VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1721882
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: lymph node swollen; somewhat having trouble breathing; This is a spontaneous report from a contactable consumer (patient, self-reported). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3180 and expiry date was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date the patient's lymph node swollen and the patient somewhat having trouble breathing. The patient wanted to know what the patient was supposed to do. The patient did not receive any treatment for the event. Outcome of the events was unknown. Consumer hung up the call abruptly. Hence further probing could not be done. Limited information available over the call.

Other Meds:

Current Illness:

ID: 1721883
Sex: F
Age:
State: NY

Vax Date: 06/02/2021
Onset Date: 06/02/2021
Rec V Date: 09/22/2021
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: 20210711; Test Name: covid test; Test Result: Negative ; Comments: PCR Nasal Swab

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Tingling on my right hand; upper lip was a little numb; dudes of my face felt tight; left leg/foot felt heavy.; Experienced one foot being very cold while the other was normal and the opposite hand of the cold foot would be cold while the other hand would be normal; tingling again all over my body, especially on my head/scalp; numbness/tingling again all over my body, especially on my head/scalp; feelings of fluttering/twitches in my claves, left shoulder and right eye lid; joint pain in my wrist every so often; numbness on my head/ under chin area and lower legs and torso-left side usually; This is a spontaneous report from a contactable consumer (patient-self reported). A 59-year-old non pregnant female received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0177 and expiry date was not reported), dose 1 via an unspecified route of administration, in Arm right, on 02June2021 at 12:30 PM (age at vaccination was 59-years-old), as dose 1, single for COVID-19 immunization at pharmacy or drug store. The patient's medical history was not reported. Concomitant medications included vitamins. The patient was allergic to erythromycin. The patient did not receive any vaccine within four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. On 02Jun2021, patient had an immediate reaction. Tingling on her right hand, upper lip was a little numb, dudes of her face felt tight left leg/foot felt heavy. Experienced one foot being very cold while the other was normal and the opposite hand of the cold foot would be cold while the other hand would be normal. That finally went away and have not had that recur since it started after a couple of weeks of receiving the shot. Tingling and numbness Symptoms went away after three days but 4 days later developed numbness/tingling again all over her body, especially on her head/scalp, intermittently as well as feelings of fluttering/twitches in her calves, left shoulder and right eye lid. Also experienced joint pain in her wrists every so often. It was been nearly 11 weeks since her first dose and still experiencing these symptoms. Not as frequent but still have majority of numbness on her head/ under chin area and lower legs and torso-left side usually. She had seen 2 neurologists, immunologist and orthopoedist. The patient received treatment xyzel allegra for the adverse events. The patient underwent lab tests and procedures on 11Jul2021 which included SARS-CoV-2 antibody test (nasal swab covid test) which showed negative results. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1721884
Sex: F
Age:
State: FL

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Name: Nerve biopsy; Result Unstructured Data: Test Result:destruction of the myelin Sheath and the axon; Test Name: lab work; Result Unstructured Data: Test Result:unusual; Comments: It was a long time ago when diagnosing when she had unusual lab work results; Test Date: 20210816; Test Name: lab work; Test Result: Negative ; Comments: everything came negative

Allergies:

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

Symptoms: Neurological disease; She did not know if she was losing immunity to the vaccine; This is a spontaneous report from a contactable nurse. This 78-year-old female nurse (patient) reported for herself that: A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration on 17Feb2021 as DOSE 1, SINGLE, received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration on 10Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included pacemaker, chronic inflammatory demyelinating polyradiculoneuropathy She had the IVIg when she was diagnosed about 11 years ago , plasmapheresis She has been having plasmapheresis treatments for about 5 - 6 years now. Patient had no concomitant medications. The patient previously took IVIg for chronic inflammatory demyelinating polyradiculoneuropathy and experienced pulmonary embolism, during the first 4-5 years she had IvIg but had the pulmonary embolism and so she was switched to plasmapheresis. On an unspecified date, the patient experienced neurological disease, she did not know if she was losing immunity to the vaccine. She got plasmapheresis every 2 weeks for a neurological disease, she asks does the plasmapheresis pull out the antibodies that are developed from the vaccine. When she gets the treatment they pull out the plasma with the antibodies and give her human albumin, she do not know if she was losing immunity to the vaccine in this process. She was having trouble finding out. Caller confirms she called about the Pfizer Covid Vaccine, she is actually one of those people that qualifies for a booster and is eligible. She asked the pharmacist but he do not know anything. Her last plasmapheresis was about 2 weeks ago, and she was due tomorrow for her next one. Caller confirmed she got plasmapheresis every 2 weeks on a Tuesday. She just had regular lab work. It was a long time ago when diagnosing when she had unusual lab work results, but everything came negative. It was a hard time, she had a Nerve biopsy for chronic inflammatory demyelinated polyneuropathy and it showed destruction of the myelin Sheath and the axon. She got plasmapheresis every 2 weeks for a neurological disease, she asked does the plasmapheresis pull out the antibodies that are developed from the vaccine. When she got the treatment they pull out the plasma with the antibodies and give her human albumin, she didn't know if she was losing immunity to the vaccine in this process. She is having trouble finding out. Caller confirmed she called about the Pfizer Covid Vaccine. The patient underwent lab tests and procedures which included nerve biopsy: destruction of the myelin sheath and the axon on unspecified date, lab work: unusual on unspecified date, It was a long time ago when diagnosing when she had unusual lab work results, laboratory test: negative on 16Aug2021 everything came negative. The clinical outcome of events were unknown. Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1721885
Sex: F
Age:
State: TX

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 09/22/2021
Hospital:

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: Swollen painful lymph nodes under right arm (injection side) x1-2 days; This is a spontaneous report from a contactable consumer. This contactable 41-year-old female consumer (patient) reported for herself. A 41-years-old female patient (non-pregnant) received (BNT162B2, formulation: Solution for injection, Lot Number: EL 3249), via an unspecified route of administration, administered in Arm Right on 08Jan2021 12:00 pm (at the age of 41-years-old) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Right on 18Dec2020 01:00 PM (Batch/Lot Number: EL 0140) as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included blood cholesterol increased and iron deficiency anaemia from an unknown date and unknown if ongoing. The patient concomitant medication (within 2 weeks of vaccination) included nifedipine, oxymetazoline hydrochloride, ethinylestradiol, norgestimate and atorvastatin all are taken for an unspecified indication, start and stop date were not reported . Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced swollen painful lymph nodes under right arm (injection side) x1-2 days on 09Jan2021 12:00. The patient did not receive treatment for event. Device date was reported as 16Aug2021. The clinical outcome of the event was recovered on an unspecified date. Follow-up attempts are completed. No further information is expected.

Other Meds: NIFEDIPINE; CLARITIN ALLERGIC; ORTHO TRI-CYCLEN; ATORVASTATIN

Current Illness:

ID: 1721886
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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 erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: receive a corticoid steroid shot in her knees; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 as 1st dose for COVID-19 immunisation. The patient experienced "receive a corticoid steroid shot in her knees". Treatment was provided for the event. The patient reported that she had received her third dose of the Pfizer COVID-19 vaccine on 14Aug2021 but on 02Aug2021 she did receive a corticoid steroid shot in her knees and she was now reading on the internet that it should not have been taken. She stated she has called the CDC, they had no information and was told to try Pfizer. She reported that before getting a corticoid steroid should wait 2 weeks and then get the booster, she got it on the 13th day not the 14th day. She wanted information about the efficacy of the booster dose after receiving that but also receiving the steroid around that time and asked if that can effect the efficacy and if so would she need another dose in 6 months because of that. She received two steroid injections in her knee on 02Aug. Then on 14Aug she received her COVID vaccine booster. She was wondering if the efficacy of the Covid booster be affected by the steroids. Relayed PMI information and transferred to (name). Faxed PSCC for AE as she needed cortisone injections after taking 1st 2 doses of Covid vaccine. Outcome of the event was unknown. Follow-up (18Aug2021): This is a follow-up spontaneous report from a Pfizer-sponsored program . A contactable consumer reported for herself included clinical information. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1721887
Sex: F
Age:
State:

Vax Date: 08/19/2021
Onset Date: 08/01/2021
Rec V Date: 09/22/2021
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 Name: Body temperature; Result Unstructured Data: Test Result:100 degrees; Comments: over 100 degrees every time; Test Date: 20210821; Test Name: over the counter COVID test; Test Result: Positive ; Test Name: over the counter COVID tests; Test Result: Negative ; Comments: She did test twice with over the counter COVID tests and they were negative; Test Name: over the counter COVID tests; Test Result: Negative ; Comments: She did test twice with over the counter COVID tests and they were negative; Test Name: PCR test; Test Result: Negative

Allergies:

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

Symptoms: runny nose; chills; fever; slight body aches / little bit of body aches; she performed an over the counter covid test, in which the results came back positive; cough/ woke up with a bad cough; neck was hurting; she is weak; muscle ache; feel tired; This is a spontaneous report from a contactable Other Health care professional (patient) reported for herself. A 45-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, NDC number: Unknown, Batch/Lot number was not reported; Expiration Date: Oct2021), dose 1 via an unspecified route of administration on 19Aug2021 (at the age of 45-year-old) as dose 1, single for COVID-19 immunization. Medical history included cough from an unknown date and unknown if ongoing. Concomitant medication included budesonide (RHINOCORT TOPINASAL) taken for cough, start and stop date were not reported. The stated that she used Rhinocort prior to performing the Covid tests before receiving the vaccine, asked if Rhinocort could hinder the covid testing results and confirmed that she did not use Rhinocort prior to performing COVID testing after receiving the Pfizer COVID-19 vaccine, prior to receiving the Pfizer COVID-19 vaccine (the week prior, probably more than 5 days to receiving the vaccine), the patient and her daughter were sick, in which she thought they had COVID-19. Another snag was that she has been using Rhinocort to help her cough because of the postnasal drip. It was unknown to her if this may hinder the PCR test because it was a corticosteroid. The patient stated she started presenting symptoms of cough, runny nose at 07:00, chills, fever, and slight body aches on 21Aug2021. On Saturday 21Aug2021, she performed an over the counter COVID test, in which the results came back positive, patient and her daughter performed two over the counter tests and a PCR test in which the results were negative for COVID-19, she asked if there was any chance for the vaccine to cause a false positive test, she did not present any symptoms the day of or the day before receiving the Pfizer COVID-19 vaccine, she never had a fever prior to receiving the vaccine and she had just gotten over it (sickness), she was finished with her cough probably the Tuesday prior. The patient questioned if Pfizer recommends that she receives a PCR test based on her symptoms she was experiencing, she was calling to speak to someone because was confused and she does not know 100 percent what to do. She was sick for probably a week and a half with congestion, cough and no fever but she did lose her taste and smell. Well after about a week and a half the cough went away and so she had gone and got the 1st dose of the COVID vaccine on that Thursday evening, later clarified and confirmed to be 19Aug2021. Then that 20Aug2021 (Friday) evening her neck was hurting, the right side, but she got her COVID vaccine on the left side, so she did not think that has anything to do with it. On Saturday morning she woke up with a bad cough and then she started with chills and then a fever. She asked her husband to go get an over-the-counter COVID test like she did last time and it came back positive for COVID. She had gone on the CDC website to see what side effects have been reported after the COVID vaccine. She has had everything on there, well not everything, but she has had a lot going on with muscle ache from the fever and she has had chills. There was nothing on the CDC website with cough and runny nose being reported and that was the only reason she tested because it said that if you have those symptoms then you need to be tested and it came out positive. She didn't know if she needed to report cough as a new side effect or that she came out positive if it was not really positive, like what if it was from the COVID vaccine since it was an antigen that she was getting and the test tests for antigens. It was important to her because she was having to quarantine for 10 days now. She should have called Pfizer first because she did not want to be out of work unless she has to, which she did run a fever this morning, she asked, should she test PCR or not worry about it? If the PCR results were negative, then she might can go back to work if her employer allows her to. The patient neck was hurting, the right side; She said she had the COVID vaccine on that Thursday, 19Aug2021, and the right side of her neck hurting began Friday evening, 20Aug2021. It was still sore. She was just riding down to the lake and it could have been from how she was holding her head and resting in the back seat, but it seems that it would have hurt when she had gotten hurt and it did not hurt until she was about to go to bed and she could tell it was really sore on the right side. It has still been sore. It has gotten better but it was still pretty sore, but it has gotten better. The patient stated about the events Cough: This began first thing Saturday morning, 21Aug2021, Runny nose: This started a few hours after she had got up around 7 something that morning, 21Aug2021. She thought that this was weird. It was a dry cough, and it was continuous that she was coughing. She was coughing every 10 to 15 minutes. She says she still having the runny nose and a little bit of a postnasal drip. The cough was nowhere near what it was, and she thought that was because using Rhinocort to help. She started using that Saturday evening and it was helping with her cough some, but the coughing continued into Sunday and then it had started to take it away. Her runny nose was not as bad as it was, but it was still there, she had a little bit of body aches and chills that started on Saturday afternoon, 21Aug2021, around 1:00 and that was when she had sent her husband to go get an over the counter COVID test. She was starting to look on the internet about the side effects and on Pfizers paper from (Withheld) it had where she had the COVID vaccine and what the side effects are, but it did not mention cough. On the CDC website it also mentioned the side effects and said that if you had cough or runny nose that you need to be tested. Yesterday she still had the chills, they never went away but she was not having any right now. Her last fever was this morning at 6 something. Every time she got fever, she had chills and body aches. She takes Advil and it goes away in about 45 minutes to an hour and then she feels fine after that and her body feels okay. She does feel tired, like yesterday, she was really tired and Saturday she was tired but today she was not extremely exhausted, but she was weak on unknown date in Aug2021 That was probably because she probably needs to drink more fluids. She just has the runny nose and the cough periodically and the fever. Fever started on Saturday as well, 21Aug2021, and she was still having it too now. She was having to take Advil every 6 hours. She has a fever when she has the body aches and chills so she would take her temperature because she got warm, and her temperature was over 100 degrees every time. She did not wait until it gets more than that because she did not see any point in doing so, she did not want to cause any more trouble. She confirmed that she was still experiencing the fever, chills and body aches to now unless she takes the Advil, and it gets better. The patient underwent lab test and procedure which included over the counter COVID test: Positive on Saturday, 21Aug2021, over the counter COVID tests: Negative, she did test twice with over-the-counter COVID tests and they were negative on an unspecified date, over the counter COVID tests: Negative, she did test twice with over the counter COVID tests and they were negative on an unspecified date, PCR test: Negative on an unspecified date. The outcome of event cough was recovering, outcome of events runny nose, fever, chills, neck was hurting, and body aches was not recovered, outcome of events she performed an over the counter COVID test, in which the results came back positive, feel tired, she was weak and muscle ache was unknown. The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.

Other Meds: RHINOCORT TOPINASAL.

Current Illness:

ID: 1721888
Sex: F
Age:
State:

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 09/22/2021
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: getting an abnormal amount of HSV outbreaks, like almost daily; breakthrough infections; I'm miserable; This is a spontaneous report from a contactable consumer (patient). A 66 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, 66-year-old at vaccination) via an unspecified route, administered in Left arm on 24Feb2021 at 11:15 (Lot Number: EL9264) as Dose 1, Single and via an unspecified route, administered in Left arm on 24Mar2021 at 15:30 (Lot Number: E6955) as Dose 2, Single, both doses for COVID-19 immunization. The patient was non-pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. The patient's medical history included HSV (herpes simplex infection ailment for 40 years. No known allergies reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for Covid post vaccination. Since getting the Pfizer-BioNtech COVID-19 vaccine she had been getting an abnormal amount of HSV outbreaks, like almost daily. She used to only get them about 3 times a year. Normally she could manage it with a lot of L-Lysine. But that doesn't even work anymore, relentless. She had to get a prescription for acyclovir which she have to take daily. Even with taking that, she would had breakthrough infections. She didn't have any of these long term infections before she took the vaccine. She had both doses; last one was in March 2021. She have had this HSV ailment for 40 years and it had never been as active as it was now. Ever since getting your vaccine. It was the only new thing that she got that could be the reason for the numerous outbreaks. She was miserable. These Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received Acyclovir, 400 mg daily as treatment medication for the resulted events. These adverse events resulted doctor or other healthcare professional office/clinic visit. Device date was mentioned as 23Aug2021. The outcome of the events was not recovered. Follow-up attempts are completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1721889
Sex: F
Age:
State: FL

Vax Date: 04/28/2021
Onset Date: 04/01/2021
Rec V Date: 09/22/2021
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: 20210823; Test Name: test; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: She felt she had the Covid virus; She felt she had the Covid virus; she still could not breath correctly and still having a hard time breathing; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6198) at single dose (age at time of vaccination in 58 years) for COVID-19 immunization in the left arm via unknown route on at 28Apr202 at 15:00. The patient did not have any medical history or concomitant medication. The patient family medical history was none. The patient had taken the first dose of Covid vaccine (Lot Number: EN6201) on 07Apr2021 in the left arm after which she felt like she had the flu for 2 days and her nose was runny, fever, shaky, and sweating and then 2 days later she was fine. The patient reported that she had a very, very bad reactions to the first and second Covid vaccines and felt she had the Covid virus (feeling abnormal). Had felt a little bit better and was able to get liquids in her. Was worried she would get dehydrated. After 4 days of getting second shot the worse symptoms had passed but she still could not breath correctly and still having a hard time breathing and was still feeling tired. She was very, very fatigued and tired all the time. The patient pulmonologist had 2 tests done on her on 23Aug2021. The patient visited the cardiologist on 17Aug2021 and the pulmonologist on the 18Aug2021. Patient visited the physician office for the events. The outcome of the event felt she had the Covid virus was recovering. Outcome for the event she still could not breath correctly and still having a hard time breathing.

Other Meds:

Current Illness:

ID: 1721890
Sex: U
Age:
State: TX

Vax Date: 07/23/2021
Onset Date: 07/23/2021
Rec V Date: 09/22/2021
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: 20210818; Test Name: Covid test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Exhausted; body aches; joint hurt; head ache; sweating; immediately cold tongue then felt as tho semi numbness.; immediately cold tongue then felt as tho semi numbness.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Er8731; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 23Jul2021 13:00 as DOSE NUMBER UNKNOWN, SINGLE and patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Ew0172; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 23Jul2021 as DOSE NUMBER UNKNOWN, SINGLE both for COVID-19 immunization. Relevant medical history, concurrent conditions and concomitant medications were not reported. Patient had not known allergies. Patient had not relevant past drug history. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the was patient diagnosed with COVID-19. On 23Jul2021 13:00 patient experienced exhausted, body aches, joint hurt, head ache, sweating, immediately cold tongue then felt as tho semi numbness, immediately cold tongue then felt as tho semi numbness. On second shot immediately cold tongue then felt as tho semi numbness. Took full 4 weeks until patient felt woke up felt like patient had no COVID symptoms. Adverse event resulted in emergency room visit. Patient had received treatment for AEs (over the counter medicines). This report was not serious. Since the vaccination, has the patient did test for COVID-19 (Nasal swab) on 18Aug2021 which was negative. The outcome of event was recovered on an unspecified date in Jul2021. Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1721891
Sex: F
Age:
State: FL

Vax Date: 07/19/2021
Onset Date: 07/29/2021
Rec V Date: 09/22/2021
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: I was diagnosed with Herpes soon after the vaccine; This is a spontaneous report from a contactable consumer (patient herself). A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: FA7485, expiry date: unknown) via unspecified route of administration, in left arm on 19Jul2021 15:00 (age at vaccination: 22-years) as dose 1, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Patient did not take any other vaccines in four weeks and medications in two weeks. On 29Jul2021, patient was diagnosed with Herpes soon after the vaccine. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment was given due to the adverse event with acyclovir. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1721892
Sex: M
Age:
State: NY

Vax Date: 08/11/2021
Onset Date: 08/24/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: diagnosed with Mono/mononucleosis; Epstein-Barr virus; sick; This is a spontaneous report from a contactable Nurse (mother of patient) reported her son. A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported and Expiration date: unknown), dose 1 via an unspecified route of administration, administered in Deltoid Left on 11Aug2021 at 11:00 (not 100 percent sure about time) (at the age of 17-year-old) as DOSE 1, SINGLE for covid-19 immunisation. There were no additional Vaccines Administered on Same Date of the Pfizer Suspect. Medical history was none. There were no concomitant medications. Patient medical history (including any illness at time of vaccination) was none. The patient had no family medical history relevant to AE. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. On 24Aug2021, the patient diagnosed with mononucleosis, Epstein-Barr virus and had been sick for like a week. The clinical details of the events as follows: Caller was calling about her son who is 17 years old. The caller is a NP. The patient received his first dose of the Pfizer COVID-19 Vaccine on 11Aug2021. Patient now had been diagnosed with Mono. Because of this new diagnosis, the caller was now hesitant to get him the second dose of his vaccine that he is supposed to receive on 02Sep2021. Caller requested to speak to a scientist or doctor with Pfizer regarding her situation and other cases possibly. The caller understanded that there was minimal information available on teens, but she would like to get further guidance on what the recommendation would be for her son having had the 1st dose and now having Mono. She did not mention speaking to a higher level than a RN several times with the backing that she is not trying to undermine. She would like to know if this was something Pfizer has knowledge about. She stated that this was above her medical knowledge as a practicing Nurse Practitioner as well. She stated that her situation was unique, and she understands this. Caller also stated that her HCP, nobody knows anything about anything to be honest. Caller stated obviously as a medical provider myself, I am not giving him the 2nd vaccine. I am not messing with his immune system while he is fighting mono. The patient went to the physician office due to the events. The caller son now has mononucleosis, Epstein-Barr Virus. The caller was asking for guidance on the son receiving the second dose Pfizer Covid Vaccine. The caller stated she knows there was no data on someone with mononucleosis and the Pfizer Covid Vaccine. The caller son now has mononucleosis within 3 weeks of receiving the Pfizer Covid Vaccine and the patient was due for his second dose Pfizer Covid Vaccine. The caller did not think the patient should receive the second dose Pfizer Covid Vaccine, knows the Pfizer Covid Vaccine effects the immune system. The caller was not happy about the situation. The caller is a Nurse Practitioner and was on the fence about her son receiving the Pfizer Covid Vaccine, but the caller did the right thing for her son. The caller wanted to speak to someone about guidance on the second dose Pfizer Covid Vaccine. The caller did think the son was going to receive the second dose Pfizer Covid Vaccine. Relevant Tests were none. Now has mononucleosis, Epstein-Barr Virus, the caller stated she knew this was not a side effect. She stated mononucleosis and Epstein-Barr virus were Unrelated to Pfizer Covid Vaccine. There was no Investigation Assessment provided. The patient outcome of the events was unknown at the time of this report. Causality: The caller stated this was not a side effect of the Pfizer Covid Vaccine. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1721893
Sex: F
Age:
State: GA

Vax Date: 08/05/2021
Onset Date: 08/01/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Had her 1st dose injection 05Aug2021 and in between she is taking antibiotics; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 05Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller was a consumer who had her 1st dose injection 05Aug2021 and in between she is taking antibiotics on Aug2021. She was asking if it is ok to get second dose, or should she wait. Caller stated she has not had any issues and before she schedules her 2nd injection she wanted to know if she took antibiotics it is ok to still get the 2nd dosage. Patient was received treatment for the event. The outcome of the event was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1721894
Sex: M
Age:
State: MD

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 09/22/2021
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: 20210820; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: my right leg swelled up to the point we're walking was impossible; My left Thigh was very painful and felt as if on fire; I have a prosthetic right knee and a rod in my left femur with several screws and nails.; My left Thigh was very painful and felt as if on fire; Within 24 hours my right leg swelled up to the point we're walking was impossible; other vaccine same date vaccine date: 28May2021; other vaccine same date dose number=2; This is a spontaneous report received from a contactable consumer or other non hcp.A 56-years-old male patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: Ew0187), via an unspecified route of administration,administered in Arm Left ,at the age of 56 years old,on 28May2021 12:00 as Dose 1,single and dose 2 via an unspecified route of administration on 28May2021 (Batch/Lot Number: EW0202) as Dose 2,single for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing.There were no concomitant medications.The patient experienced my right leg swelled up to the point we're walking was impossible and his left thigh was very painful and felt as if on fire on 19Jun2021 10:00,he had a prosthetic right knee and a rod in his left femur with several screws and nails,other vaccine same date vaccine date: 28may2021;other vaccine same date dose number 2 on 28May2021,his left thigh was very painful and felt as if on fire, within 24 hours patient right leg swelled up to the point where walking was impossible on 19Jun2021 10:00.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Aug2021.Therapeutic measures were taken as a result of my right leg swelled up to the point we're walking was impossible,my left thigh was very painful and felt as if on fire,i have a prosthetic right knee and a rod in my left femur with several screws and nails,my left thigh was very painful and felt as if on fire,within 24 hours my right leg swelled up to the point we're walking was impossible.Treatment received for the adverse event was ibuprofen.The patient was not diagnosed with covid19 prior to vaccination and not tested post vaccination.The patient had allergy to penicillin.The patient had not received any other medication within 2 weeks.Since the vaccination,the patient was tested for COVID-19. Device Date : 30Aug2021. Follow-Up (08Sep2021): Follow-up attempts are completed.No further information is expected.

Other Meds:

Current Illness:

ID: 1721895
Sex: M
Age:
State: NC

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 09/22/2021
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: 20210323; Test Name: heart rate; Result Unstructured Data: Test Result:105; Comments: My heart rate now suddenly was topping out at 105 on the minor hill on the way to work after months of maintaining 170s for the same work.; Test Date: 20210323; Test Name: O2; Result Unstructured Data: Test Result:97 to 98; Comments: O2 has been holding steady in the 97 to 98 range these days.

Allergies:

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

Symptoms: chest pain; patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization; My heart rate now suddenly was topping out at 105 on the minor hill on the way to work after months of maintaining 170s for the same work; Pain in movement; Pain in movement; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Covid-19, after months of maintaining 170s (heart rate). Patient had no other vaccine in four weeks. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 23Mar2021 for covid-19 immunization. Shot 1 hit him like a truck, it was like being back with Covid again for a day, and the second shot wasnt a lot better. But about a week after the second shot, he saw DRAMATIC improvement. Without any substantial muscle gain he had access to my general strength again, he did not need help lifting or moving every-day objects, and he could even walk my dog again without issue. Pain in movement was great-ly reduced to almost nothing. His heart rate now suddenly was topping out at 105 on the minor hill on the way to work after months of maintaining 170s for the same work. O2 has been holding steady in the 97 to 98 range these days. He was certainly not back to normal, the most he have managed at a stretch was about half a mile for a run before chest pain tilted in, but this is a huge improvement from where he was and he did continue to see incremental increases week to week. The outcome of the event chest pain was unknown, while for other events was recovered on an unspecified date. Patient had no treatment. It was unknown if patient was covid tested post vaccination. Case was reported as non-serious. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1721896
Sex: M
Age:
State: AL

Vax Date: 07/26/2021
Onset Date: 08/10/2021
Rec V Date: 09/22/2021
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: CT; Result Unstructured Data: Test Result:confirmed mesenteric lymphadenitis.

Allergies:

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

Symptoms: swelling of abdominal lymph nodes; he was in so much pain that we took him to ER; They did CT and confirmed mesenteric lymphadenitis; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EP7534, Expiration Date: not reported), via an unspecified route of administration, in left arm on 26Jul2021 16:15 as dose 1, single for COVID-19 immunization (at the age of 12-year-old). Medical history included acid reflux from an unknown date and unknown if ongoing and had no known allergies. Patient had not experienced any past drug event. There were no concomitant medications. Patient did not receive any other vaccine in four weeks and other medications in two weeks. Patient had no covid prior vaccination and was not covid tested post vaccination. The patient experienced swelling of abdominal lymph nodes, he was in so much pain that they took him to ER, they did ct and confirmed mesenteric lymphadenitis on 10Aug2021 06:00. It was reported that, both times 2 weeks after each vaccine he had experienced swelling of abdominal lymph nodes. The first time he was in so much pain that they took him to ER believing it to be appendicitis. They did CT and confirmed mesenteric lymphadenitis. Pain lasted 2 weeks. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included computerised tomogram: confirmed mesenteric lymphadenitis on an unspecified date. Therapeutic measures were taken as a result of events with prescription medications. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1721897
Sex: F
Age:
State: PA

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 09/22/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Since receiving my series of vaccinations for Covid, I have not menstruated; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A non-pregnant female patient of an unspecified age 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 Jan2021, as single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient reported I received my first vaccine in Jan2021 after having had covid since receiving my series of vaccinations for Covid, I have not menstruated on an unspecified date in 2021. I had never had issues with this prior to being vaccinated. I do not take any birth control, I am not/was not pregnant, and have had no other changes besides receiving the vaccine. It was over 7 months and I had to see my women's health physician who had to give me a hormone to initiate a period. The outcome of the event was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1721898
Sex: F
Age:
State: NY

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Name: Covid-19 Test; Test Result: Negative

Allergies:

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

Symptoms: cough; runny nose; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A contactable female consumer reported similar events for herself and 1 patient. This report is for 1 of 2 patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Aug2021 (also reported as first dose of the Pfizer covid vaccine three and a half weeks ago) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was scheduled for the second vaccine on 02Sep2021 (today) but, on an unspecified date in 2021 she was coughing with a runny nose. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The patient family was experiencing the same symptoms. Her sister already got two doses of Pfizer and had slight symptoms. Outcome for both the events were unknown. The lot number for [BNT162B2], was not provided and would be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101151527 same product and event, different patients

Other Meds:

Current Illness:

ID: 1721899
Sex: F
Age:
State: TX

Vax Date: 05/12/2021
Onset Date: 07/25/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: blood work; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210826; Test Name: vaginal and pelvic ultrasound; Result Unstructured Data: Test Result:uterine lining is pretty thick.; Test Name: ultrasound; Result Unstructured Data: Test Result:uterine lining was 19 centimeters thick; Test Name: vaginal and pelvic ultrasound; Result Unstructured Data: Test Result:Thick; Comments: uterine lining is pretty thick

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: migraines; The bleeding started two days before the second dose and continued for 23 days.; bruising on her legs; she had intense heat, burning; she had intense heat, burning; itchy, rash that later went into a hives all around her body and this was on her arms and legs; itchy, rash that later went into a hives all around her body and this was on her arms and legs; itchy, rash that later went into a hives all around her body and this was on her arms and legs; strange feeling in her feet; severe anxiety; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8733), via an unspecified route of administration in arm right on 12May2021 (at the age of 41-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included a menstrual cycle prior to when the bleeding starting. The concomitant medications of the patient were not reported. The patient previously took FLU shot on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The Family Medical History Relevant to AE(s) were reported as none. On 25Jul2021, the patient experienced the bleeding started two days before the second dose and continued for 23 days, on 29Aug2021, the patient experienced migraines and the patient also experienced bruising on her legs, she had intense heat, burning, itchy, rash that later went into a hives all around her body and this was on her arms and legs, strange feeling in her feet, severe anxiety on an unspecified date in 2021. The patient reported that the bleeding started two days before the second dose and continued for 23 days. She had a menstrual cycle prior to when the bleeding starting. She clarified her last period ended on 12Jul2021. She has barely had a break in bleeding throughout July and August. Clarified she bled from 25Jul2021 till 19Aug2021. Then started bleeding again from 28Aug2021 and was still currently bleeding. There were days it was really horrible with blood clots that were large over the size of a quarter coming out. She bled though 8 maxi pads within 12 hours on Sunday and she was afraid she was hemorrhaging. She was so weak and tired. The progesterone slowed down the bleeding but it was still coming. Doctor wants her to have a biopsy. She had an ultrasound done and it showed the uterine lining was 19 centimeters thick. She had a vaginal and pelvic ultrasound and was told her uterine lining is pretty thick. She seems to be a healthy individual. She mentioned other side effects she had experienced such as bruising on her legs both times, it was strange because they were pretty large bruises. The inner part of her thigh where the major artery runs down her leg- she had intense heat, burning, itchy, rash that later went into a hives all around her body and this was on her arms and legs. Little spots would pop on her body but it was not as intense as her arms and legs. She had a really strange feeling in her feet, she had to put an ice pack on. She had a strange sensation that she could feel on her body mainly in feet and legs. She had increased severe anxiety. Anxiety still comes and goes due to her blood loss and probably will continue till she gets more stable and balanced out. She had been having migraines for the last three days and she was associating this with the bleeding. She was referred to see her doctor and she was scheduled her for an ultrasound in Aug2021, she had a pelvic ultrasound done on 26Aug2021. On 30Aug2021 she was prescribed Progesterone. They looked at ultrasounds and compared her blood work that she had done in Jul2021. The events resulted in physician office visit. The patient underwent lab tests and procedures which included blood test: unknown result on an unspecified date in Jul2021, ultrasound pelvis: uterine lining is pretty thick on 26Aug2021, ultrasound uterus: uterine lining was 19 centimeters thick on an unspecified date, ultrasound uterus: thick on an unspecified date. Therapeutic measures were taken as a result of the bleeding started two days before the second dose and continued for 23 days, bruising on her legs, she had intense heat, burning, itchy, rash that later went into a hives all around her body and this was on her arms and legs, strange feeling in her feet and severe anxiety that included her doctor prescribed progesterone 200mg, she had been on it for two days. The outcome of the events The bleeding started two days before the second dose and continued for 23 days, severe anxiety, migraines was reported as not resolved and the patient recovered from bruising on her legs, she had intense heat, burning, itchy, rash that later went into a hives all around her body and this was on her arms and legs, strange feeling in her feet on an unspecified date in 2021.

Other Meds:

Current Illness:

ID: 1721900
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: developed hypertension; she took her third covid-19 vaccine dose; she took her third covid-19 vaccine dose; This is a spontaneous report from a contactable other hcp. A 50-years-old female patient received third dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 2021 as DOSE 3, SINGLE for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced developed hypertension on 2021, she took her third covid-19 vaccine dose on 2021, she took her third covid-19 vaccine dose on 2021. Therapeutic measures were taken as a result of developed hypertension. The outcome of the events hypertension, extra dose administered, off label use was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1721901
Sex: F
Age:
State:

Vax Date: 08/28/2021
Onset Date: 08/31/2021
Rec V Date: 09/22/2021
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: thought it was a kidney infection no infection in urine sample but, passing blood thru my kidneys; pain in my right groin; still feel pressure; pain; This is a spontaneous report from a non-contactable consumer (patient) . This 51-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28Aug2021 11:15 (Batch/Lot number was not reported) as DOSE SINGLE for covid-19 immunisation . Medical history included Aspirin allergy, abdominal discomfort sensitive in stomach , tomatoes and oranges allergy and high acid food can't tolerate. The patient's concomitant medications were not reported. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks.The clinical course was reported as follows: the patient started having some pain in my right groin. Went to my dr thought it was a kidney infection no infection in urine sample but, passing blood thru my kidneys so, will probably have to see urologist still feel pressure and pain. Not taking the second shot.Onset date of the events was on 31Aug2021.The adverse event result in Doctor or other healthcare professional office/clinic visit.The outcome of the events was not reovered.Additional information :no Covid prior vaccination. No Covid tested post vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1721902
Sex: F
Age:
State: FL

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/22/2021
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: hot; sweaty; feeling tired; weak all over and couldn't stand up; She got a third booster dose on 01Sep2021; She got a third booster dose on 01Sep2021; She felt like she would faint.; throwing up; fever/temperature; This is a spontaneous report from a contactable consumer received from regulatory authority. A 74-year old female consumer (patient) reported that she received the booster third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN6205 or ED6205), into the right arm on 01Sep2021 between 9:45AM and 10:00AM (at the age of 74-years-old) at single dose for COVID-19 immunization. The patient had received her second dose of BNT162B2 on 06Apr2021 and the first dose on 14Mar2021 (Lot Number: EN6199). Medical history included breast cancer diagnosed in 2013 and she had chemo and radiation through the first part of 2014. Concomitant drugs included Evista on it for about a year and a half for osteopenia and calcium supplements and vitamins and minerals for her thyroid. The patient reported that after her third dose on day 4 after vaccination (05Sep2021) she had a set back of hot, sweaty, temperature, fever all over and she couldn't stand up. This has since resolved however she is still feeling tired. She stated that was at church and teaching at school and it was so embarrassing. She came home and laid down. Her daughter called her other daughter that is a nurse. She said to get caller off her feet and just watch her. The sweating finally went away. Caller was throwing up, but not a lot. She thinks it was because she had not eaten much that morning. She had a small piece of toast. It has all cleared up. Within 2 to 3 hours she was totally better. She got up and took a shower because she sweated so badly. It knocked her off her feet. Nothing has ever knocked her off her feet like that. That is the only reason she called. She had never had a reaction like that ever, not with the other two. It all started in the morning at 9:30AM. All of a sudden she had to grab a chair and sit down. Her knees were like jelly. She got hot. She felt like she would faint. All of this occurred within 4 days of getting booster. Tiredness has improved some and she was able to come back to work. It was like she had stomach virus and that is what she was hoping.The patient doesn't think it was associated to BNT162B2. The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.

Other Meds: EVISTA

Current Illness:

ID: 1721903
Sex: F
Age:
State: NY

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 09/22/2021
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: 20210902; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown results; Comments: but does not have results back yet; Test Date: 20210818; Test Name: fever; Result Unstructured Data: Test Result:99 degreees; Comments: low grade fever

Allergies:

Symptom List: Unevaluable event

Symptoms: Headache; Brain fog; Insomnia; High anxiety; Was so hungry; Achy / Soreness; Sore arm; Low grade fever; This is a spontaneous report from a contactable consumer (patient herself). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 18Aug2021 at 13:30 (at the age of 68-year-old) as dose 1, single for covid-19 immunisation. Medical history included Hashimotos disease from 1995 and ongoing: This is with chronic sub actuate thyroiditis. It's where it makes her every 4-5 years her thyroid go hyper and would be very, very sick, Irregular Heartbeat: Stated it's harmless. She is not using a pacemaker or anything. Her heart will race or skip at times, insomnia: historically insomnia is something that she has that comes and goes for years. Historical vaccine included Smallpox vaccine for Immunization with had no reaction and tetanus shot for Immunization and experienced big goose egg in arm: She also had a tetanus shot and only thing can remember is having big goose egg in arm from the shot. The patient had within four weeks prior to the first administration date of the suspect vaccine reported as None. She clarified that, her reaction details. She initially stated she indicated she had the usual the first day. She had a headache and brain fog. She had the headache the second day as well. She had three things that were weird and not normal. She was told she would be tired, but she was not. She got insomnia instead. She was also highly anxious, like having anxiety. It was almost to the point of having a panic attack. This continued for over a week after getting the vaccine. This was something that has never been heard of before. Also, almost immediately after the vaccine she got so hungry. She was so hungry she could not get enough to eat for several days. She would eat and then been starving hungry again half an hour later. She did not want to take anything for her symptoms, but it got to the point where she had to take something. She tried not take Advil or Tylenol because she was told not to the first 48 hours because want the vaccine to work. However, the third night she wanted to sleep and so she took something for the insomnia and she slept good. She then felt like everything was okay after this third day. However, afterwards it was like every other day she would get symptoms. She also was achy real bad, like had the flu. She could not sleep, would be anxious again, and have this bad hunger. This was going on ten days. The first and second night was really bad. She took something for sleep the third night because her body needed sleep. She knew she needed sleep to make the vaccine work. She added, historically insomnia is something that she has that comes and goes for years. However, for some reason this seemed to be worse after the first week of getting the vaccine. She had to take the medication for insomnia for 3-4 nights straight to help try and sleep normally. The insomnia still comes and goes, but does not know if it is still from the vaccine at this point. The first week after the vaccine she knows the insomnia was from the vaccine because she had high anxiety along with it along with the bad hunger. Started the day got the shot. It was like within athe first half hour. She did not expect high anxiety to happened. She expected to be tired because was told when got the shot would be tired and and probably get a headache. However, she never got tired. She wished she did get tired. She still gets that anxiety feeling at times, but she thinks it was due being scared to get the second shot. She was so hungry, bad hunger: the day of the shot she drank a lot of fluids and ate a big breakfast before going to get the shot. She wanted to make sure she was hydrated and ate before getting vaccinated. However, a few minutes after getting the vaccine she was so hungry. She had hunger pains. She told the nurse and asked the nurse about it and the nurse said she had never heard of that. That still comes and goes, but it was better. She did mention that to the doctor who also ordered blood work. She had an annual check up and blood work was taken then. So now she had another blood test two weeks after the shot to check and make sure nothing has changed, making sure nothing inflamed or messing up since the vaccine. Achy real bad was started as clarified initially the fifth day after the vaccine. After the third day she had felt wonderful and thought yay she was done with the side effects, but by the the fifth day she had body aches. It was all over her body. She had it in her neck, arms. She also added, and stated initially, she did have a sore arm the first 3-4 days after the vaccine,but did not think anything of it. She did not have a rash or real pain, just the soreness afterwards. Now it is achy feeling. She was achy in her back, all over badly. She later added soreness, her neck, arms, shoulders, upper back was really sore and achy the first two days,but went away the the third day. Her muscles were sore. She broke down and took Tylenol because at first was not trying to take anything for pain. She also added, she had a lowgrade fever, that was off and on the first day. She never took anything for it because it was just 99 degreees. She commented she has not needed medication for her thyroid in years. She has not had a vaccine in 50 years. She was nervous to get the covid vaccine because did not want to throw it off. She stated that, when she was kid, 5 years old she remembers getting the Smallpox vaccine and had no reaction. She also had a tetanus shot and only thing can remember is having big goose egg in arm from the shot. She does not remember any other shot. On 18Aug2021, the patient experienced headache, brain fog, insomnia, high anxiety, was so hungry, achy / soreness, sore arm, low grade fever. The patient underwent lab tests and procedures which included Blood work: unknown results on 02Sep2021, but does not have results back yet and fever: 99 degreees on 18Aug2021, low grade fever. Therapeutic measures were taken as a result of insomnia and take the medication for insomnia for 3-4 nights straight to help try and sleep normally. The outcome of the event Brain fog was recovered on 18Aug2021, Sore arm was recovered on Aug2021, Headache was recovered on 19Aug2021; Was so hungry was recovering; Achy/Soreness and Low grade fever was unknown and High anxiety and Insomnia was not recovered. Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds: ATENOLOL

Current Illness: Hashimoto's disease

ID: 1721904
Sex: M
Age:
State: AZ

Vax Date: 03/06/2021
Onset Date: 08/01/2021
Rec V Date: 09/22/2021
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: Test Date: 202108; Test Name: Blood work; Result Unstructured Data: Test Result:Had no antibody; Comments: had no antibody for COVID-19; Test Date: 202108; Test Name: Covid; Test Result: Negative

Allergies:

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

Symptoms: Bleeding ulcers; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 06Mar2021 (Batch/Lot Number: EN6205) at the age of 70-years-old as single dose for covid-19 immunization. Medical history included a bariatric bypass surgery 15 years ago. the patient on unspecified date in Oct2021 had received flu vaccine and It made his arm sore for 5 days . There were no concomitant medications. The patient had received the first dose of the same vaccine on 13Feb2021, from lot EL9267. The patient experienced bleeding ulcers on Aug2021 with outcome of recovered. The patient was hospitalized for bleeding ulcers, which currently he had to receive 2 blood transfusions in the hospital. Last week he took a blood sample that was taken by his GI doctor and it revealed he has no immunity or antibodies for the Covid 19 right now. He is also Covid negative when checked by hospital. The patient stated he no longer has bleeding ulcer, but has to be on a drug regimen for the next 3 months from the GI doctor and basically for the rest of his life be taking Omeprazole once daily to prevent and too much acid from building up or happening.

Other Meds:

Current Illness:

ID: 1721905
Sex: M
Age:
State: TX

Vax Date: 02/25/2021
Onset Date: 03/03/2021
Rec V Date: 09/22/2021
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: 20210521; Test Name: Skin Biopsy; Result Unstructured Data: Test Result:Unknown Results; Comments: No definite conclusion(Atopic Dermatitis); Test Date: 20210521; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown Results; Comments: No definite conclusion(Atopic Dermatitis); Test Date: 20210521; Test Name: Nasal Swab; Test Result: Negative ; Comments: Nasal swab

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Also diagnosed with AFIB; Rash broke out all over body within 7-10 days of vaccine; Atopic dermatitis; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 14:15 (at the age of 75-year-old) (Batch/Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included high blood pressure, mild heart attack-stent, high chlolesterol. The patient had not experienced Covid-19 prior vaccination. Concomitant medication(s) included metoprolol tartrate (manufacturer unknown); atorvastatin calcium (manufacturer unknown); ramipril (manufacturer unknown); amlodipine besilate (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient previously took terbinafine hydrochloride (LAMISIL) orally for foot fungus and experienced ageusia 30 years ago. No other vaccine in four weeks. The patient experienced rash broke out all over body within 7-10 days of vaccine (non-serious) on 03Mar2021 with outcome of not recovered, atopic dermatitis (non-serious) on 03Mar2021 with outcome of not recovered, also diagnosed with AFIB (non-serious) on 29Apr2021 with outcome of unknown. Event rash broke out all over body resulted in Doctor or other healthcare professional office/clinic visit. The course of events was as follows: On 03Mar2021 rash broke out all over body within 7-10 days of Vaccine. He had 6 visits to Dermatologist. He received 2 series of Prednisone 20 mg, steroid ointment/creams. He had skin biopsy, blood work and no definite conclusion (atopic dermatitis). Also diagnosed with AFIB 29Apr2021 (emergency room--cardioversion) not sure or origin but, still fighting this skin rash. The patient underwent lab tests and procedures which included biopsy skin: unknown results on 21May2021 No definite conclusion (atopic dermatitis), blood test: unknown results on 21May2021 No definite conclusion (atopic dermatitis), Sars-cov-2 test: negative on 21May2021. Therapeutic measures were taken as a result of rash broke out all over body within 7-10 days of vaccine, atopic dermatitis. Follow-up attempts are completed. Lot/batch number has been requested. No further information is expected.

Other Meds: METOPROLOL TARTRATE; ATORVASTATIN CALCIUM; RAMIPRIL; AMLODIPINE BESILATE

Current Illness:

ID: 1721906
Sex: F
Age:
State:

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: I broke out in hives around my trunk and arms; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on Dec2020 (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 experienced "I broke out in hives around my trunk and arms" on an unspecified date with outcome of unknown. The patient went to the ER. They had given her packs of Benadryl and steroids. The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1721907
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Name: EKG; Result Unstructured Data: Test Result:Abnormal; Comments: received an EKG that was abnormal

Allergies:

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

Symptoms: Caller thinks it is Myocarditis.; Chest pain; Shortness of breath; felt like her lungs couldn't fill up; This is a spontaneous report from a contactable Nurse (patient) A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not provided), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. Immediately after receiving the vaccine patient began having chest pain, shortness of breath and felt like her lungs couldn't fill up. She has not gotten better in two weeks. She thought it sounds like Myocarditis (as reported). The patient went to urgent care center, they told her not to go to the Emergency Room for risk of getting Covid.Stated they did an office EKG and said they would send it to cardiologist. (as reported). The patient underwent lab tests and procedures which included electrocardiogram abnormal on an unspecified date. At the time of the reporting the patient had not yet recovered from chest pain and Shortness of breath, outcome of other reported events was unknown.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious event Myocarditis cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1721908
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: came in to receive the Pfizer Covid-19 booster dose/patient received Moderna for the original 2-dose series; came in to receive the Pfizer Covid-19 booster dose/patient received Moderna for the original 2-dose series; came in to receive the Pfizer Covid-19 booster dose/patient received Moderna for the original 2-dose series; This is a spontaneous report from a contactable pharmacist. A 69-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunisation. The patient medical history and concomitant was not reported. Patient previously took Moderna dose 1 and dose 2 for covid 19 immunization. It was Reported that, Caller is a pharmacist who reports a patient (69 years old, female) came in to receive the Pfizer Covid-19 booster dose. Caller reported that the patient received Moderna for the original 2-dose series and is inquiring about additional information regarding this scenario. Pfizer has no information regarding the interchangeability of Covid-19 vaccines, however the CDC released interim considerations regarding interchangeability. Refer to the attached document and states "The additional mRNA COVID-19 vaccine dose should be the same vaccine product as the initial 2-dose mRNA COVID-19 primary vaccine series (Pfizer-BioNTech or Moderna). If the mRNA COVID-19 vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine product may be administered. A person should not receive more than three mRNA COVID-19 vaccine doses. Pfizer is independent of these recommendations the patient experienced came in to receive the pfizer covid-19 booster dose/patient received moderna for the original 2-dose series on an, came in to receive the pfizer covid-19 booster dose/patient received moderna for the original 2-dose series on an unspecified date with outcome of unknown. Follow-up (07Sep2021): This is a follow-up spontaneous report from a pharmacist reported information included. Follow-up (07Sep2021):This is a follow-up spontaneous report from a pharmacist reported information included

Other Meds:

Current Illness:

ID: 1721909
Sex: F
Age:
State:

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

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

Lab Data: Test Date: 20210904; Test Name: Blood pressure; Result Unstructured Data: Test Result:little elevated; Test Date: 20210904; Test Name: Heart rate; Result Unstructured Data: Test Result:123; Comments: resting heart rate 123

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: having elevated heart rate; dizzy/Lightheaded; blood pressure being elevated/blood pressure a little elevated; Episodes of spike in heart rate; This is a spontaneous report from a contactable consumer (patient). A female consumer of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Sep2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for covid-19 immunisation. On 04Sep2021, the day after the vaccine, the patient started having elevated heart rate, resting 123 beat per minute (BPM); since then, the patient was having episodes elevated heart rate, blood pressure being elevated and dizzy. The patient had been trying to get in and of course no one was taking walk-ins, most appointments were booked. Pharmacist indicated because they are more like episodes rather than it being elevated consistently and uncontrollable, not thinking medical emergency. In 04Sep2021, blood pressure was little elevated, and heart rate was 123 (resting heart rate). The outcome of the events was unknown. Follow-up attempts are completed. The batch/lot number is not available despite the follow-up attempts made. No further information is expected.

Other Meds:

Current Illness:

ID: 1721910
Sex: M
Age:
State: TX

Vax Date: 09/05/2021
Onset Date: 09/07/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Enlarged lymph node, axillary, ipsilateral to vaccine administration site. 10.5 cm (4.0+ inches). Tender. Mobile.; This is a spontaneous report from a contactable physician. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05Sep2021 12:45 (Lot Number: FE3592) as dose number unknown, single (at the age of 53 years old) for COVID-19 immunisation. Medical history included hypercholesterolaemia, no allergies. Concomitant medications were not reported. On 07Sep2021 02:00, the patient experienced enlarged lymph node, axillary, ipsilateral to vaccine administration site. 10.5 cm (4.0+ inches). Tender. Mobile. The outcome of the events was not recovered. No treatment required. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The event lymphadenopathy was considered related to suspect drug based on temporal association and known safety profile of the drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1721911
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Headache/Cephalgia; Fatigue; Cough; Colitis ulcerative aggravated; This is a solicited report facilitated collect (marketing program name not available) from a contactable consumer (patient), based on the information received by Pfizer. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE (Tozinameran); Solution for injection, batch/lot number: unknown, expiration date Unknown), via intramuscular route of administration on 01Mar2021 (at the age of 49-years-old) as dose 1, single and received second dose via intramuscular route of administration on 01Apr2021 (at the age of 49-years-old) as single both were taken for COVID-19 immunization and adalimumab (HUMIRA, Solution for Injection In Pre-Filled Pen), via subcutaneous route of administration on an unspecified date at an unknown dose (citrate free) and frequency for moderate to severe ulcerative colitis and moderate to severe rheumatoid arthritis and stopped on an unspecified date in Jul2021. Primary reporter did not have the lot number information, because the packaging was discarded. The patient's medical history included COVID-19 with pneumonia from an unknown date in Jan2021 was recovered on an unknown date in 2021. In Jan2021, she had COVID, her symptoms were quite severe, and she was hospitalized with pneumonia, recovered in 2021. The patient had Colitis ulcerative. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Concomitant medications were not reported. In 2021, the patient experienced colitis ulcerative aggravated. In Mar2021, she got COVID vaccines and had mild covid symptoms such as experienced cephalgia or headache, fatigue and cough for four to days. In Jul2021, it was discovered that she was building antibodies to the Humira and she stopped taking it. On 25Jun2021, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The event of "Blood in stool" was amended to "Ulcerative Colitis Flare". On 28Aug2021, received updates to patient demographics, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of "Got COVID vaccines and had mild COVID symptoms such as headache, fatigue, cough " were added. The action taken in response to the events for adalimumab was Permanently withdrawn. The outcome of the event "Colitis ulcerative aggravated" was unknown, while the outcome of the remaining events was recovered in 2021. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of, ulcerative colitis flare and Antibodies to Humira With Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of got COVID vaccines and had mild COVID symptoms such as headache, fatigue, cough onset in Mar2021 was not provided. Opinion was that there was no reasonable possibility that the events of, ulcerative colitis flare, got COVID vaccines and had mild COVID symptoms such as headache, fatigue, cough onset in Mar2021, are related to Humira (adalimumab). Abbvie's opinion was that there was a reasonable possibility that the event of antibodies to Humira was related to Humira (adalimumab). The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided the causal association between the events ulcerative colitis flare, headache, fatigue and cough with the vaccine 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: HUMIRA

Current Illness:

ID: 1721912
Sex: F
Age:
State: NY

Vax Date: 06/09/2021
Onset Date: 06/01/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Name: EEG; Result Unstructured Data: Test Result:Normal; Comments: it looks like it was normal; Test Name: EMG; Result Unstructured Data: Test Result:Normal; Comments: it looks like it was normal; Test Name: Sonogram; Result Unstructured Data: Test Result:did not see a DVT

Allergies:

Symptom List: Injection site pain

Symptoms: Two weeks after her first dose she started feeling pain in her leg on left side, excruciating pain.; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. This is the second of two reports. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left upper arm on 09Jun2021 10:30 (Lot Number: EW0191; Expiration Date: 30Sep2021) as single dose (at the age of 59 years old) for COVID-19 immunisation. Medical history none. There were no concomitant medications. The patient experienced that two weeks after her first dose she started feeling pain in her leg on left side, excruciating pain in Jun2021 with outcome of recovered. The event required a visit to the emergency room and a visit to the physician's office. No treatment was required. She went to the ER and they did a sonogram but did not see a DVT. That's why it took so long to get the second dose since she was concerned. Her leg pain went away. Then she decided to get the second dose and all hell broke loose. The patient underwent lab tests and procedures which included on unknown date electroencephalogram: normal (it looks like it was normal), electromyogram: normal (it looks like it was normal, ultrasound scan: did not see a DVT. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101168866 Same patient/Vaccine, different event, different vaccine dose

Other Meds:

Current Illness:

ID: 1721913
Sex: F
Age:
State:

Vax Date: 03/09/2021
Onset Date:
Rec V Date: 09/22/2021
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: Rheumatoid arthritis flare up; Pain in arm; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. 21K-163-4065072-00) from a non-contactable female consumer (patient) reported for herself. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 09Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 66 years old) for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at Citrate Free for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose intramuscular of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE on 12Feb2021 for COVID-19 immunisation On an unspecified date in 2021, the patient experienced rheumatoid arthritis flare up (medically significant), pain in arm. The outcome of the events was unknown. The action taken in response to the events for adalimumab was not applicable. The reporter's causality for the event(s) of rheumatoid arthritis flare up with Humira (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of sore arm with Humira (ADALIMUMAB) was no reasonable possibility. The reporter's assessment of the causal relationship of the events with the 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. No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events Rheumatoid arthritis and Pain in extremity are assessed as possibly related to the suspect drug BNT162B2 based on causal association but consider also possible contributory effects from patient's medical history and/or concomitant medications.The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1721914
Sex: M
Age:
State: NJ

Vax Date: 07/23/2021
Onset Date: 07/01/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: WBC; Result Unstructured Data: Test Result:High; Test Date: 202107; Test Name: CAT Scan; Result Unstructured Data: Test Result:Negative; Test Date: 202107; Test Name: all the tests; Result Unstructured Data: Test Result:Found nothing; Test Date: 202107; Test Name: Utra sounds; Test Result: Negative ; Test Date: 202107; Test Name: Weight; Result Unstructured Data: Test Result:Decreased; Comments: 10 to 15 pounds

Allergies:

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

Symptoms: Brain fog; Tiredness; felt like whiplash coming from the back of the intestine to the front, felt like a rubber band snapped; felt like whiplash coming from the back of the intestine to the front, felt like a rubber band snapped; Unable to eat; It was a nerve/it is the nerves around the intestine; He lost 10 to 15 pounds; not bloating, it felt like he was going to explode a couple of times. The pressure was so bad he couldn't digest it; Lymph nodes were elevated; White blood cell count was elevated; Unable to sleep; Couldn't go to the bathroom; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 23Jul2021 at approximately 17:30, at the age of 41 years old, as 2nd single dose at 0.3 ml, for COVID-19 immunisation. There was no relevant medical history nor concomitant drugs to report. There were no vaccinations within 4 weeks of the BNT162b2 vaccination. The patient had received the 1st single dose at 0.3 ml of BNT162b2 on 02Jul2021 (lot number: EW098, NDC number 59267-1000-01) in the left arm. On the third day, after the first dose of BNT162b2 on 02Jul2021, he felt like whiplash coming from the back of the intestine to the front. It felt like a rubber band snapped. After that, he was unable to eat or go to the bathroom, or sleep. His intestines are not functioning 100 percent. He went to urgent care several times and they did a CAT scan and found that his lymph nodes were elevated. His white blood cell count was elevated, which was attributed to the vaccine. He kept going. The first gastro doctor said it was probably the virus and it kept happening. He also had cramping, bloating, and constipation. Then, when he took the second dose of BNT162b2, he felt better, like 60 or 65 percent. At first, he didn't feel anything, was normal, just had the typical tiredness and the brain fog, was knocked out all weekend starting from 24Jul2021. However, it started acting up again within the third or fourth day. He started feeling his intestine doing the same thing and he couldn't even sleep. The second gastro doctor confirmed it and gave him something to try and alleviate it. It was dicyclomine, for IBS, trying to alleviate the intestine from what felt like not bloating, it felt like he was going to explode a couple of times. The pressure was so bad he couldn't digest it and used it the first time but it made it worse. It was like putting your hand, putting pressure with the fingers on the other hand, it felt like that on the intestine and it migrates. It felt like he couldn't go to the bathroom and it weakened his intestines, held off a couple of days and was able to sleep. Doctor told him to try and use it once a day and see how it is. He is not taking it. Also ran all the tests that patients with similar symptoms had and found nothing. Said that it was a nerve. He hasn't been feeling better and has been a whole month. He had the incidents with the vaccine and he just had a liquid diet and fruits, like berries and drinking a lot of tea and prune juice. Apple cider did help him go to the bathroom the first week. Then, he couldn't go to the bathroom and still has not been able to get regular. He is freaking out and is hoping it is not cancer. He did not have these symptoms before, was not on any medications. The first time felt like this, felt like his body had not been able to adjust, he is at 60 to 70%. Some days, he is at 70 percent and a couple of days have been 60 or 65 depending on how the pressure is. Sometimes he feels it in his intestines and will go on throughout the night. He has been to the doctor's a couple of times and to urgent care every week. It felt like in emergency care. They did a CAT scan and ultra sounds to make sure he didn't have any blood clots in his organs. Those came out negative. The doctor believes it is the nerves around the intestine. He felt like in that month that he was going to die. He has never felt like that before. He is not really eating. Every time he would eat he would have to go to the bathroom. Something triggers it and starts the tugging again. He feels it in the back, probably the colon. It felt like tugging the first 2 weeks, was terrible, like it was actually pulling the intestine side to side. Regarding the patient's weight, at the time of the reporting, he had lost 10 to 15 pounds. He was 210 or 211 right at the time of the reporting. The patient also confirmed white blood cells being elevated also after the second dose of BNT162b2. The patient had not recovered from the reported events. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1721915
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: covid_test; Test Result: Positive

Allergies:

Symptom List: Tremor

Symptoms: Patient tested positive for COVID-19; Patient tested positive for COVID-19; This is a spontaneous report from a contactable Pfizer employee. A female patient of an unspecified age received bnt162b2 (BNT162B2) dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient was tested positive for covid-19 (medically significant) in Aug2021 with outcome of recovered in 2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Aug2021. Prior to vaccination, the patient was not diagnosed with COVID-19 Since the vaccination the patient has been tested for COVID-19? Information about Lot number has been requested.

Other Meds:

Current Illness:

ID: 1721916
Sex: F
Age:
State: WI

Vax Date: 08/20/2021
Onset Date: 08/01/2021
Rec V Date: 09/22/2021
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: Test Name: blood work; Result Unstructured Data: Test Result:she does not have Parkinson's; Comments: They did about 95 different kinds of blood work on her and DNA genetic testing at the hospital. Results stated she does not have Parkinson's; Test Name: DNA genetic testing; Result Unstructured Data: Test Result:she does not have Parkinson's; Comments: They did about 95 different kinds of blood work on her and DNA genetic testing at the hospital. Results stated she does not have Parkinson's; Test Date: 202108; Test Name: MRI; Result Unstructured Data: Test Result:Unknown result; Test Date: 202108; Test Name: Brain scan; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: diagnosed with transverse myelitis; paralysis/my legs became paralyzed/still partially paralyzed; had deep inflammation of the neck/developed inflammation of my cervical spine that was completely due to the COVID Vaccine; She can't use her right hand/she couldn't feel her right hand; still has pain in her left foot; It's numb/left hand numbness/numbness of the feet/numbness in right toes; tingling feeling; is just overall frustrated; The paralyses reached to my Bladder, where I could not hold my own urine/lost bladder control; couldn't walk anymore; This is a spontaneous report received from a contactable consumer (Patient). A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: FD8448) via an unspecified route of administration administered at left arm on 20Aug2021 13:00 (at the age of 54-year-old) as dose 1, single for COVID-19 immunisation. Medical history included occasional asthma. Patient received someone unspecified inhaler for occasional asthma as concomitant medication. It was reported that Caller has taken the Pfizer-BioNTech COVID-19 Vaccine and she is experiencing paralysis. She wants to talk to someone. She got disconnected before could transfer her. Caller reports she had the Pfizer Covid, first shot, on 20Aug2021 and ended up in the hospital for 6 days and she underwent a MRI and spinal tap and it was ruled out for any other possible reason/condition medically for her to have had deep inflammation of the neck, onset of paralysis. Attempt made to slow caller to clarify details. States just put that she was diagnosed with transverse myelitis and was hospital for 6 days and was discharged on 03Sep2021 and was sent home with a walker and crutches. She can't use her right hand and that is her bread and butter, she has been working from home and still has pain in her left foot and can't put weight on it without feeling any pain. It's numb, it's a nerve condition and hard to explain. Thinks they reported it to the CDC. Was put in for a MRI, a painful MRI and endured and had to go through a 2 hour brain scan, cervical (neck) scan, and thoracic area scan. Was put through a spinal tap. Before the Covid shot she was a 100% healthy 54-year-old. She would like some compensation, someone to help pay for her debt and time taken off work. She works for the government who forced her to do this, and it was encouraged that all government employees get it and it was against all her instincts and she did this and her employer will not pay for her sick time or medical debt. Is a good citizen. Has not left the house in 16 months. Patient did not receive any other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. No flu shot in 31 years and has never been sick for 31 years or hospitalized in 31 years ans she was super healthy. Only carries an inhaler for occasional asthma and has not ever been hospitalized for asthma. Later says except with the flu shot 31 years ago. Does not know if she was really hospitalized and does not remember it well, but she had an asthma attack. Does not know if it was a result of flu shot, she probably never even had a flu shot. Again, stated that she was not sure. She further stated that she waited probably too long to go to the hospital. It was about a day and a half after the vaccine started having problems. Probably the 20th and it progressed slowly. She was communicated this with her doctor on Thursday, 26 August about the left-hand numbness and tingling feeling and numbness of the feet. It was progressing up the legs and by that Friday by 3pm she called the nurse and told her that she couldn't feel her right hand. Finally, she went at 2pm to the hospital on the 29th, Sunday. By then she had lost bladder control and couldn't walk anymore, and they had to do a spinal tap to rule out bacterial infection, which came back negative for bacterial infection. Then she was treated and started on a 5 day, 1 hour IV drip of Methylprednisolone steroid, a heavy duty steroid, enough for a horse and was 50% better and can feel her right legs. Still has 10% of the tingling and numbness in right toes. Right hand, index finger and thumb still are numb and tingling. Left hand is perfect especially with the numbness and tingling. Her whole left leg from the thigh to toes and foot has probably about 30% improved. There was nothing more than they could do for her so they discharged her home with a walker. She further mentioned that They did about 95 different kinds of blood work on her and DNA genetic testing at the hospital. Results stated she does not have Parkinson's, MS and does not even carry cancer cells. Does not have Lupus and was in perfect health before with no diabetes, in perfect health. Has been taking care of herself for years and exercises and she does not smoke. Is just overall frustrated. Again, mentions she needs some help with financially and hopes to get it from Pfizer. Has missed work for 2 weeks and the government was not going to pay for her sick time and they don't care. They just cared about uploading her Covid shot. Her doctors even have written letters to her employer not to force her to get the second shot because of what happened with the first one and it's now on her allergies list. Knows Pfizer may care what happens and she has not called anybody else. Called Pfizer since she took Pfizer shot. Patient did not visit the emergency room and physician office for the events. The seriousness criteria as hospitalization. Outcome of events: diagnosed with transverse myelitis, paralysis/my legs became paralyzed/still partially paralyzed, is just overall frustrated, It's numb/left hand numbness/numbness of the feet/numbness in right toes, still has pain in her left foot, She can't use her right hand/she couldn't feel her right hand not recovered while remaining all events was unknown.

Other Meds:

Current Illness:

ID: 1721917
Sex: M
Age:
State: SC

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: 2021; Test Name: Nuclear stress test; Test Result: 30 %; Comments: down from 65%

Allergies:

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

Symptoms: congestive heart failure; 48 hours migraine; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose number unknown via an unspecified route of administration on an unspecified date (at an unspecified age of vaccination) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced congestive heart failure (medically significant) in 2021 with outcome of unknown, 48 hours migraine (medically significant) in 2021 with outcome of unknown. The patient underwent lab tests and procedures which included; cardiac stress test: 30% on 2021 down from 65%. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1721918
Sex: M
Age:
State:

Vax Date: 01/04/2021
Onset Date: 11/01/2020
Rec V Date: 09/22/2021
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: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Cogwheel rigidity; Micrographia; Limbs stiffness/ Stiff fingers; Hand pain; Joint pain; Parkinson's disease; Osteoporosis; Nausea; Back pain; Weakness; Hand swelling; Ruptured intervertebral disc; This is a solicited report from a contactable consumer (patient) collected based on the information received by Pfizer from AbbVie Inc. (MFR Control No. 21K-163-3913509-00). This 86-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown) via intramuscular on 04Jan2021 (at the age of 87-year-old) at single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown) via intramuscular on 21Feb2021 (at the age of 87-year-old) at single dose, for COVID-19 immunisation. Co-suspect drug included upadacitinib (RINVOQ) taken orally from an unknown date for moderate to severe rheumatoid arthritis. Relevant medical history included lumbar spine compression fracture ongoing from Nov2020, moderate to severe rheumatoid arthritis and eczema. No relevant concomitant medications were provided. On unknown date, the patient experienced Parkinson's s disease, cogwheel rigidity (described as cog wheeling in left wrist), micrographia, limbs stiffness/ stiff fingers, hands pain, joint pain, osteoporosis (described as bone density issue), and nausea. On unknown date in 2021, the patient had hand swelling and in Jun2021 he had weakness. The clinical course was described as follows: In Nov2020, the patient experienced broken back/lumbar 4 fractures in spine. The patient broke his back, most recent fracture (Lumbar 4) in Nov or Dec 2020 and had surgery on it, and the only one he had since being on RINVOQ. He had been experienced back pain and said it could be related to age or the fact he had several fractures in his spine. He also had osteoporosis. He had been experiencing puffiness in his hands and back pain since past six weeks in 2021 and had been taking medication to improve his bone density, also his joint hurt and his fingers were stiff, especially in the mornings. In Mar 2021, he had back surgery to repair a ruptured disc. He was experiencing weakness in his legs. He saw a neurologist this morning who thought the weakness might be due to Parkinson's disease. Later he was diagnosed with Parkinson's disease. The neurologist also found cog wheeling in his left wrist and micrographia. He had nausea, which he believed was being caused by the medication he had been given for Parkinson. He reported three weeks ago in Jun2021 he felt a weakness he thought was connected with the fracture in his back. Physician did not think the COVID vaccinations had been as effective because he was taking RINVOQ. Unknown Parkinson's medication was considered as co suspect. Patient stated he doesn't think the COVID vaccinations have been as effective because patient was taking RINVOQ. The reporter s causality for the events of broken back/lumbar 4 fractures in spine, ruptured disc, Parkinson's disease, cog wheeling in left wrist, micrographia, hands stiff, hands hurt, joint pain, weakness, puffiness in hands, stifness of finger, bone density issue/osteoporosis and nausea was not provided. The Reporter's causality for the events of does not think the COVID vaccinations have been as effective because patient was taking RINVOQ with upadacitinib (RINVOQ) was a reasonable possibility. Abbvie's opinion is that there is no reasonable possibility that the events of broken back/lumbar 4 fractures in spine, ruptured disc, Parkinson's disease, cog wheeling in left wrist, micrographia, hands stiff, hands hurt, joint pain, weakness, puffiness in hands, stifness of finger, bone density issue/ osteoporosis and nausea are related to RINVOQ (upadacitinib). Abbvie s opinion is that the event of does not think the COVID vaccinations have been as effective because patient was taking RINVOQ is not assessable. change history On 16Jun2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. the events of "micrographia", "broken back", "hands stiff", "hands hurt" and "nausea" were added. the event of "neurologist thought weakness in legs might be due to parkinson's disease" was amended to "Parkinson s disease". On 14Jul2021, received updates to patient demographics, event information, reporter opinion of causality, company opinion of causality, company alternative etiology and narrative description. The events of "back pain", "joint pain", "weakness", "puffiness in hands", "stifness of finger" and "bone density issue" were added. The event of "broken back" is now considered serious. On 31Aug2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of "does not think the COVID vaccinations have been as effective because patient was taking rinvoq" was added. the event of "broken back" was amended to "broken back/lumbar 4 fractures in spine". The outcome of the events 'back pain' and 'hand swelling' was unknown. The outcome 'ruptured intervertebral disc', and 'weakness' was recovering. The outcome of the remaining events was not recovered. The reporter considered there was no reasonably possibility that the events were related to upadacitinib (RINVOQ). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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 the information in the case report and a plausible temporal relationship, the causal relationship between the event Parkinson's disease, Ruptured intervertebral disc, Cogwheel rigidity, Micrographia, Stiffness, Hand pain, Joint pain, Weakness, Hand swelling, Osteoporosis, Nausea, Back pain and suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness: Lumbar spine compression fracture

ID: 1721919
Sex: F
Age:
State:

Vax Date: 07/28/2021
Onset Date:
Rec V Date: 09/22/2021
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: 2021; Test Name: Covid-19; Result Unstructured Data: Test Result:Positive

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: She then contracted COVID 19 virus; She then contracted COVID 19 virus; feeling tired; arm pain; nausea; stomach ache; not being able to sleep at night anymore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in arm on 28Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter's daughter was concerned about getting the vaccine because she had heard that it could cause problems with fertility. Caller stated that she was scheduled to have injections in her knees that would be a series and the medication started with a VO. She would like to know if she could still have these injections done after having the second dose of the vaccine. Relayed to caller that there was no information on drug interaction with the vaccine at this time. Referred to let HCP know of recent health events and vaccination prior to the shots being given to discuss possible interactions. She had side effects with the first dose of the Pfizer COVID 19 vaccine of felt tired, arm pain, nausea, stomach ache, and she reported not being able to sleep at night anymore but she was unsure if that was due to the vaccine or the COVID virus. She would like to know if the second dose of the vaccine would cause her to have worse side effects or not. Caller stated that she was being transferred when she was disconnected. She relayed that she had spoke with multiple departments and she was unsure of what departments she spoke to. After 1 dose of vaccine, she contracted COVID 19 virus and received an antibody infusion to decrease her illness. After the vaccine, she was tested positive Covid 19 virus. She would like to know if this was true and if you had to wait to get the vaccine second dose for this case. Relayed to caller that there was no information at this time on the amount of time she should wait to receive the second dose after receiving the said infusion to decrease Covid 19 symptoms. She relayed that she was told that she needed to wait 90 days before getting her second dose of the vaccine. Referred to speak with site where she received the infusion and an HCP to discuss further. Someone told her to get the vaccine second dose (information withheld). She stated that her doctor pasted away and so she did not have a doctor at that time. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on an unspecified date in 2021. The outcome of all 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: 1721920
Sex: F
Age:
State: NY

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/22/2021
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: Metallic taste in mouth; Hives all over; Flare in inflammation or pudendal nerve; Spike in hormone level; Vaginal inflammation; Vaginal infection; Change in vision; This is a spontaneous report received from a contactable other healthcare professional (patient). A 49-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 23Aug2021 as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 23Aug2021 10:00 (both doses at the age of 49-years-old) as dose 2, single for COVID-19 immunisation. Medical history included pudendal neuralgia, lichen sclerosis, pelvic congestion, covid-19 from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The most recent COVID-19 vaccine facility was administered in workplace clinic. The patient experienced metallic taste in mouth, hives all over, flare in inflammation or pudendal nerve, spike in hormone level, vaginal inflammation, vaginal infection, change in vision on 23Aug2021 10:00. Treatment was received for the events (prescription for infection). Patient visited Doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1721921
Sex: M
Age:
State: OR

Vax Date: 08/13/2021
Onset Date: 08/14/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:101 and 102; Comments: temperature between 101 and 102 but most of time 101; Test Date: 20210818; Test Name: Covid; Test Result: Negative

Allergies:

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

Symptoms: Double vision; Stated that when he woke up he coughed up miscellaneous stuff for two hours out of lungs.; stated that bowel movement was epic and watery; vision blurry; Mouth full of saliva when wake in morning and kept filling in during the day; Stated that his urination was weak and he was drinking water mixed with gatorade during the day; Chills; Could not eat all all and did not want to eat; stated that he did not have bowel movement for over a week; pressure was there but could not go; had temperature between 101 and 102 but most of time 101; had terrible stomach pain; bloated; had a headache like someone tightened a band around his head; stated that he got really weak; was still tired and weak; slept 13-14 hours a day; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Aug2021 (at the age of 67 years), (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that he wanted to report a side effect from Pfizer that happened 30 hours after his first shot at (pharmacy name). Stated that on 14Aug2021 he had terrible stomach pain, was bloated, had a headache like someone tightened a band around his head, got really weak and could not get off the couch or go get the mail like he would go down and he went back in again, slept 13-14 hours a day and was still tired and weak. Stated that he had symptoms of something he never had before. Stated that when he got weak his vision was blurry (on 16Aug2021), had double vision (on an unspecified date), had a temperature between 101 and 102 but most of time 101 on 14Aug2021. Stated that he could not eat at all and did not want to eat. Stated that his mouth was full of saliva when he woke in the morning and kept filling in during the day on 15Aug2021. Stated that when he woke up, he coughed up miscellaneous stuff for two hours out of lungs on an unspecified date. Stated that this lasted for two weeks and day. Stated that last Sunday he started feeling better. Stated that on Monday (14Aug2021) that he had a bowel movement, and it was epic and watery. Stated that it has taken since Monday (14Aug2021) to get to about 100% and that he was at 80%. was 67 years old. Stated that he got sick on Saturday and had got the shot on Friday 13th. Stated that a neighbour drove him to the health department because he thought that he had Covid, but the test was negative for Covid. 18Aug2021. Pfizer Covid vaccine. Stated that his urination was weak on 15Aug2021, and he was drinking water mixed with Gatorade during the day. Stated that this happened after the first shot. Stated that he is afraid to take the second one after this. Stated that he is normally healthy as a horse. Patient rambling on; unable to clarify information. Stated that he has been sick but has never been sick for two weeks. Stated that he had a bowel movement on 23Aug, and the bloating went away. Stated that woke up at 6 in the morning instead of 9 on Tuesday after having been sleeping 13-14 hours and knew that he was getting better. Stated that his vision being blurry and double vision was intermittent. Stated that he had double vision about three times. Stated that the double vision started on 16Aug or 17Aug. Stated that it happened when got up and tried to use energy. Patient rambling on; unable to clarify information. Stated that he had chills intermittently on 15Aug2021. Regarding the treatment patient stated that he called his doctor's office and for no bowel movement told him to take a laxative and it made him really want to go worst fast and then the laxative wore off. Stated that he took aspirin a couple of times for the fever and headache, but he stopped doing that. Stated that the aspirin did not work. Was told take aspirin for headache and if worsened to go to the hospital. The patient underwent lab tests and procedures which included body temperature: 101 and 102 on an unspecified date (temperature between 101 and 102 but most of time 101), sars-cov-2 test: negative on 18Aug2021. Product complaint of Aspirin included that it did not work, Product strength and count size dispensed: 325mg; 150 counts. Packaging sealed and intact was Yes. The clinical outcome of the event had terrible stomach pain was recovered on 29Aug2021, bloated was recovered on 23Aug2021, had a headache like someone tightened a band around his head was recovered on 27Aug2021, was still tired and weak, had temperature between 101 and 102 but most of time 101, Could not eat all and did not want to eat, Mouth full of saliva when wake in morning and kept filling in during the day, stated that his urination was weak and he was drinking water mixed with Gatorade during the day, stated that bowel movement was epic and watery, slept 13-14 hours a day, was recovered on 31Aug2021, vision blurry was recovered on 26Aug2021, Double vision, Chills was recovered on 25Aug2021, stated that he did not have bowel movement for over a week; pressure was there but could not go was recovered on 28Aug2021, stated that he got really weak was recovering and Stated that when he woke up he coughed up miscellaneous stuff for two hours out of lungs was unknown at the time of report. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1721922
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:High; Test Name: Oxygen; Result Unstructured Data: Test Result:Very low

Allergies:

Symptom List: Pain in extremity

Symptoms: her heart rate was sky high; had an allergic reaction which was probably from the lidocaine in it and was intubated; coughing; oxygen was very low; wheezing; having a hard time breathing; This is a spontaneous report from a contactable consumer. A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 23-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter reported that the patient received the second dose and within 2 hours had an allergic reaction which was probably from the lidocaine in it and was intubated. Reporter also added that patient was the one who rushed her to code and that the nurse was a 23-year-old co-worker who ended up with tubes in her throat. Reporter said the patient ended up coughing and all of a sudden, her heart rate was sky high, oxygen was very low, and she was wheezing and having a hard time breathing. The case assessed as serious (medically significant). The patient underwent lab tests and procedures which included heart rate: high and oxygen saturation: very low on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1721923
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: So many lab tests; Result Unstructured Data: Test Result:unknown results; Comments: so many lab test she can't keep tracking them all

Allergies:

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

Symptoms: wanted to kill herself it was that bad. She can hurt herself; She had a negative side effect with the first one it got worse with that second one; she was in pain, she was in constant pain since the shot it had been all over her body, she was in pain twenty four seven, three hundred, every day all day all night; did not sleep well at night; knees were in fire the legs were in fire; knees were in fire the legs were in fire; started with her toe, she had all sort of conditions, it was continuous since she had the shot; This is a spontaneous report from a contactable consumer (parent, patient's mother). A 22-year-old female patient (reporter's daughter) received bnt162b2 (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, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, both at the age of 21-year-old for COVID-19 immunization; alprazolam (XANAX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The lot number of bnt162b2 was unknown, the card was going to be, a picture was taken by patient's mother and it was going to be sent to her and she did not have it right now, the vaccination card was going to be emailed to her little later today when her mother got back. Medical history was not reported. There were concomitant medications which included psychotropics. The reporter was trying to report a very negative side effects of the Pfizer vaccine (Covid-19 Vaccine), spoke with her daughter she took it she did not have the exact date but it sometime probably the late spring, she had a negative side effect with the first one it got worse with that second one and she wanted to kill herself it was that bad. She can hurt herself. It started with her toe, she had all sort of conditions, it was continuous since she had the shot the reporter did not know what the names about the symptoms, the doctors did not even know they did not understand anything they did not realize the pain she was in, they are taking test after test, they spending money after money, no body knew. Other medications: they had tried alprazolam, they had tried psychotropics, they had tried, she was in pain, she did not sleep at night she was in constant pain since the shot it had been all over her body the knees were in fire the legs were in fire, all pain of things are appearing over her body its been since the shot. Lab test: so many lab test the reporter can't keep tracking them all, on every test they can get she was in doctor for 3 to 5 times a week since the spring she did not sleep well at night, she wanted to kill herself that was the reaction to COVID, she was never like this. Still experiencing the problem, she was in pain twenty four seven, three hundred, every day all day all night. The condition was worsened. She was getting worsened. Treatment: they had tried drugs, they had tried tests and tests and more test and doctor did not have any idea, they did not realize and doctors did not have any idea what they were doing, they all think it was something else it was not, it was the Covid shot that was when it all started. The reporter did not know why was she recording this she was just hoping may be she could find a data base because if they found one other person who had exact same symptoms that she did who wanted to kill herself and she was going to detox right now, she was getting better but the regular medical community, had no clue they were chasing they were playing the game. The action taken in response to the events for alprazolam was unknown. Treatment received for the events. Events also resulted in physician office visit. The outcome of events was unknown. The lot number for bnt162b2, was not provided and will be requested during follow up.

Other Meds: Xanax

Current Illness:

ID: 1721924
Sex: F
Age:
State:

Vax Date: 09/11/2021
Onset Date: 09/01/2021
Rec V Date: 09/22/2021
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 Name: heart is racing; Result Unstructured Data: Test Result:Unkown; Comments: heart is racing

Allergies:

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

Symptoms: She feels her heart is racing; This is a spontaneous report from a contactable consumer (Parent). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 11Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. On Sep2021, the patient experienced she feels her heart is racing. Reporter stated that her daughter received her 2nd shot yesterday for Covid 19 Vaccine and she saying that she feels her heart is racing today now, she guess her question is on the myocarditis stop when it does take the place, does the heart actually race or is just the way you feel it racing. When paraphrased the concern, Reporter stated, Correct and informed about role of Pfizer Drug Safety and Pfizer Medical Information and provided with the number as # and requested to dial and informed about timings as 8 AM to 8 PM from Monday to Friday as per EST. Reporter added, Where can she get the information as of today on Sunday instead of Monday because her daughter feels her heart is racing and she need medical information on that. Reporter was informed to contact physician and informed about call back requested when the Pfizer medical information department is open. However, Reporter deny for call back and stated, "No thats wont be necessary, she just call the doctor (Hence call back request was not made), thats should be all she need as far as thing she get. When requested for further probing, Reporter stated, she don't have time, she need to call a doctor, she need to call doctor because her daughter is serious, so she don't have time for question now. No further information could be probed as the reporter hung up the call abruptly. Hence, limited information available over the call. The patient underwent lab tests and procedures which included heart rate variability test: unknown on heart is racing. The outcome for the event she feels her heart is racing was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1721925
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Instead of diluting the Pfizer Covid-19 vaccine with 1.8ml of Sodium Chloride, it was diluted with 0.8ml by a technician and it was given to a patient; Instead of diluting the Pfizer Covid-19 vaccine with 1.8ml of Sodium Chloride, it was diluted with 0.8ml by a technician and it was given to a patient; Chills really bad; real shaky; This is a spontaneous report from a Pfizer-sponsored program. A contactable Pharmacist reported for a 15-year-old patient that, A 15-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: FC3182), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Patient did not have any medical conditions. The patient experienced, instead of diluting the Pfizer COVID-19 vaccine with 1.8ml of Sodium Chloride, it was diluted with 0.8ml by a technician and it was given to a patient Chills really bad; real shaky. She was asking also what the effects because of this. The outcome of the events were unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1721926
Sex: M
Age:
State:

Vax Date: 08/01/2021
Onset Date: 09/12/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Date: 20210912; Test Name: Heart rate; Result Unstructured Data: Test Result:45; Test Date: 20210912; Test Name: vital signs; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptom List: Vomiting

Symptoms: has bradycardia; sprained his ankle; his heart rate was 45/had a slow heart rate/he has never had a slow heart rate like that; This is a spontaneous report from a contactable consumer or other non-healthcare professional (parent). A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced has bradycardia. On an 12Sep2021, the patient sprained his ankle and his heart rate was 45/had a slow heart rate/he has never had a slow heart rate like that. The reporter stated, the 14 years old son received the Pfizer vaccine the first dose about three weeks ago and he received the first dose in a Vaccine three weeks ago, he was healthy with no medical history and today he sprained his ankle, so we had to take him to the ER and they took his vital signs and his heart rate was 45 and he is never had a heart condition or abnormal heart rate. So he was due to get the second dose of the vaccine. The reporter enquired if that was the side effect bradycardia or heart arrhythmia. The reporter asked if this was a side effects heard before. The reporter stated, the reporter don't know if it was a side effect of the Pfizer vaccine but he has never had a slow heart rate like that. So the reporter was supposed to take him for the second dose actually today and was not doing that. The reporter asked for opinion and recommendation as what should be the next step. The report was not related to a study or programme. On 12Sep2021, the patient underwent lab tests and procedures which included heart rate: 45 and vital signs: unknown result. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1721927
Sex: U
Age:
State:

Vax Date: 09/09/2021
Onset Date:
Rec V Date: 09/22/2021
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: I feel like I throw a roller coaster ride my body was moving I was sitting still I was trying to hang on to keep them falling; Felt faints; I almost passed up in that quiet; First shot really wipe me out; I break at cold sweat which it doesn't say cold sweat in here; It feels and my whole back was wet and then about 2 hours later I get up and I threw up all; I get up and I threw up all over the place; I felt like to be in the deformities; This is a spontaneous report from a Contactable Consumer. This 58-year-old consumer (Patient) received bnt162b2 ( BNT162B2,Formulation : Solution for injection, Batch/lot number: Not reported) dose 1, via an unspecified route of administration on 09Sep2021 as a single dose for (at the age of 58 year) Covid-19 immunization. Medical history include high blood pressure around February stayed around 124-128 from then on. Concomitant medication include BUSPIRONE HYDROCHLORIDE (BUSPAR), Magnesium (further clarification unknown hence not captured in tab) use for anxiety, Vitamin D NOS, doxazosin (not clarified hence not captured) for her prostrate to squeeze the prostrate when she pee. She already had her first shot and it really wipe her out. She just got the shot on Thursday about 2 or 3 o'clock and then she got home and was okay until there. The time when she had dinner and was sitting there just conversing with her roommate and all of a sudden it came on. She felt like throw a roller coaster ride. Her body was moving she was sitting still she was trying to hang on to keep them falling and then she felt faints and almost passed up in that quiet. Her roommate had help her to the room to lay down and then she break at cold sweat which it doesn't say cold sweat in here it feels and her whole back was wet. About 2 hours later she got up and threw up all over the place. She felt like to be in the deformities but they didn't mention any roller coaster ride I have been on because it came she was just sitting and talking. All of a sudden a boom it just came on her and she felt better today. It was a roller coaster ride I was on. No recent lab test performed. The outcome of the events was unknown. Reason for no lot number of Covid 19 vaccine: Other: Consumer stated, "30-30BA." (Consumer was not sure) The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: BUSPAR; VITAMIN D NOS

Current Illness: Blood pressure high (Verbatim: High blood pressure)

ID: 1721928
Sex: M
Age:
State: MA

Vax Date: 04/06/2021
Onset Date: 09/01/2021
Rec V Date: 09/22/2021
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: 20210913; Test Name: Rapid Test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: Mild case of COVID Sept 2021 - cough, congestion - up to 72 hours; Mild case of COVID Sept 2021 - cough, congestion - up to 72 hours; Mild case of COVID Sept 2021 - cough, congestion - up to 72 hours; This is a spontaneous report from 2 contactable consumers or other non-healthcare professionals. A 25-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), intramuscular, administered in arm right on 06Apr2021 12:30 (at the age of 25-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was none. Historical vaccine included bnt162b2 dose 1 intramuscular, administered in arm right on 26Mar2021 12:30 (Batch/Lot Number: EP6955) for covid -19 immunization. There were no concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 01Sep2021, the patient experienced mild case of covid sept 2021 - cough, congestion - up to 72 hours. Since the vaccination, the patient has been tested for COVID-19. On 13Sep2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative with nasal swab. On an unspecified date in Sep2021. The outcome of the events was recovered on an unspecified date in Sep2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1721929
Sex: F
Age:
State:

Vax Date: 09/13/2021
Onset Date: 09/13/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Heart failure; Weak; She wasn't sure if she was running a fever but feels really hot right now; She also mentioned she had started walking but she felt like she couldn't breathe. She had difficulty breathing while walking; felt weird; Headache; Extremely tired; received booster or third dose of product; a little ill; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received third dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number/ NDC number/ expiration date was not reported) via an unspecified route of administration on 13Sep2021 15:00 as dose 3, single for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient previously took first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiration date: not reported), via an unspecified route of administration on as dose 1, single and dose 2, single both for COVID-19 immunisation. On an unspecified date, the patient experienced heart failure. On 13Sep2021 15:00, the patient received booster or third dose of product. On the same day at 17:00, patient felt weird, headache, extremely tired and at 17:30, patient felt weak, she wasn't sure if she was running a fever but feels really hot right now. On 13Sep2021, she also mentioned she had started walking but she felt like she couldn't breathe. she had difficulty breathing while walking and little il. Additional information included that the caller is calling regarding the Pfizer COVID-19 vaccine. She received her booster or her third dose yesterday and by the time she got home she felt weird and a little ill around 5:00PM. She also stated that she experienced a headache, weakness, and she felt extremely tired. She also mentioned that she is still not feeling that great right now. She stated that she did good with the 2 previous doses of the Pfizer COVID-19 vaccine and only experienced side effects with the third dose. She also stated that she wasn't sure if she was running a fever but feels really hot right now. She also mentioned she had started walking but she felt like she couldn't breathe. She had difficulty breathing while walking. She also brought up her medical condition that she had, she has heart failure and she is taking medication for that. The agent did not get name of that medication. It is not specified if the caller had the heart failure prior to receiving the Pfizer COVID-19 vaccines. Outcome of the events was unknown. The lot number for [BNT162B2] was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1721931
Sex: U
Age:
State: NY

Vax Date: 04/12/2021
Onset Date: 04/15/2021
Rec V Date: 09/22/2021
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: 20210419; Test Name: biopsy; Test Result: Positive ; Comments: shingles

Allergies:

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

Symptoms: shingles; This is a spontaneous report from a contactable Consumer. A 59-years-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER8729, expiry date: unknown) via unspecified route of administration, in left arm on 12Apr2021 09:00 (age at vaccination: 59), as dose 1, single for covid-19 immunisation. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0172, expiry date: unknown) via unspecified route of administration, in left arm on 05May2021 09:00 (age at vaccination: 59), as dose 2, single for covid-19 immunisation. Vaccination facility type was school/student health clinic. No prior vaccinations (within 4 weeks) taken within four weeks prior to the first administration date of the suspect vaccine. Medical history included high blood pressure from an unspecified date and unknown if ongoing. Concomitant medication included ongoing Valsartan (pill), start date unknown, taken for high blood pressure. On 15Apr2021, patient experienced herpes zoster. Emergency room visit took place due to the adverse event. Treatment regimen was provided as a result of the adverse event. Patient underwent lab test which included biopsy test on 19Apr2021 with positive result (shingles). The outcome of event was recovered on an unspecified date in 2021. Follow-up attempts are completed. No further information is expected.

Other Meds: VALSARTAN

Current Illness:

ID: 1721932
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Bell's Palsy; This is a spontaneous report from a contactable consumer. A 7-decade-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch / Lot number and expiration date was not reported) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that one person had Bell's Palsy (medically significant) after the receiving the first vaccine and they did not get the second dose. Outcome of the event was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am