VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1647011
Sex: F
Age:
State: FL

Vax Date: 04/27/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210811; Test Name: Antibody test; Test Result: Negative

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: agitated; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 and dose 2 via an unspecified route of administration on 06Apr2021 and 27Apr2021 respectively, both as single for COVID-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced agitated on an unspecified date. The patient received both doses of the Pfizer Biontech COVID19. Her first dose was on 06Apr2021 while her second dose was on 27Apr2021. She reported that not even an hour ago, she had an antibody test and the result was she had no antibody (negative). She reported that her pharmacist would call them since she received a negative antibody test. She also mentioned that she knew someone who had COVID and was not vaccinated who showed antibody. She wanted to know if they have some information on receiving a negative antibody after being fully vaccinated and if she was covered or protected. The patient further reported that she was in an agitated state right now as she received both doses and did not have any antibodies. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 11Aug2021. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647012
Sex: M
Age:
State: MA

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Lymphoma /Diffuse large B cell lymphoma (DLBCL); This is a spontaneous report from a contactable consumer (the patient). A 71-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot Number: EN6208) as as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced lymphoma /diffuse large b cell lymphoma (DLBCL) (medically significant) in 2021 with outcome of unknown. Unknown therapeutic measures were taken as a result of lymphoma /diffuse large b cell lymphoma. The patient stated the lymphoma first appeared between the first and second dose. Caller stated that he is under the care of a doctor and is being treated for the lymphoma. He also added that received the second dose on 09APR2021, lot number ER8729. Also he is an "exceptionally healthy, senior athlete" and he is scared to death. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647013
Sex: M
Age:
State: NY

Vax Date: 04/22/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:138/102; Comments: in the left arm; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Comments: high blood pressure and erratic blood pressure; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:121/87; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:181/107; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:50 on the diastolic and 70, 35 points on the other; Comments: change as much as 50 on the diastolic and 70, 35 points on the other end as well; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:80 or 90 but for it to be 157/110 then 97; Comments: Maybe 80 or 90 but for it to be 157/110 then 97 for the bottom number; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:133/86; Comments: in the right arm; Test Name: Sodium; Result Unstructured Data: Test Result:High; Comments: in the summer; Test Date: 202102; Test Name: Blood test; Result Unstructured Data: Test Result:came back 5 by 5, and was perfect; Test Name: Covid tests; Test Result: Negative ; Comments: pre vaccine; Test Date: 2021; Test Name: Covid tests; Test Result: Negative ; Comments: post vaccine

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Last 5 days have been getting worse; Severe night sweats; Dehydration; Dry mouth; Little fatigued; high blood pressure; Dizzy/severe dizziness; Little unstable on his feet; Stress; Over sleeping; Little nauseated; Vertigo; Blood pressure can change as much as 50 on the diastolic and 70, 35 points on the other end as well; Severe headaches that have been running wild the last weeks; Cured his insomnia; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ZW0162), via an unspecified route of administration, administered in Arm Left on 22Apr2021 07:50 (at the age of 58-years-old) as dose 2, single for covid-19 immunization. Medical history included ongoing anxiety, ongoing acid reflux/GERD (slight case of A1C elevated but not diabetic, overweight, age), chronic pain (at his age, he does have chronic pain. He was 58 and had been on his feet for 42 years, foot pain, back pain and nothing where he has to totally take something), chronic bronchitis (not had bronchitis since Covid), A1C elevated, overweight, respiratory issues (intermittent respiratory issues with chronic bronchitis due to the medication he takes for acid reflux), insomnia (since he was 19 years old), covid-19 from an unknown date and unknown if ongoing. Family medical history Includes Has a history of lung cancer in his family. Concomitant medications included lansoprazole (PREVACID) (Has been taking for the last 11 years) taken for gastrooesophageal reflux disease, alprazolam (XANAX) taken for anxiety, vitamin d3 (has been taking about 30 months) for an unspecified indication, magnesium (has been taking forever, about 5 to 7 years) taken for prophylaxis from an unspecified start date and ongoing. Historical vaccines included dose 1 (Batch/lot number: EP8727) on 01Apr2021 in left upper arm for covid-19 immunization. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks). No adverse events following prior vaccinations. He knew there would be some side effect fatigue and what not. He had experienced within 2 weeks of the second shot, high blood pressure. He had never had that in his life. He had severe night sweats that are intermittent. In addition to that, had severe dizziness and had been a little unstable on his feet. He never had these symptoms before the vaccine, never had high blood pressure before. He had to go on medication for this. It is kind of controlled now but he was getting erratic readings. It would be 121/87 and then would be 181/107 five minutes later. Something was going on and he does not want to say that it was the Pfizer vaccine, but everything was pin pointing that way. It had been over 90 days, had been about 100 days and it should have passed by now. The CDC was now promoting a third booster shot. He had to go back to work. He could not go back to work with high blood pressure and the stress. He was an executive chef and had to do the test open first before he goes back to work. Going back to work and it was all unorganized chaos. Everything (pandemic) had been on a 2 year hiatus and was becoming exponentially insane with the variants and the side effects. He was more concerned with the blood pressure. He was oversleeping and having too much time on his hands. Another strange side effect from Pfizer which had been a godsend, was that it cured his insomnia. He had insomnia since he was 19 years old, and he was now 58. He goes into the REM sleep cycle now that he had not achieved since his late teens, early 20s. REM cycles now produces mucous on his eyes which was fantastic, and he wakes up feeling ultra-refreshed. He has been seeing the same doctor for the last 3 years. Stated we could contact them if we need to. Stated they probably would have everything acute but nothing chronic. Everything was documented. His body has broken down and he was 58. He was like a high mileage vehicle. With the second one, when he came home, the first night after the second dose, and he was told to hydrate. He had dry mouth. It was every morning and seemed like his body was burning up water, maybe trying to create antibodies. He had no diarrhea or anything like that. He was dehydrated and felt like he was never having enough water. That day, and he had gotten there at 0745, he came home and laid down. About 5:00 in the afternoon he had to get some Gatorade and water. It was about 6 to 8 hours later after the second dose. He had lots of water. The first couple of weeks, just waking up, he was having to put the blanket on a clothesline to dry it because it was so soaked. It has not happened frequently but, it still happens, the night sweats. He had night sweats before but never to this degree. He still gets them but only a fraction of what it was. His girlfriend looked at his quilt and said that sweat was coming through the quilt. He had to take it off and do an entire bed change and change his clothes. His t-shirt was even sticking to him. Stated that the dehydrated feeling has stopped but has been noticing he has bad days where it is kind of hard to explain. He get a little fatigued and dizzy, a little nauseated. He has been having to take Dramamine to make sure he doesn't fall down. He is thinking maybe he has vertigo. His high blood pressure, he should not have an issue with that. He controls his diet and does exercise. One thing that scared him with the blood pressure was that one arm was higher than the other. He could sit down and not move and his blood pressure could change as much as 50 on the diastolic and 70, 35 points on the other end as well. Right now, he had it under control. He does not want to keep taking medication. The bottom number was extremely high. The top was back to normal. It was very inconsistent and had no consistent readings. When he gets out of bed it could be through the roof and then he does a couple of things for a couple of hours and it goes back to normal. And later it was 70 points higher and was all over the place. He was an athlete. He believes the high blood pressure started after the vaccine. He did not have a cuff in the house. He thought maybe he was eating a lot of salt and had a great deal of stress. He donated blood and they said his blood pressure was through the roof. After sitting, it went down. He thought it was directly a correlation. He thought there had been a better explanation. He never had it in his life. Maybe 80 or 90 but for it to be 157/110 then 97 for the bottom number, that was extremely scary. He was checking his blood pressure now. His blood pressure was now 133/86 which was next to normal. This was taken in the right arm. His blood pressure was 138/102 in the left arm, which was the arm that he received the vaccine. Stated that was a big difference in the bottom number. He does have a pinched nerve but that was high. He knows the left arm was closer to the heart and so it might be a little higher. He just had severe headaches that have been running wild the last weeks. He had them since the vaccine, but the last 5 days have been getting worse. Adverse event hypertension and blood pressure abnormal require a visit to physician office. No relevant tests. Blood work came back 5 by 5 and was perfect. It was in Feb2021. There was more blood work due some time in Oct2021. He had it done every 6 to 8 months. Caller states that he had in excess of 15 negative Covid tests pre and post vaccine. He gets checked every 2 weeks. The medication he had been taking for high blood pressure was Losartan potassium and stated that they upped the dose from 25mg to 50mg.The reporter considered the event dry mouth as serious (medically significant). Patient asked for high bp, Is that one of the known side effects of the vaccine. Also asked, When you get the vaccine, does it produce antibodies or do you only get antibodies from the virus, Should I get an antibody test. Response was A review of the Prescribing Information for Pfizer BioNTech Covid 19 vaccine did not find information regarding erratic bl

Other Meds: PREVACID; XANAX; VITAMIN D3; MAGNESIUM

Current Illness: Anxiety (Anxiety has gotten worse with everything going on.); Gastrooesophageal reflux disease (Has acid reflux, slight case of A1C elevated but not diabetic, overweight, age intermittent respiratory issues, chronic bronchitis due to respiratory issues.); Kidney stones

ID: 1647014
Sex: F
Age:
State: MN

Vax Date: 03/22/2021
Onset Date: 06/29/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data: Test Name: Blood Work; Result Unstructured Data: Test Result:Unknown; Test Name: CT scans; Result Unstructured Data: Test Result:Unknown; Test Date: 20210629; Test Name: EMG; Result Unstructured Data: Test Result:Neuropathy; Comments: Revealed Neuropathy; Test Name: MRIs; Result Unstructured Data: Test Result:Unknown; Test Date: 20210403; Test Name: Covid-19/SARS; Result Unstructured Data: Test Result:Negative; Comments: Mouth swab; Test Date: 20210615; Test Name: Covid-19/SARS; Result Unstructured Data: Test Result:Negative; Comments: Nasopharynx swab

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: nerve damage; Revealed neuropathy; This is a spontaneous report from a contactable consumer (the patient) A 68-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular in the left upper arm on 22Mar2021 17:40 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation . Medical history included , eosinophilic pneumonia from 15Oct2012 and ongoing (courses of Prednisolone Antibiotics as needed). The patient's concomitant medications were not reported. On 01Mar2021 the patient received the first dose of BNT162B2 vaccine and experienced several events. The patient experienced neuropathy peripheral (medically significant) on 29Jun2021 with outcome of unknown , nerve damage (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood test: unknown, computerised tomogram: unknown, electromyogram: neuropathy on 29Jun2021 , magnetic resonance imaging: unknown, sars-cov-2 test: negative on 03Apr2021 Mouth swab , sars-cov-2 test: negative on 15Jun2021 Nasopharynx swab. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Carrington's pneumonia (Pertinent details: courses of Prednisolone Antibiotics as needed.)

ID: 1647015
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: Covid test; Test Result: Positive ; Comments: testing positive for Covid-19 infection

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: developed covid infection; This is a spontaneous report from a contactable consumer. This consumer (Parent) reported for 22-Years-old patient (son) that. A 22-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported he received first dose of pfizer covid vaccine and then 5 days later, he developed covid infection. He was in quarantine. He got his first dose on a Saturday and the following Wednesday he felt sick, had a fever and went to the doctor and tested positive. He still has a lingering cough, but he is better now. It was further stated that he is due to get second dose this Saturday of Pfizer Covid-19 vaccine and asked 'should he even get the second dose'. Reporter stated that 'the doctors don't know, pharmacist wasn't sure, and further stated that I don't see the point of getting the vaccine because he should already have anti-bodies. The events were assessed as Non serious by reporter. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of event was unknown. Information on the lot batch number has been requested.

Other Meds:

Current Illness:

ID: 1647016
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: chest or heart pain; chest or heart pain; tightness on her chest; This is a spontaneous report from Pfizer-sponsored program. A contactable female consumer (patient, unknown age) reported for herself that she received the first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine) at single dose for COVID-19 immunization on unknown date. Relevant history and concomitant drugs were unknown. The patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine and shortly afterwards she experienced chest or heart pain and tightness on her chest. Withheld from Pfizer-sponsored program already told her to seek medical attention but wanted to speak to a medical professional. The outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1647017
Sex: M
Age:
State: IL

Vax Date: 04/29/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210721; Test Name: Covid-19 test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210723; Test Name: Covid-19 test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: completely impotent/unable to achieve an erection; no feeling in penis; unable to achieve orgasm; This is a spontaneous report received from a contactable consumer (patient). This 54-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ew0175) at single dose on 29Apr2021 10:00 AM via an unknown route in left arm at 54-year-old for Covid-19 immunization. Medical history included diabetes, hypogonadism, slight hypertension. Patient had no known allergies. There was no any other medications the patient received within 2 weeks of vaccination. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ew0150) on 08Apr2021 10:00 AM in left arm at 54-year-old for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient become completely impotent. He had no feeling in private area. He was unable to achieve orgasm. Even taking Ed medication he was unable to achieve an erection. The event onset date was 01May2021 at 12:00 PM. The event resulted in Doctor or other healthcare professional office/clinic visit due to disability or permanent damage. No other treatment received for the adverse event. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19: nasal Swab PCR on 21Jul2021 and 23Jul2021, both were negative. Outcome of the events was not resolved. The event was reported as serious with disabling/Incapacitating.

Other Meds:

Current Illness:

ID: 1647018
Sex: M
Age:
State: CA

Vax Date: 05/10/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: moderate to severe flare up; This is a spontaneous report received from a contactable consumer (patient). This 63-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8731) at single dose via an unknown route on 10May2021 in right arm at 63-year-old for Covid-19 immunization. Medical history included epileptic, high blood pressure, and ongoing ulcerative colitis since 2012 and had been in remission for many years. Patient did not have covid prior vaccination. Patient had no known allergies. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0162) at 63-year-old via an unknown route on 19Apr2021 in right arm for Covid-19 immunization. Patient did not have other vaccine in four weeks. Concomitant medications in two weeks included eslicarbazepine acetate (APTIOM), mesalamine, atorvastatin, and triamterene. Patient had ulcerative colitis since 2012 and had been in remission for many years, but four to five weeks after the second dose , patient was having a moderate to severe flare up and having to take 40mg of prednisone daily along with 100mg/60ml nightly hydrocortisone retention enema and 4800mg mesalamine dr tabs, that had not resolved the problem. Adverse event start date was reported as Jun2021. The event resulted in doctor or other healthcare professional office/clinic visit. The event treatment was still going on as of 11Aug2021. No covid tested post vaccination. Outcome of the event was not resolved.

Other Meds: APTIOM; MESALAMINE; ATORVASTATIN; TRIAMTERENE

Current Illness: Ulcerative colitis (I have Ulcerative Colitis sense 2012 and had been in remission for many years)

ID: 1647019
Sex: M
Age:
State: NJ

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: near syncopal episode; This is a spontaneous report from a contactable physician (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient recieved the Pfizer Covid 19 Vaccine in early January. Caller stated that he had a "near syncopal episode, was seen by cardiologist and everything was fine. Patient asking if the Pfizer Covid 19 Vaccine has graphene oxide in it. He is a doctor, and one of the first people to get vaccinated in Jan2021, when his hospital got access to the vaccine. He got a bad reaction after the second dose. He had near syncope. He has been reading reports on certain websites that the vaccine could contain toxins, such as graphene oxide? has been hearing reports, that graphene oxide is poison. he has read this in many places on websites and on the internet, but wanted more information to make sure in wasn't anti vaccination hysteria. He does not know what to believe anymore. Event outcome was recovered. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647020
Sex: F
Age:
State:

Vax Date: 05/02/2021
Onset Date: 05/02/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210502; Test Name: Heart rate; Result Unstructured Data: Test Result:Elevated

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: she had a panic attack and went to the hospital; Elevated heart rate; anxiety; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. (patient reported for self) A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02May2021 (at the age of 22-years-) as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She relayed that right after having the vaccine (on 02May2021) she experienced an elevated heart rate but that the nurses at the vaccine site checked her and she was fine. She stated that, she received the dose on a Sunday and then on that following Wednesday she had a panic attack and went to the hospital. She did not have anxiety before the vaccine. She stated that her mom thought that the anxiety may have been a side effect from the vaccine, but she was not sure. She mentioned that she drank coffee that morning as well. She would like to know if this was a known side effect after the vaccine and since she had an anxiety disorder now, would like to know if this was a reason that she shouldn't get the second dose. She did not receive the second dose as scheduled due to conflict in her schedule. She asked if she would still get the second dose of the vaccine or does she need to restart with the first dose again. She was advised to speak with HCP prior to receiving the second dose of the vaccine. Lab data included elevated heart rate on 02May2021. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647021
Sex: F
Age:
State: WA

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: She states that the caller developed tachycardia 2-3 days after the first dose; Shortness of breath; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE for Covid-19 immunization. Medical history included heart valve replacement from an unknown date and unknown if ongoing She had artificial heart valve 6 years ago. The patient's concomitant medications were not reported. On Jan2021 the patient experienced she states that the caller developed tachycardia 2-3 days after the first dose, shortness of breath. Patient states that the caller developed tachycardia 2-3 days after the first dose. Patient is also on chemo for stage 4 lung cancer and her immune system is suppressed and her cancer doctor told her to get the vaccine give her approximately 80 percent resistance back in January. Patient has had a brain tumor removed, lots of surgeries and she says she only has part of one lung. Patient is not hearing that she is halfway protected being that she takes the chemo every day. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647022
Sex: U
Age:
State: TX

Vax Date: 03/18/2021
Onset Date: 03/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: patient received the second dose shot in the left arm, it was sore next few days; This is a spontaneous report from a contactable consumer (patient). A 53-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in the left arm on 18Mar2021 15:00 (batch/lot number: EP6955) at 53 years old, as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included diabetes and high blood pressure, both from 2017 and ongoing. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in the right arm on 25Feb2021 15:00 (batch/lot number: EN6202) at 53 years old, as DOSE 1, SINGLE for COVID-19 immunization and experienced shoulder pain, right arm still hurts (pain in arm), can't throw a ball or move arm quickly (mobility decreased), with limited range of motion at times (joint range of motion decreased). The patient received the second dose shot in the left arm, it was sore next few days (in Mar2021) and then went to back normal. The patient recovered from the event on an unspecified date in Mar2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Blood pressure high; Diabetes

ID: 1647023
Sex: M
Age:
State: GA

Vax Date: 03/29/2021
Onset Date: 08/11/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210808; Test Name: Nasal Swab; Result Unstructured Data: Test Result: Negative; Test Date: 20210811; Test Name: Nasal Swab; Result Unstructured Data: Test Result: Positive.

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: This is a spontaneous report from a contactable consumer or other non hcp. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205, ER8730, Expiry date: unknown), via an unspecified route of administration on 29Mar2021 as dose number unknown, single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered. The patient medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient not received any other vaccines within 4 weeks and 2 weeks prior to the COVID vaccine. On 08Aug2021, the patient underwent lab tests and procedures which included sars-cov-2 test was negative. On 11Aug2021, the patient got tested and received a positive diagnosis for COVID-19 (medically significant) and Drug Ineffective, due to which as a result of event patient had doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 11Aug2021. It was reported that patient was not prolonged hospitalization and no treatment received. The clinical outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1647024
Sex: F
Age:
State: MD

Vax Date: 07/16/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Date: 2017; Test Name: Cerebro spinal fluid culture imaging; Result Unstructured Data: Test Result:Negative; Test Date: 2019; Test Name: Cerebro spinal fluid culture imaging; Result Unstructured Data: Test Result:Negative; Test Date: 2020; Test Name: Cerebro spinal fluid culture imaging; Result Unstructured Data: Test Result:Negative; Test Date: 202001; Test Name: x-ray biopsy; Result Unstructured Data: Test Result:Positive; Test Date: 198610; Test Name: Spinal tap; Result Unstructured Data: Test Result:Negative; Test Date: 201508; Test Name: Mammogram/Biopsy; Result Unstructured Data: Test Result:Positive; Test Date: 198610; Test Name: Diagnostic X-ray; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: The polyneuropathy increased 10-fold after the Pfizer vaccine for the first 2 days after the first shot and even worse after the 2nd shot.; fever; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 16Jul2021 14:00 (Lot Number: EW0198) as single dose (at 65 years old) for COVID-19 immunisation. The vaccine was administered at Pharmacy or Drug store. Medical history included Guillain-barre syndrome from Oct1986 to Apr1987 (Paralyzed waist down), breast cancer from Aug2015 to Jul2016 (Right mastectomy reconstruction), lung neoplasm malignant from Jan2020 to Jan2020. Concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number: EW0173 on 25Jun2021 (at 64 years old) for COVID-19 immunisation and experienced polyneuropathy. The patient previously also received tetanus boost on 04Jun2017 for immunization and experienced polyneuropathy and muscle weakness. The patient experienced the polyneuropathy increased 10-fold after the Pfizer vaccine for the first 2 days after the first shot and even worse after the 2nd shot in Jul2021 with outcome of recovering, fever in Jul2021 with outcome of unknown. No treatment required for polyneuropathy. The patient underwent lab tests and procedures which included central nervous system infection: negative in 2017, central nervous system infection: negative in 2019, central nervous system infection: negative in 2020, chest x-ray: positive in Jan2020, lumbar puncture: negative in Oct1986, mammogram: positive in Aug2015, x-ray: negative in Oct1986. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100908602 same patient, different event and dose

Other Meds:

Current Illness:

ID: 1647025
Sex: M
Age:
State: WA

Vax Date: 08/06/2021
Onset Date: 08/06/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Within one hour of receiving my second Pfizer covid 19 shot, I started experiencing ringing in my ears. It has not gone away 5 days later.; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Aug2021 12:00 (at vaccination age of 36-year-old) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 16Jul2021 13:15 (lot number: EW0186) (at vaccination age of 36-year-old) as single dose for COVID-19 immunisation. The patient medical history was reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no any other medications the patient received within 2 weeks of vaccination. Relevant past drug history was reported as no. The patient experienced 'Within one hour of receiving my second Pfizer Covid 19 shot, I started experiencing ringing in my ears. It has not gone away 5 days later' on 06Aug2021 13:00. Hospitalization prolonged was reported as no. Treatment received was reported as no. Facility where the most recent COVID-19 vaccine was administered was in doctor's office/urgent care. As reported, within one hour of receiving his second Pfizer Covid 19 shot, he started experiencing ringing in his ears. It has not gone away 5 days later. Since the vaccination, the patient had not been tested for COVID-19. The seriousness was reported as disability. Device date was 11Aug2021. The outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647026
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: A1C test; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: adenocarcinoma of the pancreas; some immune system challenges; a participant in the 3rd booster Pfizer-BioNTech COVID-19 Vaccine study; a participant in the 3rd booster Pfizer-BioNTech COVID-19 Vaccine study; This is a spontaneous report from a contactable other HCP. A 79-year-old male patient received third booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and expiry date was unknown), via an unspecified route of administration on shoulder (arm) left on an unspecified date as dose 3, single for COVID-19 immunization. The patient medical history included Hypertension and diabetes (but his A1C test is normal). He has a bad family history of cardiovascular disease. The patient Concomitant medications included fish oil (O3 OMEGA 3) taken for unspecified indication, start and stop date was not reported, fish oil taken for unspecified indication, start and stop date was not reported. He takes a statin, Omega 3 Fish Oil as preventatives. The historical vaccines included patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: P220395-0021L), via an unspecified route of administration on shoulder right on 21Sep2020 (at the age of 78 years) as dose 2, single and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: P220395-0047L), via an unspecified route of administration on shoulder right on 30Aug2020(at the age of 78 years) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced adenocarcinoma of the pancreas and some immune system challenges. It was reported that Caller was recently diagnosed with "adenocarcinoma of the pancreas", and it can be "removed without any metastases". Caller mentioned that he was terminated on 2nd study (for the 3rd immunization) and switched to a different study: still for the Pfizer-BioNTech COVID-19 Vaccine. Prior to the switch, Caller had his antibody titers measured. Caller wanted to know if he has enough COVID-19 antibodies without un-blinding the study. He reports he was a participant in the Covid 19 vaccine study and he is now in the new study regarding the third booster Covid 19 vaccine. He was recently diagnosed with a mass in his pancreas, an adenocarcinoma in his pancreas. The adenocarcinoma is highly isolated and can be removed without any metastasis. He is calling because he wants the results for the Covid 19 antibody titer that he recently had drawn 6-8 weeks ago. He has had Covid 19 antibody testing since being a part of the original study. He has received a third injection in the new study but he does not know if he received a placebo or if he received a third Covid 19 vaccine. He sees no reason why the Covid 19 antibody titer can't be unblinded, meaning, making the results known to him despite the fact that he is part of the third Covid 19 booster study.He would like the results of the Covid 19 antibody test. He's wondering if he has enough Covid 19 antibodies prior to treatment of his adenocarcinoma. This part of the study was unblinded and he knows that he did receive both doses of the Covid 19 vaccine. He was given a third injection but he can't recall the exact date. He either received a placebo or the Covid 19 vaccine booster. He had to turn his head when getting the injection because the consistencies of the placebo and the Covid 19 vaccine are different. He received the third injection in his left shoulder. He has no NDC/Lot/Expiry for this dose. When probing if caller was a healthcare professional he states he worked as a physician's assistant and later he got his MD. But he worked only as a physician's assistant. Caller is a Dr. but is also a participant in the Clinical vaccine study and he just recently got a 3rd injection. He's needing to know what the value of that report shows because they found a mass in his pancreas and he needs to know if he has any antibody's. It was reported that Phase 3 Covid trial participant is about to have a surgery and stated he is worried he may have some immune system challenges. The lab tests included test: Glycosylated haemoglobin, result: Normal on an unknown date. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Based on the available information reported event pancreatic carcinoma cannot be totally assessed. This case will be reassessed when additional information particularly the clinical course of pancreatic carcinoma becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: O3 OMEGA 3; FISH OIL

Current Illness:

ID: 1647027
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: extreme fatigue; nauseated; muscle aches everyway; dizziness; headaches really bad; generalized weakness through out the body and it effected her vision; generalized weakness through out the body and it effected her vision; she was sick for about a week; chills; diarrhea; This is a spontaneous report from a contactable other HCP (nurse) via Pfizer sponsored program. An 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patient has mitral and tricuspid leaky valves and faulty heart valves. Ileostomy s/p large bowel removal and clotting problems that patient took Eliquis for this. Patient also has Lupus, Rheumatoid Arthritis, a pacemaker and patient was being watched closely for a blood cancer. Blood cancer runs in patient family. The patient's concomitant medications were not reported. Patient previously took Eliquis for clotting problems. On an unspecified date, patient experienced extreme fatigue, nauseated, muscle aches everyway, dizziness, headaches really bad, and generalized weakness through out the body and it affected her vision, patient was sick for about a week, Felt like patient was going to die, also chills and diarrhea. Reporter further wanted to know that there was any chance that this cardiac inflammation, listed in the possible side effects, could be exacerbated by the fact that patient has the 2 leaky valves? Patient was afraid to get the second dose because they have heard the second dose was worse than the first. Therapeutic measures were taken as a result of events experienced. The outcome of events was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647028
Sex: M
Age:
State: OR

Vax Date: 07/28/2021
Onset Date: 07/28/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Cough; running nose; tiredness; upset stomach; diarrhea lasted for another 7 days; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 28Jul2021 19:30 (age at the time of vaccination 79-years-old), as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 28Jul2021 19:30 (age at the time of vaccination 79-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. Patient had no known allergies. On 28Jul2021 19:30, the patient experienced Cough, running nose, tiredness, upset stomach, and diarrhea lasted for another 7 days. Patient received cough syrup / aspirin / steam vaporizer as a treatment for adverse events. Patient visited to physician office. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was recovered on an unspecified date Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647029
Sex: M
Age:
State: PA

Vax Date: 05/26/2021
Onset Date: 07/07/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:perfect; Test Date: 20210707; Test Name: Blood clot; Result Unstructured Data: Test Result:4 blood clots in left leg

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: swelling started July 19; pain started July 7; 4 blood clots in left leg; This is a spontaneous report from a contactable consumer (the patient). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 26May2021 13:00 at age of 60-year-old at single dose for COVID-19 immunisation, the patient also received the second dose of other unspecified Pfizer vaccine on 26May2021 in Arm Left. Medical history was none. Perfect health. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had been tested for COVID-19 since the vaccination. There was no concomitant medication (the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient did not receive other medications within 2 weeks of vaccination). The patient experienced 4 blood clots in left leg on 07Jul2021, pain started 07Jul2021, swelling started 19Jul2021, spread then went to ER on August 8. They were shocked that there were FOUR. He have ZERO risk factors for blood clots. Perfect health, active, perfect blood work. Said blood clots don't occur with people with no risk factors, and definitely not four. The events resulted in Emergency room/department or urgent care, Life threatening illness(immediate risk of death from the event). Treatment was received for "4 blood clots in left leg", the patient was still on clot dissolving medication. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647030
Sex: M
Age:
State: AR

Vax Date: 06/12/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Subconjunctival hemorrhage; This is a spontaneous report from a contactable hcp. A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Jun2021 (Batch/Lot number was not reported) as a single dose, for covid-19 immunisation . Medical history included , ongoing hypertension , ongoing diabetes mellitus (AODM , ongoing hypercholesterolaemia. Concomitant medication(s) included amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing; valsartan (VALSARTAN) taken for hypertension from an unspecified start date and ongoing; rosuvastatin (ROSUVASTATIN) taken for hypercholesterolaemia from an unspecified start date and ongoing; metformin (METFORMIN) taken for diabetes mellitus from an unspecified start date and ongoing; glimepiride (GLIMEPIRIDE) taken for diabetes mellitus, start and stop date were not reported. On 21Jun2021, the patient experienced subconjunctival hemorrhage. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: AMLODIPINE; VALSARTAN; ROSUVASTATIN; METFORMIN; GLIMEPIRIDE

Current Illness: Diabetes mellitus; Hypercholesterolemia; Hypertension

ID: 1647031
Sex: M
Age:
State: TN

Vax Date:
Onset Date: 08/09/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result: 100-101; Test Date: 20210809; Test Name: Tested positive for Covid; Test Result: Positive.

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date in 2021 (age at vaccination: 88 years) as dose number unknown, single for COVID-19 immunization. The patient medical history included Myelodysplasia and immunocompromised from an unknown date. The patient Concomitant medications included PROCRIT taken for Myelodysplasia from an unknown date. On 09Aug2021, the patient tested positive for covid-19. On an unspecified date in 2021, the patient experienced fever of 100-101, congestion, fatigue. It was reported that Received vaccine Jan/Feb2021. Male Patient has myelodysplasia and is on Procrit twice/month. The Myelodysplasia, immunocompromised, injection bi-monthly to boost red blood cell count. The lab tests included Body temperature: 100-101 on an unknown date in 2021. SARS-CoV-2 test positive on 09Aug2021. The outcome of events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: PROCRIT

Current Illness:

ID: 1647032
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: weak; tired; cough; headache; This is a spontaneous report from a contactable consumer or other non hcp (patients grandmother) via medical information team. A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 14 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced weak, tired, had a cough, headache that went away. Reporter stated she read the side effects for the vaccine but did not see cough and headache. Reporter wanted to know if these are side effects to the vaccine. The outcome of the events was recovered on an unspecified date. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647033
Sex: F
Age:
State:

Vax Date: 01/17/2021
Onset Date: 01/19/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210729; Test Name: PCR; Test Result: Positive; Comments: Nasal Swab.

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: This is a spontaneous report from a contactable other hcp (patient). A 33-year-old non-pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Dec2020 (Lot Number: EL1284) (at the age of 33-years-old) as dose 1, single and administered in left arm on 17Jan2021 (Lot Number: EL3246) (at the age of 33-years-old) as dose 2, single for covid-19 immunisation. Medical history included sinusitis and hashimoto's thyroiditis. The patient had no relevant past drug history. The patient did not receive any other concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. The patient developed vertigo on 19Jan2021, multiple episodes increasing in frequency through early Mar2021. The symptoms returned 2-3 months later, less frequent than previously, but mildly intermittent for several weeks. On 29Jul2021, the patient had polymerase chain reaction (PCR) test (nasal swab) and the result was positive. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was not hospitalized. The patient received evaluation by vertigo specialist as treatment for vertigo. The outcome of vertigo was recovered with sequelae on an unspecified date in 2021 and outcome all the other events was unknown. The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure, COVID-19 cannot be ruled out.

Other Meds:

Current Illness:

ID: 1647034
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210803; Test Name: Covid rapid test; Test Result: Negative

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: exposed to covid and symptomatic; Congestion; cough; runny nose; fatigue; This is a spontaneous report from a contactable consumer (Patient). A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included glaucoma, OAB (hypertonic bladder), osteoarthritis all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced exposed to covid and symptomatic, congestion, cough, runny nose and fatigue. The patient underwent lab tests and procedures which included Covid rapid test (sars-cov-2 test): negative on 03Aug2021. Reportedly, event took place after use of product. Outcome of the events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647035
Sex: U
Age:
State:

Vax Date: 03/01/2021
Onset Date: 08/11/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Date: 20210811; Test Name: Positive rapid antigen Covid test; Test Result: Positive; Comments: Positive rapid antigen Covid test following full vaccination.

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Mar2021 as DOSE 2, SINGLE and received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was tested positive on 11Aug2021. Full vaccination (2 doses) completed in Mar2021. It was symptomatic, not hospitalized. Event took place after use of product. The patient underwent lab tests and procedures which included sars-cov-2 test, positive on 11Aug2021. Positive rapid antigen Covid test following full vaccination. The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647036
Sex: F
Age:
State: NJ

Vax Date: 07/25/2021
Onset Date: 07/25/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Name: Blood test; Test Result: Negative ; Comments: tested Covid negative before I got the vaccine but before I did the both I did the rapid. The other blood test that takes longer, I had done both test prior to the vaccine; Test Name: I tested Covid negative; Test Result: Negative

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Diarrhea; I had very dark black stool; Feeling of being unsafe like mentally mind just got blank and I became very emotional; I am still not right and tired; haven't got my previous stamina back yet; Injection site burning and my arm was burning; arm started to hurt; arm was burning; Dizziness; Weakness; Shortness of breath; Neck stiff; Headache; Chills; Joint pain; Fever; Stomach pain; Muscle pain in arm; arm started to hurt; Nauseous; Feeling of being unsafe like mentally mind just got blank and I became very emotional; Feeling of being unsafe like mentally mind just got blank and I became very emotional; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 61-years-old via an unspecified route of administration, administered in Arm Right on 25Jul2021 (Batch/Lot Number: FA7428) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included addison's disease from Dec1999. Concomitant medication included hydrocortisone (CORTEF) taken for addison's disease, start and stop date were not reported. The patient reported that on 25Jul2021, she was still not right, she was still tired. She had not gotten her previous stamina back yet. She experienced burning at the injection site and her arm was burning. She had dizziness, weakness and Shortness of breath. She had a very stiff neck, severe headache when she got home she was experiencing tiredness, chills, joint pain, Fever and Shortness of breath continued. She was getting stomach pain, stiff neck continued and then her arm started to hurt. She had muscle pain two days in the arm. She got nauseous then she got severe diarrhea for two days. When diarrhea stopped she had very dark black stool. She also have a feeling of being unsafe like mentally her mind just got blank and she became very emotional and she have been advised not to take the second vaccine. The events occurred on 25Jul2021. The patient underwent lab tests and procedures which included blood test: tested Covid negative before she got the vaccine but before she did the both she did the rapid. The other blood test that takes longer, she had done both test prior to the vaccine and sars-cov-2 test negative: negative on unspecified dates. The patient recovered from diarrhea on an unspecified date but did not recover from the other events. Follow-up attempts are completed. No further information is expected.

Other Meds: CORTEF [HYDROCORTISONE]

Current Illness:

ID: 1647037
Sex: F
Age:
State: CA

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: red blotches on both of my forearms; my skin looked blotchy and inflamed; had random itchy spots on my body including my scalp, legs, palms, nose and chest; This is a spontaneous report from a non-contactable consumer reporting for herself. A 33-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Aug2021 18:15 (lot number: FC3180) at the age of 33 years old on the left arm as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at Pharmacy or Drug Store. Medical history included congenital spinal fusion in C1 and C2, Ovary and breast cysts, wasp/hornet allergy. Concomitant medication included norethisterone acetate (NORETHINDRONE). The patient stated "About 15 minutes after receiving the vaccine (10Aug2021 18:30), I started noticing red blotches on both of my forearms. There were no hives but my skin looked blotchy and inflamed. I also had random itchy spots on my body including my scalp, legs, palms, nose and chest." Treatment received for the events included Benadryl. The outcome of the events were resolved in Aug2021.

Other Meds: NORETHINDRONE [NORETHISTERONE ACETATE]

Current Illness:

ID: 1647038
Sex: M
Age:
State: NJ

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: continuous urination; he was a type 2 diabetic and knew this could be a symptom of that, but he has not had an issue with frequent urination since 2005; continuous urination/waking up 6 times a night urinating and a lot during day/frequent urination; could be a symptom of type 2 diabetic, but he has not had an issue with frequent urination since 2005; continuous urination/waking up 6 times a night urinating and a lot during day/frequent urination; could be a symptom of type 2 diabetic, but he has not had an issue with frequent urination since 2005; continuous urination/waking up 6 times a night urinating and a lot during the day/frequent urination; agitated for a few days/insomnia agitation; insomnia agitation/ sleeping problem that had tapered off; still didn't get proper sleep; felt like he was kind of like on a steroid; he's an asthmatic and was taking steroids and he was having an effect like that for the first week; The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on 11Aug2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient himself). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in May2021 at the age of 44 years old (Batch/Lot number and Expiration date were unknown) as dose 1, single for COVID-19 immunization. The vaccination facility type was not reported; the vaccine was not administered at a facility. Relevant medical history included type 2 diabetic; frequent urination, but has not had an issue with it since 2005; and ongoing asthmatic; all from an unknown date. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on the same date of the Pfizer suspect. The patient had no prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient had no adverse events (AEs) following prior vaccinations. Family medical history relevant to AEs was not provided. The patient was an asthmatic and was taking unspecified steroids for it. The patient initially called to complain about the side effect of the vaccine, and stated that he had experienced continuous urination; stated he had been waking up 6 times a night urinating and a lot during the day; the patient stated he was a type 2 diabetic and knew this could be a symptom of that, but he has not had an issue with frequent urination since 2005. The patient stated this had been happening since the day he got the vaccination in May2021. The patient was also concerned and so was the doctor he spoke with. The patient stated he felt like he was kind of like on a steroid; stated he was really agitated for a few days after the vaccination, but that had resolved. The patient stated he has not had second shot under the doctors care and that was why. The reporter confirmed on 11Aug2021 that the product he received was the Pfizer COVID-19 vaccine. He stated he didn't have his vaccine card with him at the time of the report. He was administered it, just one dose and he had a side effect immediately thereafter and he's still suffering from it since May2021, the same side effect. The patient stated he's having constant urination, well not constant, frequent urination. The patient reported it started immediately after the vaccine in May2021, that night after, he couldn't stop urinating, up to 6 times at night. He reported he still didn't get proper sleep; he didn't know what's going on, it's agitating his bladder and kidneys. The patient also experienced insomnia agitation, further described that he had a sleeping problem, that was the first week (in May2021), that had tapered off, but because of frequent urination, he still didn't get proper sleep. The patient confirmed it began in May2021 and ended in May2021 and had recovered completely to his knowledge. He reported he's an asthmatic and was taking steroids and he was having an effect like that for the first week (in May2021). The AEs did not require a visit to an emergency room, but had a physician office visit; he did talk with his physician about it. The patient had no investigations and relevant tests. The patient had recovered from the events "agitated for a few days/insomnia agitation, sleeping problem that had tapered off, felt like he was kind of like on a steroid, and having an effect like he was asthmatic and was taking steroids" on an unspecified date in May2021, while he was not recovered from the rest of the events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness: Asthmatic

ID: 1647039
Sex: U
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Being quarantine by my employer; Have symptoms of COVID; I have COVID; Being quarantine by my employer; Have symptoms of COVID; I have COVID; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EK9231) via an unspecified route of administration on an unspecified date in Jan2021 as DOSE 2, SINGLE and received dose 1 (Lot number: EJ1685) via an unspecified route of administration on an unspecified date in Dec2020 as DOSE 1, SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that, being quarantined by my employer, had symptoms of COVID, I had COVID on an unspecified date in 2021. Well, I was calling because I wanted some information about the I guess the booster vaccine for people that are immune compromised. I would like information about the third injection for the pfizer COVID vaccine for the people that are immune compromised. The reason I was asking is because I had my first shot in december and my second in january and I was now being quarantined by my employer because I had symptoms of COVID. The outcome of the events was unknown at the time of this report. Further probing could not be done as the consumer was unwilling to share any further information, hence limited information available over the call.

Other Meds:

Current Illness:

ID: 1647040
Sex: F
Age:
State: WA

Vax Date: 03/26/2021
Onset Date: 08/11/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 20210809; Test Name: Nasal Swab; Test Result: Positive.

Allergies:

Symptom List: Nausea

Symptoms: This is a spontaneous report from contactable consumer. A 29-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6199) intramuscularly, administered in Arm Right on 04Mar2021 12:00 as single dose and dose 2 intramuscularly, administered in Arm Left on 26Mar2021 12:00 (Batch/Lot Number: EP7533) as single dose (at the age of 29-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 11Aug2021, patient experienced breakthrough Infection, patient tested positive for COVID 19. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The patient underwent lab tests and procedures which included sars-cov-2 test, positive on 09Aug2021 Nasal swab. The outcome of the events was resolving. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647041
Sex: U
Age:
State:

Vax Date: 08/09/2021
Onset Date: 08/10/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: All the symptoms of vertigo okay then I have but it's like each time is worse than what it ever has been./it's gonna intensify the effect of vertigo like 8 times more; I have been in bed all day sick.; I have been in bed all day sick; nauseous; being dizzy; It makes my ear ringing; I am gonna vomit; It was so bad this morning that I almost have gout.; I almost have gout.; it less up my sinuses; I was nervous; This is a spontaneous report from a contactable consumer (patient). A 51-year-old patient of an unspecified gender received bnt162b2 (BNT162B2, solution for injection, lot Number: FA6780, NDC number and Expiry Date: unknown), via an unspecified route of administration, administered in Arm Left on 09Aug2021 17:00 (age at vaccination 51-year-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing vertigo and the patient had corona virus back in Dec2020 before became the pandemic before even had the vaccination. The patient's concomitant medications were not reported. The patient experienced all the symptoms of vertigo then it's like each time was worse than what it ever has been or it's gonna intensify the effect of vertigo like 8 times more on 10Aug2021 10:00. The patient have been in bed all day sick, nauseous, being dizzy, it makes the ear ringing, the patient was gonna vomit, it was so bad the morning that almost have gout and also had sinusitis, patient was nervous on 10Aug2021 10:00. Therapeutic measures were taken as a result of the event of Vertigo aggravated and treatment was unspecified medicine. It was clarified that the patient got the Pfizer vaccine yesterday on 09Aug2021 17:00 and did a lot of research withheld nothing about it, patient asked a pharmacist before got the shot if patient would have any adverse reaction or anything because patient have vertigo. Okay nowhere in your literature or research or any of that patient have done that anything about the affecting vertigo and it does. Because patient haven't had an episode with vertigo and probably 9 months and as soon as patient got the shot, this morning, I woke up and I was just been sick all the morning with the vertigo symptoms and patient call the pharmacist and the pharmacist said it might affect that and bring it on more. And patient asked them and they nowhere said that because that would used 'cautions'. The patient would have took the medicine for the vertigo while patient got just the shot and patient have been in bed all day sick. The patient stated, 'The vertigo, it makes me nauseous like being dizzy and that it make my ears ringing. It makes, it just makes sick like patient was gonna vomit. It was so bad this morning that patient almost have gout.' The patient stated that vertigo was the worst that ever had vertigo like this. And the thing was this that don't really have the vertigo but patient get all these symptoms because patient have the corona virus back in Dec before became the pandemic before even had the vaccination. They didn't know what it was and sum it less up my sinuses, it's a mother thing. The patient stated, "10 'o' clock this morning and patient I got this shot yesterday 5 'o' clock. The patient even took medicine like normal it takes it right away, the symptom of the vertigo and it's have keep struggling patient just have to take the second dose and never have to take the second dose that's the problem." The patient stated, had the vertigo, need to know, it's gonna intensify the effect of vertigo like 8 times more So, need to prepared and take medicines before or right after or something till don't experience, this is what patient have been feeling. Considering it nowhere in the research I did on the Pfizer before with the CDC, everything on the web about the vaccine side effects, it was illnesses all that and I even ask the pharmacist and he's like no it shouldn't have affect it and then I called this morning and the pharmacist said though it can effect it, the patient was like really because it does and pharmacist said didn't know and took me on hold for a while and went to look up all the stuff and pharmacist couldn't find anything out about somebody having vertigo and taking the Pfizer vaccine. The patient was nervous if it's like taking the vaccine to begin with because of side effects, you know patient was waiting quite a long time." The outcome of the event of Nervous was unknown and all other events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Vertigo

ID: 1647042
Sex: U
Age:
State: TX

Vax Date: 05/07/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20200925; Test Name: COVID-19; Test Result: Positive; Test Date: 20201230; Test Name: COVID-19; Result Unstructured Data: Test Result: Positive; Test Date: 20210806; Test Name: COVID-19; Result Unstructured Data: Test Result: Positive.

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 18Dec2020 (Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 07May2021 (Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19 from 25Sep2020 to 25Sep2020, rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced got vaccine 18Dec2020. got covid infection 30Dec2020, received second vaccine 07May2021. 3rd covid infection on 06Aug2021 on an unspecified date, got vaccine 18Dec2020. Received second vaccine 07May2021. The patient underwent lab tests and procedures which included covid-19: positive on 25Sep2020, covid-19 positive on 30Dec2020. Covid-19 positive on 06Aug2021. Therapeutic measures were taken as a result of experienced got vaccine 18Dec2020. Covid infection 30Dec2020, received second vaccine 07May2021. 3rd covid infection on 06Aug2021. Got COVID infection 30Dec2020 monoclonal therapy on 15Jan2021 out of work for over 100 days. I have RA but have been off my medication since Jan2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647043
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Name: COVID; Result Unstructured Data: Test Result:Contracted

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: contracted COVID; contracted COVID; This is a spontaneous report from a contactable physician. This physician (patient's wife) reported for a male patient (reporter's husband). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the patient contracted COVID-19 after having been vaccinated on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: contracted on an unspecified date. It was unknown if any treatment was received for the events. Outcome of the events was recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The possibility of COVID-19, Drug Ineffective cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.

Other Meds:

Current Illness:

ID: 1647044
Sex: U
Age:
State: KS

Vax Date: 06/05/2021
Onset Date: 06/22/2021
Rec V Date: 08/28/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Renal Infarction; assumed it was kidney stones; pain in kidney; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received the first dose of Pfizer COVID vaccine on 05Jun2021. The patient started feeling pain in kidney a few days later on 22Jun2021. It eventually got to the point the patient had to go to the emergency room on 22Jun2021 (the patient assumed it was kidney stones). The patient was admitted with a renal infarction and they believe it was caused by the Pfizer vaccine. The patient would like to reach out and make sure that the company is aware of these. Outcome of the events was unknown. The events were assessed as serious (hospitalization). Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1647045
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: heart problems; This is a spontaneous report from a contactable consumer (not the patient) via telephonic activity. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-immunization. The patient experienced heart problems (seriousness criteria: death, medically significant) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), was not provided and will be requested during follow up.; Reported Cause(s) of Death: heart problems

Other Meds:

Current Illness:

ID: 1647046
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data: Test Date: 202108; Test Name: covid-19 test; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: PCR: Covid-19 Positive and related symptoms; PCR: Covid-19 Positive and related symptoms; This is a spontaneous report from a contactable consumer. This consumer reported for a 40-Year-old male (patient) that, A 40-years-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: not reported) via an unspecified route of administration on Apr2021 (at the age of 40-years-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Aug2021 the patient experienced PCR: COVID-19 positive and related symptoms (drug ineffective) (medically significant). PCR: COVID-19 positive and related symptoms (COVID-19) (medically significant). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On Aug2021 the patient underwent lab tests and procedures which included sars-cov-2 test as positive (Nasal Swab). No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. No prolonged hospitalization. Therapeutic measures were taken as a result of adverse events. Treatment received for the adverse event was Advil. The outcome of the events was unknown. Follow-up(12Aug2021): This is a follow up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. The response included that: Awareness date: 11Aug2021, EA: 11Aug2021 and Full vaccinated Best. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1647047
Sex: U
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: SARS-CoV-2 test; Test Result: Positive

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: breakthrough case of Covid; breakthrough case of Covid; This is a spontaneous report from a contactable physician received via a Pfizer representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer vaccine and had a breakthrough case of Covid. Patient is alive and stable. The patient underwent lab tests and procedures which included sars-cov-2 test: positive un an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1647049
Sex: F
Age:
State: CO

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 202108; Test Name: PCR; Result Unstructured Data: Test Result:Positive; Comments: Nasal Swab; Test Date: 202108; Test Name: rapid test; Result Unstructured Data: Test Result:Negative; Comments: Unknown; Test Date: 202108; Test Name: rapid test; Result Unstructured Data: Test Result:Positive; Comments: Unknown

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: patient experienced a breakthrough covid infection; patient experienced a breakthrough covid infection; swollen lymph node in her arm pit; This is a spontaneous report from a contactable consumer. A consumer reported for 37-year-old female that: A Non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 intramuscular, administered in Arm Left on 05May2021 17:15 (Batch/Lot Number: EW0176) as DOSE 2, SINGLE for Covid-19 Immunization. The patient medical history included Historical vaccine BNT162B2 on 11Apr2021 12:45 for Covid-19-Immunization with Lot number ER2613 via intramuscular route on Left arm. Concomitant medication(s) included Escitalopram Oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient experienced a breakthrough Covid infection on Aug2021, Swollen lymph node in her arm pit on 05May2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Aug2021 Nasal Swab, Sars-cov-2 test: negative on Aug2021 Unknown, Sars-cov-2 test: positive on Aug2021 Unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received treatment for the events. The clinical outcome for all the events was Unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: LEXAPRO

Current Illness:

ID: 1647050
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Date: 2021; Test Name: Covid; Test Result: Positive

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Got Covid about 48 hours after getting the first shot; Headaches went away after receiving the vaccine; This is a spontaneous report from a contactable physician (patient's husband). A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included headache from an unknown date to 2021 (She had always gotten headaches). The patient's concomitant medications were not reported. She had always gotten headaches and she wasn't getting them anymore. It was statedthat it's very obvious that it's the Covid Vaccine that had gotten rid of headaches (Headaches went away after receiving the vaccine). She got Covid about 48 hours after getting the first shot (in 2021), so she was probably exposed to it before getting the vaccine. But she got better right away, so the Covid vaccine helped her. The patient underwent lab tests and procedures which included COVID test: positive in 2021. The outcome of the event COVID-19 was recovering, of the other event was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Vaccine BNT162B2 requires atleast a period of 14 days to be effective since vaccination of the first dose. 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: Headache (She has always gotten headaches)

ID: 1647051
Sex: M
Age:
State: TN

Vax Date: 07/29/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 202107; Test Name: weight; Result Unstructured Data: Test Result:lost a lot of; Test Date: 202107; Test Name: weight; Result Unstructured Data: Test Result:165 lbs; Test Date: 20210811; Test Name: weight; Result Unstructured Data: Test Result:145 lbs

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: felt like he was going to have a heart attack; heart is hurting; face turned pure red; face was hot; Chest pain; Hernia in middle of stomach got real big; Hernia in middle of stomach got real big; his face turned beet red and was hot and burning up; He cannot eat anything; his stomach starts burning real bad; panic attack; could hardly breathe/short of breath; lost a lot of weight since the shot; arm swelled up and it never went down; His arm swelled 2 weeks ago after getting the vaccine and it is still hurting; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of bnt162b2, via an unspecified route of administration, administered in Right arm on 29Jul2021 (at the age of 60-year-old) (Lot Number: FA7458) as single dose for covid-19 immunisation. Medical history included small hernia in the middle of his stomach, Diabetic and high blood pressure (Began 30 years ago), diet from Jul2021 for about a month; all ongoing. The patient's concomitant medications were not reported. The patient felt like he was going to have a heart attack (medically significant), heart is hurting (medically significant), face turned pure red, arm swelled up and it never went down, face was hot, chest pain, hernia in middle of stomach got real big, his arm swelled 2 weeks ago after getting the vaccine and it is still hurting, his face turned beet red and was hot and burning up, he cannot eat anything, his stomach starts burning real bad, panic attack, could hardly breathe/short of breath, lost a lot of weight since the shot; all from Jul2021. The clinical course was reported as follows: Patient said he took the Pfizer shot, it has been two weeks and he is not going to take the second shot. Patient said his face turned pure red, his arm swelled up and it never went down, his face was hot, and he felt like he was going to have a heart attack. He says he was beet red, and he is still red. Patient said that he felt like he was going to have a heart attack, and his heart is hurting now. He has lost a lot of weight since the shot, a month ago he weighted 165 and now he is down to 145lbs. Caller clarifies that he has been leaving sweets alone in the middle of the night, he has been on a diet, the shot had nothing to do with it. He had symptoms after the first dose and is not going to take the second dose. It has been two weeks since he got the first dose and all symptoms started 2 weeks ago. He did not have an exact date. He previously had a small hernia in the middle of his stomach, and after he received the vaccine, it got real big. His arm swelled 2 weeks ago after getting the vaccine and it is still hurting. He said he should have never gotten the shot. After getting the shot, he went back home to get his girlfriend and take her and noticed his face turned beet red and was hot and burning up. Chest pain started same day his arm swelled up. Hernia started getting bigger 2 weeks ago. He cannot eat anything and his stomach starts burning real bad. His right arm swelled up and is hurting so bad. This also started two weeks ago. He was supposed to get second dose 19Aug2021, but he is not going to. He then said he is having a panic attack and could hardly breathe. He felt like he needed oxygen. He gets short of breath. This all started after he got the vaccine. The patient underwent lab tests and procedures which included weight: 165 lbs on Jul2021, weight: 145 lbs on 11Aug2021, weight: lost a lot of on Jul2021. The outcome of the event vaccination site swelling was not recovered, others was unknown.

Other Meds:

Current Illness: Abdominal hernia; Blood pressure high (Began 30 years ago); Diabetic (Began 30 years ago); Dietary control (for about a month)

ID: 1647052
Sex: M
Age:
State:

Vax Date: 07/31/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: not feeling good; nauseous; blood sugar is not very stable; This is a spontaneous report from a contactable consumer (parent). A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA6780), via an unspecified route on 31Jul2021 as dose 2, single for covid-19 immunization. The patient medical history included Type-1 diabetic from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 2021 as dose 1, single for covid-19 immunization. On unspecified date, the patient experienced adverse reaction to medication for diabetics. Reporter stated, "patient father was calling about some questions regarding, and wanted to know any side effects of the Pfizer vaccine how long it last for? his kids all had their second dose on the same day, 3 of his kid. patients children 3 children had vaccination, second dose at the same time at same day. One kid had stomach ache and was really yucky for couple of days. Patients fathers other child had to continue to have headache since during the second shot migraine headaches since the second vaccine. patient father himself personally had his second shot. There was, last Saturday and he had headache so, like bad headache, may get headache all days. So, he took two Ibuprofen (Hence, captured as suspect) it's (headache) not going away so, he just wants to know. he wants to know, his son was Type-1 diabetic and it's not little managed and he had his first vaccination try to figure out to have his second and he didn't tried Ketone and BKA since he got his first vaccination, his first shot. He was not feeling good at all, he was been sick, he had no energy and he just feel yucky. So, how long last for how long before we are ok, just wanted to know about headache and stuff." Reporter stated, "He immediately, first of all like we sat there for 30 minutes after vaccination, because he had an adverse reaction to medication for diabetics (Further not clarified, hence Captured as unspecified Medication). So, we waited 30 minutes before they left there and got home, and it take 20 minutes of time. So, he has not feeling good nauseous didn't feel good, he lay down, he didn't take ketones because he is diabetic should have blood sugar his blood sugar is not very stable and he is not feeling good." The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1647053
Sex: M
Age:
State: LA

Vax Date: 08/07/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data: Test Date: 202108; Test Name: pressure; Result Unstructured Data: Test Result:went up; Test Date: 202108; Test Name: tested; Result Unstructured Data: Test Result:they ruled him out; Test Date: 202108; Test Name: labs and tests; Result Unstructured Data: Test Result:nothing showed up; Test Date: 202108; Test Name: Covid swab; Test Result: Negative

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: started having spasms in the prostate area; Prostatitis; hard time being able to breathe, almost every 10 seconds; pain in the chest; it felt like gas, but it was more than gas; he felt pressure in his prostate; thought he was coming down with a bladder infection; pressure went up; he was coming down with a sinus infection; felt like he was having a heart attack; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right at the age of 59-year-old on 07Aug2021 11:15 (Lot Number: FC3180; Expiration Date: Mar2022) as single dose for COVID-19 immunisation. Medical history included ongoing low testosterone, trouble sleeping at night. Concomitant medications included testosterone taken for low testosterone from an unspecified start date and ongoing; clonazepam (KLONOPIN) taken for trouble sleeping at night/ help him sleep from an unspecified start date and ongoing. The patient previously took steroids and experienced respiratory distress. The caller states he just called the people he had gotten the shot from and they recommended him to call Pfizer. He states what happened was Saturday morning around 11am, he received the first vaccination shot from Pfizer. He states about midnight, he was watching TV, and then all of a sudden, at first it felt like gas then he ended up having a hard time being able to breathe, it was almost every 10 seconds , like a wave on 08Aug2021. He states it was more than gas, he had pain in the chest area on 08Aug2021. Any position he put himself into it didn't help. He states he took Phazyme, the max dose, and it didn't touch it, he didn't know what to do. He had considered going to the emergency room because his pressure went up (Aug2021) and at one point he was just thinking he had to go to the emergency room. He had seen a doctor and he said the emergency room is filled with Covid patients, and he doesn't need to expose himself so he stopped himself from going. He states it lasted for 3 hours, it was non-stop, but it finally subsided. He doesn't know exactly what happened but about 0330, he was finally able to drift off to sleep. It felt like he was having a heart attack (Aug2021). He states he's had a reaction before that was very similar when he had a steriod shot years ago, he told the doctor and the doctor told him that he should never take a steriod shot again because it gave him some kind of respiratory distress. He does not know what happened, he just needed to report this. The person that he spoke with said according to CDC guidelines, only if he went to the emergency room is when they say not to get the second shot and he would have had he known COVID patient were not there. He states he did go to the urologist Monday, he thought he was coming down with a bladder infection within an hour of getting the shot on 07Aug2021, he felt pressure in his prostate on 07Aug2021, he started having spasms on 09Aug2021 morning about 5:00. He states the urologist said he's gone through a patient who was in pain and having pressure in the prostate and he did lots of labs and tests (Aug2021) and nothing showed up. The doctor said the best guess is its a side effect of the Covid shot, and there is nothing to do but time and it will wear off. Started feeling pressure down there: He states that Saturday morning, within the hour, he started feeling pressure down there, it subsided, then it would come and go. He states he woke up Monday (09Aug2021) morning about 5:00 and it started spasming and that's when he called the urologist and he was diagnosed with prostatitis and the doctor said it would go away with time. He doesn't have prostate problems. Prostatitis: diagnosed 09Aug2021, ongoing, persisting. He states it has subsided, not enough even to mention. Monday was the worst and then that afternoon he felt like he wasn't spasming. It may happen once or twice during the day but it subsides quickly. He states he doesn't even know, he is scared to take the second shot. It was asked if the call handler recommend taking the second shot. States it's probably not a good time right now to be transferred, he will call them later. He states he went to see doctor about another reason and he thought he had COVID, he was coming down with a sinus infection (Aug2021), and the doctor said go ahead and get him tested (Aug2021) with everything going on so they ruled him out and they gave him a Covid swab (Aug2021) and that came back negative and the doctor started telling him what was going on and the doctor scared him to the point where he said he was going to get the injection.The patient underwent lab tests and procedures which included blood pressure measurement: went up in Aug2021, laboratory test: nothing showed up in Aug2021, investigation: they ruled him out in Aug2021, sars-cov-2 test: negative in Aug2021. Therapeutic measures were taken as a result of events (Treatment: Over the counter Phazyme 250 mg, 12 gel capsules, took 2, box says only allowed to have 2 within a 24 hour period). Not visit to Emergency Room. AE(s) require a visit to Physician Office (on Monday, but he diagnosed with prostatitis, he went to the urologist). The outcome of event 'hard time being able to breathe, almost every 10 seconds' 'pain in the chest' 'it felt like gas, but it was more than gas' was recovered on 08Aug2021. The outcome of event 'thought he was coming down with a bladder infection' 'he felt pressure in his prostate' was recovering. The outcome of prostatitis was not recovered. The outcome of other events was unknown.

Other Meds: TESTOSTERONE; KLONOPIN

Current Illness: Testosterone low

ID: 1647054
Sex: F
Age:
State: MS

Vax Date: 08/09/2021
Onset Date: 08/10/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: disoriented; ran a red light when driving; don't feel right; Anxiety; Euphoria; Nausea; pain around site; Muscle pain; chills; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 09Aug2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included diabetic and bone on bone. Concomitant medications included cortisone acetate (CORTISONE) taken for bone on bone and unspecified heart medications (as reported: and stuff). The patient experienced disoriented, ran a red light when driving, don't feel right, anxiety, euphoria, nausea, pain around site, muscle pain, and chills on 10Aug2021. The clinical course was reported as follows: She had to leave work on 10Aug2021 because of anxiety, euphoria, nausea, and pain around site. She had to finish most of her job. She was just trying to report the muscle pain and soreness at site. She wanted to go into work on 11Aug2021, but she was not one hundred percent. She works night shift. She went to have a cortisone injection put in the knee and that was the main reason she went in. While she was there, she got the BNT162B2 vaccine. That evening she had to stay home and iced it. She took ibuprofen (MANUFACTURER UNKNOWN) that night and iced her knee. She works shift work from 14:30 to 23:00. On 10Aug2021, she had to leave at 20:30 which was two and a half hours early because she was so disoriented in a way. She shouldn't have been driving. She made it to the house. She still didn't feel right. The patient clarified her symptoms started about 18:00. It started coming on and she pushed through and finished the job. She had to sit down because she was disoriented. It was so bad that she ran a red light when driving. Everyone was sitting at the red light. She wasn't just taking off and going through it. They were just sitting there and a person did a U-turn and she just went ahead and went. That was about nine something at night. She is not going to get on the road. She also iced her arm. The patient stated she knows that it was not the cortisone injection as she has had them before. She had one 8 months prior to this one in the right knee as both of her knees have bone on bone. Therapeutic measures were taken as a result of pain around site, muscle pain, and chills as aforementioned. The clinical outcome of disoriented, ran a red light when driving, don't feel right, anxiety, euphoria, nausea, pain around site, muscle pain, and chills was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds: CORTISONE [CORTISONE ACETATE]

Current Illness:

ID: 1647055
Sex: F
Age:
State: IL

Vax Date: 04/14/2021
Onset Date: 05/04/2021
Rec V Date: 08/28/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: falling; couldn't walk; broke leg; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in Left arm on 14Apr2021 14:15 (at the age of 71-year-old) (Lot Number: ER8735) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced couldn't walk after falling, broke leg (all hospitalization from 04May2021 to 06May2021, medically significant, resulted in emergency room) on 04May2021. The patient received her first dose Pfizer Covid Vaccine and was scheduled to receive the second dose Pfizer Covid Vaccine on 05May2021. On 04May2021 the patient broke leg and ended up going to the hospital and rehab. The patient received the second dose Pfizer Covid Vaccine in the rehab center on 17May2021. The patient received the second dose of bnt162b2, via an unspecified route of administration, administered in right arm on 17May2021 4:15 or 5:00 (at the age of 71-year-old) (Lot Number: GW0168, not sure if it is the letter o or the number 0 in the lot number) as single dose for covid-19 immunisation. The patient went to the emergency room because she couldn't walk after falling on the night of the 04May2021. The patient was hospitalized for two days. On 04May2021, the patient was going down the stairs to feed the cat. The patient was going down the stairs and missed the last step. The patient remembers holding onto the rail and telling herself not to hit head or hips. The patient rolled onto the floor and felt something awkward in the leg like an electricity shock and The patient made out a yell. The patient laid down in the floor and got up and fed the car and went back upstairs to her room for one hour. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647056
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Depression; This is a spontaneous report from a contactable consumer or other non hcp. A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: was not reported; Expiry Date of COVID Vaccine: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced depression on an unspecified date. It was reported that the patient got into depression and she didn't go to take her second dose; it's been 90 days since she took the first dose. Reporter seriousness for the event was unspecified. The patient denied to answer any question when asked about batch number. The patient called, her initial question was about her mother who live in withheld (Further clarification was unknown, hence COI was captured as withheld by default), was instructed to take the second vaccine 3 months later. She said that she received the vaccine 90 days ago and reported that, she received the Pfizer COVID Vaccine 90 days ago and she was instructed to come back it's been 3 months to receive the second vaccine and she was calling from (privacy). The patient said she did not go for second dose and asked what she should do and if not taking the second dose would work. She reported she got into depression, not because of the vaccine in unclear words. She reported as 90 days was crossed from the first dose can she take the second dose and would she be protected. She said that she read something that stated that it was supposed to take maximum 42 days after first dose. She was frustrated with the calls being on hold and transferred. She wanted the answer if the second dose after 90 days would protect her. She asked to transfer her call to someone who could respond to her query. Outcome of the event was unknown. Follow-up activities closed. Batch/lot number not available.

Other Meds:

Current Illness:

ID: 1647057
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Rheumatoid arthritis flare up; This is a solicited report based on the information received by Pfizer. A non-contactable 55-year-old female consumer (patient) reported for herself. Solicited report by a consumer of an adult male with an event of Non-serious rheumatoid arthritis flares after second pfizer covid shot with rinvoq (upadacitinib). There was no reported medical history. On an unknown date, the patient experienced rheumatoid arthritis flares after second pfizer covid shot. on an unknown date, rheumatoid arthritis flares after second pfizer covid shot resolved. COVID-19 VACCINE was also considered suspect. The patient had flares following the second Pfizer Covid shot. He had not stopped The Rinvoq as directed by the physician. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown Causality assessment: Causality assessment between the event Rheumatoid arthritis flare up with RINVOQ (upadacitinib) was No reasonable possibility by the reporter, with COVID VACCINE was Not Reported. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment The lot number for BNT162b2 was not provided and will be requested during follow up; Sender's Comments: Based on the available information in the case, the causal association between the event rheumatoid arthritis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 1647058
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Not Happy that pfizer is not as effective as Moderna I had Pfizer; This is a spontaneous report from a Pfizer sponsored program Pfizer.com - General Company Information. A contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. It was mentioned that, patient was not happy that pfizer was not as effective as Moderna patient had Pfizer. Get the ball going now on a booster and vaccines for all ages. Push the FDA. No time to waist. Very disappointed in Pfizer. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647059
Sex: U
Age:
State:

Vax Date: 08/10/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Really really lethargic; Really really lethargic or tiredness because it seems like I am just sleeping and that was about; Really really lethargic or tiredness because it seems like I am just sleeping and that was about; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 10Aug2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date in Aug2021, after first dose of vaccination (received 18 hours ago-from the report time), patient was really lethargic or had tiredness because it seems like patient was just sleeping. Outcome of the events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

Date Died:

ID: 1647060
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: female died 3 days after receiving the first COVID vaccine shot of a massive stroke; This is a spontaneous report from two contactable consumers. A 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported the female died 3 days after receiving the first COVID vaccine shot of a massive stroke. Healthy patient. It was not reported if an autopsy was performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: female died 3 days after receiving the first COVID vaccine shot of a massive stroke.

Other Meds:

Current Illness:

ID: 1647061
Sex: F
Age:
State: FL

Vax Date: 08/02/2021
Onset Date: 08/02/2021
Rec V Date: 08/28/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 202108; Test Name: Blood works/blood tests; Result Unstructured Data: Test Result:came back normal and nothing out of the ordinary; Test Date: 202108; Test Name: CT scan; Result Unstructured Data: Test Result:came back normal and nothing out of the ordinary; Test Date: 202108; Test Name: MRI; Result Unstructured Data: Test Result:came back normal and nothing out of the ordinary

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: stroke-like symptoms; her arm went numb/her face went numb; fire burning through her body; her head feels like her brain was laying dead and her brain feels to her like deadweight; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm (unsure if right or left arm) on 02Aug2021 at 17:00 (Lot Number: FC3180, at the age of 45-year-old) as single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. There were no prior vaccinations (within 4 weeks). Patient took the 1st dose of the vaccine 9 days ago (on 02Aug2021 at 17:00) and 5 minutes after taking the vaccine (on 02Aug2021 at 17:05) her arm went numb and she had been going back and forth to the emergency rooms for the past couple of days; the patient had stroke-like symptoms, her face went numb along with something she described like fire burning through her body and her head felt like her brain was laying dead and her brain felt to her like deadweight. The patient had been going back and forth to different emergency rooms and had several records to show it and her other healthcare professional primary care did all a bunch of blood tests and nothing had come back so far out of the ordinary. The patient kept having the symptoms since she took the Pfizer COVID Vaccine. The patient was in excellent shape and had no health issues in the past before and took the Pfizer COVID vaccine at 5:00pm and by 5:05pm started having the symptoms and by 5:30pm was in the emergency room and it had been that way since then. When she laid down for an extended period of time sometimes it calmed down a little bit regarding her symptoms and then when she got up or started moving or any movement the symptoms kick back in so she had been laying down since then. The patient had been to the emergency room three times in a few days and had hospital visits and then clarified she had not had an overnight stay in the hospital but they pulled her blood and did computerised tomogram (CT) scans and magnetic resonance imaging (MRI) and they were there 6, 7, or 8 hours and then were back home and then went back to the same place but he did not have the additional dates of the emergency room dates to provide. The blood work, CT scans and MRI on Aug2021 that everything came back normal and nothing out of the ordinary and she was in perfect shape before this and takes no medications. The adverse events require a visit to emergency room and physician office. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am