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: 1647212
Sex: M
Age:
State: HI

Vax Date: 04/28/2021
Onset Date: 07/25/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Blood Sugar; Result Unstructured Data: Test Result:173; Test Name: Blood Sugar; Result Unstructured Data: Test Result:400; Test Name: Blood pressure; Result Unstructured Data: Test Result:200 Over; Comments: 200 Over or something; Test Name: Blood pressure; Result Unstructured Data: Test Result:189 over something

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: His blood pressure was 200 over something/ his blood pressure was too high/ hypertension; anxiety; facial swelling/ facial swelling mouth and eye stuck open; swollen lips; swollen lips, mouth; couldn't sleep; Bell's Palsy; excursionizing headache; tingling in his head; This is a spontaneous report from a contactable consumer (patient) via the non-clinical study Pfizer program. A 62 year old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 on 28Apr2021 09:30 (Batch/Lot Number: ER8734; Expiration Date: Jul2021), via an unspecified route of administration (at the age of 61 years old) for COVID-19 immunization. Medical history included diabetic for 11 years. Stopped drinking to prepare for a Hep C eradication three years ago. He doesn't like to take anything that will hurt his liver. States 325mg of acetaminophen for each tablet is too much. Concomitant medication(s) included lisinopril (LISINOPRIL), 20mg once daily by mouth taken to protect the kidneys; insulin aspart (NOVOLOG), 20 units at breakfast and lunch daily by injection for diabetes mellitus; insulin glargine (BASAGLAR), 35 unit by injection at night for diabetes mellitus; all with start and stop date reported from an unspecified start date and ongoing. The patient previously received dose 1 of BNT162b2 on 07Apr2021 09:00 (Batch/Lot Number: ER8734; Expiration Date: Jul2021) for COVID-19 immunization. On 25Jul2021 he started expiring tingling in his head which lead into an excruciating headache and when he got up (26Jul2021) he saw he had facial swelling, swollen lips, mouth and eyes were stuck open. On 27Jul2021 he was diagnosed with Bell's Palsy. He further described that for two days he had tingling of the head that changed into a headache. This was over the weekend on the 25Jul2021 and 26Jul2021; he had an excruciating headache. He took ibuprofen PM and thought he might be have facial swelling from the PM part, the diphenhydramine, and he couldn't sleep. He also added that the PM part (diphenhydramine) makes him feel groggy. When he woke up and went to the bathroom he saw that his lip was swollen and face wasn't working right. When he brushed his teeth he couldn't spit right. He didn't get much relief from ibuprofen. He went to three emergency rooms and one clinic. On 27Jul2021 he went to the emergency room and they prescribed prednisone 6 tablets the first day tapering down, and valacyclovir. One doctor prescribed him prescribed anti-anxiety medication that really helped, him but he didn't know what he was going through and he finally actually got some rest. Lorazepam 1mg as needed for anxiety was the antianxiety medication that helped him. Now (as of 13Aug2021), his headache was not as bad as it was when he had to put a compress on his head; but he just ran out of ibuprofen. He also had a prescription for oxycodone with acetaminophen, 14 count and he just finished them too. He was given gabapentin for the nerve pain and that helped a lot. Also states he just finished tapering off of prednisone. He was also prescribed amlodipine because his blood pressure was too high. He was taking one amlodipine by mouth daily for two weeks, then was to be reassessed for his hypertension. He was already prescribed lisinopril to protect his kidneys. He didn't know it was also for hypertension. Then he wanted to get a B12 shot, so he called his healthcare organization and they directed him to a drug store who suggested he go to an urgent care to get a doctor prescribe it. He went to an urgent care; he thinks the prednisone had been driving up his blood sugar; it was 173 that morning. The urgent care took his blood sugar right after eating lunch and it was 400. Then they wanted to send him somewhere else down the street. Adds his blood pressure was 189 over something and they wouldn't treat. He feels that the HMSA, the organization that he gets his healthcare through, is not addressing his pain. Later then, he was unsure of the date, but after that he went to the emergency room in excruciating headache pain, relentless and cracking open. He got there at 1600PM. His blood pressure was 200 over something; they finally gave him morphine at 1700PM; and then DILAUDID that finally relieved the headache pain after two hours. They prescribed amlodipine which was sent to the wrong pharmacy and he finally got it at his Withheld two days later; they also prescribed oxycodone with acetaminophen, but that didn't knock the pain out. The next morning he felt he had so much acetaminophen in him he couldn't take anymore of that medication; he was staggering around his property; and so he called the ambulance because his head was double killing him. They took him to the emergency room; he thinks it was on Tuesday morning; and they gave him DILAUDID again which helped. That is where the doctor prescribed the lorazepam. The patient has an upcoming appointment on Tuesday with a new provider. The outcome of the excruciating headache and couldn't sleep (onset 25Jul2021) was recovering. The outcome of facial swelling mouth and eye stuck open (onset 26Jul2021) was not recovered. The outcome of the tingling of the head (onset 25Jul2021) was recovered in Jul2021. The outcome of the remaining events was unknown.

Other Meds: LISINOPRIL; NOVOLOG; BASAGLAR

Current Illness:

ID: 1647213
Sex: F
Age:
State: SC

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: itching; hives; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included systemic lupus erythematosus (SLE) and the patient reported that he was allergic to penicillin, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12Aug2021 (about 8 hours later after the injection), the patient experienced itching and hives. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL. The patient outcome of the events was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647214
Sex: M
Age:
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: currently having dental issues; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer reported for a male patient (reporter's husband) that a male patient of an unspecified age received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration on 28Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced currently having dental issues on Aug2021. received his 1st dose 28Jul and has been having dental issues may need to start antibiotics. The caller wants to know if there are contraindicatios bewteen the vaccine and antibiotics. Will Fax AE for dental issues after the 1st dose. Relayed PMI and transferred to PMI withheld for more information. Support CEP. The outcome of the event was not resolved.

Other Meds:

Current Illness:

ID: 1647215
Sex: F
Age:
State: WA

Vax Date: 04/10/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: numbness in my leg; pins and needles in my legs from the knees down; had something neurological migraine; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer reported for herself. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 10Apr2021 as dose 2, single for COVID-19 immunisation. Medical history included psoriasis she has a history of psoriasis, stroke from Feb2016 to an unknown date. She was placed on warfarin daily because she has atrial fibrillation. Concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, after the vaccination she developed pins and needles in my legs from the knees down, it got bad for a while. Caller asked because of insurance, if is there a specific type of doctor she should go to. It was reported that I still had the numbness in my leg and had something neurological migraine. I had pins and needles, never had this experience before, I had this second shot. My first shot does not gave me any of that but when I had my second shot I live with this, its not constant but right now it's been going on since 3:30 pm and I still had the numbness in my leg. Just merely strong pins of needles feeling in my leg and I had never called to let anyone know that happened it was right after the shot I had it. Now that's been several months now, and I still get it like I thought it will go away, but it is still, every other day several times a week it comes back to me. So, I dont know I am on blood thinners. Somebody said something about maybe it's a prerequisite to stroke that I already had a stroke in the past that didn't had anything like that. I had something neurological, migraine. I dont know if this is affecting my blood vessels in my legs so I am having this experience all the time and asked what she do to prevent it. I do take Warfarin so because of my stroke and I had AFib but that this is totally different. The clinical outcome of the event numbness in my leg, pins and needles in my legs from the knees down was not resolved and the event had something neurological migraine was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101050574 same reporter/drug/AE with different patient(s).

Other Meds:

Current Illness:

ID: 1647216
Sex: M
Age:
State: CA

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Migraine Headaches, Severe Nerve Pain in the Left Arm at injection site.; Migraine Headaches, Severe Nerve Pain in the Left Arm at injection site.; Migraine Headaches, Severe Nerve Pain in the Left Arm at injection site.; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8734), as dose 1, single and dose 2, single (Lot number: ER8735), both via unspecified routes of administration, in left arm on 07Apr2021 (at the age of 67-years-old), for COVID-19 immunization. Medical history included chronic lower back pain due to osteoarthritis and codeine allergy. Concomitant medications included atorvastatin, clonazepam, tadalafil (CIALIS) and fluticasone propionate (FLUTICASON). No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced migraine headaches, severe nerve pain in the left arm at injection site on 07Apr2021. Both the doses were reported to be given on the same date. The event resulted in doctor/ other healthcare professional office visit and disability or permanent damage. The patient received treatment for the event which included Imitrex and Neurontin. The outcome of all events was not recovered.

Other Meds: ATORVASTATIN; CLONAZEPAM; CIALIS; FLUTICASON

Current Illness:

ID: 1647217
Sex: F
Age:
State: MD

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

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

Lab Data: Test Date: 20210806; Test Name: Blood pressure; Result Unstructured Data: Test Result:190/110; Test Date: 20210809; Test Name: Blood pressure; Result Unstructured Data: Test Result:160/118; Test Date: 20210809; Test Name: heart rate; Result Unstructured Data: Test Result:120

Allergies:

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

Symptoms: heart rate of 120; dehydration regardless; On arrival BP was 190/110 / alarming pressure 160/118; until anaphylaxis symptoms were stable; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 06Aug2021 18:00 (Batch/Lot Number: FA7484) (at the age of 54-year-old) as dose 1, single for COVID-19 immunization. The vaccination facility type was pharmacy/drug store. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history was not reported. Concomitant medications included colecalciferol (D3), menaquinone-7 (K2), iodine, and curcuma longa (TURMERIC); all taken for unspecified indications, start and stop dates were not reported. The patient previously took clindamycin, bupropion (WELLBUTRIN), lidocaine, and epinephrine, and experienced allergies with these drugs. The patient also had a past heart event in 2013 after lidocaine and epinephrine injection during operation. No chronic health conditions treatment at the time of vaccine and no medications prescribed. Within 5 minutes after vaccine was administered (06Aug2021 18:05) began itching over entire body. Approximately 13 -15 minutes after vaccine, the patient had difficulty swallowing and breathing. The patient took antihistamine in the store before being told by pharmacist assistant to immediately go to hospital. On arrival, BP was 190/110 was given steroids and benedryl intravenously (since has previous history of heart event with Epinephrine) until anaphylaxis symptoms were stable. Discharged and prescribed 40 MG of Prednisone and antihistamine every 24 hours. The patient returned to ER 3 days later (09Aug2021) with alarming pressure 160/118 and heart rate of 120. The patient received tests and fluids and continual concern as steroid wears off anaphylaxis symptoms continue. The patient received IV fluids 2 days later once again due to dehydration regardless of liquid intake throughout the day. Currently continually monitoring BP/ placed on blood pressure medication, continual use of prednisone 40 MG a day with an antihistamine and advised to see a cardiac specialist. The events were further reported as 5 minutes after vaccine, the patient experienced itching on hands and arms. Then 10 minutes after vaccine, the patient experienced itching all over her body. Then 30 minutes after vaccine, the patient experienced swelling throat and swallow difficulties, patient experienced high blood pressure and dehydration. The patient stated that the symptoms were not getting much better. The anaphylaxis required a visit to emergency room and physician office. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient has not been tested for COVID post vaccination. Treatment for the events included IV Steroid, Antihistamine, IV Fluids, BP Meds. The outcome of the events was not recovered.

Other Meds: D3; K2; IODINE; TURMERIC [CURCUMA LONGA]

Current Illness:

ID: 1647218
Sex: F
Age:
State: NV

Vax Date: 12/16/2020
Onset Date: 12/16/2020
Rec V Date: 08/28/2021
Hospital: Y

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: CTA of Abdomen; Result Unstructured Data: Test Result:Unknown result; Test Name: Colonoscopy; Result Unstructured Data: Test Result:Unknown result; Comments: diagnosis of Ischemic Colitis; Test Name: MRI of abdomen; Result Unstructured Data: Test Result:Unknown result; Test Name: EGD; Result Unstructured Data: Test Result:unknown result; Comments: diagnosis of Ischemic Colitis

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: iagnosed with Ischemic Colitis; then began to have frank blood coming from my rectum.; severe abdominal pain; swelling to area; This is a spontaneous report from a contactable Nurse reporting for herself. This 32-year old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number 6H9899) via unspecified route of administration on the right arm on 16Dec2020 at 03:15 PM (at the age of 32-year old) at single dose for COVID-19 immunization at hospital. Relevant medical history included hypothyroidism. There no known history of drug allergy and no concomitant medications. On 16Dec2020 after vaccination the patient experienced swelling to area. On 18Dec2020 at about 08:30 PM the patient began to have severe abdominal pain, then frank blood coming from her rectum. She went to the hospital and was admitted for 2.5 days and diagnosed with ischemic colitis after after CTA of abdomen, MRI of abdomen and then finally an EGD and Colonoscopy. Treatment of events was reported to be CTA, MRI, EGD, Colonoscopy, Medications. The events resulted in emergency room/department or urgent care and hospitalization. The outcome of the events was recovered.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Ischemic colitis, Rectal hemorrhage, Abdominal pain) and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1647219
Sex: F
Age:
State: GA

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: irregular vaginal bleeding/ period should not start for another two weeks, the period started within 36 hours after the vaccination; Dose 1 (31Mar2021)/Dose 2 (09Aug2021); This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 09Aug2021 18:00 (at the age of 33-years-old) as dose 2, single for covid-19 immunization in a Pharmacy or Drug Store. Patient had no relevant medical history or known allergies. The patient is not pregnant at the time of vaccination. Concomitant medication included regular birth control pills (unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 31Mar2021 10:00 at a dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19. On 11Aug2021 12 am, the patient experienced irregular vaginal bleeding described as the period should not start for another two weeks however the period started within 36 hours after (as reported) the vaccination. Treatment was not taken for the event. The outcome of the event was reported as recovering at the time of the report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647220
Sex: F
Age:
State: IN

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Heart flutters; dizziness; shortness of breath; headaches; chest pressure; fatigue; This is a spontaneous report from a contactable consumer (reported herself). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration, administered in arm left on 04Apr2021 12:00 (age at vaccination 49-year-old) as dose number unknown, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Medical history included heart problems from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced heart flutters, dizziness, shortness of breath, headaches, chest pressure, fatigue on an unknown date of 2021 12:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment medication was received for the events. Since the vaccination, the patient was not tested for COVID-19. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647221
Sex: F
Age:
State: IN

Vax Date: 06/21/2021
Onset Date: 06/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: irregular heart rhythm; heaviness feeling in neck; swollen lymph nodes in left neck and breast since my first dose; fatigue; This is a spontaneous report from a contactable other HCP (patient). A 29-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 21Jun2021 (at the age of 29-years-old) as dose 1, single for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient medical history was not reported. The patient was no known allergies. Concomitant medications included amitriptyline, received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 22Jun2021, the patient had not felt right since vaccine, which clarified that patient had swollen lymph nodes in left neck and breast since her first dose. The patient had been very fatigue and also have been experiencing a heaviness feeling in neck ever since as well. The patient have noticed a irregular heart rhythm too. The adverse events resulted in [Doctor or other healthcare professional office/clinic visit]. The patient did not received treatment for the events. 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.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event Arrythmia cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: AMITRIPTYLINE

Current Illness:

ID: 1647222
Sex: M
Age:
State: MD

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

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

Lab Data:

Allergies:

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

Symptoms: Significantly reduced mental clarity, or "brain fog"; Significantly reduced mental clarity, or "brain fog"; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Lot Number: EW0183)), dose 1 via an unspecified route of administration, administered in the left arm on 07May2021 (age at the time of vaccination was 26-year-old) and dose 2 via an unspecified route of administration on 28May2021 (Lot Number: EW0191); both as single dose for COVID-19 immunization. The patient's medical history included Sulfa drugs allergy. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07May2021, the patient experienced significantly reduced mental clarity, or "brain fog". He felt these effects started immediately upon both doses and has lingered on for the past 3 months. The outcome of the events was not resolved. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1647224
Sex: F
Age:
State: NY

Vax Date: 02/14/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: fever; chills; This is a spontaneous report from a contactable Other HCP. This 69-year-old female Other HCP reported for herself that: A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 69-year-old) as single dose for covid-19 immunisation. Patient reported I am immunocompromised, and I have Antiphospholipid syndrome, I took the first two doses. I don't have cancer and I don't take steroids. I had a reaction to the second dose I know it's the same. Should I even attempt to take the third dose. I don't think I will have a reaction when asked what reactions she experienced patient stated the typical reactions fever and chills. It was the second dose I took on 14Feb. It's been so long ago I don't even remember. This agent confirmed with the caller that she is speaking of the Pfizer Covid 19 Vaccine. This case assessed as non-serious by the reporter. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested

Other Meds:

Current Illness:

ID: 1647225
Sex: F
Age:
State: RI

Vax Date: 04/25/2021
Onset Date: 05/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Comments: treatment received for the adverse event: MRI; Test Date: 20210706; Test Name: COVID-19 Test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: Seizures; I was having trouble focusing; my eyes had trouble focusing; Big headache; Depersonalization; My legs lost function and I could hardly walk; My legs lost function and I could hardly walk; The rest of my body felt weak but kept doing involuntary movements (like hand opening and closing); I struggled to think or talk, and it felt like my body was forgetting how to work; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0171), via an unspecified route of administration, administered in the left arm on 25Apr2021 (at the age of 23-years-old) as dose 1, single for COVID-19 immunization at other. Medical history included depression, anxiety, lactose intolerance, temporal lobe seizure, migraines, post-traumatic stress disorder (ptsd); all from an unknown date and unknown if ongoing. Patient had known allergy to Lithium. Concomitant medications within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC), pyridoxine hydrochloride (B6 supplement), cannabidiol (CBD OIL); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19 and Since the vaccination, patient has been tested negative for COVID-19. On 09May2021, after receiving the first dose of the vaccine, the patient experienced trouble focusing and developed a big headache, eyes had trouble focusing, and patient was experiencing severe depersonalization. The patient legs lost function and could hardly walk, and the rest of her body felt weak but kept doing involuntary movements (like hand opening and closing). Patient struggled to think or talk, and it felt like her body was forgetting how to work. The patient was brought to an Emergency Room (ER). Since then, patient had seizures. The events resulted in to Emergency room/department or urgent care (ER visit) and Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test (covid test, Nasal Swab) post vaccination which resulted negative on 06Jul2021 and MRI with unknown results on an unspecified date in 2021. The patient received treatment for events with IV fluids, Benadryl, Reglan, Heart monitor and MRI (Magnetic resonance imaging). The outcome of the events was not recovered at the time of report.

Other Meds: PROZAC; B6; CBD OIL

Current Illness:

ID: 1647226
Sex: M
Age:
State: PA

Vax Date: 07/26/2021
Onset Date: 07/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: my heart rate starting climbing and fast; My blood pressure, when first taken was very high; chest discomfort; whole body aches; general feeling of being exhausted and weak; general feeling of being exhausted and weak; respiratory rate climbed; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA6780 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jul2021 at 19:30 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced my heart rate starting climbing and fast, my blood pressure, when first taken was very high, chest discomfort, whole body aches, general feeling of being exhausted and weak and respiratory rate climbed on 27Jul2021 at 13:30 (After almost 24hrs from the first shot). The event resulted in Emergency room/department or urgent care. The patient received treatment for the adverse events as Ativan, nitrostat and Zofran with IV. Outcome of the events was recovered on an unknown date in 2021.

Other Meds:

Current Illness:

ID: 1647227
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: milk supply decreased to nearly zero.; breastfeeding mother; breastfeeding mother; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Arm on an unspecified date (lot Number: FC3180) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. There were no concomitant medications. Historical vaccine includes dose 1 of BNT162B2, lot number: FA6780. The patient did not have COVID-19 prior vaccination. The patient is a breastfeeding mother and had her son on 30Jun2021. After I received the second dose of the vaccine, her milk supply decreased to nearly zero. The onset of the events was reported as 09Aug2021. The events involved physician office visit. The event her milk supply decreased to nearly zero was assessed as serious, disabling. The patient has not been tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101051671 same reporter/drug, different patient/event (son case)

Other Meds:

Current Illness:

ID: 1647228
Sex: F
Age:
State: OH

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210812; Test Name: hypertension; Result Unstructured Data: Test Result:156/100; Test Date: 20210812; Test Name: d-dimer; Result Unstructured Data: Test Result:High; Test Date: 20210812; Test Name: tachycardia; Result Unstructured Data: Test Result:156; Test Date: 20210812; Test Name: multiple imaging; Result Unstructured Data: Test Result:other clots; Test Date: 20210812; Test Name: Oral swab; Test Result: Negative ; Comments: Other Oral swab

Allergies:

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

Symptoms: hospitalized on day 13 with TIA stroke symptoms and high d dimer; sudden hypothyroid; hypertension 156/100; tachycardia 156; 3 doses of IV steroids and multiple imaging for other clots; hospitalized on day 13 with TIA stroke symptoms and high d dimer; developed a DVT 2 days after the vaccine in my left leg; Had an anaphylactic reaction within 30 minutes of the vaccine/severe autoimmune reaction to the vaccine; tongue tingling, swelling; tongue tingling, swelling; moderate throat swelling; itchy rash; Covid toes; sudden bruising; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: Fc3181, expiry date not reported) via an unspecified route of administration, administered in right arm on 30Jul2021 16:45 (at the age of 40 years old), as dose 1, single for covid-19 immunisation. Medical history included gulf war illness, asthma, allergies, Ehler danlos, known allergies to penicillins, and being monitored for autoimmune disease but not diagnosed. The patient had covid prior vaccination (date unspecified). Concomitant medications included cetirizine hydrochloride (ZYRTEC), omeprazole, sertraline, celecoxib (CELEBREX), and pregabalin (LYRICA), all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient previously took anthrax vaccine as immunization and experienced neurocardiogenic syncope; and patient had known allergies to doxycycline, clindamycin, duloxetine hydrochloride (CYMBALTA), and higher doses of sertraline. The patient was covid tested post vaccination which included oral swab negative on 12Aug2021. Patient had an anaphylactic reaction within 30 minutes of the vaccine (30Jul2021 05:15 PM) with tongue tingling, swelling, moderate throat swelling. These reactions continued for 2 weeks and throat and tongue kept swelling off and on. Patient also developed an itchy rash and covid toes and sudden bruising on 30Jul2021 05:15 PM. Patient was hospitalized with TIA stroke symptoms and high d dimer, sudden hypothyroid, hypertension 156/100 and tachycardia 156, that all began on 12Aug2021 (also reported as on day 13). Patient received 3 doses of IV steroids and multiple imaging for other clots (12Aug2021). Patient believed patient developed a DVT on 01Aug2021, also reported as 2 days after the vaccine, in the left leg but it had seemed to resolve with aspirin so patient did not go to the ER until patient had stroke symptoms on 12Aug2021. Doctors contributed my symptoms to a severe autoimmune reaction to the vaccine (anaphylactic reaction). Adverse events (AEs) resulted in emergency room/department or urgent care, hospitalization for 3 days (12Aug2021 to 15Aug2021), life threatening illness (immediate risk of death from the event), and disability or permanent damage. Therapeutic measures were taken as a result of the events reported which included mag sulfate, high dose solu-medrol, aspirin, and atorvastatin. The event "developed a DVT 2 days after the vaccine in left leg" was recovered on an unspecified date in 2021. The outcome of the other events reported was not recovered.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events paraesthesia oral ,swollen tongue, pharangeal swelling, ill defined disorder, contusion, transient ischaemic attack, hypothyroidism, hypertension, tachycardia, thrombosis, deep vein thrombosis,and cerebrovascular accident cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; OMEPRAZOLE; SERTRALINE; CELEBREX; LYRICA

Current Illness:

ID: 1647229
Sex: F
Age:
State: CA

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

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

Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:higher than normal; Comments: sleeping heart rate of 84 average; Test Name: lab; Result Unstructured Data: Test Result:irregularities in my blood

Allergies:

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

Symptoms: heavy bleeding from rectum; being totally exhausted; very high (for me) heart rates; lab results showed that I had irregularities in my blood; This is a spontaneous report from a contactable consumer (patient). A 80-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and Expiry date was not reported), (age 80 year at the time of vaccination) via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:00 as dose 2, single for COVID-19 immunisation. Medical history included several chronic autoimmune conditions, known allergies: Penicillin, Known allergies: Sulfa, from an unknown date and unknown if ongoing. Concomitant medication includes medications prescribed in two weeks was yes. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on Feb2021as dose 1, single for COVID-19 immunization. On Mar2021, patient experienced heavy bleeding from rectum, being totally exhausted, very high (for me) heart rates, lab results showed that i had irregularities in my blood. No other vaccine in four weeks. No covid prior vaccination was reported. No covid tested post vaccination. Adverse event was resulted in Emergency room/department or urgent care. No treatment received for adverse event. The patient underwent lab tests and procedures which included heart rate was higher than normal (sleeping heart rate of 84 average) and lab investigation was irregularities in my blood on an unspecified date. The outcome of the event for heavy bleeding from rectum was recovered on an unspecified date 2021 where as rest all events was unknown. Information on lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1647230
Sex: F
Age:
State: CA

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

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

Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Patient had Lyme Disease, in remission, vaccine has caused relapse, far worse than years ago; perseverating obsessions with being killed or killing family and other, suicidal/euthanistic ideation and fixation; her brain was hemorrhaging and she was bleeding internally; seizure; Anxiety; panic attacks; stabbing pains in head; extreme pain; delusion; feeling like her legs don't have energy; inflammation; nervous system deterioration; not in control of her limbs; This is a spontaneous report from a contactable consumer. A 23-year-old non-pregnant female patient ( reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in Arm Left in Jul2021 (Batch/Lot number and expiration date were not reported) at age of 23 years old as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. Medical history included Lyme Disease, coinfections babesia, bartonella, Epstein-Barr. Concomitant medication included ivermectin. The patient previously took amoxycillin and experienced allergy. The patient had lyme disease, in remission, vaccine has caused relapse, far worse than years ago (Life threatening), perseverating obsessions with being killed or killing family and other, suicidal/euthanistic ideation and fixation (Life threatening), anxiety (Life threatening), panic attacks (Life threatening), stabbing pains in head (Life threatening), extreme pain, her brain was hemorrhaging and she was bleeding internally, delusion, feeling like her legs don't have energy, inflammation, nervous system deterioration, not in control of her limbs, seizure, all on an unspecified date. The patient underwent lab tests and procedures which included blood test: unknown results on an unknown date. Therapeutic measures were taken as a result of all events. The outcome of the events 'Patient had Lyme Disease, in remission, vaccine has caused relapse, far worse than years ago, perseverating obsessions with being killed or killing family and other, suicidal/euthanistic ideation and fixation, Anxiety, panic attacks, stabbing pains in head, her brain was hemorrhaging and she was bleeding internally' was not recovered, the rest events was unknown. All events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. All events were received treatment (IV). The patient had no COVID prior vaccination. The patient had not tested COVID post vaccination. Clinical course: Patient had Lyme Disease, in remission, vaccine has caused relapse, far worse than years ago, despite recommendation that Lyme patients receive vaccine. Anxiety, panic attacks, stabbing pains in head, perseverating obsessions with being killed or killing family and other, suicidal/euthanistic ideation and fixation. Any Prior vaccination (within 4 weeks): No. Now this was an Emergency and the patient was in extreme pain. Caller stated his daughter got her 1st Pfizer COVID vaccine and has Lyme disease that was in remission. States that this seemed to have triggered all her Lyme events and that she had adverse effects for 4 weeks now. States she had been to the ER a few times and he is seeking medical treatment that is quite expensive. Stated that no one knows what to do. Caller stated his daughter felt like she was going to have seizures sometimes. She had delusion that she was about to be stabbed by someone of that she is stabbing someone. States she had stabbing pains in her head. Caller stated his daughter went to the ER yesterday an she was convinced her brain was hemorrhaging and she was bleeding internally. Caller stated he is very concerned. Stated he would like help with the (dollar sign) 20,000- (dollar sign) 30,000 cost and the best case scenario is that price and she feels better. Caller stated he would like professional help and guidance. Prescribing Healthcare Professional Info: Caller does not have address or email to provide. Caller states she got the vaccine approximately 4 weeks ago this coming Wednesday and her symptoms started within 24 hours and he doesn't know if they gradually worsened into this. Caller states one thing he would add is that recently she is feeling like her legs don't have energy and is wondering if she has some nervous system deterioration and will end up in a wheelchair in the family of ALS. She is wondering if she will walk much longer, that if she walks very far her legs give out. Stated that she feels like a seizure might be coming on, that she had to pull over the other day and they had to go get her and called a patrol car. Caller states that she feels like she is not in control of her limbs. States he has not seen any involuntary movements and she has not reported any to him. Suspect Product: Caller states he does not have the NDC, lot or expiry to provide. Concomitant Medication: Caller states she has treatment for Lyme but it is not ongoing, she had IV treatment and that was within the 2 weeks. States there were many treatments at the clinic they were at in (Place). Medical History: Caller states she was diagnosed with Lyme Disease about 4 years ago and is also allergic to Amoxicillin. Investigations: Caller states she has had blood tests and has an appointment with a neurologist but they are backing off testing for encephalitis as she has no fever and the MRI and spinal tap are big steps. States they assume it is some sort of inflammation. All events require a visit to Emergency Room and Physician Office. States she saw her general practice and was referred to a general practice in Location. Stated she was in State and travels there on a medical tour and she has a practice. States his daughter has seen 3 general practice doctors. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds: IVERMECTIN

Current Illness:

ID: 1647231
Sex: M
Age:
State: HI

Vax Date: 05/28/2021
Onset Date: 07/17/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210807; Test Name: Covid-19 virus test; Test Result: Negative ; Comments: Nasal Swab, Nasopharyngeal; Test Date: 2021; Test Name: weight; Result Unstructured Data: Test Result:Lost 21 lbs

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Been having acute gastroentinitis for over 4 weeks. From 7/17/21 to present (8/14/21); Can't eat regular yet; Uneasy stomach; Lost 21 lbs; This is a spontaneous report from a contactable consumer, the patient. A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration, administered in Left arm on 28May2021 as dose 2, single (at the age of 16 years), for covid-19 immunization, at Hospital. Medical history and concomitant medications were not reported. There were no known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration, administered in Left arm on 07May2021 as dose 1, single (at the age of 16 years), for covid-19 immunization, at Hospital. There were no other vaccine in four weeks and no other medications in two weeks. The patient reported that, since 17Jul2021, he had been having acute gastroenteritis (for over 4 weeks to present 14Aug2021) and since unknown dates in 2021, he could not eat regular yet, had uneasy stomach and lost 21 lbs. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not have Covid prior to vaccination. The patient was tested for covid post vaccination. The patient underwent lab tests and procedures which included Covid-19 virus test (sars-cov-2 test) via Nasal Swab, Nasopharyngeal on 07Aug2021 with negative result and on an unknown date in 2021, measured weight in which realized he lost 21 lbs. Therapeutic measure for Acute gastroenteritis was taken, received IV for dehydration (IV drug was not specified). The outcome for the event Acute gastroenteritis was not recovered at the time of report, however the outcome for the rest of the events was unknown.

Other Meds:

Current Illness:

ID: 1647232
Sex: F
Age:
State: ME

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

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

Lab Data:

Allergies:

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

Symptoms: had stopped my period 6 days prior to 1st dose & 24 hours post-injection: menstrual cycle began'; menstrual cycle began and lasted for 2 weeks. Patient had consistent, normal cycles and had stopped, patient's period 6 days prior to 1st dose; the metallic taste in mouth, lasted for 24 hours; This is a spontaneous report from a contactable consumer (the patient). A 31-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EW0177), via an unspecified route of administration, in the left arm, on 25Jul2021 at 11:00 (at the age of 31-year-old) as dose 1 ,single for COVID-19 immunization. The patient's relevant medical history included bipolar II, ADHD (Attention deficit hyperactivity disorder), general anxiety disorder and relevant past drug history included Oxycodone and Maxalt. The concomitant medications included lamotrigine, bupropion hcl and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (AMPHETAMIN SALTS). On 25Jul2021 at 12:30, 1.5 hours post-injection, patient experienced the metallic taste in mouth, lasted for 24 hours. On 26Jul2021 at 14:00, 24 hours post-injection, menstrual cycle began and lasted for 2 weeks. Patient had consistent, normal cycles and had stopped, patient's period 6 days prior to 1st dose. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the events. Outcome of the event taste metallic was recovered on Jul2021 and outcome of the rest events was recovered on an unknown date in 2021. Follow-up attempts are completed. No further information is expected.

Other Meds: LAMOTRIGINE; BUPROPION HCL; AMPHETAMIN SALTS

Current Illness:

ID: 1647233
Sex: F
Age:
State: FL

Vax Date: 04/01/2021
Onset Date: 08/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210811; Test Name: COVID test name post vaccination= PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

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

Symptoms: breakthrough Covid positive through PCR test; breakthrough Covid positive through PCR test; This is a spontaneous report from a contactable consumer (patient).A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 12:00 PM as a single dose and dose 2 via an unspecified route of administration, administered in Arm Left at public health clinic/facility on 01Apr2021 at 12:00 PM (Batch/Lot Number: ER8737; Expiration Date: 31Jul2021) as a single dose for COVID-19 immunization (at the age of 67-years-old). Medical history included atrial fibrillation, Heart arrhythmias, perianal fistula, and seasonal asthma. Concomitant medications included sotalol (SOTALOL), apixaban (ELIQUIS), cyanocobalamin (VIT B12), colecalciferol (VIT D3), and magnesium (MAGNESIUM) taken for an unspecified indication. The patient previously took mobic and chlorhexidine and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 since the vaccination. The patient had not taken any treatment for reported events. On 11Aug2021, the patient experienced breakthrough covid positive through pcr test (vaccination failure) and (covid-19). On 02Apr2021 at 15:00, the patient experience flu like symptoms, fever, chills, severe headache, body aches. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): positive on 11Aug2021. The outcome of the events breakthrough covid positive through pcr test (vaccination failure) and (covid-19) was unknown. The outcome of the event fever was recovered on 03Apr2021. The outcome of the other events was recovered on an unspecified date in 2021. Conclusion of Previously Completed Investigation (Lot: EN6202): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6202 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6202, fill lot EN5334, and the formulated drug product lot EN5323. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause. Conclusion of Previously Completed Investigation (Lot: ER8737): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8737 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8737, fill lot EW3426, and the formulated drug product lot EP8586. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.

Other Meds: SOTALOL; ELIQUIS; VIT B12; VIT D3; MAGNESIUM

Current Illness:

ID: 1647234
Sex: U
Age:
State: TX

Vax Date: 12/18/2020
Onset Date: 12/30/2020
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: got vaccine 18Dec2020.Got COVID infection 30Dec2020; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Dec2020 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis (RA) from an unknown date, had been off medication since Jan2021, covid-19 from 25Sep2020 to an unknown date. The patient's concomitant medications were not reported. The patient got vaccine on 18Dec2020 and got COVID infection 30Dec2020, the patient received monoclonal therapy on 05Jan2021 and out of work for over 100 days. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647235
Sex: M
Age:
State: PA

Vax Date: 05/25/2021
Onset Date: 08/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210814; Test Name: Coronavirus Antigen/Nasal Swab; Test Result: Positive ; Comments: Nasal Swab; Test Date: 20210812; Test Name: Coronavirus PCR/Nasal Swab; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: Had a second test performed on 14Aug2021 and received positive result; began experiencing symptoms on 11Aug2021; This is a spontaneous report from a contactable consumer and from pfizer product quality group providing investigation results. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via intramuscular route, administered in left arm on 27Apr2021 (at the age of 45 -years) (Lot Number: EW0170; Expiration Date: 31Aug2021) as dose 1, single and dose 2 intramuscular, administered in left arm (at the age of 45 years) on 25May2021 (Lot Number: EW0191; Expiration Date: 30Sep2021) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that he had received positive COVID19 result. He had unknowingly exposed on 10Aug2021. The patient began experiencing symptoms on 11Aug2021. Tested showed negative for COVID-19 on 12Aug2021. Had a second test performed on 14Aug2021 and received positive result on 14Aug2021. Covid is tested post vaccination. The patient underwent lab tests which included Coronavirus PCR/Nasal Swab showed negative on 12Aug2021 and coronavirus Antigen/Nasal Swab showed positive on 14Aug2021. The patient had not received any treatment for the events. The outcome of the events was unknown. Lot number: EW0170; Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0170 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0170, fill lot EP8701, and the formulated drug product lot EP8603. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Lot number: EW0191; Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0191 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EW0191, fill lot EP8738, and bulk formulation lot EP8619. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Evaluation Comment: Pfizer reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid, and an investigation will be performed. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647236
Sex: U
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Muscle twitching; Headache; some wired discoloration on my nail; This is a spontaneous report from a contactable consumer (patient). A 24-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EA6780) as dose 1, single and dose 2 (Batch/Lot Number: EW0178) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported side effect that not going away from the Pfizer vaccine. Patient experienced muscle twitching and headache and there is like some wired discoloration on patient nail. The patient does not know if the events are the vaccine. Treatment was not taken for events. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1647237
Sex: M
Age:
State:

Vax Date: 02/15/2021
Onset Date: 08/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210813; Test Name: covid test; Result Unstructured Data: Test Result:Positive; Comments: Positive

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Patient has tested positive for COVID-19 following the completion of the COVID-19 vaccine series.; Patient has tested positive for COVID-19 following the completion of the COVID-19 vaccine series.; This is a spontaneous report from a non-contactable other hcp. A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Lot Number: EN5318, and Expiration date: Unknown), via an unspecified route of administration on 15Feb2021 (at the age of 48-year-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19, prior to vaccination. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN5318, and Expiration date: Unknown), via an unspecified route of administration on 25Jan2021 (at the age of 48-year-old), as dose 1, single for COVID-19 immunization (No reaction on previous exposure to vaccine). It was reported that on 13Aug2021, "Patient has tested positive for COVID-19 following the completion of the COVID-19 vaccine series" and it resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-CoV-2 test (COVID-19 test): positive, on 13Aug2021. The type of the COVID test was unknown. It was unknown if the patient received treatment for the events. The outcome of the events was reported as not resolved. No follow up attempts were possible. No further information was expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 1647238
Sex: U
Age:
State:

Vax Date: 03/01/2021
Onset Date: 04/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210411; Test Name: Covid-19; Test Result: Positive ; Comments: symptomatic and positive for Covid-19 Infection

Allergies:

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

Symptoms: Positive for Covid-19 Infection; positive for Covid-19 Infection; This is a spontaneous report from a contactable consumer. A patient (reporter roommate) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), in Mar2021 (Lot number: EP7534, Expiration date: not reported) as dose 1, single and on 08Apr2021 (Lot number: EW0153, Expiration date: 31Jul2021) as dose 2, single, both via Intramuscular for covid-19 immunization. Medical history and concomitant medications were not reported. On 11Apr2021, the patient had symptomatic and positive for Covid-19 Infection after being fully vaccinated with the Pfizer BioNTech Covid-19 Vaccine. The outcome of events was unknown.

Other Meds:

Current Illness:

ID: 1647239
Sex: M
Age:
State: CO

Vax Date: 03/24/2021
Onset Date: 03/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202103; Test Name: BP; Result Unstructured Data: Test Result:Irregular heartbeats; Test Date: 202106; Test Name: BP; Result Unstructured Data: Test Result:Irregular heartbeats; Test Date: 2021; Test Name: Holter Monitor; Result Unstructured Data: Test Result:Neither showed anything alarming.; Comments: 72 hour holter monitor. Neither showed anything alarming.; Test Date: 2021; Test Name: echocardiogram; Result Unstructured Data: Test Result:Neither showed anything alarming.; Comments: 72 hour holter monitor. Neither showed anything alarming.

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: completely lost feeling in his left leg from the knee down; Arm soreness after receiving the shots; dose 1 24Mar2021; dose 2 24Mar2021; Irregular heartbeats; Hypervitaminosis B6; paresthesia; palpitations; Tremors; Bradycardia; Uncontrolled hypertension; Peroneal neuropathy; Blurry vision; Dizziness; Angina; Tinnitus; lameness; limp in his left leg; allergies; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 24Mar2021 11:30 (Batch/Lot Number: ER8730), at the age of 45 years old, as dose 1, single, and then via an unspecified route of administration, administered in left arm on 24Mar2021 (Batch/Lot Number: ER8371), at the age of 45 years old, as dose 2, single for covid-19 immunisation administered in a pharmacy of drug store. Medical history included attention deficit hyperactivity disorder (ADHD) from an unknown date and unknown if ongoing. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and losartan taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks. The patient was healthy and athletic with no known allergies to vaccines, 45 years old, male, 160 lbs. He had no immediate reaction other than arm soreness after receiving the shots on 24Mar2021. He never felt any sickness or immune response after the 2nd shot. He walked 8 miles after receiving the 2nd dose. He takes his BP regularly and began detecting irregular heartbeats on both his BP monitor and on his smartwatch during Mar2021-Jun2021. His doctor ordered an echocardiogram and 72 hour holter monitor in 2021 and neither showed anything alarming. On 20Jun2021, he completely lost feeling in his left leg from the knee down. He was sitting with his left leg crossed over his right leg, and his left leg went to sleep. It never woke up. After vaccination, on an unspecified date in 2021, he had been diagnosed with hypervitaminosis B6, parasthesia, palpitation, tremors, bradycardia, uncontrolled hypertension, peroneal neuropathy, blurry vision, dizziness, angina, tinnitus, lameness, irregular heartbeats. He was perfectly healthy before the vaccine. Now he has a limp in his left leg. Known allergies: Pfizer Covid Vaccine. The events resulted in doctor clinic visit and emergency room/department or urgent care. The events were reported as serious - life threatening illness (immediate risk of death from the event), and disability or permanent damage. Treatment included acute care, medication, and physical therapy stress ma (as reported). The patient has not recovered from the events.

Other Meds: ADDERALL; LOSARTAN

Current Illness:

ID: 1647240
Sex: F
Age:
State: CT

Vax Date: 07/13/2021
Onset Date: 07/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Blood Test; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Talking about committing suicide; Twitching and vibrating sensation throughout her whole body; Twitching and vibrating sensation throughout her whole body; This is a spontaneous report from a contactable consumer (patient's fiance). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose number unknown, via an unspecified route of administration, administered in the left arm on 13Jul2021 (Batch/Lot Number: FA6780, at the age of 60-years-old at vaccination) as a single dose for COVID-19 immunisation. Medical history included ITP (Immune thrombocytopenic purpura). Concomitant medications were not reported. On 13Jul2021, the patient received the BNT162B2 vaccine. Two days later (on 15Jul2021), she started getting a twitching and vibrating sensation throughout her whole body. She has been to numerous doctors but it won't stop and she was talking about committing suicide now because the twitching and vibrating sensation is constant and it doesn't let up. She describes it as- like sitting on a washing machine that never stops. She was in extremely bad shape now. The fiance stated that he needed to get her some kind of help because she was ready to commit suicide. It was extremely bad now and the patient needs to get help because this side effect was about killing her. She just can't cope anymore because the twitching and vibrating sensation doesn't stop. She was having an extremely hard time coping. The patient had some blood test and was awaiting the results. The outcome of the events talking about committing suicide and twitching and vibrating sensation was not recovered. Follow-up (17Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647241
Sex: F
Age:
State: IA

Vax Date: 03/16/2021
Onset Date: 08/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210809; Test Name: Covid test; Test Result: Positive

Allergies:

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

Symptoms: she could only taste salt; Has gotten Covid; Has gotten Covid/taste salt/bad cold/coughing; Can't really hear well; She had allergies and was sneezing a lot before confirmation; she had allergies and was sneezing a lot before confirmation; This is a spontaneous report from a female nurse reported for herself that. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Batch/Lot Number: EL9266; Expiration Date: 30May2021) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 16Feb2021 (Batch/Lot Number: EL9263) as DOSE 1, SINGLE for covid-19 immunization(Age at vaccination 72 years). The patient past Medical history included dry eye from an unknown date and unknown if ongoing She doesn't usually take antihistamines because of her dry eye syndrome, nasopharyngitis from an unknown date and unknown if ongoing she has gotten in the past as far as a cold , hypersensitivity from an unknown date and unknown if ongoing Allergies. The patient's concomitant medications were not reported. ON 09Aug2021, The patient experienced Has gotten Covid/taste salt/bad cold/coughing.Has been doing research for 4 hours and is leaving on the 30th and wanting to know if the Pfizer vaccine is accepted. She is deaf and can't hear well and is calling in because they want to know if they may not be allowed overseas. No other vaccines given the same time and no problems with vaccines in past. After the Covid vaccines later she got the pneumonia vaccine. It would have been after Mar2021 when she was able to get it, does not know if it was 6 weeks or later when she got that, but it was well after she got the Covid shots. Unable to provide NDC, Lot, or expiry for the pneumonia shots. States she didn't get any diagnosis for her ears. They were just full, and she couldn't hear. Must turn the tv way up to hear that. Was diagnosed this past Monday with Covid and then on Wednesday the 11th she could only taste salt. Prior to confirming Covid she had allergies and was sneezing a lot before confirmation and had stuff running down her throat on an unspecified date 2021. She tried to irrigate her sinuses on Monday or Tuesday and had been using an antihistamine ointment in nostrils to help. She doesn't usually take antihistamines because of her dry eye syndrome, but it built up a lot and she couldn't take it anymore. When she was diagnosed with Covid they didn't give her any treatment and the provider asked what she was taking. Informed provider she was taking Allegra and the antihistamines. States her husband had the vaccines the same time as her, the same vaccines and they both were diagnosed with Covid on this past Monday. Declines to report for husband stating he is not available and doesn't think she can do that. Mentions she worked on a concert on a large venue and come to find out at the venue they allowed all the people to use their custom vape of marijuana which she does not do. Does not know, but she did wear her mask, but was worried because she had to inhale that would that havemade an affect. This was her first time experiencing anything like that before. Later states she only had the nasal testing for covid at an Urgent Care. She had quit taking the Allegra and antihistamines and now in a solid phase with the secretions. Had only used the Allegra and Tylenol intermittently. Felt like it was just a bad cold and no different from what she has gotten in the past as far as a cold. It could have been worse. She did have some coughing that was related to the crap that ran down her throat. Provides events are not serious and not medically significant, but it was tough, and she didn't end up in the hospital when queried for seriousness criteria for events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Aug2021. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9266 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL9266, fill lot EL9257, and the formulated drug product lot EL9248. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The event outcome was Not recovered for Has gotten Covid/taste salt/bad cold/coughing and Can't really hear well. Unknown for rest of the events; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events of drug ineffective, COVID-19 and deafness cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1647242
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Rash/ like a big, circular, and big rash; allergic reaction; big redness not rash, redness randomly popped up in her body/a red, red round thing underneath her forearm, left and right arm; got the vaccine on her left arm and then she is also having redness up to her second arm; breathing a little bit congested; This is a spontaneous report from a contactable pharmacist. A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180; Expiration/Date: 31Oct2021) DOSE 1 via an unspecified route of administration in the left arm on 10Aug2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Aug2021, the patient experienced, rash/ big, circular, and big rash; big redness not rash, redness randomly popped up in her body/a red, red round thing underneath her forearm, left and right arm; got the vaccine on her left arm and then she is also having redness up to her second arm; allergic reaction; and breathing a little bit congested. The pharmacist stated, "I am calling because I have your patient that got the vaccine last Tuesday (10Aug2021) and she is having a reaction. Patient got the vaccine on Tuesday and she got the rash. She noticed the rash yesterday. It's big, circular, and then big rash that appeared on her, big redness not rash I should say but redness that randomly popped up in her body. So she had a red, red round thing underneath her forearm and I guess she got the vaccine on her left and then it also I guess it's on the left but somehow it also went to the right side. She got the vaccine on her left arm and then she is also having redness up to her second arm and she said prior to that it also shows up in her other parts of the body. It's the redness that she had been experiencing. She had been taking Benadryl and she was fine and then she went to urgent care too. The urgent care provider told her for the second dose it's not recommended, for the second dose now that the patient has the reaction. It's considered an allergic reaction. It's the rash and she ended up getting redness that randomly popped up in her body. She was confused because according to her some people said to get it but I told her that the standard protocol is if patient is suffering the reaction, then it's not recommended to get the second dose". For treatment, the pharmacist stated, "She took a Benadryl and it's already kind of ok right now. All the rashes, it's still on there. I asked her how is her breathing and she said it's fine but it's a little bit congested so I told her to really monitor that one and the urgent care did not give her any EpiPen just the Benadryl". The patient had not recovered from the event, rash. The outcome of the other events was unknown. No further information could be probed as there was no response from the pharmacist and the call was disconnected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events rash, erythema, hypersensitivity, vaccination site erythema and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1647243
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: I am break through patient of your Pfizer vaccine, I think I got Covid 19; I am break through patient of your Pfizer vaccine, I think I got Covid 19; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient was going to give an advice, the patient was break through patient of Pfizer vaccine (Unspecified Vaccine). The patient thought, the patient got Covid 19 on an unspecified date, and she (the girl) was asking me questions, when patient was fill out with some kind of stuff. The patient asked can you put that into the system and see who the patient was taking to.The outcome of Suspected COVID-19 was unknown The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647244
Sex: M
Age:
State: CA

Vax Date: 04/12/2021
Onset Date: 04/28/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Pericarditis; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) Dose 2 via an unspecified route of administration, administered in the right arm on 12Apr2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. There were no medical history or concomitant medications. The patient previously received the first dose of BNT162b2 on 12Mar2021 (Lot Number: EN6208) via an unspecified route of administration in the right arm for COVID-19 immunisation. The patient experienced pericarditis on 28Apr2021, for which he was hospitalized from 29Apr2021 to 01May2021. The patient stated that on 12Apr2021, he had his second shot of the vaccine. The patient stated he is very thankful for the vaccine and he was over the moon to receive it. The patient stated on 29Apr2021, he ended up in the hospital and he had pericarditis, an inflammation of the lining around his heart. The patient stated when it first happened, it was a feeling like indigestion at night and when he went to bed, he had sharp pains in his chest. The patient stated at 2:00a.m. he started looking up symptoms of a heart attack and by 3:00a.m., he woke his husband up, who is a doctor, and he took him to the hospital at 4:00a.m. The patient stated his cardiologist told him it may be a side effect of the vaccine. The patient stated he has never had any issues with his heart. The patient stated they did complete research of his heart and said it was in great shape, it was weird why the lining swelled up. There were no relevant tests reported. The patient recovered from the event on 01May2021.

Other Meds:

Current Illness:

ID: 1647245
Sex: F
Age:
State: LA

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

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

Lab Data:

Allergies:

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

Symptoms: I have the COVID symptoms; Like I have the COVID; Fever; Breaking fever; Chills; Body Ache; I don't feel good right now; I feel like I want throw up; My arm is swollen; and my arm is swollen at the site; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 47-year-old female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: Unknown), via an unspecified route on 11Aug2021 (age at vaccination: 47-year-old), as a single dose for covid-19 immunization. Medical history included type 2 Diabetes, vitamin D deficiency and cholesterol. Concomitant medications included Vitamin D because she is vitamin D deficient, she took most of Vitamins, statins for cholesterol and she takes regular medicine/every day. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Aug2021, patient started having fever, breaking fever, started having Chills, body ache. Patient did the Pfizer the first shot experienced covid symptoms because she was having fever, chills; on an unspecified date in Aug2021, her arm was swollen at the site, like she has the covid, she doesn't feel good right now. She felt like she wants to throw up. Patient will go back in three weeks for the second dose. Therapeutic measures taken as a result of the events included Tylenol for fever. The clinical outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647246
Sex: U
Age:
State:

Vax Date: 07/24/2021
Onset Date: 07/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Itching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EY0584, expiry date: not reported), via an unspecified route of administration on 24Jul2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EY0587), via an unspecified route of administration on 05Jul2021, as single dose for COVID-19 immunization. On 24Jul2021, after second dose,the patient experienced itching and had a doctor visit, took some unspecified medications in response to the event. It was reported that the medication gave some relief temporarily, but keep on coming back again. At the time of report, still it did not go away. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1647247
Sex: U
Age:
State: GA

Vax Date: 06/09/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: hives; itchy; Sneezing; severe allergies; This is a spontaneous report from a contactable consumer, the patient. This 47-year-old patient of unspecified gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: EW0179) via unspecified route in the left arm on 19May2021 at 14:00 (at the age of 47-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: EW0778) via unspecified route in the left arm on 09Jun2021 at 14:00 (at the age of 47-years-old), both doses as single doses for COVID-19 immunization. Medical history included high blood pressure. The patient did not receive any vaccinations prior to the COVID vaccine. Concomitant medication included azilsartan medoxomil, chlortalidone (EDARBYCLOR) for high blood pressure. On an unspecified date in 2021, after the first vaccine, the patient broke out in hives they are mainly really itchy. Patient had to take diphenhydramine hcl (BENADRYL) and his/her doctor gave prednisone. Then a month later (2021) the same thing happened, patient got the hives again and got itchy all over again. It only happens on the same side and the same arm, that patient got the vaccine in. Patient reported he/she received it from the both doses of the vaccine, but the second one was worse than the first one. Patient stated got the regular Benadryl over the counter but the doctor has been prescribing prednisone (patient thinks it was 10 mg) for severe allergies to help with the itching and the sneezing. Patient only take its during that time when he/she had the hives and itching. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: EDARBYCLOR

Current Illness:

ID: 1647248
Sex: M
Age:
State: NH

Vax Date: 01/30/2021
Onset Date: 02/10/2021
Rec V Date: 08/28/2021
Hospital: Y

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:

Allergies:

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

Symptoms: Had a stroke a week after the first vaccine; His left side is nonfunctional/ his left side never came back; He almost died; Muscle spasm; He is not able to walk; This is a spontaneous report from a contactable consumer (patient's wife). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN5813) via an unspecified route of administration on 30Jan2021 (at the age of 67-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history included rheumatoid arthritis, diabetes both from an unknown date and unknown if ongoing, he was diabetic, he was borderline diabetic so he was controlling it from diet. Concomitant medications included methotrexate taken for rheumatoid arthritis, start and stop date were not reported. On 10Feb2021, the patient experienced had a stroke a week after the first vaccine, in 2021 patient experienced he almost died, muscle spasm, he was not able to walk, his left side was non-functional/his left side never came back. Reporter was taking care of her husband 24/7 at home, his left side was non-functional. Reporter stated, his blood pressure pretty normal, of course after he got the, after he had the stroke a lot of stuff went. He was in the hospital for 30 days, he almost died. It had not did any improvement on the left side. Seriousness criteria reported as caused/prolonged hospitalization. The patient was hospitalized for had a stroke a week after the first vaccine (cerebrovascular accident) from 10Feb2021 to Mar2021. Reporter stated, 10Feb2021 was when it happened, he went right in and he stayed there 30 days and then he went to rehab for another 30 days so, 10Feb2021 she would say, Mar2021 he came out of the hospital around in middle of the Mar2021. He was not able to walk, his left side never came back. Reporter seriousness for other events was unspecified. Reporter stated, He was on a blood thinner Eliquis, which was very expensive but other one for that so we have to keep him on that, he was on, they put him on the cholesterol medication to keep his arteries clear and they did a procedure with an open duct the blockage and they took care of that, but by the time they did that the damage had been done so and he was also on Baclofen for his muscle spasm (further clarification unknown). Outcome of the events he was not able to walk, his left side is non-functional/ his left side never came back was not recovered and for all other events was unknown.

Other Meds: METHOTREXATE

Current Illness:

ID: 1647249
Sex: M
Age:
State: NY

Vax Date: 04/02/2021
Onset Date: 04/04/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rash on the left side of his ear and neck, then came back and moved down to his chest; This is a spontaneous report from a contactable consumer (patient's wife). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) Dose 2 via an unspecified route of administration, administered in the left arm on 02Apr2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing , blood cholesterol increased from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , cerebrovascular accident from Jan2020 to an unknown date , arrhythmia from an unknown date and unknown if ongoing , wheelchair user from an unknown date and unknown if ongoing , paralysis from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received the first dose of BNT162b2 on 12Mar2021 (Lot Number: EN6206) via an unspecified route of administration in the left arm for COVID-19 immunisation. The patient experienced he developed a rash on the left side of his ear and neck, which then came back and moved down to his chest (medically significant) on 04Apr2021 at 12:00. The wife reported that after the first shot, he was fine. 48 hours after the second shot, he developed a rash on the left side of his ear and neck. It was on the same side as the shot. This was his left side. It went away, but came back on his face, ear, and neck. Then, it went away again, but then came back and moved down to his chest. It was also on his ear, neck, and left side of his face. The doctor doesn't know what it is. He has been to the doctor a couple of times. They have taken picture of it. The doctors don't know where it came from. He did have a stroke last Jan2020 so he is scooter bound/wheelchair bound now. He doesn't get outside to get a rash from that, and they haven't changed any soaps. The doctor did give him creams for the rash that help for a day or so. They tried to add another cream that was too expensive. Cream for his face given was Pimecrolimus 1%, (expiration: Feb2022, lot: 15210057) and cream for his chest was clobetasol propionate USP 0.05%; (lot: AC15690 expiration:Jan2023). The rash looks the same but is spreading. It is on some sort of track. It always starts behind his left ear. The patient had not recovered from the event.

Other Meds:

Current Illness:

ID: 1647250
Sex: F
Age:
State: WA

Vax Date: 03/31/2021
Onset Date: 05/21/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Appendix ruptured; Possible appendicitis; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) Dose 2 via an unspecified route of administration, administered in the left arm on 31Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing (Verbatim: Cholesterol), thyroid disorder from an unknown date and unknown if ongoing (Verbatim: Thyroid). Concomitant medications included levothyroxine for thyroid disorder, start and stop date were not reported; simvastatin for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 on 10Mar2021 (Lot Number: EN6208) via an unspecified route of administration in the left arm for COVID-19 immunisation. Consumer stated, "I didn't know if you are collecting data on possible appendicitis side effects from the Pfizer vaccines. I started getting sick on 21May2021 and then, went to the doctor on 25May2021, who just told me I had a gastric virus and to take probiotic. I continued to feel bad and the pain got severe with fever on the 29May2021 and I went to the walk-in clinic on 31May2021, and they sent me to the ER and I was admitted to the hospital on 31May2021. Consumer stated reason of hospitalization was "my appendix ruptured." I was released on 03Jun2021." Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: LEVOTHYROXINE; SIMVASTATIN

Current Illness:

ID: 1647251
Sex: F
Age:
State:

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

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

Lab Data: Test Date: 2021; Test Name: COVID-19 test; Test Result: Positive; Comments: received a positive COVID-19 test.

Allergies:

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

Symptoms: positive COVID-19 test; positive COVID-19 test; loss of taste; loss of taste and smell; This is a spontaneous report from a non-contactable consumer, the patient. This report was received via a sales representative. A 30-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 12Apr2021 as dose 2, single and for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated that, recently on an unspecified date in 2021, she had received a positive COVID-19 test and loss of taste and smell. These loss of taste and smell have begun to return to normal after three days. She also reported that the event took place after use of product and she did not wish to be contacted for follow-up. The patient underwent lab test which included COVID-19 test: received a positive COVID-19 test on an unspecified date in 2021. The outcome for the event positive COVID-19 test was unknown and loss of taste and smell was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1647252
Sex: F
Age:
State: IL

Vax Date: 08/11/2021
Onset Date: 08/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:No brain bleed; Comments: The test showed no brain bleed.; Test Name: EKG; Result Unstructured Data: Test Result:No brain bleed; Comments: The test showed no brain bleed.

Allergies:

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

Symptoms: Dizzy; Fall; left eye is swollen shut and the right is swollen half shut; she might have a little flu-like symptoms; brain bleed; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0191) via an unspecified route of administration, administered in Arm Left on 11Aug2021 (at the age of 66-years-old) at about 11:30-12 noon as a dose 1, single for covid-19 immunisation. Medical history included ongoing bad heart she had this since she was 44 years old, it was check in the emergency room. There were no concomitant medications. The patient did not take any other vaccines within four weeks prior to vaccination. It was reported that the patient got her first dose. she might have a little flu like symptoms on an unspecified date in 2021 and so she thought she could handle that. Yesterday (12Aug2021) she felt like a tornado hit her, was dizzy. When she got up, she hit the wall twice, hit her head, bounce off the wall 2 more time, then hit her head again and ended up on the floor, had fall on 12Aug2021. She ended up going to the emergency room but to be honest, she cannot remember much of yesterday (12Aug2021). she did not pass out but felt like she was flying through the kitchen. When at the emergency room, she was treated and released. They did a CT scan and EKG. The test showed no brain bleed. She reports she was on a blood thinner which caused them to be worried. If this had happened 4 weeks when her blood was 3.9 it might had been a brain bleed on an unspecified date in 2021. Everything hurts her left eye was swollen shut and the right was swollen half shut on 12Aug2021, this was from the fall and bouncing off the walls when trying to walk. She explains this was not like getting dizzy where she can grab a wall or something to hold on to, it was different. She was still a little funny on her feet and was given something for dizziness but was told this could happen again, so she was being careful. She was told there this was because of the COVID vaccine she got. In the emergency room the doctor told her there were a lot of people with a lot different reaction to the COVID vaccine. The patient underwent lab tests and procedures which included CT (Computerised tomogram) scan the test results showed no brain bleed, and underwent EKG the test resulted showed no brain bleed both on an unspecified date. The patient received treatment for the event brain bleed. The patient was not recovered from the event dizzy. The outcome of the events brain bleed, fall, left eye is swollen shut and the right is swollen half shut, she might have a little flu like symptoms was unknown at the time of report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Heart disorder (Verbatim: bad heart she has had this since she was 44 years old, it was check in the emergency room)

ID: 1647253
Sex: M
Age:
State: WA

Vax Date: 04/01/2021
Onset Date: 08/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210813; Test Name: Covid test PCR; Test Result: Positive ; Comments: Post vaccination: Nasal Swab

Allergies:

Symptom List: Pain in extremity

Symptoms: breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); This is a spontaneous report from a contactable consumer. A 50-years-old male patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: unknown), via an unknown route of administration in Apr2021 (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included asthma. Concomitant medications were not reported. No other vaccine in four weeks. On 11Aug2021, the patient had breakthrough infection diagnosed via PCR (mild head congestion and cough). Patient had not been diagnosed with COVID-19 prior to vaccination. He had tested post the vaccination. On 13Aug2021, the patient had Covid test PCR by nasal swab which resulted positive post vaccination. No treatment received. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1647254
Sex: U
Age:
State: NJ

Vax Date: 08/08/2021
Onset Date: 08/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210813; Test Name: corona virus 19, tested positive; Test Result: Positive

Allergies:

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

Symptoms: I got corona virus 19, I tested positive; I got corona virus 19, I tested positive; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 20-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Aug2021 (age at vaccination: 20 years) as dose number unknown, single for covid-19 immunisation at Pharmacy. Medical history included herpes (was sexually transmitted disease; Treatment: "Valacyclovir 1000mg tablets morning and night") from an unknown date and unknown if ongoing. Concomitant medication included valacyclovir [VALACICLOVIR] at the dose of 1000 mg, two times a day, taken for herpes virus infection, start and stop date were not reported. The patient got the vaccine 6 days ago and on 13Aug2021 (yesterday), tested positive on 13Aug2021, was feeling a little sick on an unspecified date in Aug2021 and went to the doctor and they tested the patient, and had corona virus. So, the patient was just wondering what the vaccine does if it does not stop the patient from getting corona virus. The patient underwent lab tests and procedures which included Corona virus 19, tested positive on 13Aug2021. The outcome of the event Covid-19 was unknown at the time of this report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: VALACYCLOVIR [VALACICLOVIR]

Current Illness:

ID: 1647255
Sex: F
Age:
State: MO

Vax Date: 04/19/2021
Onset Date: 04/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fatigue; My energy level has not fully retuned.; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in the right arm on 19Apr2021 at 07:00 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization in hospital. Medical history included influenza from 2003 to an unknown date; Asthma (triggered by smoke) and congenital hearing loss; both from an unknown date and unknown if ongoing. Patient had past drug history or known allergies to Tree nuts, coconuts, palm oil. The patient previously took first dose of BNT162B2 (Batch/Lot Number: not reported) via an unspecified route of administration, administered in the right arm on 20Mar2021 at 07:00 (at the age of 30-years-old) as dose 1, single for COVID-19 immunization and experienced no reaction on previous exposure to vaccine. Concomitant medications within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC); paracetamol (TYLENOL) (reported as 9 days before); benzocaine (ANBESOL); all taken for unspecified indication, start date and stop date were not provided. Prior to vaccination, patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. Since the vaccination, the patient has not been tested for COVID-19. On 21Apr2021 at 08:00, after second vaccination, patient experienced fatigue for about 3 months and patient's energy level has not fully retuned. Further clarified that patient was normally active, and reports walks 3 miles/day, go to a dog park almost daily and walk an additional 3 miles, and pedal on an exercise bike with moderate resistance for 60 minutes. But after the 2nd dose, walking 1 mile exhausted her and she could only bike for 5 minutes. Patient was easily exhausted until 16Jul2021 and my energy became to come back. Her energy level still has not fully returned. Patient used to work 12 hour days and still felt energized at the end of the day. Now, after working 8 hours, She feel fatigued and unable to exercise. There is no hospitalization prolonged due to events. Patient did not receive any treatment for adverse events. The outcome of events was recovering at the time of report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: ZYRTEC; TYLENOL; ANBESOL

Current Illness:

ID: 1647256
Sex: M
Age:
State: IA

Vax Date: 02/16/2021
Onset Date: 08/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210809; Test Name: Covid test; Test Result: Positive

Allergies:

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

Symptoms: has gotten Covid; has gotten Covid; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient's wife) reported for a male patient (reporters husband) that male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9263; Expiration Date: 31May2021), via an unspecified route of administration on 16Feb2021 as dose 1, single, via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: EL9266; Expiration Date: 30Mar2021) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Aug2021, the patient experienced has gotten covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Aug2021. Reporter stated her husband had the Covid vaccines. Patient had the Pfizer Covid vaccines and was diagnosed with Covid on this past Monday. Patient got both doses of the Pfizer Covid vaccine and since then has gotten Covid. Diagnosed with Covid on 09Aug2021. got the first Covid dose 16Feb2021 with Lot number of EL9263. Received the second dose on 16Mar2021 with Lot number of EL9266 and what she believes is an expiry of 30Mar2021. Investigation Assessment: Yes. The clinical outcome of event was unknown. There was product complaint. Description of Product Quality Complaint: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9266 and lot EL9263 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL9266, fill lot EL9257, and the formulated drug product lot EL9248. A complaint sample was not returned, and photographs were not received. No related quality issues were not identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the known drug safety profile, a causal association between the reported events of vaccination failure and covid-19 cannot be excluded.

Other Meds:

Current Illness:

ID: 1647257
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: my wife puts the vaccine two days ago and she is also pregnant and she feels bad; Vomiting; she feel bad with vaccine; This is a spontaneous report from a contactable consumer (husband) reported for a patient (wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date on Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, my wife puts the vaccine two days ago and she is also pregnant and she feels bad, vomiting, she feel bad with vaccine on an unspecified date on Aug2021. Reported as, "Well, my wife she was pregnant and she takes the vaccine two days ago and she feel bad with vaccine, she started vomited, she vomit, she started getting vomiting and I take yesterday to the hospital (Further clarification unknown) and they say that it seems look I mean the laboratory is looking good but she still feel the same thing she started vomiting and then she takes that kind of shower in the head". The mother reported she became pregnant while taking bnt162b2. Outcome of all the events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647258
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Vaccine is not working; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that her concern here was that what was in the vaccine (Not clarified hence captured as Unspecified vaccine) that does not work she mentioned that on unknown date, vaccine is not working. she stated, "Where are you at in the world. Okay well listen why did they put me in this stupid vaccine that they seem to think can save the world which we already know it's not. Why did they put me in it". When informed about Pfizer Medical Information: Consumer stated, "Alright thank you. You have a good one. Product details and pharmacy details could not be probed as the consumer hung up abruptly. Hence limited information available over the call and appropriate response could not be provided. This might be a split however it was not made by the call handler as there was no further details of the other patients. The events assessed as serious (medically significant). The outcome of the events was reported as unknown. No Follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1647259
Sex: F
Age:
State: TN

Vax Date: 08/11/2021
Onset Date: 08/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: when I lay down to close my eyes, I've had hallucinations; Chest pain; headache; ear ache; nausea; tiredness/ extremely tired; sweating; chills; major night sweats; terrible nightmares; body feels like someone has beat me with a bat; This is a spontaneous report from a contactable (patient) via Regulatory Authority. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 11Aug2021 17:00 (lot number: 59267-1000-01; expiry date: unknown) as dose 1, single, for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a pharmacy/drug store. On 12Aug2021, at 3:00 AM, the patient experienced chest pain, headache, ear ache, nausea, tiredness, sweating, chills, major night sweats, terrible nightmares, body feels like someone has beat her with a bat, extremely tired and when she lays down to close her eyes, she had hallucinations. The patient did not receive treatment for the events. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was not recovered. .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events hallucination and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: PROZAC

Current Illness:

ID: 1647260
Sex: M
Age:
State: RI

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Throwing up blood; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 12Aug2021 (Lot Number: FD8448) as single dose (at age of 40-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 12Aug2021 patient experienced throwing up blood. Reporter stated that patient got first dose of Pfizer Vaccine on 12Aug2021 after 12:10 at (Withheld) and he was throwing up blood at the time of the report. Reporter stated that patient was not treated for the event. Second dose vaccination date was reported as 02Sep2021. Outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647261
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: tinnitus; ear fullness; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: FA6780), via unspecified route of administration, administered in left arm, on 29Jul2021 17:00 (age at the time of vaccination 54-year-old) as single dose for COVID-19 immunization. The patient was not a pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient was allergic to penicillin. On 29Jul2021 at 19:00, the patient experienced horrible non-stop tinnitus, ear fullness and nausea. The patient visited emergency room and physician office. The patient had not received any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The seriousness was reported as disability. Device Date was reported as 15Aug2021. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647262
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: this effect is similar to Guillain-Barre syndrome; Pain at the site for 2 to 3 days off and on; Loose bowels; minor stomach cramps; Cold sweat; Chills; Tingling all over my hands, my body but mostly my hands 1000's of needle pricks, that is the effect; Shaking; Could not move; Cramps in legs; This is a spontaneous report from a contactable consumer, the patient. An unspecified patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FC3180, expiration date: 01Oct2021), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that, patient wanted to report a side effect. There was pain at the site for 2 to 3 days off and on, loose bowels, minor stomach cramps. About on the 4th day patient was woken up, about 4 in the morning, cold sweat, chills, tingling all over hands, patient's body but mostly patient's hands 1000's of needle pricks, that was the effect. Patient was shaking. Patient could not move, Patient had cramps in legs and this lasted 3 hours. If Patient had been driving a car when this happened, patient did not know if patient could operate the car. Patient further stated, from what I understood, it was not a good idea for me to have a second shot, this effect was similar to Guillain-Barre syndrome. Outcome of the event cramps in legs was recovered on an unknown date and outcome of the rest events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am