't think of it as anything else. Thought it was a bite or she touched a plant and then it went away. It was not much. In the evening of Tuesday she had a bad reaction and on the 10th (10Feb2021) she had rash, hives, and itching that just moved to different places over the body. Her feet were so hot on the 3rd day and had to plunged them into cold water and used Epsom salt off and on and it helped some. This happened only for 2 nights and the reason she didn't go to the doctor, it went away. Again, mentions the first night she had a couple bumps and didn't think much about it. The second night, it was all over her body, the rash, and she took Epsom baths that helped, but she didn't get much more than an hour of sleep. She tried to take pictures of her thighs and backside, but unable to take good pictures, not a selfie person. The next morning she had her husband take pictures in case it went away and she went to the doctor they would have pictures to show. Her husband thought it may be shingles. Called the doctor on Thursday and had pictures to show her since the rash went away. Again, mentions the reaction was so bad on Wednesday. The doctor didn't believe areas on pictures of her back were shingles since shingles does not come and go away like that and that she must have had an allergic reaction to something. Provider didn't believe it was from the vaccine. Was given a prescription for Hydroxyzine HCL 25mg and was informed if areas didn't improve or returned she may need to see an allergist or immunologist. After the appointment she didn't get much sleep and woke up at 4pm in the afternoon and felt a little off, it could have been in her head or maybe she was paranoid, but she wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL and went to bed at 7:30pm and didn't do anything since. Got up and the reaction/rash, hives, itching was all gone after taking only one. It's like an antihistamine or Zyrtec. No further details provided. Later mentions after getting the first vaccine on the 4th, the next day she had arm soreness up until that Monday when the rash started. No further details provided. Says as far as recommendations were concerned for the paper she printed, the fact sheet. It says pretty much listed, she shouldn't have the second dose if difficulty breathing, swelling in the face and throat. The only thing she had was the rash on the neck, not the face. Paperwork also lists heart beating fast, or severe allergic reaction. The patient had no emergency room visit. The patient visited the physician office. The outcome of the event hot feeling in feet was recovered on feb2021 and rest of the events was recovering.

Other Meds:

Current Illness:

ID: 1068233
Sex: F
Age:
State:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:increased; Test Name: heart rate; Result Unstructured Data: Test Result:spiked

Allergies:

Symptoms: increased blood pressure; spiked heart rate; nausea; dizziness almost to the point of fainting; dizziness almost to the point of fainting; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 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 reporter wants to know if it is recommended for her to get the second dose of the bnt162b2 after she has experienced side effects from the first dose. The patient stated that she had increased blood pressure, spiked heart rate, nausea, dizziness almost to the point of fainting that the patient ended up in the emergency room. The patient also wanted to know if she has to wait some time before she gets the second dose and how long she can wait. The patient queried does she have to start over if she waits longer than the recommended period? The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1068234
Sex: F
Age:
State: WA

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

Lab Data: Test Name: CRP increased; Result Unstructured Data: Test Result:Below 0.29; Comments: normally below 0.29 which is within normal limits.; Test Date: 20210215; Test Name: CRP increased; Result Unstructured Data: Test Result:11.5; Test Date: 20210215; Test Name: EKG; Result Unstructured Data: Test Result:Pending; Test Name: CBC; Result Unstructured Data: Test Result:Okay; Test Name: Heart rate; Result Unstructured Data: Test Result:130; Test Name: Heart rate; Result Unstructured Data: Test Result:90-100; Test Name: Heart rate; Result Unstructured Data: Test Result:70s; Comments: Her heart rate is down in the 70s , but when moving it is in the low 100s.; Test Name: Heart rate; Result Unstructured Data: Test Result:100s; Test Name: Chemical Panel; Result Unstructured Data: Test Result:Okay; Test Name: peak flow; Result Unstructured Data: Test Result:450; Test Name: peak flow; Result Unstructured Data: Test Result:350; Test Date: 20210214; Test Name: peak flow; Result Unstructured Data: Test Result:250

Allergies:

Symptoms: it showed a "CRP value" of 11.5 which is usually below 0.29 which shows inflammation; loss of appetite; Nausea; breathing problems; mild fever; Muscle ache; Joint ache; Rapid heart rate up to 130; Itchy skin; roof of mouth itching; eyes were also really sore; This is a spontaneous report from a contactable Other HCP (patient). A 75-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6201), via an unspecified route of administration in the right arm on 11Feb2021 at single dose for COVID-19 immunisation. Medical history included ongoing asthma initially diagnosed at 21 years old, ongoing arthritis diagnosed 10-15 years before but she thinks she had it since she was 35, multiple joint replacements, past pneumonia. The patient's concomitant medications were not reported. The patient previously received methotrexate 25mg a week orally for arthritis but she quit taking it about 3 months before in preparation of getting the vaccine. The patient previously received the first dose of bnt162b2 on unspecified date (lot EL8982) at single dose for COVID-19 immunisation in the right arm. The patient experienced mild fever on 12Feb2021 with outcome of recovered on 14Feb2021, roof of mouth itching on 11Feb2021 with outcome of recovered on 11Feb2021, muscle ache on 12Feb2021 with outcome of recovered on 12Feb2021, joint ache on 12Feb2021 with outcome of recovering, breathing problems on 12Feb2021 with outcome of recovering, rapid heart rate up to 130 on 12Feb2021 with outcome of recovering, itchy skin on 11Feb2021 with outcome of recovered on 11Feb2021, it showed a "crp value" of 11.5 which is usually below 0.29 on 15Feb2021 with outcome of unknown, nausea on 12Feb2021 with outcome of recovered on 13Feb2021, loss of appetite on 13Feb2021 with outcome of recovered on 13Feb2021, eyes were also really sore on 11Feb2021 with outcome of recovered on 15Feb2021. An EKG performed on 15Feb2021 as pending results. The event of breathing problems was serious due to disability. The events mild fever, roof of mouth itching, muscle ache, joint ache, rapid heart rate up to 130 and itchy skin were medically significant. The patient reported that initially, the roof of her mouth started itching. It literally happened as soon as she had the vaccine. She took a Benadryl. She didn't have a skin irruption, but did have itchy skin. The next day, she had a low grade fever. She had muscle and joint aches. She had no rash, but a little nausea. She had breathing problems. She had asthma issues and wheezing after the vaccine. That is how she described her breathing issues. She had a rapid heart rate. It went up to 130. It could of been because of fever, her breathing, or pain. There was a period of days then it resolved. On 15Feb2021, she feels almost human. She had routine arthritis lab drawn on 15Feb2021. They showed a CRP level of 11.5 which shows inflammation. She normally was below 0.29 which was within normal limits. That was an extreme difference. That was a lot of inflammation. The patient had to get her nebulizer out to breathe. She has taken Tylenol a couple of times. Her lab work was essentially normal. The CBC and chemical panel was okay. The patient thoughts the fever was important because she has been immunocompromised for years by Methotrexate. She has had pneumonia before with no fevers. Her eyes were also really sore. They bothered her. She already had to use eye drops. That was 11Feb2021 it was gone on 15Feb2021 but it kind of lasted a few days. Her muscles were better, but her joints still hurt some. But her joints always hurt some. She has had multiple joint replacements. The muscles in her legs were severe Friday and Saturday. Her muscles aren't hurting now, but her joints were but that was kind of normal. Her peak flow was way down on 14Feb2021. It was at 250. She did finally get it up to 350 by using her nebulizer. Her best effort normally is 450. Her peak flow was down quite a bit. She has been having breathing changes for a year. They were not sure what it was about. It could be an acute episode of something. On unknown date (next morning as reported), her pulse was 90-100. Now her heart rate was only elevated with activity. Her heart rate was down in the 70s, but when moving it was in the low 100s. With activity it was still up. It was hanging out in the 70s except exercising. She considers walking across the room exercising. All her other labs were in within normal limits. The patient wanted to know if the inflammatory response was secondary to the vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if 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: Arthritis (10-15 years ago diagnosed, but she thinks she had it since she was 35.); Asthma (initially diagnosed at 21 years old)

ID: 1068235
Sex: M
Age:
State: NC

Vax Date: 02/02/2021
Onset Date: 02/04/2021
Rec V Date: 03/03/2021
Hospital: Y

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:Low-grade; Test Name: cultures; Test Result: Negative ; Test Date: 20210203; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: fever; Patient was unable to go to work due to disorientation, confusion, headache, and chillsPatient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chillsPatient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chills; bronchitis; This is a spontaneous report from a contactable Pharmacist. A 67-year-old male patient received second dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 at 07:30 at single dose in left arm for COVID-19 immunisation at the age of 67-year-old. Lot number was EL3248. Medical history included Cerebrovascular accident (CVA), Hypertension, Coronary artery disease (CAD), Transient ischaemic attack, Myocardial infarction, migraine induced stroke like symptoms, seizures. Concomitant medications included acetylsalicylic acid, dipyridamole (AGGRENOX), atorvastatin calcium (ATORVASTATIN), cetirizine hydrochloride (CETIRIZINE), Clonazepam, Diclofenac sodium, valproate semisodium (Depakote), docusate sodium (COLACE), lansoprazole, lisinopril, metoprolol succinate (TOPROL XL), morniflumate (FLOMAX), tadalafil (CIALIS). The patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 12:30 at single dose in left arm for COVID-19 immunisation at the age of 67-year-old; lot number EL0140. Patient missed worked on 03Feb2021 due to effects from COVID vaccine. Patient was unable to go to work due to disorientation, confusion, headache, and chills on 04Feb2021. The patient's employee health department advised the patient's family to send patient to be seen by emergency department (ED). Per ED note patient had complaint of intermittent confusion and disorientation, and fever. Symptoms started after he received his second Covid vaccine. Patient was alert and oriented when seen by ED physician. Patient described symptoms as coming and going, have been worse when he first wakes up. Patient has a past history of seizures and transient ischemic attack (TIA). Provider admitted making sure he was not having further seizures or TIA. Patient was observed and discharged on 05Feb2021. Per discharging provider the patient had some mild low-grade fever with negative cultures on unknown date. On 03Feb2021, nasal swab resulted negative. Provider unsure if fever due to vaccine or mild case of bronchitis (04Feb2021), patient discharged on a ZITHROMAX pack, antibiotics-one dose of Zosyn, Vancomycin, Rocephin. The patient was treated for the events. The patient recovered from the events. The patient did not have covid-19 prior to vaccination; the patient was tested for covid-19 post vaccination (nasal swab, negative). No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: AGGRENOX; ATORVASTATIN [ATORVASTATIN CALCIUM]; CETIRIZINE [CETIRIZINE HYDROCHLORIDE]; CLONAZEPAM; DICLOFENAC SODIUM; DEPAKOTE; COLACE; LANSOPRAZOLE; LISINOPRIL; TOPROL XL; FLOMAX [MORNIFLUMATE]; CIALIS

Current Illness:

ID: 1068236
Sex: F
Age:
State: CA

Vax Date: 01/15/2021
Onset Date: 02/03/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: cellulitis in elbow of injected arm; This is a spontaneous report from a contactable healthcare professional (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 15Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included known allergies to penicillin and sulfa. Concomitant medication included acyclovir. The patient was not pregnant at the time of vaccination. The patient experienced cellulitis in elbow of injected arm on 03Feb2021 07:00 with outcome of recovering. Therapeutic measures were taken as a result of cellulitis in elbow of injected arm (cellulitis) with doxycycline as treatment. The event resulted in doctor or other healthcare professional office/clinic visit. The patient already took the second dose of BNT162B2 (lot number: EL9264) on 05Feb2021 08:00 at the right arm.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported cellulitis 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: ACYCLOVIR [ACICLOVIR]

Current Illness:

ID: 1068237
Sex: F
Age:
State: FL

Vax Date: 02/12/2021
Onset Date: 02/01/2021
Rec V Date: 03/03/2021
Hospital: Y

Lab Data: Test Date: 20210213; Test Name: Blood pressure; Result Unstructured Data: Test Result:high, over the top blood pressure; Test Date: 20210213; Test Name: Blood pressure; Result Unstructured Data: Test Result:178/113; Test Date: 202102; Test Name: Blood pressure; Result Unstructured Data: Test Result:good; Test Date: 20210213; Test Name: unspecified blood labs; Result Unstructured Data: Test Result:kidney was extremely dehydrated; Test Date: 20210213; Test Name: Heart checking; Result Unstructured Data: Test Result:unknown; Test Date: 20210213; Test Name: Chest X-ray; Result Unstructured Data: Test Result:was good; Test Date: 20210213; Test Name: Heart rate; Result Unstructured Data: Test Result:103

Allergies:

Symptoms: delirious: incapable of sleeping, insomnia and inability to be awake and aware; high, over the top blood pressure; Sweating; on and off chills; she gets warm and cold, hot and cold; concerned about one kidney/ was dehydrated; affecting her kidney; incapable of sleeping, insomnia; she was weak; feeling like she would slip onto the floor; she is still not clear headed; she is woozy, like foggy; she is still not clear headed, she is woozy, like foggy; arm is still sore from second vaccine; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number EL9262 expiry date 21May2021), via an unspecified route of administration on 12Feb2021 (at the age of 86 years old) at single dose in right arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number EL8982) on 22Jan2021 at single dose in upper right arm and on 22Jan2021 experienced severe headache and arm hurting. Relevant medical history includes ongoing compromised immune system diagnosed many years ago, and ongoing one kidney functioning. The patient received no concomitant medications. On 13Feb2021 the patient experienced high, over the top blood pressure, delirious incapable of sleeping, insomnia and inability to be awake and aware which both required hospitalization from 13Feb2021 to 14Feb2021. It was also reported they were concerned about one kidney/ was dehydrated in 13Feb2021. On 13Feb2021 unspecified blood labs showed kidney was extremely dehydrated and Chest X-ray was good. Clinical course was reported as follows: she was just released from hospital yesterday, she took the second Pfizer COVID shot, on 12Feb2021, and became so very very ill, she expected some side effects, the first shot wasn't bad, the first all she had was a severe headache and arm hurting, but that was 3 weeks ago, and the second one she can't say how horrible it was: she had to get the paramedics there, she was very very ill. It was the worst night she has had, and she is 86 years old, and has had a multitude of serious issues but that shot was the worst. It was a combination of high blood pressure, over the top, and insomnia like she couldn't budge and open her eyes, she couldn't see anything but squares, it was like a horrible, if there is such a thing as a trip, a horrible trip, something she can't imagine wishing on anyone. The county administered it, she has several doctor, she initially provides her primary care doctor, for consent to contact, but says her nephrologist would be better, as she hasn't seen her primary care doctor in some time. Her primary care doctor doesn't know she had this, another doctor gave her permission, her nephrologist. States they were more concerned in the hospital about her kidney, she has one kidney functioning and, on mistake of the hospital, they didn't connect her to hydration, the night nurse didn't, and she was dehydrated and it was affecting her kidney. Her husband tried to call Saturday, when she had this reaction at like 06:30/07:00, but there was a huge long wait, he was calling to see about side effects, but they were beyond waiting, had to get the paramedics, her blood pressure was 178/113 and heart rate was 103. First shot was 3 weeks back. It looks like she had it on 22Jan2021, the headache and arm hurting started towards the evening, the shot was taken earlier in the day, and they started in the evening, her headache was quite severe, but with Tylenol it went away, the arm is still sore from the second vaccine, but is slightly better. Clarifies she was hospitalized for the blood pressure and delirium, like, it is best explained, like delirious: incapable of sleeping, insomnia and inability to be awake and aware, all she could see was, like if she talked about people who did LSD and trips, it was a bad trip, it was squares, she wanted to open her eyes, but could only see squares. She fell asleep Friday night about 11PM, and felt this at 04:00, and she pulled off her sleep apnea mask, she had to run to the restroom, she was weak, feeling like she would slip onto the floor, and had to get right in bed, and the insomnia continued until about 7AM, that was when she started to be able to focus on like words, she was able to say words in her mind, it was like a bad nightmare. She was admitted to the hospital, she was in the emergency room (ER), the paramedics took her there Saturday, about 07:30, took her to the hospital after immediate heart checking, an intravenous (IV) of some kind, and brought her to the hospital and she was in X-rays and what not, they did procedures in the ER, and they suggested her to be observed overnight, they watched her and things started to become more normal, but she is still not clear headed, she is woozy, like foggy. High, over the top blood pressure outcome: It has been back to a good blood pressure. Insomnia is ok- she slept ok last night. What is left: the night she woke up, so early Sunday morning, in the hospital, she was profusely sweating like someone came to her room and showered her bed with water, her sheets and blankets were soaked and this morning she woke, she got up, was still very woozy, and asked her husband to help get her out of bed, and she changed her nightgown and after an hour she got in the shower, as she was sweating again, not sweating, but occasionally on and off chills, she is taking off her nightshirt and putting on a bed jacket, she gets warm and cold, hot and cold. She had blood labs a chest X-ray, heart monitor the whole time until she was discharged, and everything was good except the kidney was extremely dehydrated. This was all on Saturday as well. On her first visit to get the vaccine, at that time, the facility was a big mall, and they handed her what to look for after the injection, and she didn't notice until this morning, it says if you have an immune system that is compromised, it could affect it, and she has immune system that is compromised diagnosed many years ago. Over the top blood pressure and insomnia had resolved, arm sore was resolving, dehydrated and affecting kidney had not resolved, final outcome of the remaining events was unknown.

Other Meds:

Current Illness: Immune system disorder (Verbatim: compromised immune system/Diagnosed many years ago); Single functional kidney

ID: 1068238
Sex: F
Age:
State: FL

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severe headache; arm hurting/arm sore; This is a spontaneous report from a contactable consumer. This consumer reported for herself that an 86-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: 20May2021) at the age of 86-years, via an unspecified route of administration in upper right arm on 22Jan2021 at single dose for COVID-19 immunization. Medical history included compromised immune system (diagnosed many years before) and ongoing one kidney functioning. Concomitant medications were none. The patient experienced severe headache and arm hurting on 22Jan2021. It was reported that the first shot wasn't bad, the first all she had was a severe headache and arm hurting. It looks like she had the first on 22Jan2021, the headache and arm hurting started towards the evening on 22Jan2021, the shot was taken earlier in the day, and they started in the evening, her headache was quite severe, but with paracetamol (TYLENOL) it went away, the arm was still sore from the second single dose of BNT162B2 on 12Feb2021 for COVID-19 immunisation, but was slightly better. Outcome of the event headache was recovered/resolved in 2021 while of rest was recovering/resolving.

Other Meds:

Current Illness: Single functional kidney

ID: 1068239
Sex: F
Age:
State: OH

Vax Date: 01/21/2021
Onset Date: 02/03/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: feeling sick with covid symptoms; feeling sick with covid symptoms; feeling sick with covid symptoms; This is a spontaneous report from a Pfizer Sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Jan2021 at single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient felt sick with COVID symptoms on 03Feb2021. Second dose is scheduled 11Feb2021. Patient wondered when she should receive the second dose of the vaccine. The outcome of events was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1068240
Sex: M
Age:
State: NY

Vax Date: 01/01/2021
Onset Date: 02/09/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 20210209; Test Name: tested; Test Result: Positive

Allergies:

Symptoms: first shot was 2 weeks ago. Yesterday he tested positive for covid; first shot was 2 weeks ago. Yesterday he tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported a male patient (Reporter's Father) of an unspecified age received first dose of bnt162b2 (lot number unknown), via an unspecified route of administration, on Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had covid vaccine, first shot was 2 weeks ago. Yesterday he tested positive for covid. Inquiring how protected is he with vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Feb2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1068241
Sex: F
Age:
State: VA

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sore arm with first dose; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via intramuscular on left arm on 24Jan2021 at 18:30 at single dose for COVID-19 immunization. The relevant medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: autoimmune disease, PBC (Primary biliary cholangitis) (PBC is her autoimmune condition and was diagnosed 10 years ago). Concomitant medications were reported as none. The patient had sore arm with first dose on 24Jan2021. The outcome of the event was recovering.

Other Meds:

Current Illness:

ID: 1068242
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: diabetic peripheral neuropathy which was hitting her hard right now; diabetic peripheral neuropathy which was hitting her hard right now; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunisation. Medical history included ongoing diabetic peripheral neuropathy. Concomitant medication included calcium mefolinate, pyridoxine hydrochloride, vitamin b12 nos (METANX) from unspecified date and ongoing for diabetic peripheral neuropathy. The patient previously received first single dose of BNT162B2 on an unspecified date for COVID-19 immunisation. It was reported that she just had her second dose on 08Feb2021 Monday. She was wondering if she could now take her METANX which was a diabetic medication. She said she didn't stop the medication, hadn't needed it for a long time, it was for her diabetic peripheral neuropathy which was hitting her hard right now. She would like to take a pill if it wouldn't hurt the vaccine. Outcome of the event was unknown. Information on lot /batch number has been requested.

Other Meds: METANX

Current Illness: Diabetic peripheral neuropathy

ID: 1068243
Sex: F
Age:
State:

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

Lab Data: Test Date: 20210212; Test Name: fever; Result Unstructured Data: Test Result:102 Fahrenheit

Allergies:

Symptoms: heavy feeling in her chest; The top right quadrant of her right breast hardened and it was "incredibly painful" for her; The top right quadrant of her right breast hardened and it was "incredibly painful" for her; fever (102F); chills; fatigue; joint and muscle pain; joint and muscle pain; swelling of the lymph nodes; she felt intoxicated/drugged up; she felt intoxicated/drugged up; watery effect on her right eye; pain in her lower leg; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) solution for injection, via an unspecified route of administration on 11Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first dose of COVID-19 vaccine on Thursday, 11Feb2021. Immediately, she felt intoxicated/drugged up and had a watery effect on her right eye. When she got home, she experienced pain in her lower leg. The next day, 12Feb2021, she experienced fever of 102 Fahrenheit, chills, fatigue, joint and muscle pain, and swelling of lymph nodes. On Sunday, 14Feb2021, she had a heavy feeling in her chest. The top right quadrant of her right breast hardened, and it was incredibly painful for her. She said everything has been resolved except for her breast. She has spoken with her 2 doctors and asked her to contact Pfizer for her adverse events. She wanted to know if what she was experiencing was normal and wanted to know the recommendation for the second dose of the vaccine. The outcome of the events breast induration and breast pain was not recovered and recovered on Feb2021 for all other events. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1068244
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 03/03/2021
Hospital: Y

Lab Data: Test Name: Test; Result Unstructured Data: Test Result:showing the symptoms were improving

Allergies:

Symptoms: Had shallow breathing; Very weak; Could not walk; Disoriented; Wanted to sleep; Incoherent; couldn't/wouldn't eat; Dehydrated; This is a spontaneous report from two contactable consumers (primary reporter was patient's husband). An 80-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included ended up in the hospital for 2 weeks with pneumonia and COVID-19 at the end of last Summer. The patient's concomitant medications were not reported. The patient's husband reported that the patient received the first Covid shot about a week to two weeks ago. She went to the facility and got the shot and was fine afterwards until she came home. Later that afternoon, she started showing symptoms of problems, was weak and couldn't walk, disoriented, wanted to sleep, was incoherent, couldn't/wouldn't eat, was very, very much having trouble, shallow breathing. He tried to stay right her and eventually it got to be scary for him with her shallow breathing. He ended up calling an ambulance and she went to the hospital. They gave her tests and was there until about 4 or 5 in the morning before she started showing signs. She was dehydrated was a part of it. The tests were showing the symptoms were improving and she was beginning to come out of it fortunately with doctor's care because he didn't know what to do. He had been going through materials and she is coming up on another shot next Monday and does not want her to go through that if it can be helped. She was coming up for the second shot. Saw something on the tv that rattled him to his bones. It had been found that people who had Covid virus previously and then got the shot may not need a second shot. He is trying to flush that out to whether or not that is something or not that she should be considering. They have the card to go back to the same place for the second shot and they are trying to figure if they need to set up an appointment now. Hoping that this was the worse of it and it is hard for them to call back and his physician is not an expert on this and he got Pfizer's office contact number and decided to call. Outcome of the events was recovering. Information on the batch/ lot number has been requested.

Other Meds:

Current Illness:

ID: 1068245
Sex: F
Age:
State: FL

Vax Date: 01/25/2021
Onset Date: 01/01/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: Fever; Result Unstructured Data: Test Result:100 Fahrenheit; Comments: over a 100?F

Allergies:

Symptoms: chest pains; fever over a 100?F; AFib; diabetic; COPD; stomach issues; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose on 25Jan2021 and experienced health issues in Jan2021 as AFib, diabetic, COPD, stomach issues, and reported to "have a lot of issues". The primary doctor thought it's better for her to get the dose than get COVID-19. Patient also reported that about 20 minutes after the first dose on 25Jan2021, patient had chest pains, from one side clear across the other side and took a Nitro, and patient had fever over a 100 degree F for 24 hours. The outcome of the events was unknown. Information on about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1068246
Sex: U
Age:
State: GA

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

Lab Data:

Allergies:

Symptoms: The baby had to be delivered at 35 3/7 weeks; Exposure during pregnancy; Fetal tachycardia noted 1 week after the 2nd dose of the vaccine. The infant had to be delivered at 35 3/7 weeks due to non-reassuring status during monitoring; This is a Spontaneous report from a contactable physician. This physician reported information for a mother and baby. This is baby report. A neonate's mother (mother was reported as 35-year-old) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN ), intramuscular on 02Feb2021 as a single dose for COVID-19 immunization. The patients mothers medical history and concomitant medications were not reported. The baby experienced fetal tachycardia noted 1 week after the 2nd dose of the vaccine in Feb2021 (also reported as 02Feb2021). The baby had to be delivered at 35 3/7 weeks due to non-reassuring status during monitoring on. The patient was hospitalized for 5 days. The clinical outcome of Fetal tachycardia noted 1 week after the 2nd dose of the vaccine. The baby had to be delivered at 35 3/7 weeks due to non-reassuring status during monitoring was unknown. Information on lot number was requested.; Sender's Comments: Based on the available information a causal relationship between events "fetal tachycardia noted 1 week after the 2nd dose of the vaccine" and "the baby had to be delivered at 35 3/7 weeks" and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021166872 mother/fetus

Other Meds:

Current Illness:

ID: 1068247
Sex: F
Age:
State: OH

Vax Date: 01/28/2021
Onset Date: 02/01/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); Nausea; Heart pounding; Lightheadedness; tingling feeling below her neck on the flat area of her upper chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included Afib (diagnosed about 4-5 years ago) and stress. There were no concomitant medications. It was reported that when she got her first COVID-19 Vaccine, her arm didn't hurt, but she had a headache, sore throat, an upper throat and chest type of thing, aches (clarified as body or muscle ache in her arm or leg that occurred occasionally), a little nausea, heart pounding, and lightheadedness on an unspecified date in Feb2021. She said she has AFib (atrial fibrillation) on an unspecified date. She said she is scheduled to get her second COVID-19 Vaccine shot next Monday (22Feb2021), and wanted to know if her side effects are going to be worse. She clarified that her upper throat and chest type thing to be a tingling feeling below her neck on the flat area of her upper chest on an unspecified date in Feb2021. She said she spoke with her doctor on a video call. She said her doctor said her tingling sensation would not be from the COVID-19 Vaccine shot, and the tingling sensation maybe her sinuses on an unspecified date. She said her doctor put her on antibiotics for 10 days (prescribed Cephalexin 500mg capsules, twice a day for 10 days. She said she started the Cephalexin 500mg capsules on 05Feb2021 and finished the prescription yesterday, 15Feb2021. She said the Cephalexin 500mg capsules were dispensed in a pharmacy bottle). The patient stated that she has no other medical conditions, except stress. She said she and her husband have been quarantined, and the quarantine has felt like the longest 2 weeks of her life. It was reported that the patient still gets heart palpitations. She said the other side effects lasted 5-7 days, and improved during that time. She said the side effects have all resolved with the exception of the heart palpitations. The event atrial fibrillation was assessed as serious (medically significant). The outcome of the event heart pounding was not recovered, while recovered on an unspecified date in Feb2021 for the rest of the events.

Other Meds:

Current Illness:

ID: 1068248
Sex: F
Age:
State: OR

Vax Date: 01/25/2021
Onset Date: 02/02/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: slight uptick in Sjogren's syndrome and Discoid Lupus symptoms. Her lesion opened and oozed, and dry eyes and dry mouth increased significantly.; slight uptick in Sjogren's syndrome and Discoid Lupus symptoms. Her lesion opened and oozed, and dry eyes and dry mouth increased significantly.; slight uptick in Sjogren's syndrome and Discoid Lupus symptoms. Her lesion opened and oozed, and dry eyes and dry mouth increased significantly.; This is a spontaneous report from a contactable consumer (patient) reported that a 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9264), via an unspecified route of administration on the right arm on 25Jan2021 16:30 at a single dose for Covid-19 immunization. The vaccine was administered at the hospital. The patient medical history included Systemic Lupus with Interstitial Lung Disease, Anti phospholipid syndrome, Discoid Lupus, Sjogren's Syndrome, Joint Hypermobility, Post-Traumatic Stress Disorder (PTSD), Traumatic Brain Injury (TBI), and Borderline Personality; all from an unknown date. Patient was not pregnant at the time of vaccination. Concomitant medication included buspirone taken from an unspecified date for an unspecified indication. It was reported that on 02Feb2021 08:00, the patient had slight uptick in Sjorgren's syndrome and Discoid Lupus symptoms. Her lesion opened and oozed, and dry eyes and dry mouth increased significantly. The patient will resume prednisone after 10 days as recommended by physicians. The patient received Clobetasol eye drops as treatment for the events. The outcome of the events was recovering. The patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 8982) on 15Feb2021 17:15.

Other Meds: BUSPIRONE

Current Illness:

ID: 1068249
Sex: F
Age:
State: CT

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: pain in her hand/ lower part of each finger hurt; joint pain in right hand; bled quite a bit; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9263), intramuscular on 27Jan2021 (at the age of 79-years-old) as a single dose in the left shoulder for COVID-19 vaccination. Medical history included shoulder surgery about 10 years ago and she lost use of her thumb and index finger, the nerve comes from the shoulder; her hand might be numb and stiff, often but not every morning from an unknown date. Concomitant medications were reported as she is on medication but nothing she feels is relevant. On 03Feb2021, the patient experienced pain in her hand and all the lower part of each finger hurt for about 5-10 seconds, joint pain in her right hand lasting 10-15 seconds, it did not last very long; and she bled quite a bit stating she thinks she got it right in the vein on 27Jan2021. The pain happened about four different mornings but has not had pain "since Friday" and that was lighter sharp pain with no numbness. The clinical outcome of the event bleeding was unknown; pain in extremity and joint pain was recovered on 12Feb2021.

Other Meds:

Current Illness:

ID: 1068250
Sex: M
Age:
State:

Vax Date: 02/08/2021
Onset Date: 02/13/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fainting episode; Loss of hearing; Left collar-bone lymph node enlarged noticeable swelling to area and left lower neck near carotid artery/lymph nodes; Soreness in area; Cold sweats; Light-headedness; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Feb2021 at 07:00 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no symptoms until 5 days post vaccination. On 13Feb2021 at 12:15, the patient experienced fainting episode, loss of hearing, left collar-bone lymph node enlarged (noticeable swelling to area and left lower neck near carotid artery/lymph nodes), soreness in area, cold sweats, and light-headedness. The events required a visit to the physician's office and emergency room (as reported). The clinical outcomes of the fainting episode, loss of hearing, left collar-bone lymph node enlarged, soreness in area, cold sweats, and light-headedness were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1068251
Sex: M
Age:
State: MI

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

Lab Data:

Allergies:

Symptoms: Developed Belle's Palsy within 48 hours; This is a spontaneous report from contactable consumers. An 85-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 03Feb2021 16:00 at single dose (left arm) for COVID-19 immunisation. Medical history included prostate cancer from 1994. The patient was not diagnosed with covid prior vaccination and since the vaccination, patient was not covid tested. Patient was not aware of any known allergies. Concomitant medication included bisoprolol. The patient did not receive no other vaccine in four weeks prior to Covid vaccine. On 05Feb2021, 15:00, the patient developed bell's palsy within 48 hours. The patient was treated with a prescription of prednisone 5mg. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of event was not recovered. Information on the Lot/batch number has been requested.

Other Meds: BISOPROLOL

Current Illness:

ID: 1068252
Sex: F
Age:
State: VA

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: felt hot; nauseous; lost control of bowels; "I knew that I would pass out soon so I lower my head to the floor and tried to take deep breaths, ...never lost consciousness"; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm, on 15Feb2021 at 04:45 (at the age of 69-years-old) at a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included trazodone (MANUFACTURER UNKNOWN) and letrozole (MANUFACTURER UNKNOWN). The patient previously took codeine (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, tetracycline (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, doxycycline (MANUFACTURER UNKNOWN for an unspecified indication and experienced allergies, and cyclobenzaprine hydrochloride (FLEXERIL) for an unspecified indication and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Feb2021 at 01:15, the patient felt hot, nauseous, and lost control of bowels. The events were reported as non-serious. The clinical course was reported as follows: About 8.5 hours (as reported) after the vaccination, the patient briefly felt hot and nauseous. She knew she would pass out soon, so she lowered her head to the floor and tried to take deep breaths. The patient lost control of her bowels but never lost consciousness. The episode was reported to be over in about 20 minutes. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered on 16Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: TRAZODONE; LETROZOLE

Current Illness:

ID: 1068253
Sex: M
Age:
State: KS

Vax Date: 02/12/2021
Onset Date: 02/01/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 202011; Test Name: COVID-19; Test Result: Positive ; Comments: tested negative since from Dec onwards 2020; Test Date: 202012; Test Name: COVID-19; Test Result: Negative ; Comments: tested negative since from Dec onwards 2020

Allergies:

Symptoms: under my lymph nodes are very painful; right arm was sore for first 2 days/under my right arm are very painful; This is a spontaneous report from a contactable consumer (patient himself). A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 12Feb2021 13:45 at single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unspecified date in Nov2020 (diagnosed with COVID 19 at the end of November 2020 but tested negative since from Dec onwards 2020). Concomitant medication included finasteride at 1 mg (within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. It was reported that, my right arm was sore for first 2 days on an unspecified date in Feb2021, however since Monday (15Feb2021 06:00 AM) under my lymph nodes, under my right arm are very painful. The events were considered as non-serious by the consumer. The patient did not receive treatment for the adverse events. The outcome of the events was not recovered.

Other Meds: FINASTERIDE

Current Illness:

ID: 1068254
Sex: F
Age:
State: KS

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: anaphylaxis; head was feeling funny; sweating profusely; This is a spontaneous report from a contactable consumer (patient). This 79 (unit unknown) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 10Feb2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose on 10Feb2021 at 12:00. On the same day (10Feb2021), at 20:00, the patient's head was feeling funny, sweating profusely, and felt like "anaphylaxis". Patient also asked about potential receipt of second dose. Patient stated she will reach out to healthcare professional (HCP). Outcome of the events was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1068255
Sex: M
Age:
State: NC

Vax Date: 01/29/2021
Onset Date: 02/04/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Name: influenzas A; Test Result: Negative ; Test Name: influenzas B; Test Result: Negative ; Test Date: 20210208; Test Name: COVID-19 nasal swab; Test Result: Negative ; Test Date: 20210211; Test Name: COVID-19 nasal swab; Test Result: Negative ; Test Date: 20210212; Test Name: COVID-19 nasal swab; Test Result: Negative

Allergies:

Symptoms: neuropathy on feet, arms, and chest; chills; fatigue; lack of sleep for the last 12 days; This is a spontaneous report from a contactable consumer, reporting for himself. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264), via an unspecified route of administration at the left arm on 29Jan2021 10:00 at a single dose for COVID-19 immunization. Vaccination was administered at a military base. Medical history included hypertension (controlled with medication) from an unknown date and unknown if ongoing. There were no known allergies. There was no other vaccine in four weeks. Concomitant medication included lisinopril, felodipine and tamsulosin (reported as medications in two weeks). On 04Feb2021 at 17:00, the patient experienced chills, fatigue, neuropathy on feet, arms, and chest and lack of sleep for the last 12 days. The patient was advised to drink plenty of water and take Tylenol. The patient had no COVID prior vaccination. The patient was not COVID tested post vaccination. The events required a doctor office and emergency room visits. The patient underwent lab tests and procedures which included influenzas A: negative, influenzas B: negative, both on unspecified dates; and COVID-19 nasal swab: negative on 08Feb2021, 11Feb2021 and 12Feb2021. The outcome of the events was not recovered.

Other Meds: LISINOPRIL; FELODIPINE; TAMSULOSIN

Current Illness:

ID: 1068256
Sex: F
Age:
State: FL

Vax Date: 02/15/2021
Onset Date: 02/01/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 202102; Test Name: blood pressure; Result Unstructured Data: Test Result:Fine; Test Date: 202101; Test Name: Fever; Result Unstructured Data: Test Result:Over 100?F Fahrenheit; Test Date: 202102; Test Name: oxygen level; Result Unstructured Data: Test Result:Fine

Allergies:

Symptoms: my chest started hurting me at 3:50 a.m. this morning; stomach hurts; felt squeezed, I could not breath; had the feeling of being squeezed; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiry date unknown), via an unspecified route of administration on 15Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 25Jan2021 and experienced AFib, diabetic, COPD, stomach issues, chest pains and fever. About 20 minutes after the first dose, I had chest pains, from one side clear across the other side. She took a nitro, and had fever over a 100?F for 24 hours on Jan2021. She received second dose on 15Feb2021 and experienced they had her get an EKG. Patient felt squeezed, she could not breath on Feb2021. Her oxygen level and blood pressure were both fine on Feb2021. She had the feeling of being squeezed on Feb2021. Her chest started hurting at 3:50 a.m. (16Feb2021) this morning, stomach hurts like doing flip flops inside her. She did not have anything that would aggravate it. The outcome of the events was unknown. The events was reported as non-serious. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1068257
Sex: F
Age:
State: WA

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 06:30 (at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included COVID-19 (with taste and smell loss). The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), hydroxyzine hydrochloride (MANUFACTURER UNKNOWN), and duloxetine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization and experienced head to toe itching and progress with taste and smell disappeared/worse than COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild anaphylactic reaction on 16Jan2021 at 20:00 and itching throat, cough, and taste and smell loss on an unspecified date. The patient reported that all the progress she made with taste and smell, disappeared after the vaccine and was actually worse than when she got COVID-19. Therapeutic measures were taken as a result of mild anaphylactic reaction, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of mild anaphylactic reaction was not recovered and of itching throat, cough, and taste and smell loss was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event anaphylactic reaction cannot be excluded.

Other Meds: WELLBUTRIN; HYDROXIZINE; DULOXETINE

Current Illness:

ID: 1068259
Sex: F
Age:
State:

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 03/03/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: muscle spasms; bad fibromyalgia; runny nose; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 (at the age of 81 years old), for COVID-19 immunisation. Medical history included highly allergic to some medications and bleeding disorder (she was on a blood thinner). Concomitant medications were not reported. On an unspecified date the patient experienced muscle spasms and spent 3 days at the hospital. She had to go again on an unspecified date in Feb2021, she got a lot of illnesses, she was also on a blood thinner and was highly allergic to some medications. Since an unspecified date she had really bad fibromyalgia. All these symptoms were usual for the patient, other than the runny nose. She needed to get a hold of her doctor, she had a follow up like right now. She wasn't supposed to go (for her appointment) until the 23Feb2021. She was scheduled for the second vaccine dose on 08Feb2021, however she was in the hospital and was wondering if it was too late. Events outcome was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1068260
Sex: F
Age:
State: MD

Vax Date: 02/16/2021
Onset Date: 02/01/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 202102; Test Name: BP; Result Unstructured Data: Test Result:180/120; Test Date: 20210216; Test Name: BP; Result Unstructured Data: Test Result:high; Test Date: 20210219; Test Name: BP; Result Unstructured Data: Test Result:stable; Test Date: 20210204; Test Name: Sofia SARS Antigen; Test Result: Negative

Allergies:

Symptoms: Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.

Other Meds: LISINOPRIL + HIDROCLOROTIAZIDA

Current Illness: Blood pressure abnormal

ID: 1068261
Sex: F
Age:
State: KS

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache; vomited in the toilet for 15 minutes; Woke up another couple times with soft urgent poop; Woke up another couple times with soft urgent poop; couldn't get comfortable or to sleep because of position and chills/hot flashes; nausea; cold flash; acid reflux; small dose of lower back pain; had arm and shoulder pain; had arm and shoulder pain; uncomfort on side of injection/shoulder joint uncomfort on left side (vaccination side); chills; hot flashes; This is a spontaneous report from a contactable consumer (patient). The 22-year-old female patient received second dose BNT162B2(lot_number: EN 5318?, incomplete number), via an unspecified route of administration in left arm on 15Feb2021 15:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included venlafaxine, ethinylestradiol, norgestimate (TRI-SPRINTEC), loratadine (ALLERCLEAR). The patient previously took z-pak for antibiotic therapy and experienced rash, sertraline hydrochloride(ZOLOFT) and experienced dizziness, first dose bnt162b2(lot: EN5318?) for covid-19 immunization on 26Jan2021 at 03:30 in left arm. The patient experienced started on 15Feb2021 at 10 pm with acid reflux and a small dose of lower back pain, had arm and shoulder pain, uncomfort on side of injection, chills and hot flashes kept waking her up throughout the night, at 2:15 on 16Feb2021 she woke up went to bathroom and had a hot flash/nausea so laid on the floor until cold flash came. At 2:30 She got back up and vomited in the toilet for 15 minutes (total of 10 or so times within the 15 minutes first few were just dry heaving until anything came out.) She took acetaminophen before going back to bed. She woke up another couple times with soft urgent poop. She couldn't get comfortable or to sleep because of position and chills/hot flashes. At 6:30 I was feeling nauseous and still chills. At 11 am she woke up with just a headache and minimal chills. Headache lasted until 5pm or so she had taken meds again for the headache. On 16Feb2021 had acid reflux again. After finally getting to sleep she woke up 17Feb2021 morning with just shoulder joint uncomfort on left side (vaccination side). Therapeutic measures were taken as a result of vomited in the toilet for 15 minutes, headache. There was no treatment for other events. Events were assessed as non-serious. Outcome of events was recovered in Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.

Other Meds: VENLAFAXINE; TRI-SPRINTEC; ALLERCLEAR

Current Illness:

ID: 1068262
Sex: M
Age:
State: PA

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Name: temp; Result Unstructured Data: Test Result:temp between 100-102 for 30hrs; Test Date: 20210214; Test Name: ekg; Result Unstructured Data: Test Result:normal

Allergies:

Symptoms: random heart-racing; random dizziness; occasional headaches; Temperature between 100-102 for 30hrs; flu-like symptoms; extreme burning resulting in fainting; extreme burning; This 42-year-old male patient contactable consumer (reported for himself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EN5318,; expiration not provided), via an unspecified route of administration, on 14Feb2021, 12:00 PM (at the age of 42-year-old) as a single dose for COVID-19 immunization, in Left arm. The facility where COVID-19 vaccine was administered was at a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2 (Lot number: el8982) intramuscularly on 24Jan2021 at 09:00 am for COVID-19 immunization on left arm. The patient did not have any other vaccine within four weeks prior to the vaccination. No relevant medical history reported. Concomitant medication included: Levothyroxine 125 "mg", once a day. On 14Feb2021 at 12:15pm, the patient experienced extreme burning resulting in fainting. Ekg normal in ER. Day-2 flu-like symptoms, temp between 100-102 for 30hrs. Day-2 and now day-3, random dizziness, feeling of heart beat, random heart-racing, occasional headaches, no current fever. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The clinical outcome of the events extreme burning resulting in fainting, flu-like symptoms, temp between 100-102 for 30hrs, random dizziness, random heart-racing, occasional headaches, was unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1068263
Sex: F
Age:
State: TX

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

Lab Data: Test Date: 2021; Test Name: medical tests; Result Unstructured Data: Test Result:unknown results; Test Date: 20210211; Test Name: covid test; Test Result: Negative

Allergies:

Symptoms: fractured T12; unable to walk on own; Fell; largely stopped eating and drinking; enfeebled; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: el9269), via an unspecified route of administration at left arm on 02Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included T-cell large granular lymphocytic (tCell LGL), type 2 diabetes and high blood pressure. No known allergies. No COVID prior vaccination. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. There were other medications in two weeks (unspecified). Within a week, patient was unable to walk on own. She fell and fractured T12. On 02Feb2021, she walked on her own to the car, got in the car, then out of the car, walked to the injection site, including standing in a long line, and walked back to the car. She was aware, recognized people and places, and walked from the car to her home. On 05Feb2021 12:00 (also reported as 'during 02Feb2021 thru 08Feb2021), she largely stopped eating and drinking. Within the week on 05Feb2021 12:00, she was enfeebled. At about 01:30 on 08Feb2021, she fell and fractured her back. She is now awaiting acceptance at a rehab facility. The events unable to walk on own and fractured T12 resulted to hospitalization and disability or permanent damage. The patient was hospitalized for 4 days. The events required Emergency room/department or urgent care visit. Various medical tests and treatments were administered as treatment for the events. Patient tested for COVID post vaccination. Covid test post vaccination on 11Feb2021: (covid test type post vaccination: Unknown) Negative. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1068264
Sex: M
Age:
State: FL

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

Lab Data: Test Date: 20210205; Test Name: WBC; Result Unstructured Data: Test Result:150,000

Allergies:

Symptoms: bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 02Feb2021, 13:00PM (at 82 years old) at a single dose for COVID-19 immunization. The patient was vaccinated in the Nursing Home/Senior Living Facility. The patient's medical history included myeloid leukaemia (CML) diagnosed a few months earlier, WBCs abnormal, blood pressure, and heart surgery valve repair. The patient has no known allergies. Concomitant medications included atorvastatin, carvedilol, vitamin d nos, dasatinib monohydrate (SPRYCEL) from an unknown date to help get WBCs back in normal range; cyanocobalamin (VITAMIN B12), and cetirizine hydrochloride (ZYRTEC), all were received within 2 weeks of vaccination. At 82 years old, the patient received the first dose of BNT162B2 (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination and did not receive any other vaccines within 4 weeks prior to BNT162B2. It was unknown if patient was tested for COVID post vaccination. On Friday (unknown date in Feb2021), patient's WBC was 150,000 and on Saturday (unknown date in Feb2021), patient had bilateral blood clots in legs that then went to lungs then went into BLAST crisis. The adverse events resulted in emergency room/department or urgent care as well as hospitalization due to life threatening illness (immediate risk of death from the events). The patient was hospitalized for 12 days. Therapeutic measures which include steroids, blood thinners, and lots of other meds were administered. Outcome of the events "patient's WBC was 150,000" and "bilateral blood clots in legs that then went to lungs then went into BLAST crisis" was recovering. Information on the lot/ batch number has been requested.

Other Meds: ATORVASTATIN; CARVEDILOL; VITAMIN D NOS; SPRYCEL; VITAMIN B12 [CYANOCOBALAMIN]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1068265
Sex: M
Age:
State: FL

Vax Date: 01/29/2021
Onset Date: 02/03/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 2021; Test Name: Blood Work; Result Unstructured Data: Test Result:was fine; Test Date: 2021; Test Name: fever; Result Unstructured Data: Test Result:fever

Allergies:

Symptoms: Loss of taste and partial smell; Loss of taste and partial smell; Hard to talk or eat or drink; Hard to talk or eat or drink; Hard to talk or eat or drink; Bells Palsy; Blurry vision; Fever; Felt achy; This is a spontaneous report from a contactable consumer (patient). This 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261), via an unknown route, on 29Jan2021 (at 10:00 AM) at a single dose in the left arm for COVID-19 immunisation. Relevant medical history includes diabetes, arteriolosclerosis, blocked carotid artery, gastrooesophageal reflux disease (GERD) and chronic prostatitis. Past drug history included allergy to penicillin and cefixime (FLEXERIL). Relevant concomitant medications included doxazosin mesylate (CARDURA), lisinopril, metformin, omeprazole, repaglinide (PRANDIN) and other unspecified medications. He had fever and felt achy for a couple of day. On 03Feb2021 (at 08:00), the patient had total paralyzed on right side of his face, right eye will not close, mouth paralyzed on right side. Hard to talk or eat or drink. Blurry vision in right eye due to not closing. On 04Feb2021, the patient has loss of taste and partial smell. The patient performed physician office visit. Then, he went to the emergency room (ER) and Bells Palsy was confirmed on 06Feb2021. He stated that his blood work is currently fine. He was given prednisone and acyclovir for Bells Palsy and for hard to talk or eat or drink. The patient was not treated for the remaining events. Pre and post vaccination COVID test were not performed. All events were considered serious for disability except of fever and felt achy. The outcome of the events fever and felt achy was unknown while the outcome of the remaining events was not recovered.

Other Meds: CARDURA; LISINOPRIL; METFORMIN; OMEPRAZOLE; PRANDIN

Current Illness:

ID: 1068267
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 03/03/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Shingles; This is a spontaneous report from a contactable consumer (consumer). A female patient of an unspecified age received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if it is okay to receive as scheduled on 20Feb2021 her second dose of Pfizer-BioNTech COVID-19 Vaccine if she has shingles. She stated that she went to the hospital because of it and it started 2 and a half weeks ago. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1068268
Sex: F
Age:
State:

Vax Date: 02/05/2021
Onset Date: 02/12/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: stroke; This is a spontaneous report from a contactable Pharmacist, the patient's daughter-in-law. An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 (at the age of 84-years-old) as a single dose for COVID-19 vaccination. Medical history included stroke and atrial fibrillation from unknown dates. Concomitant medications were not reported. On 12Feb2021, the patient experienced a stroke. The clinical outcome of the event stoke was unknown. No additional information was reported. Information about lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1068269
Sex: F
Age:
State: CA

Vax Date: 02/10/2021
Onset Date: 02/12/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: eczema flare up, skin red, her left anterior chest was burning and itchy, skin pain; headache; on early Friday evening she ended up with joint pain that was so bad, she thought she was going to die. She said her wrist, elbows, fingers, hips, knees, every joint down to her ankles, hurt; This is a spontaneous report from a contactable nurse (patient; retired nurse) via a Pfizer-sponsored program. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6201), via an unspecified route of administration in the right deltoid on 10Feb2021 at 12:35 PM (at age of 69 years old) at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a convention center. The patient's medical history included eczema from 24Dec2018 and ongoing, rosacea (developed Rosacea at 65 years old), and the patient also reported that she used to be 5'4" and she lost 2 inches. She said she had a bone density test recently and was told she is 5'2". She said she objected to the measurement of 5'2", so the nurse told her to stand as tall as she can, and then the nurse noted her height as 5'2-1/2". There were no concomitant medications. There were no additional vaccines administered on same date of BNT162B2. The patient had no prior vaccinations within 4 weeks. On 12Feb2021, the patient experienced eczema flare up, skin red, her left anterior chest was burning and itchy, headache, skin pain, and "joint pain that was so bad, she thought she was going to die. She said her wrist, elbows. fingers, hips, knees, every joint down to her ankles, hurt". The patient said she received her first COVID-19 Vaccine on 10Feb2021. She said everything was fine after she received her COVID-19 Vaccine. She didn't even have a mark on her arm where she received the COVID-19 Vaccine. The patient reported that she got the first dose of the COVID-19 vaccine on 10Feb2021 and is due to the second dose on 03Mar2021. Approximately 2 and half days later she got an eczema flare that was quite severe out of the blue since she was having eczema diagnosed since she was 67 (as reported; she is 69 today). She still has some itching and burning and she wondered if this was something that has been reported also for other psoriasis/eczema patients. She was concerned about taking the second dose since she thinks this may be caused by the vaccine as she stated that nothing has changed in her life aside the vaccination. The patient reported she takes tacrolimus for the treatment of her eczema. Also she said that she had some joint pain for a couple of days. She said 2-1/2 days later (Friday, 12Feb2021), out of the blue, she had an eczema flare up. She said she was diagnosed with eczema at 67 years old. She said Friday night (12Feb2021) into Saturday (13Feb2021) her left anterior chest was burning and itchy. She clarified her skin was really red and angry looking, and painful. She said she has not had any pain with her eczema in a long time. She said she took topical ointments and medication for the eczema flare up. She said she was surprised at the intensity of her eczema flare up. She clarified her initial diagnosis for eczema was on her left anterior chest and bra strap area, and arms. She said she has never had eczema on her face or any other part of her body. She said she was totally asymptomatic prior to getting her first COVID-19 Vaccine. She said on early Friday evening (12Feb2021) she ended up with joint pain that was so bad, she thought she was going to die. She said her wrist, elbows, fingers, hips, knees, every joint down to her ankles, hurt. She said she had a headache. She said by Sunday (14Feb2021) her joint pain and headache were gone. She said her symptoms went away so quickly. The patient asked if people reported a flare up with psoriasis or eczema after getting the COVID-19 Vaccine and if should she have any concerns about getting the second COVID-19 Vaccine shot on 03Mar2021. The patient her eczema treatment included a combination of oral and topical medications. She clarified she used more of the prescription topical lotion than the over-the-counter oral medications. She received Famotidine 10mg (clarified as Pepcid AC; NDC Number: 11673-031-65, Lot Number: OFE2821, Expiration Date: Feb2022). Her doctor told her she could take up to 20mg of Famotidine if her symptoms were bad. She said on Friday (12Feb2021) and Saturday (13Feb2021) she took 20mg of the Famotidine until she felt her symptoms were under control. The patient also received cetirizine 10 mg (reported as generic Zyrtec; NDC Number: 11673-502-87, Lot Number: 8ME2877A, Expiration Date: Sep2022). The patient reported that she took 20mg of the generic Zyrtec for the itching. She said her doctor told her she can take up to 20mg of the generic Zyrtec, if needed for itching. She said otherwise, she would normally take 10mg generic Zyrtec, as needed. The patient also received Tacrolimus Ointment 0.1% (Protopic Ointment; NDC Number: 0168-0416-30, Lot Number: JZ8459, Expiration Date: Apr2021), applied to affected areas twice a day and Triamcinolone Acetonide Cream, 0.1% (she stated she refers to it as "TAC" Cream; NDC Number: 67877-251-80, Lot Number: Y064, Expiration Date: Oct2022). The patient reported that she uses the "TAC" Cream under her breasts where her bra sits because the "TAC" Cream is less expensive than the Tacrolimus Ointment 0.1%. She said she uses the "TAC" Cream as needed, and the "TAC" Cream keeps her skin hydrated. She said she used the Protopic Ointment (Tacrolimus Ointment 0.1%) on Friday (12Feb2021), and then switched to the "TAC" Cream. The patient has had no itching or pain since early Monday (15Feb2021). Her joint pain and headache treatment included Advil Liquid Gel 200mg (UPC Number: 305730169080, Lot Number: 56264, Expiration Date: Jun2023). She said she took a couple Advil Liquid Gels on Friday (12Feb2021). The patient reported that she switched from Tylenol to Motrin because the Motrin worked well. She clarified she meant Ibuprofen when she said Motrin. She said she calls everything Motrin when she is referring to Ibuprofen. She said she took Tylenol occasionally and never felt the Tylenol worked. She said she hasn't taken Tylenol in a long time. She said Tylenol didn't work as well as the NSAIDs. She did not have the Tylenol NDC, Lot, and Expiration Date. The patient reported that she takes Bufferin Brand Aspirin normally for pain. She said she sees someone who treats her holistically, and that person recommended the Bufferin Aspirin because it was not as damaging to the body. She said since the Bufferin Aspirin takes longer to work, she took the Advil Liquid Gel for faster pain relief. No further details provided. The events eczema flare up, skin burning sensation, skin red, skin pain, joint pain, and headache were reported as serious - medically significant. The patient reported that she felt her symptoms were medically significant because her eczema flare up was so different from what she has ever experienced before. She said nothing had changed in her routine, and she has been in control of her eczema. She said she has had only very minor eczema flare ups. The events did not require a visit to emergency room and to physician office. The outcome of the events eczema flare up and skin red was recovering. The outcome of the events headache and joint pain was recovered on 14Feb2021. The outcome of the events skin burning sensation, skin pain, and itchy skin was recovered on 15Feb2021. The events eczema flare up, skin burning sensation, itchy skin, skin red, skin pain, joint pain, and headache were assessed by the (patient) as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported 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 ide

Other Meds:

Current Illness: Eczema

ID: 1068270
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date: 02/06/2021
Rec V Date: 03/03/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Suffered a stroke 4 days later 06Feb2021; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 02Feb2021 at 14:45 (at the age of 71-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient suffered a stroke 4 days later 06Feb2021 after vaccination. The event resulted in an emergency room/department visit and hospitalization in Feb2021 for 3 days. Treatment for the event stroke included medication and therapy. The outcome of the event stroke was recovering. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1068271
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/03/2021
Hospital: Y

Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:below100 Fahrenheit; Comments: her fever was below 100 F

Allergies:

Symptoms: Anaphylactic response to Covid vaccine; stopped breathing; fever; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sales representative. An adult female patient of unspecified age (reported as mid-twenties) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included allergy to steroids. The patient's concomitant medications were not reported. The patient previously took propylene glycol and the patient was allergic to propylene glycol. On an unspecified date, the patient had an anaphylactic response to Covid vaccine. The patient stopped breathing. She was treated with epinephrine and transported to the hospital. The patient received other fluids and was and was released a day later when her fever was below 100F. The patient had similar allergy to steroids and did not connect that she was allergic to propylene glycol. It was reported that the events took place after use of the vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1068272
Sex: F
Age:
State: NC

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

Lab Data:

Allergies:

Symptoms: posterior vitreous detachment of left eye; This is a spontaneous report from a contactable pharmacist. A 44-year-old female pharmacist reported for herself that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9261), via an unspecified route of administration left arm single dose on an unspecified date for covid-19 immunisation. Medical history included Crohn's disease, drug hypersensitivity to NSAIDs. Concomitant medication included certolizumab pegol (CIMZIA). The patient experienced posterior vitreous detachment of left eye on 11Feb2021. Laser treatment was used to repair. The outcome was not recovered.

Other Meds: CIMZIA

Current Illness:

ID: 1068273
Sex: M
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 03/03/2021
Hospital: Y

Lab Data: Test Name: Height; Result Unstructured Data: Test Result:He shrunk, he is 5'11.75; Test Name: hemoglobin; Result Unstructured Data: Test Result:has been going up and down

Allergies:

Symptoms: artery had been nicked and they went in and fixed that; lower right abdominal area was swollen and he was in a lot of pain; lower right abdominal area was swollen and he was in a lot of pain; he had a hernia removed; his hemoglobin has been going up and down; He shrunk, he is 5'11.75; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 78-year-old male patient received the first dose of 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 just recently had surgery he had a hernia removed and a week after that; he had the operation done arthroscopically and a week after that; the lower right abdominal area was swollen and he was in a lot of pain and he ended up going to the hospital and they admitted him in the ER and they gave him some Morphine and hooked up to all kinds of stuff and eventually they found out that an artery had been nicked and they went in and fixed that and his hemoglobin has been going up and down. At any rate he had surgery again and they cleaned out all of that blood and they didn't find any more leaks but the patient's wife was wondering if it would be okay to have the booster for the COVID vaccine on 18Feb2021 (Thursday). The patient's wife confirmed that all of this happened since him having the first dose of the vaccine, but it was not related. The patient's wife also reported that the patient's height shrunk, and he was 5'11.75". The outcome of artery had been nicked was recovered, and unknown for the rest of the events. Information on the lot/batch number has been requested.; Sender's Comments: There is no reasonable possibility that the reported events were related to BNT162b2. These are more likely associated with the surgical condition and post surgical complications.

Other Meds:

Current Illness:

ID: 1068274
Sex: F
Age:
State: SC

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: face and jawline went absolutely numb; Headache; Swelling arm; This is a spontaneous report from a contactable consumer reported for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 16Feb2021 10:15 (at the age of 67-year-old) from lot # EN6200 at single dose for COVID-19 immunization via intramuscular route at the left arm. The caller stated she had a half an hour of sitting afterwards and then they let her go. Concomitant medications included loratadine (CLARITIN) for sinusitis and insulin for Type 2 diabetes mellitus. Relevant medical history included type 2 diabetic (Diagnosed about 17 years ago), allergic to some food, allergic to sulfa, she had a number of allergies and she had an anaphylactic reactions in the past, asthma diagnosed around the age of 40, sinuses, high blood pressure after a D&C, she had a miscarriage, uterine dilation and curettage, one headache before this in her entire life. The patient had received Flu vaccine on unknown date. The patient, on 16Feb2021 had headache that lasted for 5 minutes. It was right after the first shot of the Pfizer COVID-19 vaccine, her face went numb and she couldn't breathe through her nose. She was only able to breathe through her mouth. Her jaw got really numb. It happened when she was driving home from the vaccination center and she had to pull over because she might go into an accident. She wasn't sure if she was having a stroke or not but she was scared since her sister had histories of multiple strokes. She wanted to know Pfizer's recommendations for the second dose considering her adverse events. He had a really short headache tonight, He stated "it hit me out of the blue right in my temporal; I got on the floor it was so bad. 5 minutes after I left my face went totally numb" She stated she also had the second headache she had ever had in her entire life. She also mentioned she had some swelling in her arm but she didn't think that was unusual. She clarified as she was driving home after receiving her shot, her entire face went numb and her jawline went numb. It scared her so bad. She thought she was having a stroke or something. She confirmed she recovered completely from this, the numbness cleared up in 10 minutes. The Outcome of the event swelling arm was unknown while the outcome of the other events was recovered on 16Feb2021.

Other Meds: CLARITIN [LORATADINE]; INSULIN

Current Illness:

ID: 1068275
Sex: F
Age:
State: PA

Vax Date: 02/10/2021
Onset Date: 02/01/2021
Rec V Date: 03/03/2021
Hospital: Y

Lab Data: Test Date: 202102; Test Name: Lab test; Result Unstructured Data: Test Result:Unknown results; Test Date: 202102; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever

Allergies:

Symptoms: I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; Unable to eat, loss of appetite.; Not feeling too well; very sick; can hardly move; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9069), via an unspecified route of administration at single dose on 10Feb2021 for covid-19 immunisation. Medical history included diabetes, thyroid removed. Concomitant medication included influenza vaccine, metformin, levothyroxine, ferrous sulfate, atorvastatin. The patient stated that experienced: I got fever, I got diarrhea. I got body ache, headache, unable to eat, loss of appetite, not feeling too well, very sick, can hardly move , all on an unspecified date in Feb2021 with outcome of unknown. The patient was hospitalized for these events from Feb2021 to an unknown date. The patient underwent lab tests and procedures which included investigation: unknown results in Feb2021.

Other Meds: INFLUENZA VACCINE; METFORMIN; LEVOTHYROXINE; FERROUS SULFATE; ATORVASTATIN

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm