VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 0971279
Sex: F
Age: 42
State: CA

Vax Date: 01/15/2021
Onset Date: 01/24/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies: Neomycin Had a reaction about 5 years ago to this when having some type of eye infection. Maybe pink eye.

Symptoms: 8 days later red circle around the site of the shot. Minor puffiness. Looked better next morning

Other Meds: N/A

Current Illness: N/A

ID: 0971280
Sex: F
Age:
State:

Vax Date: 12/15/2020
Onset Date: 12/23/2020
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 20201223; Test Name: Pain; Result Unstructured Data: Test Result:pain from 8 to 5; Comments: headaches pain from 8 to 5; Test Date: 20201231; Test Name: Pain; Result Unstructured Data: Test Result:left neck pain 10/10; Test Date: 20210113; Test Name: Pain; Result Unstructured Data: Test Result:10/10 left arm pain

Allergies:

Symptoms: left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left jaw; face swelling including eyes; left ear and teeth pain; left ear and teeth pain; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; numbness/swelling to left side of face/some numbness and tingling intermittent left arm; numbness/swelling to left side of face; some numbness and tingling intermittent left arm; Left neck stiffnes and pain; Left neck stiffnes and pain; Left arm pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Dec2020 15:45 at left arm, at single dose for covid-19 immunization. Medical history included facial paralysis from 2010, ongoing chronic migraine, Known allergies was None. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen; paracetamol (TYLENOL); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient was not pregnant at the time of vaccination. The patient experienced left arm pain day of vaccine lasting through the week from 23Dec2020 06:00. Headache everyday after. On 28Dec2020 the patient noted numbness/swelling to left side of face, some numbness and tingling intermittent left arm. Left neck stiffness and pain. On 31Dec2020 increased left neck pain 10/10 and noted drooping of right side of face at mouth, left ear and teeth pain. On 02Jan2021 face swelling including eyes, increase ear and teeth pain including left jaw. Headache and neck pain continued. On 05Jan2021 Virtual visit with NNP started AbX and steroids (possible bells palsy flair up) and dentist visit no issues with teeth. On 08Jan2021 neurology visit diagnosed with bells palsy reoccurrence related to vaccine. Throughout the week increased numbness, tingling, and pain to left arm. With intermittent sciatic type pain to left leg. her whole left side had felt different since the vaccine. Constant left arm numbness, tingling, and pain since 09Jan2021. Minimal relief from headaches pain from 8 to 5. On 13Jan2021 10/10 left arm pain, sharp, stabbing, weak, painful to move. Treatment Steroids, pain meds, and MRI scheduled were received. All events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event headache was recovering, the outcome of the other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association, the facial paralysis recurrence is possibly related to suspect BNT162b2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: ZYRTEC; IBUPROFEN; TYLENOL; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYR

Current Illness: Chronic migraine

ID: 0971281
Sex: F
Age: 65
State: OK

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: On Friday, January 22, I opted to stop by LabCorp for a Covid antibody test. The results were negative.

Allergies: Demerol Meloxicam Crestor

Symptoms: 1. swelling, redness, heat, itching at injection site. Lasting 10 days. Peak discomfort at day 8. Hard lump, hot to touch, red, strong itch. Was 3 inches by two inches. The arm is now back to normal. .2. Day 8. Woke at roughly midnight with extreme heat and burning in all toes. Quite painful. Very unusual, as I have never experienced anything like this before. When pain and burning became overwhelming I took Tylenol. It helped and I was able to sleep. The next morning the pain and burning were gone but my toes were, and continue to be quite numb, as is the area of my feet that surrounds my toes. I can't fully feel my socks, shoes, sheets, etc. It feel like I have cotton stuffed in my shoes. It is hard for me to related the level of heat, burning and pain that happened. I felt like I could melt a block of ice with my feet. It was severe. I marked "disability or permanent damage" below because I don't know if the nerves in my feet will return to normal.

Other Meds: Metformin Losartan pravastatin CoQ10 Quercetin Melatonin Levothyroxine Liothyronine

Current Illness: none

ID: 0971282
Sex: F
Age:
State: HI

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: MRI scanner; Result Unstructured Data: Test Result:Unknown result; Test Date: 202101; Test Name: Weight; Result Unstructured Data: Test Result:175-180 lbs

Allergies:

Symptoms: significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness; muscle weakness/lower leg feel shaky and weak and tingly; depersonalization; shakey/lower leg feel shaky and weak and tingly; mild nausea; arm pain; The caller would touch her hand but couldn't feel her hands, it was like they weren't hers; lower leg feel shaky and weak and tingly; hand on that same side was painful, but not unbearable, just uncomfortable; emotional; tearful; felt completely overwhelmed; This is a spontaneous report from a contactable consumer. A 56-Year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 12Jan2021 about 9:15am at single dose for COVID-19 immunization. Vaccination facility type was hospital. Medical history and concomitant drugs were not reported. Weight: 175-180 lbs. No additional vaccines administered on same date of the Pfizer suspect vaccine. No prior vaccinations within 4 weeks. Past drug included rivaroxaban (XARELTO) been using the product more than 10 years and never had a problem with it, she didn't think that was related to her experience. Patient received first vaccine yesterday 12Jan2021. 45 minutes after receiving vaccine (12Jan2021 10 AM), she developed hot flashes in sternum (flushing sensation in her sternum or upper chest area. It was like when she had a dye injected), anxiety, dizziness/ light headedness, muscle weakness, significant dissociation, depersonalization, shakey, mild nausea, arm pain. The patient explained that this was why she was in the MRI scanner (Jan2021). This came a couple of times yesterday and had not been experienced this today (13Jan2021). It (dizziness) was ongoing and sporadic and had happened couple times yesterday and today. There were a few hours yesterday 12Jan2021 where she felt like herself but then it all started again last night. The patient reported feeling disassociated from her body, this was within about 20 minutes of the flushing and went in and out of being more or less alarming. She stated she felt disconnecting from where she was and space she was in, mentally. She knew where she was but could feel no connection to where she was or her body. The patient would touch her hand but couldn't feel her hands, it was like they weren't hers. This was during the half hour of the events occurring. She had mild nausea, this started not long after the flushing and it came and went a little bit but it was not too troublesome. The patient felt disconnect from her body and had shakiness like her lower leg feel shaky and weak and tingly. This happened on and off since the episodes started. The patient reported she slept great and had a few hours yesterday where she felt good. Her arm was tender, this might have been yesterday but she thought it was this morning and was only tender to touch. The hand on that same side was painful, but not unbearable, just uncomfortable. The patient apologized for being emotional and tearful. She felt completely overwhelmed. She couldn't believe that she put herself in this position and she was perfectly fine before the shot. She did contact her doctor. No AE required a visit to emergency room/ physician office. There had been no treatment, she didn't know what to do. She remarked she was not going back for the second dose. Outcome of event dizziness was not recovered, and the rest of events was unknown.

Other Meds:

Current Illness:

ID: 0971283
Sex: M
Age:
State: TX

Vax Date: 12/15/2020
Onset Date: 12/01/2020
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: Covid PCR; Test Result: Negative ; Test Date: 202012; Test Name: rapid covid test; Test Result: Negative

Allergies:

Symptoms: everything was muffled and he had constant ringing in the ears; This is a spontaneous report from a contactable nurse (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left deltoid on 15Dec2020 at single dose as his first dose, via an unspecified route of administration at left deltoid on 06Jan2021 at single dose as his second dose for COVID-19 immunization. Medical history reported as none. There included unspecified medications and stopped several of them a week ago on 05Jan2021. The patient was having a side effect that popped up out of the middle of nowhere, and he went through his meds, and he wanted to see if anyone else was having these issues. The patient was having ringing in both ears that happened late Dec2020, and in the beginning of Jan2021, and he had both rounds, he was an RN (registered nurse) at a hospital, and the ringing had gotten louder, and the only thing, medication, drug, that he took PO, over the counter, the only thing that correlates was it happened after both vaccines, later clarified as COVID vaccines. Right before the second dose, it was really really loud, and then he got the second dose, and over the last 1.5 weeks, the ringing has gotten worse in both ears, so he called his primary care, who referred him to ENT (ear, nose and throat), and he saw ENT, and to look in the ear, he said it was the nerve, he didn't know what triggered it in both ears, he said it was usually only in one ear if it's a viral thing, so it's uncommon in both ears, and the doctor asked if he was on medication, and the caller stopped several of them a week ago on 05Jan2021, that would cause it, but it had gotten worse. The patient didn't know etiology or how the vaccine worked, but he tested for COVID and it was negative, and his doctor was asking him if he experienced this any other time, told him to stop medications, and it's gotten worse, asked him if he was on any recreational drugs, he was on no new meds, he was a nurse, and works in ICU, and basically didn't know where it come from, but suddenly, everything was muffled and he had constant ringing in the ears. COVID test was about 2 weeks ago, the rapid was negative, then the PCR was negative. The outcome of event was recovering.

Other Meds:

Current Illness:

ID: 0971284
Sex: U
Age:
State: CA

Vax Date: 06/29/1979
Onset Date: 01/21/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: had chills, non stop shaking for 2 hours, very disturbing. Vomiting, fever, chills with headache.

Other Meds:

Current Illness:

ID: 0971285
Sex: F
Age:
State: MN

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

Lab Data:

Allergies:

Symptoms: Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and unknown if there is any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and unknown if the patient had been tested for COVID-19 since the vaccination. On Jan2021, the patient experienced faint, shaking, febrile for around 36 hours, rigors, and light-headed. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0971286
Sex: F
Age:
State: IL

Vax Date: 01/07/2021
Onset Date: 01/01/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds:

Current Illness: Diabetic (Additional Information for Other Conditions: Diagnosed about 6 years ago.); Hyperthyroidism (Additional Information for Other Conditions: Diagnosed about 6 years ago.)

ID: 0971287
Sex: F
Age:
State: TN

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 20201229; Test Name: Potassium; Result Unstructured Data: Test Result:Low; Test Name: Blood pressure; Result Unstructured Data: Test Result:Improved; Test Date: 20201229; Test Name: Blood pressure; Result Unstructured Data: Test Result:158/86; Test Date: 20201229; Test Name: Blood pressure; Result Unstructured Data: Test Result:165/95; Test Date: 20201229; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/90; Test Date: 20210101; Test Name: Blood pressure; Result Unstructured Data: Test Result:Elevated; Test Date: 20201228; Test Name: temperature; Result Unstructured Data: Test Result:99.1 degree Fahrenheit; Test Date: 20210101; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Normal; Test Date: 20210101; Test Name: CAT scan; Result Unstructured Data: Test Result:Normal; Test Date: 20201229; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Date: 20210101; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Date: 20210108; Test Name: EKG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201229; Test Name: Heart rate; Result Unstructured Data: Test Result:83; Test Date: 20201229; Test Name: Heart rate; Result Unstructured Data: Test Result:73; Test Date: 20201229; Test Name: Heart rate; Result Unstructured Data: Test Result:77

Allergies:

Symptoms: forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most uncomfortable at this point; seemed like UTI symptoms were coming back; felt really wiped out and worn down/tired; anxiety; racing/ pounding in chest; potassium was a little low; elevated blood pressure; arm a little bit sore; 99.1 degrees Fahrenheit fever; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 28Dec2020 07:15 at single dose on deltoid left for COVID-19 immunisation. Medical history included hepatitis C which cleared in 2016, hysterectomy was done in 2004 or 2005, cyst removed from breast long ago, ongoing arthritis in left knee, urinary tract infection was treated in Nov2020. The patient's concomitant medications were not reported. She received the first vaccine on 28Dec2020. She did fine that day. She came home and laid down and rested. Her temperature went up to 99.1 degrees Fahrenheit but was resolved that same day/night. Early in the morning on 29Dec2020, around 3:30 a.m., she woke up and had a racing/pounding feeling in her chest. She took her blood pressure and it was 158/86, heart rate (HR) was 83. She felt really funny. She hadn't been diagnosed with high blood pressure before, so this was high for her. She took her blood pressure again about an hour later and it was 165/95, HR 73. She took it again about an hour later and her blood pressure read 180/98, HR 77. Her heart rate stayed in the normal range, but the force felt really strong. She did go to the emergency room around 5:00 am on 29Dec2020. She told them what she was experiencing and that she had received the COVID-19 vaccine. About the time she got to the hospital, her blood pressure was starting to come down. An EKG was done and they drew bloodwork. Her potassium came back a little low-they didn't tell her how low or what her level was. She was given 2 potassium tablets which did help. She confirms she doesn't have any NDC, Lot number or expiration date for the potassium she was given. It was given to her at the hospital. She was also given a sheet to monitor her salt intake, which she already does that. She confirmed she was not admitted into the hospital, she was discharged from the Emergency Room. She felt pretty good. She didn't go to work that Wednesday, 30Dec2020, but she went to work on Thursday, 31Dec2020. On 01Jan2021, the same thing happened to her again. She had elevated blood pressure, forceful beat. She went back to the ER early in the morning, around 5:00 am, on 01Jan2021. Her pulse stayed within normal range, but she had such a forceful beat. She informed them that she was really uncomfortable in her chest, the force was the most uncomfortable at this point. They wanted to make sure she wasn't have a stroke or heart attack, so they did their normal procedures to rule this out. They did 2 EKG's, 2 sets of labs, Chest X-ray, CAT scan and everything came back normal. She had a discussion with the physician that saw her about what she was experiencing and the physician was asking her about having anxiety. Caller explains she has never really had problems with anxiety before, but she can't say she hasn't had it. Being around COVID patients and getting the shot, sometimes anxiety can be there. The physician wanted her to try a low dose of Hydrochlorothiazide 12.5mg. She was to only to take a half dose by mouth, if her top number (systolic blood pressure) was between 140-160. Caller clarifies when she means half of a dose, the dose equals 12.5mg. She was instructed to take this 12.5mg dose until she saw her PCP. So, she did this and called her PCP and wasn't able to get an appointment to speak with a provider until the following Wednesday, 06Jan2021. She did a tele visit with her provider and let her know what had happened and that the half of the pill will only bring her top number (systolic blood pressure) to 130's-140's. Caller states she was used to her top number (systolic) being maybe in the 120's, low 130's. Her doctor increased her dose to 25mg. She was prescribed to take 25mg, tablet, by mouth, once a day. She confirmed she still checks her blood pressure before she takes the medicine. Caller verifies she has 2 bottles, one being the 12.5mg dose and the second being the 25mg dose. With the 12.5mg bottle, she sees refills and the date 05Jan2022. Caller clarifies both bottles are dispensed in pharmacy vials with no NDC, Lot number or expiry date. About a month prior to all of this and receiving the COVID-19 vaccine, clarified as Nov2020, she was treated for a UTI. During that time, her blood pressure went up a little and kind of bounced around a little bit, but came back down. Then, she got the COVID-19 shot. She initially felt fine but later on by the time she got a chance to do the tele visit with her PCP, she was telling her about her previous UTI, and the provider put her on Cipro because it seemed like her UTI symptoms were coming back. Caller verifies she doesn't have any NDC, Lot number or expiration for the Cipro. She already took of all of that. She went to the ER for the third time on 08Jan2021 because she again felt the forceful beat feeling in her chest. She explained she felt really wiped out and worn down and she was tired. An EKG was done and they did labs. She confirms she doesn't have any results with her at this time. She was taken off of work for a couple of weeks. She is currently getting in contact with a Cardiologist to make sure everything is alright. The cardiologist wants her to have a stress test. The caller states so this is where she is now. She is taking blood pressure medicine and getting set up to do a stress test. Sore arm outcome: Caller confirms she recovered from the arm soreness within that same day. Her arm didn't stay sore long at all. Racing/pounding in chest: This had improved. It's not like it was. She still has it a little bit of it now, but she is going to see her cardiologist and do a stress test. The blood pressure medicine has helped some. Elevated blood pressure: Today her blood pressure top number got to 161 and she had to take medication but her blood pressure has improved. Outcome of elevated blood pressure, racing/ pounding in chest was resolving; outcome of forceful beat feeling in her chest, UTI, potassium was a little low, felt really wiped out and worn down/tired, anxiety was unknown; outcome of arm a little bit sore, 99.1 degrees Fahrenheit fever was resolved on 28Dec2020.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness: Knee arthritis

ID: 0971288
Sex: F
Age:
State: MI

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 20210113; Test Name: Potassium; Result Unstructured Data: Test Result:3; Comments: low; Test Date: 20210113; Test Name: blood pressure; Result Unstructured Data: Test Result:170/113; Comments: went up; Test Date: 202101; Test Name: blood pressure; Result Unstructured Data: Test Result:111/82; Comments: as when she left the ER this morning, blood pressure was 111/82; Test Date: 20210112; Test Name: temperature; Result Unstructured Data: Test Result:102; Test Date: 20210113; Test Name: temperature; Result Unstructured Data: Test Result:103.6; Comments: in the morning around 4:30 or 5 am, woke up with a pool of sweat and temp 103.6; Test Date: 20210113; Test Name: temperature; Result Unstructured Data: Test Result:103; Comments: took Motrin and had a cold shower; Test Date: 20210113; Test Name: temperature; Result Unstructured Data: Test Result:102.6; Comments: after like 10-15 minutes of her laying on the couch with ice packs on her arms and stuff, it went down to 102.6; Test Date: 202101; Test Name: temperature; Result Unstructured Data: Test Result:98; Comments: as when she left the ER this morning, her temperature was 98; Test Date: 20210113; Test Name: EKG; Result Unstructured Data: Test Result:Sinus Tachycardia; Test Date: 20210113; Test Name: heart rate; Result Unstructured Data: Test Result:176; Test Date: 20210113; Test Name: heart rate; Result Unstructured Data: Test Result:156; Comments: she went to the hospital, and when they took her heart rate, it was 156; Test Date: 202101; Test Name: heart rate; Result Unstructured Data: Test Result:96; Comments: as when she left the ER this morning, her heart rate was 96.

Allergies:

Symptoms: Heart Palpitations; Sinus tachycardia; high blood pressure; fever; woke up in a pool of sweat; headache; ringing in her ears; Potassium was a little low, it was 3; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EK9231, expiration date Apr2021) intramuscularly on 12Jan2021 (between 8:30 to 9 am) at left deltoid for Covid-19 prevention. The first dose was received on Wednesday (unspecified date). Patient had no medical history and had no concomitant medications. At night of 12Jan2021, the patient had a fever of 102, but she went to bed with it and she woke up in the morning around 4:30 or 5 am (13Jan2021) in a pool of sweat, so she took her temperature and she was fever with 103.6. Patient took Motrin (Store Brand, lot number as either: 0GE2417A or OGE2417A, expiry: Apr2022) three 200 mg tablets, for a totally of 600 mg for the fever and had a cold shower, and the temperature came down to 103. Then after like 10-15 minutes of her laying on the couch with ice packs on her arms and stuff, it went down to 102.6. Patient was not going to go to the ER for just the fever, but then she started having heart palpitations, and she took her blood pressure and it was 170/113 and her heart rate was 176. Patient went to the hospital, and when they took her heart rate, it was 156. She had her blood taken at the hospital and everything was normal, except that her Potassium was a little low, it was 3. The ER did an EKG that showed Sinus Tachycardia and she was given IV Fluids (two boluses of 0.9% Normal Saline, 2000 mL total via IV, a bag of Potassium IV, two oral tablets of Potassium, unspecified total dose), and everything went back down. She had to call out from work that day and planed to follow up with her Primary Care Physician (PCP) in a couple of days. Patient was no longer had the fever, high blood pressure or high heart rate, as when she left the ER this morning, her temperature was 98, blood pressure was 111/82, and her heart rate was 96. She felt good now, but she did not know if it could happen again. Patient thought that it was maybe just her immune response to the vaccine, so she would say that she has recovered probably close to completely. Patient also had a headache and ringing in her ears, and those had resolved by now as well. The events Fever, Sinus tachycardia, Heart Palpitations, high blood pressure resolved on 13Jan2021 and other event resolved in Jan2021. The patient stated that the events (Fever, Sinus tachycardia, Heart Palpitations, high blood pressure) could have been serious with her blood pressure being so high, but it was not so serious because she did the right thing and went to the ER for treatment and got fluids. She believes the events (Fever, Sinus tachycardia, Heart Palpitations, high blood pressure) are medically significant. The patient believes that the events she experienced were directly caused by her receiving the vaccine, as she has never had these symptoms before other than she of course has had fevers in her life in the past.; Sender's Comments: A possible contribution role of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) to the onset of the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0971319
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 01/15/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Absolute neutrophil, 15-Jan-2021, 673 cells per microlitre

Allergies:

Symptoms: [Moderna COVID-19 vaccine] treatment under Emergency Use Authorization(EUA): Moderna COVID-19 Vaccine Lot #039K20A; 70 yo physician with known normal blood counts prior and with no underlying medical conditions 17 days post first dose of vaccine noted to have leukopenia (WBC 3.4) and neutropenia (PMN 673). Also noted to have decreased HRV coincident. Simultaneous routine COVID PCR testing negative. Otherwise asymptomatic. Follow up CBC will be performed. All other hematologic and comprehensive metabolic profile values WNL

Other Meds:

Current Illness:

ID: 0971320
Sex: F
Age:
State:

Vax Date: 12/18/2020
Onset Date: 01/18/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies: no known drug allergies

Symptoms: [Pfizer Covid-19 vaccine] treatment under Emergency Use Authorization(EUA):received the Pzifer COVID vaccine on 12/18/20 at 10:50. I began experiencing numbness and tingling from my knees to my toes 40 minutes following the vaccine in both legs. I am still experiencing tingling and numbness in my legs at times.

Other Meds:

Current Illness:

ID: 0971321
Sex: F
Age:
State: MA

Vax Date:
Onset Date: 01/20/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Received 2nd dose of Shingrix on 1/19/2021. No side effects from first dose. Woke in middle of the night nauseous, very dizzy, headache, vomited. Next day experienced continued headache, tiredness, muscle pain, and shivering. Did not need medical assistance.

Other Meds:

Current Illness:

ID: 0971322
Sex: U
Age:
State:

Vax Date:
Onset Date: 01/08/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: [Covid-19 vaccine] treatment under Emergency Use Authorization(EUA): drew 9 doses out of 1 vial

Other Meds:

Current Illness:

ID: 0971331
Sex: F
Age: 40
State: KY

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies: Z pack

Symptoms: Moderna COVID-19 vaccine EUA Red, hard bump/knot raised , circle form , Warm to touch Lasts about 3 days

Other Meds: Phentermine, loraxepam ,escitalopram

Current Illness: n/a

ID: 0971332
Sex: F
Age: 28
State: MO

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies: Eggs

Symptoms: 13:21 -vaccine administered 13:40-c/o HA, nausea, dizziness, "hot, sweaty," diaphoretic HR116 BP 135/80 13:45-HR 107 BP 126/74 with worsening HA, persistent nausea.

Other Meds: bupropion, adderal, ativan, fiber

Current Illness:

ID: 0971342
Sex: F
Age: 76
State: NY

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data: None

Allergies: N/A

Symptoms: Vaccine administered > 6hrs after the beyond use time

Other Meds: None

Current Illness: None

ID: 0971352
Sex: U
Age: 90
State: NY

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data: None

Allergies: none

Symptoms: Vaccine administered > 6 hrs after the beyond use time.

Other Meds: N/A

Current Illness: None

ID: 0971521
Sex: U
Age: 4
State: IL

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: temperature excursion; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-DEC-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), lot# T021638, expiry date was reported as 21-FEB-2021, but upon internal validation established as 21-DEC-2021 (formulation, strength, dose, dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -13.3 degrees Celsius for 4 hours 15 minutes. There were no previous excursions related. Data logger was involved.

Other Meds:

Current Illness:

ID: 0971522
Sex: U
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: Caller informed the administration of improperly stored ROTATEQ.; No additional AE/PQC reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender (caller unable to provide patient and administration date information). Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided. On an unknown date, the patient was vaccinated with an improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (unknown dosage regimen) orally, lot # S017642 with expiration date 28-FEB-2021, administered as prophylaxis. The improperly stored dose of the suspect vaccine experienced a temperature excursion of 31 degree farenheit (?F) for 1 hour on 16-SEP-2020; a previous temperature excursion was reported of 47.7 ?F, for 9 hours This case was classified as non-valid due to no patient identifiers.

Other Meds:

Current Illness:

ID: 0971523
Sex: F
Age: 56
State: TX

Vax Date: 05/20/2014
Onset Date: 05/20/2014
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severe allergic reaction to it/and went into anaphylactic shock/started choking; severe allergic reaction to it/her arm swelled up; This spontaneous report was received from a 56 years old female patient, who was referring to herself. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. It was reported that she did not have any drug reactions or allergies in her life. On 20-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) lot # J014566, expiration date was not reported but upon internal validation process it was established as 18-FEB-2015 (formulation, dose, route of administration and anatomical location were not reported) for prophylaxis. On the same date, the patient experienced severe allergic reaction to zoster vaccine live (ZOSTAVAX). Her arm swelled up, she started choking, and went into anaphylactic shock. She was sent to an emergency room (ER) and they were waiting. They "pumped her with shot after shot", it was really bad, and finally was able to pull out. They told her if she received another vaccine they may not be able to save her. No laboratory diagnostics or studies were performed. She did not take any vaccines since then. The outcome of the events was reported as recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of anaphylactic shock was determined to be medically significant.

Other Meds:

Current Illness:

ID: 0971524
Sex: F
Age:
State: PA

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

Lab Data: Test Name: spine MRI; Test Result: Negative

Allergies:

Symptoms: vasculitic neuropathy / vasculitic neuropathy is a rare subtype of immune-mediated neuropathy; weakness / acute onset lower extremity weakness; distal symmetric axonopathy due to vasculitic neuropathy; This literature marketed report has been received from the authors of a published literature article and refers to a 60-year-old, female (reported as a woman) patient. She was healthy, non-diabetic. Her medical history, concomitant medications, previous drugs or allergies were not provided. Several autoimmune disorders have been linked to vaccination. One that stood out was Guillain-Barre syndrome (GBS) following "influenza vaccine" (unspecified). Molecular mimicry was a proposed mechanism. As opposed to GBS, the vasculitic neuropathy was a rare subtype of immune-mediated neuropathy. It might or might not have been associated with systemic vasculitis. The most common phenotype was multifocal neuropathy known as mononeuritis multiplex. To the best of knowledge, distal symmetric axonopathy due to vasculitic neuropathy has not been described following pneumococcal vaccination. On an unknown date, previously healthy, non-diabetic woman developed purpuric rash 3 days after she received a Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dose, strength, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The rash was biopsied showing vasculopathy. For persistent eosinophilia, that was noted after vaccination, she underwent bone marrow biopsy without any evidence of malignancy. On an unspecified date, she developed acute onset lower extremity weakness worse in distal muscles. She became non-ambulatory prompting her admission to neurology service. Cerebrospinal fluid was normal, spine magnetic resonance imaging scans (MRI) were negative. Nerve Conduction Studies (NCSs) and Electromyography (EMG) revealed acute axonal neuropathy (also reported as distal symmetric axonal neuropathy). She was treated with intravenous (IV) immunoglobulin G (Ig) for possible axonal GBS without any improvement. On an unknown date, a radial sensory nerve biopsy was undertaken showing perivascular lymphocytes in the epineurial connective tissue. Rheumatology was consulted and confirmed the diagnosis of eosinophilic granulomatosis with polyangiitis. The patient was treated with high dose corticosteroids (unspecified), cyclophosphamide followed by azathioprine. The outcome of the events was not reported (unknown). Vasculitic neuropathy was a rare entity. When it occurred, the typical presentation was multifocal neuropathy. This case described the unique case of vasculitic neuropathy, that developed in the setting of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) vaccination and presented as a distal symmetric axonal neuropathy causing weakness. The causality between the suspect vaccine and the events was assessed by the authors to be related. Upon internal review, the event immune-mediated neuropathy was determined to be medically significant.

Other Meds:

Current Illness: Routine health maintenance

ID: 0971525
Sex: F
Age: 17
State: KS

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Arm soreness; Concerned about her age at the time of vaccination; A spontaneous report was received from a nurse concerning a 17-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced arm soreness. This also resulted in the event, recipient of the vaccine who was younger than 18 years old. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient began to experience arm soreness, but no other symptoms, for 1-2 days. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event recipient of vaccine who was younger than 18 years old, was considered resolved on 30 Dec 2020. The outcome of the event arm soreness was resolved on an unknown date. The reporter did not provide an assessment for the events.; Reporter's Comments: This report refers to a case of 17- year-old female patient who experienced non-serious unexpected event of recipient of the vaccine was younger than 18 years old (product administered to patient of inappropriate age) for mRNA-1273, lot # unknown, Exp date-unknown. The patient experienced arm soreness, with no other associated adverse events. Based on temporal association and the known safety profile for the vaccine, a causal association with the event of arm soreness cannot be excluded.

Other Meds:

Current Illness:

ID: 0971526
Sex: F
Age: 84
State: FL

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: It all went down her arm; A spontaneous report was received from a consumer concerning an 84-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and the vaccine appeared to leak back out of her arm and it went all down her arm and 5 drips drained. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12-Jan-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection. Patient's daughter-in-law reported that patient received the Moderna vaccine on 12-Jan-2021 at a carside vaccination clinic. She stated that after the vaccine was administered by injection to her right arm, it appeared to leak back out of her arm. She said it all went down her arm and five drops drained. Patient was reportedly handed a paper towel to wipe up the fluid. Caller reported wondering if her mother (the patient) received the full dose of the vaccine. The patient had not had any symptoms or adverse events following vaccine administration. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event the vaccine appeared to leak back out of her arm and it went all down her arm and 5 drips drained, was considered resolved. The reporter did not provide an assessment for the event.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 0971527
Sex: F
Age:
State: PA

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; his arm remains very tender to touch; Lost sleep due to pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EJ1686, expiry date unknown) intramuscular at the left arm on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included COVID-19 prior to vaccination; HTN, High cholesterol, and Asthma, all from an unknown date. The patient is not pregnant. Concomitant medications included ASA, carvedilol, ferrous sulfate, losartan potassium, magnesium, rosuvastatin, calcium carbonate, colecalciferol (CALCIUM + VITAMIN D, pantoprazole sodium sesquihydrate (PROTONIX), budesonide, and formoterol fumarate (SYMBICORT). The patient had previous allergies with Zocor, Prolia, Evista, Daypro, Amlodipine, and Lisinopril. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Since the vaccination, the patient had not been tested for COVID-19. On 08Jan2021, 12:00 PM, the patient experienced 3in x 3in lump at the injection site, red in color and hot to touch. She lost sleep due to pain, his arm remains very tender to touch. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events vaccination site mass, vaccination site erythema, vaccination site warmth and vaccination site pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: ASA; CARVEDILOL; FERROUS SULFATE; LOSARTAN POTASSIUM; MAGNESIUM; ROSUVASTATIN; CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; SYMBICORT

Current Illness:

ID: 0971528
Sex: F
Age:
State:

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: injection she had a bruise like 1.5 inches long/ she had a knot as wide as a baseball now; injection she had a bruise like 1.5 inches long/ she had a knot as wide as a baseball now; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer-BioNTech COVID-19 Vaccine, lot/batch number and expiry date not reported), via an unspecified route of administration on 11Jan2021 at single dose, for Covid-19 immunisation. The patient's medical history concomitant medications were not reported. On 11Jan2021 she received the vaccine and within hours of that injection she had a bruise like 1.5 inches long and had not seen that anywhere in the material. She knew it could swell, but she had a knot as wide as a baseball now. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0971529
Sex: F
Age:
State: TN

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: suspect that it may be Bell's Palsy; tingling in the left side of her tongue; This is a spontaneous report from a contactable nurse. A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly at 0.3ml single injection in the left arm on 22Dec2020 09:00 for covid-19 prophylaxis. Medical history included persimmon fruit allergy from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced tingling in the left side of her tongue on 22Dec2020, the event was reported as serious per medically significant, suspect that it may be bell's palsy on an unspecified date. The adverse event was not required a visit to emergency room or physician office. Caller was an employee health nurse that reported that she had an employee that received the first dose Covid-19 vaccine on 22Dec2020 and as they were administering the vaccine, the patient developed tingling in the left side of her tongue. The caller said that the patient reported that the tingling was still there. She said that the patient was concerned that it might cause her to get bell's palsy. Caller wanted to know if this was this common and whether she could move forward with getting the 2nd dose of the vaccine. The caller said that the patient received the vaccine in her left arm. The caller said that the patient reported that the tingling in her tongue was mild and not stopping her from eating and she was not having any respiratory issues. Caller said that the only allergy that the patient has was to Persimmon fruit. The side effect mentioned is not necessarily Bell's palsy since the characteristic eye drooping is not present. The outcome of events for tingling in the left side of her tongue was not resolved, for suspect that it may be bell's palsy was unknown. Vaccination Facility Type was hospital. Vaccine Administered at Military Facility: No. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No relevant tests. Drug result was related.; Sender's Comments: The causality between the reported tingling in the left side of her tongue, which was suspected that it may be Bell's Palsy and the administration of COVID-19 vaccine, BNT162B2, cannot be denied, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 0971530
Sex: F
Age:
State: PA

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: temperature; Result Unstructured Data: Test Result:101.6 Fahrenheit; Comments: fever; Test Date: 20210112; Test Name: swab; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more than a normal vaccine; She had a fever then; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) at single dose at left deltoid for COVID-19 immunisation on 11Jan2021 at 4:30 pm. Relevant history included contraception. Family Medical History Relevant to AE(s) was none. Concomitant drug included ongoing ethinylestradiol, etonogestrel (NUVARING) for contraception for years. The patient experienced a headache, back ache, nausea and was almost passing out. She had the first dose of the vaccine on the 11Jan2021 at 4:30 PM and was in bed around 10:00 that night. She woke up at 5:00 AM on 12Jan2021 and didn't feel great, her arm was killing her more than a normal vaccine and she was nauseated at 5:30, which was not that horrible. She took some Tylenol. Then she got to work and around 9:00 she felt like she was going to get sick. She had horrendous nausea, chills, weakness, eye pain, headache/ head pain, and back pain. Her clothes hurt because the body aches were so bad. She felt like she was going to pass out, like a vasovagal. She went to urgent care because her manager didn't think it was side effect. She went and got swabbed (result unknown), whatever. She had a fever then. They told her it was a reaction to the vaccine. Her temperature was 101.6 degrees Fahrenheit when she went to Urgent care. She would say the fever started at 12:30PM on 12Jan2021. She did not know if fever would be ongoing because she was taking fever reducer and it was working. The events weakness, eye pain, head pain, and back pain were reported as serious since medically significant. The nausea was better around 2:00PM. The outcome of event nausea, Chills was and Weakness was resolved on 12Jan2021. The outcome of events eye pain, head pain, and back pain was resolving. The outcome of event 'her arm was killing her more than a normal vaccine' was recovering. The outcome of fever was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, weakness, eye pain, head pain, and back pain, and the administration the suspect vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds: NUVARING

Current Illness:

ID: 0971531
Sex: F
Age:
State: TN

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/25/2021
Hospital: Y

Lab Data: Test Name: BP; Result Unstructured Data: Test Result:96/58; Comments: patient's normal BP; Test Date: 20210108; Test Name: BP; Result Unstructured Data: Test Result:170/100; Test Name: Blood Works; Result Unstructured Data: Test Result:Unknown; Test Name: EKG; Result Unstructured Data: Test Result:Unknown; Test Name: Heart rate; Result Unstructured Data: Test Result:65; Comments: patient's normal heart rate; Test Date: 20210108; Test Name: Heart rate; Result Unstructured Data: Test Result:125; Test Name: heart and lung examination; Result Unstructured Data: Test Result:clear; Test Date: 20210105; Test Name: Covid Test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptoms: Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.

Other Meds: HYDROXYCHLOROQUINE [HYDROXYCHLOROQUINE SULFATE]; CELEBREX; DRAMAMINE; ALLEGRA; PEPCID [FAMOTIDINE]

Current Illness: Autoimmune disorder

ID: 0971532
Sex: F
Age:
State:

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode of hypertension; feeling hot; was "swaying"; had menstrual like cramps that radiated from her abdomen to her entire body; had menstrual like cramps that radiated from her abdomen to her entire body; This is a spontaneous report from a contactable pharmacist. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at the first single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. Within in minutes of receiving the vaccine on 13Jan2021, the patient reported a fruity taste in her mouth, turned "Beet red" on her neck/face, and passed out briefly. When she regained consciousness, she was given Benadryl, and also was reported to have an episode of hypertension. She reported feeling hot and was "swaying" and had menstrual like cramps that radiated from her abdomen to her entire body. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the event "passed out briefly". The impacts of this report on the benefit/risk profile of the 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-2021027150 same reporter/drug, similar event, different patient

Other Meds:

Current Illness:

ID: 0971533
Sex: F
Age:
State: MO

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 20210111; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Mental fog; Chills; Dizziness sensation; Headache; Extremely large lymph nodes; Fevers; This is a spontaneous report from a contactable nurse reported for self. This 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 08Jan2021 12:00 PM at single dose in right arm for COVID-19 immunization. The patient is not pregnant. The patient had no COVID prior vaccination. The patient had none known allergies. The patient medical history included hypertension/ gastric sleeve 2020. The patient concomitant mediations included metoprolol 100mg once a day. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 18-Dec-2020 12:00 PM at single dose in right arm for COVID-19 immunization. The patient experienced extremely large lymph nodes, chills, fevers, Constant headache and dizziness sensation, mental fog. The events onset date was reported 08-Jan-2021 20:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. The COVID test post vaccination (COVID test type Nasal Swab, COVID test name COVID/flu AB by PCR) resulted Negative on 11-Jan-2021. The patient received no treatment. The outcome of events was recovering. Information on the Lot/batch number has been requested. Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported mental fog and the administration of the suspected vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds: METOPROLOL

Current Illness:

ID: 0971534
Sex: F
Age:
State: CA

Vax Date: 01/11/2021
Onset Date: 01/01/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: Body temp; Result Unstructured Data: Test Result:101.7; Test Date: 20210112; Test Name: Body temp; Result Unstructured Data: Test Result:101.7; Test Date: 20210112; Test Name: Heart rate; Result Unstructured Data: Test Result:130's; Test Date: 20210112; Test Name: Heart rate; Result Unstructured Data: Test Result:130; Test Date: 20210112; Test Name: Heart rate; Result Unstructured Data: Test Result:112-115; Test Date: 20210112; Test Name: Heart rate; Result Unstructured Data: Test Result:125-130; Test Date: 20210112; Test Name: Heart rate; Result Unstructured Data: Test Result:115-108; Test Date: 20210111; Test Name: Oxygen Saturation; Result Unstructured Data: Test Result:91-94 %; Test Date: 20210111; Test Name: Oxygen Saturation; Test Result: 93 %; Test Date: 20210112; Test Name: Oxygen Saturation; Test Result: 93 %; Comments: on average; Test Date: 20210112; Test Name: Oxygen Saturation; Result Unstructured Data: Test Result:91-95 %; Test Date: 202101; Test Name: Oxygen Saturation; Test Result: 95 %; Comments: for a second

Allergies:

Symptoms: Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0971535
Sex: F
Age:
State: MI

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: lost consciousness; Severe cramping; diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3249, expiry date unknown), via an unspecified route of administration on the left arm on 13Jan2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included chronic fatigue syndrome from an unknown date and unknown if ongoing. The patient has no known allergies. Patient is not pregnant at the time of vaccination. Concomitant medications included cyanocobalamin (VITAMIN B-12), Iron, and Vitamin D (VITAMIN D NOS); patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Jan2021 04:00 AM, the patient experienced severe cramping, followed by episode of diarrhea. During the cramping, she lost consciousness for an unknown amount of time. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering. The events were reported as non-serious.; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of lost consciousness cannot be excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Other Meds: VITAMIN B-12; IRON; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 0971536
Sex: F
Age:
State: OH

Vax Date: 12/28/2020
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 7 days after the vaccine-developed onset of Pericarditis; This is a spontaneous report from a contactable Other HCP reporting for a patient. A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EK9231) intramuscular at single dose at left arm on 28Dec2020 13:00 for Covid-19 immunisation, administered at Nursing Home/Senior Living Facility. Medical history included recurrent idiopathic pericarditis, hypertension, pre-eclampsia, Covid-19. No known allergies. Patient was not pregnant. The patient had experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient developed onset of pericarditis 7 days after the vaccine on 04Jan2021. AE resulted in doctor or other healthcare professional office/clinic visit. Patient received Colchicine and Ibuprofen as treatment. Post vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.; Sender's Comments: Based on the temporal relationship, the association between the event pericarditis with BNT162b2 can not 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.

Other Meds:

Current Illness:

ID: 0971537
Sex: F
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/25/2021
Hospital: Y

Lab Data: Test Name: cardiac diagnosis tests; Result Unstructured Data: Test Result:negative for structural or functional abnormalitie

Allergies:

Symptoms: Vasovagal syncope with asystole; Vasovagal syncope with asystole; This is a spontaneous report from a contactable pharmacist (patient). A 36-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1686), via an unspecified route of administration in the right arm on 11Jan2021 at 14:45 at 36-years-old at a single dose for COVID-19 immunization in a hospital. Medical history included Wilms tumor from an unknown date and unknown if ongoing, Kidney resection and chemo from 1986 to an unknown date, sulfonamide allergy from an unknown date and unknown if ongoing, premature ventricular contractions (PVCs) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899) for COVID-19 immunization on 21Dec2020. On 12Jan2021 at 04:00, the patient experienced vasovagal syncope with asystole (hospitalization, medically significant). The patient was hospitalized for vasovagal syncope with asystole on unknown dates for 4 days (at the time of the report). It was reported that the patient did not receive any treatment due to the events. The clinical course was reported as follows: The patient experienced what was believed to be a vasovagal syncope with asystole; approximately 12 hours after receiving the second dose. The patient had been admitted to the hospital since all cardiac diagnosis tests were negative for structural or functional abnormalities. The patient remained in-patient at this time for initiation of therapy for frequent PVCs, which were diagnosis about one year ago; but chose not to treat at that time, as the symptoms were not affecting her lifestyle. The patient underwent lab tests and procedures which included cardiac diagnosis tests: negative for structural or functional abnormalities on an unknown date. The clinical outcome of the events was recovering. The patient did not have COVID prior to vaccination; and was not tested for COVID post vaccination.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in the development of the vasovagal syncope with asystole cannot be excluded. The event is confounded by the patient's underlying premature ventricular contractions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0971538
Sex: F
Age:
State: IN

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Name: Chest X-Ray; Result Unstructured Data: Test Result:negative; Test Date: 20210111; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Date: 20210111; Test Name: Halter monitor; Result Unstructured Data: Test Result:Unknown results; Test Name: hematocrit; Result Unstructured Data: Test Result:slightly low; Test Name: Hemoglobin; Result Unstructured Data: Test Result:slightly low; Test Name: Hemoglobin; Result Unstructured Data: Test Result:10.7; Test Name: labs; Result Unstructured Data: Test Result:Ok; Test Name: Red blood cells; Result Unstructured Data: Test Result:little low

Allergies:

Symptoms: Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hematocrit were slightly low; fluttering in chest; Rash on left side of face and neck; skin started burning; Anxiety and fear; Anxiety and fear; Racing heart beat; Dizziness/Lightheadedness; Headache; Nausea; Has been on her period for three weeks/Is premenopausal/Was bleeding at time of vaccination; This is a spontaneous report from a contactable Nurse reporting for herself. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at right arm on 06Jan2021 15:22 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, No agency site. Medical history reported included breast implants, She was healthy and had no medical diagnoses. The patient's concomitant medications was reported as none, She took no medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to report a possible reaction to the COVID Vaccine. Has been to the ER three times. Had a racing heart beat, dizziness, lightheadedness, and nausea on 08Jan2021. Developed a rash and skin started burning on 11Jan2021. The rash was on the left side of her face and neck. Racing heart beat started first. Then dizziness, headache, lightheadedness, and nausea began. She also had anxiety and fear. All symptoms began on 08Jan2021. Went to the ER on 08Jan2021. Was discharged from the Emergency room. Last night, 11Jan2021, she felt fluttering in chest, but it wasn't as severe as two nights ago. Her EKG was normal. Patient Hoped nothing occurs today. Took three Benadryl last night. Racing heart beat, rash, dizziness, headache, lightheadedness, nausea were all ongoing. The patient was wearing a Halter monitor until 12Jan2021 at 15:00, total duration for Halter monitor is 24 hours. Seriousness: Definitely disabling. Sunday night she thought she might not wake up Monday. She was fearful of all of the weird. Investigations: The patient was advised her labs were ok. Red blood cells are a little low. Hemoglobin and hematocrit were slightly low. Thought hemoglobin was 10.7. EKG was normal, Chest X-Ray was negative. The patient was just trying to figure out why reaction occurred. She Had been on her period for three weeks, was pre-menopausal. Was bleeding at time of vaccination on 06Jan2021. She did have breast implants, and didn't know if that was related or not. The patient Would not be getting the second injection. The nurse assessed the events of Racing heart beat, Anxiety and fear and Rash on left side of face and neck as related. The outcome of the event fluttering in chest was recovering, the outcome of the events Racing heart beat, rash, dizziness/ lightheadedness, headache, and nausea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac flutter, palpitations, headache, dizziness and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0971539
Sex: F
Age:
State: WI

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 20210107; Test Name: BP; Result Unstructured Data: Test Result:60s/30s; Comments: dropped to 60s/30s; Test Date: 20210107; Test Name: neutrophils; Result Unstructured Data: Test Result:elevated; Comments: WBCs and neutrophils and platelets elevated 3 hours later; Test Date: 20210107; Test Name: platelets; Result Unstructured Data: Test Result:elevated; Comments: WBCs and neutrophils and platelets elevated 3 hours later; Test Date: 20210107; Test Name: WBCs; Result Unstructured Data: Test Result:elevated; Comments: WBCs and neutrophils and platelets elevated 3 hours later

Allergies:

Symptoms: WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; Coat hanger neck/ shoulder pain; Coat hanger neck/ shoulder pain; flushed; felt uncomfortable; couldn't sit still; feeling clammy; saw spots; BP dropped to 60s/30s; felt like throat was closing; couldn't breathe well; hands were numb; lips were white/ blue; This is a spontaneous report from a contactable nurse (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via an unspecified route of administration in right arm on 07Jan2021 13:30 at first single dose for COVID-19 immunization. Medical history included asthma, fibromyalgia, idiopathic hypersomnia, seasonal allergies (dust, ragweed, pollen, dander), covid-19. Concomitant medication in two weeks included duloxetine hydrochloride (CYMBALTA), modafinil, montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D). No other vaccine in four weeks. 1-2 min after shot the patient became flushed and felt uncomfortable/ couldn't sit still, began feeling clammy, saw spots, BP dropped to 60s/30s, all other vitals stable, felt like throat was closing and couldn't breathe well, hands were numb, lips were white/ blue. No itching or hives. Resolved with trendelenburg and rest, fluids given in ED. WBCs and neutrophils and platelets elevated 3 hours later. Coat hanger neck/ shoulder pain for the next few days. Adverse event start date was 07Jan2021 01:30. Event resulted in emergency room/department or urgent care. Covid was not tested post vaccination. Outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: CYMBALTA; MODAFINIL; SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VIT D

Current Illness:

ID: 0971540
Sex: M
Age:
State: NY

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/25/2021
Hospital: Y

Lab Data: Test Date: 20210110; Test Name: MRI; Result Unstructured Data: Test Result:Diagnosis of Bells Palsy; Test Date: 202012; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative; Test Date: 20210110; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative

Allergies:

Symptoms: Unable to move the left side of my face/I could quite noticeably see asymmetry in my face/I was provided with the diagnosis of Bells Palsy; I felt moderate tingling sensations associated with the distribution of the paralysis; Generalized muscle aches; I felt fatigue; Dizziness; This is a spontaneous report from a contactable Physician. A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246) on 07Jan2021 at 09:00 a.m. intramuscular on left deltoid, at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 on 18Dec2020 at 09:00 on left arm (lot number: EK5730) and experienced headaches that started on the third day and ended on the tenth day. Following the second dose on 07Jan2021, patient experienced fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On 10Jan2021, he noticed that was unable to move the left side of his face. He felt moderate tingling sensations associated with the distribution of the paralysis. When looked in the mirror, he could quite noticeably see asymmetry in his face. Patient immediately visited emergency department at the hospital where his primary care doctor was located. Patient was kept in the hospital into the next day for observation (as reported). After evaluation by a neurology team and an MRI, patient was diagnosed with Bells Palsy. He had never previously been diagnosed with Bells Palsy, and never previously had a hospital stay before. It was also informed that patient underwent Nasal Swab for SARS-CoV-2 test on an unspecified date in Dec2020 and on 10Jan2021, both resulted negative. At the time of the reporting, the symptoms continued.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diagnosed Bells Palsy presented as unable to move the left side of his face/felt moderate tingling sensations associated with the distribution of the paralysis/asymmetry in his face cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: OMEPRAZOLE

Current Illness:

ID: 0971541
Sex: U
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: received the entire vial contents (0.45 mL), without dilution; overdose/ received the entire vial contents (0.45 mL), without dilution; flu-like symptoms from the overdose; This is spontaneous report from the two contactable nurses, two contactable physicians, one contactable pharmacist. These reporters reported 8 similar reports. This is the first one. An unknown age and gender patient received 1st dose of BNT162B2 (LOT# unknown) at single dose for immunization. Medial history and concomitant drug were not reported. It was reported that patient experienced flu-like symptoms from the overdose. Eight healthcare workers in a long-term care (LTC) facility received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine. Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose. Outcome of the event was unknown. Information on the Lot/batch number has been requested.; Sender's Comments: Based on the available information, the event "flu-like symptoms" is possibly relate to overdose of vaccine BNT162B2 due to product preparation error. 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-2021032448 same reporter/SD, AE/ different patient;US-PFIZER INC-2021032447 same reporter/SD/AE, different patient;US-PFIZER INC-2021032263 same reporter/SD/AE, different patient;US-PFIZER INC-2021032446 same reporter/SD/AE, different patient

Other Meds:

Current Illness:

ID: 0971542
Sex: U
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose; Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose; This is spontaneous report from two contactable nurses, two contactable physicians, one contactable pharmacist. These reporters reported similar events for four patients. This is a 2nd of 4 reports. An unknown age and gender patient received 1st dose of BNT162B2 (LOT# unknown) at single dose for immunization. Medial history and concomitant drug were not reported. It was reported that patient experienced flu-like symptoms from the overdose. Eight healthcare workers in a long-term care (LTC) facility received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine. Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose. Outcome of the event was unknown. Information on the Lot/batch number has been requested.; Sender's Comments: The association between the events "received entire vial contents without dilution" and flu-like symptoms with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021032445 same reporter/SD/AE, different patient

Other Meds:

Current Illness:

ID: 0971543
Sex: U
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: received the entire vial contents (0.45 mL), without dilution; overdose/ received the entire vial contents (0.45 mL), without dilution; flu-like symptoms from the overdose; This is spontaneous report from the two contactable nurses, two contactable physicians, one contactable pharmacist. These reporters reported similar events for four patients. This is 3rd of 4 reports. An unknown age and gender patient received 1st dose of BNT162B2 (LOT# unknown) at single dose for COVID-19 immunisation. Medial history and concomitant drug were not reported. It was reported that patient experienced flu-like symptoms from the overdose. Eight healthcare workers in a long-term care (LTC) facility received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine. Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose. Outcome of the event was unknown. Information on the Lot/batch number has been requested.; Sender's Comments: Based on the available information, the event "flu-like symptoms" is possibly relate to overdose of vaccine BNT162B2 due to product preparation error. 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-2021032445 same reporter/SD/AE, different patient

Other Meds:

Current Illness:

ID: 0971544
Sex: U
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: received the entire vial contents (0.45 mL), without dilution; Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose; This is Spontaneous report from 2 contactable Nurses, 2 contactable physicians and a contactable Pharmacist. These Nurses, physicians and pharmacist reported similar events for 4 patients. This is a 4th of 4 reports. A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration at single dose (first dose) for unknown indication. Medical history and concomitant medications were not reported. Eight healthcare workers in a long-term care (LTC) facility received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine. Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported Flu-like symptoms was associated with the accidental overdose, received the entire vial contents (0.45 mL) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), without dilution. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021032445 same reporter/SD, AE/ different patient

Other Meds:

Current Illness:

ID: 0971545
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: heavier than normal vaginal bleeding following vaccination 2 weeks before unspecified date; This is a spontaneous report from a contactable Pharmacist reported that a 5 decade (40's) female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient have heavier than normal vaginal bleeding following vaccination 2 weeks before unspecified date, now having vaginal bleeding for 12 days wondering if this was related to the vaccine. The outcome of event was not recovered. Information on the batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported vaginal bleeding cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0971546
Sex: F
Age:
State: LA

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

Lab Data: Test Date: 20210111; Test Name: MRI; Result Unstructured Data: Test Result:good

Allergies:

Symptoms: wobbling profusely as she walks out of a bathroom/getting even worse; This is a spontaneous report from non-contactable consumers from a Pfizer sponsored program Corporate (Pfizer) Social Media Platforms. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had been injured by the vaccine. She was wobbling profusely as she walked out of a bathroom. She was admitted to the hospital and was cautious about taking the vaccine. She was getting even worse today (11Jan2021) and still did not have any answers from doctors as to how to fix this. The shots cause harm. Injury was real and not rare. She had a bad night last night but today was a little better for her. They still didn't know how to treat this problem. Magnetic resonance imaging (MRI) results came back good today (11Jan2021). She just had another serious episode and she thought it's getting worse when the shakes come. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 0971547
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Bells Palsy; This is a spontaneous report from a non-contactable physician (patient) via Pfizer Sales Representative. A 34-year-old (reported as 34, unit was not provided) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced bells palsy on an unspecified date with outcome of unknown. The event took place after vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bells palsy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0971548
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: TIA/mini stroke; This is a spontaneous report from non-contactable consumer via Pfizer Sales Representative. A 5-decade-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included insulin dependent diabetic in mid 40s. The patient's concomitant medications were not reported. The patient experienced TIA (transient ischaemic attack) /mini stroke on same day he received COVID vaccine. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0971549
Sex: F
Age:
State: NY

Vax Date: 12/23/2020
Onset Date: 12/01/2020
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 20210108; Test Name: scan; Test Result: Negative ; Test Date: 20210108; Test Name: X rays; Result Unstructured Data: Test Result:Develop pneumonia

Allergies:

Symptoms: Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and shoulder became swollen; she also has something else going on in her shoulder; achy all over in her neck, arm, and shoulder; achy all over in her neck, arm, and shoulder; Felt sick to her stomach; her arm was sore that evening; This is a spontaneous report from a Pfizer Sponsored Program made from a contactable consumer (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK5730) at single dose on left arm on 23-Dec-2020 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; COPD (chronic obstructive pulmonary disease). Concomitant Medication was nothing new, her normal medication, she took vitamins, and high blood pressure medication. She had had no positive test for Covid prior to the vaccine, she had had no antibody test, she had had no issues with vaccine in the past. The patient experienced left arm swelling in Jan2021 and pneumonia on 08Jan2021. The patient worked in a hospital and received her first dose on 23Dec2020 and she was supposed to get the second dose today but she was not at work today. She was wanting to know if she should go ahead and take the second dose because her arm was still swollen. The product was the Covid vaccine. She stated that her arm was still swollen, when she got shot she was fine, her arm was sore that evening (Dec2020) and then nothing, then a weekend after new years her arm and shoulder became swollen (Jan2021) and she had been to the ER and the doctor thought the swelling was because of the shot, but she also had something else going on in her shoulder (Jan2021). So in the meantime she went to the ER and they took X rays, and they told her that she was starting to develop pneumonia. She was going back to work tomorrow, being that she was on the antibiotics now, still had swelling in the arm, and had pneumonia, should she still get the 2nd shot. She noticed the swelling Saturday after New Years. She was also achy all over in her neck, arm, and shoulder (Jan2021). She felt sick to her stomach, this was all the first Week of Jan2021. She went to the ER, she was not admitted and came home the same day. She went to the ER on 08Jan2021. 08Jan2021 was also when the pneumonia was diagnosed. The name of antibiotic she was prescribed was doxycycline. She started it on Saturday 09Jan2021, she was prescribed 100 mg 2 pills a day for 10 days. When they did the X ray, they said that the pneumonia had showed up, or she was just starting to get pneumonia. Patient stated that she didn't believe because they made a comment about the way she was laying however she had been taking the medication and feeling better. She was schedule for the second dose today. She did reschedule for Friday, and wanted to know if she should still get it. In the ER, they said it could have been a blood clot and so they did a scan to find blood clots but it was negative. The outcome of event pneumonia was resolving; events left arm swelling and shoulder became swollen was not resolved. The outcome of rest evens was unknown..

Other Meds:

Current Illness:

ID: 0971550
Sex: F
Age:
State: SC

Vax Date: 01/09/2021
Onset Date: 01/11/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: COVID-19 immunization on 22Dec2020/ COVID-19 immunization on 09Jan2021; Syncopal episode; loss of consciousness; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231) via unspecified route on right arm single dose for COVID-19 immunization on 09Jan2021, 11:00 AM, at 43-year-old. Medical history included: allergies: Cephlasporins; sulfa; clarithromycin (BIAXIN); metronidazole benzoate (FLAGYL). The patient did not have COVID prior vaccination. Concomitant medications in two weeks included: ibuprofen; loratadine, pseudoephedrine sulfate (CLARITIN-D); fluticasone propionate (FLONASE). The patient did not have other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on right arm for COVID-19 immunization on 22Dec2020, 12:00 PM, at 43-year-old. On 11Jan2021, 12:15AM, the patient had syncopal episode, loss of consciousness for approximate 10 minutes, more than two hours to fully recover. This resulted in emergency room/department or urgent care. Treatment received included: IVFs, sutures. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events syncope and loss of consciousness was resolved on 11Jan2021, of else event was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events syncope and loss of consciousness 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: IBUPROFEN; CLARITIN-D; FLONASE [FLUTICASONE PROPIONATE]

Current Illness:

ID: 0971551
Sex: F
Age:
State: GA

Vax Date: 01/09/2021
Onset Date: 01/01/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Name: Weight; Result Unstructured Data: Test Result:125 lbs; Comments: 125 pound range

Allergies:

Symptoms: can't even think; no sense of smell; sick; headache; flu type symptoms with sinus pressure; flu type symptoms with sinus pressure; sore throat; brain fog; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 28-year-old female patient received BNT162b2 (lot number: EL3246), via an unspecified route of administration in left arm on 09Jan2021 at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient got the COVID 19 vaccine on 09Jan2021, and symptoms started shortly right after, with headache, flu type symptoms with sinus pressure, all on 09Jan2021; and this morning (13Jan2021) she woke up with no sense of smell. She is so sick right now (13Jan2021), said she can't even think right now (13Jan2021). The patient stated the only thing that improved was the headache went away, and in the first two days (Jan2021), she had a sore throat, and that has gone away, but everything else has stayed constant. The patient had brain fog in Jan2021. The patient underwent lab tests and procedures which included weight: 125 pound range. The outcome of the event headache was recovered on 09Jan2021, the sore throat was recovered in Jan2021, other events was not recovered.

Other Meds:

Current Illness:

ID: 0971552
Sex: F
Age:
State: PA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Passed out; Chest tightness; Dizziness; Trouble breathing; Itching throat; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration at site of left arm at 17:15 on 11Jan2021 at single dose for COVID-19 immunization. Medical history included migraine and seizure. Concomitant medication included lamotrigine (LAMICTAL) and zonisamide (ZONEGRAN). Both received within two weeks of vaccination. The patient experienced passed out, chest tightness, dizziness, trouble breathing, and itching throat, all at 17:30 on 11Jan2021. No other vaccines received in four weeks. Facility type vaccine was in hospital. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received salbutamol (ALBUTEROL), steroids, diphenhydramine hydrochloride (BENADRYL), lansoprazole (PREVACID) and IV fluids for treatment. No covid prior vaccination. No covid tested post vaccination. No known allergies. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: LAMICTAL; ZONEGRAN

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm