VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.







Manufacturers

Total Manufacturer
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 0925653
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: after a flu shot that had numerous elements in it patient was allergic to; Initial information was received on 05-Jan-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media. This case involves a patient of unknown age and after a flu shot that had numerous elements in it patient was allergic to (hypersensitivity), while patient received vaccine INFLUENZA VACCINE. Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient had numerous elements in it patient was allergic to (hypersensitivity). No laboratory data was provided. It was not reported if the patient received a corrective treatment. At the time of report, the outcome of event was unknown. Information on lot number was requested for this case.

Other Meds:

Current Illness:

ID: 0925654
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: got the flu; Initial information was received on 05-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer. This case is linked to case 2021SA003714 (same reporter). This case involves male patient (unknown age) who got the flu (influenza), while he received INFLUENZA VACCINE. Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious had the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of report, the outcome was unknown for the event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 0925655
Sex: F
Age:
State: NC

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

Lab Data:

Allergies:

Symptoms: Received the rabies vaccine all three doses within the 30 days but not on schedule/No AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via call-center via Medical Information (Reference number- 00393542) and transmitted to Sanofi on 15-Dec-2020). This case involves a female patient of unknown age who received all three doses of RAGE DIPLOIDE VACCINE [IMOVAX RABIES] ((frequency, strength, lot number and expiry date unknown) via an unknown route within the 30 days but not on schedule (wrong schedule) for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications were not reported. It was an actual medication error case due to Inappropriate schedule of vaccine administered. Reporter wanted to know the efficacy of the rabies vaccine when it had not been administered on time and received all three doses of RAGE DIPLOIDE VACCINE [IMOVAX RABIES]. At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 0925656
Sex: F
Age: 30
State: MA

Vax Date: 12/30/2020
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Redness, swelling, itchiness at injection site (left deltoid) that began 7 days after injection

Other Meds: None

Current Illness: None

ID: 0925657
Sex: F
Age: 60
State: ND

Vax Date: 12/28/2020
Onset Date: 12/30/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: CMP abnormal range results: glucose 120; BUN 18; Creatinine 0.3; Albumin 3.3; BUN/cr. ratio 60. CBC abnormal range results: MCV 96.3; RDW CV 11.5; Monocytes relative 21.7; Monocytes absolute 1.1

Allergies: No Known Allergies

Symptoms: Patient presented to the ED with c/o of injection site reaction of firmness approximately baseball sized to the left deltoid and redness. This is not what triggered the visit. The reason for the visit was that she felt itchy all over, and this started at approximately 4:30 pm. Patient was given IV normal saline, benadryl 50 mg IM and Pepcid 20 mg IV. Patient had significant improvement in itching and was discharged from the ED at 6:10 pm.

Other Meds: Fluconazaole 150 mg; Furosemide 20 mg; losartan 25 mg;

Current Illness: COVID-19

ID: 0925658
Sex: M
Age: 32
State: NY

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data: n/a

Allergies: n/a

Symptoms: Parasthesia on injection arm and parasthesia on ipsilateral skull base

Other Meds: Prozac, omeprazole

Current Illness:

ID: 0925659
Sex: F
Age: 36
State: TX

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: none- need advise on what to do.

Allergies: Sulfa drugs: Nausea/vomiting

Symptoms: There is swelling, hardness, redness and pain at the site of injection with some itching. The area also feels warm compared to other arm.

Other Meds: None

Current Illness: none

ID: 0925660
Sex: F
Age: 39
State: IN

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data: None

Allergies: Phenobarb

Symptoms: Woke up at 3am with the chills took my temp was 99.8. Took my morning medicines and then some ibuprofen, was having body aches and severe chills. Went back to bed and took my temp an hour later was 101.0. Had body aches, chills, thirst, weakness, headache for the rest of the day. Temperature went from 99.0 to the highest of 102.0. Got ahold of covid 19 hotline at work, they said it was a reaction to the shot and should be gone within 72hrs. If not then I would need to get covid tested. Got ahold of my pcp and they ordered a covid test but I told them what the hotline had said and that I would wait to get one done. It has been 24 hour since and now I no longer have a fever and am feeling better just tired.

Other Meds: Lisinopril, hydrochlorothiazide, lexapro, metoprolol,

Current Illness: None

ID: 0925661
Sex: F
Age: 49
State: NY

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Right after injection had vaccine taste in her mouth bodycache, chills, headache, nosebleed left nostril,could not move had joint pain, nausea and loss of appetite ,arm tenderness swollen" Popeye arm" temp 99.5

Other Meds:

Current Illness:

ID: 0925662
Sex: F
Age: 28
State: MO

Vax Date: 12/28/2020
Onset Date: 01/04/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies: sulfa, mouth wash, coconut

Symptoms: 1 week out injection site red, warm, swollen, itchy, slightly painful visiting PCP January 11th.

Other Meds:

Current Illness:

ID: 0925663
Sex: F
Age: 34
State: FL

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

Lab Data: HCG - negative Medications given: ketoroloc 20mg PO, fluids, ondansetron 4mg PO, Acetaminophen 500mg PO

Allergies: Unknown

Symptoms: dry heaving and nausea

Other Meds: Unknown

Current Illness: Unknown

ID: 0925664
Sex: F
Age: 57
State: CT

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies: Percocet , otezla. Hydroxychloroquie methotrexate.

Symptoms: On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early am got up at 5 am. Took Tylenol 1000mg. Went to work. Around 9am of 1/6/21 chills more pronounced body aches. Temp 99.3. Continued to feel poorly, rechecked temp 1.00 pm. Now 99.9. Sent home. At 2:15 pm temp 104.00. More severe chills and body pain, nauseous. Toast for dinner, Tylenol again at 6 pm , recheck temp 100.8. Went to bed. 1/7/22 am some body aches, not as severe, nauseous and migrai. Type headache. Did no take temp, because didn't feel one. Call to nurse at covid vaccine holiness. Check temp while on phone 97.4.

Other Meds: Vitamin D 2000 iu, vitamin c, calcium, prantoprazole 40 mg

Current Illness:

ID: 0925665
Sex: F
Age: 68
State: IN

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

Lab Data: none

Allergies: Erythromycin Preservatives in personal hygiene products

Symptoms: 1-5-2021 uncontrollable Shaking of entire body Fever started at 99.1 at 9:30 pm by 11:30 fever was 101.1. I took 2 tylanol at 9:30 and 2 more at 11:30 pm and went to bed the shaking had subsided by about 11:00pm and woke up about 1 am and the fever was gone. I woke up at 5 am on 1-6-2021 with the shaking, but no fever and the shaking just lasted about 45 minutes. I had a headache off and on 1-6-2021 and of course the sore arm. I was very tired the 2nd day, too.

Other Meds: Carvedilol Cinnamon Niacin Lutein Beta Carotene Zinc Preservision Flonase Warfarin Spironolactone Montelukast Elderberry Vitamin C Citirizine D3 Fish Oil

Current Illness: Sinus drainage due to allergies is ongoing problem.

ID: 0925666
Sex: M
Age: 35
State: NY

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: 01/06 -Upon waking: generalized body ache, more intense left arm ache -12PM: intermittent chills without rigors -4PM: diffuse tension headache rated 1/10 -No other signs and symptoms 01/07: no change compared to 01/06.

Other Meds: None

Current Illness: None

ID: 0925667
Sex: F
Age: 47
State: IL

Vax Date: 12/22/2020
Onset Date: 12/24/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies: tetracaine (reaction not documented)

Symptoms: Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 days ago on 12/22. Patient also reporting flushing, intermittent tachycardia, and headache x2 days. Vitals were taken and follow: blood pressure 108/117, heart rate 111, spO2: 100%. Injection site observed to be red and tender. Patient reports history of allergies to tetracaine. Patient did not take medication OTC prior to coming in to clinic. Patient was transferred and admitted to the emergency department. In the emergency department was given benadryl and monitored for symptom improvement. Was discharged on the same day.

Other Meds: amitriptyline 25mg nightly vitamin d3 daily cyclobenzapril 10mg nightly pantoprazole 40mg daily rosuvastatin 10mg daily vitamin B complex daily

Current Illness: none

ID: 0925670
Sex: F
Age: 63
State: ME

Vax Date: 12/28/2020
Onset Date: 01/05/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data: no tests done

Allergies: Coffee, corn, carrots, Bakers yeast, Candida yeast

Symptoms: fatigue on onset. 7th day, left arm felt heavy, tingly, injection site had a lump, red with lumps inside the lump. Went to clinic 01/05/21, Dr marked the site. Advised to apply ice and use topical benedryl (I did not have at home). Next day, worsened, injection site, very red, itchy, burning, and had redness had spread beyond the markings of Dr. On 01/06/21 went to clinic, saw PAC. Put me on antibiotics. Stated allergic reaction and looked like cellulitis too. Today arm is less swollen, but still red and itchy. Going back to clinic to see Dr Friday 01/08/21 at 10:30 am

Other Meds: Vitamin D Q Saturday

Current Illness: no

ID: 0925676
Sex: M
Age: 61
State: VA

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Sent to ED on 1/6/21

Allergies:

Symptoms: Previously had Covid 19 May of 2020, received the Moderna vaccine on 12/31/20. That evening temp of 102.4, SI joint back pain, body aches until Saturday 1/2/21, also has shaky hands, feels anxious, nervous, racing thoughts, foggy + restless. Difficulty sleeping Blood pressure 156/101

Other Meds: PCP

Current Illness: None

ID: 0925712
Sex: F
Age: 25
State: PA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Patient experienced headaches the evening after injection, the day following vaccination patient reports dizziness, shaky legs, and face/throat numbness and tingling. Emergency room visit on 1/4/2021. Patient reports botox lip injections approximately 6 months prior.

Other Meds:

Current Illness:

ID: 0925736
Sex: U
Age:
State: OK

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

Lab Data:

Allergies:

Symptoms: herpez zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided. On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient vaccination, the patient presented herpes zoster. As a direct and proximate result, the patient had been treated by a medical provided. Additionally, the symptoms had been resulted in physical limitation not presented prior vaccination. The patient sustained severe and permanent injuries; the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).

Other Meds:

Current Illness:

ID: 0925737
Sex: U
Age: 4
State: MD

Vax Date: 12/22/2020
Onset Date: 11/17/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No other AE/PQC identified; Caller reports AE related to administration of expired PROQUAD; Excursion occurred 11/17/2020; This spontaneous report was received from a office manager concerning to a 3-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided. On 17-NOV-2020, a dose of the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number reported as T016991 and expiration date as 11-NOV-2021) had a temperature excursion. On 22-DEC-2020 (discrepant information as onset date was also reported as ''29-DEC-2020''), the patient was vaccinated with an expired (discrepant information as the vaccination date was on 22-DEC-2020 and the vaccine expiration date would be on 11-NOV-2021) and improperly stored dose of the mentioned vaccine at a dose of 0.5 milliliter (ml) for prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided). No additional adverse events were reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 0925738
Sex: U
Age: 1
State: IL

Vax Date: 11/17/2020
Onset Date: 11/17/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No other AE details available at this time; Caller reported temperature excursion. / Temperature -13.3C; This spontaneous report was received from a registered nurse concerning to a 12-month-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided. On 17-NOV-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter (ml) for prophylaxis, lot number reported as T017688 and expiration date as 21-MAY-2022 (vaccination scheme, route of administration and anatomical site of vaccination were not provided). No additional adverse events were reported. The administered vaccine had a temperature excursion of -13.3?C (degrees Celsius) for a time frame of 4 hours and 15 minutes, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2012USA013095:

Other Meds:

Current Illness:

ID: 0925739
Sex: U
Age: 24
State: TX

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No further adverse events reported; MMRlI given had expired on 12/17/2020; This spontaneous report was received from a pharmacist concerning to a 24-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided. On 31-DEC-2020, the patient was vaccinated with an expired dose of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 milliliter (ml) for prophylaxis, lot number reported as R036581, expiration date reported and validated as 17-DEC-2020 (vaccination scheme, route of administration, and anatomical site of vaccination were not provided). It was reported that the vaccine did not experienced temperature excursion. No further adverse events were reported.

Other Meds:

Current Illness:

ID: 0925740
Sex: U
Age:
State: LA

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

Lab Data:

Allergies:

Symptoms: herpes zoster; post herpetic neuralgia; Information has been received regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not provided). On an unspecified date (reported as "shortly after receiving the vaccine"), the pt suffered herpes zoster and post herpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of the vaccine, the pt's symptoms resulted in physical limitations not present prior to using the product, and experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. The pt suffered serious, severe, progressive, permanent, and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reported events were not resolved. The events of herpes zoster and post herpetic neuralgia were considered to be related to zoster vaccine live (ZOSTAVAX) by the reporter. Upon internal review, the events of herpes zoster and post herpetic neuralgia were considered to be disabling.

Other Meds:

Current Illness:

ID: 0925741
Sex: F
Age: 71
State: NJ

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

Lab Data:

Allergies:

Symptoms: itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. In December 2020, the patient received Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was not recovered/not resolved. It was unknown if the reporter considered the injection site itching to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in right arm. The patient experienced intense itching at the injection site. The reporter did not consent to follow-up. All information was not available.

Other Meds:

Current Illness:

ID: 0925742
Sex: F
Age:
State: TN

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Date: 20201229; Test Name: fever; Result Unstructured Data: Test Result:102; Test Date: 20201229; Test Name: Lab Test; Result Unstructured Data: Test Result:negative; Comments: All test were negative.

Allergies:

Symptoms: Fatigue and overall lethargic feeling/Sore throat; Dark colored urine despite pushing fluids; Frequent urination; Migraine; Swollen joints and could not move arm that received vaccine in; Swollen joints and could not move arm that received vaccine in; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Chills, body aches, spiked fever of 102.; Chills, body aches, spiked fever of 102.; Chills, body aches, spiked fever of 102.; Fatigue and overall lethargic feeling; Fatigue and overall lethargic feeling; Sore throat; The initial case was missing the following minimum criteria: Invalid for no adverse effect. Upon receipt of follow-up information on (31Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EH9899, Expiry Date: Mar2021), intramuscular at Deltoid Left on 29Dec2020 07:20 at single dose for COVID-19 immunization. Medical history included covid-19 from Nov2020 to an unknown date (had covid in the middle of November), surgeries from an unknown date and unknown if ongoing (She also had previous surgeries and has foreign objects in her body. Those areas were super hot. Those antibodies were like rejecting those foreign bodies because they were super hot.) There were no concomitant medications. Received call from RN calling about the Pfizer COVID vaccine. She got the vaccine on Tuesday and had a terrible reaction to it and she called a couple of different hotlines and spoke with the people who administered it. She confirmed that she did not report to Pfizer though. The people at her work that she spoke with told her to go to an Urgent care. They told her she should not get it within 90 days of having COVID. She had COVID in the middle of Nov2020. She went ahead and got it on Tuesday and had this terrible reaction. She would like to know if she should get the second dose or wait until 90 days after she had COVID and start again. There was no prescriber. She received it as part of the (hospital name withheld) front line health worker precaution. She thought that this was a normal reaction, but was told it was not. Fatigue and overall lethargic feeling happened exactly 12 hours after receiving. She works night shift and that is her base line. Pretty much everything hit after that within an hour. She was told low grade fever was normal, but not 102. She never spikes fevers, so it is medically significant. It persisted for 24 hours and is better today. She is on the 48 hour mark now. Stomach pains, nausea, diarrhea, lymph node swelling all over, including swelled armpits and groin area, Migraine, Frequent urination, were also listed as side effects. She was trying to push more fluids but her urine was dark color more than normal, despite pushing fluids. Swollen lymph nodes in her groin and armpits were concerning. Her head is lumpy. Meaning, she can feel swollen lymph nodes in back of neck area. Migraine was consistent through 24 hours and now has improved. Urine color remains dark and she will keep an eye on color. She had swollen joints, but really terrible swollen joints, and she could not move the arm that she got the vaccine in. She could not lift to above shoulder height. AE Details and time of onset: Sore Throat 12:00 on 29 Fatigue and overall lethargic feeling 20:00 Chills, body aches, spiked fever of 102: 21:00 Stomach pains, nausea, diarrhea, swollen lymph nodes- 21:00 Migraine- 21:00 Frequent Urination 23:00 Dark colored urine despite pushing fluids 23:00 Swollen joints and could not move arm that received vaccine in: 21:00. ER or physician's office required: Went to urgent care 36 hours after administration. No treatment given. She just wanted to make sure no additional infection was causing anything weird. All test were negative. Prior Vaccinations (within 4 weeks): none. Events Swollen joints and could not move arm that received vaccine in, Stomach pains, nausea, diarrhea, swollen lymph nodes, Chills, body aches, spiked fever of 102 were serious with criteria of medically significant, while the other events were non-serious. The outcome of the event Fatigue and overall lethargic feeling/Sore throat (Condition worsened) was unknown, the outcome of the events Swollen joints and could not move arm that received vaccine in, Chills, body aches, spiked fever of 102., Migraine, Dark colored urine despite pushing fluids, Frequent urination was recovering, while the outcome of the other events was not resolved.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.

Other Meds:

Current Illness:

ID: 0925743
Sex: F
Age:
State: IL

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL0140) at single dose on left arm on 30Dec2020 at 09:00 for COVID-19 immunization. Medical history included asthma (controlled); hypertension diagnosis 1 year ago; allergies to medications, food and environmental. Concomitant medications in two weeks included antihypertensives - amlodipine and losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 9:15 AM, the patient experienced anaphylactic reaction within 10 minutes of administration, neuropathy in fingers, toes, roof of mouth/lips. Neuropathy continued to date. The adverse events resulted in emergency room/department or urgent care. The patient received treatment Epinephrine IM (intramuscular) and IV (intravenous) steroids. The outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of anaphylactic reaction and neuropathy peripheral due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase and nerve conduction studies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: ;

Current Illness:

ID: 0925744
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: brain felt swollen; glands were also swollen; bad headache; minimal arm pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included lupus-like history and chronic Lyme disease. The patient's concomitant medications were not reported. The patient stated she received the first vaccine dose on 30Dec2020 and had minimal arm pain, fatigue that went to a very bad headache on Thursday (31Dec2020). By Friday headache and fatigue were terrible until this morning. Her brain felt swollen and her glands were also swollen on 03Jan2021. The patient stated that she called healthcare professional (HCP) and was told that her body was "having an auto immune response", "due to a lupus like history and a history of chronic Lyme disease and to hydrate well". It was so hard to talk, she was so fatigued. Her doctor compared it to like an encephalopathy. The patient was feeling better today but was concerned about taking the second dose. She works in a facility with a lot of Covid-19 patients. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product to the development of event brain felt swollen cannot be totally excluded. Medical history of lupus-like history and chronic Lyme disease may provide plausible alternative explanations for the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0925745
Sex: F
Age:
State: NY

Vax Date: 12/21/2020
Onset Date: 12/29/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Name: CT scan of neck; Result Unstructured Data: Test Result:it was normal

Allergies:

Symptoms: numbness and weakness in left arm; numbness and weakness in left arm; had a brachial plexus pathology; her grip and fine motor are affected in her left arm/she could not do her job; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration in right arm on 21Dec2020 at single dose for Covid-19 immunisation. Medical history included ongoing birth control. No other medical history. Concomitant drug included other medication she took for birth control. On 29Dec2020, the patient experienced numbness and weakness in left arm, had a brachial plexus pathology, went to the emergency department on 30Dec2020 and was seen by one of the facility doctors and stated this doctor had her on steroids for treatment. She got the vaccine in her right arm, stated her grip and fine motor are affected in her left arm. States this was disabling since she could not do her job. She was following up with neurology on Monday (unspecified), that she had a CT scan of her neck and it was normal. Only other medication she was taking was for birth control, but she did not feel like it was relevant. The outcome of events numbness and weakness in left arm was recovering, while outcome of other events was unknown. This case was reported as serious, seriousness criteria was disabling.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness: Birth control

ID: 0925746
Sex: F
Age:
State:

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: exam; Result Unstructured Data: Test Result:did not have any weakness; Comments: did not have any weakness, facial droop or dumbness with sharp or dull testing. The patient perceived it along the face still and the arm

Allergies:

Symptoms: it hits a nerve; perceived it along the face still and the arm; Bell's Palsy; numbness in a small area of her tongue; right eye was irritated a little dry; right eye was irritated a little dry; right sided ear pain; fluid in the ear but no infection; This is a spontaneous report from a contactable health care professional (nurse practitioner). A 35-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on the right side on 21Dec2020 for Covid-19 immunization. Medical history included intermittent hives. Concomitant drug included ongoing cetirizine hydrochloride (ZYRTEC) 5 mg for intermittent hives. The reporting nurse practitioner saw a patient on 31Dec2020 who was vaccinated on 21Dec2020 and had a Bell's Palsy reaction (reported as not serious). She did some research and saw no more incidents in the general population but she wanted to report this. She also wanted to get more information on if the patient should proceed with dose number 2 of the vaccine. The patient developed the Bell's Palsy within 5 minutes after getting the vaccine. She thought it was because she was anxious to get the vaccine, so she brushed it off. The Bell's Palsy was still occurring but per the patient it had improved. On exam she did not have any weakness, facial droop or dumbness with sharp or dull testing. The patient perceived it along the face still and the arm. The reporting nurse practitioner said that the arm was probably not Bell's Palsy, but more related to getting the vaccine in the arm and it hits a nerve. Patient stated that her smile was also unequal and it was difficult for her to close her right eye, although now (as of 31Dec2020) she can. Her right eye was irritated a little dry. Regarding treatment, the patient was started on steroids on 31Dec2020. She did not start her on an anti-viral as she did not want it to impact her immunity to the vaccine. The patient also complained of right sided ear pain. She was unsure if that was related to the Bell's Palsy, but it was also on the right side. There was fluid in the ear but no infection. The pain was still ongoing. The patient also mentioned numbness in a small area of her tongue when she first got the vaccine. This was still ongoing. Outcome of Bell's Palsy was resolving. Outcome of the event numbness in a small area of her tongue, right sided ear pain was not resolved. Outcome of the other events was unknown. The reporting nurse practitioner stated that this was not serious as this was a mild case and was thankfully resolving. The reporting nurse practitioner comment that nothing of history was relevant besides for the last several months (as of 31Dec2020) the patient had been taking 5mg of cetirizine hydrochloride for intermittent hives. She wondered if she had not been taking it how she would have reacted or if the reaction would have been more severe. Information on the lot/Batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of Bell's Palsy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 0925747
Sex: F
Age:
State: MO

Vax Date: 12/17/2020
Onset Date: 12/26/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pitting edema/Edema: It was her feet, ankles, and 3/4 way up her shins.; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730, expiry date: Mar2021), intramuscular in the left deltoid on 17Dec2020 at 07:15 at single dose for COVID-19 immunization. Medical history included ongoing neuralgia since 2003 (has nerve pain in her face and neck. It has never caused swelling and that she has had it for a long time. Symptoms started 17 years ago, became apparent in 2009), ongoing hypothyroidism since 2003 (Diagnosed about 17 years ago. Nothing has changed medication wise). The patient's concomitant medications were not reported. The patient reported that she got the vaccine on 17Dec2020. On 25Dec2020, her shoes felt snug and by the next day she had 4 plus pitting edema. She could not fit in the shoes. She had the pitting edema for several days. She said that she went and bought compression stockings to help with the edema. It was her feet, ankles, and 3/4 way up her shins. It was more of the pedal area that was pitting. The patient further reported that she never had pitting edema before and the only thing new she had was the vaccine. Therapeutic measures were taken as a result of the event which included compression stockings. The patient was recovering from the event.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported event pitting edema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness: Hypothyroidism; Neuralgia (.)

ID: 0925748
Sex: F
Age:
State: MI

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: a strong, whole body heat, and flushing; a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable Nurse. This Nurse reported similar event for 6 patients. This is 3rd of 6 reports. A 24-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Pfizer employee reporting on behalf of a friend, reported her friend texted her last night, 30Dec2020, at around midnight. The nurse and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. Caller said she had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. Caller said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. Outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 vaccine cannot be excluded for events flushing, feeling hot, tachycardia and palpitations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 0925749
Sex: F
Age:
State: MI

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 6th of 6 reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend is a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. The registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter did not know if the patient received any other vaccines at the same time as the COVID-19 Vaccine, and if had received any other vaccines within the last 4 weeks. The patient works at a hospital but doesn't believe that she received any medical attention. she believed just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported whole body heat, flushing, tachycardia and palpitations, and the administration of BNT162B2, based on the reasonable temporal association and lacking alternative explanations. 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 RA, IEC, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 0925750
Sex: F
Age:
State: MO

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Rash; Welts; she had a very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 65-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid Vaccine, lot EH9099 or EH9899), via an unspecified route of administration in her left deltoid on 22Dec2020 09:32 at single dose for Covid-19 immunisation. Medical history included broken toe for 3 weeks. This was from her taekwondo and doesn't complain. No history of all previous immunization with the Pfizer vaccine considered as suspect drug. There were no additional vaccines administered on same date with Covid-19 vaccine. There were no concomitant medications. On 24Dec2020, she broke out in a rash on different parts of her body. She said the rash would come and go. She said she then had welts appear on different parts of her body and the welts would come and go. She said on the 3rd day, she had rash and welts together only on her trunk. She said on days 4, 5, and 6, she would have either a rash or welts come and go on different parts of her body. She clarified she had the rash and welts on her hands, wrists, ankles, and body. She reported that the rash and welts were serious-medically significant. On 22Dec2020, she had arm soreness and was just inconvenient and uncomfortable. She said she was not saying that what she was experiencing was related to receiving the COVID-19 Vaccine, but she doesn't know what else can be causing the rash and welts. She said she hasn't changed anything she has been eating or doing. She said she was worried about taking the 2nd COVID-19 Vaccine dose. She used Hydrocortisone 1% cream, Equate brand (reported to be expired) and took an oatmeal bath. She also took Benadryl and brand of Zyrtec called Wal-Zyr. Her height was 175cm, weight was 63kg. The rash and welts recovered on 30Dec2020; arm soreness recovered on 23Dec2020. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events rash and urticaria cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0925751
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Name: Temperature; Result Unstructured Data: Test Result: 101.3; Test Name: pulse; Result Unstructured Data: Test Result: Rapid Pulse; Test Name: Saturation; Test Result: 84 %

Allergies:

Symptoms: Saturation down to 84%; Temperature of 101.3; Rapid pulse having some difficulty; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 30Dec2020, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The reporter is working in long term in Nursing care facility. It was reported that they have a resident who recovered from COVID. They are having some questions following the guidelines stuff, just kind of asking some more questions. Just one of their resident had temperature of 101.3, saturation down to 84%, 'frustration' at 24% and rapid pulse having some difficulty. The patient was put in her bed. The reporter contacted the doctor in house. 'The reporter wanted to see if any of the recommendation were for (incomplete sentence). The long term care facilities recovered COVID, the reporter wanted to know any of the lasting short term and any guideline for treating. They were all recovered COVID, all of two of the resident two weeks or more out and we (Further clarification was unknown) just had the vaccine yesterday' (as reported, pending clarification). Outcome of the events was unknown. Information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 0925753
Sex: F
Age:
State: NY

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: BP; Result Unstructured Data: Test Result:elevated

Allergies:

Symptoms: Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left arm (Lot number: ek9231) for COVID-19 immunisation. Medical history included asthma, bronchitis, mitral valve regurgitation, herpes, depression, ADHD. COVID prior vaccination: Yes. Known allergies: tramadol, milk products. No other vaccine in four weeks. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion, and, losartan/hydrochlorothiazide. The patient experienced red palms/blotching, sweating profusely, heart palpitations, chest pain and fainting, elevated BP, all on 28Dec2020 09:15. All these events required Emergency room visit. Therapeutic measures were taken as a result of the events included 50 mg of Benadryl, 60 mg of Prednisone, omepresol. No COVID tested post vaccination. Outcome of events was recovered with sequelae.

Other Meds: ADDERALL; ; LOSARTAN/HYDROCHLOROTHIAZIDE

Current Illness:

ID: 0925754
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: I have a sleep problem almost eight hours; I was so tired; Headache; My arm was sore for 24 hours; so stiff; This is a spontaneous report from a contactable physician. A 69-year-old patient of an unspecified gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVD-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the vaccine and had a pretty significant reaction, one say serious to moderate reaction. The patient's question was do they know yet if you take a second shot was your reaction get even worse because the patient had a sleep problem almost eight hours. The patient was so tired, had headache and so stiff, arm was sore for 24 hours. The patient was a little afraid to take a second shot. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agencys, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0925755
Sex: F
Age:
State: NY

Vax Date: 01/02/2021
Onset Date: 01/02/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chills while driving home; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the left arm, on 02Jan2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home on 02Jan2021 at 12:00. The patient did not receive any treatment for the events. The clinical outcome of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath cannot be excluded, considering the plausible temporal relationship. The underlying predisposing condition of penicillin allergy may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0925756
Sex: F
Age:
State: LA

Vax Date: 12/29/2020
Onset Date: 12/31/2020
Rec V Date: 01/07/2021
Hospital: Y

Lab Data: Test Name: Cat scan; Result Unstructured Data: Test Result:Unknown results; Test Name: ultrasound of heart; Result Unstructured Data: Test Result:Unknown results; Test Name: labs; Result Unstructured Data: Test Result:Unknown results; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210101; Test Name: Nasal Swab/ Covid 19; Result Unstructured Data: Test Result:Negative

Allergies:

Symptoms: Right sided facial & top lip Numbness & recurring pain; Right sided facial & top lip Numbness & recurring pain; Right sided facial & top lip Numbness & recurring pain; This is a spontaneous report from a contactable consumer reporting for herself. A 66-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via unspecified route of administration on 29Dec2020 13:30 on left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. Medical history included Hypertension, Reflux and low back pain. Concomitant medications included ibuprofen, dicycloverine hydrochloride (BENTYL), Valsartan and omeprazole. The patient previously took codeine, Bactrim, Zyrtec and experienced allergies. The patient experienced Right sided facial and top lip Numbness, recurring pain on 31Dec2020 16:00. All events resulted in emergency room visit and Hospitalization on 31Dec2020 for 1 day. The patient underwent lab tests and procedures, which included Cat scan, MRI, ultrasound of heart and labs on unspecified dates, Nasal Swab/Covid 19 test on 01Jan2021 with negative result. The outcome of the events were not resolved.

Other Meds: ; BENTYL; ;

Current Illness:

ID: 0925757
Sex: F
Age:
State: NY

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: hives on her legs; a slight rash on abdomen (started morning on the next day when she woke up) and it spread to her legs (leg rash started 2 days later in the morning); This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 29Dec2020 10:30 at single dose for COVID-19 Immunization. No medical history. No family medical history. There were no concomitant medications. Patient received first dose last Tuesday, 29Dec2020, at the hospital. The next day, she had a slight rash on abdomen (started morning on the next day when she woke up) and it spread to her legs (leg rash started 2 days later in the morning). It was a pretty severe case of hives on her legs now (31Dec2020). Spread to legs and now has hives on legs was reported as worsened. Physician's office visit involved. She had a question. Her doctor prescribed a dosing pack of prednisone to get rid of the hives and her question was, will it affect the effectiveness of the vaccine if she takes it, also, is it ok to get 2nd dose in 2 weeks. She confirmed she had not taken the prednisone yet. There was no prescriber. She received it because she is a healthcare worker. Patient asked if there is any recommendation on getting pre medicated with ex: Benadryl before getting the vaccine. No previous history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect product. No medications prior vaccinations (within 4 weeks). No test done. This is a serious report. The slight rash on abdomen, spread to legs and now has hives on legs was considered medically significant per reporter. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events rash and urticaria cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0925759
Sex: F
Age: 21
State: CA

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data: NONE

Allergies: No

Symptoms: 1825 Pt received the Pfizer vaccine. Patient sat in chair being monitored for 15 minutes. At 1832 pt felt lightheaded and fainted, emergency response CALLED. Patient appeared pale and diaphoretic. RNs assisted patient down to the floor with head supported with jacket and legs elevated. 1837 Patient's vital signs BP: 101/59, HR: 60, o2: 97%. Patient woke up stating that she is ok. Emergency response arrived 1838. Continued to monitor patient, @ 1845 BP: 110/71, HR: 64, o2:98%. Pt states feeling better, offered juice, pt able to tolerate 1 cup of apple juice with no complications. 1850 patient states feeling better, assisted patient to sitting position from lying down. VS obtained BP: 96/57, HR: 72, o2: 97%. Emergency response recommended patient to to the Emergency Department, but patient refused. States that she is going to go home. Advised that she call for a ride, and patient agreed. 1855 Assisted patient in the standing position, BP: 99/63, HR: 65, o2: 96%. Pt was able to tolerate more apple juice, denies any lightheaded, dizziness or headache. Patient stated that her ride was on the way. Patient agreed and continued to be monitored for another 15 minutes. Pt discharged @ 1915 in stable condition.

Other Meds: Not known

Current Illness: Not known

ID: 0925760
Sex: F
Age: 44
State: NH

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data: N/a

Allergies: Toradol, soma, ibuprofen, metformin

Symptoms: Severe joint pain, migraine headache

Other Meds: Abilify, metroprolol, duloxetine, Effexor XR, lamotrigine, pantoprazole, sprintec birth control, b12, amlodipine

Current Illness: N/a

ID: 0925761
Sex: F
Age: 49
State: NJ

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: n/a

Allergies:

Symptoms: ASTHMA EXACERBATION: Acute onset of cough and wheezing HTN: BP 167/100

Other Meds:

Current Illness:

ID: 0925762
Sex: F
Age: 32
State: ID

Vax Date: 12/29/2020
Onset Date: 01/06/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Large red area with prominent swelling, appearing 1 week after vaccine administration. Warm to touch and itching.

Other Meds: None

Current Illness: Sinus infection, treated with Augmentin

ID: 0925763
Sex: F
Age: 60
State: IL

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

Lab Data:

Allergies: tree nuts gabapentin ceclor demerol tegretol ultram

Symptoms: "Hot, flushing. took Benadryl liquid several doses, chest tightness and shortness of breath, resolved by next morning"

Other Meds:

Current Illness:

ID: 0925764
Sex: F
Age: 36
State: AR

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

Lab Data: none

Allergies: NKDA

Symptoms: Pfizer-BioNTech COVID-19 Vaccine EUA After receiving the vaccine developed symptoms later that evening, fatigue, muscle aches (nighttime only) and headache that was relieved with Tylenol .

Other Meds: yzal, Vitamin C & D Probiotic, Metformin, Topamax, Zoloft

Current Illness: seasonal allergies and cold

ID: 0925765
Sex: F
Age: 30
State: OH

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies: Latex

Symptoms: Pt presented back to clinic on 1/7/21 and shared adverse event of numbness/tingling on right side of face and right leg (same side as vaccine was given). She was treated by PCP for potential bells palsy.

Other Meds: unknown

Current Illness: none

ID: 0925766
Sex: M
Age: 74
State: NJ

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Second day (Tuesday 1/5/21) swelling and some soreness on inside of throat right side. Wednesday 1/6/21 swelling had spread significantly to inside the right side of mouth and tongue also affecting right jaw. By 3 Pm that day my tongue was numb and swollen on the right side as well as the right side of my mouth and jaw. I could only chew, eat, and swallow effectively on the left side of my mouth using the left side of my tongue to negotiate eating. I could only this with small amounts of food. By that evening about 4 hours later I could eat , chew etc. pretty good but the swelling & discomfort remained but reduced to a functional level. Today, Thursday 1/7/21, the soreness and discomfort remains inside throat, mouth, tongue and jaw all on the right side.

Other Meds: None

Current Illness: None

ID: 0925767
Sex: F
Age: 60
State:

Vax Date: 12/30/2020
Onset Date: 01/01/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 12/30: received Moderna Vax Jan. 1: left upper arm (injection site) with redness and swollen Jan. 6 & 7: left upper arm still with redness and tender to touch She?s been taking over the counter meds and hasn?t required a visit to her PCP.

Other Meds:

Current Illness:

ID: 0925768
Sex: F
Age: 33
State: NY

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

Lab Data: None.

Allergies: Levaquin Toradol

Symptoms: After 6-10 minutes of the injection , I started having shooting pain from the injection site, through my left clavicle area to around the back of my neck. After 15 minutes those muscles described started tensing and my muscles in the back of my neck tightened to the point I can?t look left to right (turning motion). It?s now Almost 3 hours after and symptoms remain same.

Other Meds:

Current Illness: None

ID: 0925769
Sex: F
Age: 46
State: DE

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

Lab Data: NONE

Allergies: Bactrim DS

Symptoms: Chills, body sore, temp 101.2

Other Meds: Protonix,

Current Illness: None

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm