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: 1056638
Sex: F
Age:
State: IL

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Rigors and severe back pain; Rigors and severe back pain; syncope; prolonged PT; Loss of work as a physician for 2.5 weeks; This is a spontaneous report from a contactable physician (patient) A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 11Jan2021 12:30 at single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease and allergies. The patient was not pregnant. Concomitant medication included lansoprazole (PREVACID). The patient experienced rigors and severe back pain, syncope, prolonged pt and loss of work as a physician for 2.5 weeks on 12Jan2021 with outcome of recovered with sequelae in Feb2021. The events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient was hospitalized due to the events for 2 days. The patient received steroids, pain meds, muscle relaxers as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile causality between event chills and syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be excluded. The events prolonged PT and loss of work as a physician for 2.5 weeks are attributed to intercurrent conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: PREVACID

Current Illness:

ID: 1056639
Sex: M
Age:
State: MA

Vax Date: 01/27/2021
Onset Date: 02/01/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Left eye 6 nerve palsy and could not move my eye laterally; This is a spontaneous report from a contactable physician (patient) A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 27Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 01Feb2021, patient started to notice, left eye 6 oculomotor nerve ("abduscens") palsy and could not move his eye laterally. Patient also asked information about 6 oculomotor nerve and possible interaction with vaccine. At the time of the reporting event outcome was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported event cannot be excluded, due to a 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: 1056640
Sex: M
Age:
State: FL

Vax Date: 01/22/2021
Onset Date: 01/26/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data: Test Name: CTA; Result Unstructured Data: Test Result:Pulmonary arteries negative for PE; Test Date: 20210130; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:84 mmHg; Test Date: 20210130; Test Name: Blood pressure Systolic; Result Unstructured Data: Test Result:141 mmHg; Test Date: 20210126; Test Name: Body mass index; Result Unstructured Data: Test Result:26.4684 kg/m2; Test Date: 20210130; Test Name: temperature oral; Result Unstructured Data: Test Result:98.2 degree Fahrenheit; Test Name: Cardiovascular; Result Unstructured Data: Test Result:Normal rate, regular rhythm, No murmur, No gallop; Test Name: CT Scan; Result Unstructured Data: Test Result:No hemorrhage; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Bubble study negative for an inter-arterial shunt; Test Name: Gastrointestinal; Result Unstructured Data: Test Result:Soft, Non-tendor, Non-distended,; Comments: Normal bowel sounds, No organomegaly; Test Name: Gastrointestinal examination; Result Unstructured Data: Test Result:Soft, Non-tender, Non-distended; Comments: Normal bowel sounds, No organomegaly; Test Date: 20210130; Test Name: Heart rate; Result Unstructured Data: Test Result:55 bpm; Test Name: MRI; Result Unstructured Data: Test Result:Acute left parietal lacunar infarct; Test Name: Eye test; Result Unstructured Data: Test Result:Pupils are equal, round and reactive to light; Comments: Extraocular movements are intact, Normal conjunctive.; Test Date: 20210130; Test Name: SpO2; Test Result: 95 %; Test Date: 20210130; Test Name: Resp rate spontaneous; Result Unstructured Data: Test Result:18 br/min; Test Name: Skin test; Result Unstructured Data: Test Result:Warm, Pink, No pallor; Test Date: 20210127; Test Name: Temperature Axillary; Result Unstructured Data: Test Result:98.8 Fahrenheit; Test Name: Lower extremity ultrasound; Result Unstructured Data: Test Result:left popliteal vein DVT

Allergies:

Symptoms: Lt parietal occlusion; DVT; Right paralysis; This is a spontaneous report from a contactable Nurse reporting for her husband. A 71-years-old male patient received the first dose of bnt162b2 (BNT162B2; Lot # EL 1284) vaccine , intramuscular in the left deltoid on 22Jan2021 17:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. Concomitant medication included apixaban (APIXABAN), acetylsalicylic acid (ASPIRIN) atorvastatin (ATORVASTATIN), cyanocobalamin (CYANOCOBALAMIN), metoprolol tartrate (METOPROLOL TARTRATE) , pantoprazole (PANTOPRAZOLE), sumatriptan (IMITREX [SUMATRIPTAN]), triazolam (TRIAZOLAM). The patient experienced DVT (deep vein thrombosis) on 26Jan2021 with outcome of not recovered , left parietal occlusion (ischaemic stroke) on 26Jan2021 05:30 with outcome of unknown , right paralysis on an unspecified date with outcome of unknown. The patient was hospitalized for DVT (deep vein thrombosis) and stroke from 26Jan2021 to 30Jan2021. The patient underwent lab tests and procedures including blood pressure diastolic: 84 mmhg on 30Jan2021 , blood pressure systolic: 141 mmhg on 30Jan2021 , body mass index: 26.4684 kg/m2 on 26Jan2021 , body temperature: 98.2 ?F on 30Jan2021, heart rate: 55 bpm on 30Jan2021 , magnetic resonance imaging: acute left parietal lacunar infarct, Lower extremity ultrasound: left popliteal vein DVT, oxygen saturation: 95 % on 30Jan2021 , respiratory rate: 18 br/min on 30Jan2021. The reporter considered the reported events to be possibly related to BNT162B2 vaccine. Follow up information has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: APIXABAN; ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; CYANOCOBALAMIN; METOPROLOL TARTRATE; PANTOPRAZOLE; IMITREX [SUMATRIPTAN]; TRIAZOLAM

Current Illness:

ID: 1056641
Sex: M
Age:
State: OH

Vax Date: 01/22/2021
Onset Date: 01/25/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data: Test Date: 202102; Test Name: CT of the Brain; Result Unstructured Data: Test Result:Normal; Test Date: 202102; Test Name: CT of the Neck; Result Unstructured Data: Test Result:Normal; Test Date: 202102; Test Name: MRI of the Orbits; Result Unstructured Data: Test Result:Normal; Comments: MRI of the Orbits; Test Date: 202102; Test Name: MRI brain; Result Unstructured Data: Test Result:Normal; Comments: MRI brain

Allergies:

Symptoms: cranial nerve 3 palsy. Ptosis of the left eye, it was completely shut; cannot hear; This is a spontaneous report from a contactable physician. A 93-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation, hypertension, hyperlipidaemia, diabetes, and chronic kidney disease. Concomitant medications were not reported. No additional vaccines administered on the same date of the vaccine and no prior vaccinations within 4 weeks. The reporter is the family's physician, who stated that the patient received the first dose of the Pfizer COVID vaccine on 22Jan2021 and three days later (25Jan2021), his left eye had ptosis - he was unable to open his left eye and it was completely shut. The patient came to him and when he would try to lift the eyelid up, it would just drop down. He then called a neuro ophthalmologist, he thought to himself that the patient could be having a stroke. The patient was sent to the Emergency Room and kept overnight to do CT of brain, MRI of brain, CT of orbits and MRI of neck. All tests came back normal, there was no stroke. The patient was discharged and was told to go see an ophthalmologist; the eye doctor diagnosed him with Cranial Nerve 3 Palsy. The reporter had read the consultation notes; the eye doctor "wrote 1-2 days after he had COVID and had this happen". The reporter clarified that the patient never had COVID, maybe this was a misunderstanding or typo with the doctor, but the patient just had the vaccine. The point is that the patient was diagnosed. The reporter further added that the patient can't hear, and so he will provide the patient's son's phone number. The reporter would like to know if this is a possible side effect of the vaccine and if he should receive the second dose of the vaccine as he is due in two days (Friday at 8:30AM on 12Feb2021). It was also reported that the ptosis has not gotten worse and has not resolved. The reporter added that the patient was admitted to the hospital for a full day. The patient underwent lab tests and procedures which included computerized tomography (CT) of the brain, CT of the neck, magnetic resonance imaging (MRI) of the brain and MRI of the orbits-all of which resulted normal in Feb2021. The events cranial nerve 3 palsy and 'Ptosis of the left eye, it was completely shut' had not resolved while the outcome of the rest of the events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: By close temporal relationship, the company cannot completely exclude that the reported cranial nerve 3 palsy' is related to BNT162b2 administration, even though medical history including atrial fibrillation, hypertension, hyperlipidemia, diabetes, and chronic kidney disease, in the setting of elderly age, can be considered confounding factors in the overall clinical evaluation of this event occurred three days after the vaccination. Conversely, even though cannot be excluded as reportable event based on the information provided, the company deems there is not a reasonable possibility that the reported deafness is related to BNT162b2 administration, but, at the present time, evaluated as an intercurrent condition that cannot be also excluded as already present before the vaccination. The impacts 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: 1056642
Sex: F
Age:
State: TN

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

Lab Data: Test Date: 20210205; Test Name: blood pressure; Result Unstructured Data: Test Result:were up; Test Date: 20210205; Test Name: heart rate; Result Unstructured Data: Test Result:were up

Allergies:

Symptoms: anaphylaxis; high blood pressure; elevated heart rate; her throat felt funny, like it was getting tight; very nauseous/sick of her stomach; rash on her chest; She could not swallow; This is a spontaneous report from a contactable consumer (parent of the patient). Information were received also from a Pfizer-sponsored program COVAX US Support. A 20-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9261), via an unspecified route of administration in the left arm on 05Feb2021 09:30 at single dose for COVID-19 immunisation. Medical history included acne, allergy environmental cats dogs and latex. Adrenaline (EPIPEN) and Corticosteroid were used to treat these allergies. Due to these severe allergies, the patient had to take weekly allergy shots. Got allergy shot the day before the 2nd vaccine shot. Concomitant medication included isotretinoin (AMNESTEEM), buspirone (unknown manufacturer), calcium (unknown manufacturer), azelastine hydrochloride, fluticasone propionate (DYMISTA), gabapentin (unknown manufacturer), melatonin (unknown manufacturer), omeprazole (unknown manufacturer), estrogens conjugated, medroxyprogesterone acetate (PREMELLA), probiotics (PROBIOTICS), fluoxetine hydrochloride (PROZAC) , trazodone (unknown manufacturer), colecalciferol (VITAMIN D), cetirizine hydrochloride (ZYRTEC). The patient previously took clindamycin, bactrim and corticosteroids and experienced hypersensitivity. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249) intramuscular in left arm on 15Jan2021 at 11:00AM. It was reported that 15 minutes after receiving her second COVID-19 vaccine dose the patient developed anaphylaxis, her throat started closing up, her throat felt funny, like it was getting tight. A nurse administered her anaphylactic shot (EPI-PEN shot) and was taken to the hospital by ambulance. The patient was monitored in the Emergency Room because her blood pressure and heart rate were up, but the Emergency Room didn't give her any further treatment. The patient was discharged home on 05Feb2021. On Saturday, 06Feb2021, at 4-5AM she developed anaphylaxis again, the patient had the same throat tightening happen again. The mother gave her an Epi-Pen shot (AUVI-Q) and brought her back to the Emergency Room. While in the Emergency Room, the patient was given steroids and Pepcid, and then sent back home. On Sunday, 07Feb2021, at approximately 1:00AM she had the same throat tightening so the mother gave her an Epi-Pen shot (AUVI-Q) again, and brought her back to the Emergency Room. The patient was admitted to hospital and discharged on 09Feb2021 evening (at 16:00). At hospital the patient received some steroid shots in the hospital. The patient was given 3-125mg steroid shots, and 3-40mg steroid shots, every night she spent in the hospital, she woke up with her throat closing and she was administered 125 steroids 50 mg Diphenhydramine (BENADRYL) and 4-5 hours later 40 mg of steroids 20 mg Famotidine (PEPCID) IV. They kept IV fluids. On 10Feb2021 at 7:50AM the patient experienced throat tightness again. The mother gave her some Diphenhydramine (BENADRYL) and steroids which were prescribed at hospital. The patient started a taper dose of Prednisone 10mg tablets. She was to take 2 Prednisone 10mg tablets twice a day for 3 days, then to take 2 Prednisone 10mg tablets in the morning and 1 Prednisone 10mg tablet in the evening for 3 days; then to take 1 Prednisone 10mg tablet twice a day for 2 days, and then 1 Prednisone 10mg tablet daily for 2 days. The patient was prescribed generic Famotidine (PEPCID), 40mg, one tablet, twice a day, and generic Diphenhydramine (BENADRYL) 25mg capsules. On unknown date in feb2021 the patient gets very nauseous when her throat starts to close. She could not swallow and was sick of her stomach. She experienced a rash on her chest. The outcome of the event heart rate increased and blood pressure high was recovered, for anaphylactic reaction and throat tightness was not recovered. For the other events was unknown. The events anaphylaxis, throat tightness, heart rate increased and blood pressure were serious due to hospitalization.

Other Meds: AMNESTEEM; BUSPIRONE; CALCIUM; DYMISTA; GABAPENTIN; MELATONIN; OMEPRAZOLE; PREMELLA; PROBIOTICS; PROZAC; TRAZODONE; VITAMIN D [COLECALCIFEROL]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1056643
Sex: M
Age:
State: TX

Vax Date: 01/27/2021
Onset Date:
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: shortness of breath; bad headaches; chest pain; rash on his neck and behind his ears; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number N5318), via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shortness of breath, bad headaches, chest pain and rash on his neck and behind his ears, all on an unspecified date in 2021. The events were all serious as they involved hospitalization from 02Feb2021 to 03Feb2021. Details were as follows: patient received the first dose of the vaccine on 27Jan2021; he had a lot of bad side effects and went to the hospital: shortness of breath, bad headaches, chest pain, rash on his neck and behind his ears. All this happened a few days after receiving the vaccine. He had an appointment with his cardiologist and he will have a cardiac catheter placed on 19Feb2021. The second dose of the vaccine was scheduled for 18Feb2021. The outcome of the events were unknown.

Other Meds:

Current Illness:

ID: 1056644
Sex: F
Age:
State: NJ

Vax Date: 01/23/2021
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freezing; severe allergic reaction; Bell's Palsy; This is a spontaneous report from a contactable consumer (parent). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9262), via an unspecified route of administration in the left arm, on 23Jan2021 (at the age of 27-years-old) at a single dose for COVID-19 immunization. Medical history included Bell's Palsy (motor nerves involved) from 2017 to 2017. Concomitant medications included unspecified birth control. The patient had no prior vaccinations within four weeks of vaccination. The patient experienced Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction on an unspecified date. It was reported that the Bell's Palsy lasted 8 days and was considered a modified Bell's Palsy because it only sensorial nerves were involved. It was reported that the patient did not receive any treatment for Bell's Palsy. The clinical outcome of Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction was recovered on an unspecified date.

Other Meds:

Current Illness:

ID: 1056646
Sex: F
Age:
State: FL

Vax Date: 01/21/2021
Onset Date: 01/01/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: heart rate; Result Unstructured Data: Test Result:Fast

Allergies:

Symptoms: My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel well; Nauseous; I got cold; Sick; was very hot and so hot; was round up/she was feeling she would faint; waves of feeling like i would pass out; it was just being very hot, then being cold; Blood drained from my head, I just knew I was going to pass out; I took 0.2 rather than the 0.3ml of the first dose; very fast heart rate intermediately for many day; squeezing of chest; muscle hurting/Pain in my body in every muscles, my fingers, my hands, my calves, my feet, my back, neck, everything; digestive disorders; feeling gassy, uneasy; stomach abdomen was just tight; abdominal issue; feeling gassy, uneasy; stomach abdomen was just tight; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: E18982), on 21Jan2021 (at the age of 71-year-old) at single dose for COVID-19 immunisation. The patient reported that based on her history of reactions to medications, the nurses giving injections "decided 0.2ml instead of 0.3ml", which is what they gave, so she got 0.2 that is two-third of the shot. The 2nd shot was for 8'oclock on 11Feb2021. She is very sensitive to shots, vaccines, and to all medications and injections and things like that. She has sensitives thanks to two concussions she had in her life. She never was before that she had two concussions. Second one had a crazy man hit her after that just noticed that just have reactions not adverse or dying but definitely take rest of everything. So she take less of a shot, like a dental shot or cortisone shot, which she had taken in the past. If she has dental shot she cannot take Novocain, had to take Carbocaine or Marcaine and they give her half. Also she had been taking cortisone shot for shoulder for rotator cuff injury. They also have to give her less. Or flu shot: she takes half one week and come back for the other half the next week. Just have reactions. She told to when arrive for medication and did have one anaphylactic reaction but that was to cat skin dye, was told to this two nurses who was administering the vaccine and said to them she was really afraid to take. It is just too much for her. She knows her body. She is sure have reaction but is really afraid and don't know what is the first one will do to her. They just did two nurses and she decided that she will be taking 0.2 instead of 0.3ml which is what they gave. She got 0.2 so that two third of the shot and waited the half an hour, a nurse watched her card and 7 other cards. She did not have the anaphylactic reaction. She went home. Her arm hurt and started to get little tired. The events started the day that she got the shot. Like about 3 or 4 hours later. It is just few hours later she couldn't watch TV so went to laid down and an hour later she woke-up. She walked to her kitchen and blood drained from her head, she just knew she was going to pass out. Her stomach suddenly did not feel well. She tried to get back her bed but she was round up and as far as the bathroom. She got very nauseous, she laid down on bathroom floor. She thought she was sick but didn't round up having to use toilet of few times. Although while she was feeling she would faint. She was very hot and so hot. While lie down, she couldn't even pulling off her pajamas. So when she got cold so she was pulling a towel down and stop and she laid to for two hours, she finally got to her bed. It was a terrible experience. Next day she drank water and had potatoes prepared and went up eating back to later baked potatoes. Next day luckily she did not have repeat of the nausea. She didn't have that anymore of. She did have abdominal issue just not diarrhea or anything but just not feeling well, feeling gassy, so uneasy. This all lasted, that part lasted for 7 days. What concerned her was especially beside first day it was few days she got off again. She was just feel blood drain but not this first time she laid on floor. She couldn't sit on chair to watch TV for about 3 days. She mostly laid on bed but she would get very hot and then very cold during the day. She would get very fast heart beat not continue but really fast like heart was pounding her chest. She felt like someone has their hand inside her body squeezing her chest. She got afraid but didn't want to go hospital. She didn't think she was sick enough. She was concerned. So that was happened and this last was for about 7 days. Then the squeezing of chest part went away. She doesn't want to wind-up on the floor feeling that sick again, she felt so sick it felt like food poisoning. After that, it was just being very hot, then being cold, the fast heart rate, every muscle hurting. Those were the main things that continued for a week. And digestive disorders. It all lasted for about 13 days. She was concerned she had a very fast heart rate intermediately for many days, for about a week. And that's considered an adverse reaction and also she was getting waves of feeling like she would pass out, everything would drain from her head. She experienced stomach ache, feeling hot then cold. She wants to do precautions before taking the second dose on 11Feb2021. She did take may be 3 days later two Tylenol but didn't take anything (clarification requested). She didn't even take vitamins during that time. She was afraid to take anything so she did not. At the same time also there was pain in her body in every muscles, fingers, hands, calves, feet, back, neck, everything. Her stomach abdomen was just tight. She was concerned that last for few days. In last few days she started feel herself and now she is going again tomorrow. So that how she reacted. She doesn't know how much of this shot she told them she could tolerate because everybody is saying second shot will give you more reactions. All she can take this more than that because that was lot. She wants to be herself, don't want laying on floor, don't want to have 105 temperature or anything. The patient was asking if she should take another 0.2ml another two-third of the shot. She just asked them for half that is 0.15 would that be a big difference. She needed to know by 8 o'clock tomorrow. I might be in a queue to get it. She stated: 'So, that's my concern. I'm all alone, I'm a senior, I have no family. I lost my mother to covid. I know I need this vaccine, but I just, I cant get that sick and I'm so afraid I'll wind up with a 105 something, fainting away and no one knowing'. She was asking if reactions after the 2nd dose are worse than the 1st dose, if she didn't have anaphylaxis after 1st one, she shouldn't have it a 2nd time, right. She said, "1st half of flu shot, I get sick, then the 2nd half nothing". She also asked if she can take medications after the vaccine, like Tylenol, or irritable bowel syndrome (IBS) medication she takes as needed. The events resolved, but the patient reported it took her like 13 days before she felt better.

Other Meds:

Current Illness:

ID: 1056647
Sex: M
Age:
State: IN

Vax Date: 01/19/2021
Onset Date: 01/24/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Both legs from knees down got swollen and were painful to touch, walk on, etc.; Both legs from knees down got swollen and were painful to touch, walk on, etc.; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EX923, in hospital, via an unspecified route of administration in left arm from 19Jan2021 at 20:45 (at age of 66 years) at single dose for COVID-19 immunization. Medical history included spinal stenosis, arthritis and allergy to penicillin, all from an unknown date. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medication included gabapentin, meloxicam (MOBIC), zinc, ascorbic acid (VIT C), magnesium and cinnamomum verum stem bark/elettaria cardamomum fruit/syzygium aromaticum (CINNAMOL). On 24Jan2021 at 16:00 both patient's legs from knees down got swollen and were painful to touch, walk on, etc. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with steroids. The reported events were resolving at the time of the report.

Other Meds: GABAPENTIN; MOBIC; ZINC; VIT C; MAGNESIUM; CINNAMOL

Current Illness:

ID: 1056648
Sex: F
Age:
State: NY

Vax Date: 02/10/2021
Onset Date: 02/01/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: some pain in my left shoulder; severe pain in my lower back; significant nausea; This is a spontaneous report from a contactable physician (patient). An 82-year-old female patient received second dose of bnt162b2 (BNT162B2) , via an unspecified route of administration on 10Feb2021 12:00 at single dose on right arm for covid-19 immunisation. Medical history included ongoing allergy to perfumes/scents, ongoing allergy to linseed oil, ongoing chronic osteoarthritis (six joint replacements), GERD, hypertension. Concomitant medication included duloxetine hydrochloride (CYMBALTA), enalapril, ferrous sulfate, gabapentin. The patient previously received first dose of bnt162b2 on 20Jan2021 11:00 for covid-19 immunisation and experienced no adverse event. The patient stated that, "I had no reaction, not even a sore arm, after the first shot. However, for two days (Feb2021) so far after the second shot I have severe pain in my lower back, some pain in my left shoulder, and significant nausea." No treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The outcome of the events was not resolved. Information on Lot/Batch number has been requested.

Other Meds: CYMBALTA; ENALAPRIL; FERROUS SULFATE; GABAPENTIN

Current Illness: Food allergy; Osteoarthritis (Chronic osteoarthritis (six joint replacements)); Perfume sensitivity

ID: 1056649
Sex: M
Age:
State: CT

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210210; Test Name: body temperature; Result Unstructured Data: Test Result:99.8 Fahrenheit; Comments: fever

Allergies:

Symptoms: Joint pain in arm, shoulder, hip, and leg on side of injection site; joint pain in arm, shoulder, hip, and leg on side of injection site; Joint pain in arm, shoulder, hip, and leg on side of injection site; fever of 99.8 F; Headache; Constipation; Sweating, so much sweating; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 10Feb2021 (13:00) (at the age of 32years) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration on 20Jan2021 (12:00PM) (at the age of 32years) for COVID-19 immunization. The patient has no medical history; no allergies to medications, food, or other products. Concomitant medication included vitamin B complex (VITAMIN B) also reported as "B vitamin supplement" taken from an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021, the patient experienced joint pain in arm, shoulder, hip, and leg on side of injection site. The patient woke up with fever of 99.8 F that ended approximately 03:00 PM on 11Feb2021. The patient also experienced headache, constipation and sweating, so much sweating. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event fever was recovered on 11Feb2021; the outcome of other events was recovered on an unspecified date. This case is non-serious.

Other Meds: VITAMIN B

Current Illness:

ID: 1056651
Sex: F
Age:
State: CA

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210210; Test Name: blood sugar level; Result Unstructured Data: Test Result:over 400

Allergies:

Symptoms: blood sugar level is over 400; This is a spontaneous report from a contactable consumer who reported for herself. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN5318) on 09Feb2021 at 15:00 (at 74 years) at single dose in left arm for covid-19 immunisation. Medical history included type 2 diabetes mellitus, high blood pressure. Concomitant medication included metformin and diphenhydramine hydrochloride (LURISPAN). Patient was not pregnant.The patient previously took epinephrine and had drug allergy. The patient blood sugar level was over 400 on 10Feb2021. No treatment given for the event. The final outcome of the event was not recovered.

Other Meds: METFORMIN; LURISPAN

Current Illness:

ID: 1056652
Sex: M
Age:
State: FL

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

Lab Data: Test Name: Ejection fraction; Result Unstructured Data: Test Result:from 40 down to 20

Allergies:

Symptoms: chest pains; Ejection fraction decreased (from 40 down to 20); This is a spontaneous report from a Pfizer-sponsored program "Covax US Support"received from a contactable consumer reporting for himself. A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. The patient experienced chest pains and ejection fraction decreased (from 40 down to 20) both on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included ejection fraction: from 40 down to 20 on unknown date. The events were considered serious as caused patient's hospitalization. The information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1056653
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: pneumonia; pneumonia; This is a spontaneous report from a contactable consumer (patient's son) An 84-years-old female patient received the second 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. The patient medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1056654
Sex: M
Age:
State: FL

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

Lab Data: Test Name: tested; Result Unstructured Data: Test Result:positive; Comments: he tested positive after the first dose

Allergies:

Symptoms: ok to get the 2nd dose if he tested positive after the first dose.; ok to get the 2nd dose if he tested positive after the first dose.; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was scheduled for 2nd shot on 13Feb2021; asked if it is ok to get the 2nd dose if he tested positive after the first dose on an unknown date. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1056655
Sex: F
Age:
State: TX

Vax Date: 01/01/2021
Onset Date: 02/09/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Aspiration pneumonia; This is a spontaneous report from a Pfizer sponsored program from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, in Jan2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 09Feb2021, the patient experienced aspiration pneumonia but no fever and on antibiotic. Clinical outcome was unknown at time of this report. The information on the lot number has been requested.; Sender's Comments: Event aspiration pneumonia represents a coincidental medical condition unrelated to the vaccine use. 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: 1056656
Sex: F
Age:
State: FL

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210129; Test Name: blood pressure; Result Unstructured Data: Test Result:150 systolic; Comments: usually 107-110/79

Allergies:

Symptoms: blew a blood vessel under her eye lid; stroke; tasted rubber band taste in her mouth; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), in a clinic, intramuscularly in the right arm on 29Jan2021 at 14:00 at 65-years-old at a single dose for COVID-19 immunization. There were no prior vaccinations within four weeks of the bnt162b2. Medical history included ongoing fibromyalgia from an unknown date, reflex sympathetic dystrophy from an unknown date and unknown if ongoing, irregular heart beat from an unknown date and unknown if ongoing, ongoing hemangioma from an unknown date, thyroid problems from an unknown date and unknown if ongoing, low white blood cell counts from an unknown date and unknown if ongoing, ongoing pinched nerves in her neck and back from an unknown date, migraines from an unknown date and unknown if ongoing, diastolic heart failure from an unknown date and unknown if ongoing (diagnosed about 5 years ago.), abdominal pains from an unknown date and unknown if ongoing, numbness in her nose, foot from an unknown date and unknown if ongoing, nausea from an unknown date and unknown if ongoing, vomiting from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1283) for COVID-19 immunization on 08Jan2021 at 64-years-old and experienced metallic taste (Recovered), carbamazepine (TEGRETOL) from an unknown date to an unknown date and experienced white count was down to 1, influenza vaccine (MANUFACTURER UNKNOWN) in Jul2020 at 64-years-old for immunization. The patient experienced the following events and outcomes: stroke (medically significant) on 29Jan2021 at 14:10 with outcome of unknown, blew a blood vessel under her eye lid (medically significant) on 31Jan2021 with outcome of recovering, tasted rubber band taste in her mouth (non-serious) on 29Jan2021 with outcome of unknown. The clinical course was reported as follows: The patient reported a history of migraines/ weather migraines, that cause numbness in nose and foot as well as gastro-intestinal symptoms. The patient received her first dose of the Pfizer COVID vaccine on 08Jan2021 and felt a metallic taste in her mouth (said that the metallic taste lasted about three hours; ate to get rid of the metallic taste). On 29Jan2021, the patient received her second dose; after 10 minutes her face went numb; her nose, forehead, and under her eyes all the way up felt numb. Also, the patient's systolic blood pressure was at 150. The patient reported that she also tasted rubber band taste in her mouth. The patient's neighbor that was there with her getting the vaccine told the nurse and they called the paramedics. The paramedics stated that they thought she had a stroke. She said that her blood pressure was 150 systolic (usually 107-110/79). The patient had diastolic heart failure which was diagnosed about 5 years prior. The numbness stayed with her until about 22:00 on 29Jan2021. The patient had a history of "migraines and gets abdominal pains, numbness in her nose, foot", and she experienced "nausea and vomiting and stuff with her migraines." The patient thought the vaccine just gave her a big migraine. The patient took sumatriptan succinate (IMITREX) and it did nothing. The patient said that on 31Jan2021 her eye felt weird. The patient blew a blood vessel under her eye lid. The patient's eye looked like a blood clot in the corner of her eye then it dispersed throughout the eye and then now it was just below the pupil of her eye. The patient called the doctor on 01Feb2021, but they were out because of the snow. On 02Feb2021, the patient received a call from the doctor's office saying that the physician assistant would call her back, but the patient had not heard anything yet. The blood circulated around her eye and now it was just only under her pupil. The patient said that her daughter sent her something that said that some people have gotten Bell's palsy after getting the vaccine. The patient said that she was concerned about this with the facial numbness. The patient said that every once in a while, her face felt weird; her cheeks feel weird and her nose. The patient said that it comes and goes. The day after she got the second shot, she felt like she got run over by a truck and like someone beat her up. The patient's migraines were under control with magnesium. The migraine came on so quick it was like a boom. The patient said that was why she was concerned. The patient said that she declined going to the hospital; and there was no trip to the emergency room or physician office. The patient underwent lab tests and procedures which included blood pressure: 150 systolic on 29Jan2021 (usually 107-110/79). Therapeutic measures were taken as a result of stroke.

Other Meds:

Current Illness: Fibromyalgia; Hemangioma; Pinched nerve

ID: 1056657
Sex: M
Age:
State: CA

Vax Date: 01/23/2021
Onset Date: 02/02/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: 10 days after 1st dose patient suffers ischemic stroke 4 days later the patient suffered a seizure; 10 days after 1st dose patient suffers ischemic stroke 4 days later the patient suffered a seizure; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 23Jan2021 at 08:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included Parkinson's disease, dementia, Post-traumatic stress disorder, high blood pressure and high cholesterol. Concomitant medication were not reported. It was mentioned other vaccine on 28Jan2021, but no further information provided. On 02Feb2021 at 12:00 am, 10 days after 1st dose of BNT162B2 patient experienced ischemic stroke and 4 days later the patient suffered a seizure. The events resulted in 6 days of hospitalization. At the time of the reporting the patient was recovering from events. Information about lot/ batch number has been requested

Other Meds:

Current Illness:

Date Died:

ID: 1056659
Sex: M
Age:
State: NJ

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

Lab Data:

Allergies:

Symptoms: heart issue; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient passed away after taking the vaccine. He was healthy but developed heart issue after taking vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: heart issue

Other Meds:

Current Illness:

Date Died: 02/19/2021

ID: 1056660
Sex: M
Age:
State: CA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Cardiac Event MI or Stroke; Cardiac Event MI or Stroke; This is a spontaneous report from a contactable consumer (Son in law). A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 17Feb2021 14:00 at single dose for covid-19 immunisation. Medical history included atrial fibrillation (AFib), prostate cancer Survivor. Concomitant medication included alirocumab (PRALUENT), escitalopram oxalate (LEXAPRO), apixaban (ELIQUIS), nitroglycerin and Ca channel blocker. The patient received the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient experienced cardiac event myocardial infarction (MI) or stroke on 17Feb2021. Adverse event result in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient died on 19Feb2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. The reporter didn't know if this was associated or not. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardiac Event MI or Stroke; Cardiac Event MI or Stroke

Other Meds: PRALUENT; LEXAPRO; ELIQUIS; NITROGLYCERIN

Current Illness:

ID: 1056661
Sex: M
Age:
State: NJ

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210119; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210126; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210202; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210209; Test Name: Nasal Swab; Result Unstructured Data: Test Result:unknown results-pending

Allergies:

Symptoms: bleeding through bandage (ceased quickly); pain at needle insertion; cold/chill sensation at injection site; very large bruise at injection site; residual discomfort at injection site; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm from 15Jan2021 at 13:00 at 71-years-old at a single dose for COVID-19 immunization; administered at a Nursing Home/Senior Living Facility. The patient's medical history was reported as none. Concomitant medications included finasteride (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN), vitamins nos (MULTIVITAMIN [VITAMINS NOS]); all taken for an unspecified indication from an unspecified date to an unspecified date; received within two weeks of the vaccine. On 15Jan2021 at 13:00, the patient experienced: bleeding through bandage (ceased quickly) (medically significant), pain at needle insertion (non-serious), cold/chill sensation at injection site (non-serious), very large bruise at injection site (non-serious), residual discomfort at injection site (non-serious); with no treatment received . The clinical course was reported as follows: The patient's concern was whether these issues affect the efficacy of the injection. The patient wanted to know if the vaccine was administered incorrectly. The patient wanted to know if he should be concerned about the continuing discomfort. The patient reported that he received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN9581), via an unspecified route of administration in the right arm from 05Feb2021 at 13:00 at 71-years-old at a single dose for COVID-19 immunization; and there was no reaction whatsoever to the second injection (other than slight arm discomfort; none of the above-described issues). The patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test): negative on 19Jan2021, negative on 26Jan2021, negative on 02Feb2021, unknown results-pending on 09Feb2021. The clinical outcome of the events was recovered with sequelae ("recovered with lasting effects") on an unspecified date.

Other Meds: FINASTERIDE; PRAVASTATIN; TAMSULOSIN; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1056662
Sex: F
Age:
State: NV

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 02/26/2021
Hospital: Y

Lab Data: Test Date: 2021; Test Name: Platelet Count; Result Unstructured Data: Test Result:9K; Test Date: 2021; Test Name: WBC; Result Unstructured Data: Test Result:Normal

Allergies:

Symptoms: Vaccine induced severe ITP; This is a spontaneous report from a contactable Other HCP. A 95-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 29Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included rectal cancer from 1998 (S/P AP resection, cured), Abdomino-perineal resection of rectum from an unknown date, Sulfonamide allergy. No Covid prior vaccination. There were no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two week. The patient previously took amikacin sulfate (NOVACIN) and experienced drug allergy. In 2021, patient developed multiple ecchymotic/purpuric skin lesions on extremeties and trunk 1-2 weeks after vaccination. Platelet count 9k. No anemia. Normal WBC. Oncologist diagnosis vaccine induced severe ITP (Idiopathic thrombocytopenic purpura). Admitted to Hospital 20Feb2021. Ongoing treatment. The patient was hospitalized for the events from 20Feb2021 to 25Feb2021 for 5 days hospitalisation. No Covid tested post vaccination. AES resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The patient underwent lab tests and procedures which included platelet count: 9k in 2021, white blood cell count: normal in 2021. Therapeutic measures were taken as a result of events (IV Decadron, IVIG). The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of idiopathic thrombocytopenic purpura due to temporal relationship. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1056663
Sex: U
Age:
State:

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Diarrhea; This is a spontaneous report from a consumer (patient). A patient of unspecified age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea on 18Feb2021 with outcome of unknown. The patient asked how long should patient tolerate diarrhea? What was the next step? When offered the contact number for Pfizer Medical Information, the patient stated "I would be dead by then, you don't know?". The information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 1056664
Sex: F
Age:
State: NC

Vax Date: 01/30/2021
Onset Date: 02/04/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: his wife had blood in her stool, but his wife thinks the blood may be from hemorrhoids; his wife developed bad diarrhea; Gastrointestinal pain; This is a spontaneous report from a contactable consumer reporting for his wife. A 69-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL9262) vaccine , via an unspecified route of administration in the left arm, on 30Jan2021 13:30 at single dose for Covid-19 immunisation . Medical history included clostridium difficile infection 4 or 5 years ago , haemorrhoids. The patient's concomitant medications were not reported. The patient had blood in her stool, but she thinks the blood may be from hemorrhoids on 09Feb2021 with outcome of unknown , his wife developed bad diarrhea on 04Feb2021 with outcome of not recovered , gastrointestinal pain on 04Feb2021 with outcome of not recovered. Hematochetia was considered an Important Medical Event. Course of the event. The reporter said approximately 4-5 days later (Thursday, 04Feb2021), his wife developed bad diarrhea. He said his wife was tested negative for bacteria and virus in her blood. He said his wife still has the diarrhea. He said his wife provided a stool sample to her GI doctor's office yesterday, 10Feb2021, and his wife's stool is being checked for everything. He said his wife has been having 2-3 bowel movements per day. He said the day-before-yesterday (09Feb2021), his wife had blood in her stool, but his wife thinks the blood may be from hemorrhoids. He said his wife has had hemorrhoids before, and her recurring diarrhea has brought the hemorrhoids out. He said his wife has ongoing gastrointestinal pain, as well. Follow up information has been requested.

Other Meds:

Current Illness:

ID: 1056665
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: her very ill after the 2nd shot; Patient had COVID-19 and received COVID-19 vaccine; Patient had COVID-19 and received COVID-19 vaccine; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received the second dose of (at the age of 80-year-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: not known), via an unspecified route of administration on unspecified date at SINGLE DOSE for COVID-19 immunization. Medical history included ongoing COVID-19. Concomitant medication included apixaban (APIXABAN) from unknown dates and indications. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on an unknown date and the patient experienced COVID-19. It was stated that the patient had COVID-19 and received COVID-19 vaccine which made her very ill on an unknown date after the 2nd shot. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: APIXABAN

Current Illness: COVID-19

ID: 1056666
Sex: F
Age:
State: GA

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Light cough; Shortness of breath; Anaphylaxis; lost voice entirely; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 11Feb2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history was none. Patient did not have known allergies and did not have COVID-19 prior to vaccination. Concomitant medications included piroxicam (PAXIL) and lisdexamfetamine mesilate (VYVANSE). Patient did not receive other vaccines in four weeks. The patient experienced light cough on 11Feb2021 at 14:45 with outcome of recovering, shortness of breath on 11Feb2021 with outcome of recovering, anaphylaxis on 11Feb2021 with outcome of recovering, lost voice entirely on 11Feb2021 with outcome of recovering. The events required emergency room visit and physician office visit. The patient was hospitalized due to the events in Feb2021 for 1 day. Events were considered life threatening. Clinical course: light cough after half an hour from vaccination. Within 2 to 3 hours had lost voice entirely and was suffering from shortness of breath. Her primary physician told her to go to the emergency room or he was calling an ambulance because he said it sounded like anaphylaxis and that her life was in danger. Therapeutic measures were taken as a result of the events and included treatment with intravenous (IV) Decadron Pepcid and epinephrine. She received the 2nd dose on 21Feb2021 at 01:15 PM. Patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.

Other Meds: PAXIL; VYVANSE

Current Illness:

ID: 1056667
Sex: F
Age:
State: FL

Vax Date: 01/20/2021
Onset Date: 02/01/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210208; Test Name: Hearing test; Result Unstructured Data: Test Result:complete hearing loss; Test Name: blood work; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptoms: hearing totally gone/complete hearing loss in left ear; tinnitus in ears and feeling of pressure; tinnitus in ears and feeling of pressure; Didn't make a real issue out of it and thought it was just congestion; This is a spontaneous report from a contactable consumer. A 78-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 in left arm at 11:15 at single dose for COVID-19 immunisation at the age of 78-year-old. Lot number was E18982. Medical history and concomitant medications were unknown. Historical vaccination included flu in Jan2021 for immunization. On 08Feb2021, the patient woke up with complete hearing loss in left ear, hearing totally gone, tinnitus in ears and feeling of pressure. In Feb2021, the patient did not make a real issue out of it and thought it was just congestion. On 08Fb2021, the patient saw ENT. On 08Feb2021, the patient performed a hearing test: complete hearing loss. On unknown date, blood work was performed, and the results were unknown. The patient did not recover from woke up with complete hearing loss in left ear/ hearing totally gone, tinnitus in ears and feeling of pressure, the outcome of nasal congestion was unknown.

Other Meds:

Current Illness:

ID: 1056668
Sex: F
Age:
State: TN

Vax Date: 01/25/2021
Onset Date: 01/29/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Comments: She has high blood pressure; Test Name: Blood pressure; Result Unstructured Data: Test Result:going better; Comments: she is going better with her blood pressure; Test Name: Heart beat; Result Unstructured Data: Test Result:heart beating real fast; Comments: she could feel her heart beating real fast; Test Name: Heart beat; Result Unstructured Data: Test Result:heart rate was like 100; Comments: her heart rate was like 100; Test Name: Heart beat; Result Unstructured Data: Test Result:80 beats per minute; Comments: it slowed it down to 80 beats per minute

Allergies:

Symptoms: She has high blood pressure; she developed Afib; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old female patient received bnt162b2 (BNT162B2; Lot # EN5318) vaccine, via an unspecified route of administration on 25Jan2021 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient developed atrial fibrillation on 29Jan2021 with outcome of unknown , she has high blood pressure on an unspecified date with outcome of unknown. The patient laid down and she could feel her heart beating real fast. She has high blood pressure so she went to taking her blood pressure and her heart rate was like 100. On Sunday night of that week it got worse and her blood pressure got higher so she called 911 and they took to the ER. She says this was her first ever episode with Afib she never had it before this. The patient was treated with metoprolol and rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood pressure measurement: high and heart rate: heart rate was like 100. Both the reported events were considered serious because Important Medical Events. Follow up information has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1056669
Sex: U
Age:
State: NV

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

Lab Data:

Allergies:

Symptoms: She knows one person did die; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned that 'she knows one person did die' on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: She knows one person did die

Other Meds:

Current Illness:

ID: 1056670
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: sore throat; miserable time; Initial information was received on 16-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210219000583). This case involves an adult patient who experienced sore throat (oropharyngeal pain) and miserable time (feeling abnormal), while the patient received INFLUENZA VACCINE. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious sore throat (oropharyngeal pain) and miserable time (feeling abnormal) unknown latency following the administration of INFLUENZA VACCINE. Details of laboratory data were not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the event outcome is unknown. There will be no information on batch number for this case.

Other Meds:

Current Illness:

ID: 1056671
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Almost lost patient due to the flu vaccine; Initial information was received on 12-Feb-2021 regarding an unsolicited valid non-serious social media case from a consumer via social media. This case involves a child male patient who was almost lost (unevaluable event), while he received vaccine INFLUENZA VACCINE. Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient was almost lost (died) (unevaluable event), (unknown latency) following the administration of INFLUENZA VACCINE. Laboratory data was not reported. It reporter said that there was no way their child will be getting the flu shot EVER again, they almost lost him due to the flu vaccine. It was not reported if the patient received any corrective treatment or not. The outcome for the event was unknown at the time of reporting. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1056672
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: flu; Initial information was received on 12-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210217000689). This case involves an adult patient who experienced flu, while the patient received INFLUENZA VACCINE. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE. Details of laboratory data were not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the event outcome is unknown. There will be no information on batch number for this case.

Other Meds:

Current Illness:

Date Died:

ID: 1056673
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Flu shots do kill; Initial information received on 11-Feb-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp via media. This case involves Adult female patient (reporter's mother in-law) (age unspecified) who died (death), after she received INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient died from flu shot (death) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events before death. It was unknown if there were laboratory data/results available. It was not reported if the patient received any corrective treatment before death. It was unknown if an autopsy was done. There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented media case which involves an adult female patient who died, after she received vaccines INFLUENZA VACCINE. The time to onset was unknown. Further information regarding medical history, concomitant disease or risk factor, concurrent condition during vaccination, previous vaccination and tolerance, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Flu shots do kill

Other Meds:

Current Illness:

ID: 1056674
Sex: F
Age:
State: PA

Vax Date: 10/15/2020
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Name: MRI; Result Unstructured Data: she had an MRI last week, which "spiked" her tinnitus.

Allergies:

Symptoms: nerve pain- a migrating pain that went everywhere; she had an MRI last week, which "spiked" her tinnitus; swollen left ankle; overstimulated my immune system; began to limp; she also developed inflammation of her veins, in her hands and feet; sore (left) arm, pain in her left hand/ wrist joint, in-between the web of her left hand (she describes as between the bones on the back of her hand) that night, the pain spread to her right hand; on-going myalgia of her neck, shoulders and back; poly-arthralgia- all over specifically mentioning her ankles, feet and toes; headaches; sore (left) arm, pain in her left hand/ wrist joint, in-between the web of her left hand (she describes as between the bones on the back of her hand) that night, the pain spread to her right hand; Initial information received on 09-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional. This case involves a 65 years old female patient who experienced nerve pain- a migrating pain that went everywhere (neuralgia), had an MRI last week, which "spiked" her tinnitus (tinnitus), swollen left ankle (joint swelling), overstimulated immune system (immune system disorder), began to limp (gait disturbance), she also developed inflammation of her veins, in her hands and feet (inflammation), sore (left) arm, pain in her left hand/ wrist joint, in-between the web of her left hand (she describes as between the bones on the back of her hand) that night, the pain spread to her right hand (pain in extremity) (vaccination site reaction), on-going myalgia of her neck, shoulders and back (myalgia), poly-arthralgia- all over specifically mentioning her ankles, feet and toes (arthralgia),and headaches (headache) , after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Patient had never received a flu vaccine before and states that she does not remember ever receiving any vaccines unless it was when she was a child and does not have a memory of it. Past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 15-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ469AB and expiration date not reported) via intramuscular route in the left arm for prophylactic vaccination given by her primary care provider. On an unknown date, the patient reported that when she "first got it" she quickly noticed that in addition to a sore (left) arm, she developed pain in her left hand/ wrist joint, and in-between the web of her left hand (she describes as between the bones on the back of her hand). That night, the pain spread to her right hand (vaccination site reaction) (pain in extremity). The bilateral hand pain became so severe over the next few days, that she couldn't lift her iPhone. On an unknown date, the patient complained of on-going myalgia of her neck, shoulders and back (myalgia). She stated that her left arm was sore down to elbow area, and both shoulders still hurt. The pain has decreased since initial onset but was still quite painful. She described "poly-arthralgia- all over"; specifically mentioning her ankles, feet and toes (arthralgia). She reported nerve pain- a migrating pain that went everywhere (neuralgia). She states that she cannot use her hands properly even now. She mentions hand and wrist braces being used, those may be discontinued at this time, she was not specific. On an unknown date, also reported that one day she was in her garage, just walking around, and her foot started to hurt badly. She began to limp (gait disturbance), and "had to go to bed" for the rest of the day. Also reported that two weeks ago, she sprained her knee, trying to rise from a sitting to standing position. Caller emphasized that she has always been a healthy, active person, who does not take medications, including over-the-counter analgesics. Reporter reported that she had seen two rheumatologists since the onset of these symptoms- she had an MRI (Magnetic resonance imaging) last week, which "spiked" her tinnitus (tinnitus). She further reported, a swollen left ankle (joint swelling) and headaches (headache). Patient stated that "the scariest part" was that she also developed inflammation of her veins, in her hands and feet (inflammation). Her various HCPs (health care professional) had told her that the vaccine "overstimulated my immune system and made it attack itself" (immune system disorder). All the reported events were non serious and the latencies were unknown for all the events. Patient was prescribed Prednisone, but "couldn't take it" because it increased her heart rate. She is now very depressed and feels that the vaccine has so debilitated her that it "has maimed her" She states that it should be taken off the market. She also reported extreme fear of taking the COVID 19 (coronavirus disease) m-RNA (Messenger Ribonucleic Acid) vaccines, because she had been reading about all the people who have died from that vaccine. And now the patent needs a list of all the ingredients in FLUZONE HIGH-DOSE QUADRIVALENT as She states that she suffered a serious adverse event, which she has already reported. Other relevant laboratory tests were not reported. At the time of reporting, the outcomes were unknown for all the events.

Other Meds:

Current Illness:

ID: 1056675
Sex: M
Age:
State: SC

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 5 year old male patient received dose of Daptacel after the injection they scanned the bottle and it registered as Pentacel, no AE; Initial information received on 18-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional, This case involves a five years old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] after the injection they scanned the bottle and it registered as DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered). Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 17-Feb-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was a case of actual medication error due to wrong product administered (latency on same day). It was also reported that Caller reports vaccine may have been administered in error. Caller they were trying Daptacel. After the injection they scanned the bottle and it registered as Pentacel. Caller reports they have contacted the manufacturer of the scanning equipment but they have not heard back yet. Caller reports this was administered on 17Feb2021. There was a call back request made and she provided the inquiry number to this case. She wanted to verify that the Daptacel was not mislabeled in anyway and that they could still use it. Additional Description of event adverse events: Reported by the She states that on Wednesday they received a new package of Daptacel and they opened it and run the bar code through a machine and it automatically runs the bar code and entered it as Pentacel and not Daptacel and it was given to a five year old child who is ok. She states that they manually loaded it in the system with the codes on the vial. She said they were questioning if it was the right codes on the vial. She said they are still waiting to hear back from the manufacturer of the scanning equipment but they have not heard back yet. This is all the information she provided at the time of her call. Reporter relationship: HCP (health care professional). At the time of report no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1056676
Sex: F
Age:
State:

Vax Date: 10/01/2015
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Potential anaphylactic type reaction; Difficulty breathing; Tightness in throat; Pain that was shooting to neck and back; Pain that was shooting to neck and back; Pain that was shooting to neck and back; Site reaction with redness; This spontaneous case was received on 17-Feb-2021 from other health professional via Agency (reference number: SEQW21-00550) and concerned female patient of an unknown age. The patient's medical history and concomitant medications were not provided. On an unspecified date in Oct-2015, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose, route of administration and anatomical location: not reported) as influenza prophylaxis. The batch number reported was U50309. On an unknown date in 2015, an unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to Afluria. She experienced site reaction with redness, pain that was shooting to neck and back. Nurse stated that the patient had potential anaphylactic type reaction as she woke in the middle of the night and had difficulty breathing and tightness in throat. Patient did not seek medical attention immediately. On an unknown date in fall or winter, the patient was seen by medicine doctor (MD) to discuss the incident and was referred to a dermatologist. The patient had not had a flu shot since then. The outcome of the events was not reported. The reported assessed the events as related to Afluria Quadrivalent. Patient had an allergic reaction to Afluria in 2015. The events of 'anaphylactic type reaction', difficulty breathing and tightness in throat were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. Company comment:The patient developed anaphylactoid reaction, dyspnoea, throat tightness, neck pain, pain, back pain and vaccination site erythema after vaccination with the suspect product, Afluria Quadrivalent. Although onset date for the events was not provided, narrative suggested plausible temporal relationship. The patient's medical history and concomitant medications were not provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: Patient had an allergic reaction to Afluria in 2015.; Sender's Comments: The patient developed anaphylactoid reaction, dyspnoea, throat tightness, neck pain, pain, back pain and vaccination site erythema after vaccination with the suspect product, Afluria Quadrivalent. Although onset date for the events was not provided, narrative suggested plausible temporal relationship. The patient's medical history and concomitant medications were not provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).

Other Meds:

Current Illness:

ID: 1056677
Sex: M
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: Had a more severe reaction / in terms of flu symptoms; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included sinus headache (occurs generally this times of the year). Previously administered products included Flu vaccine with an associated reaction of influenza (received on an unknown date refer case US2021AMR016788). On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. The reporter considered the influenza-like symptoms to be related to Shingrix. Additional details were provided as follows: The patient got the Shingles vaccine this fall and had more severe reaction with it in term of flu symptoms. The patient think the Shingles vaccine was Shingrix.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR016788:Same reporter.

Other Meds:

Current Illness:

ID: 1056678
Sex: M
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: Mild flu symptoms for a day; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the influenza-like symptoms to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. With the Flu vaccine the patient normally had mild flu symptoms for a day. The case had been linked with US2021AMR016766 for the same patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR016766:Same reporter.

Other Meds:

Current Illness:

ID: 1056679
Sex: U
Age:
State: OH

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

Lab Data:

Allergies:

Symptoms: Facial swelling; hives; This case was reported by a consumer and described the occurrence of facial swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced facial swelling and hives. On an unknown date, the outcome of the facial swelling and hives were recovered/resolved. It was unknown if the reporter considered the facial swelling and hives to be related to Shingrix. Additional information were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per vaccine indication. The patient received dose of shingrix and experienced facial swelling and hives for over a year. The patient inquired would it be safe to have any of the Covid vaccines and were there any components of Shingrix that would be in the Covid vaccines. The information regarding consent to follow was not reported.

Other Meds:

Current Illness:

ID: 1056680
Sex: F
Age:
State: KY

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

Lab Data:

Allergies:

Symptoms: titers were inconclusive; This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a 19-year-old female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient had completed a Hepatitis B vaccine series as a child had titers drawn and the titers were inconclusive, which led to therapeutic response decreased. The reporter consented to follow up. Brand name of previous HepB series was unknown. Titers were drawn for this patient was starting nursing school. The medical assistant stated additional patient details are not available at this time. The physician just asked the Medical Assistant to call and did not provide any further details. The medical assistant consents to follow up from safety.

Other Meds:

Current Illness:

ID: 1056681
Sex: F
Age: 60
State: TX

Vax Date: 10/08/2020
Onset Date: 10/08/2020
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Site was red / Still bothers her / Symptoms are worse again; Site was swollen / Still bothers her / Symptoms are worse again; Arm at the injection site is still weak / muscle is weak / started after the shot / Still bothers her / Symptoms are worse again; Can't lift her arm higher than shoulder height / Still bothers her / Symptoms are worse again; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date unknown) for prophylaxis. On 8th October 2020, the patient received Shingrix. On 8th October 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, weakness of arms and mobility decreased. On 8th January 2021, the outcome of the injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the weakness of arms and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, weakness of arms and mobility decreased to be related to Shingrix. Additional details were provided as follows: The reported batch number JPA27 for Shingrix did not exist and was updated to JP427 as per the sales database. After receiving dose of Shingrix, the patient experienced her arm at the injection site is still weak, the muscle was weak and can't lift her arm higher than shoulder height following. The HCP reports for the first 10 days the site was red and swollen, the weakness started after the shot. The Pharmacist reports that symptoms were bad at the beginning, got a little better during November and are worse again. The patient called her doctor about it, but he couldn't see her over the holidays. The patient wants to go see him though because it still bothers her. The reporter consent to follow up.

Other Meds:

Current Illness:

ID: 1056682
Sex: F
Age: 76
State: CA

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she is in a lot of pain; pain is in her RIGHT arm; right upper back pain that burns and goes numb and tingly; right shoulder blade pain; back / goes numb and tingly; back / goes numb; This case was reported by a consumer and described the occurrence of pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 15th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 15th January 2021, 1 hr after receiving Shingrix, the patient experienced pain, pain in arm, upper back pain, shoulder blade pain, tingling and numbness. On an unknown date, the outcome of the pain, upper back pain, shoulder blade pain and tingling were not recovered/not resolved and the outcome of the pain in arm and numbness were unknown. It was unknown if the reporter considered the pain, pain in arm, upper back pain, shoulder blade pain, tingling and numbness to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. 1 hour after receiving Shingrix patient experienced lots of pain. The patient received Shingrix in left arm and experienced pain in right arm and in upper back area, back pain burns and tingling and numbness. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1056683
Sex: F
Age: 31
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: The right side of my face got very hot, tingly, and itchy.

Other Meds: None

Current Illness: None

ID: 1056684
Sex: F
Age: 56
State: VA

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

Lab Data:

Allergies: No

Symptoms: Soreness at the point of injection; loose stool; slight rapid heartbeat/pulse but then back to normal.

Other Meds: Chewable Centrum and Caltrate.

Current Illness: No

ID: 1056685
Sex: M
Age: 70
State: NJ

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: My heart beats per minute went up to 75 from 57. (I wear a fitbit fitness tracker) It started at about 5:30 pm and lasted for less than 30 minutes and then returned to normal the fifties again

Other Meds: Nexium

Current Illness: none

ID: 1056686
Sex: M
Age: 65
State:

Vax Date: 02/24/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Patient hospitalized due to fevers, hypoxia to mid 70s, severe fatigue and lethargy which developed within hours of receiving vaccine.

Other Meds:

Current Illness:

ID: 1056687
Sex: F
Age: 79
State: PA

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

Lab Data:

Allergies:

Symptoms: headache and temp of 99.7

Other Meds:

Current Illness: Chronic kidney disease

ID: 1056688
Sex: M
Age: 66
State: NC

Vax Date: 02/24/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: N/A

Allergies: N/A

Symptoms: Severe chills, headache, body aches and sweats.

Other Meds: Losarten , low dose asparin, vitamin d, vitamin e, vitamin c.

Current Illness: N/A

ID: 1056689
Sex: F
Age: 35
State: TX

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

Lab Data: I did an online telemedicine visit only.

Allergies: None

Symptoms: Started with pain in left breast a couple days after vaccine given, then developed the Shingles rash a week after vaccine was given.

Other Meds: None

Current Illness: None

ID: 1056690
Sex: M
Age: 38
State: VA

Vax Date: 01/07/2021
Onset Date: 01/18/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Skin Biopsy

Allergies: None

Symptoms: SDRIFE Drug Exanthem

Other Meds: None

Current Illness: None

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm