VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer
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: 1677476
Sex: F
Age:
State: TN

Vax Date: 08/10/2021
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
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: 202108; Test Name: blood pressure; Result Unstructured Data: Test Result:200s/ high; Comments: her blood pressure was running in the 200s; Test Date: 20210811; Test Name: Heart rate/ pulse; Result Unstructured Data: Test Result: Increased/ irregular; Comments: Increased heart rate with rapid pulse/ my pulse race really hard.

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Increased heart rate with rapid pulse/ pulse racing; Weakness, tingling, numbness in both arms and legs; Weakness, tingling, numbness in both arms and legs; Weakness, tingling, numbness in both arms and legs; Feeling real real tired; Feeling jittery; Nausea; Headache; Sore arm/ clarified sore in the injection arm; Sore arm/ clarified sore in the injection arm; Her blood pressure was running in the 200s.; She knew it was inflammation around the heart, lungs, and liver that can cause a problem; dizzy; don't know if that a sign of having stroke; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: FC3181), via an unspecified route of administration, administered in right arm on 10Aug2021 at 19:30 (at the age of 65-years-old) as dose 1, single for COVID-19 immunization. Medical history included family history of high blood pressure (and patient always had it, As high as 200) and Patient diagnosed with congestive heart failure from an unknown date and unknown if ongoing (prior to the vaccine). There were no concomitant medications. On 10Aug2021, after vaccination, sore arm or sore in the injection arm (began 3 to 4 hours after the vaccine), nausea (5 to 6 hours after the vaccine, lasted couple hours), headache (and every day since the vaccine, but getting better, comes and goes), feeling real real tired (Began right after the vaccine, Feels energy drained) and feeling jittery (Began after the shot, hasn't stopped, it's on and off, it's better after the blood pressure. Can feel her pulse real fast and heart like it's beating out of her chest). On 11Aug2021 at 02:00, patient experienced increased heart rate with rapid pulse or pulse racing; weakness, tingling, numbness in both arms and legs (Clarified it went on 4-5 days). On an unknown date in Aug2021, patient had blood pressure running in the 200s, inflammation around the heart, lungs, and liver that can cause a problem, sign of having stroke and dizzy. It was reported patient had symptoms of a sore arm which she can handle, patient work in the medical field, she had nausea, headache everyday and all that, Patient looked online and it says if you had allergic reaction and it had a list of the symptoms well the same day maybe 2 or 3 hours later heart, patient have a high blood pressure, heartbeat felt like it was going to beat out of body and pulse was racing, heartbeat and the pulse, And patient wants to know is that normal and states she could have an allergic reaction and asks if you have irregular heartbeat, how high. Patient arms and legs feel numb and feel jittery, and don't know if that a sign of having stroke but feel jittery and arms and legs for 4 or 5 days and rapid heart beat came on the same night she took a shot, 5 hours later her chest and pulse was racing. Patient went to work night shift at 2:00 it hit her with racing pulse and heartbeat lasted an hour got up dizzy. It just scared her; she could stand there and feel how bad her heart and pulse was beating. She needed to go to the ER but couldn't leave. Patient went to emergency room because she had a headache and her blood pressure was running in the 200s. Had to get an IV to bring it down. Patient had Numbness and tingling in arms for 5 to 6 days. Patient tried to get an appointment to have her heart checked out and blood work done, but can't get an appointment for 2-3 months. Sore lasted just a couple days, it's gone. Patient knows it's inflammation around the heart, lungs, and liver that can cause a problem and asks is there something to get rid of that, and asks if to take shots of antioxidants and B12. Patient was scheduled to get her second shot on 31Aug2021 and wanted to know if she could get the second dose because she read about an allergic reaction, and doesn't know if she's going to take the chance and get the second shot. Patient want to be protected by and was scared to take it because of the reaction after getting the first vaccine, because it made blood pressure and pulse race really hard. Patient states vaccine could kills her or stops her heart, and may lead to ended up dying or something she don't know what to do. Patient wants a letter by Health Care Professional that she had allergic reaction to vaccine which she can take to work. The patient underwent lab tests and procedures which included blood pressure resulted 200s or high in Aug2021 (her blood pressure was running in the 200s) and heart rate resulted as increased or irregular on 11Aug2021 (increased heart rate with rapid pulse or my pulse race really hard). Therapeutic measures were taken as a result of her blood pressure was running in the 200s. The event her blood pressure was running in the 200s resulted in emergency room visit. The outcome of the event inflammation around the heart, lungs, and liver that can cause a problem and sign of having stroke was unknown; outcome of feeling real real tired was not recovered; outcome of feeling jittery and headache was recovering; outcome of events nausea recovered on 10Aug2021, increased heart rate with rapid pulse or pulse racing recovered on 11Aug2021, and rest of the events recovered on an unspecified date in 2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1677477
Sex: F
Age:
State: FL

Vax Date: 08/02/2021
Onset Date: 08/11/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data: Test Date: 20210811; Test Name: Covid-19 test; Test Result: Positive

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: tested positive for Covid 19; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 02Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient tested positive for COVID-19 on 11Aug2021. She had mild fever, fatigue, nausea and headache. It was reported that, patient had the Covid 19 vaccine and did fine. But about 6 or so days after her Covid 19 vaccine she thought she had the Covid 19 virus and she had a test done and it was positive for the Covid 19 virus. Patient were exposed to people who later tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Aug2021. The outcome of the event was unknown. Follow up attempts are needed. Information on the lot/batch number has been requested. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1677478
Sex: M
Age:
State: CO

Vax Date: 04/10/2021
Onset Date: 04/01/2021
Rec V Date: 09/07/2021
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:

Allergies:

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

Symptoms: He had peeling on his hands and the bottoms of his feet.; He had increased sensation on his lips, inside of his mouth; He had increased sensation on his lips, inside of his mouth, and in his stomach.; Even if he drank water it would burn his mouth; It hit my RA and made my joints hurt like hell for 2.5 days; It hurt for about an hour and a half; He had little spikes of pain in his ankles; He had little spikes of pain in his ankles and hands that was pretty intense.; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable 66-year-old male consumer reported himself who received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Right on 10Apr2021 (Batch/Lot Number: EW0153) (at the age of 66-years-old) as SINGLE for covid-19 immunization. Vaccination was given in afternoon, like just passed midday between 1-3 at PVMC, SEL health. Historical vaccine included pneumonia vaccine on Jan2021 or Feb2021. Patient medical history included RA, emphysema, copd, cervical spinal stenosis, fusion, laminectomy, nerve damage and doesn't feel a thing, he does have hay fever and other minor allergies/ He did have a reaction to one thing. It was an inhaler from an unknown date and unknown if ongoing. In 2011, he had a neck surgery. Patient denied for any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. He called in to know and get some advice when to take the follow up shot or booster shot. He states he has been fine since the initial injections, however he did react to it. He was seeking information about the third booster dose and information regarding protection against the lima and delta variants of the covid 19 infection following vaccination with the comirnaty vaccine and was asking how the booster dose of the Comirnaty vaccine is going. Patient reported that he would be interested in participating in any research thing on the new booster. He would be more than happy to participate because of his age. His daughter wants to be a part of it too. He has another daughter that wouldn't, and one that would consider it. He also worries about shedding the vaccine. With the different variants will that increase shedding. Patient mentioned that when he got his first shot, it hurt for about an hour and a half and it was more intense in the second shot. On 02May2021, patient stated that "It hit his RA and made his joints hurt like hell for 2.5 days" also stated he reacted to some vaccines and flu vaccines growing up. On Apr2021, Patient stated that couple of hours after the first dose of the Vaccine, he had little spikes of pain in his ankles and hands that was pretty intense. He has a high tolerance of pain anyway so it wasn't that bad. It lasted an hour or two and it went away. He got some syndrome related to the medicine. He had peeling on his hands and the bottoms of his feet. He had increased sensation on his lips, inside of his mouth, and in his stomach. Even if he drank water it would burn his mouth. It was like he was oversensitive. He always eats hot sauce on everything. When he went through his reaction to the inhaler, mild sauce felt like he bit into a ghost pepper. Patient denied for any emergency room or physician office visit and also denied for any lab test procedure. The patient did not received any treatment. The outcome of event for hurt for about an hour and a half, little spikes of pain in ankles and hands that was pretty intense was recovered whereas for other events it was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1677479
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: COVID-19 pneumonia/ got Covid; COVID-19 pneumonia/ got Covid; felt like crap/ how bad he still felt/didn't feel good; fell/ Falling down; was not eating anything but fruit and drinking lots of power aide and water; stumbling; Lost weight; dizzy; Feeling sick; Throwing up; diarrhea; This is a spontaneous report from a contactable nurse (patient's sister). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right in Mar2021 (at the age of 68 years old) (Batch/Lot number was not reported) as single dose; dose 2 via an unspecified route of administration, administered in Arm Right in 2021 (at the age of 68 years old) (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. Medical history included Spinal meningitis from 1956: When he was 3 years old. The patient's concomitant medications were not reported. No Other Products. Vaccination Facility Type: Military Base. Vaccine Administered at Military Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks), no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. No Family Medical History Relevant to AE(s). On an unspecified date in 2021, the patient experienced COVID-19 pneumonia/ got Covid, felt like crap/ how bad he still felt/didn't feel good, Throwing up, Lost weight, dizzy, diarrhea, fell/ Falling down, Feeling sick, was not eating anything but fruit and drinking lots of power aide and water, stumbling. Events COVID-19 pneumonia required a visit Emergency Room. Event felt like crap/ how bad he still felt/didn't feel good resulted in Physician Office Visit. The patient was hospitalized for 7 days at hospital for events COVID-19 pneumonia. It was reported that: The patient got both doses of the Pfizer Covid vaccine, and he got Covid Pneumonia. He suffered, but was able to come home. He had been home for 2 weeks, but still told her every day that he felt like crap and felt like he needs to be re-admitted to the hospital. Caller stated that he was now 69 years old and was stumbling in his apartment, but he was 68 years old when he got Covid. Caller verified that he received both doses of the vaccine. Stated that he got his vaccine a month before her. He got his 1st dose in Mar2021, then about 3 weeks after his 2nd dose he was feeling sick but didn't say anything. Then he actually got really sick. The caller stated that she called to check on him and he picked up the phone, but it fell on the floor because he couldn't hold onto it. Caller stated that it sounded like he was in a tunnel. She went over to his house and he was sitting in the recliner in a pull up with no other clothes on because he woke up sick and couldn't get to the bathroom so he had an accident. He tried to get to the kitchen to get juice, but he fell. Stated that she walked him to the bathroom with double gloves and cleaned him up and dressed him in clean pajamas, and asked him if he thought it was time to go to the ER, but he refused. Caller stated that she thought he was scared to go. He sat home for another 2 weeks; he was throwing up, had diarrhea, was falling down, and was not eating anything but fruit and drinking lots of power aide and water. Stated that her sister called EMS, and they went over to his address, she opened the door for them, but they said that they couldn't make him go to the ER because he was answering all their questions appropriately. The next week he finally called her to go get him, so she went over there with her daughter and they took him to the ER. The triage nurse went out and told her and her daughter to go get tested because the doctor said he had Covid Pneumonia. He was admitted to the hospital, but they weren't allowed to go in the hospital to see him. Caller tried to determine when her brother got sick based on when her mom was sick and in the hospital, but she wasn't able to figure it out. The best she could figure was that her mom went to the hospital around 06Jul2021 or 07Jul2021 and she was there 2 weeks before she died. She thought her brother started getting sick about 4-5 days after their mom got sick, but she really wasn't sure. Stated that she brought her brother to the hospital and that's where he was originally admitted, but they sent him to Hospital because they didn't have anymore Covid beds. He was kept in Withheld for 7 days. She kept calling to check on him about 3 times a day because she wasn't allowed to visit, but on day 8 when she called she was told that he was discharged. Stated that she was upset because she was his ride and no one called her. Stated that no one called her when he was transferred either. But he called her and said that he was home, so she went to his house to check on him. Caller stated that he told her how bad he still felt. She went out and bought his prescriptions, some water, Pedialyte, and fruit. Stated that the next day he fell down the wall while he was trying to regulate the thermostat on his A/C. Stated that he has lost weight to the point that his jeans and belt don't fit anymore. He kept saying that he didn't feel good. He was taking his medication, and went to his appointment like he was supposed to. Caller stated that she told him to ask his doctor if he could be re-admitted because he felt crappy and didn't feel safe at home, but instead they set him up with home health. Stated that the nurse came all hooded up and gloved up, in like a chemical suit. He told the nurse that he felt like he needed to go back to the hospital because felt like he still had Covid and she said that she couldn't help him then, and she left. She left everything she brought with her there, all the equipment she had, and when she took off her suit she put it in a black garbage bag in her trunk and she left. He went back to the doctor's and told the doctor the same thing again, but the doctor changed something with his meds and sent him home. Stated that no one from home health ever came back. Caller stated that he's not falling anymore, but was still dizzy a lot. The patient's weight was 210-215 lbs, caller stated this was just a guess. The outcome of the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of event covid19 pneumonia cannot be totally excluded.

Other Meds:

Current Illness:

ID: 1677480
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: 2021; Test Name: Covid-19; Test Result: Positive

Allergies:

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

Symptoms: Terrible deep cough; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer. This is report 3 of 5. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown) via an unspecified route of administration in arm left on 07Aug2021 as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were none. On an unspecified date, patient tested positive for COVID and experienced cough. Reporter also stated she was with person who was coughing their brains out but had a mask on, another person who wasn't wearing a mask, and the third per-son who only had one shot. All three tested positive for COVID and she was the only one who did-n't. She had a terrible deep cough. She was very contagious. Patient's husband had COVID and didn't know it but was cured. His symptoms resolved in 2 days but was shedding the virus appar-ently. She clarifies husband was not wearing a mask and was talking a mile a minute, he had just gotten over COVID that week and was fine. He had gone back to work and everything. Reporter confirms they all three people at the dinner with her tested positive for COVID. 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: 1677481
Sex: F
Age:
State: TX

Vax Date: 03/24/2021
Onset Date: 04/06/2021
Rec V Date: 09/07/2021
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: Test Date: 20210803; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210823; Test Name: tested for COVID-19; Result Unstructured Data: Test Result:no result

Allergies:

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

Symptoms: chest pain that radiated to my back (between by shoulder blades); chest pain that radiated to my back (between by shoulder blades); difficulty breathing; Disease recurrence; Pericarditis; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Right as single doses for covid-19 immunisation on 24Mar2021 at 08:00 (first dose at 49 years; Lot Number EP6955) and on 14Apr2021 at 08:00 (second dose at 49 years; Lot Number ER8731) . Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19.Concomitant medications included vitamin b complex (B COMPLEX) and minerals nos, vitamins nos both taken for an unspecified indication, start and stop date were not reported.On 06Apr2021 at 06:00 AM, patient began having chest pain that radiated to her back (between by shoulder blades) and was having difficulty breathing. After two days, she got better (recovered in Apr2021). On 28Apr2021, she had another episode similar to the one noted above. That episode lasted 3 days. On 21May2021, she had a third episode which lasted 3 days (recovered in May2021). She saw a cardiologist on 11Jun2021 who stated that she likely had Pericarditis (onset on an unspecified date in 2021, unknown outcome). She has had a number of episodes since. On 03Aug2021, the chest pain was so bad, she had to go to the Emergency Room. The chest pain has gotten progressively worse even with treatment (anti-inflammatory). Nasal Swab on 03Aug2021 was negative. On 23Aug2021 the patient been tested for COVID-19, no result provided. Events required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care; Sender's Comments: ~~~

Other Meds: B COMPLEX [VITAMIN B COMPLEX]; VITA-LEA

Current Illness:

ID: 1677482
Sex: F
Age:
State: CA

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/07/2021
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: Pyrexia, White blood cell count decreased

Symptoms: Subconjunctival hemorrhage; This is a spontaneous report from a contactable nurse (patient herself). This 50-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route, on 19Aug2021 16:00 at single dose for COVID-19 immunisation, administered at pharmacy/drug store. No other vaccine was received in four weeks. Relevant medical history included colitis ulcerative. No known allergies. The patient was taking concomitant medications (no details provided). On 19Aug2021, the patient developed subconjunctival hemorrhage. No seriousness criterion was provided by the reporter. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was not treated for the event. The patient had not recovered from the event. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relation, the association between the event of subconjunctival haemorrhage and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1677483
Sex: F
Age:
State: TX

Vax Date: 04/13/2021
Onset Date: 04/01/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data: Test Date: 20210414; Test Name: fever; Result Unstructured Data: Test Result:102.9; Test Date: 20210414; Test Name: O2 levels; Result Unstructured Data: Test Result:dropped to 90 at times; Test Date: 20210417; Test Name: diagnosed with COVID; Result Unstructured Data: Test Result:COVID; Test Date: 2021; Test Name: investigation NOS; Result Unstructured Data: Test Result:for auto immune disease (unknown results)

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: hair loss; extreme fatigue; Spiked a fever of 102.9 less than 24 hrs after; extreme shortness of breath; coughing; bronchitis; O2 levels dropped to 90 at times; diagnosed with COVID; auto immune disease; This is a spontaneous report from a contactable Other HCP (patient). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 (Batch/Lot Number: EW0158) age at vaccination of 51-years-old, as single dose, for covid-19 immunisation. Medical history was none. The patient was not pregnant and was not pregnant at the time of vaccination. Known allergies: NKDA; no food allergies; seasonal allergies. Concomitant medications included losartan potassium (LOSARTIN) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had spiked a fever of 102.9 less than 24 hrs after; was diagnosed with COVID 4 days later; had extreme shortness of breath and coughing; bronchitis; O2 levels dropped to 90 at times; fever for ten days; cough lasted for several weeks; now the patient had hair loss and extreme fatigue. DR was concerned that patient may have an auto immune disease now and now patient having bloodwork done to test for this (unknown results); still have shortness of breath some days and require an inhaler when that happens. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient underwent lab tests and procedures which included body temperature: 102.9 on 14Apr2021, oxygen saturation: dropped to 90 at times on 14Apr2021, sars-cov-2 test: covid on 17Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19 (as reported). Therapeutic measures were taken as a result of the events and included administration of steroids. The patient was considered recovered with sequelae from the events on an unspecified date in 2021.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event autoimmune disorder cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: LOSARTIN; VITAMIN D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1677484
Sex: F
Age:
State: AZ

Vax Date: 02/01/2021
Onset Date: 02/02/2021
Rec V Date: 09/07/2021
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: Shingles; chronic pain at injection site, L deltoid; Increased incidence and severity of acute Rheumatoid Arthritis flares; This is a spontaneous report from a contactable nurse. A 52-year-old female nurse (patient) reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1283) intramuscularly in left arm (deltoid) on 01Feb2021 at 12:45PM (at the age of 52-year-old) for COVID-19 immunisation. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899) intramuscularly in left arm on 08Jan2021 at 10:30AM (at the age of 52-year-old) at single dose for COVID-19 immunisation. Relevant medical history included depression, rheumatoid arthritis and endometriosis. The patient did not receive other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included an unspecified anti-depressive drug. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient had chronic pain at injection site (left deltoid) since second shot and increased incidence and severity of acute rheumatoid arthritis flares on 02Feb2021, along with diagnosis of shingles in Mar2021. The events were serious as medically significant and disabling, and required emergency room and physician office visit. Antiviral for shingles were given. The events were resolving with sequelae at the time of report.; Sender's Comments: Based on the available information and the close drug event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events rheumatoid arthritis flares up, herpes zoster and vaccination site pain cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1677485
Sex: F
Age:
State: CA

Vax Date: 08/20/2021
Onset Date: 08/21/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Miscarriage; Left Arm pain; Nausea; Headache (HA); This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185), via an unspecified route of administration, administered in left arm on 20Aug2021 at 12:45 (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient's concomitant medications were not reported. On 21Aug2021 at 08:00 the patient experienced left arm pain, nausea and headache (HA). The vents were resolved with sequelae on an unspecified date in Aug2021. On 22Aug2021 the patient experienced miscarriage. The mother reported she became pregnant while taking bnt162b2. The mother was 5 weeks pregnant at the onset of the event. The mother was due to deliver on 18Apr2022. The outcome of event miscarriage was reported as unknown. The patient did not receive treatment for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of event abortion spontaneous cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1677486
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
Hospital: Y

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

Lab Data: Test Name: COVID; Test Result: Positive

Allergies:

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

Symptoms: tested positive for COVID; tested positive for COVID; This is a spontaneous report from contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tested positive for covid on an unspecified date. The events outcome was unknown. The patient was hospitalized for tested positive for covid for 14 days. The patient was hospitalized for tested positive for covid (covid-19) for 14 days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. Additional information: Caller makes the comment she was with three people on 24Jul2021, inside at dinner. She was with person who was coughing their brains out but had a mask on, another person who wasn't wearing a mask, and the third person who only had one shot. All three tested positive for COVID and she was the only one who didn't. She clarifies she still has immunity obviously, and she doesn't want to get another shot. The guy next to the caller had one vaccine but he must have caught COVID from both of the other two guests at dinner. The guy next to the caller was barely masked because he was eating and talking throughout dinner, but he must have been catching COVID during that time. He didn't show any symptoms at all that night, but tested positive later. Apparently the male guest that had COVID that week was still shedding the virus because the other male guest at the dinner got COVID and was in the hospital for 2 weeks. Caller confirms they all three tested positive for COVID. Caller declines to complete a report on these 3 people at the time of the call, requesting she would rather have her medical questions addressed at this time. No further details were provided or obtained. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1677488
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data: Test Name: both had Covid; Test Result: Positive

Allergies:

Symptom List: Rash, Urticaria

Symptoms: had Covid; had Covid; cough; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for her husband that include: A male patient of an unspecified age received first dose of bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated that her son has already received the 1st dose of the Pfizer BioNTech Covid vaccine but was not able to get the vaccine on the recommended date due to congestion and mucus. Caller asked if her son was still eligible to receive the second dose. Caller also asked if she and her husband should get the second dose after 42 days from the first dose since they both had Covid. She and her husband recovered from Covid-19 two weeks ago and was wondering when they can get the Pfizer BioNTech Covid vaccine. She stated that they did not have the monoclonal antibody treatment and was not admitted in the hospital instead just at home. Caller also asked if it was fine for her husband to receive the vaccine even though he had cough. She said she did not think the cough was from the Covid virus but instead he got it somewhere else. The patient experienced had covid on an unspecified date, had covid on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1677489
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: had a reaction and you know it felt, flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, on an unspecified date, at dose 2, single for covid-19 immunization. The patient had the third shot of vaccination on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient experienced a reaction and it felt like flu like symptoms on an unspecified date. 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: 1677490
Sex: F
Age:
State: AR

Vax Date: 08/16/2021
Onset Date:
Rec V Date: 09/07/2021
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: 20210821; Test Name: CBC lab; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: I have just been to the emergency room twice and I have a severe reaction; I am broke out and I am completely hives like with blisters and this morning it is up to my face; I have just been to the emergency room twice and I have a severe reaction; I am broke out and I am completely hives like with blisters and this morning it is up to my face; This is a spontaneous report from a contactable consumer. A contactable 51-year-old female consumer reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FA7485) intramuscular in right arm on 16Aug2021 (at the age of 51-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 vaccine, Lot number unknown) on 25Jul2021 (at the age of 51-year-old). Relevant medical history included fibromyalgia from around 2017. Concomitant medications included paracetamol (TYLENOL), tramadol, hydroxychloroquine and sulindac, all taken for fibromyalgia. The patient reported that she has just been to the emergency room twice and she had a severe reaction: she broke out and she had completely hives like with blisters and that morning it was up to her face. The patient reported that she was currently on steroid pack of methoprednisolone tablet and she was almost done with that, she also received a steroid shot at the ER for this reaction. Full blood count was done on 21Aug2021 (no results provided). The event was not resolved and getting worse. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event Urticaria and Blister cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: TYLENOL; TRAMADOL; HYDROXYCHLOROQUINE; SULINDAC

Current Illness:

ID: 1677491
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: she catch COVID; she catch COVID; heart issues from COVID; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Reporter's sister-in-law). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date, it was reported that, the patient got both doses and 2 months after she was fully vaccinated, not only did she catch COVID, the patient now has heart issues from COVID and had spread it to her in-laws as well. The patient was very confused on how this vaccine could protect her community the patient got sick. The patient was also the only one that developed severe issues while all the family did not have much symptoms at all. How was that safe and effective and protecting the community if her sister-in-law received both vaccines and had the worst symptoms of COVID than everyone else who did not receive the vaccine. Caller also asked if the vaccine would protect individuals in transmission of the COVID vaccine. 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: 1677492
Sex: M
Age:
State: AZ

Vax Date: 02/14/2021
Onset Date:
Rec V Date: 09/07/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: inflammation around his heart; pericardial effusion; difficulty breading; severe weakness; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Feb2021 (Lot Number: EL9263) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 24Jan2021 (Lot: EL3247) for covid-19 immunisation. After two dose of vaccination, the patient developed inflammation around his heart. He had difficulty breading and had severe weakness. He was taken to the emergency on 13Apr2021 and given steroid treatment. He was taken again on 10May2021 and admitted with steroid treatment. On 14Jun2021, he was admitted again and they did a pericardial effusion. His symptoms have returned. Need some answers. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1677493
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: It has been 4 months since the last shot . If I have to describe the pain I would describe it as pain muscle; This is a spontaneous report from a contactable consumer reporting for herself A 42-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at the age of 42 years as DOSE 2, SINGLE for covid-19 immunisation. Historical Vaccine dose 1 of bnt162b2 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that "it has been 4 months since the last shot . if I have to describe the pain I would describe it as pain muscle (medically significant) on 2021 with outcome of unknown. The lot number for the vaccine, [Pfizer Covid-19 Vaccine], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1677494
Sex: F
Age:
State: CA

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 09/07/2021
Hospital: Y

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

Lab Data: Test Name: CT Scan; Result Unstructured Data: Test Result: UNKNOWN; Test Name: MRI; Result Unstructured Data: Test Result: UNKNOWN.

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: I developed Bells Palsy affecting the left side of face On 04Jul, 4 months after my 2nd Pfizer vaccine on 04Mar; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6200), via unspecified route of administration, administered in arm left on 04Mar2021 (at the age of 74-years-old and she was not pregnant at the time of vaccination) as Dose 2,Single for COVID-19 immunization. The patient's medical history was none. Other medications in two weeks included atorvastatin calcium (LIPITOR) 10 mg daily. There was no other vaccine in four weeks. There was no covid prior vaccination and not tested COVID post vaccination. There was no known allergies. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9265), via unspecified route of administration, administered in arm left on unspecified date as DOSE 2, SINGLE for COVID-19 immunisation at hospital. The patient experienced Bell's Palsy affecting the left side of face on 04Jul2021 at 6:00 AM, 4 months after my 2nd Pfizer vaccine on 04Mar2021. The adverse event resulted into Emergency room visit, Hospitalization for one day. She received treatments for adverse event included CT Scan, MRI, medication. The patient underwent lab tests and procedures included CT Scan, MRI on unspecified date. The outcome of event was not recovered. No follow-up attempts were possible. No further information was expected.

Other Meds: LIPITOR

Current Illness:

ID: 1677495
Sex: F
Age:
State: NY

Vax Date: 08/03/2021
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Chest cold symptoms; Missed period X5 days (still awaiting cycle as of date); extreme muscle pain (every muscle in body hurt for 1 day approximately 1 week after 2nd dose); This is a spontaneous report from a contactable consumer (patient). This 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Aug2021 at 10:0 AM, at the age of 38 years, as the second single dose, in right arm, for COVID-19 immunisation. No other vaccine was administered in 4 weeks. Medical history included breast cancer, allergy to taxol chemo drug, dairy and bee venom. The patient received the first dose of BNT162B2 vaccine on 13Jul2021 at 10:00 AM, at the age of 38 years, in right arm. The patient did not have COVID prior vaccination. Concomitant medications were none. On an unspecified date in Aug2021, after the second dose, the patient experienced chest cold symptoms for 3 weeks, missed period for 5 days (still awaiting cycle as of date), extreme muscle pain (every muscle in body hurt for 1 day approximately 1 week after 2nd dose). The events required treatment with OTC pain medications. Events outcome was unknown. COVID was not tested after vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1677496
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: She states she is very upset and very furious with this product; pain; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown, Expiry date, NDC and UPC number: unknown), via an unspecified route of administration, administered in arm on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated on an unspecified date she was very upset and very furious with this product, because if she knew it was not fully approved, she would not have gotten it and would never allowed her 12-year-old to get it. The patient recently had, when she had first got it, the patient was experiencing the pain on an unknown date. So then when the patient got the second shot the patient was having the same pain. The report was non-serious. 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: 1677497
Sex: M
Age:
State:

Vax Date: 03/23/2021
Onset Date: 04/22/2021
Rec V Date: 09/07/2021
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:

Allergies:

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

Symptoms: it's an auto immune which I believe got triggered after the vaccine; developed Lichen Planus in the mouth; This is a spontaneous report form a contactable consumer (patient). A 39-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 (Batch/Lot number was not reported) at the age of 38-year-old, as single dose for covid-19 immunisation. The patient had received the first dose of the same vaccine on unknown date. The patient medical history was none. The patient's concomitant medications were not reported. On 22Apr2021 at 12:00 AM after the second dose of Pfizer COVID Vaccine, he developed Lichen Planus in the mouth, it's an auto immune which he believes got triggered after the vaccine. The outcome of the events was not recovered. The patient received an unspecified treatment. No covid prior vaccination and no covid test post vaccination. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1677498
Sex: F
Age:
State: TX

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 09/07/2021
Hospital: Y

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result: High; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:180; Comments: paramedics monitored her blood pressure and it was really high, like 180; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result: High; Test Name: endoscopy; Result Unstructured Data: Test Result: Unknown results; Test Date: 2021; Test Name: all of her tests; Result Unstructured Data: Test Result: Normal; Test Name: MRI; Result Unstructured Data: Test Result: Unknown results; Comments: had the MRI and got a rash; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result: Unknown results; Comments: did tests and they wanted to admit her to run all other tests like MRI and things; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result: couldn't find anything; Test Date: 2021; Test Name: x-ray; Result Unstructured Data: Test Result: couldn't find anything.

Allergies:

Symptom List: Unevaluable event

Symptoms: mini-stroke; weird heart pounding sensations/Heart started pounding; numbness on the side of her head/numbness in face from eyebrow down face; her blood pressure and it was really high, like 180; tingling in one arm; cold hands off; weird chills; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left at the age of 68-year-old on 26Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included high blood pressure from Dec2020, neck injury from 2001 (had an neck injury from a chiropractor from 20 years ago), nerve damage (had some nerve damage on the face under the eye and cheek and the side of her head and back, but it mostly cleared ), heart pounding from Dec2020 (She did have heart pounding the week before 2nd shot ), abdominal stomach pain from Dec2020, cramping from Dec2020, nauseated from Dec2020, chills from Dec2020, shaking from Dec2020, rash, memory issues, car accident, irregular heartbeat, anxiety. Concomitant medicationincluded nebivolol hydrochloride (BYSTOLIC) taken for high blood pressure from an unspecified start date and ongoing; unspcified anti-anxiety pill. The patient previously took bnt162b2 (left arm around 9am in the morning. lot number of EN5318) at the age of 68-year-old on 30Jan2021for COVID-19 immunisation and experienced pain, chest pain, tired, stomach aches, loose stools, slight angina; rabies vaccine at the age of 67-year-old in Aug2020 for immunisation, antibiotics and experienced sensitive to antibiotics, bnt162b2 for COVID-19 immunisation and experienced chest pain. Her symptoms have resolved, but she experienced a weird heart pounding sensations and numbness on the side of her head in 2021. She was diagnosed with a mini-stroke in 2021. The doctor at the hospital said the only cause he could think of was the covid vaccination because all of her tests came back normal. Caller reports the first vaccine was ok, it was the second vaccine. reporting she was later admitted to the hospital stating I went to the ER that Friday night, then back to the ER Monday and Tuesday where I was in the hospital and they ran every test they could think of and thats when they decided they didnt see anything else so it must have been the vaccine. She reports that before the first vaccine patient took half of a blood pressure pill not because of that, for something else. Then the second patient didnt do that and thinks this may have something to do with her symptoms after the second dose because she had a pounding heart. Have there been reports of people experiencing the same symptoms that she did after her second dose. Caller is just now getting to report an apparent reaction to the vaccine she had at the end of February. Is hoping to be able to get a booster and she does not know what she didn't try back then and she couldnt get through. She just called the number from Pfizer and was told she should report. Got the first shot and then got the second one about 3 weeks after the first one, but she ended up getting it 1 more week afterwards because of a snow storm, so a month later. The second shot she looked back and maybe it made a difference, but she is not sure, but at the time she had been on blood pressure medicine off and on and at that time she was currently not on it. She guesses it was doing something and when her doctor found out he told her she was not supposed to be doing that. She took blood pressures every day and it has been on occasion been reading high and so she would be taking one half of a pill she had. It was Bystolic and that would always bring it down. This also happened before the first vaccine that she was taking half a dose because the blood pressure was high and it was high the day before the vaccine. Maybe that is why nothing happened with the first dose. A week later after the second dose, immediately afterwards her heart started pounding. When she looked at her notes she had some slight pounding before this, but it was not as hard as this one. Had slight palpitations, but she wasnt worried about it and she noticed she was having them and not had them before the second dose. It really started pounding and on the sheet they gave her it said to watch out for that and report it she you do. After getting the second dose she waited the 15 minutes in the sitting room and then it got to like 20 minutes and it was still pounding. They had paramedics there who were giving the shots and they told her they were concerned and it was about 4 of them with her. She is guessing about 30 minutes later with them still standing there they monitored her blood pressure and it was really high, like 180 in 2021 and the pulse monitor was high. It didnt slow or stop or anything. They told her they thought she needed to go to the ER and she declined stating she wanted to go home and she can take half of the blood pressure pill she has there and maybe it would stop and they had her sign a waiver and she went home. They made her promise that if it didn't get better after about an hour to call 911. It didnt get better after the half a pill and she didnt call withheld. Thought to call her friend to take her to the ER and after getting settled in the ER bed and they hooked her up and all that and within the next hour or two she seemed to be getting better, but they kept her until 1am and kept doing tests on her. They reran everything to make sure everything was okay and then they released her and that was on a Friday. Was fine on Saturday and Sunday. That following Monday she did fine, but my mid-morning was on the phone and then all of a sudden her heart started pounding again just as it had when she first got the second vaccine for no apparent reason. Called withheld again and they didnt go right away and the paramedics came out and she told them what had happened a few days earlier with the same things with the blood pressure and heart rate and pounding and they recommended to take her to the emergency room. She asked them to wait and so they continued to monitor her about another 20 minutes and it was going down and they told her they can still take her to the emergency room, but she declined and didnt want to go since she had already just been. That was that Monday morning and then 2 hours later around noon time she was sitting at the table about to eat and all of a sudden felt this sensation going down the right side of her head like near the hairline and it started and kind of moved down. It was kind of unrolling down the right side of her face. What then came to her mind was she thought it was possibly a stroke/symptoms of stroke. States she has a back story where she had an neck injury from a chiropractor from 20 years ago and clarifies this was prior to the covid vaccines where she had some nerve damage on the face under the eye and cheek and the side of her head and back, but it mostly cleared. States the unrolling feeling she had was kind of like this, but she never had experienced numbness not since a long time, the numbness feeling rolling down the side of the face, this was new. Wondered if this was a stroke symptom and she called withheld again and let them take her to the ER. They stated it sounded like it could be a stroke and she was admitted to hospital and they did further tests. The ER doctor thought it probably could have been a stroke and she told the provider about what she experienced earlier with the pounding and thought it was somehow connected. After the provider did his tests they wanted to admit her to run all other tests like MRI and other things. They thought it was probably a stroke and was looking for signs of a mini or big stroke. They ran all of the tests and couldnt find anything else and the hospital floor doctor (the second doctor) deduced that it was a vaccine reaction. It is located across from that and they did like 4000 shots at that city, it was a city wide event. States the blood pressure medication she was taking was Bystolic. Had

Other Meds: BYSTOLIC

Current Illness:

ID: 1677499
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
Hospital: Y

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

Symptoms: bad reaction" to "a vaccine" that resulted in her being admitted to the hospital with encephalitis; 7 months pregnant; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient was 7 months pregnant and experienced a bad reaction to vaccine that resulted in her being admitted to the hospital with encephalitis. 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: 1677500
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date: 08/24/2021
Rec V Date: 09/07/2021
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: 20210824; Test Name: Covid-19; Test Result: Positive ; Comments: diagnosed with Covid-19 infection today (24 Aug)

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: got diagnosed with Covid today; got diagnosed with Covid today; This is a spontaneous report from a contactable consumer or other non hcp (reporters sister-in-law). A 42-years-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got diagnosed with COVID today on 24Aug2021. Caller stated, the patient actually have several questions and the patient also recording for information internet channel to help clear up a lot of misinformation about COVID vaccination hopefully this can help some people, the patient know a lot of people afraid to take it. The patient know the FDA approved Monday vaccination for 16 and older, totally different vaccination than the one that was produced back in Feb/Mar. Can you confirm or deny that. Caller continued, Pfizer initially did their preliminary tests the vaccination was about 95% effective from people getting Covid versus the placebo in the 22000-some people that they did and now the patient believed its around 38% with the breakthrough cases but with those 72% that have broke through the patient believed that those cases were considered mild compared to those that have not had their vaccination so yes there may be breakthrough cases but those tend to be less severe than those that have not had the vaccination if could confirm that as well. The last question would be on the breakthrough cases do you have research as far as how many of those breakthrough cases that had the vaccination were actually continuing to also wear the mask at the same time or did they get the vaccination and think okay we are good we do not need to wear masks anymore and that was how they got it you know if you could come up with those kinds of information it sure would help clear up a lot of misinformation that was out there. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 24Aug2021 diagnosed with COVID-19 infection today. 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: 1677501
Sex: F
Age:
State: TX

Vax Date: 08/17/2021
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
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: 20210823; Test Name: COVID 19 RTQ PCR; Test Result: Positive ; Comments: Positive released 23 Aug 2021 at 5:16 am. Blood PCR test

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Body aches; Her wife got the first dose of the Pfizer BioNTech covid-19 vaccine on 17Aug2021 and tested positive for covid last 23Aug2021; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FC3182) via an unspecified route of administration, administered in arm left on 17Aug2021 12:47 (at the age of 39 years-old) as dose 1, 0.3 ml single for COVID-19 immunization. Medical history included Seasonal Allergies, mostly mold from onset Date: 2-3 years ago, from an unknown date and unknown if ongoing. Concomitant medications paracetamol (TYLENOL), dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL), vitamin c [ascorbic acid] taken for an unspecified indication start and stop date were not reported. The patient experienced her wife got the first dose of the pfizer biontech covid-19 vaccine on 17aug2021 and tested positive for covid last 23Aug2021 on 23Aug2021 05:16, nausea on unknown date in Aug2021, body aches on 24Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test is positive on 23Aug2021: Positive released 23 Aug 2021 at 5:16 am. Blood PCR test is done. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.s

Other Meds: TYLENOL; NYQUIL; VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1677502
Sex: F
Age:
State:

Vax Date: 06/25/2021
Onset Date: 06/01/2021
Rec V Date: 09/07/2021
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 Date: 202007; Test Name: Tuberculosis Test; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: tingling needles in chin and in bottom of front teeth; Cataract aggravated; This is a solicited report based on the information received by a regulatory authority. The consumer reported 2 reports for same patient and different doses, this is the first of 2 reports. A contactable consumer (patient) reported that a 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 25Jun2021 at age of 65 years old (Batch/Lot Number: EV00196) as DOSE 1, SINGLE for COVID-19 Vaccination; risankizumab (SKYRIZI, Solution for injection in pre-filled syringe, strength:75mg), subcutaneous from Jul2020 (Batch/Lot number was not reported) and ongoing, at 150 mg, (1 in 12 wk) for moderate to severe chronic plaque psoriasis. Medical history included appendix removal from Jan1973, left shoulder surgery from 2015, cataract in both eyes from Mar2020 (in spring time), abstains from alcohol, moderate to severe chronic plaque psoriasis, acid reflux, hormone level abnormal and non-tobacco user, all unknown information reported for ongoing. In Jul2020, the patient's last tuberculosis test was and resulted to normal. Other relevant history: No known allergies. The cataract in both eyes of the patient originally started in spring time of 2020 before Skyrizi. Concomitant medications included pantoprazole taken for acid reflux, start and stop date were not reported; estradiol taken for hormone level abnormal, start and stop date were not reported. The patient experienced cataract aggravated in Jun2021 and tingling needles in chin and in bottom of front teeth on 25Jun2021. In Jun2021, the patient experienced worsened cataract on right eye. On 25Jun2021, the patient experienced tingling needles in chin and bottom of front teeth. PFIZER BIONTECH COVID-19 VACCINE (Tozinameran) was also considered suspect. She did not have any managements and treatments done for the side effects of Covid 19 vaccines. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient underwent lab tests and procedures which included mycobacterium tuberculosis complex test: normal in Jul2020. The action taken in response to the events for risankizumab was dose not changed. The outcome of event was not recovered without treatment given. Causality with Risankizumab as per reporter for event cataract aggravated was not reported, for event tingling mouth Paraesthesia oral was not related. Causality with PFIZER BIONTECH COVID-19 VACCINE (Tozinameran) as per reporter for event cataract aggravated was not reported, for event tingling mouth paraesthesia oral was probable. The reporter's causality for the events of worsened cataract on right eye, tingling needles in chin and bottom of front teeth with Skyriz (Risankizumab) was no reasonable possibility. Withheld opinion is that there was no reasonable possibility that the events of worsened cataract on right eye, numbness in both wrists, thumbs and index fingers and tingling needles in chin and bottom of front teeth are related to Skyrizi (Risankizumab). No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Paresthesia oral and Cataract which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-202101098266 same reporter/patient/product, different dose/event.

Other Meds: PANTOPRAZOLE; ESTRADIOL

Current Illness:

ID: 1677503
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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 Name: COVID-19 PCR Test; Test Result: Positive.

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 19) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 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's medical history and concomitant medications were not reported. The consumer reported an event that happened on 04Jul2021 with 400 people about 60% of those who were vaccinated got infected with the covid-19 virus but only 2 of those people had to go to the hospital. A PCR test confirmed their covid-19 infection. Consumer reported he is 19 received first doses of Pfizer covid-19 vaccine. On an unspecified date, he got symptoms and was tested positive for covid-19 with a PCR test on an unspecified date. The reporter asked what their effectiveness after just one shot was. The reporter was seeking information about the 3rd dose of Comirnaty vaccine being offered for immunocompromised patients and if this was the same dose as the first and second. Consumer stated that recent studies showed that you can still inquire infection after the vaccine and was asking regarding the efficacy rate. Outcome of event was unknown. The lot number for bnt162b2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1677504
Sex: U
Age:
State: SC

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data: Test Name: Covid-19; Test Result: Positive.

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: tested positive for COVID months after receiving the vaccine; tested positive for COVID months after receiving the vaccine; This is a spontaneous report from a contactable patient reporting via representative. A patient of unspecified age and gender 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 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID months after receiving the vaccine it was reported that event took place after use of product. The events assessed as medically significant. The patient underwent lab tests and procedures which included Covid-19 (sars-cov-2 test): positive on an unspecified date. The outcome of events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. The information available in this report is limited, and the reported events covid19 and drug ineffective cannot be totally excluded or assessed. The case will be reassessed when the new information available.

Other Meds:

Current Illness:

ID: 1677505
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date: 05/01/2021
Rec V Date: 09/07/2021
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: Test Date: 202105; Test Name: COVID-19 virus test positive; Test Result: Positive.

Allergies:

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

Symptoms: Tested positive for COVID-19; Tested positive for COVID-19; This is a report based on the information received from a non-contactable female consumer (patient) (No. 21K-163-4037026-00). A 69-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular in Feb2021 (Batch/Lot number was not reported, at age of 69 years old) as single dose, dose 1 intramuscular on Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. HUMIRA subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date for psoriatic arthritis and moderate to severe rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tested positive for COVID-19 in May2021. The patient underwent lab tests and procedures which included COVID-19 virus test positive in May2021. The action taken in response to the events for Humira was unknown. The outcome of events was recovered in 2021. The reporter's causality for the event(s) of Tested positive for COVID-19 with HUMIRA was no reasonable possibility. The reporter's assessment of the causal relationship of the event with the suspect product bnt162b2 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 the vaccine, [BNT162B2], was not provided and will be requested during follow-up. Sender's Comments: The causal association between the suspect product BNT162B2 and the reported events Covid-19 and Drug ineffective was assessed as unrelated. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is as expected. Vaccination per does not contribute to the infection of this disease, so it is difficult to attribute covid-19 infection to vaccination, so the causal relationship between covid-19, drug ineffective and BNT162B2 is considered as unlikely.

Other Meds:

Current Illness:

ID: 1677506
Sex: M
Age:
State:

Vax Date: 02/03/2021
Onset Date: 06/01/2021
Rec V Date: 09/07/2021
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: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:elevated; Test Date: 202108; Test Name: computed tomography; Result Unstructured Data: Test Result:normal; Test Date: 202108; Test Name: Blood work; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: X-ray; Result Unstructured Data: Test Result:normal

Allergies:

Symptom List: Nausea

Symptoms: Stoma site hypergranulation; Sleep disturbance; j tube knotted; Loss of consciousness; fall; Agitated; Elevated blood pressure; FACILITATED COLLECT This is a solicited report from a contactable consumer (patient) based on information received by Pfizer (Mfr. Control No.:21K-163-4042042-00). A 72-year-old male patient received BNT162B2, dose 1 intramuscular on 03Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; dose 2 of covid-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), intramuscular on 09Mar2021, at unspecified dose for covid-19 immunisation; carbidopa, levodopa (DUOPA, Gastroenteral suspension), via Percutaneous J-tube administration from 2009 (Batch/Lot number was not reported) and ongoing, at unspecified dose for Advanced parkinson's disease. Medical history included Bladder frequency, Labile blood pressure. Concomitant medications included quetiapine; donepezil hydrochloride (ARICEPT) for brain function; mirabegron (MYRBETRIQ); trospium; melatonin (MELATONIN GUMMIES) for sleep, gabapentin for Leg pain. The patient experienced loss of consciousness in Aug2021 with outcome of recovered in Aug2021, fall in Aug2021 with outcome of recovered in Aug2021, blood in urine in 2020 with outcome of unknown, j tube knotted on 06Aug2021 with outcome of not recovered, elevated blood pressure in 2021 with outcome of unknown, agitated in Jun2021 with outcome of not recovered, stoma site hypergranulation and sleep disturbance on an unspecified date with outcome of unknown. Clinical course: Tissue around the stoma and sleep disturbance overnight with DUOPA (LEVODOPA/CARBIDOPA). On unknown dates, the patient experienced possible hypergranulating tissue around the stoma and sleep disturbance overnight. In 2020, the patient experienced blood in urine. In 2021, the patient experienced blood pressure elevated. In Jun2021, the patient experienced agitated. In Aug2021, the patient experienced loss of consciousness, falls and fell about 20 times. On 06Aug2021, the patient experienced j tube knotted. In Aug2021, the loss of consciousness, falls and fell about 20 times resolved. COVID-19 VACCINE was also considered suspect. The spouse stated that the was falling because he would not use his walker. On an unknown date back in 2020, the patient was diagnosed with slight blood in his urine. The patient was supposed to undergo an unknown procedure for the bladder but when he presented for surgery, his blood pressure was elevated and physician postponed the surgery. Reading value was not known. The spouse stated she and the patient had been very agitated since Jun2021 due to their move and loss of personal belongings. The spouse could not assess if COVID vaccine was related to events. It was stated he began falling about 20 times in early Aug2021. One of the times, he loss consciousness. He was taken to the Emergency Room (ER) whereby two scans, blood work and an x-ray of unknown body part were normal. He lost consciousness for approximately 10-15 seconds. He was doing well on DUODOPA with nil issues flushing tubes and mobilizing tube daily. Carer described possible hyper granulating tissue around the stoma and advice given for the ongoing treatment using hypertonic solution on the area. He was advised to continue to mobilize the stoma and that the mild ooze at times was normal. Stoma education revisited regarding the possible signs of infection to look out for. He was having some sleep disturbance overnight and as advised to speak with the Treating Specialist regarding this at the next appointment. Patient had only been requiring a single extra dose through the days that she had poor sleep the night before. It was reported that the patients tube was knotted again and he had not been able to use Duopa 1 week took oral. Alternative etiology for falls and fell about 2o times was given not using walker. Gel/ Cassette lot number: 1144163, Primary reporter did not have the lot number information, because the packaging was discarded. The action taken in response to the events for carbidopa, levodopa was dose not changed. The event loss of consciousness was serious with Other medically important condition. Causality for DUOPA (LEVODOPA/CARBIDOPA): The reporter's causality for the event(s) of loss of consciousness, blood in urine, blood pressure elevated and agitated with DUOPA (LEVODOPA/CARBIDOPA) was no reasonable possibility. The reporter's causality for the event(s) of falls, j tube knotted, fell about 20 times, possible hypergranulating tissue around the stoma and sleep disturbance overnight was not provided. Opinion is that there is no reasonable possibility that the events of loss of consciousness, falls, j tube knotted, blood in urine, blood pressure elevated, fell about 20 times, agitated, possible hypergranulating tissue around the stoma and sleep disturbance overnight are related to DUOPA(LEVODOPA/CARBIDOPA). Drug: DUOPA (Gastroenteral suspension) (LEVODOPA/CARBIDOPA) Causality: Loss of consciousness: Causality as per reporter (Drug/Vaccine): Not Related; Causality as per Mfr. (Drug/Vaccine: No reasonable possibility; Fall (10016173): Causality as per reporter (Drug/Vaccine): Not assessable; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Device kink: Causality as per reporter (Drug/Vaccine): Not Reported; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Blood in urine (Blood urine present): Causality as per reporter (Drug/Vaccine): Not Related; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Elevated BP (Blood pressure increased): Causality as per reporter (Drug/Vaccine): Not Related; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Fall: Causality as per reporter (Drug/Vaccine): Not assessable; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Agitated (Agitation): Causality as per reporter (Drug/Vaccine): Not Related; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Stoma site hypergranulation: Causality as per reporter (Drug/Vaccine): Not Reported; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Sleep disturbance (Sleep disorder): Causality as per reporter (Drug/Vaccine): Not Reported; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility. Drug: COVID-19 VACCINE (COVID-19 VACCINE) Daily Dose: 2) MFR - MODERNA Loss of consciousness: Causality as per reporter (Drug/Vaccine): Not assessable; Fall (10016173): Causality as per reporter (Drug/Vaccine): Not assessable; Device kink (Device kink): Causality as per reporter (Drug/Vaccine): Not applicable; Blood in urine (Blood urine present): Causality as per reporter (Drug/Vaccine): Not assessable; Elevated BP (Blood pressure increased): Causality as per reporter (Drug/Vaccine): Not assessable; Fall: Causality as per reporter (Drug/Vaccine): Not assessable; Agitated (Agitation): Causality as per reporter (Drug/Vaccine): Not assessable; Stoma site hypergranulation: Causality as per reporter (Drug/Vaccine): Not Reported; Sleep disturbance (Sleep disorder): Causality as per reporter (Drug/Vaccine): Not Reported. The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 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.; Sender's Comments: As there is limited information in the case provided, the causal association between the events (Loss of consciousness, Blood pressure increased, Agitation, Sleep disturbance ) and the BNT162B2 cannot be excluded. Consider also contributory role of co-suspect drug levodopa and Moderna vaccine. "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."

Other Meds: QUETIAPINE; ARICEPT; MYRBETRIQ; TROSPIUM; MELATONIN GUMMIES; GABAPENTIN

Current Illness:

ID: 1677507
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: stroke like symptoms; problems walking without being tired; face on the left still sags; This is spontaneous report from contactable consumer. A patient of unspecified age and gender reported that received first dose and second 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 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that had both shots the first and 2nd shots. Each time had problems after had stroke like symptoms and still suffered about 2 months in. The patient had problems walking without being tired. The face on the left still sags. The outcome of the events was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up

Other Meds:

Current Illness:

ID: 1677508
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/07/2021
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: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Psoriatic arthritis aggravated/flare up of psoriatic arthritis; This is a solicited report based on information received by Pfizer. Solicited report by a consumer of a 68-year-old female with an event of non-serious after second Pfizer vaccine, had a flare up of psoriatic arthritis with adalimumab (HUMIRA). The patient received adalimumab (HUMIRA, Solution for injection in pre-filled pen) via subcutaneous in 2021 for psoriatic arthritis. Pfizer Biontech COVID-19 vaccine (tozinameran) was also considered suspect. In Mar 2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer for COVID-19 vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021, patient received 1st dose COVID-19 Vaccine via intramuscular manufactured by Pfizer for COVID-19 vaccination. There was no reported medical history. The patient's concomitant medications were not reported. In 2021, the patient experienced after second Pfizer vaccine, had a flare up of psoriatic arthritis/psoriatic arthritis aggravated. The action taken in response to the event for the suspect drug adalimumab was unknown. In 2021, the after second Pfizer vaccine, had a flare up of psoriatic arthritis resolved. Primary reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for the event of after second Pfizer vaccine, had a flare up of psoriatic arthritis with adalimumab (HUMIRA) was a reasonable possibility. The reporter's assessment of the causal relationship of the event with the suspect product Pfizer Biontech COVID-19 vaccine (tozinameran) 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose- event relationship post-vaccination and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern 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: HUMIRA

Current Illness:

ID: 1677509
Sex: F
Age:
State:

Vax Date: 12/01/2020
Onset Date: 07/01/2021
Rec V Date: 09/07/2021
Hospital: Y

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: High cholesterol; Result Unstructured Data: Test Result:High cholesterol; Comments: High cholesterol; Test Name: MAGNETIC RESONANCE IMAGING; Result Unstructured Data: Test Result:Plaques building in carotid artery; Test Date: 202010; Test Name: MAGNETIC RESONANCE IMAGING of WRIST; Result Unstructured Data: Test Result:Fractured right wrist, torn tendon; Test Name: X-RAY; Result Unstructured Data: Test Result:Fracture in right wrist, tear in right tendon; Test Date: 202001; Test Name: X-RAY OF RIGHT WRIST; Result Unstructured Data: Test Result:No breaks; Test Date: 202010; Test Name: X-RAY OF RIGHT WRIST; Result Unstructured Data: Test Result:Fractured right wrist

Allergies:

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

Symptoms: Wound infection; Atherosclerosis of aorta; FALL; Pain; Injury; Delayed healing of wound; Swelling of feet; HIGH CHOLESTEROL; FEELING HOT; FELLING COLD; Cerebral disorder; This is a Solicited report based on information received by a regulatory authority from a contactable consumer (patient) . A 60-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular on Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2017 (Batch/Lot number was not reported) to Dec2020, at 40 mg, 1 in 2 wk, subcutaneous from Jul2020 (Batch/Lot number was not reported) to an unspecified date, at 40 mg, 1 in 1 wk, subcutaneous from Jan2021 (Batch/Lot number was not reported) and ongoing, at 40 mg, 1 in 1 wk for rheumatoid arthritis . Medical history included depression from an unknown date and unknown if ongoing she was very depressed , tobacco user from 1975 to 1995 TOBACCO USE: ABOUT A PACK PER DAY OF CIGARETTE (1975 - 1995) , hysterectomy from 1979 to an unknown date HYSTERECTOMY (Started 1979) , TUMOR IN OVARY (Started 1979) , ELECTRO SHOTS IN BRAIN (Started 2010) , NO ALCOHOL USE , rheumatoid arthritis (family history), bipolar disorder (FAMILY HISTORY OF BIPOLAR DISORDER/BROTHER HAD BIPOLAR) DEGENERATIVE SPINE DISEASE , osteoarthritis , SHORT TERM MEMORY LOSS, SUICIDAL, surgery done in Oct2020 to fix the torn tendon in right wrist, surgery to scrape the bone in Nov2020. In 2021, two more surgeries for the fracture right wrist, fourth surgery was done in Jun2021, INFECTION IN OVARIAN TUBES (Started 1979), SEVERE ANXIETY, PANIC ATTACKS, POST TRAUMATIC STRESS DISORDER, MOOD SWINGS, HELP SLEEP, SUPPLEMENT, IMMUNE HEALTH SYSTEM BOOST, MANIC DISORDER. The patient previously took morphine and experienced ALLERGY MANIFESTED BY SEVERE HEADACHE.The patient received the first dose of bnt162b2 for covid-19 immunisation via IM in May2021 at age of 60 years.Concomitant medication(s) included aripiprazole (ABILIFY) taken for bipolar disorder, psychotic disorder, start and stop date were not reported; fluoxetine hydrochloride (PROZAC) taken for depression, start and stop date were not reported; lamotrigine (LAMICTAL) taken for bipolar disorder, start and stop date were not reported; alprazolam (ALPRAZOLAM) taken for anxiety, panic attack, post-traumatic stress disorder, bipolar disorder, start and stop date were not reported; quetiapine fumarate (SEROQUEL) taken for bipolar disorder, mood swings, sleep disorder, depression, start and stop date were not reported; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for rheumatoid arthritis, start and stop date were not reported; methylprednisolone (METHYLPREDNISOLONE) taken for rheumatoid arthritis, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for supplementation therapy, immune system disorder, start and stop date were not reported; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for supplementation therapy, start and stop date were not reported; folic acid (FOLIC ACID) taken for supplementation therapy, start and stop date were not reported; quetiapine (QUETIAPINE) taken for mania, bipolar disorder, depression, start and stop date were not reported; lamotrigine (LAMOTRIGINE) taken for an unspecified indication, start and stop date were not reported; mecobalamin (METHYL B12) taken for vitamin supplementation, start and stop date were not reported. The patient experienced feeling hot (feeling hot) (hospitalization, medically significant) on Jul2021 with outcome of unknown , felling cold (feeling cold) (hospitalization, medically significant) on Jul2021 with outcome of unknown , cerebral disorder (cerebral disorder) (hospitalization, medically significant) on Jul2021 with outcome of unknown , wound infection (wound infection) (hospitalization, medically significant) on an unspecified date with outcome of recovered , atherosclerosis of aorta (aortic arteriosclerosis) (hospitalization, medically significant) on an unspecified date with outcome of unknown , fall (fall) (hospitalization, medically significant) on an unspecified date with outcome of unknown , pain (pain) (hospitalization, medically significant) on an unspecified date with outcome of not recovered , injury (injury) (hospitalization, medically significant) on an unspecified date with outcome of unknown , delayed healing of wound (impaired healing) (hospitalization, medically significant) on an unspecified date with outcome of not recovered , swelling of feet (peripheral swelling) (hospitalization, medically significant) on an unspecified date with outcome of not recovered , high cholesterol (blood cholesterol increased) (hospitalization, medically significant) on an unspecified date with outcome of unknown.The clinical course was reported as follows: solicited report from a patient with events of torn tendon of right wrist, right wrist became inflamed, recurrent falls, fractured/ broke right wrist, infection after surgery and infection on the wound site and non-serious sprained right ankle which was described as foot turned out and turned blue, bone scrapping due to rheumatoid arthritis, swelling in right wrist, feeling hot, felling cold, brain not functioning, right wrist feels hot, bruised legs, plaques build in carotid artery, inflammed legs, rheumatoid arthritis flare up, wound that would not heal, fall, broke wrist, had another fall that hurt left side, painful, swollen feet, pain in right wrist, high cholesterol and pain in ankle with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use: about a pack per day of cigarette, rheumatoid arthritis, degenerative spine disease and osteoarthritis. There is also a family history of rheumatoid arthritis.On unknown dates, the patient experienced infection on the wound site, plaques build in carotid artery, wound that would not heal, had another fall that hurt left side, painful, swollen feet and high cholesterol. In 2020, the patient experienced right wrist became inflamed, infection after surgery, swelling in right wrist, right wrist feels hot, rheumatoid arthritis flare up and pain in right wrist. In Feb2020, the patient experienced recurrent falls and fractured/ broke right wrist. In Aug2020, the patient experienced sprained right ankle which was described as foot turned out and turned blue, inflammed legs, inflammed legs, fall and pain in ankle. In Aug2020, the fall resolved. In Sep2020, the patient experienced sprained right ankle which was described as foot turned out and turned blue and broke wrist. In Oct2020, the patient experienced torn tendon of right wrist and bone scrapping due to rheumatoid arthritis. In Jul2021, the patient experienced feeling hot, felling cold and brain not functioning. In 2021, the infection after surgery and sprained right ankle which was described as foot turned out and turned blue resolved. On unknown dates, recurrent falls and infection on the wound site resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect.The patient suffered from plaques build in carotid artery and high cholesterol. In feb2020, she had a fall which resulted in a broken right wrist. She had two surgeries for the fractured right wrist. she had infection after her surgery and her physician advised her to stop humira until she was healed. While she was off humira her rheumatoid arthritis symptoms returned. She had pain from her wrist and was taking unspecified steroids for it. she also described her broken wrist as being misshapen and permanently damaged. In Aug2020 she had another fall and she sprained her ankle. Her legs were bruised in turned into black and blue. She went to emergency room and was informed that there's no surgery needed for her wrist and bondage was put on it and it recovered on its own. She suffered from pain on right wrist when she visited a specialist. Her physician informed her that there was a tear on the tendon and it was too late to perform surgery for the bones. She had a surgery done in oct2020 to fix the torn tendon in right wrist. She had a follow up in 2020 and her physician told her that the

Other Meds: ABILIFY; PROZAC; LAMICTAL; ALPRAZOLAM; SEROQUEL; HYDROXYCHLOROQUINE; METHYLPREDNISOLONE; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]; FOLIC ACID; QUETIAPINE; LAMOTRIGINE; METHYL B12

Current Illness:

ID: 1677510
Sex: F
Age:
State: TX

Vax Date: 08/19/2021
Onset Date: 08/20/2021
Rec V Date: 09/07/2021
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: 20210811; Test Name: Covid test/BinaxNow; Test Result: Negative

Allergies:

Symptom List: Tremor

Symptoms: chest pain upon inspiration while sitting down; numbness and tingling to face; numbness and tingling to face; arms and left hand cramping/contracted; This is a spontaneous report from a contactable Nurse (patient). A non-pregnant 38-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 19Aug2021 15:00 (Batch/Lot Number: FC3180) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergies, covid-19 prior vaccination. Concomitant medication(s) included curcuma longa root (TURMERIC CURCUMIN). No other vaccine in four weeks. On 20Aug2021 14:00, approximately 24 hours after received the vaccine at about 2 pm, patient began to experience chest pain upon inspiration while sitting down (she works from home). Symptoms got worse and also felt numbness and tingling to face and arms and left hand cramping/contracted. Treatment Benadryl 50mg received for the events. The outcome of events was unknow. Nasal Swab Covid test BinaxNow conducted post vaccination was Negative on 11Aug2021. Case reported as serious due to medically significant.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events paraesthesia, chest pain, hypoaesthesia and muscle spasm and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: TURMERIC CURCUMIN

Current Illness:

ID: 1677511
Sex: F
Age:
State: OR

Vax Date: 08/08/2021
Onset Date: 08/08/2021
Rec V Date: 09/07/2021
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: Going to pass out; Immediately got dizzy; Sweating; Vision was grey and unclear; Vision was grey and unclear; All face and arm colors turned white; Could barely hear; This is a spontaneous report from a contactable consumer (patient). A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient had allergies to Clindamycin and penicillin, green beans, raspberries, coffee, and tea. Patient was not pregnant. Patient received the first dose of bnt162b2 on 08Aug2021 (as reported), at the age of 17 years old. Concomitant medication included unspecified birth control rod in arm 3 months ago. Patient immediately got dizzy, started sweating, vision was grey and unclear, all face and arm colors turned white, could barely hear, and felt Like going to pass out on 08Aug2021. Pharmacist gave glucose tablets (4) not diabetic. Outcome of events was recovered in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1677512
Sex: F
Age:
State: HI

Vax Date: 03/01/2021
Onset Date: 04/02/2021
Rec V Date: 09/07/2021
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: 20210522; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative; Comments: Nasal swab

Allergies:

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

Symptoms: Psoriatic arthritis; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left in Mar2021 01:00 AM (at the age of 47-year-old) (Batch/Lot Number: EN6198) as single dose, and dose 1 via an unspecified route of administration, administered in arm left on 25Mar2021 01:00 AM (Batch/Lot Number: ER2613) as single dose for COVID-19 immunisation, administered at hospital. Medical history included autoimmune disorder. The patient's concomitant medications were not reported. Past drug history was none. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Patient was not pregnant. The patient experienced psoriatic arthritis (medically significant) on 02Apr2021 with outcome of not recovered. The adverse event psoriatic arthritis resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Sars-cov-2 test (nasal swab): negative on 22May2021. Therapeutic measures were taken as a result of psoriatic arthritis: topical solution.

Other Meds:

Current Illness:

ID: 1677513
Sex: U
Age:
State:

Vax Date: 06/29/2021
Onset Date: 07/01/2021
Rec V Date: 09/07/2021
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: TAC SCAN; Result Unstructured Data: Test Result:Unknown result; Test Name: Magnetic resonance; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: started semi-paraesthesia in the lower and upper limbs as well as muscle weakness; muscle weakness; 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 29Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. In Jul2021, a month later after the second dose, the patient experienced started semi-paraesthesia in the lower and upper limbs as well as muscle weakness. The patient has always been healthy. The patient was wondering if it could be a reaction to the vaccine since neurologist and orthopedist were unable to give an explanation after TAC scan and magnetic resonance that excluded possible pathologies. Outcome of events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1677514
Sex: F
Age:
State: AL

Vax Date: 08/12/2021
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
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: Asthenia, Chills, Headache, Myalgia

Symptoms: feeling like I was going to pass out; aches, and pains; itching of my torso; left arm wouldn't raise up all the way; shortness of breath; confusion; I couldn't concentrate; uncontrollable bowel movements; started sleeping all the time; I have got vertigo really-really bad/this vertigo just keeps getting worse; my neck is been stiff/I started getting stiff in my neck from below my lower left right ear down to the front of my collarbone; I can't even walk/I couldn't walk; swelling; chills; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FD8448, Expiry Date: Unknown) via an unspecified route of administration on 12Aug2021 (two weeks ago, Thursday) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she had lots of side effects from the shot I had 11 days ago, she had got vertigo really-really bad to the point I can't even sometimes function and so bad two days ago, I can't even walk and my neck is been stiff had swelling and the chills and other symptoms when she first got it. Within two hours she began experiencing chills, aches, and pains, itching of my torso, and my left arm wouldn't raise up all the way (12Aug2021). And then around the same time she started getting stiff in her neck from below my lower left right ear down to the front of my collarbone (on an unspecified date in Aug2021); was really painful and then she started sleeping all the time (on an unspecified date in Aug2021), and I got vertigo (on an unspecified date in Aug2021) that just kept getting worse instead of better. And by the seventh day she could barely move her neck at all, was having trouble balancing or walking because of the vertigo. By the eighth day I couldn't walk. The neck wasn't quite as bad; the vertigo was still there. The stiffness, she had uncontrollable bowel movements (on an unspecified date in Aug2021), got shortness of breath (on an unspecified date in Aug2021), confusion, feeling like she was going to pass out (on an unspecified date in Aug2021), she could not concentrate (on an unspecified date in Aug2021). And just walking to the bathroom she felt like she ran five miles and am out of breath, her torso was still itching but not as bad. The patient questioned how long does this last and do you know there on the CDC website in their website it does not say anything about. How long it last or what going on with it? Does this someone percent reported it? she stated that she did not have a doctor, and everyone, including the vaccination provider keeps referring her back to her doctor. And then she was told to call Pfizer, she does not have insurance and asked if Pfizer was going to cover the costs of her medical care, she declined contact information for Pfizer Legal, stating she would call back another time when someone can write it down for her since she cannot concentrate well right now, she asked if she should get the second dose of the Pfizer Covid-19 Vaccine after experiencing these side effects after the first dose. The patient was instructed that as noted in the Fact Sheet for Recipients, she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They referred her to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. her healthcare provider knows your health situation and has access to information that could better help inform this decision. The patient explained that those were the only reference numbers she has but she has filed a report with Pfizer specifically, she filed a report with everyone. When providing the spelling to her name, she missed to speak a letter and remarked she was sorry, she has some confusion. The patient took treatment with Benadryl and it let off some of the symptoms (unspecified). And today (on an unspecified date in 2021) she felt a little bit better as far as most of the symptoms (unspecified) but the vertigo keeps coming on, she was scared to drive, was still having aches and pains. The event of feeling like I was going to pass out was considered as Serious (Medically Significant). The outcome of the events aches, and pains was of not recovered, i have got vertigo really-really bad/this vertigo just keeps getting worse was not recovered, the outcome of events my neck is been stiff/i started getting stiff in my neck from below my lower left right ear down to the front of my collarbone, i can't even walk/i couldn't walk, swelling, chills was of recovered on an unspecified date in Aug2021, The outcome of events feeling like i was going to pass out, itching of my torso, left arm wouldn't raise up all the way, shortness of breath, confusion, i couldn't concentrate, uncontrollable bowel movements, started sleeping all the time was unknown.

Other Meds:

Current Illness:

ID: 1677515
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: terrible tinnitus after receiving your vaccine; This is a spontaneous report from a contactable consumer. This consumer reported same event in two patients. This is the second of two reports. A consumer (patients husband) reported that his wife of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknow date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving the vaccine the patient experienced terrible tinnitus in 2021. The patient has been to the doctor once including an ENT visit. The reporter told CDC and they don't care. The doctors just shrug. It's nowbeen 5 months with no improvement. The outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101102231 Same drug/AE, different patient

Other Meds:

Current Illness:

ID: 1677516
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
Hospital: Y

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:

Allergies:

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

Symptoms: after the second one a undisclosed problem with my colon caused hospitalization; This is a spontaneous report from a contactable consumer reporting for self: A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included scalp psoriasis, itching scalp. Historical vaccine dose 1 of bnt162b2 for covid-19 immunisation. The patient's concomitant medications were not reported. The patient experienced after the second one a undisclosed problem with my colon caused hospitalization in 2021 with outcome of unknown. Therapeutic measures included "many bags of saline and antibiotics drips". The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1677517
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: I woke up just freezing; one of them chills or just being very cold; This is a spontaneous report from a contactable consumer. This contactable consumer (patient) reported that: A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration, on unspecified date as a dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient stated that patient woke up just freezing and one of them chills or just being very cold. Patient stated that, "About a reaction possibly, patient had a shot about 7:09 here where patient located. Patient probably had it about 3 o'clock this afternoon so it was been 16 hours and patient woke up just freezing like never had been just cold patients entire life and live-in world's wintertime and understand side effects and patient was looking in this was got a bunch of side effects was that one of them were chills or just being very cold. Patient queried if Is that a side effect to that. Patient was informed about Pfizer Medical Information Department, Patient just wanted to know that was a side effect this time. Because patient had never been this cold in life. Patient stated that patient was sure, it was a side effect. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1677518
Sex: M
Age:
State: OH

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data: Test Name: heart was racing; Result Unstructured Data: Test Result:increase

Allergies:

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

Symptoms: heart been hurting; I am getting infection in my body in my bladder, it hurt all the time; my bladder getting wider; I get real bad infections now and like my testicles and my kidney and bladder; Diarrhea; My heart been hurting all my joints are hurting. My heart is racing; I am getting infection in my body in my bladder, it hurt all the time; my bladder getting wider; I get real bad infections now and like my testicles and my kidney and bladder; I am getting infection in my body in my bladder, it hurt all the time; my bladder getting wider; I get real bad infections now and like my testicles and my kidney and bladder; got hurt so bad in stomach; My hands, my fingers and my arms it feels like it is going numb when needle pricks and certain pain in my chest; Rash; Joint pain / all joints were hurting; I mean I got bunch of swellings; It's swollen all over place; I am itching all the time, can't stop it, it's swollen all over place; lot of problems started to develop; had taken diarrheal but still its real bad it has gone by worse the diarrhea; pain in my chest; heart was racing; This is a spontaneous report from a contactable consumer (patient) and a consumer. A 47-year-old male patient received the second dose of BNT162B2 (COVID-19 VACCINE) via an unspecified route of administration on 01May2021 (Batch/Lot Number: EW0162; Expiration Date: Unknown) at the age of 46-year-old as single dose for COVID-19 immunization. Medical history included high blood pressure and asthma. Investigation assessment was none. Concomitant medication was none. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 05Apr2021 (Batch/lot number: EN62O1) at the age of 46-year-old as single dose for COVID-19 immunization. The patient previously received the flu shot in 2021 (before Apr). On an unspecified date, the patient experienced rash, joint pain, heart been hurting, all joints were hurting, heart was racing. The patient gotten infection in body in bladder, it hurt all the time; bladder getting wider, he get real bad infections now and like testicles and kidney and bladder. The patient got hurt so bad in stomach and everything hurt that bad. He hands, fingers and arms it feels like it was going numb when needle pricks and certain pain in chest (Events confirmed to occur after Covid-19 vaccination hence, captured as event). He was itching all the time, can't stop it, got bunch of swellings, it was swollen all over place, lot of problems started to develop. He had taken diarrheal but still its real bad it has gone by worse the diarrhea. The patient had been having some concerns about the vaccine. He got both the Pfizer vaccines (COVID-19 Vaccine) from withheld. It was been a long time. He was mean when it first came that was when he got. He still had diarrhea. He did everything he was supposed to have any diarrheal antibiotic (Unclear and further clarification unknown). This was all which was he got that. He got all lot that started since he got that vaccine. For the diarrhea, he had taken diarrheal (Further clarification unknown hence captured as Unspecified medication) but still it real bad it has gone by worse the diarrhea and he guess his heart was always racing like it enlarged(Unclear and not clarified hence not captured in tab). The outcome of diarrhea and condition aggravated was not recovered. The outcome of other 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: 1677519
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: Throat is scratchy; Feeling nauseous; Extremely horse voice; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on 2021 as a single for covid-19 immunisation. Medical history included allergy to plants from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took codeine and experienced drug hypersensitivity, morphine, and experienced drug hypersensitivity. She also has allergies with codeine, morphine, and penicillin. On an unspecified date the reporter stated that her throat was scratchy, feeling nauseous, had extremely horse voice. She took Benadryl and seemed to be okay. She had a similar reaction with other products. Therapeutic measures were taken as a result of throat is scratchy, feeling nauseous, extremely hoarse voice. Outcome of the events was recovered on unspecified date in 2021. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1677520
Sex: M
Age:
State:

Vax Date: 08/21/2021
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
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: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Keep coughing, it is so hard on heart and really bad dry cough; he is not doing very well; not doing very well; This is a spontaneous report from a contactable consumer reporting for the son. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date on 21Aug2021 (at an unspecified age of age) (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. The patient medical history included need for new heart and lung (further not clarified). The concomitant medications were not reported. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date in 2021 3 weeks ago (at an unspecified age of age) (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation (received in the Hospital) and experienced needed "new Heart and Lung". In Aug2021 the patient experienced got so hard and kept coughing, it was so hard on heart and really bad dry cough; he was not doing very well with outcome of unknown. Coughing was so hard on his heart. This report was not related to a study or programme. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1677521
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: Bell's Palsy; Quivering, shaking; This is a spontaneous report from a non-contactable other health care professional (NURSE) received via a Pfizer sponsored program. A patient of unspecified age and gender received bnt162b2 (BNT162B2, 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 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bell's palsy, quivering and shaking on an unspecified date. Caller, a registered Nurse wanted to know more information about the vaccine, if there was a fact sheet or website to check. Caller was also asking about the ingredients because she was allergic to sulfur chloride and Benzalkonium Chlorides (which she experienced a heart attack). Caller was an immunocompromised patient. Caller was asking for the information if she and her patients should take the vaccine or not. Caller said from what I have heard, I am very much against this vaccine. I had a friend who had a neurological reaction. Quivering, shaking, Bell's Palsy. These people are not getting these reactions back to their doctors and it was not something that they were allowing other people to know about. I really need to know what was in this drug for myself and whether or not I participate in giving it to others. 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. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event Bell's palsy and the suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1677522
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: itchy all over; rash on both my arms; plus red itchy blotches; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Protein in red meat allergy and multiple allergies. The patient's concomitant medications were not reported. The patient experienced itchy all over (medically significant) on 2021 with outcome of unknown, rash on both my arms (medically significant) on 2021 with outcome of unknown, plus red itchy blotches (medically significant) on 2021 with outcome of unknown. Therapeutic measures were taken "Benadryl since the end of Jun2021". The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1677523
Sex: F
Age:
State: NY

Vax Date: 03/08/2021
Onset Date: 06/14/2021
Rec V Date: 09/07/2021
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: Test Date: 2021; Test Name: Antibody level; Result Unstructured Data: Test Result:2.93; Test Date: 2021; Test Name: B2 glycoproteins I (IgM) AB; Result Unstructured Data: Test Result:73.6; Comments: High; Test Date: 2021; Test Name: Cardiolipin AB (IgM); Result Unstructured Data: Test Result:23.4; Comments: High

Allergies:

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

Symptoms: Blood clot; burning sensation throughout my body; B2 glycoproteins I (igm) ab and the value is 73.6 high; cardiolipin AB (igm) and this value is 23.4 also high; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 08Mar2021 (at the age of 67-years-old) at dose 2, single for COVID-19 immunization. Medical history included known allergies to penicillin and latex. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (METOPROLOL ER) and acetylsalicylic acid (ASPIRIN). She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En5318), via an unspecified route of administration in left arm on 13Feb2021 (at the age of 67-years-old) at dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as hospital. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose of vaccine on 08Mar2021. She had no out of ordinary reaction, however, she has been experiencing a burning sensation throughout her body since 14Jun2021 (also reported as mid Jun). After many tests, her antibody level was only 2.93 on an unspecified date in 2021. A rheumatologist ordered two other tests: B2 glycoproteins I (IgM) AB and the value was 73.6 which was high and cardiolipin AB (IgM) and the value was 23.4 which was also high on an unspecified date in 2021. The patient was asked about blood clot experience (14Jun2021) but was never diagnosed with one. Her question was whether COVID vaccines play a significant role in these tests and if there could be a correlation. After all, they heard about people developing blood clots. The events required doctor or other healthcare professional office/clinic visit. She did not receive any treatment in response to the events. The outcome of the events was not recovered. The case was reported as serious, medically significant. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds: METOPROLOL ER; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1677524
Sex: F
Age:
State: NY

Vax Date: 05/25/2021
Onset Date:
Rec V Date: 09/07/2021
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: Test Name: Covid test; Test Result: Positive ; Comments: previous Covid 19 infection; Test Name: WBC; Result Unstructured Data: Test Result:abnormal; Comments: abnormal white cell count

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: a cut that would not stop bleeding.; Afterwards she got really sick.; had a big bruise on her neck; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0176), via an unspecified route of administration, administered in left arm, 25May2021 (at the age of 81-year-old), as dose 2, single for covid-19 immunisation. Medical history included polymyalgia rheumatica, abnormal white cell count, rheumatoid arthritis (reported as: Caller clarified that she was diagnosed with Rheumatoid Arthritis a couple of years ago. She had a bad cold and all of sudden she was in terrific pain. She said that the arthritis was brought on by the cold. Her immune system went wild and attacked her joints) and covid 19 and received monoclonal antibody treatment on 31Dec2020. Concomitant medications included ongoing citalopram (MANUFACTURER UNKNOWN, Strength: 10 mg) for anxiety disorder and ongoing clonazepam MANUFACTURER UNKNOWN, Strength: 0.25 mg) for sleep. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0175, Expiry date unknown), via an unspecified route of administration, administered in left arm, on 04May2021 (at the age of 80-years-old), as dose 1 for covid-19 immunisation. Consumer completed her Pfizer Covid 19 vaccine series on 25May2021. Afterwards she got really sick. She noted that she previously did not have issues with bruising/bleeding but then had a big bruise on her neck and a cut that would not stop bleeding. The next morning there was blood on her sheets. She had a previous Covid 19 infection and received monoclonal antibody treatment on 31Dec2020. She waited per provider guidance to get vaccinated after treatment. She also has abnormal white cell count. She has a history of polymyalgia rheumatica and confirms she has Rheumatoid Arthritis. She explains she was immunocompromised but did not share if the RA diagnosis followed the vaccine series. Consumer was concerned of bleeding risk and was convinced what she experienced was a result of the vaccine. Because these reactions were reported voluntarily, it was not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Caller was a consumer that was calling about the Covid-19 Vaccine and stated that she received her second dose on 25May2021. The next day she gets very sick. She had huge bruise on her neck and she got a little cit that started bleeding and did not think it would stop. She said that she saw blood on her sheets when she woke up in the morning. She has a picture of the bruise. In a few days it got better, but not totally gone. She has been diagnosed with RA and her white count goes up when she has an illness. Caller clarified that she was diagnosed with Rheumatoid Arthritis a couple of years ago. She had a bad cold and all of sudden she was in terrific pain. She said that the arthritis was brought on by the cold. Her immune system went wild and attacked her joints. She was concerned about getting a booster. She already had Covid and a monoclonal infusion also along with the 2 shots. The outcome of the events was unknown.

Other Meds: CITALOPRAM; CLONAZEPAM

Current Illness:

ID: 1677525
Sex: M
Age:
State:

Vax Date: 07/01/2021
Onset Date: 07/21/2021
Rec V Date: 09/07/2021
Hospital: Y

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: This is a solicited report based on information received by Pfizer. A 59-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on Jul2021 (at the age of 59-years-old) as dose 2, single for COVID-19 immunisation; and carbidopa, levodopa (DUOPA), via an unspecified route of administration from 2018, at unspecified dose, via an unspecified route of administration from 11Feb2020 to an unspecified date, at unspecified dose for an unspecified indication. Previously the patient received the first dose of bnt162b2 on an unspecified date in Jul2021 for COVID-19 immunisation. Medical history included naso Jejunal Tube Placement, Non Smoker, Abstains From Alcohol and hospitalisation from Jan2021 (palliative care). The patient's concomitant medications were not reported. The patient experienced multiple falls on an unspecified date, parkinson's disease on an unspecified date, difficulty breathing on an unspecified date, feeling unwell on an unspecified date, unable to swallow on an unspecified date, unable to walk on an unspecified date, weakness on an unspecified date, device dislocation on 21Jul2021, device connection issue on 21Jul2021 with outcome of not recovered. The patient's wife reported that from Jan2021 the patient was in the hospital and spent three months in hospital. He was in palliative care. GIMD changed the tubing both times he was in the hospital. On 21Jul2021, connector was coming off the inner tube and wanted to order a new connector. The registered nurse who came two times week told wife she could change the tubing for him. NCM encouraged wife to rule out to gimd. Wife reported something happened with the pump. She told the nurse could do it. NCM encouraged to rule out to morning dose. Offered with to mdo. Wife did not have time to speak to him. He had oral carbidopa and levodopa on hand. He was still used Duopa. NCM asked if tube was coming out of connector. Wife said yes. NCM offered to discontinue Duopa. He had a J tube replacement. Replaced the J tube only with all connectors. New Tube lot number was 32463288 for the J tube placed 12Aug2021. He was hospitalized with a psychotic episode on an unknown date and that's when he removed the J tube and the Y connector was broken. He was in restraints. On 10Aug2021, patient was hospitalized and was currently still in the hospital with the possible plan of care of being discharge to a rehab center. He was not feeling well because of the dislocation of the J tube and he was not getting the Duopa medication. His psychotic episode was the hallucinations. His Duopa dose was increased by approximately eight months ago from daily to 24-hour use (off label use). His wife suspects that the second dose of the Covid- 19 vaccination resulted in the he becoming weaker. The patient was hospitalized for multiple falls. The outcome of events Device connection issue and Device dislocation was Unknown, the other events were not resolved. The reporter assessed the event weakness as possible related to bnt162b2, the causality assessment for events Device connection issue and Device dislocation was not provided, and the other events were assessed as not related to bnt162b2. The reporter's assessment of the causal relationship of the reported events Device connection issue and Device dislocation with the suspect product bnt162b2 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 Causality for DUOPA (LEVODOPA/CARBIDOPA)The reporter's causality for the event(s) of unspecified hospitalization, connector issue/connector was came off the inner tube and J TUBE DISLOCATION was not provided. The reporter's causality for the event(s) of multiple falls, advanced Parkinson's disease, not feeling well, difficulty breathing, inability to move/walk, inability to swallow, off label use/patient used duopa for 24 hours and weak with duopa(levodopa/carbidopa) was no reasonable possibility. AbbVie's opinion is that there is no reasonable possibility that the events of unspecified hospitalization, multiple falls, connector issue/connector was came off the inner tube, j tube dislocation, advanced Parkinson'sdisease, not feeling well, difficulty breathing, inability to move/walk, inability to swallow, off label use/patient used duopa for 24 hours and weak are related to duopa(levodopa/carbidopa). The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (falls, Parkinson's disease) and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: Duopa

Current Illness:

ID: 1677526
Sex: F
Age:
State: CA

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: soreness; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support. A 68-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EB5313 and Expiration date was unknown), via an unspecified route of administration, administered in right arm on 05Feb2021, as dose 1, single (at the age of 67-years-old) for COVID-19 immunisation. Medical history included immunocompromised from and unknown date and ongoing, primary immune deficiency disease from 2017 (Spring of 2017) and ongoing, Mycobacterium avium complex infection (has been fighting it for 4 years) from 2017 and ongoing and also diagnosed with something else that was related to her being immunocompromised. Patient previously had the Shingrix vaccines for immunisation and had no problems, but they were kind of painful, but caused no problems, had Prevnar 13 on 24Aug2018 (does not have the lot or expiration date for the product) and Pneumovax vaccine both for immunisation and had no problems with either of them. Patient mom died of cancer. Patient had no prior vaccinations (within 4 weeks), prior to the first administration date of the suspect vaccine. Concomitant medication (s) included immunoglobulin human normal (Cuvitru) taken for immunodeficiency from Jun2017 and ongoing (takes the medication at least 48 hours apart from her vaccines, as she will be on it for life). On an unspecified date of 2021, patient had soreness after the first dose. No relevant tests were performed. Patient had no physician office and emergency room visit. Patient weight was 100-102lbs. The outcome of the event was unknown.

Other Meds: CUVITRU

Current Illness: Immunocompromised; Mycobacterium avium complex infection (She has been fighting it for 4 years); Primary immunodeficiency syndrome (Diagnosed in Spring of 2017)

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am