VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1313025
Sex: M
Age:
State: IL

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Rec V Date: 05/13/2021
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Symptoms: my uncle had a heart attack a week after getting the vaccine; This is a spontaneous report from a contactable consumer (patient's niece). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that her uncle had a heart attack a week after getting the vaccine on an unspecified date with outcome of unknown. Information on batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1313026
Sex: M
Age:
State:

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 05/13/2021
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Symptoms: tested positive for Covid 19 virus; tested positive for Covid 19 virus; feeling under the weather/feel bad; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 as single dose, second dose via an unspecified route of administration on 20Apr2021 as single dose for covid-19 immunisation. Medical history included seasonal allergies. The patient's concomitant medications were not reported. The patient had received both doses of his Covid 19 vaccine, first dose was 30Mar2021, second dose was about one week ago on 20Apr2021. He was feeling a little under the weather when he received the second vaccine on 20Apr2021 but he had seasonal allergies so he thought that was what he was experiencing. His temperature was taken at the Covid 19 vaccine clinic and he was able to receive his second vaccine. He continued to feel bad and was tested for the Covid 19 virus. He got the results back today, 27Apr2021, and was positive for the Covid 19 virus. That means he had the Covid 19 virus when he received his second Covid 19 vaccine. He was asking what happens if he's already infected with the Covid 19 virus when he receives his Covid 19 vaccine? Is there a reason if he's asymptomatic with the Covid 19 virus and gets the Covid 19 vaccine, does it matter or does he have to get another Covid 19 vaccine? He started having side effects then decided to take a covid test on Sunday (25Apr2021) and positive. He wanted to know if he will have to take another covid vaccine since he tested positive after receiving his second covid vaccine. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1313027
Sex: F
Age:
State: AR

Vax Date: 04/12/2021
Onset Date: 04/01/2021
Rec V Date: 05/13/2021
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Symptoms: stiffness of joints; Didn't sleep at all last night.; Back pain; can't walk; Knee pain; right and left arm pain/legs hurt/hands were also hurting; not as hard of a pain but it is in the muscles below the knee and in the back of the calf.; neuropathy; whip lash in shoulders and neck; feel radiation or heat; uncomfortable; shoulders became sore; tired; Eyes hurt; vasculitis pain flare up; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in right upper arm, at age 48 years, on 12Apr2021 13:00 (Batch/Lot Number: 9R8732) as second dose, single, for COVID-19 immunization. Relevant medical history includes two autoimmune diseases and two lung diseases further reported as ongoing Post-traumatic stress disorder (PTSD) diagnosed in 2017 because of trauma from vasculitis because both her arms looked like sleeves of nothing but broken blood vessels; Chronic obstructive pulmonary disease (COPD) from unspecified dates; ongoing bronchiolitis from unspecified date that does not go away; ongoing Hepatitis B contracted after vasculitis had gotten back together with her baby daddy and contracted it that way; ongoing small cell vasculitis (CSVV) from Oct2017 is her main disease; immune system weaker than her mom; body is weak; has weak muscles; generalized anxiety disorder; depression; she had fell on both arms, she's had a knee surgery; and she can barely walk because she pulled a back muscle before, her back and her having an injury from 2 years ago in 2019. Patient also usually gives blood at her primary care. Family history includes arthritis, her mom has it. Concomitant medications included tenofovir alafenamide fumarate (VEMLIDY) taken for antibiotic therapy from an unspecified start date and ongoing; meloxicam taken for joint swelling from an unspecified start date and ongoing; alprazolam (XANAX) taken for generalised anxiety disorder from an unspecified start date and ongoing; quetiapine fumarate (SEROQUEL) taken for post-traumatic stress disorder from an unspecified start date and ongoing; pantoprazole taken for ulcer from an unspecified start date and ongoing; sertraline taken for depression from an unspecified start date and ongoing; promethazine taken for prophylaxis of nausea and vomiting from an unspecified start date and ongoing; albuterol sulfate taken for an unspecified indication from an unspecified start date and ongoing; and budesonide taken for lung disorder, start and stop date were not reported. Patient historically took first dose of BNT162B2 (injection, Batch/lot number: EN6202) in the left upper arm at age 47 years on 19Mar2021 at 1:40pm at a clinic for COVID-19 immunization and experienced no adverse event; and an unspecified flu shot last Oct2020 (also reported as last winter). Patient has some 5 or 6 doctors there as specialists or prescribers. She has a liver specialist and a vasculitis specialist, whom she has not seen since the flare up because of her insurance, a main primary that saved her and brought her into remission is not covered with her insurance, and a GI doctor as well. She also reported that her immune system is probably weaker than her mom's because of her own 2 diseases. She also said that she was supposed to be in lung therapy but her body is weak. She stated that every time something hurts, it may be neuropathy. She has weak muscles and they haven't been this weak. She could move around and do things before. Patient was tired from the autoimmune and lung disease, she has had to stop and rest. Patient clarified that she had these prior to COVID coming. Patient wanted to get the vaccine to have more immunity so she could go out. She didn't want to get the Corona virus. The doctors said she wouldn't make it. It was her choice but the doctors recommended it. It was reported that patient has completed vaccination. About a week ago (13Apr2021), started experiencing a lot of pain from a vasculitis flare up. It is as if it just happened and was having a lot of pain in various parts of the body. Patient stated that it didn't start until like the second day (13Apr2021). Patient was not disgruntled, believes in the vaccine. She has an appointment with the tele doc this week and with another doctor at the same office since doctor was not in this week, because of her back and her having an injury from 2 years ago, X-rays, and can't walk right now, is in a lot of pain. She did not know if she can take pain pills, with all her other stuff. Patient stated that both her legs hurt and she can't walk. Her hands were also hurting with it in Apr2021. Patient had knee pain on 19Apr2021, leg pain was still there but getting better and was still hurting when she walks. It is not as hard of a pain but it is in the muscles below the knee and in the back of the calf in Apr2021. On 21Apr2021 or 22Apr2021, right and left arm just hurts all the way down started. They are the same and are still hurting and staying persistent. On 26Apr2021, back pain was added and stated that she got it for complaining about her arm. It started About 3 days after the shot, around 14Apr2021 or 15Apr2021, patient had whiplash in shoulders and the neck. It started in the back of the head and was like she could feel radiation or heat. It would be so uncomfortable, her shoulders became sore. When she looked left or right, it felt like whip lash. It has gotten better. For her arm, she wanted to revert to ice/heat but she hasn't done anything yet. Patient called her primary in hopes that he would give her something for the pain, she was not in pain management but it is hurting so bad. Since the injection, she has been so tired, so she has not been taking her XANAX. She takes them as needed for generalized anxiety disorder and her anxiety has not been up. A lot of the time she does not have to take them. The diseases make her tired and fatigued. If her mind is too racy, she will take to keep as calm as possible, especially with the small cell vasculitis or then she could have a flare. Her main objective is to keep calm. She was already taking 1 XANAX a day when diagnosed with PTSD but they just raised it because then came her PTSD and depression from the vasculitis. Has muscle relaxer cyclobenzaprine hydrochloride (FLEXERIL) at 100mg once a day which she doesn't take. Did not normally take these but has been taking them since this happened. She is in so much pain. Does not generally have high tolerance for pain. Does not like taking opioids because they make her throw up. She can only take them with Phenergan. Does not take if she does not need them because they do not sit well with the liver. She has an inhaler that keeps the lungs dilated for 10 hours, is not Pulmicort but something else. Eyes hurt on Apr2021 and can't read the label because its so little. She has bronchiolitis which is another rare disease with the airways in her lung and medication keeps the lungs dilated. Haven't seen the doctor yet so no tests yet. Since this happened, she can't walk. On 26Apr2021, when she went back down she couldn't walk since. It is her lower back on the right side, above her hip. She had pulled it 2 years ago (2019), above the hip on the right side. She recognized this feeling from a couple of years ago. It seems to be the place where she feels over winded. It may be neuropathy problems, wondering if it's not neuropathy since it's not her muscles (Apr2021). Everything that was wounded has come back and hurts as bad as it does. For can't walk, the pain just hurts. She didn't sleep at all last night (26Apr2021). Tries to turn and get up and if she is on either of her arms. Other than the neck, shoulders and back of her head, she never got a fever. When it started she thought that it was normal. Then, it started hitting in all of these other places and she was barely moving. Patient had the normal feeling like when she would breathe. On an unspecified date, she was having stiffness of the joints, as if they were traveling, then taking a vacation to every place that she has ever hurt itself. S

Other Meds: VEMLIDY; MELOXICAM; XANAX; SEROQUEL; PANTOPRAZOLE; SERTRALINE; PROMETHAZINE; ALBUTEROL SULFATE; BUDESONIDE

Current Illness: Bronchiolitis (Verbatim: Bronchiolitis); Hepatitis B (Verbatim: Hepatitis B); Post-traumatic stress disorder (Verbatim: PTSD); Vasculitis (Verbatim: small cell vasculitis)

ID: 1313028
Sex: M
Age:
State: FL

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 05/13/2021
Hospital: Y

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Symptoms: diagnosed with Pneumonia; sick; tested positive for the COVID19 virus; tested positive for the COVID19 virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got sick and had been hospitalized and had been diagnosed with Pneumonia. Also, reported patient ended up in the hospital because he got pneumonia. The patient tested positive for the COVID19 virus. The events outcome was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1313029
Sex: F
Age:
State: AR

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/13/2021
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Symptoms: having Skin Cancer removed; About a week ago, started experiencing a lot of pain from a vasculitis flare up.; a lot of pain from a vasculitis flare up/a lot of pain in various parts of the body; This is a spontaneous report from the Pfizer Sponsor Program. A contactable consumer (patient's daughter) reported that a 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. Medical history included arthritis (had pain sin those areas during cold weather), 2 autoimmune diseases, surgery and shoulder joint pain. The patient's concomitant medications were not reported. Clinical course: patient started experiencing a lot of pain from a vasculitis flare up. It was as if it just happened and was having a lot of pain in various parts of the body in Apr2021. Patient was actually in the care of her vasculitis doctor because she was having skin cancer removed by him. Patient had glasses. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1313030
Sex: M
Age:
State: MD

Vax Date: 04/08/2021
Onset Date: 04/27/2021
Rec V Date: 05/13/2021
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Symptoms: two blood clots in his right calf; It is painful; This is a spontaneous report from a contactable nurse. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in arm left at 10 am on 16Mar2021 (Batch/Lot number was not reported) as 1st dose, single; dose 2 via an unspecified route of administration, administered in arm left at 10 am on 08Apr2021 (Batch/Lot number was not reported) as 2nd dose, single, both for covid-19 immunisation. Medical history included ongoing varicose vein (for years, barely noticeable). No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations received within 4 weeks. The patient's concomitant medications were not reported. The patient experienced two blood clots in his right calf on 27Apr2021, it is painful. The event 'two blood clots in his right calf' was reported as serious and seriousness criteria were medically significant and disability. He said it is better today once he started apixaban (ELIQUIS). He did not know if that was physical or mental. The adverse event required a visit to physician office. The patient underwent lab tests and procedures which included sonogram on leg: unknown results. The outcome of events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: Varicose veins (for years, barely noticeable.)

ID: 1313031
Sex: M
Age:
State: MA

Vax Date: 03/31/2021
Onset Date: 04/04/2021
Rec V Date: 05/13/2021
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Symptoms: Severe pain to muscle and joint; Severe pain to muscle and joint; tingling from shoulder blade to wrist; unable to drive or work; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:00 at the age of 64 years old (Lot Number: Er8735) as 1st dose, single for covid-19 immunisation. Medical history was none. Known_allergies was no. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered in the Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 04Apr2021 00:15, the patient experienced Severe pain to muscle and joint, tingling from shoulder blade to wrist never went away x 4 weeks unable to extend arm unable to drive or work. The adverse events result in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received for the adverse events included Ongoing dr neurologist neurontin pain medicine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1313032
Sex: F
Age:
State: AR

Vax Date: 04/09/2021
Onset Date: 04/14/2021
Rec V Date: 05/13/2021
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Symptoms: arm soreness; tiredness; hives that is getting worse on legs, stomach, breast, on head, arms back and thigs; constriction of the windpipe; This is a spontaneous report from a contactable consumer who reported for herself. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, at the age of 64 years, on 09Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included back pain, fibromyalgia, restless legs syndrome, depression from 1987 to an unknown date, headache, hyperthyroidism. Concomitant medications included gabapentin (GABAPENTIN) taken for restless legs syndrome, start and stop date were not reported; hydrocodone (HYDROCODONE) taken for an unspecified indication, start and stop date were not reported; fluoxetine (FLUOXETINE) taken for depression, start and stop date were not reported; methimazole (METHIMAZOLE) taken for an unspecified indication, start and stop date were not reported; topiramate (TOPIRAMATE) taken for headache, start and stop date were not reported and apixaban (ELIQUIS) taken for an unspecified indication from Feb2021 to an unspecified stop date. The patient received first dose of COVID vaccine BNT162B2 on 19Mar2021 for COVID-19 immunization and experienced hives on legs, top of the arm and swollen lips/lip swelled really big. The patient stated, "I have had both shots of the COVID Pfizer and that the first time I had it, I had some symptoms about a little over a week out. What I had was hives. It is not that real big. This time, I have been about a week out. I was starting to have have hives and I keep having them. They are not just complete blocks just all over but spreaded and I am having kind of constriction of my wind pipe also (14Apr2021). Is that a symptom to that with the COVID virus, the shot. Yes, last I had was April 9th and I am still having spots coming out of me and I am taking Benadryl like crazy and today I have still got them on me, you know the spots and I have like something is cutting my wind pipe off, you know, constriction, you know it's not all the time but its quite a few times a day on that and I am wondering if that. When I started having the problem. The first vaccine I had on night on March 19th and about a week and a half, I had about, I would say 8 to 9 days after that. I started having the hives and then I had a real bad frozen layup out of that (further not clarified) but the second time I had the vaccine also the night and I had the hives about a week out and then I have had constriction of the wind pipe that just completely chocked me out." The patient stated that after the second dose she had arm soreness, tiredness, hives that is getting worse on legs, stomach, breast, on head, arms back and thigs and constriction in the wind pipe. She took Benadryl and Phenergan for it. Therapeutic measures were taken as a result of constriction of the windpipe and urticaria. The outcome of the event constriction of the windpipe was not recovered while other events were unknown.

Other Meds: GABAPENTIN; HYDROCODONE; FLUOXETINE; METHIMAZOLE; TOPIRAMATE; ELIQUIS

Current Illness:

ID: 1313033
Sex: F
Age:
State: NC

Vax Date: 03/26/2021
Onset Date: 03/28/2021
Rec V Date: 05/13/2021
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Symptoms: extreme fatigue; malaise/feel sick; the bottoms of my feet hurt so it's hard to walk; the bottoms of my feet hurt so it's hard to walk; This is a spontaneous report from a contactable other hcp (Patient). A 49-year-old female patient received bnt162b2 (Pfizer), dose 1 via an unspecified route of administration, administered in Arm Right on 26Mar2021 13:15 (Lot Number: er8733) as single dose for covid-19 immunisation at the age of 49-year-old. The patient was not pregnant at time of vaccination. Medical history included herniated disc (l5-s1) and back pain from an unknown date. No known allergies. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced extreme fatigue and malaise/feel sick, the bottoms of feet hurt so it's hard to walk on 28Mar2021 with outcome of not recovered. The events were considered serious as disability. The events resulted in Doctor or other healthcare professional office/clinic visit. The clinical course was reported as follows: I am having extreme fatigue and malaise. Prior to receiving the vaccine I had NO health issue other than back pain, but now I have extreme fatigue, the bottoms of my feet hurt so it's hard to walk, (and I'm fit) and I feel sick ALL OF THE TIME. Follow up needed, further information has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1313034
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
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Symptoms: About 3 weeks after second does the person tested positive for Covid; About 3 weeks after second does the person tested positive for Covid; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. About 3 weeks after second does the patient tested positive for covid. The adverse events result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included monoclonal antibodies. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1313036
Sex: M
Age:
State: CT

Vax Date: 03/13/2021
Onset Date: 03/13/2021
Rec V Date: 05/13/2021
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Symptoms: Shingles; blood pressure turned dropping/107/70; Tingling; Throwing up; since of that all he had anaphylactic reaction because he is allergic to Penicillin; his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side; cold and sweaty; cold and sweaty; Headache; Dizziness; he did "fall on the ground"; "creepy"; This is a spontaneous report from a contactable consumer (patient's fiance). A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 13Mar2021, single for the prevention of corona virus. Medical history included high blood pressure and allergy to penicillin both from an unknown date and unknown if ongoing. The patient's fiance and the patient took their first Pfizer Covid shot on 13March2021 and within 4 minutes the patient started showing symptoms of everything. The patient had his shot on his left arm, his whole left side of his body went numb. He was asked "are you allergic to anything" and he said he cannot have Penicillin. The reporter stated that event on the day of the report, the patient still has the numbness down in his foot, his toe and on his left side but also originally within 4 minutes he was sat down and also within 12 minutes he was throwing up and they could not figure out what was wrong, he did "fall on the ground" (as reported, not further clarified). The patient was experiencing, not as strong but still experiencing, tingly and shingles and originally was numb. The patient is concerned about it. The patient only took the first one because that was on the Saturday and on Monday he went to the doctor and the doctor suggested to not take the second one because his blood pressure turned dropping, he does have the blood pressure and it was 107/70. The reporter said that the patient has allergy and since of that all he had anaphylactic reaction because he is allergic to Penicillin (as reported, pending clarification). He had tingling and shingles after the shot. He was very cold and sweaty and "creepy" (as reported not further clarified). The reporter called the nurse and they took over to have his blood pressure and it was 107/70. The reporter also added that just 4 minutes after the shot he had headache and dizziness and numbness bottom of his left foot and his toe, tingling under his foot and numbness under his toe. The patient did not take any treatment for the events but might take Tylenol for the headache. The outcome of the events his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side, shingles, blood pressure turned dropping 107/70, headache and dizziness was not recovered while the outcome of the other events was unknown.

Other Meds:

Current Illness:

ID: 1313037
Sex: F
Age:
State: AK

Vax Date: 04/02/2021
Onset Date: 04/01/2021
Rec V Date: 05/13/2021
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Symptoms: second dose was April 2nd and and her one two weeks earlier; second dose was April 2nd and and her one two weeks earlier; she has myocarditis; Sick for several days; This is a spontaneous report from a contactable consumer (patient's mother). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Batch/Lot Number: Unknown), via an unspecified route of administration on 02Apr2021 at age of 50 years old as 2nd dose, single for COVID-19 immunization. Medical history included mast cell disease (mast cell activation syndrome). The patient's concomitant medications included other medication: "She received chemo every 2 weeks for it." The patient experienced myocarditis, sick for several days, both on an unspecified date in Apr2021. The second dose was 02Apr2021 and other one two weeks earlier. Description: Reporter stated, the oldest daughter (patient) had, well all of this happen, little last when they got Pfizer Covid 19 vaccine, she got her last one 02Apr2021 and she was sick for several days and they finally diagnosed her at the reporting date, they taken her to emergency room then finally she was able to see a cardiologist, she said that she had myocarditis and they were just wondering, the reporter realized that it could possibly be from the vaccine because reporter just saw that on news and reporter was calling because some information about. When probed if start experiencing the side effect after the second shot: Reporter stated, "Actually she didn't right way." When confirmed about the patient, reporter stated, "She was the only one their whole family got this. Just her." Treatment: She went to the emergency room 2 times and saw cardiologist. No." The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1313038
Sex: M
Age:
State: WA

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 05/13/2021
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Symptoms: possible thrombosis reaction; Unexpected bruising near injection site.; Bruise was purple and red splotches and has now progressed to mostly yellow/discoloration; Bruise was purple and red splotches and has now progressed to mostly yellow/discoloration; minimal pain/stiffness following the shot; minimal pain/stiffness following the shot; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 53-year-old via an unspecified route of administration, administered in Arm Left on 20Apr2021 11:15 (Lot Number: EW0153) at 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient received no 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 had not been tested for COVID-19. Concomitant medication included famotidine (PEPCID AC). The patient previously took flu shot in Oct2020, prilosec [omeprazole magnesium] for seasonal allergy and experienced drug hypersensitivity. The patient experienced unexpected bruising near injection site. Bruise was the size of the bandaid, approximately 1" x 2". Bruising had persisted for more than a week now. The patient had never experienced bruising like this with other vaccines. He would like to rule out possible thrombosis reaction before second shot. He did not have bruising at any other locations other than the injection site. Bruise was purple and red splotches and has now progressed to mostly yellow. He believed the discoloration was a reaction to the vaccine and not the result of the needle. The shot itself was painful but patient felt minimal pain/stiffness following the shot. The event start date was on 20Apr2021. No treatment was received. The outcome was unknown.

Other Meds: PEPCID AC

Current Illness:

ID: 1313039
Sex: M
Age:
State: VA

Vax Date: 04/10/2021
Onset Date: 04/13/2021
Rec V Date: 05/13/2021
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Symptoms: hemoglobin had dropped 1.1 grams/now anemic; thrombocytopenia; This is a spontaneous report from a contactable physician. A 63-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10Apr2021 (Lot Number: ER8729) as single dose for covid-19 immunization. Medical history included autoimmune thyroiditis, psoriasis. Concomitant medications included levothyroxine. The patient experienced thrombocytopenia on 13Apr2021, one week later, platelets rebounded but his hemoglobin had dropped 1.1 grams, now anemic. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, patient was unknown diagnosed with COVID-19. The outcome was recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events thrombocytopenia and hemoglobin decreased and the suspect drug. 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 agency, as appropriate.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1313040
Sex: M
Age:
State: IL

Vax Date: 04/18/2021
Onset Date: 04/21/2021
Rec V Date: 05/13/2021
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Symptoms: Extreme heart pain; Pericarditis; very hard to breath; This is a spontaneous report from a contactable consumer (patient). A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 18Apr2021 11:00 (Batch/Lot Number: ER8735) at the age of 23-years-old as single dose for covid-19 immunization. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included known allergies Gluten. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: Er8730) in Right arm on 28Mar2021 11:00 AM at the age of 23-years-old for covid-19 immunization. The patient experienced Pericarditis- Extreme heart pain, very hard to breath, taken to Emergency room (ER) 21Apr2021 19:00. Events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. 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 underwent lab tests and procedures which included blood tests: unknown results, electrocardiogram (EKG): unknown results, x-ray: unknown results, all on an unknown date. The outcome of the events was recovering.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1313041
Sex: M
Age:
State: KY

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 05/13/2021
Hospital: Y

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Symptoms: neuropathy; ataxia; neurological deficits with headache; Headache; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm left on 16Mar2021 (Lot Number: En6208) (at age of 47-year-old) as single dose for covid-19 immunization. Medical history included high blood pressure, there was no known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 23Feb2021 (Lot number: En6198) for covid-19 immunization. There was no other vaccine in four weeks. Adverse event: Headache occurred 10-15 mins after second vaccination. Persistent headache after 3 weeks of 2 COVID vaccination. After the 3 weeks (also reported as on 26Mar2021) started experiencing neurological deficits with headache. Symptoms include: motor sensory weakness, ataxia and neuropathy. Admitted to hospital for neuropathy and ataxia on 21Apr2021. AE results in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Apr2021.There was no COVID prior vaccination. The outcome of the events was not recovered.

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Current Illness:

ID: 1313044
Sex: F
Age:
State: NV

Vax Date: 03/12/2021
Onset Date: 03/16/2021
Rec V Date: 05/13/2021
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Symptoms: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 57 years, administered in Arm Left, on 12Mar2021 14:00 (Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included High Blood Pressure. The patient was not pregnant at time of vaccination. Concomitant medications included labetalol; furosemide; spironolactone. The patient previously took naproxen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Bell's Palsy (medically significant) on 16Mar2021 21:00. The adverse event result in "Emergency room/department or urgent care". The patient received treatment of steroids and antibiotics for event. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. Event outcome was recovering.

Other Meds: LABETALOL; FUROSEMIDE; SPIRONOLACTONE

Current Illness:

ID: 1313045
Sex: F
Age:
State: NJ

Vax Date: 04/21/2021
Onset Date: 04/26/2021
Rec V Date: 05/13/2021
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Symptoms: DVT in right calf; This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 53-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Left arm on 21Apr2021 14:30 (Lot Number: EWO170) as 1st dose, single for covid-19 immunization. Medical history included hypertonic bladder. The patient's concomitant medication included unspecified medication. The patient experienced DVT in right calf on 26Apr2021. The event resulted in Emergency room/department or urgent care. The patient received the Xarelto 15mg as treatment. The patient was not pregnant at time of vaccination. The outcome of the event was recovering.; Sender's Comments: The event DVT was considered related to suspect drug BNT162B2 based on compatible temporal association and known safety profile of the drug. however, the contribution of age and underlying medical conditions cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

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Current Illness:

ID: 1313046
Sex: F
Age:
State: KY

Vax Date: 04/26/2021
Onset Date: 04/27/2021
Rec V Date: 05/13/2021
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Symptoms: began having severe cramping and heavy bleeding with clots the next day; Started menstrual cycle a week early a day after getting second dose; began having severe cramping; heavy bleeding with clots the next day; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (BNT162B2, Pfizer COVID 19), dose 2 via an unspecified route of administration, administered in left arm on 26Apr2021 08:45 (Lot Number: unknown) as single dose for covid-19 immunization. Medical history included Anemia, ulcerative colitis, intracranial hypertension. None allergies reported. Concomitant medications included iron taken for anaemia. The patient received dose 1 on 01Apr2021 07:45 in right arm for covid-19 immunization. The patient started menstrual cycle a week early a day after getting second dose. The patient began having severe cramping and heavy bleeding with clots the next day 27Apr2021. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. The outcome was recovering. Follow up attempts are needed. Further information has been requested.

Other Meds: IRON

Current Illness:

ID: 1313047
Sex: M
Age:
State: CA

Vax Date: 04/06/2021
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Rec V Date: 05/13/2021
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Symptoms: First Vaccine, BRVO in the right eye approx 1 week after injection. (sucks).; This is a spontaneous report from a contactable consumer (patient) reporting different event under the same suspect product. This is one of two reports. A 53-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 06Apr2021 15:45 (Batch/Lot Number: ER8729) at the vaccination age of 53 years old as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, Hypertension, High T3. Patient had allergies penicillin, Tetracycline, "Teramyacin". Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; liothyronine sodium (CYTOMEL) taken for an unspecified indication, start and stop date were not reported; nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication, start and stop date were not reported. The patient experienced BRVO in the right eye approx 1 week after injection. Therapeutic measures were taken as a result of the event and patient visited other healthcare professional office/clinic visit. Outcome of event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: SYNTHROID; CYTOMEL; BYSTOLIC

Current Illness:

ID: 1313048
Sex: F
Age:
State: PA

Vax Date: 03/24/2021
Onset Date: 04/16/2021
Rec V Date: 05/13/2021
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Symptoms: Blood clotting with spotting and pain; Irregular period; Pain in lower left side of abdomen; Blood clotting with spotting and pain; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Mar2021 10:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included none. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications the patient received within 2 weeks of vaccination. The patient previously received the first dose on 05Mar2021 08:00 as single dose for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced irregular period after second dose, pain in lower left side of abdomen and blood clotting with spotting and pain on 16Apr2021 12:00. The outcome of the events was unknown. No treatment received for the events. Information related lot/batch number has been requested.

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Current Illness:

ID: 1313049
Sex: F
Age:
State: CA

Vax Date: 04/18/2021
Onset Date: 04/19/2021
Rec V Date: 05/13/2021
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Symptoms: kidney stone irritation; chills; aches and pains; dehydration; low white blood cell count/ White blood cells: Before: 4.9 and After: 2.4; Neutrophils, before 2.9, after 1.6; Lymphocytes: before 1.2, after 0.4; This is a spontaneous report from a contactable consumer (patient). A 46-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 46 years, administered in Right arm, on 18Apr2021 13:15 (Lot Number: 8737) as single dose for covid-19 immunisation. Medical history included ongoing Kidney stones. The patient was not pregnant at time of vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 46 years in the Left arm on 27Mar2021 15:30 (Lot Number: 8734) as single dose for COVID-19 immunisation. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient, on 19Apr2021 01:30, had typically reported side effects (chills, aches and pains), plus dehydration which caused kidney stone irritation and resulted in ER visit. While there, noticed really low white blood cell count during labs. Here are labs two days before and two days after vaccine: White blood cells: Before: 4.9 and After: 2.4; Neutrophils: Before: 2.9 and After: 1.6; Lymphocytes: Before: 1.2 and After: 0.4. The adverse event result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". The patient received treatment for event that included Hydration, pain/nausea meds for kidney stones. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. Events outcome was recovering.

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Current Illness: Kidney stones

ID: 1313050
Sex: M
Age:
State: CA

Vax Date: 04/20/2021
Onset Date: 04/01/2021
Rec V Date: 05/13/2021
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Symptoms: Sore throat; not been feeling well; Nasal congestion; Headache; Fever; Fatigue/Tiredness; she gave her son Extra Strength Tylenol 500mg tablets: NDC Number: 50580-449-09, Lot Number: LEA012, Expiration Date: Feb2021; Now sick at the Urgent Care; This is a spontaneous report from two contactable consumers one of (patient mother) via Medical information team. A 23-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0161, Expiration date was not reported), via an unspecified route of administration, on 20Apr2021 12:00 on left arm as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The transferring agent stated the caller said her son felt fatigued on 20Apr2021 the next day (21Apr2021), and had a headache, fever, and a sore throat. Reported she had called her son's doctor today (28Apr2021) because her son had not been feeling well since yesterday (27Apr2021). She said her son's doctor told her to take her son to an urgent care. She said her son had a COVID-19 Virus test and a Strep Throat Test today (28Apr2021) at urgent care. She said the urgent care also took her son's vital signs. She said she was told by an urgent care staff member that her son's symptoms could be from a number of things, but the urgent care staff member said her suspicion was that her son's symptoms were a side effect from the COVID-19 Vaccine. She clarified that her son's COVID-19 Virus Test was negative today (28Apr2021), but she was told by the urgent care staff member the negative COVID-19 Virus test could be a false negative. She stated her son's Step Throat test results had not come back yet. Clarified her son's sore throat started yesterday (27Apr2021). She said her son couldn't stand having the sore throat. She clarified her son was not feeling well yesterday, and that was why she called her son's doctor today. Reported her son's fever had subsided with Tylenol, and her son's headache had gone away, and not come back. She said her son also had nasal congestion that started yesterday (27Apr2021), but her son was not blowing his nose and also reported she gave her son Extra Strength Tylenol 500mg tablets: NDC Number: 50580-449-09, Lot Number: LEA012, Expiration Date: Feb2021. Reporter calling for her son who took the Covid vaccine and is now sick at the Urgent Care. She is wondering about side effects 7-8 days after taking the vaccine. As per the reporter seriousness criteria reported for the event now sick at the Urgent Care was medically significant. The patient underwent lab tests and procedures which included Strep throat test: unknown and COVID-19 virus test: negative on 28Apr2021. Therapeutic measures were taken as a result of fever. The outcome of the event Sickness and expired drug used was unknown, fatigue, headache, fever was recovered on Apr2021 and not recovered for another events. No follow-up attempts are needed. No further information is expected.

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Current Illness:

ID: 1313052
Sex: F
Age:
State: FL

Vax Date: 04/25/2021
Onset Date: 04/25/2021
Rec V Date: 05/13/2021
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Symptoms: Pancreatitis flare-up began as the side effects intensified/ Felt like pancreatic and GI inflammation; Pancreatitis flare-up began as the side effects intensified; Felt like pancreatic and GI inflammation; Could't keep any food or liquid down; vomited green stomach bile; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 11:45 AM (Batch/Lot Number: ER8734) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 40 years old. Patient was not pregnant. Medical history included Chronic Pancreatitis (idiopathic) from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Occassional Benadryl allergy and Tylenol, both taken for an unspecified indication, start and stop date were not reported. The patient previously took clindamycin and experienced known allergies, bnt162b2 for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (brand=Pfizer; lot number=EW0172) on Apr2021 03:45 PM at Left arm for covid-19 immunization. The patient experienced pancreatitis flare-up began as the side effects intensified (medically significant), felt like pancreatic inflammation (medically significant), GI inflammation (non-serious), could't keep any food or liquid down (non-serious), vomited green stomach bile (non-serious), all on 25Apr2021 18:00 with outcome of recovering. Reported as pancreatitis flare-up began as the side effects intensified. Could't keep any food or liquid down and vomited green stomach bile. Felt like pancreatic and GI inflammation as my immune system responded to vax. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected

Other Meds: BENADRYL ALLERGY & COLD; TYLENOL

Current Illness:

ID: 1313053
Sex: M
Age:
State: CA

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 05/13/2021
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Symptoms: heart fluttering; arrhythmias; Fever; chills; intense pressure behind eyes; headache; muscle weakness; fatigue; brain fog; intense body pains/aches; intense body pains/aches - especially at joints (knees, wrists, ankles); heart pounding; insomnia; lack of appetite; migraine with aura; lethargy; This is a spontaneous report from a contactable pharmacist (patient). A 30-years-old male patient received bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/facility. The patient medical history was not reported. No known allergies. The patient's concomitant medications were none. No other vaccine in four weeks. No other medication in two weeks. The patient previous received the first dose on 31Mar2021 11:00 (Lot number=ER8737) as single dose at Left arm for covid-19 immunization. The patient had no reaction on previous exposure to vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Fever, chills, intense pressure behind eyes, headache, muscle weakness, fatigue, brain fog, intense body pains/aches - especially at joints (knees, wrists, ankles), arrhythmias/heart fluttering, heart pounding, insomnia, lack of appetite, migraine with aura, lethargy on 22Apr2021 13:00. The outcome of the events was recovering. No treatment received.; Sender's Comments: The contributory role of the suspect product bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization to reported events is possible based on temporal association and known profile of the product.

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Current Illness:

ID: 1313054
Sex: F
Age:
State: CO

Vax Date: 04/03/2021
Onset Date: 04/01/2021
Rec V Date: 05/13/2021
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Symptoms: 2 or 3 days after first shot, I noticed my face drooping a bit on the left side of my mouth. then my left eye would not open imediately when would wake up. 2 days after my 2nd muscle weakness worsened; 2 or 3 days after first shot, I noticed my face drooping a bit on the left side of my mouth. then my left eye would not open imediately when would wake up. 2 days after my 2nd muscle weakness worsened; 2 or 3 days after first shot, I noticed my face drooping a bit on the left side of my mouth. then my left eye would not open imediately when would wake up. 2 days after my 2nd muscle weakness worsened; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 03Apr2021 12:15 (Batch/Lot Number: EP6955) as SINGLE DOSE, patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 24Apr2021 12:30 (Batch/Lot Number: ER8735) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, stroke after surgery (No lasting effects from stroke). Relevant past drug history: known drug hypersensitivity to Sulfa drugs. Concomitant medications included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), gabapentin (GABAPENTIN), loratadine (LOTADINE). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19 On an unspecified date Apr2021,The patient experienced Bells Palsy, Facial droop, muscle weakness worsened.. The clinical course was reported as follows 2 or 3 days after first shot, patient 'I noticed face drooping a bit on the left side of my mouth. then my left eye would not open immediately when would wake up. 2 days after my 2nd muscle weakness worsened. The events were medically significant. The adverse events did required an Emergency Room Visit. Therapeutic measures were taken as a result of Bells Palsy, Facial droop , muscle weakness worsened. The clinical outcome of the events was recovering. Follow up needed, further information has been requested.

Other Meds: LISINOPRIL; ATORVASTATIN; GABAPENTIN; LOTADINE

Current Illness:

ID: 1313057
Sex: F
Age:
State: TX

Vax Date: 02/28/2021
Onset Date: 03/11/2021
Rec V Date: 05/13/2021
Hospital: Y

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Symptoms: a blot clot discovered in lung within 2 weeks of first shot.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number En6202, on 28Feb2021 10:45 at single dose in right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no covid prior vaccination. The patient had not tested covid post vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a blot clot discovered in lung within 2 weeks of first shot on 11Mar2021. The event resulted in Physician Office Visit. Treatment included blood thinner for blood clot. The outcome of the event was unknown. The event is serious with hospitalization and disability. Follow-up attempts are needed. Further information is expected.

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Current Illness:

ID: 1313058
Sex: F
Age:
State: CA

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 05/13/2021
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Symptoms: Fell and blacked out briefly; Dizziness; Fell and blacked out briefly; This is a spontaneous report received from a contactable consumer (patient). A 32-years female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8735, on 15Apr2021 07:45 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The patient had no known allergies. The patient had Dizziness on Friday in the evening (16Apr2021). Fell and blacked out briefly at evening. No treatment was received for the events. The outcome of the events was unknown.

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Current Illness:

ID: 1313059
Sex: M
Age:
State: TX

Vax Date: 01/23/2021
Onset Date: 02/01/2021
Rec V Date: 05/13/2021
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Symptoms: Detached retina; This is a spontaneous report from a non-contactable consumer (patient). A 67-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262, on 23Jan2021 at 14:00 at single dose in left arm for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The patient had no Known allergies. The patient experienced Detached retina on 01Feb2021. The event resulted Physician Office Visit. Treatment received included Surgery. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 Since the vaccination. Lab data included Nasal Swab with unknown results. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1313060
Sex: F
Age:
State: WV

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 05/13/2021
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Symptoms: twitches in her legs and then pain after; Face periodically twitches; eye twitches periodically especially after sneezing or coughing; twitches in her legs and then pain after; Face periodically twitches; eye twitches periodically especially after sneezing or coughing; Face periodically twitches; eye twitches periodically especially after sneezing or coughing; stinging in her legs and it went up to her waist and felt like a band around her waist; stinging in her legs and it went up to her waist and felt like a band around her waist; Unexpected weight loss; no appetite; Unexpected weight loss; no appetite; This is a spontaneous report received a contactable nurse, the patient. A 50-year-old adult female received the first dose of BNT162b2 (solution for injection; Lot EW0158 and expiry information not provided) as a single dose via unspecified route in the right arm on 08Apr2021 at 19:30 (at 50-years-old) for COVID-19 immunisation. Relevant medical history included COVID with insomnia (Nov2020). There were no concomitant medications or past drug history reported. The patient reported as soon as she got the shot, she did not feel sick or nauseated, maybe she had no appetite, but she has lost ten pounds three weeks. States before the vaccine she was 138 pounds. The patient reported that on 18Apr2021, reported as eight to ten days later she developed stinging in her legs and it went up to her waist and felt like a band around her waist. The patient reported that on 20Apr2021 she experienced twitches in her legs and then pain after, her face periodically twitches; eye twitches periodically especially after sneezing or coughing. The patient reported that she had COVID back in Nov2020 and she had some problems after and then recovered. States she just got the Pfizer COVID vaccine three weeks ago and she did really well with the first one; however eight to ten days later, she noticed stinging in her legs and it went up to her waist and felt like a band around her waist. Then she started having twitches in her legs, and then pain, states the twitches have remained, she cannot see them, but she can feel them. Caller states her face periodically twitches as well. Her eye will twitch periodically when she sneezes or coughs. The patient, a retired nurse, assessed the events as medically significant, because she needs to know if it is something more serious. The patient denied any visits to the emergency room or to any doctor's office for the events reported. The patient reported that she called a few neurologists to see if she could have gotten in but they are so booked up that she could not get an appointment until August. The patient stated that the neurology place said they are seeing some very strange things, so the patient believes she is not the only one. The reporter stated that maybe because she had COVID, she does not know if it is because of that, but maybe the first one acting is acting like the second dose for her. The patient inquired if it was okay to get the second dose. The outcome of the event stinging in her legs and it went up to her waist and felt like a band around her waist was recovered on 20Apr2021. The outcome of the event weight loss; no appetite, twitches in her legs and then pain after, and Face periodically twitches; eye twitches periodically especially after sneezing or coughing was not recovered.; Sender's Comments: Based on a compatible temporal association a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1313061
Sex: F
Age:
State: NY

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 05/13/2021
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Symptoms: having faint spells; blood pressure is a little bit higher than normal; Feeling kind of funny; had severe headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8727, second dose) solution for injection intramuscular in the left arm on 25Mar2021 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. Medical history included thyroid disease (diagnosed with probably 20-21 years ago) and blood pressure increased (takes blood pressure medicine). Concomitant medication included hydrochlorothiazide for blood pressure increased began taking this 4 or 5 years ago. Historical vaccine included BNT162B2 (first dose, lot EN6200) for COVID-19 vaccination on 04Mar2021 with no adverse effect reported. On 25Mar2021, the patient was feeling kind of funny and had a severe headache. In Apr2021, the patient had faint spells and blood pressure was a little bit higher than normal at 137/80 which began after the second dose Pfizer Covid Vaccine. The patient stated she never felt like fainting before in her life. Her blood pressure was never over 150 and can't keep blood pressure under 130 for some reason. The outcome of the events feeling kind of funny and headache was unknown. The outcome of the events faint spells and blood pressure was a little bit higher was not recovered. Information on batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event faint spells and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1313062
Sex: F
Age:
State: NV

Vax Date: 04/08/2021
Onset Date: 04/01/2021
Rec V Date: 05/13/2021
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Symptoms: passing blood clots from her rectum; blood clots; deathly ill; the lymph nodes underneath the arm swell up / She swelled up on her right side; kind of in the breast/chest area, up a little higher than the breast and it was very uncomfortable; This is a spontaneous report received a contactable consumer, the patient. A 68-year-old elderly female received the first dose of intramuscular BNT162b2 (solution for injection; Lot ER8737 and expiry information not provided) as a single dose in the left arm on 08Apr2021 at 11:00 (at 68-years-old) for COVID-19 immunisation. Relevant medical history included ongoing back problems for which she takes medication. Concomitant medications included unspecified medication for back problems. The patient denied any other vaccines within four weeks prior to this vaccine. The patient reported that she generally gets the flu shot every year and has never had any adverse reactions. The patient also mentioned that she previously tramadol (for an unspecified indication) in the past but has not taken it for years. The patient reported that she received her first dose on 08Apr2021 at (Privacy). The patient explained that within six hours she was deathly ill. The patient reported that stayed very ill for quite a few days. The patient stated when she gets up in the morning, she gets up early and she always goes to the bathroom. The patient stated that on 13Apr2021, when she went to the bathroom, she started passing blood clots from her rectum which went on until 16Apr2021. When describing the blood clots, the patient stated 'envision sunny side up eggs, between six to eight of them, and in between that was all this webbing holding the clots together'. The patient stated while she was urinating, the clots were just pouring out of her rectum. The patient clarified that there was not blood in her stool. The patient explained that she took the opportunity to get some plastic gloves and look through her stool for blood and there was not any. The patient stated that her underwear and the toilet paper was stained. The patient also stated that she was reading that whichever arm you get the vaccine, the lymph nodes underneath the arm swell up. The patient explained that her lymph nodes did not swell up underneath her left arm where she got the shot. She swelled up on her right side. She clarifies she was swollen underneath her arm, kind of in the breast area and chest area, up a little higher than the breast. It was very uncomfortable. The patient denied any visits to the emergency room or doctor's office for the events. The outcome of the event passing blood clots from her rectum was recovered on 16Apr2021. The outcome of the events deathly ill, the lymph nodes underneath the arm swell up / She swelled up on her right side, and was very uncomfortable was unknown.

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Current Illness:

ID: 1313063
Sex: F
Age:
State:

Vax Date: 01/08/2021
Onset Date: 04/23/2021
Rec V Date: 05/13/2021
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Symptoms: She had a rapid test performed that was positive and went a received a PCR test for confirmation; She had a rapid test performed that was positive and went a received a PCR test for confirmation; This is a spontaneous report from a contactable consumer (patient self, a Physician Assistant). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, the first dose on 18Dec2020 at single dose and the second dose on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had a weekly PCR test. Her last test on Tuesday April 20th was negative. On evening (Friday 23Apr2021) patient felt exhausted and slightly congested and realized she was the only member of the household that had not received a screening test that day. She had a rapid test performed that was positive and went to receive a PCR test for confirmation. Her symptoms had progressed since then including severe fatigue, dry cough, significant congestion, and become easily winded with minimal exertion. She had been monitoring her temperatures and O2 sats. The outcome of the events was unknown. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1313064
Sex: F
Age:
State: NH

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 05/13/2021
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Symptoms: Tested positive For Covid on 19Apr2021; Nasal Swab tested positive for Covid on 19Apr2021; body aches; Sorearm; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 12:15 (Lot Number: EW0150) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hypothyroidism. The patient's concomitant medications were not reported. Relevant past drug history included Pennicilin and sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient first reported she received her first dose on 05Apr2021 and then got COVID on April 15th. She was due for her second vaccine on 26Apr2021 but due to isolation she was unable. She further reported that she had body aches and sore arm on 05Apr2021 for over a week. Nasal Swab tested positive for Covid on 19Apr2021 and was out of work for 10 days. The outcome of the events body aches and sorearm was resolving and for other events was unknown. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 on 30Apr2021.

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ID: 1313065
Sex: F
Age:
State: FL

Vax Date: 03/22/2021
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Rec V Date: 05/13/2021
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Symptoms: Received first dose of Covid Vaccine on 22Mar. Husband and daughter came down with Covid; Received first dose of Covid Vaccine on 22Mar. Husband and daughter came down with Covid; This is a spontaneous report from a contactable consumer (parent; mother) and a physician via a Pfizer-sponsored program. This consumer (mother) reported same events for two patients. This is the second of 2 reports. A female patient (daughter) of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, unknown lot number and expiration), via an unknown route of administration on 22Mar2021 at 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's mother reported that the patient received first dose of COVID vaccine on 22Mar. Husband and daughter came down with COVID on unspecified date. Patient came down with COVID as she was in quarantine and will miss her second dose. As of 27Apr2021, it was confirmed that the husband (patient's father) and daughter tested positive for COVID. The patient underwent lab test and procedure which included: COVID-19 PCR test: positive on unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested. Amendment: This follow-up report is being submitted to amend previously reported information: The event coded to Missed dose in error was deleted. Verbatim term "Received first dose of Covid Vaccine on 22Mar. Husband and daughter came down with Covid" was also coded to Drug ineffective and was upgraded to serious (medically significant). Case is now serious. New information received from a physician includes: course details.; Sender's Comments: Linked Report(s) : PFIZER INC-2021481080 Same reporter, product, event; different patient

Other Meds:

Current Illness:

ID: 1313066
Sex: F
Age:
State: PA

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 05/13/2021
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Symptoms: burning between her belly button and breasts; sharp pain in her belly; arm felt like someone punched her; Severe Stomach Pain; stomach pain was unbelievable; So Much Diarrhea; Peeing out of her butt; This is a spontaneous report from a contactable nurse reporting for herself. A 72-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 13Apr2021 11:30 (Batch/Lot Number: ER8731) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced severe stomach pain; stomach pain was unbelievable on 13Apr2021 with outcome of recovering , so much diarrhea; peeing out of her butt on 13Apr2021 with outcome of recovered on 17Apr2021 , sharp pain in her belly on 14Apr2021 with outcome of recovering , burning between her belly button and breasts on 15Apr2021 with outcome of recovered on 17Apr2021 , arm felt like someone punched her on 13Apr2021 with outcome of recovered on 15Apr2021. The patient underwent lab tests and procedures which included blood test: unknown on 26Apr2021. All the reported events were considered Important Medical Events. Causality: Caller stated yes, it is related to the vaccine. Stated she doesnt get diarrhea. Stated she eats healthy and doesnt ever get diarrhea, well maybe once in a blue moon. Caller states she thinks it is totally related to the vaccine. Follow up information has been requested. Lot number was already provided.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.

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ID: 1313067
Sex: F
Age:
State: VA

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 05/13/2021
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Symptoms: seizure; This is a Spontaneous report from a contactable other healthcare professional (HCP). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 at single dose for COVID-19 immunisation. Medical history included Bipolar disorder, Depression, Attention deficit hyperactivity disorder (ADHD) and sleep (disorder). Concomitant medication included cariprazine hydrochloride (VRAYLAR) orally from 18Mar2021 to 02Apr2021 at 1.5 mg, daily for Bipolar disorder; escitalopram oxalate (LEXAPRO) at 10 mg for Depression; amfetamine sulfate (EVEKEO) 2 times a day for ADHD; bupropion hydrochloride (WELLBUTRIN) and mirtazapine (REMERON) for sleep (disorder). It was reported patient experienced seizure on 02Apr2021 after using concomitantly Vraylar, Lexapro, Evekeo, Wellbutrin and Remeron, experienced seizure after using concomitantly Lexapro and Wellbutrin. The initial report from the United States was received via Company representative originating from a nurse on 15Apr2021, regarding an 18-year-old female patient who experienced seizure, drug interaction, and labelled drug-drug interacton medication error following the administration of cariprazine hydrochloride, amfetamine sulfate, escitalopram oxalate, mirtazapine, Pfizer Covid-19 and bupropion hydrochloride. Company received the report on 16Apr2021. Reportedly, the patient began cariprazine hydrochloride 1.5mg daily orally for Bipolar disorder on 18Mar2021, had the Covid-19 vaccine on 01Apr2021, and had a seizure on 02Apr2021. The patient had no history of seizures. The reporter did not believe the seizure was caused by the cariprazine hydrochloride (causality for seizure was also reported as unlikely). The patient was taken to the emergency room but not admitted, treatment and outcome unknown other than the emergency room staff advised the patient to "discontinue everything". The reporter assessed the relationship between cariprazine hydrochloride and the event of seizure as unlikely. Laboratory tests were not reported. The patient experienced the seizure one day after Covid 19 vaccine. Considering the short onset latency, the vaccine was also considered co-suspect. The case in confounded by patient's use of co-suspect medications that could have lowered the seizure threshold. The following important missing medical information will be helpful for further case evaluation: medical history, indications and therapy dates for all suspects, action taken, lab results (drug blood levels), investigations, treatment, outcome. Treatment information was not provided. At the time of the report, the outcome of seizure was reported as unknown. This case was considered serious due to the following seriousness criterion: medically significant. Information on batch number has been request.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. Contributory role of concomitant medications should also be considered. 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: VRAYLAR; LEXAPRO; EVEKEO; WELLBUTRIN; REMERON

Current Illness:

ID: 1313068
Sex: M
Age:
State: TX

Vax Date: 04/20/2021
Onset Date: 04/21/2021
Rec V Date: 05/13/2021
Hospital: Y

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Symptoms: Left arm weakness; Unable to flex wrist or fingers; This is a spontaneous report from a contactable physician. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 71 years of age), intramuscular, administered in arm left on 20Apr2021 (Batch/Lot Number: ER8731) as 1st dose, single for COVID-19 immunisation. Medical history included anxiety, hyperlipidaemia, depression and hypertension, all from an unknown date and unknown if ongoing. The patient had no known allergies. The patient's concomitant medications were not reported. The patient had not received any other vaccine within four weeks prior covid-19 vaccine. He had no covid-19 prior to vaccination. He had not been tested for covid-19 post vaccination. The patient was taking Legendz, Powerful enhanced energy, and Horny goat weed. On 21Apr2021, the patient experienced left arm weakness, unable to flex wrist or fingers. The events resulted to doctor or other healthcare professional office/clinic visit. The patient was admitted to the hospital for the events. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered. Information on lot/batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1313069
Sex: M
Age:
State: FL

Vax Date: 04/16/2021
Onset Date: 04/18/2021
Rec V Date: 05/13/2021
Hospital: Y

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Symptoms: slurred speech; Right arm and right leg weakness; TIA; Fever; Weakness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8737), via an unspecified route of administration in right arm on 16Apr2021 16:00 as 2nd dose, single for COVID-19 immunization. Medical history included hypertension (Htn) and non-insulin dependent diabetes mellitus (Niddm). Concomitant medications included amlodipine and vitamins nos (MULTIVITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8730) in the left arm on 26Mar2021. The patient experienced slurred speech, right arm and right leg weakness, transient ischaemic attack (TIA), fever, and weakness, all on 18Apr2021 08:00. The events resulted to ER visit (Emergency room/department or urgent care) and patient was hospitalized for 2 days. Therapeutic measures were taken as a result of the events and reportedly included treatment with blood thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered with sequel. Events seriousness was hospitalization and disability. Information on lot/batch number was available. Additional information has been requested.

Other Meds: AMLODIPINE; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1313070
Sex: U
Age:
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Rec V Date: 05/13/2021
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Symptoms: flu; Based on information previously received, the following information [Delete Non-Valid classification and the justification product not otherwise specified (NOS) and Influenza Vaccine to be recoded] has been amended. Initial and additional information regarding an unsolicited non-valid non-serious case received from a consumer (patient) from via social media on 12-Oct-2020 and 17-Oct-2020 respectively (both processed together). This case is linked to case 2020SA289533(CLUSTER). This case involves patient (unknown demographics) who experienced flu (influenza), while receiving vaccine INFLUENZA VACCINE. Medical history, medical treatment, concomitant medication, vaccination 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. It was also reported that Only had the flu one time. The year patient took the Flu shot. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event influenza was reported as unknown. There will be no information available on the batch number for this case. Follow-up information regarding an unsolicited non-valid non-serious case received from a consumer (patient) from via social media on 17-Oct-2020 transmitted to Sanofi on 17-Mar-2021. Action taken changed unknown to not applicable. Corresponding field and narrative were updated accordingly.

Other Meds:

Current Illness:

ID: 1313071
Sex: F
Age: 0
State: TX

Vax Date: 05/03/2021
Onset Date: 05/03/2021
Rec V Date: 05/13/2021
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Symptoms: Vaccine was reconstituted the hib with sterile water, instead of the diluent, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Agency (Reference number- 00585910) and transmitted to Sanofi on 03-May-2021. This case involves a two-month-old female patient who received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ390AAA and expiry date: 29-Oct-2021) via an unknown route in the left thigh for prophylactic vaccination, which was reconstituted the hib part with sterile water, instead of the diluent on 03-May-2021 (product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination. The reporter wanted to know that the revaccination should be needed or not. This was a case of actual medication error due to inappropriate reconstitution technique (latency same day). At the time of reporting, 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: HEPATITIS B VACCINE; PREVNAR; ROTATEQ

Current Illness:

ID: 1313072
Sex: U
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Rec V Date: 05/13/2021
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Symptoms: yellow fever; Initial information received on 03-May-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare Professional. This case involves a adult patient (unspecified gender and age) who had yellow fever while receiving YELLOW FEVER VACCINE. Medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect YELLOW FEVER 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 developed a serious yellow fever (unknown latency) following the administration of YELLOW FEVER VACCINE. This event was assessed as medically significant. Medication Details and reason for taking the medicine: prophylactic vaccination It is unknown if the patient had any medical history, concomitant disease or risk factor. It was unknown if there were lab data/results available. causality not reported It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was unknown. There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a patients (unspecified age and gender) who had yellow fever after vaccination with YELLOW FEVER VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.

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Current Illness:

ID: 1313073
Sex: M
Age:
State: TX

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Symptoms: he suffered from adverse events as a result of the error; at the age of 34, patient was administered Fluzone High Dose Quadrivalent in error, instead of Fluzone Quadrivalent; at the age of 34, patient was administered Fluzone High Dose Quadrivalent in error, instead of Fluzone Quadrivalent; at the age of 34, patient was administered Fluzone High Dose Quadrivalent in error, instead of Fluzone Quadrivalent; Initial information received on 21-Apr-2021 regarding an unsolicited valid non-serious case from a patient via Medical Information (inquiry reference 00571004). This case involves a 34 years old male patient, who was administered with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in error, instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiration date for both the suspects were not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (wrong product administered, product administered to patient of inappropriate age and overdose) and suffered from adverse events as a result of the error (adverse event). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose (same day latency). On an unknown date, the patient had developed a non-serious adverse events as a result of the error (adverse event), (unknown latency) following the vaccination. The caller stated that his immunization chart shows that he received 2 doses of the Fluzone on the same date. It was reported that today (that is, on the day of reporting), the caller would like to receive documentation from Sanofi stating the exact number of cytokines that are in Fluzone Quadrivalent as well as Fluzone High Dose Quadrivalent. The caller wanted to know what is the safety threshold of someone of his age having received Fluzone High Dose Quadrivalent. No laboratory data reported. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome of adverse event was unknown. 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. Reported that, this inquiry was placed in proxy for further handling of only the medical inquiry of this case. The caller was advised as per the legal SRD (system Requirements Document) regarding requesting documentation or correspondence. The caller was in the Vaccination Compensation Program. The caller stated that he has an attorney and he needed specific documentation. The caller also stated that his VAERS (Vaccine Adverse Event Reporting System) documentation has him listed as a female and he needs this corrected- the caller entered his information into the VAERS system incorrectly. Case was reviewed and copied to legal. There will be no information on the batch number for this case.

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ID: 1313074
Sex: U
Age:
State: IL

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 05/13/2021
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Symptoms: Initial information received on 29-Apr-2021 regarding an unsolicited valid non-serious case from other health professionals via Agency (inquiry number 00582945). This case involves a patient with unknown demography who was administered with an expired 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number was not reported and expiry date: 19-Apr-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 20-Apr-2021. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. The reporter asked if it counts as a valid dose. It was an actual medication error due to expired vaccine used (latency: same day). At the time of reporting, it was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information on the batch number for this case.

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ID: 1313075
Sex: U
Age:
State: TX

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Rec V Date: 05/13/2021
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Symptoms: vaccine was mixed with a sterile diluent but not the one that comes with the vaccine, no AE; Initial information was received on 30-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional in. This case involves a patient (demographics unknown) who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] mixed with a sterile diluent but not the one that came with the vaccine, (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (Product preparation error). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of an actual medication error due to Wrong diluent used (latency same day). At the time of report, no adverse event was reported. The caller stated that they administered a dose of Pentacel and that the vaccine was mixed with a sterile diluent but not the one that comes with the vaccine. She had questions about side effects and re-administering the vaccine. she would like to know when they can give another Pentacel dose since it is not considered a valid dose. She would like to know if they can give it as soon as possible or do they have to wait. She said they were planning on giving another Pentacel dose to the patient not until the week of the 10th. The Caller had questions about side effects and re-administering the vaccine. She was referred to the Pentacel Reconstitution Guide. She was asked for additional information for the adverse event (AE) report and she said that she does not know if she would give accurate information. She said she does not believe it was reconstituted the way that it should have been. This is all the information she provided at the time of her call. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

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Current Illness:

ID: 1313076
Sex: M
Age: 3
State: CA

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 05/13/2021
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Symptoms: patient received expired IPOL/ NO AE; Initial information received on 30-Apr-2021 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 36 months old male patient who received expired dose of 0.5 mL IPV (VERO) [IPOL] (strength: standard, frequency: once, batch number: R1B251M, expiry date: 13-Mar-2021 via subcutaneous route in left arm) (expired product administered) on 30-Apr-2021 for prophylactic vaccination The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications included HIB VACCINE CONJ (TET TOX) (HIBERIX); INFLUENZA VACCINE (INFLUENZA VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic Vaccination. It was an actual medication error case due to expired vaccine used (latency: same day). At the time of reporting, 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 set out in Directive 2001/83/EC and Module VI of the Good Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

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Current Illness:

ID: 1313077
Sex: F
Age:
State: CA

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Rec V Date: 05/13/2021
Hospital: Y

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Symptoms: seizures; Initial information received on 04-May-2021 regarding an unsolicited valid serious case received from a consumer. This case involves a 8 month old female patient who experienced seizure, while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. Past vaccination included PENTACEL (October and January) with no problems. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, concomitant medication and family history were not provided. On an unknown date (March), the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported) (Suspension for injection) (Frequency once) via an intramuscular route in the leg for prophylactic vaccination. On an unknown date, the patient developed a serious seizure (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. It was also reported that Caller is requesting information on ingredients of PENTACEL, and also asks if the ingredients change from lot to lot because his daughter received two PENTACEL vaccines with no problems, but the third one she received resulted in adverse event. He wonders if the third one had any different ingredients. It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. Corrective treatment: anti-seizure medication. At the time of reporting, the outcome of event was reported as unknown. Information on the batch number was requested.; Sender's Comments: This case involves a 8 month old female patient who had seizure, after receiving PENTACEL. The time to onset is unknown. Past vaccination included PENTACEL. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.

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Current Illness:

ID: 1313078
Sex: F
Age: 64
State: GA

Vax Date: 10/04/2019
Onset Date: 10/05/2019
Rec V Date: 05/13/2021
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Symptoms: Chest feels strange; Shortness of breath; Affected breathing; Immune system doesn't work well; Bedridden due to the pain; Very low energy; Lump nodules were swollen under chin and underarms; Trouble moving around doing normal tasks; Tingling in face, hands, and feet; Tired quickly; Feel full; Underarm lymph nodes and chin lymph nodes were hurting; Bedridden due to the pain; Face swollen; Body temperature 102 and 104; Joints still hurt greatly/sore joints/joints hurting; This is a spontaneous case, initially received from other non-health professional via agency (reference number: SEQ20-00719) on 24-Feb-2020 with an additional document received on the same day (being processed together), concerning a 64-year-old, female patient. The patient's relevant medical history included increased body mass index (BMI), cigarette smoker, allergy to ciprofloxacin, sulfadiazine and dexlansoprazole, vitamin B12 deficiency disease, bladder muscle dysfunction - overactive, diverticular disease of colon, obstructive sleep apnea syndrome, mixed hyperlipidemia, mild intermittent asthma, spinal stenosis of lumbar region, nicotine dependence, panacinar emphysema and tobacco dependence in remission. The patient had two surgical procedures bilateral oophorectomy and hysterectomy. The patient's past medications included unspecified flu shot, Zoster vaccine live (varicella zoster vaccine live), Pneumococcal 13 valent vaccine (pneumococcal vaccine 13v), Pneumococcal 23-polyvalent vaccin (pneumococcal vaccine polysacch 23v) and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). The patient's concomitant medications included ranitidine, oxybutynin, Symbicort (budesonide, formoterol fumarate), budesonide;formoterol, amlodipine and Albuterol (salbutamol) all for unknown indication. On 04-Oct-2019, the patient was administered with Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261222, dose, route of administration, anatomical location and expiration date: not reported] for unknown indication. It was reported that no other medication was given at the time of shot. On the same day, ever since (as reported) after vaccination, the patient's chest felt strange. On 05-Oct-2019, one day after vaccination, the patient's face became swollen just a little, but she went to a play. By the end of night after vaccination, the patient developed sore joint and had temperature of 102. The patient took Aspirin (acetylsalicylic acid). On 06-Oct-2019, reported as Sunday, two days after vaccination, the patient was bedridden. On 07-Oct-2019, reported as Monday, three days after vaccination, the patient's temperature was 104 while joints, underarms lymph nodes and chin lymph nodes were hurting. The patient went to emergency room (ER) and was given unspecified intravenous (IV) steroid therapy and to her physician who discharged her the same day with diagnosis of adverse reaction to influenza vaccine. The vital signs showed blood pressure 122/89 mmHG. No laboratory tests for vaccine were performed. Assessment and Plan included scheduled tests on radiology: Bone density (BD), hip and bone spine (BS) on 06-Jan-2020, X ray chest 2 views post anterior (PA) and lateral (LAT) standard protocol on 09-Dec-2019, magnetic resonance imaging (MRI) of brain with contrast completed on 13-Dec-2019 and mammogram (MG) screen bilateral with tomosynthesis (Tomo) and coronary artery disease (CAD) standard protocol on 06-Jan-2020. On an unspecified date, after vaccination, the patient's lump nodules under her chin and underarms were swollen. Most days, the patient had trouble moving around and doing normal tasks. Some days, the patient was bedridden due to the pain. It has affected patient's breathing, tingling in face, hands, feet. Also, the patient's joints still hurt greatly and shortness of breath was still an issues. The patient had very low energy, felt full, got tired quickly and her immune system didn't work well anymore. The patient stated that other physicians didn't known how to treat an adverse effect of a vaccine, so she was going to the medical facility, but Covid-19 came out. The patient was taking unspecified probiotics NOS, lots of vitamin C (ascorbic acid) and Elderberry (sambucus nigra) for what she believed that kept her going. At the time of this report, the patient had not recovered from the events of 'mobility decreased', 'bedridden', 'pain', 'chest discomfort', 'tiredness', 'shortness of breath', 'immune system disorder (NOS)', 'energy decreased', 'arthralgia' and 'feeling abnormal'. The outcome of the events 'swelling face', 'swollen lymph nodes', 'lymph node pain', 'body temperature increased', 'tingling', and 'abnormal breathing' was not reported. The reporter assessed the events as related to Flucelvax Quadrivalent, according to physician's diagnosis. Follow up information received from other health professional on 05-Jun-2020: New reporter added and race updated. Batch number was confirmed while expiration date was confirmed as unknown. Start date for the events of 'swelling face', 'bedridden' and 'painful joints' was updated. New events of 'lymph node pain', 'body temperature increased', 'chest discomfort', 'tiredness', 'shortness of breath', 'immune system disorder (NOS)', 'energy decreased' and 'feeling abnormal' added. Treatment measures with Aspirin (acetylsalicylic acid), unspecified probiotics NOS, vitamin C (ascorbic acid) and Elderberry (sambucus nigra) added. Ranitidine, oxybutynin, Symbicort (budesonide, formoterol fumarate), budesonide;formoterol, amlodipine and Albuterol (salbutamol) added as concomitant medication. Vaccine facility information updated while blood pressure measurement and body temperature added as laboratory tests. Medical history updated for increased (BMI), cigarette smoker, allergy to ciprofloxacin, sulfadiazine and dexlansoprazole, vitamin B12 deficiency disease, overactive bladder, diverticular disease of colon, obstructive sleep apnea syndrome, mixed hyperlipidemia, mild intermittent asthma, spinal stenosis of lumbar region, nicotine dependence, unspecified colon disease, panacinar emphysema, tobacco dependence in remission and two surgical procedures bilateral oophorectomy and hysterectomy. The case and all events changed from medically confirmed as 'NO' to 'YES'. Event Trouble moving around doing normal tasks recoded to 'movement disorder' and therefore case downgraded. Narrative amended accordingly. Significant case correction performed on 14-Jul-2020: The event of Trouble moving around doing normal tasks was recoded from LLT: Movement disorder to LLT: Mobility decreased. The narrative was amended accordingly. Company comment: The patient experienced swelling face, chest discomfort, respiration abnormal, lymph node pain, body temperature increased and arthralgia after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. On an unspecified date, after vaccination the patient also developed lymphadenopathy, mobility decreased, pain, bedridden, paraesthesia, dyspnoea, asthenia, feeling abnormal, immune system disorder and fatigue. The patient's relevant medical history included increased body mass index (BMI), cigarette smoker, diverticular disease of colon, obstructive sleep apnea syndrome, mixed hyperlipidemia, mild intermittent asthma, spinal stenosis of lumbar region, panacinar emphysema and tobacco dependence in remission. Considering all the above mentioned, causality between suspect product and the events cannot be excluded and is assessed as possibly related except for lymphadenopathy, mobility decreased, pain, bedridden, paraesthesia, dyspnoea, asthenia, feeling abnormal, immune system disorder and fatigue, which is unassessable.; Reporter's Comments: The events are assessed as 'adverse reaction to influenza vaccine'; Sender's Comments: The patient experienced swelling face, chest discomfort, respiration abnormal, lymph node pain, body temperature increased and arthralgia after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. On an unspecified date, after

Other Meds: RANITIDINE; OXYBUTYNIN; SYMBICORT; BUDESONIDE;FORMOTEROL; AMLODIPINE; ALBUTEROL [SALBUTAMOL]

Current Illness: Asthma; Body mass index high; Cigarette smoker (The patient has smoked for past 12 months, used packs/day4 cigarettes per week.); Diverticular disease; Drug allergy; Emphysema pulmonary; Mixed hyperlipidemia; Nicotine dependence; Obstructive sleep apnea syndrome; Overactive bladder; Tobacco use disorder, in remission; Vitamin B12 deficiency

ID: 1313080
Sex: F
Age: 78
State:

Vax Date: 08/18/2020
Onset Date: 08/18/2020
Rec V Date: 05/13/2021
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Symptoms: Redness on the site of injection; Vaccine was administered after temperature excursion of -0.8?C; Vaccine was administered after temperature excursion of -0.8?C; This is a spontaneous case, initially received from physician via agency (reference number: SEQW20-00869) on 25-Aug-2020, concerning a 78-year-old, female patient. The patient's medical history included type 2 diabetes mellitus with diabetic neuropathy unspecified, essential (primary) hypertension, hyperlipidemia unspecified, obesity unspecified, other iron deficiency anemias, overactive bladder, type 2 diabetes mellitus with hyperglycemia, localized scleroderma (morphea), edema unspecified, dependence on supplemental oxygen, sleep apnea unspecified, chronic obstructive pulmonary disease (COPD) unspecified, venous insufficiency, (chronic, peripheral), nontoxic single thyroid nodule and chronic diastolic (congestive) heart failure. The patient's concomitant medications included fexofenadine-pseudoephedrine extended release (ER), vitamin D3, iron, glyburide, simvastatin, Aspirin (acetylsalicylic acid), irbesartan, doxazosin mesylate, atenolol, Norvasc (amlodipine besilate), bumetanide, portable oxygen concentrator, albuterol sulfate, ProAir HFA (salbutamol sulfate) and Symbicort (budesonide, formoterol fumarate), all used for an unreported indications and glucose for DXDM-2 (type 2 diabetes melitus). The patient was also using One Touch II test strips, One Touch II glucose meter, lancets and a roller-walker (as directed). On an unspecified date in 2020, Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; batch number: 279734 and expiration date: 04-May-2021] was exposed to temperature excursion of minus 0.8 degrees Celsius for 4 hours and 23 minutes (explicitly coded as 'Product storage error temperature too low'). On 18-Aug-2020, the patient was administered Fluad (TIV) vaccine after temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported] (explicitly coded as 'Product administration error' for influenza prophylaxis. On the same date, after vaccination the patient developed redness on the site of injection. The outcome of the event 'vaccination site erythema' was unknown. The case was assessed as non-serious. The reporter did not provide causality assessment. This case is linked to cases: 202004116, 202004159, 202004164, 202004167, 202004168, 202004170, 202004171, 202004172, 202004175, 202004177, 202004179, 202004197, 202004203, 202004210, 202004213, 202004215, 202004216, 202004217, 202004218, 202004219, 202004220, 202004222, 202004223, 202004224, 202004225, 202004226, 202004227, 202004228, 202004229, 202004230, 202004231 and 202004232 (the same reporter). Company comment: The patient developed vaccination site erythema on the same day after vaccination with the suspect product, Fluad (TIV). Chronology is suggestive. Reportedly, vaccine was administered after temperature excursion of -0.8?C (explicitly coded as product administration error and product storage error temperature too low). Based on this information, causal relationship between the suspect product and the events of product storage error temperature too low and product administration error is assessed as not related (per company conventions), while for vaccination site erythema is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed vaccination site erythema on the same day after vaccination with the suspect product, Fluad (TIV). Chronology is suggestive. Reportedly, vaccine was administered after temperature excursion of -0.8?C (explicitly coded as product administration error and product storage error temperature too low). Based on this information, causal relationship between the suspect product and the events of product storage error temperature too low and product administration error is assessed as not related (per company conventions), while for vaccination site erythema is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).

Other Meds: FEXOFENADINE;PSEUDOEPHEDRINE; VITAMIN D3; IRON; GLYBURIDE; GLUCOSE; SIMVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; IRBESARTAN; DOXAZOSIN MESILATE; ATENOLOL; NORVASC; BUMETANIDE; OXYGEN; ALBUTEROL SULFATE; PROAIR HFA; SYMBICORT

Current Illness: Congestive heart failure; COPD; Dependence on oxygen therapy; Diabetic nephropathy NOS; Edema NOS; Essential hypertension; Hyperlipidemia; Iron deficiency anaemia; Obesity, unspecified; Overactive bladder; Scleroderma; Sleep apnea; Thyroid nodule (nontoxic); Type 2 diabetes mellitus; Venous insufficiency

ID: 1313081
Sex: M
Age: 77
State:

Vax Date: 08/18/2020
Onset Date: 08/01/2020
Rec V Date: 05/13/2021
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Symptoms: Vaccine was administered after temperature excursion of -0.8?C; Diarrhea; Vomiting; Vaccine was administered after temperature excursion of -0.8?C; This is a spontaneous case, initially received from physician via agency (reference number: SEQW20-00875) on 25-Aug-2020, concerning a 77-year-old, male patient. The patient's medical history included atherosclerotic heart disease of native coronary artery without angina pectoris, essential (primary) hypertension, hyperlipidaemia unspecified, generalized anxiety disorder, Barrett's oesophagus without dysplasia, disorder of carbohydrate metabolism unspecified, vitamin D deficiency unspecified, tendinitis, upper arm unspecified side, age-related cataract Morgagnian type bilateral, bilateral primary osteoarthritis of first carpometacarpal joints, secondary osteoarthritis right hand, osteoarthritis left hand, obstructive sleep apnoea, type 2 diabetes mellitus without complications, strain of unspecified quadriceps muscle fascia and tendor sequela, diverticulosis if intestine part unspecified without perforation or absces without bleeding, benign prostatic hyperplasia without lower urinary tract symptoms and rash. The patient's concomitant medications included clotrimazole anti-fungal for rash, Ventolin HFA (salbutamol sulfate ), pantoprazole sodium, hydrochlorthiazid, metoprolol succinate, bupropion HCL ER (XL), metformin HCL, Crestor (rosuvastatin calcium), clonazepam, lisinopril, Aspirin (acetylsalicylic acid), Plavix (clopidogrel bisulfate), Nitroglicerin (glyceryl trinitrate), cyclobenzaprine HCL, all used for an unreported indication. On an unspecified date in 2020, the Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; batch number: 279734 and expiration date: 04-May-2021] suffered temperature excursion of minus 0.8 C for 4 hours and 23 minutes (explicitly coded as 'Product storage error temperature too low'). On 18-Aug-2020, the patient was administered Fluad (TIV) vaccine [dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported] (explicitly coded as 'Product administration error') for influenza prophylaxis. On an unspecified day in Aug-2020, an unknown amount of time after vaccination, the patient experienced diarrhoea and vomiting. That lasted for 24 hours. The patient reported that he thought that was due to fish he had eaten. On an unspecified day in Aug-2020, the patient recovered from diarrhoea and vomiting. This case was assessed as non-serious. The reporter did provide causality assessment This case is linked to cases 202004116, 202004159, 202004163, 202004164, 202004167, 202004168, 202004170, 202004171, 202004172, 202004175, 202004177, 202004179, 202004203, 202004210, 202004213, 202004215, 202004216, 202004217, 202004218, 202004219, 202004220, 202004222, 202004223, 202004224, 202004225, 202004226, 202004227, 202004228, 202004229, 202004230, 202004231 and 202004232 (the same reporter). Company Comment: The events of 'diarrhoea' and 'vomiting' are assessed as related to Fluad (TIV). The events of 'Product storage error temperature too low' and 'Product administration error' are assessed as not related to Fluad (TIV).; Sender's Comments: The events of 'diarrhoea' and 'vomiting' are assessed as related to Fluad (TIV). The events of 'Product storage error temperature too low' and 'Product administration error' are assessed as not related to Fluad (TIV).

Other Meds: CLOTRIMAZOLE; VENTOLIN HFA; PANTOPRAZOLE SODIUM; HYDROCHLORTHIAZID; METOPROLOL SUCCINATE; BUPROPION HCL ER; METFORMIN HCL; CRESTOR; CLONAZEPAM; LISINOPRIL; ASPIRIN [ACETYLSALICYLIC ACID]; PLAVIX; NITROGLICERINA; CYCLOBENZAPRINE HCL

Current Illness: Atherosclerotic cardiovascular disease; Benign prostatic hyperplasia; Carbohydrate metabolism disorder; Diverticulosis; Essential hypertension; Generalized anxiety disorder; Hand osteoarthritis; Hyperlipidemia; Muscle strain; Obstructive sleep apnea syndrome; Senile cataract; Tendinitis; Tendon injury; Type 2 diabetes mellitus; Vitamin D deficiency

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm