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: 1645952
Sex: M
Age: 71
State: NY

Vax Date: 08/26/2021
Onset Date: 08/26/2021
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: NONE

Allergies: NONE

Symptom List: Dysphagia, Epiglottitis

Symptoms: ABOUT 6 HOURS AFTER RECEIVING SHOT MY LEFT ARM WAS SLIGHTLY SORE BUT NOT BAD. iT WAS SORER THE NEXT MORNING BY ABOUT DOUBLE, BUT STILL NOT EXCRUTIATING. JUST MADE IT DIFFICULT TO RAISE MY ARM OVER MY HEAD TO REMOVE MY T-SHIRT. BY THE MORNING OF THE 2ND DAY (~42 HOURS AFTER GETTING THE SHOT) THE ARM WAS ONLY MILDLY SORE BY ABOUT HALF AND RAISING MY ARM WAS NOT BIG DEAL. NO HEADACHES LIKE I HAD AFTER THE FIRST OR SECOND DOSE JUST OVER 6 MONTHS EARLIER.

Other Meds: ASPIRIN, ACETAMINOPHEN, CAFFIENE, TURMERIC, Dr. H REJOINT, PRE

Current Illness: HEADACHES

ID: 1645953
Sex: M
Age: 39
State: NY

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

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

Lab Data: LE US duplex and CTA PE (see results above)

Allergies: None

Symptom List: Anxiety, Dyspnoea

Symptoms: Patient presented with 1 week of chest pain, hemoptysis, and worsening dyspnea and pain w/ inspiration over the past week. Found to have extensive occlusive DVT within the left common femoral, femoral, popliteal and posterior tibial veins on US Duplex and Acute bilateral pulmonary embolism with moderate to large amount of clot burden with suggestion of mild right heart strain. Pt had no personal history or family history of prior venous embolisms or clotting disorders. Pt was healthy and active with no inciting factors save for the J&J covid-19 vaccine. pt was admitted to the hospital and started on a heparin gtt with further workup pending.

Other Meds: amlodipine 10mg qd HCTZ 12.5mg qd

Current Illness: None

ID: 1645954
Sex: M
Age: 50
State: OH

Vax Date: 03/03/2021
Onset Date: 03/08/2021
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: still doing

Allergies: none

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

Symptoms: Double vision,high blood pressure,bad rash

Other Meds: none

Current Illness: none

ID: 1645955
Sex: M
Age: 56
State: DE

Vax Date: 06/16/2021
Onset Date: 06/18/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies: NONE

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Ringing in ears noticed 2 days after 1st dose. It is always there, making it harder to concentrate and have trouble sleeping. Lack of sleep has affected my stress level and ability to perform my job and do chores at home. I have reported the progression of this on the V-SAFE site that has been sending me questionnaire since getting shot. I also reported it to my doctor during routine physical. I have not gotten a response for help with this condition. This was not mentioned as a possible side effect of vaccine, but was known to be a potential side effect. I had no other side effects. I have recently quit my job due to stress, so I no longer have healthcare.

Other Meds: OLMESARTAN MEDOXOMIL 20mg CENTRUM MULTIVITAMIN CALCIUM 60Omg GLUCOSAMINE HCI 750mg with MSM 750mg ECHINACEA 400 mg ZINC 50 mg VITAMIN C 500mg VITAMIIN D3 50mcg

Current Illness: NONE

ID: 1645956
Sex: F
Age: 30
State: AL

Vax Date: 08/25/2021
Onset Date: 08/26/2021
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: None

Allergies: None

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

Symptoms: Red rash on arm where shot was injected

Other Meds: Hydroxychloroquine, vitamin E, women?s multivitamin, Theralith

Current Illness: None

ID: 1645957
Sex: F
Age: 33
State: NC

Vax Date: 08/24/2021
Onset Date: 08/27/2021
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:

Allergies: None

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

Symptoms: Breakthrough menstruation bleeding

Other Meds: None

Current Illness: None

ID: 1645958
Sex: F
Age:
State: TX

Vax Date: 07/24/2021
Onset Date: 07/27/2021
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: Pyrexia, White blood cell count decreased

Symptoms: Oral ulcer inside bottom lip 3 days after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Jul2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included adenoids removed as child and C-section 9 years ago. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ascorbic acid; herbal nos; levoglutamide; lysine; magnesium; manganese; retinol; riboflavin; selenium; tocopherol; zinc (AIRBORNE), clonazepam (ZICAM), colecalciferol (VIT D3), one a day womens vitamin (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. On 27Jul2021 at 12:00, 3 days after vaccine, the patient experienced oral ulcer inside bottom lip. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if any therapeutic measures were taken for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event oral ulcer inside bottom lip was not recovered at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds: AIRBORNE; VIT D3; ZICAM [CLONAZEPAM]

Current Illness:

ID: 1645959
Sex: M
Age:
State: WI

Vax Date: 07/28/2021
Onset Date: 07/28/2021
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: Test Date: 2021; Test Name: Lab test INR; Result Unstructured Data: Test Result:2.7; Comments: the only lab test that patient had was INR, to determine warfarin level is in this last two weeks and that was 2.7 by INR

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: My arm is just killing me, I can't move my arm, the pain is really bad; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right on 28Jul2021 11:45 (at the age of 65-years-old male) (Lot Number: FA7484) as single dose for COVID-19 immunization. Medical history included suffering from diabetes, suffering from COPD and high blood pressure also congestive heart failure. Its been the patient would say at least 15 years, he did not know the exact date. The patient also had GERD (gastrooesophageal reflux disease) (problem with GI), blood clots, major depression and PTSD (post-traumatic stress disorder), pain, anxiety, asthma. Concomitant medication(s) included insulin taken for diabetes, start and stop date were not reported; budesonide, formoterol fumarate (SYMBICORT) taken for chronic obstructive pulmonary disease, start and stop date were not reported; atorvastatin calcium (LIPITOR) taken for hyperlipidaemia, start and stop date were not reported; furosemide sodium (LASIX) taken for blood insulin, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; pantoprazole taken for gastrooesophageal reflux disease, start and stop date were not reported; warfarin (WARFARIN) taken for prevention of multiple blood clots to reoccur that was in his both lungs pulmonary and the one in his leg from an unspecified start date taking almost for about 9 years now and ongoing; sertraline hydrochloride (ZOLOFT) taken for major depression, post-traumatic stress disorder from an unspecified start date and ongoing; diazepam (VALIUM) taken for pain, start and stop date were not reported; bupropion hydrochloride (NICOTEX) taken for anxiety, start and stop date were not reported; salbutamol (VENTOLIN) taken for asthma, start and stop date were not reported; albuterol [salbutamol] taken for asthma, start and stop date were not reported; salbutamol taken for asthma, start and stop date were not reported, taking medication for the congestive heart failure, high blood pressure. The patient did not receive prior vaccination (within 4 weeks). The patient got the vaccine today (28Jul2021) and got it noon, they came to his house and right now his arm was just killing him. He can't even move it. The patient was just sharing this, because, he meant he could take a little pain, he was 65 but this arm pain did not allow him he can't move his arm, the pain was really bad. So, that's one reason he was calling its just a little pain, he would he can tolerate that just ignored just pre substantial its like somebody feel like baseball bat and hurt you know it was really quite painful. For this shot today, the patient did not take anything for the pain he haven't taking anything because he ever looked confused he was told not to take anything. He thought they should don't take anything whether can interfere with the vaccine. So, he don't know if he should take anything or it would make the vaccine less effective. The patient was told to come back on 18Aug2021 sometime. They were making a visit to his home because of him, because of his, this point interedition do not transfer to get the injection. So, they made home visit in another words. The patient stated that he did not have any other lab tests, the only lab test that he had was INR, to determine what his warfarin level was in this last two weeks and that was 2.7 by INR. Outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: INSULIN; SYMBICORT; LIPITOR; LASIX [FUROSEMIDE SODIUM]; LISINOPRIL; PANTOPRAZOLE; WARFARIN; ZOLOFT; VALIUM; NICOTEX [BUPROPION HYDROCHLORIDE]; VENTOLIN [SALBUTAMOL]; ALBUTEROL [SALBUTAMOL]; SALBUTAMOL

Current Illness:

ID: 1645960
Sex: F
Age:
State:

Vax Date:
Onset Date: 07/23/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: she could feel it moving down, like her arm and into my hand; she was having a reaction; I could feel it moving down, like my arm and into my hand and then I fainted; I felt like a warmth moving through my arm; my hand was punched and I was not able to like open it; This is a spontaneous report from a contactable consumer (Patient). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Age at vaccination 36 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 23Jul2021, patient received her first dose of vaccine few days ago, since she got it she felt like a warmth moving through her arm. They were like, she was good to go. She started walking and she did, she had fainted before from needle. So, she was like she was gonna sit down. She sat down and she could feel it moving down, like her arm and into my hand and then she fainted. Whenever she came to, they brought her an ice pack and her hand was punched and she was not able to like open it. She had used her other hand to open the one hand which was the hand that she received the shot in that arm and they were kind of concerned at first when they thought she was having a reaction. They asked all the questions, and everything seem to be okay, they said that they were going to report it but then she should check all before she get second dose. Outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645961
Sex: F
Age:
State: MO

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: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210511; Test Name: Covid-19 test; Test Result: Positive

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: really bad headache; jaw painful; It is a little sore in the back; migraines; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA7484), via an unspecified route on 26Jul2021 at 11:40 (at the age of 48-years) as dose 1, 0.3 ml single in the left arm for covid-19 immunisation. The patient medical history included Covid-19 on 11May2021 and migraines, allergies, nasal congestion, allergy and sinus from an unknown date and unknown if ongoing. The patient concomitant medications included fluticasone propionate (FLONASE), Azelastine for allergy and sinus, loratadine 10 mg, 1x/day for antiallergic therapy, Xylometazoline hydrochloride (SUDAFED) 30 mg as needed for nasal decongestant. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jul2021, the patient experienced really bad headache, jaw painful, little sore in the back and migraines. Reporter stated that really bad headache started early in the evening. States that it was not as bad now but was now towards the back. The jaw is still hurting and it started the same time as the headache. It was a little sore in the back. It had gotten a little better. Patient took Ibuprofen 800 and took Maxalt, that she takes for migraines. She does get migraines, it felt like that, but with the jaw pain, it was a little bit worse. She takes allergy medicines and does not know if that contributed at all. She takes all of these every day for allergies when they are really bad in the summer. The patient did not visited to emergency room or physician office. She had just been self medicating. The outcome of the events was recovering.

Other Meds: FLONASE [FLUTICASONE PROPIONATE]; AZELASTINE; LORATADINE; SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]

Current Illness:

ID: 1645962
Sex: F
Age:
State: NC

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

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

Lab Data: Test Date: 202103; Test Name: Barium test; Result Unstructured Data: Test Result:only saw a little problem with reflux; Test Date: 2021; Test Name: cholesterol; Result Unstructured Data: Test Result:Excellent; Test Date: 20210303; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 202103; Test Name: Heart monitor; Result Unstructured Data: Test Result:Nothing wrong; Test Date: 2021; Test Name: chest X-RAY; Result Unstructured Data: Test Result:unknown result; Test Date: 2021; Test Name: EKG; Result Unstructured Data: Test Result:fine; Test Date: 20210303; Test Name: Physical examination; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: pounding heart; trembling/shaking; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 31Mar2021 (at the age of 75 years) (Batch/Lot number unknown, reported as ER87(9 or 3)0) as a single dose for COVID-19 immunization. Medical history included ongoing discoid lupus, ongoing blood pressure high, ongoing spondylosis, ongoing allergies, ongoing diverticulitis, ongoing pre-diabetic, ongoing collapsed mitral valve and in 2019 she became diabetic, but when she went back to her doctor it had gone down so she is now back to pre-diabetes. On prior vaccinations (within 4 weeks), it was reported that the patient had a yearly physical on 03Mar2021, and patient was unsure as to whether or not she received a flu shot at that appointment. AEs following prior vaccinations was reported as nothing other than pains or a slight headache when she gets the flu shot and it really made her feel bad. Reporter thinks she took a Tylenol when she got home on 03Mar2021. Concomitant medication included cyanocobalamin (VITAMIN B12). No additional vaccines administered on same date of the Pfizer suspect. Patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 10Mar2021 13:10 (lot number: EN6207) in the right arm and the glands in the patient's neck were swollen 4 days later, woke up racing and pounding heart on the morning of day 5, and has had that ever since. Patient also experienced having acid problems with gas, tightness in her chest, and little problem with reflux. Patient had been to the ER multiple times and she was told that it was not a side effect of the vaccine. Patient was hospitalized and put on monitor, had tests, etc, and found nothing wrong. After the second vaccination, the patient experienced pounding heart, shaking, and trembling. The event pounding heart was reported as serious with seriousness criteria: caused/prolonged hospitalization. Heart racing and pounding required a visit to the emergency room and physician office. Lab tests included heart monitor: nothing wrong, barium test: only saw a little problem with reflux (after the first dose), taking a lot of blood, EKG, and chest x-ray. Most of these tests occurred while she was in the hospital. After she was discharged and she was still having problems, she went back to her doctor's office to complain of the same things, so they did an EKG in the doctor's office, and it was fine; said she was not having a heart attack. Her doctor also told her that her cholesterol is excellent. Patient is having an upper GI on 10Aug2021 to see if it's coming from her stomach and is having a sleep study on the fifth of next month. Outcome of the events was not recovered. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.

Other Meds: VITAMIN B12

Current Illness: Allergy; Blood pressure high; Discoid lupus erythematosis; Diverticulitis; Mitral valve disease; Pre-diabetic (In 2019 she became diabetic.); Spondylosis

ID: 1645963
Sex: F
Age:
State: IA

Vax Date:
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: arm hurt; This is a spontaneous report from a contactable consumer. A contactable consumer reported different events for 3 patients. This is one of reports. This consumer reported for 14-year-old female patient (reporter's daughter) that, A 14-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date (at the age of 14-years-old) as a dose number unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior Vaccination within four weeks were none. The patient had arm hurt on an unspecified date. Reporter stated that, my girls all their arms hurt (Further clarification wasn't available hence split not made), but none of their neck turn back you got to understand though they are young they are 14 and 16 ok their COVID shot. No Lab Tests were done. Reporter seriousness for the events were Unspecified. The outcome of the event was unknown. QR comment: This might be a split however it was not made by the call handler as there was no information regarding the details of the other patients. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645964
Sex: F
Age:
State: IA

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

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (who was also a patient) reported for a 16-years-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported ), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm hurt on an unspecified date. The event was non-serious. The outcome of the event arm hurt was unknown. Follow-up attempts are required; information about Lot/batch number will be obtained.

Other Meds:

Current Illness:

ID: 1645965
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: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: sense of smell was heightened; she felt an out of body experience, like she was not really present or there; a weight in her chest, it's not pain; it tore her stomach up and she had loose bowels; stomach was on the fritz/it tore her stomach up and she had loose bowels; made her feel like she had coffee and feels like she is going to go through the roof; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 1,single for covid-19 immunization.The patient medical history was not reported.There were no concomitant medications.The patient experienced her sense of smell was heightened, she felt an out of body experience, like she was not really present or there,a weight in her chest, it's not pain,it tore her stomach up and she had loose bowels, made her feel like she had coffee and feels like she is going to go through the roof on an unspecified date.The outcome of the event was unknown.The caller only provided her 1st name details.Caller declined to provide a mailing address or email.Caller stated that she was a nurses aide in a nursing home.The caller stated that her son asked her to drink lots of fluids and rest and stay quiet and that is what she is doing. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645966
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: 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: I have a lots of pain in my hand where I received the vaccination; It is too painful; This is a spontaneous report from a contactable consumer (patient, self-reporting). A patient of unspecified age and gender received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), unknown dose via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included allergic to preservatives (patient cannot take preservatives). The patient concomitant medications were not reported. The patient experienced had lots of pain in hand where received the vaccination; it is too painful. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645967
Sex: M
Age:
State: VA

Vax Date: 03/04/2021
Onset Date: 03/06/2021
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:

Allergies:

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

Symptoms: tendon inflamed; 2 days later developed extreme pain my my left ankle and calve.; 2 days later developed extreme pain my my left ankle and calve.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 (58-years-old at the time of vaccination), as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included ticagrelor (BRILINTA), naproxen, chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX [CHONDROITIN SULFATE; GLUCOSAMINE HYDROCHLORIDE]), vitamin b complex, vitamin c, vitamin d3, acetylsalicylic acid (ASPIRIN LOW), atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021, the patient experienced Extreme pain in my right knee and thigh. Got the 2nd shot 04mar2021 and 2 days later developed extreme pain my left ankle and calve. Pain had not left yet (at the time of report). Therapeutic measures were taken as a result of tendon inflamed, 2 days later developed extreme pain my left ankle and calve as Prednisone and tramadol. Device Date was 29Jul2021. The clinical outcome of the event tendon inflamed was recovered in 2021 with Sequel, remaining all other events were not recovered at the time of the report. The lot number for the vaccine, (PFIZER-BIONTECH COVID-19 VACCINE) was not provided and will be requested during follow up.

Other Meds: BRILINTA; NAPROXEN; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]; VITAMIN B COMPLEX; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; ASPIRIN LOW; LIPITOR

Current Illness:

ID: 1645968
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: cant eat; This is a spontaneous report from a contactable consumer. A 37-years-old male patient (reporter brother) received bnt162b2 (PFIZER COVID 19, Solution for injection, 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. The reporter called his parents his brother who was not blood related and, in another state, and 37 has similar symptoms-could not eat. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.

Other Meds:

Current Illness:

ID: 1645969
Sex: M
Age:
State: NY

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:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: he had numbness in his face; Migraine was so bad/Migraine was returning after 1st dose Covid vaccine; Migraine was so bad/Migraine was returning after 1st dose Covid vaccine; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 19 years old on 01Jul2021 (Batch/Lot Number: EW0180) as dose 2, single for covid-19 immunisation. Medical history included diabetes mellitus, allergy and migraine. Concomitant medication(s) included topiramate (TOPAMAC) taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 (lot number: EW0177) on 10Jun2021 for covid-19 immunisation and experienced migraine, headache and numbness in the face. On an unspecified date, the patient experienced migraine. It was stated that migraine was returning after first dose of Covid vaccine that it was so bad he had numbness in his face. The patient received Tylenol and Ibuprofen but was not helping. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: TOPAMAC

Current Illness:

ID: 1645970
Sex: F
Age:
State:

Vax Date:
Onset Date:
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:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: This is a spontaneous report from a contactable consumer reporting for a patient received from a Pfizer sponsored program COVAX US support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. Medical history included covid-19 on an unknown date. The patient's concomitant medications were not reported. The reporter stated that someone in her family who had COVID after doing what she was told to do go the second dose of the vaccine and she was sick as a dog on an unspecified date. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645971
Sex: F
Age:
State: FL

Vax Date: 04/11/2021
Onset Date: 05/01/2021
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: she was felt like she was going to die and that she did not feel good; fever; sick; my arm is swollen big. It's really, really painful/her arm is swollen very big like something eating inside of her arm; my arm is swollen big. It's really, really painful/her left arm is very painful like someone has a knife in her arm slicing; This is a spontaneous report from a contactable consumer (patient). A 57-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 arm left, on 11Apr2021 as dose 1, single, then on 03May2021 as dose 2, single, both at the age of 57-years-old, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first Pfizer Covid vaccine 11Apr2021 and had swelling in arm and fever. Her swelling went down, and she decided to get her second Pfizer Covid shot on 03May2021. Her arm was swollen very big like something eating inside of her arm. Her arm was very painful like someone has a knife in her arm slicing. She had to miss a week of work. Clarified that the pain in her left arm lasted two days and no fever with the first dose. With the second one, she was sick. She felt like she was going to die and that she did not feel good. She cannot do something with left arm. If she does something heavy that it was painful in her hand. She explained she did not know what to do because had a lot of pain in her left arm. Clarified that second shot was on 03May2021. She had fever with the second dose. It was not getting better and was getting worse. It was hurting nonstop. She did not know what to do. Clarified that the arm involved both times was her left arm. The outcome of the events was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645972
Sex: F
Age:
State: NJ

Vax Date: 06/18/2021
Onset Date: 06/18/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: blood work; Result Unstructured Data: Test Result:everything came back to normal; Test Date: 2021; Test Name: CAT scan; Result Unstructured Data: Test Result:everything came back to normal

Allergies:

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

Symptoms: Severe migraine daily ever since my 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Jun2021 (Batch/Lot Number: EW0180; Expiration Date: 31Aug2021) as dose 2, single for covid-19 immunisation. Medical history included migraine. The patient used to suffer from migraine, her last migraine was probably about 3 years ago. The patient's concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EW0178, expiry: 31Aug2021) in the left arm on 28May2021 for COVID-19 immunization. The patient got her 2nd dose of the Pfizer vaccine and she was having a very severe migraine daily ever since her 2nd dose, it was administered on 18Jun2021, and she had migraine everyday ever since. It started like on the first day (18Jun2021). For a while, she was using Tylenol. About two weeks ago, she went to the emergency room and they gave her another medication, it was the generic one Fioricet, this is just the generic one. In the beginning, the patient was using Tylenol as well as Advil, sometimes she used ibuprofen. Once she went to emergency room, she got prescription of the generic Fioricet. The patient went through blood work as well as CAT scan, they didn't give the name of that, but they were checking for all the information level, everything came back to normal. The outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645973
Sex: F
Age:
State: KY

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: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Severe headache; Diarrhoea; sore throat; runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 12-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FAT484), via an unspecified route of administration in arm right on 29Jul2021 (at the age of 12-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included asthma. The patient known allergies were reported as antibiotic bactrim, pears, corn, environment allergies. The other medications in two weeks were reported as yes. The patient was not pregnant at the time of vaccination. 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 not been tested with covid-19. The patient previously took bactrim and experienced drug hypersensitivity. On 29Jul2021, the patient experienced severe headache, diarrhoea, sore throat and runny nose. The patient received no treatment for the events. The outcome of the events was reported as unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1645974
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: can not swallow or sip water; shortness of breath/difficulty breathing; pain in the trachea; pain in the gland; pain goes to the back of the brain; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 28Jul2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 25Jun2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization and experienced a lot of pain in the joints, the shoulder and the neck. On 29Jul2021, the patient experienced cannot swallow or sip water, shortness of breath/difficulty breathing, pain in the trachea, pain in the gland and pain goes to the back of the brain. The course of events was reported as follows: About 3 hours ago, in the morning, the patient started to experience some shortness of breath, difficulty breathing, pain in the trachea, pain in the gland, which was quite strong and the patient could not swallow or sip water. The pain went to the back of the brain. The patient wanted to know if these symptoms were normal. He was 100% sure that these were due to the vaccine, because he had never experienced anything like this. When he went to see his PCP the day before yesterday he told him that after the first dose of the vaccine he had a lot of pain in the joints, the shoulder and the neck, and the PCP stated that several of his patients also had those symptoms. The clinical outcomes of the events cannot swallow or sip water, shortness of breath/difficulty breathing, pain in the trachea, pain in the gland and pain goes to the back of the brain were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645975
Sex: F
Age:
State: FL

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

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

Lab Data: Test Name: Allergy Test; Result Unstructured Data: Test Result:Allergies; Comments: last time she was tested for allergies she had 3 pages with 2 columns on each page of allergies

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: small patch of rash around the injection site; she had a bright red kind of bumpy rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously the patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced small patch of rash around the injection site and she had a bright red kind of bumpy rash. It was reported that the first day after the callers second shot of the Pfizer covid 19 vaccine she had a small patch of rash around the injection site, then two days after the second shot she had a bright red kind of bumpy rash that went down to the elbow, it lasted for 11 days. She talked to her pharmacist and they said yes it was definitely the vaccine. The last time she was tested for allergies she had 3 pages with 2 columns on each page of allergies. On an unspecified date, the patient underwent lab and procedure which included Allergy Test, last time she was tested for allergies, she had 3 pages with 2 columns on each page of allergies. Outcome of the events was recovered in 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645976
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: She has a cough since two or three days before the first dose of the vaccine and it hasn't stopped; This is a spontaneous report from a contactable consumer or other non hcp. A female patient (reporter's mother) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection),via an unspecified route of administration on an unknown date in 2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Patient medical history included cough from an unknown date (has a cough since two or three days before the first dose of the vaccine). The patient's concomitant medications were not reported. The patient experienced she has a cough since two or three days before the first dose of the vaccine and it hasn't stopped on an unknown date in 2021. It was reported that reporter's mother who received the first dose of the Pfizer Covid-19 vaccine from this week, two weeks ago and it's her turn to get the second dose of the vaccine today or tomorrow. She had a cough since two or three days before the first dose of the vaccine and it hadn't stopped, it's not a flu, she mentions that the cough was not constant, but it was every day and especially at night. She would like to know if her mom should receive the second dose of the vaccine. The outcome for event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645977
Sex: U
Age:
State: KS

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

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

Lab Data:

Allergies:

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

Symptoms: I have a rash in my right arm and both of my left and right foot; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had rash in right arm and both of left and right foot on an unspecified date with outcome of unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1645978
Sex: F
Age:
State: LA

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Headaches; Lightheadedness; lump under left armpit; This is a spontaneous report from a contactable nurse. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0164) via an intramuscular route of administration in the left arm on 27Jul2021 at 16:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The medical history included polycystic ovarian syndrome (PCOS), hypertension (HTN), obesity and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) and lisdexamfetamine mesilate (VYVANSE), all from unknown dates and for unspecified indications. On 27Jul2021, the patient experienced headaches, light-headedness and lump under left armpit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, light-headedness and lump under left armpit were unknown at the time of this report.

Other Meds: FLUOXETINE; METFORMIN; LISINOPRIL; HCTZ; VYVANSE

Current Illness:

ID: 1645979
Sex: F
Age:
State: LA

Vax Date: 07/23/2021
Onset Date: 07/23/2021
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: 20210729; Test Name: Nasal Swab; Test Result: Negative ; Comments: covid test result=Negative

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Face swelling; Lips swelling; Leg cramps; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration in the left arm on 23Jul2021 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not have any concomitant medications. On 23Jul2021, after1 hour of vaccination the patient experienced face swelling, lips swelling and leg cramps. Therapeutic measures were taken as a result of events and included treatment with prescribed steroids and Benadryl. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 29Jul2021, the patient underwent nasal Swab, SARS CoV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of face swelling, lips swelling and leg cramps were recovered on Jul2021. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645980
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: not feeling well; This is a spontaneous report from a Pfizer-sponsored program received via a contactable consumer or other non-health care professional (patient). A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On and unspecified date in Apr2021, the patient after receiving 1st shot experienced not feeling well. She stated that she received her 1st Pfizer Covid 19 vaccine at the end of Apr, 2nd vaccine was scheduled on 04May and was opted not to go back because she was feeling unwell after receiving 1st shot (did not go in to detail regarding symptoms). She would now like to know what the efficacy of the 1st shot is, if she can still get her 2nd shot or if she needs to begin the vaccination series again. She wanted to know if there will be a need to retake the entire vaccination series of the Pfizer BioNTech Covid-19 Vaccine if there 3 weeks dosing interval of the first and the second dose was not observed. She was advised by her doctor to not take the 2nd dose because she was not feeling well. She wanted to know the risks associated after receiving a dose of the Pfizer BioNTech Covid-19 Vaccine. She wanted to know the efficacy of the Pfizer BioNTech covid-19 vaccine after one dose and wanted to know if she will be contraindicated in getting the second dose of the Pfizer BioNTech Covid-19 Vaccine. The clinical outcome of the events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645981
Sex: F
Age:
State: WI

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: Nausea

Symptoms: Can't sleep or stay sleep; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old, non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 29Jul2021 at 16:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. Concomitant medications included paracetamol (TYLENOL) for unknown indication from an unknown date. The patient previously received morphine (MANUFACTURER UNKNOWN) and linaclotide (LINZESS) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jul2021, the patient could not sleep or stay sleep. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event could not sleep or stay sleep was unknown at the time of this report. The lot number for BNT162b2, were not provided and will be requested during follow up.

Other Meds: TYLENOL

Current Illness:

ID: 1645982
Sex: M
Age:
State: TX

Vax Date: 07/23/2021
Onset Date: 07/24/2021
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: Test Date: 20210728; Test Name: Coronavirus (COVID-19) YHL; Test Result: Negative; Comments: Nasal Swab

Allergies:

Symptom List: Injection site pain

Symptoms: This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 23Jul2021 at 19:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic and high cholesterol. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and atenolol (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jul2021, the patient experienced mildly lethargic. On 25Jul2021 at 17:00, the patient experienced dry coughing, deep, dry cough persisted for two days. On 27Jul2021, the patient felt legitimately ill with coughing (semi productive with mucus), body aches and sinus pressure. The patient had no fever at any point. On 28Jul2021, the patient had more sinus drip than he had ever had in his life. He went through a box and a half of Kleenex in 24 hours. The patient had to stand in shower and let nose just run, several times throughout the day and experienced lots of vigorous sneezing, coughing largely subsided by that point. On 29Jul2021, the patient's sinuses began to clear up but the patient woke up at night in an aggressive, unexplained fit of coughing that persisted for about 30 minutes. On 30Jul2021, the patient felt he was on the mend and symptoms were finally subsiding. The patient had scheduled an appointment with his doctor for next Wednesday for antibody test. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 28Jul2021, the patient underwent coronavirus (COVID-19) YHL test and the result was negative. The clinical outcome of the events vigorous sneezing, mildly lethargic, dry coughing, legitimately ill with coughing (semi productive with mucus), body aches, sinus pressure and sinus drip was resolving at the time of this report.

Other Meds: METFORMIN; ATENOLOL

Current Illness:

ID: 1645983
Sex: F
Age:
State:

Vax Date:
Onset Date: 07/02/2021
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: Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Lymphoma; This is a spontaneous report from a contactable nurse. An 85-year-old female patient not pregnant received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose 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 02Jul2021 the patient experienced lymphoma. The patient was hospitalized for lymphoma for 5 days. Event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. Therapeutic oncology measures were taken as a result of lymphoma. Patient did not have COVID prior vaccination, patient was tested for COVID post vaccination with Nasal Swab result was negative on unknown date. Patient had not recovered from the event, at the time of the report. No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the events "lymphoma" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1645984
Sex: F
Age:
State: LA

Vax Date: 01/28/2021
Onset Date: 02/01/2021
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: Test Name: ANA; Test Result: Positive ; Comments: Initially; Test Name: ANA; Test Result: Negative ; Comments: second test was negative; Test Date: 202102; Test Name: biopsied; Result Unstructured Data: Test Result:eczema

Allergies:

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

Symptoms: got staph in one area of it; biopsy showed eczema; rash which was mostly on her face/ spread to other areas of her body; This is a spontaneous report received from a contactable nurse (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), administered in left arm on 28Jan2021 (at the age of 40-year-old) around same time of first dose reported as in the early afternoon between 2-3 PM as dose 2, single for COVID-19 immunisation. The patient's medical history included hypertension from 2010, anxiety and depression both from 2019. The patient was taking unspecified concomitant medications reported as non-relevant. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), administered in right arm on 07Jan2021 (at the age of 40-year-old) in the early afternoon between 2-3 PM as dose 1, single for COVID-19 immunisation. The patient experienced eczema on Feb2021 reported as serious with medically significant criteria. Caller was a registered nurse (RN) and she was calling to report her side effects after receiving both doses of the Pfizer COVID-19 vaccine. Caller (nurse) reported that two weeks after her second dose (Feb2021), received on 28Jan2021, she developed a rash which was mostly on her face. The rash then spread to other areas of her body. She saw a dermatologist, the biopsy showed eczema, was worked up for lupus, her antinuclear antibody (ANA) test was positive initially and the second test was negative. She said she was 100% glad she got the vaccine but that it seems strange to suddenly had eczema at her age. She wanted to know if this had been reported by anyone else and wanted to report her symptoms. She said that she didn't have eczema before she got the vaccine but now (unspecified date and time) she did, so she wanted to see if anyone had that experience, not to complain. She clarified she got the Pfizer COVID-19 vaccine, two dose, clarified further to Pfizer-BioNTech COVID-19 vaccine. Caller said it seems like the eczema happened right about then, she had never had it in her life. She said the eczema started a couple weeks after second dose of the vaccine. She said her first dose (lot number EL3246) was given 07Jan2021 in her right arm in the early afternoon between 2-3 PM. She said her second dose was given on 28Jan2021 (lot number EL9265), given around same time of day in her left arm. Caller said that she was taking concomitant medications but nothing relevant (as reported. Caller said that the eczema started two weeks after second dose so in early to mid-Feb2021, and it was still flaring pretty bad. She said she did not have it before and they had just kind of treated it like mask rash on her face then it spread to other areas of her body. She said they had it biopsied and said it was eczema, during May2021. Caller said that she was using steroid creams for treatment pretty much. No further details provided about steroid creams. Caller said all this had not made her anxiety and depression better for sure. Caller said that she would like to know if there were any resources, if people had verbalized having issues with eczema after vaccination. About seriousness caller said to her it was significant, she also got staph in one area of it, this was in May2021, and she had to work, it was very taxing dealing with it for such a long period of time and emotionally going from not having it to having it for months. The outcome of the events was unknown for "got staph in one area of it" and not resolved for all other events.

Other Meds:

Current Illness:

ID: 1645985
Sex: F
Age:
State:

Vax Date: 07/29/2021
Onset Date: 07/30/2021
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: pain; lymph nodes popping out under her left armpit and side of her left breast; injection site pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Jul2021 14:35 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 30Jul2021 03:00 the patient experienced pain, lymph nodes popping out under her left armpit and side of her left breast, injection site pain. Reporter, female, aged 63, received first dose of the Pfizer BioNTech Covid 19 vaccine yesterday on 29Jul2021 at 2:35pm-2:40pm. This morning on 30Jul2021 around 3am she woke up with pain and noticed lymph nodes popping out under her left armpit and side of her left breast. She says the lumps her real bad. She received the shot on the right side but has no pain on the right side, just injection site pain if she presses on it but nothing severe. While on the phone she noticed she has a swollen one on her neck as well. Is this a side effect of the vaccine. Question: She has an upcoming biopsy bladder surgery on Wednesday, is it still okay to do. Outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up (23Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1645986
Sex: M
Age:
State:

Vax Date: 07/23/2021
Onset Date: 07/23/2021
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:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Lymphedema / swelling of lower left leg; Lymphedema / swelling of lower left leg; Body aches, back pain and neck pain for following week.; Body aches, back pain and neck pain for following week.; Body aches, back pain and neck pain for following week.; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 23Jul2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient previously had tree nuts and experienced allergy to nuts. The patient also had peach previously and experienced fruit allergy. The patient did not have any other medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 02Jul2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jul2021 at 19:00, the patient experienced lymphedema / swelling of lower left leg. The patient also experienced body aches, back pain and neck pain for following week on 23Jul2021 at 19:00. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events lymphedema / swelling of lower left leg; body aches, back pain and neck pain for following week was resolved with sequelae on an unknown date in Jul2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1645987
Sex: M
Age:
State: CA

Vax Date: 06/06/2021
Onset Date: 07/06/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: severe pain, tingling sensation in both feet/not able to walk/neurologist suspects neuropathy; I am not able to walk/I have to use crutches to walk; severe pain; Tingling sensation in both feet; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 14-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0187), via an unspecified route of administration, administered in Arm Right on 06Jun2021 16:00 (at the age of 14-years-old) as dose 2, single for covid-19 immunisation at Pharmacy or Drug Store. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EW0177), via an unspecified route of administration, administered in right arm on 16May2021 at 04:00 PM (at the age of 14-years-old) as single dose for COVID-19 immunisation. The patient stated 4 weeks after booster dose, on 06Jul2021 at 08:00, he woke up one morning with severe pain, tingling sensation in both feet. He was not able to walk, he saw a podiatrist who referred me to a neurologist and the neurologist suspects neuropathy. He has to use crutches to walk and was on gabapentin. She has had these indications for 3 weeks now, its not getting better. Patient is otherwise very healthy with no other medical issues. Therapeutic measures were taken with gabapentin as a result of all event. The outcome of all event was not recovered. Follow-Up (03Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645988
Sex: M
Age:
State:

Vax Date: 07/27/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: Temperature last night; Result Unstructured Data: Test Result:Low

Allergies:

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

Symptoms: low temperature last night; sore throat; This is a spontaneous report from a contactable Consumer (patient) that. A 12-years-old male patient received BNT162B2 (Pfizer-BioNTech covid-19 vaccine, Solution for injection), via an unspecified route of administration on 27Jul2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller asks about if the vaccine could cause a sore throat as a side effect for a 12-year-old because her grandson went swimming yesterday and had a low temperature last night but complained of a sore throat on an unspecified date in Jul2021. Caller states she didn't know if it was the pool that was treated the day before with chlorine or would it be the vaccine. Caller asks if it is known which manufacturer is suitable for a heroin or opioid addict or is it recommended, they get the vaccine? Caller asks if there is a specified time that an addict stop using before receiving the vaccine such as five days or ten days? Caller states the person she is calling about does not have any health issues other than he has used before. Caller states she can't believe that after developing the vaccine that his question hasn't arisen to as to how it would affect someone on heroin or opioids because this had to have been a concern and been in a clinical trial or something. The patient underwent lab tests and procedures which included body temperature: low on Jul2021. The event outcome was Unknown. Provided disclaimer that Pfizer cannot provide individual treatment recommendations.

Other Meds:

Current Illness:

ID: 1645989
Sex: F
Age:
State: AZ

Vax Date: 03/25/2021
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: IM
Vax Site: LA

Lab Data: Test Name: EMG; Result Unstructured Data: Test Result:GBS

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Guillain Barre syndrome; diffuse weakness; This is a spontaneous report from a contactable physician (Neurologist). A 64-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 25Mar2021 (Lot number was not reported) as single dose (age at vaccination: 64-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. It was unknown about any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On an unspecified date patient experienced guillain barre syndrome and diffuse weakness. Events resulted in Emergency Room and Physician Office visit. The reporting Neurologist stated that he saw a patient this week and wanted to report the patient presented with guillain barre syndrome (GBS) approximately 2 weeks after receiving the vaccine. He clarifies that within 2 weeks after receiving the vaccine, the patient presented to the Emergency room with diffuse weakness and Guillain-Barre syndrome. Caller is wanting to know what the appropriate way to follow-up is. He clarifies he knows how to treat Guillain-Barre, he is a neurologist, he knows what to do, he just really wanted to know what channels to go through to log the adverse event. Reporter stated he had rules about HIPAA. He had yet to contact the patient to discuss the possibility of sharing their information. Reporter stated that the patient had knee surgery 2 days before the onset of weakness. The surgery date was 06Apr2021. The patient had electrodiagnostic testing done, clarified as an electromyogram (EMG). An EMG makes the diagnosis of GBS on unknown date. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided regarding, the causal association between the event Guillain Barre syndrome and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1645990
Sex: F
Age:
State: AL

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: slight headache; weak and tired; weak and tired; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 15Mar2021 (Batch/Lot Number: EN6200) (at age 65-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. When the patient received the first dose Pfizer Covid Vaccine on 15Mar2021, she had a severe reaction from it and was taken to the emergency room then discharged. The paramedics had to come to the vaccination site and give the patient mediations there. She was sick for about a week behind the first dose Pfizer Covid Vaccine with slight headache, just weak and tired as soon as the first dose was administered on 15Mar2021. She was in bed for about what seemed like a month or at least three weeks until the patient went to get the second dose of Pfizer Covid Vaccine. Outcome of the event of headache was not recovered while for the remaining events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645991
Sex: F
Age:
State: TX

Vax Date: 04/01/2021
Onset Date: 04/10/2021
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:

Allergies:

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

Symptoms: consistent dull headache with bursts of sharpstabbing pain; bursts of sharp stabbing pain; tense up; eyes roll back, almost like a tic.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 13:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 13:30 as a single dose for COVID-19 immunisation. On 10Apr2021, after the second dose of vaccination, the patient experienced consistent headache which was a dull headache with bursts of sharp stabbing pain that caused the patient to tense up and the eyes rolled back, almost like a tic. The patient got the bursts 2-3 times daily since April 2021 and did not have medical coverage to get seen by a doctor. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dull headache, bursts of sharp stabbing pain, tense up and eyes rolled back almost like a tic were not recovered at the time of the report.

Other Meds:

Current Illness:

ID: 1645992
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: My mom had a stroke with in a month or two after getting vaccine.; This is a spontaneous report from a Pfizer sponsored program Pfizer.com - General Company Information. A contactable consumer reported for a female patient (reporters mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date 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, reporters mother had a stroke within a month or two after getting vaccine on an unspecified date. She was fine now and the doctors found no indication of legs or other area throwing off clot. Reporter's friend's brother had same issue. Reporter was suggesting to make inquiry on both cases. She told anyone can contact to her she would be trying to help. The outcome of event was recovered on an unspecified date. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645993
Sex: M
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: had a stroke with in a month or two after getting vaccine.; This is a spontaneous report from a Pfizer sponsored program- General Company Information. A contactable consumer reported for a male patient (reporter's friend's brother) that: A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, unknown dose (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. His mom had a stroke within a month or two after getting vaccine. She was fine now, and the doctors found no indication of legs or other area throwing off clot. A friend of his brother had same issue. He would suggest you make and inquiry on both cases. Contact his if you want. Just trying to help. Outcome of event was unknown. The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645994
Sex: M
Age:
State: TN

Vax Date: 03/23/2021
Onset Date: 04/06/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: Test Result:gradually increasing; Comments: peaked in April; Test Name: Calcium score test; Result Unstructured Data: Test Result:18% of my soft plaque has developed within the; Comments: past year, some calcification of a valve

Allergies:

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

Symptoms: Calcium score test indicates that 18% of my soft plaque has developed within the past year, some calcification of a valve; Chest pain; gradually increasing along with blood pressure; This is a spontaneous report from a contactable consumer or other non HCP (The patient reported for self). A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; FORMULATION: solution for injection, Batch/Lot Number: en6207), via an unspecified route of administration, administered in left arm on 23Mar2021 14:00 (at the age of 68-years-old) as dose 2, single for COVID-19 immunisation. Medical history included Tobacco user from an unknown date and unknown if ongoing (former smoker). No known allergies. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; FORMULATION: solution for injection, Batch/Lot Number: en6201) via an unspecified route of administration, administered in left arm on 02Mar2021 as dose 2, single for COVID-19 immunisation. No other vaccine in four weeks. Concomitant medication(s) /Other medications in two weeks included: Aminobenzoic acid, BIOTIN, Calcium Pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate (B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE; CYANOCOBALAMIN; FOLIC ACID;INOSITOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE]); Colecalciferol (D3) both taken for an unspecified indication, start and stop date were not reported. The patient experienced Chest pain, gradually increasing along with blood pressure on 06Apr2021, Calcium score test indicates that 18% of my soft plaque has developed within the past year, some calcification of a valve on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: Gradually increasing on Apr2021 peaked in April, Investigation: 18% of my soft plaque has developed within the on past year, some calcification of a valve. Therapeutic measures were taken as Lisinopril and statin for the events. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACI; D3

Current Illness:

ID: 1645995
Sex: F
Age:
State: CA

Vax Date: 07/29/2021
Onset Date: 07/30/2021
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:

Allergies:

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

Symptoms: heart is racing; This is a spontaneous report from a contactable consumer, the patient. A 64- year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0186) via an unspecified route of administration in the left arm on 29Jul2021 at 16:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol, anxiety and menopause. Prior to the 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. Concomitant medications included vitamins (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and atorvastatin calcium (LIPITOR); all for unknown indication on unknown date, unknown if ongoing. Patient did not know of any allergies to food, medication or other products. On 30Jul2021 at 06:30, the patient experienced heart racing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse event heart racing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heart racing was not recovered at the time of this report.

Other Meds: LEXAPRO; LIPITOR

Current Illness:

ID: 1645996
Sex: F
Age:
State: PA

Vax Date: 03/04/2021
Onset Date: 05/21/2021
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: Test Date: 2021; Test Name: Blood Test; Result Unstructured Data: Test Result:likely lupus; Comments: Blood tests indicated likely autoimmune disease-most likely lupus

Allergies:

Symptom List: Vomiting

Symptoms: Neck pain; knee pain; Swollen knee; autoimmune disease-most likely lupus; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration, administered right arm on 04Mar2021 (at the age of 26-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (lot number: EN6199) on an unspecified date in 2021. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Medical history included childhood epilepsy and migraines. The patient was not diagnosed with COVID-19 prior vaccination and since the vaccination she was not tested for COVID-19. Concomitant medication included sumatriptan taken for an unspecified indication, start and stop date were not reported. The patient reported that on 21May2021 (also reported about 2 months after 2nd dose) she experienced neck pain that has migrated down to her left knee. Left knee swelled up and remained swollen for 2 months. Blood tests indicated likely autoimmune disease-most likely lupus. The events were reported as serious (disability). The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit. The events were treated with Prednisone and hydroxychloroquine. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: SUMATRIPTAN

Current Illness:

ID: 1645997
Sex: M
Age:
State: NC

Vax Date: 04/27/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:62/42; Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:180-190; Test Date: 20210214; Test Name: treadmill test; Result Unstructured Data: Test Result:everything was perfect, looked great; Test Date: 2021; Test Name: ELISA; Result Unstructured Data: Test Result:it was a Coronavirus 2; Test Date: 2021; Test Name: pulse; Result Unstructured Data: Test Result:107; Test Date: 2021; Test Name: pulse; Result Unstructured Data: Test Result:110; Test Date: 2021; Test Name: pulse; Result Unstructured Data: Test Result:Low; Test Date: 2021; Test Name: COVID-19; Result Unstructured Data: Test Result:never had Covid or antibodies or was never sick; Test Date: 20210214; Test Name: ultrasound; Result Unstructured Data: Test Result:everything was perfect, looked great

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Profusely sweat/get sweaty quickly; Dizzy/Light-headed; Erratic blood pressure; Erratic heart beat; Almost passed out and fell on the steps; permanent heart damage; These symptoms were what caller found "disturbing"; Not feeling well; This is a spontaneous report from a contactable consumer (patient). This 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number ER8731), via an unspecified route of administration, on 27Apr2021 (at the age of 66-year-old) at single dose for COVID-19 immunization. Historical vaccine includes the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number lot EP7533) on 06Apr2021 (at the age of 66-year-old) at single dose for COVID-19 immunisation. Relevant medical history included little bit of gastrooesophageal reflux disease (GERD) before receiving the vaccine for which the patient received a prescription, indigestion (before vaccination) and suspected COVID-19 (symptoms of the COVID but said it wasn't in his system, as reported) from Dec2019 until an unknown date. The patient is retired and used to pull the weeds and cut the grass and plat plants. No relevant concomitant medications were provided. Before vaccination, on 14Feb2021, the patient had a cardiac evaluation with a treadmill study ad well as an ultrasound to follow up after having indigestion concerns. The testing showed the following results: "everything was perfect, looked great!". About a week or two before vaccine, the patient had to go to the doctor, and they did a test to see if he had COVID or not or if he had it in the past. The results were that the patient never had COVID or antibodies or was never sick. In Dec2019 patient had symptoms of the COVID but said it wasn't in his system. In Apr2021, after second shot, the patient started to not feeling well, get sweaty quickly and dizzy and light headed. The patient began having "erratic heart beat and erratic blood pressure." The patient come inside, he had a blood pressure machine and his blood pressure was low. The caller' pulse was also low. The patient used to be able to walk about 2 miles a day. The patient tried doing two block and he felt sweaty, light headed. The last time before the patient went to the doctor he almost passed out and fell on the steps. The caller's blood pressure was 62/42 with a pulse of 107. The patient made an appointment with his doctor and said they changed the blood pressure medicines and the problem was his heart. The patient started to record hourly blood pressure readings for a week. Even when the patient laid down to go to bed his blood pressure was 180-190. When the patient would wake up and it would be maybe normal but his pulse was 110. The patient hadn't done anything strenuous. The patient went to a heart doctor and went through everything a determined to an ELISA test that it was a Coronavirus 2 and the shot had screwed up his heart. The patient has a heart monitor for 3 days and didn't know the results until next week. The patient's medicines were changed, and the result was as long as he stayed in the house and didn't do anything active his blood pressure stayed okay. But as soon as the patient went outside, he got halfway washing the car and had to stop. This is supposed to wear off in about 4 months after the last shot. Several of the heart doctor's patients have had this. The patient has read the information given to him and he saw a fast pulse was listed but doesn't see that his blood pressure will go erratic. These symptoms were what caller found "disturbing" and prompted his cardiology follow up. The patient won't know if there is any permanent heart damage until later which is what he is scared of. The patient had not recovered from 'erratic blood pressure' and 'erratic heart beat' while the outcome of the remaining events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645998
Sex: M
Age:
State: FL

Vax Date: 07/22/2021
Onset Date: 07/24/2021
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: multiple personality disorder; couldn't remember some things; having an angry outburst; Some things he was saying, he seemed to be confused like he didn't know where he was; disoriented; talking like he wasn't himself; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 16-years-old male patient received bnt162b2 (BNT162B2, Pfizer Covid-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jul2021 (Batch/Lot Number: FA7484, Expiry date was not reported) (at the age of 16-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included epilepsy and asthma (she reports when her son was younger, he had epilepsy, but he outgrew that and hasn't had a seizure in several years. He also has asthma). There were no concomitant medications. It was reported that at the end of Jun2021 he received a vaccine, it was the DTaP vaccine, but she was not sure. There were no adverse events reported prior to vaccination. On 24Jul2021, the patient experienced talking like he wasn't himself, some things he was saying, he seemed to be confused like he didn't know where he was and disoriented. On 25Jul2021, the patient experienced having an angry outburst. On 26Jul2021, the patient experienced couldn't remember some things. On an unspecified date, She said that it's like her son has multiple personality disorder. The mother called because she wanted to report symptoms that her son was having after receiving the Covid 19 vaccine. She stated that her son received first dose of the Pfizer Covid19 vaccine last Thursday, 22Jul2021 and was scheduled to get the second dose on 12Aug2021. However, the caller mentioned her son experienced side effects. On Saturday, 24Jul2021 her son was talking like he wasn't himself. He ended up having an angry outburst. Some things he was saying, he seemed to be confused like he didn't know where he was. He was disoriented. The agent is transferring the caller; she is not in any Pfizer program. She confirmed the details provided by the transferring agent. She reported that it was Sunday, 25Jul2021 that her son had the angry outburst. She was asking if these are side effects that have not been reported. She has called so many people trying to figure out if the Covid 19 vaccine caused this. Everything else for her son was normal, normal activities and normal diet, nothing was different except the Covid 19 vaccine. She did not know how many people she called. She did call Pfizer yesterday and spoke to someone who put her on hold. She doesn't think that agent took a report. She has no report or reference number. She further reported that on Monday, 26Jul2021 he was still disoriented and couldn't remember some things. She reported that on Tuesday, 27Jul2021 her son seemed to be ok. It seems his symptoms resolved. She stated that when school starts, the schools may be requiring the vaccine for the kids who can get the vaccine. There were no relevant tests reported. The events did not result in emergency room or physician office visit. The clinical outcome of the event multiple personality disorder was unknown, and all other events was recovered on 27Jul2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645999
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
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: stomach ache; dizzy; Migraine; Head was really foggy she could not concentrate; experienced some allergic reactions; itchiness all over the body; diarrhea; body ache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. Medical history included allergic to Sulfa (almost died when she had it) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unknown date in 2021, the patient experienced some allergic reactions like itchiness all over the body, diarrhea, body ache, stomachache, was dizzy, had migraine for 3 weeks, and head was really foggy she could not concentrate. When patient went to get the second dose of the vaccine, the pharmacist told her that due to her allergies, she should not had gotten the first dose because sulfur was a component of the vaccine and would not give the patient her second dose. The patient wanted to know if sulfur was a component of the vaccine. Response from Pfizer mentioned that Sodium Chloride is listed as an ingredient of the Pfizer BioNTech COVID-19 vaccine and Sodium Chloride may contain trace amount of sulphate which can be converted to sulphite. The patient wanted to know if she can get the second dose of the Pfizer COVID-19 vaccine considering her allergy to sulfur drugs and her experience (some allergic reaction) with the first dose of the vaccine. The outcome of the events migraine and head was really foggy she could not concentrate was resolved on an unknown date in 2021. The outcome for the other events was unknown. The patient declined to make a report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646000
Sex: F
Age:
State: TX

Vax Date: 03/26/2021
Onset Date: 05/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210303; Test Name: CT scan; Result Unstructured Data: Test Result:Stomach OK; Comments: Had stomach pain; Test Date: 20200505; Test Name: X-rays; Result Unstructured Data: Test Result:Compression fracture; Comments: Had a fall-fractured L-2 vertebrae, fine now

Allergies:

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

Symptoms: Had a fall fractured L-2 vertebrae, fine now; This is a spontaneous report from a contactable consumer, the patient. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202; Expiration Date: Jun2021), dose 2 intramuscular, administered in Left upper arm on 26Mar2021 11:00 as dose 2, single (69-years-old) for covid-19 immunisation. Medical history included , ongoing osteoporosis (drug name: vitamin d, reason for use: osteoporosis ongoing: yes), ongoing allergies (drug name: Claritin, reason for use: allergies ongoing: yes), ongoing acid reflux (drug name: pantoprazole sodium, reason for use: acid reflux ongoing: yes). Concomitant medication(s) included colecalciferol (VITAMIN D) taken for osteoporosis from 2018 and ongoing; loratadine (CLARITIN) taken for allergies from 2017 and ongoing; pantoprazole sodium taken for acid reflux from 2016 and ongoing. Patient previous took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810; Expiration Date: Jun2021), dose 1 intramuscular, administered in Left upper arm on 05Feb2021 11:00 as dose 1, single (69-years-old) for covid-19 immunisation. On 05May2021, patient had a fall fractured l-2 vertebrae and fine at the time of reporting. The patient underwent lab tests and procedures which included computerised tomogram: stomach ok on 03Mar2021 Had stomach pain, x-ray: compression fracture on 05May2021 Had a fall-fractured L-2 vertebrae, fine now. The outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: VITAMIN D [COLECALCIFEROL]; CLARITIN [LORATADINE]; PANTOPRAZOLE SODIUM

Current Illness: Acid reflux (oesophageal) (Drug name: Pantoprazole sodium Reason for use: Acid reflux Ongoing: yes); Allergy (Drug name: Claritin Reason for use: Allergies Ongoing: yes); Osteoporosis (Drug name: Vitamin D Reason for use: Osteoporosis Ongoing: yes)

ID: 1646001
Sex: M
Age:
State: CA

Vax Date: 06/06/2021
Onset Date: 07/06/2021
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: RA

Lab Data: Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Comments: had a lumbar MRI in the last two weeks; Test Date: 2021; Test Name: Metabolic Panel; Result Unstructured Data: Test Result:Normal; Comments: Investigation: metabolic panel (Date: Unknown, Result / Units: normal)

Allergies:

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

Symptoms: bilateral ankle pain, with pins and tingling pain; bilateral ankle pain, with pins and tingling pain; The pain started on 06Jul2021 and is getting worse./bilateral ankle pain, with pins and tingling pain:/for not able to walk normally; not able to walk normally; developed neuropathy in his ankle; lot of pain in the last three weeks./ The pain started on 06Jul2021 and is getting worse.; pain occurred in both legs at the same time "all of sudden"; This is a spontaneous report from a contactable consumer or other non-healthcare professional (parent). Parent called on behalf of his son. A 14-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0187) via an unspecified route of administration, administered in arm right on 06Jun2021 at 16:00 (at age of 14-years old) as DOSE 2, SINGLE for covid-19 immunization at pharmacy. The patient medical history included he had the big toe kind of curved since he was a child, a little curl in his toes. Doctors had checked him before, and he has grown over time. Concomitant medication was reported as none. Prior vaccination within 4 weeks or adverse events (AEs) following prior vaccinations, family medical history relevant to AE(s) were reported as none. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0177) via an unspecified route of administration, administered in arm right on 16May2021 at 16:00 (at age of 14-years old) as DOSE 1, SINGLE for covid-19 immunization. There was no additional vaccines administered on same date of the pfizer suspect. It was reported that, his son received both doses of the Pfizer covid 19 vaccine and on unspecified date in 2021, four weeks exactly to the day of the second shot he developed neuropathy in his ankle where his shin bone/feet intersect. He has been in a lot of pain in the last three weeks. The pain occurred in both legs at the same time "all of sudden". Caller reported that they had been to the urgent care, pediatrician, and neurologist. He had seen several doctors, and now they were working with a neurologist. His son has had a metabolic panel drawn and has had a lumbar (Magnetic resonance imaging) MRI in the last two weeks. For 25 days he had been in pain. He shared his son used to be a very active kid and was now on crutches. Caller was asking if we have seen similar cases or reports and what, if any, recommendations coming from Pfizer. He also said his wife reported his son's case on a website not sure which website. On 06Jul2021, the patient was not able to walk normally and had bilateral ankle pain, with pins and tingling pain which worsened. Caller confirmed information provided by transfer agent but adds he doesn't know for sure it was neuropathy. Stated he thinks it was some form of neuropathy; his son was in pain; he had pins and tingling pain; with funny sensations; and he had not been able to walk like he used to. He was active, riding a bike, running and hiking. Went out to play the previous day and came home that evening complaining of pain and the next day it was even worse. The pain started on 06Jul2021 and getting worse. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown results (had a lumbar MRI in the last two weeks) on unspecified date in 2021, metabolic function test: normal (reported as Investigation: metabolic panel (Date: Unknown, Result / Units: normal) on unspecified date in 2021. The patient visited Physician Office due to AEs and no Emergency Room visit. No PQC involved. The outcome of the events not able to walk normally, the pain started on 06Jul2021 and was getting worse, bilateral ankle pain, with pins and tingling pain was not recovered while the outcome the events pain occurred in both legs at the same time "all of sudden", lot of pain in the last three weeks and developed neuropathy in his ankle was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am