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
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: 0942639
Sex: F
Age:
State:

Vax Date: 12/23/2020
Onset Date: 01/02/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210102; Test Name: COVID; Test Result: Positive

Allergies:

Symptoms: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a non-contactable nurse (patient) and a contactable consumer. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID Prevention because of occupation. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for COVID on 02Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID test: positive on 02Jan2021. The patient got the first dose of the COVID vaccine, and then tested positive for COVID afterward. The patient was inquiring about if there are any recommendations for getting the second dose, if the person tested positive for COVID after getting the first dose. The patient did not provide prescriber information. The patient should come off of quarantine on 15Jan2021. It was unknow if the patient received any other vaccines on the same day as the COVID vaccine and if there were any concomitant medications, history or investigations other than the COVID test. The type of COVID test the patient received was unknown, just that she got the positive result on 02Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0942640
Sex: F
Age:
State: FL

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: felling dizziness; nausea; not feeling strong; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at left arm on unspecified date in Dec2020 at SINGLE DOSE for COVID-19 immunization and lubiprostone (AMITIZA) , via an unspecified route of administration from Dec2020 to an unspecified date at 1 DF, 2x/day as laxative..Medical history included:TIA started in Dec2020, bowel problem, fell (she fell about 3 weeks before she got the Pfizer COVID-19 shot) and some memory loss ( not serious).She wanted to know if she should receive her second dose of the COVID-19 vaccine if she was presenting the following side effects: felling dizziness, nausea and not feeling strong. She was currently taking Amitiza as a laxative. She believed these side effects were not related to the administration of the first dose of the vaccine and were rather common conditions for her age , she also stated that she did not have any "negative feelings" with the first shot of the vaccine. Consumer said she had an appointment today for her second shot of the Pfizer COVID-19 vaccine and got a letter yesterday that said she could get it at 03:00PM today at the center where she got the first vaccination. She said that they gave the shot in her left arm for her first vaccination. She said it was very common at this age that she very often didn't feel well, and she was on a new laxative that might be causing some upset. She said she had no fever, she was not nauseated, she had no headache, there was nothing wrong. However the outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dizziness, nausea and asthenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. Further details about the patient's medical history, concomitant conditions and the events would be helpful. The contributory role of the concomitant laxative also 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: AMITIZA

Current Illness:

ID: 0942641
Sex: M
Age:
State: CA

Vax Date: 12/21/2020
Onset Date: 01/05/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210106; Test Name: SARS-Cov-2; Test Result: Positive ; Comments: Positive COVID test 06Jan2021, 13:00 Nasal swab COVID

Allergies:

Symptoms: He is losing some taste/but reduced by 30-40%; received first dose of vaccine 21DEC2020 and SARS-Cov-2 positive/Nasal swab COVID positive; received first dose of vaccine 21DEC2020 and SARS-Cov-2 positive/Nasal swab COVID positive; Sniffles; This is a spontaneous report received from Pfizer sponsored program Pfizer First Connect via a contactable other HCP (parent) reported for the patient (son). A 22-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EK5730) intramuscularly in left arm on 21Dec2020 (15:00-16:00) at single dose for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient received first dose of vaccine 21Dec2020 and SARS-Cov-2 positive 06Jan2021 13:00. The patient got COVID vaccine 21Dec2020, and was scheduled to get second dose on 11Jan2021. He had a sniffle the other day on 05Jan2021 night time and tested positive for COVID on 06Jan2021, so reporter wanted to know if he should still get second dose. His symptoms are stable. He is quarantining. He is on his way to do a PCR now. Reporter read somewhere people could have false positive in nasal. He is losing some taste from 07Jan2021 (01:00 - 02:00). Most things he can taste. Some he cannot. It is not completely gone but reduced by 30-40%. He did a mouthwash with a sting and is not feeling that sting anymore. He said last night, same thing. He did a mouth wash and did not really taste much. It is not as prevalent as it was before. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 06Jan2021, positive COVID test 06Jan2021, 13:00, Nasal swab COVID. Event outcome of sniffles was recovering, while for other events was unknown.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported event ___ cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0942642
Sex: F
Age:
State: NV

Vax Date: 12/17/2020
Onset Date: 12/17/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Was pretty weak; This is a spontaneous report from a contactable nurse(patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration in the right arm on 17Dec2020 at single dose for covid-19 immunization; diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included high blood pressure from 2008 and ongoing. Concomitant medication included amlodipine from 2017 and ongoing at 5 mg at night for high blood pressure, losartan from 2017 and ongoing at 12mg once in the morning for high blood pressure. Following her 1st dose of the COVID vaccine on 17Dec2020, the patient had throat tightening, metallic taste in her mouth. She was scheduled to have her 2nd dose today (07Jan2021) and would like to know what to do and if she was still covered 80% from the 1st dose of her COVID vaccine shot. When she got her first COVID shot 3 weeks ago she got a metallic taste in her mouth and her throat tightened up a little. Throat tightening happened right after she got the shot and lasted about less than 2 minutes. She also turned red when she got it. Then about 14 hours later, on the same day she got nausea, diarrhea, and was pretty weak. This lasted until about 20Dec2020 as well. She was supposed to get 2nd dose today (07Jan2021). Before her first shot she had taken paracetamol and hydrochloride prior. She also took both of those today (07Jan2021). But then she was reading through the paperwork and it says that a severe reaction includes tightening of the throat. She was not sure if what she had was truly a reaction or not. She did not have other allergies. She had many flu shots and never had any difficulty with those. She was a nurse, she wanted the second dose, but she was concerned about the throat tightening, and it getting worse with the second dose. She was unsure of seriousness. She figured that she would get aches and pains. Everyone else who got it said their arm hurt, but nothing else. She thought it was weird. She was just wired differently she guesses. The action taken in response to the events for paracetamol and hydrochloride was unknown. The outcome of events throat tightening, turned red was recovered on 17Dec2020. The outcome of event metallic taste in her mouth, nausea, diarrhea, and was pretty weak was recovered on 20Dec2020.

Other Meds: ; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] (no brand name); TYLENOL (no brand name)

Current Illness: Blood pressure high

ID: 0942643
Sex: F
Age:
State: FL

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: tiredness; stress; feeling terribly; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date Apr2021) intramuscular on 31Dec2020 11:30 at single dose in the left arm for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient called for information about if severe tiredness and stress are symptoms reported for the administration of the Pfizer's COVID-19 vaccine and how to properly manage them. The patient reported that she was administered with the Pfizer's COVID-19 vaccine on 31Dec2020 and since then she has been experiencing severe tiredness and stress (31Dec2020). The patient reported that she has spoken with her physician and he could not provide guidance about how to proceed with this particular situation. She received the first dose of Pfizer Biontech Covid vaccine on 31Dec2020. She was feeling terribly, she has severe, severe tiredness that comes over her and stress. She was overwhelmed by what was happening to her and she was asking if anybody else has experienced this. Her second dose was supposed to be on 21Jan2021. The outcome of the events severe tiredness, feeling terribly and stress was not recovered.

Other Meds:

Current Illness:

ID: 0942645
Sex: F
Age:
State:

Vax Date:
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210107; Test Name: Covid-19; Test Result: Positive

Allergies:

Symptoms: an employee who received the first dose of the Covid 19 vaccine, has tested positive for Covid 19 today; an employee who received the first dose of the Covid 19 vaccine, has tested positive for Covid 19 today; This is a spontaneous report from a contactable other HCP and a nurse. A female patient of an unspecified age 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 COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient employee who received the first dose of the COVID 19 vaccine, has tested positive for COVID 19 today, 07Jan2021. The outcome of the event was unknown. The reporter would like to know if the patient can get the second COVID-19 vaccine. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported event.

Other Meds:

Current Illness:

ID: 0942646
Sex: F
Age:
State: AL

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210107; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Chills; headache; nausea; diarrhea; muscle and joint pain; muscle and joint pain; strange coffee taste; This is a spontaneous report from a contactable Nurse (patient). A 63-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 05Jan2021 14:30 on right arm at a single dose for COVID-19 immunization. The patient known allergy included Penicillin allergy and other medical history included Diabetes 2, Hypertension, Reynauds and obesity. There is no other vaccine in the four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications in two weeks included losaeten, metformin, hydrochlorthiazide, duloxetine hydrochloride (CYMBALTA). The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 14:30 on left arm at a single dose for COVID-19 immunization. The patient experienced chills, headache, nausea, diarrhea, muscle and joint pain, strange coffee taste on 06Jan2021 02:00 and result in doctor or other healthcare professional office/clinic visit. No treatment received for these adverse events. The patient did covid test post vaccination via Nasal Swab on 07Jan2021 and result negative. The outcome of the events was not recovered. Information on lot/batch number has been requested.

Other Meds: ; ; HYDROCHLOORTHIAZIDE; CYMBALTA

Current Illness:

ID: 0942647
Sex: F
Age:
State: WV

Vax Date: 01/06/2021
Onset Date: 01/01/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: cold sore; body aches; They have worsened as the day went on; stress; This is a spontaneous report from a contactable other healthcare professional (patient, Physical Therapist) from a Pfizer-sponsored program. A 29-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. Medical history included cold sores. Concomitant medication included valaciclovir hydrochloride (VALTREX) from 2009 and ongoing for cold sores, ongoing fluticasone propionate (FLONASE ALLERGY RELIEF), ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) from 2006 and ongoing for birth control. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) on 15Dec2020 for COVID-19 immunization and experienced fever and body aches. The reporter wanted to verify if it was an interaction. She didn't feel like it was a drug interaction. She was questioning if there could be a drug interaction. She took Valtrex for cold sores on her face. She received her second dose of the COVID vaccine yesterday on 06Jan2021. Today 07Jan2021, she got a cold sore this morning and took Valtrex. She was wondering if the Valtrex, being an antiviral, could affect the vaccine in any way. She got the cold sores randomly anyway. They come on because of stress. She has a history with them. Caller didn't have a prescribing doctor. She got the vaccine through work. This time for second dose she developed body aches only. She received the vaccine yesterday 06Jan2021, and developed body aches today 07Jan2021. They have worsened as the day went on, but she was at work. Since she was home now and not moving around as much they weren't as bad. She got the vaccine because she worked in a nursing home. She was an essential worker who was at high risk. The outcome of events was unknown.

Other Meds: VALTREX; FLONASE ALLERGY RELIEF; BLISOVI FE 1/20

Current Illness:

ID: 0942648
Sex: M
Age:
State:

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: "baseball size lump under his armpit "; "baseball size lump under his armpit "/like a swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on 06Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the Pfizer COVID vaccine on Sunday (06Jan2021), and the next day (07Jan2021), he woke up with a baseball size lump under his armpit. His doctor said it sounded like a swollen lymph node. He thought it was a side effect and wanted to find out if that was expected. Outcome of the events were unknown. Information on lot/batch has been requested.

Other Meds:

Current Illness:

ID: 0942649
Sex: M
Age:
State: TN

Vax Date: 01/02/2021
Onset Date: 01/06/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Rash is itching; rash under his arms from armpit to elbows underneath and on his sides below his belly button and in the groin area and on his buttocks; This is a spontaneous report from a contactable consumer (patient's wife). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the right arm on 02Jan2021 00:45 at a single dose for COVID-19 immunization. Medical history included hard of hearing, surgery to remove the cancer, cancer broke his arm and he had a reverse shoulder replacement (medical conditions predating treatment with Pfizer COVID 19 vaccination); kidney failure that is better, muscle (disorder), blood pressure (abnormal), anxiety and radiation. The patient was previously given oxycodone, Ativan, and Xanax to take as needed after his surgery, but he has not taken them since Oct2020. Concomitant medication included sertraline hydrochloride (ZOLOFT) for anxiety, amlodipine for blood pressure, metoprolol for blood pressure, tamsulosin hydrochloride (FLOMAX) from Sep2020 for kidney, carisoprodol (SOMA) from 22Oct2020 for muscle relaxant, ferrous sulfate, docusate sodium (STOOL SOFTENER), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) all were ongoing and other unspecified products. The reporter stated that she and her husband got the vaccine on 02Jan2021 and the husband has developed a rash under his arm from his arm pit to elbow underneath, on his sides, below his belly button and in the groin area and on the buttocks. Rash was itching on 06Jan2021. She wanted to know could the COVID 19 vaccine cause this 4 days later. The patient noticed the itchy rash four days later on Wednesday afternoon 06Jan2021. He took Benadryl 25mg tablet by mouth that night before bed and then in the morning and put over the counter itch relief cream on it so in the night around 0200AM not too long after taking the Benadryl, the rash went away, pretty much gone. Today it seems to have come back and now it was worse because he has it on his buttocks. He didn't have it there at first. Mentioned that the patient also took a cool shower before going to bed. Wife mentioned that she just looked the rash right now and it was improved. Asking should he continue taking his relief or stop and let the doctor look at it? Advised caller to consult HCP. He is planning to get the next vaccine 23Jan2021. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The events did not require a visit to physician office and ER. No prior vaccinations (within 4 weeks). No relevant family medical history. No relevant tests done. Outcome of the events was recovering. Information on the Lot/Batch number has been requested.

Other Meds: ZOLOFT; ; ; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; SOMA [CARISOPRODOL]; ; STOOL SOFTENER; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 0942650
Sex: F
Age:
State: TX

Vax Date: 12/30/2020
Onset Date: 01/06/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Name: Pain; Result Unstructured Data: Test Result:10

Allergies:

Symptoms: Day 1-3 Injection site pain; Muscle pain; Joint pain; Headaches; Dizziness; Nausea; Unable to raise my arm/arm weakness; Pain was at a 10 and I had to go to the ER for care; Fatigue/tiredness; This is a spontaneous report from a contactable other HCP (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), on 30Dec2020 14:15 at single dose in Left arm for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Breast cancer, Hypertension (HTN), high cholesterol, lymphedema, endometriosis, hysterectomy, myomectomies x 2, anxiety, seasonal allergies, hx of pleurisy x 3. Known allergies included adhesive glue in tape and bandaids, pollen, dust, pet dander. The patient was not pregnant at the time of vaccination. Concomitant medication included escitalopram, losartan potassium 50 mg, anastrozole (ARIMIDEX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Day 1-3 Injection site pain Day 6-7-muscle pain, joint pain, headaches, dizziness, nausea, unable to raise my arm/arm weakness, pain was at a 10 and had to go to the ER for care, fatigue/tiredness. All the events were reported onset on 06Jan2021 18:00. AE resulted in Emergency room/department or urgent care. Received Morphine, Muscle relaxer, steroid via IV, RX as treatment. The events were assessed non-serious.

Other Meds: ; ; ARIMIDEX

Current Illness:

ID: 0942651
Sex: F
Age:
State: CA

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210106; Test Name: X-Ray; Result Unstructured Data: Test Result:did not show any type of dislocation or fracture

Allergies:

Symptoms: It is causing a decrease in mobility and effecting her mobility; soreness in her arm; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number: EL1284) via an unspecified route of administration on the left arm on 23Dec2020 17:20 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the COVID vaccine and was still experiencing soreness in her arm for more than 2 weeks. She wanted to know if she should get the second dose. She also wanted to know if she does get the second dose can she ask for a different needle size and different injection site. She had soreness in her arm on 24Dec2020 and if it was related to the COVID Vaccine. The soreness in her arm is in the left arm where the site of injection was. She noticed when woke up like am in the morning. She had an X-Ray done yesterday 06Jan2021 and it did not show any type of dislocation or fracture. She stated she knew the soreness in the arm was most commonly seen 48 hours after getting the injection, the COVID shot, she knew this was a normal side effect. However, she was wondering why she is still experiencing this and it's going on 2.5 weeks now. She later clarified when speaking to previous agent they were providing the number to speak to someone more about the side effects and questions. She wanted to know why she was having it more than 2.5 weeks after getting it. She has read literature and she saw there where it can occur, but it indicated it would not be more than 72 hours. She was worried about this. It was causing a decrease in mobility and effecting her mobility. There was no history of all immunizations with the Pfizer Vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The events did not require a visit to the emergency room or physician office. Outcome of the event soreness in her arm was not recovered, while unknown for the other event.

Other Meds:

Current Illness:

ID: 0942652
Sex: F
Age:
State: NY

Vax Date: 12/29/2020
Onset Date: 01/06/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: armpit swelling; Itchiness, injection site and armpit swelling/It started itching and it is a little swollen; It is like the injection site reaction; Redness and swelling around the injection site; Redness and swelling around the injection site; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EJ1685, expiry date: Mar2021) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. Medical history included asthma, anxiety. Concomitant medication included salbutamol (ALBUTEROL) for asthma, venlafaxine hydrochloride (EFFEXOR) for anxiety. The patient had noticed redness and swelling around the injection site. It doesn't seem like an infection but a typical reaction. This happened to the patient on day 8 post vaccination (06Jan2021). She also reported itchiness, injection site and armpit swelling since last night (06Jan2021). She had her vaccine on 29Dec2020 and then the last night (06Jan2021) it started itching and it is a little swollen. It is like the injection site reaction but she did not know it was normal this far after getting it. Like she was just curious that sort of reaction is normal this far after getting the vaccine. Events outcome was unknown.

Other Meds: ALBUTEROL [SALBUTAMOL]; EFFEXOR

Current Illness:

ID: 0942653
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: After getting my vaccine I got a headache on both side of my head for seven days; This is a spontaneous report from a non-contactable physician, the patient. A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via an unknown route of administration on an unknown date as a single dose for COVID-19 vaccination. The patient's medical history was unknown. The patient's concomitant medications were not reported. The patient reported that "after getting my vaccine, I got a headache on both sides of my head for seven days." The event was reported as non-serious. Treatment for headache was unknown. The clinical outcome of headache was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0942654
Sex: M
Age:
State: NY

Vax Date: 12/28/2020
Onset Date: 12/29/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: swollen lymph nodes under left clavicle; tiredness; pain at the site; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number: EK9231) via an unspecified route of administration on his left arm on 28Dec2020 at a single dose for COVID-19 immunization. The patient had no medical history and no relevant family medical history. There were no concomitant medications. The patient worked at 12-13 different hospitals and around first responders and COVID positive patients. The patient got the first dose of the Pfizer BioNTech COVID vaccine on 28Dec and he has developed adverse events as of 'yesterday'. Reported he was tired and having swollen lymph nodes under the left clavicle, no fever or other symptoms. The patient noticed the swollen lymph nodes on 06Jan2021 when coming out of the shower. Since he worked in the hospital he asked a few Physicians about it. Mentioned he did do something with the (Public health agency name) and signed up and they sent him text messages every day to see how he was feeling the first 7-8 days. He never had symptoms that day except for pain at the site and a little tiredness post day (29Dec2020) of getting vaccine and then nothing after that. The Physicians he spoke to were only to palpate the one lymph node, it was pretty visible. He had none visible or palpated in the neck and they couldn't feel anymore there or anywhere else. He has had some tiredness today also, but no fever or anything else. He did not receive any other vaccines the same day or 4 weeks prior. Has not had any problems with previous vaccines. He was to go back for the second vaccine scheduled on 15Jan, but not sure if he should hold off. He worked with medical Devices, pacemakers, defibrillators, pacemaker devices. He does not take any medications and has not had any bloodwork. Patient was asking what should he do if he still has the swollen lymph nodes when he is due to get the second vaccine. The patient had no relevant tests done. Outcome of the events swollen lymph nodes and tiredness was not recovered, while unknown for the other event.

Other Meds:

Current Illness:

ID: 0942655
Sex: F
Age:
State: TN

Vax Date: 01/04/2021
Onset Date: 01/01/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: dizziness; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse, the patient. A female patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via an unknown route of administration on 04Jan2021 as a single dose for COVID-19 vaccination. The patient's medical history included ear infection prior to receiving the COVID-19 vaccine. The patient's concomitant medications were not reported. On an unknown date in Jan2021, the patient experienced dizziness. The event dizziness was reported as non-serious. Treatment for dizziness was unknown. The clinical outcome of dizziness was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness: Ear infection (nurse reports her ear infection is not yet resolved)

ID: 0942656
Sex: M
Age:
State: TX

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: constipation; neck stiffness; headaches; fatigue; soreness/Body soreness; soreness (both body soreness and injection site soreness); This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 12:00 pm at single dose at left arm for covid-19 immunization. There were no concomitant medications. Patient previously had the flu vaccine and had what was described as a less reaction, like a sensitivity. He had a slight fever and fatigue, like his body was fighting something. The patient has no product name, NDC, Lot, or Expiry for that product. Patient had no other medical history (including any illness at time of vaccination). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the Pfizer suspect. On 07Jan2021 01:00, patient had the side effect of constipation after getting the vaccine, neck stiffness, and headaches, patient was experiencing these as well as fatigue and soreness (both body soreness and injection site soreness). The body soreness was like he worked out and his whole body was sore, the injection site soreness was more sore than his body but this was to be expected and it was about the same though didn't feel at first but felt it more on 07Jan2021. All the events started at about 1am on 07Jan2021. No history of all previous immunization with the Pfizer vaccine considered as suspect. No family medical history relevant to adverse events. Outcome of events neck stiffness, and headaches was recovering, and outcome of other events was not recovered. This report is considered as non-serious. The adverse events didn't require a visit to emergency room nor physician office. Information on Lot/Batch has been requested.

Other Meds:

Current Illness:

ID: 0942657
Sex: F
Age:
State: VA

Vax Date: 12/21/2020
Onset Date: 12/26/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20201226; Test Name: Tested positive for COVID; Result Unstructured Data: Test Result:Positive

Allergies:

Symptoms: Tested positive for COVID after receiving the first dose of the vaccine; Tested positive for COVID after receiving the first dose of the vaccine; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ-685, expiration date: Mar2021), via an unspecified route of administration in the right arm on 21Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient tested positive for COVID on 26Dec2020. Now, she is wanting to know if she should still get the second dose. Outcome of the events was unknown.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020, and COVID-19 test positive on 26Dec2020. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.

Other Meds:

Current Illness:

ID: 0942658
Sex: F
Age:
State: CA

Vax Date: 12/19/2020
Onset Date: 12/19/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Name: COVID; Test Result: Negative ; Test Date: 20201222; Test Name: COVID; Test Result: Positive

Allergies:

Symptoms: tested positive/had the COVID infection/cough; tested positive/had the COVID infection/cough; PFIZER-BIONTECH COVID-19 VACCINE at 1.3 mL; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 19Dec2020 at 1.3 mL, single for COVID-19 immunization. There were no medical history and concomitant medications. She received the first COVID-19 vaccine dose on 19Dec2020 then she tested positive on 22Dec2020. She got the first dose of the COVID vaccine and now she had the COVID infection. She was wondering if she should continue to get the second dose. She was also wondering if it will affect whether or not she gets the second dose. She couldn't find information online about what to do. Before she got the vaccine, she did take a test on an unspecified date to make sure she was negative, and she was. She had a cough at the end of the call. Outcome of the events was unknown. Information on lot/batch number has been requested.; 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 COVID-19 and suspected LOE 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, 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: 0942659
Sex: F
Age:
State: WI

Vax Date: 12/21/2020
Onset Date: 12/27/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Idiopathic trigeminal neuralgia; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), intramuscular (right deltoid) first dose on 21Dec2020 at single dose for Covid-19 immunization. The patient's medical history included multiple sclerosis from 2015 (Diagnosed 5 year) and ear infection from 03Dec2020 prior to vaccination, she was seen in urgent care with an ear infection, states it was super painful and lasted about 7-10 days treated it with drops.. There were no concomitant medications. The patient requested guidance on whether or not she should get the second dose of the covid vaccine after being diagnosed with Trigeminal Neuralgia following the first dose. The patient stated that she received the first done on 21Dec2020 and on 27Dec2020 was diagnosed with Idiopathic trigeminal neuralgia. The patient was unclear if the vaccine played a part in the diagnosis and wonders if there is any data available about this as an adverse event as she read that Bells Palsy was reported and this was similar. The patient need guidance on whether to get second dose of the Covid vaccine scheduled for on Monday. Wondering if getting the second dose would be risking it flaring up, states she was now on anticonvulsant medication and gabapentin and they have increased the anticonvulsant medication. The patient experienced idiopathic trigeminal neuralgia (trigeminal neuralgia) (non-serious) on 27Dec2020 with outcome of not recovered. The action taken in response to the event(s) for bnt162b2 was not applicable. The outcome of the event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Trigeminal Neuralgia due to temporal relationship. However, the event may possibly represent concurrent medical condition in this patient with medical history of multiple sclerosis. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and viral serologies, 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: 0942660
Sex: F
Age:
State:

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:101.4 Fahrenheit

Allergies:

Symptoms: fever of 101.4F; chills; bodyache; headache; joint pain; This is a spontaneous report from a contactable Nurse (the patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date in Dec2020 (at an unknown age) at an unspecified dose for COVID-19 vaccination.The patient's medical history was not reported. The patient's allergies were not reported. The patient's concomitant medications were not reported. The reporter stated that she is scheduled for her second dose of the vaccine today (07Jan2021), as it is the end of the 21-day period. With her first dose she experienced fever of 101.4F, chills, bodyache, headache and joint pain - all of which lasted for 48 hours. She was concerned about getting the second dose. Treatment information was not provided. The clinical outcomes of the events fever, chills, body ache, headache and joint pain was reported as recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0942661
Sex: F
Age:
State: MO

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: soreness to arm injection site; might have lymph node swelling or something; a sharp pain/soreness right below her left ear; sharp pain below left ear that comes and goes; the first dose on 18Dec2020 10:00 AM/ second dose on 06Jan2021 13:00; the first dose on 18Dec2020 10:00 AM/ second dose on 06Jan2021 13:00; This is a spontaneous report from a contactable consumer for self. This 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 13:00 on left arm at single dose (Lot # EL1284) for COVID prevention. Medical history included ongoing arthritis in some form probably since 2011 (reported as ten years ago, as of 07Jan2021), ongoing Osteoporosis had it probably at least since five years ago, maybe longer, ongoing Barrett's esophagus had it probably since 2016 (reported as five years ago, as of 07Jan2021) High cholesterol this is managed or lowered with medication, and was diagnosed in 2001 (reported as probably 20 years ago, as of 07Jan2021) her whole family has it. Concomitant medications were none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 10:00 AM at age of 64-year-old on right arm at single dose (Lot # EL0140) for COVID prevention. She says that the first time she got the injection in her right arm, but the second time her right arm was still hurting, which she has arthritis over there also, this time she got the injection in her left arm. She says that the soreness or sharp pain under her left ear could be or not be related. She experienced soreness to arm injection site. She says that the area below her left ear doesn't feel swollen, it just feels like not a sore throat, but every so often she has a sharp pain, and it could be that she slept on it wrong. She says she was wondering if that goes away fast or is connected, like a possible side effect. The patient received the 2nd dose of the vaccine 06Jan2020 13:00 and reported to have a sharp pain/soreness right below her left ear on 07Jan2021, sharp pain below left ear that comes and goes. She read that swollen lymph nodes were a side effect and is asking if that area is a lymph node and would that be considered a side effect and is asking how long it will it take before it goes away. She is wondering since side effects said might have lymph node swelling or something. She says in her arm where her shot was given is sore, and also kind of right below her left ear, which she thinks that is where a lymph node is. She says every so often she has a sharp pain there that goes away, and she wanted to know if this could be a part of it, since she is guessing that is where a lymph node is, or wondering it this is something even related that could be a side effect. Treatment included she took Tylenol Rapid Relief Extra Strength a while ago, dose queried but not provided. EXP: Jul2022, LOT: SJA072, this is not on the bottle, it must have been on an outer box which was discarded. Treatments received for the events pain, pain in ear, vaccination site pain and swollen lymph nodes. Outcome of the events were unknown.

Other Meds:

Current Illness: Arthritis (in some form probably since ten years ago); Barrett's esophagus; Osteoporosis (probably at least since five years ago, maybe longer,)

ID: 0942662
Sex: F
Age:
State: NY

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Name: chest x-ray; Result Unstructured Data: Test Result:Unknown results; Test Name: nuclear cat scan; Result Unstructured Data: Test Result:Unknown results; Test Name: EKG; Result Unstructured Data: Test Result:showed some abnormal activity; Test Date: 20201230; Test Name: heart rate; Result Unstructured Data: Test Result:rose to 113, and remained between 110-113; Comments: for 48 hours; Test Date: 20201230; Test Name: heart rate; Result Unstructured Data: Test Result:110-115; Comments: resting heart rate was elevated around 110-115; Test Name: d-dimer; Result Unstructured Data: Test Result:1,131; Test Name: lab work; Result Unstructured Data: Test Result:Unknown results; Test Name: cardiac enzymes; Test Result: Negative ; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: EKG which showed some abnormal activity; resting heart rate rose to 113, and remained between 110-113 for 48 hours/her resting heart rate was elevated around 110-115; she felt slightly short of breath; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date Mar2021), intramuscular (top of her right arm) first dose on 29Dec2020 11:00 at single dose for Covid-19 immunization. The patient's medical history included ongoing allergic to contrast dye, allergic to dust, and covid from Apr2020. There were no concomitant medications. The patient had the first dose of the Pfizer covid vaccine and she had an uncommon reaction. She received the first dose of the covid vaccine on 29Dec2020 around 11am. 24 hours after receiving the vaccine on 30Dec2020 around 11am she felt slightly short of breath and her resting heart rate was rose to 113, and remained between 110-113, elevated around 110-115. Her heart rate stayed elevated for about 2 hours. She called her doctor and she was instructed to go to urgent care where they did an EKG which showed some abnormal activity. Reports she has no history of cardiac issues in the past. The doctor at urgent care recommended for her to be transported by ambulance to emergency room to rule out a pulmonary embolism. Her heart rate remained elevated and while she was in the ER she had an EKG, lab test, chest x-ray, and nuclear cat scan since she is allergic to iv contrast dye. Her cardiac enzymes were negative. She did not have a pulmonary embolism. Her d-dimer was 1,131. She confirms she was not admitted. She has an apple watch and was told to monitor her heart rate. She was instructed to call # if she experienced shortness of breath. The patient heart rate remained elevated for the next 48 hours and she did not start to feel normal and recovered completely around noon on 01Jan2021. She just had a follow up with her primary doctor. She asked if she should get the second dose of the vaccine. Her doctor consulted with the allergist and stated she should call Pfizer to ask if she should receive the second dose. Vaccination Facility Type was Nursing home where she works. No additional vaccines administered. No prior vaccinations within 4 weeks. The outcome of the events heart rate increased and dyspnoea was recovered on 01Jan2021 and unknown for the remaining event.

Other Meds:

Current Illness: Contrast media allergy

ID: 0942663
Sex: F
Age:
State: TX

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: her left, upper arm became bruised and sore; her left, upper arm became bruised and sore/muscle soreness, like from a flu shot; half of the vaccine came out at the injection site and she did not receive the full dose.; This is a spontaneous report from a Pfizer from a contactable nurse reporting for self. This 42-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: 31May2021) via unspecified route of administration on 06Jan2021 at single dose in left upper arm for COVID-19 immunisation. Medical history and concomitant medications were none. The patient previously received her first dose of BNT162B2 (Lot Number: EJ1685) on 18Dec2020 IM in her right deltoid muscle at single dose for COVID-19 immunisation at age of 42-year-old. She said when she received her first dose, the person who administered the shot used a 3-finger width distance from her right shoulder bone when administering the vaccine into her right deltoid muscle. She said after receiving the first dose, it was about 9 hours later before her right shoulder hurt. The patient received the second dose on 06Jan2021. She said at least half of the vaccine came out of her arm (came out at the injection site), so she did not receive the full second dose. She said when she received her second dose, the person who administered the vaccine used only a 2- finger width distance from her left shoulder, and administered the vaccine very high up on her left arm. She said her left, upper arm became bruised and sore within an hour after receiving the second dose of vaccine. She said her left arm is still hurting today, clarifying she had a muscle soreness, like from a flu shot. The events did not require a visit to emergency room or physician office. The outcome of events was not recovered. The reporter considered the relatedness of vaccine to all events was related, and considered event her left, upper arm became bruised and sore/ muscle soreness, like from a flu shot as not serious.

Other Meds:

Current Illness:

ID: 0942664
Sex: F
Age:
State: IN

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: nausea/Nauseated; severe diarrhea; Her arm is sore; She is not feeling well; This is a spontaneous report from a contactable other HCP (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 11:00 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. She worked in a hospital. She got the vaccine at 11:00 and within an hour she had severe diarrhea. She hasn't thrown up. It is like a bowel prep. She was nauseated, not really bad but it was annoying. She can smell. She was not weak. Her arm was sore but that was normal. Following administration of the vaccine she experienced severe diarrhea and now nausea. She can't take Imodium, so she took Kaopectate. She was out for breakfast and then this happened. She has never had anything happen like this before. She was not feeling well. The onset date of events was 07Jan2021. She reported that the diarrhea was now gone. The outcome of diarrhea was recovered, of other events was unknown. Treatment received for nausea and diarrhea. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0942665
Sex: F
Age:
State: HI

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Chills; Night sweats; Body aches; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL1284) intramuscular in left arm on 05Jan2021 at 14:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 06Jan2021 at 19:00, the patient experienced chills, night sweats and body aches. No treatment given.The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 0942666
Sex: M
Age:
State: CA

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210107; Test Name: Fever; Result Unstructured Data: Test Result:Over 100 Fahrenheit

Allergies:

Symptoms: Fever over 100 F; brief body aches and chills; brief body aches and chills; This is a spontaneous report from a contactable other HCP reporting for a patient. A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EJ1658/expiration date: unknown), via intramuscular route of administration, on 17Dec2020 at 05:30 PM (at the age of 32 years old) as a single dose in the right arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL3249/expiration date: unknown), via intramuscular route of administration, on 06Jan2021 at 03:45 PM (at the age of 32 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021, the patient experienced fever over 100*F, brief body aches and chills. Treatment was received for the events fever over 100*F, brief body aches and chills included acetaminophen (TYLENOL). The outcome of the events fever over 100*F, brief body aches and chills was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0942667
Sex: F
Age:
State: PA

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: itching/itching at the site and on her chest going all the way to her groin; rashes/She does have the rash some already but she expects it to get worse. The rash starts at the armpits and goes down to the groin; itching at the site; soreness on her arm; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for herself that the 56-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), by injection via an unspecified route of administration on Arm Left on 06Jan2021 12:00 noon at single dose for covid-19 immunisation (front line health care worker). Medical history included Hot flashes, Hashimoto's disease, Osteoporosis and Allergy. Concomitant medications included ongoing estrogens conjugated/medroxyprogesterone acetate (PREMPRO) at 0.45mg; take once daily by mouth for Hot flashes from 2017, ongoing Levothyroxine at 50mcg; take once daily by mouth for Hashimoto's disease from 2014, ongoing alendronate sodium (FOSAMAX) at 70mg; take once weekly by mouth for Osteoporosis from 2017, montelukast sodium (SINGULAIR) at 10mg; take once daily by mouth for allergy from 2018, ongoing Azelastine at one spray per nostril daily for Allergy from 2019, ongoing Fluticasone at 50mg; one spray each nostril daily for Allergy from 2019, ongoing Hydroxyzine at 10mg; once daily by mouth for Allergy from 2019. The patient had the COVID-19 vaccine yesterday (06Jan2021) and today (07Jan2021) 16:00 experienced itching and rashes. She also had soreness on her arm. She is concerned whether this is expected of the COVID-19 vaccine and will it happen again because she has heard that the side effects may worsen on the second dose of the vaccine. What would happen if I don't get the second dose of the vaccine? Itching was reported as worsened. Rash was reported as worsened. Occupational Therapist calling regarding the Pfizer COVID 19 vaccine. States she had the vaccine yesterday and just started itching and can't get up with her primary care provider. Asking if this is a normal side effect? Will it happen again? Reports she received the first dose of the COIVID 19 vaccine 06Jan2021 at 12:00 noon in the left arm. Today 07Jan2021 within the last the hour, 16:00, she started itching at the site and on her chest going all the way to her groin. Adds she has a lot of allergies and that is how it always starts. She knows she will wake up with a red bathing suit rash. She does have the rash some already but she expects it to get worse. The rash starts at the armpits and goes down to the groin. Reporter is Occupational Therapist reporting on herself She is unsure if she will take the second dose of the vaccine. Vaccination Facility Type was nursing home. No vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Physician Office or ER.Prior Vaccinations (within 4 weeks) was none. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was none. The outcome of the events Itching and rash was not recovered. The outcome of the other events was unknown.

Other Meds: PREMPRO; ; FOSAMAX; SINGULAIR; ; ;

Current Illness:

ID: 0942668
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: massive headache; body ache; got hives all over body but did not experience difficulty in breathing; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received vaccine at work and the following day the patient experienced massive headache and body ache on an unspecified date. It was also reported that the next day, the patient got hives all over body but did not experience difficulty in breathing. The patient already spoke to her doctor regarding the adverse events that she experienced. Outcome of the events were unknown. Information on the lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 0942669
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: burning and itching sensation in his eyes; burning and itching sensation in his eyes; runny nose; This is a spontaneous report from a contactable consumer (patient). This male patient of an unspecified age (Age-92, Unit-Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient has received the first dose of the vaccine on an unspecified date (reported as today) at 10:35am. He mentioned that nothing happened during the 30 min observation period for allergic reactions. Then at around 4pm, he experienced a burning and itching sensation in his eyes and had a runny nose. Outcome of the events was unknown. Information about Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0942670
Sex: F
Age:
State: CA

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: chills; body aches; headache; nausea; dry heaves; fatigue; This is a spontaneous report from a contactable Nurse. This Nurse reported for self that the 55-year-old female patient received second dose of bnt162b2 (BNT162B2, brand:ELI,, Batch/lot number: 283), via Intramuscular on Left arm on 06Jan2021 03:30 PM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Known allergies to medications, food, or other products: Penicillin, sulfa drugs and Hypothyroid, genital herpes. Concomitant medications included the patient received within 2 weeks of vaccination: levothyroxine, Valacyclovir. The patient previously took first dose of bnt162b2 (BNT162B2, brand: EK, Batch/lot number: 5730), by injection via Intramuscular on Arm Right on 16Dec2020 03:30 PM at single dose for covid-19 immunisation. Facility type vaccine was Hospital. No other vaccine in fourweeks. At approximately 12 hours post injection chills, body aches, headache, nausea, dry heaves, fatigue from 07Jan2021 03:30 AM. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: ; VALACYCLOVIR [VALACICLOVIR]

Current Illness:

ID: 0942671
Sex: F
Age:
State: AZ

Vax Date: 12/28/2020
Onset Date: 12/29/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Name: COVID test; Test Result: Negative ; Comments: Did not test positive

Allergies:

Symptoms: I just had a sore in the left arm the next day; This is a spontaneous report from a contactable Nurse (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date not reported), intramuscular on the left arm on 28Dec2020 07:00 at single dose for COVID-19 immunization. Medical history included allergies to PCN/Sulfa. Concomitant medications included calcium and an unspecified allergy pill. The patient reported that she just had a sore in the left arm the next day on 29Dec2020 and there were no other problems. No treatment was given for the event. The event was reported as non-serious. The patient had no prior COVID vaccination and did not test positive for COVID post vaccination. The patient recovered from the event on an unspecified date.

Other Meds:

Current Illness:

ID: 0942672
Sex: F
Age:
State: TX

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Mild Tenderness of Nose; Slight Swelling of Nose; This is a spontaneous report from a contactable Other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), intramuscular from 05Jan2021 10:00 at single dose in the right arm for COVID-19 immunization. There were no medical history and concomitant medications. On 06Jan2021 16:00, the patient experienced mild tenderness of nose and slight swelling of nose. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. 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 outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 0942673
Sex: M
Age:
State: TX

Vax Date: 12/18/2020
Onset Date: 12/30/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I lost all the hair at the top of my head. I was already slowly balding/ thinning. Two weeks after the injection my scalp felt like it was on fire and the hair started falling out in clumps easily.; I lost all the hair at the top of my head. I was already slowly balding/ thinning. Two weeks after the injection my scalp felt like it was on fire and the hair started falling out in clumps easily.; This is a spontaneous report from a contactable Other-HCP (patient). A 29-year-old male patient received BNT162B2 (Lot/Batch number and expiry date unknown), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included High blood pressure and depression, both from unknown date. Concomitant medication included venlafaxine and lamotrigine. On 30Dec2020, the patient lost all the hair at the top of her head. He was already slowly balding/thinning. Two weeks after the injection, his scalp felt like it was on fire and the hair started falling out in clumps easily. The hair has not grown back. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds: ;

Current Illness:

ID: 0942674
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 01/01/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Name: chest X-ray; Test Result: Negative ; Comments: She was tested for Sars-Cov-2 infection and had a chest X-ray, both negative; Test Name: Sars-Cov-2 infection; Test Result: Negative ; Comments: She was tested for Sars-Cov-2 infection and had a chest X-ray, both negative

Allergies:

Symptoms: trouble breathing- feeling like she "had yawn or having to take a deep breath; legs felt super heavy when I tried to walk; fatigue; Numbness and tingling in L-arm (opposite from vaccine given) which lasted for 20 minutes, then tingling went to feet up to thigh (5-10 min)/Tingling sensation continued to her tongue (3 minutes) then to her R-arm and to the top of her head; Numbness and tingling in L-arm; This is a spontaneous report from a contactable Other-HCP. This Other HCP reported for self that the female patient of unknown age who received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Arm right on 30Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient reports that she got the vaccine 30Dec2020 2 days after felt great, day 3 and 4 fatigue (fatigue on days 3 and 4 after dose). Then 06Jan2021 reports trouble breathing-feeling like she "had yawn or having to take a deep breath,". She reports having Sars-Cov-2 infection previous to this experience. She was tested for Sars-Cov-2 infection, had Covid in the past and had a chest X-ray, both negative. Numbness and tingling in L-arm (opposite from vaccine given) which lasted for 20 minutes, then tingling went to feet up to thigh (Didn't last long 5-10 min) then reported her "legs felt super heavy when I tried to walk". Tingling sensation continued to her tongue (3 minutes) then to her R-arm tingly and to the top of her head. She states she is "getting better" and is "fine now" but wanted to know if this is a reported AE and how long it might last. She is asking for guidance on getting the second dose after her experience. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0942675
Sex: F
Age:
State: NY

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccine received Monday 04Jan, severe headache afterwards. Tuesday 05Jan, full body itchy rash. Unchanged with use of benadryl.; Vaccine received Monday 04Jan, severe headache afterwards. Tuesday 05Jan, full body itchy rash. Unchanged with use of benadryl.; This is a spontaneous report from a contactable healthcare professional. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), via an unspecified route of administration in the left arm on 04Jan2021 14:00 at a single dose for COVID-19 immunisation. Medical history included depression and celiac disease. Concomitant medications included sertraline hydrochloride (ZOLOFT), omeprazole, calcium, and lactobacillus acidophilus (ACIDOPHILUS). The patient previously took amoxicillin, gluten and experienced allergies. It was reported that the patient had a vaccine received on Monday 04Jan2021, and experienced severe headache afterwards. On Tuesday 05Jan2021, the patient experienced full body itchy rash. These were unchanged with the use of Benadryl. Clinical outcome of the events was not recovered.

Other Meds: ZOLOFT; ; ; ACIDOPHILUS

Current Illness:

ID: 0942676
Sex: M
Age:
State: IL

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210107; Test Name: Low Grade Fever; Result Unstructured Data: Test Result:99-100's; Comments: no units; Test Date: 20210107; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Pending

Allergies:

Symptoms: Low grade fever 99-100's; Muscle aches; Fatigue; Chills; Malaise; This is a spontaneous report from a contactable Physician (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK5730/expiration date: unknown), via unknown route of administration, on 18Dec2020 at 02:00 PM (at the age of 43 years old) as a single dose in the left arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0130/expiration date: unknown), via unknown route of administration, on 06Jan2021 at 03:45 PM (at the age of 43 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypertension (HTN) and GERD. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Metoprolol, Hydrochloride, Acetylsalicylic acid (ASPIRIN), Omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 12:00 PM, the patient experienced low-grade fever 99-100's, muscle aches, fatigue, chills, malaise. Treatment was received for the events low grade fever 99-100's, muscle aches, fatigue, chills, malaise included ibuprofen (ADVIL), acetaminophen (TYLENOL), rest and fluid. The outcome of the events fever 99-100's, muscle aches, fatigue, chills, malaise was recovering. Patient underwent COVID-19 PCR test which was pending result. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds: ; ASPIRIN [ACETYLSALICYLIC ACID];

Current Illness:

ID: 0942677
Sex: F
Age:
State: PA

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210107; Test Name: Fever; Result Unstructured Data: Test Result:100.4; Comments: no fever until the evening 100.4

Allergies:

Symptoms: In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; This is a spontaneous report from a contactable other HCP (patient). A 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), intramuscularly on 06Jan2021 14:45 at single dose in Left arm for COVID-19 immunisation. No Pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Irritable bowel syndrome. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included fluticasone propionate, ethinylestradiol, norethisterone (WERA). The patient experienced In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4 on 07Jan202105:30 AM. No treatment received for the adverse events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome was unknown.

Other Meds: FLUTICASONE PROPRIONATE; WERA

Current Illness:

ID: 0942678
Sex: M
Age:
State: MA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; This is a spontaneous report from a contactable Physician (patient). This 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 05Jan2021 15:00 (lot number: EK9231) at single dose in Arm Left for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Migraines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included paracetamol (TYLENOL), ibuprofen (ADVIL) occasionally as needed. The patient previously received first dose of BNT162B2 intramuscularly on 16Dec2020 12:00 at 31-year-old (lot number: EH9899) at single dose in Arm Left for COVID-19 immunisation. The patient experienced Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing on 06Jan2021 03:00 AM. The outcome of Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing was recovering. Tylenol, Advil, Bed Rest was received for the adverse events Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing as treatment. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: TYLENOL; ADVIL [IBUPROFEN]

Current Illness:

ID: 0942679
Sex: F
Age:
State:

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: muscle weakness; fatigue; nausea; headaches; fever; This was a 17 day interval between doses; This was a 17 day interval between doses; This is a spontaneous report from a contactable consumer (patient). This 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 21Dec2020 at single dose for COVID-19 immunisation. She received her first dose of Covid vaccine on 21Dec2020 and second dose of Covid vaccine on 06Jan2021. This was a 17 day interval between doses. After receiving second dose of COVID vaccine, she has been experiencing muscle weakness all over, fatigue, nausea, headaches, and fever. The outcome was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0942680
Sex: F
Age:
State: NY

Vax Date: 12/16/2020
Onset Date: 12/01/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: labs; Result Unstructured Data: Test Result:everything was ok

Allergies:

Symptoms: Her bones were hurting her; hip was hurting more/ pain in hip; Dental implants and bridge fell out; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar event for two patients. This is the 1st of two reports. A 75-years-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Batch/lot number: EK5730), via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunization (reported as works with COVID patients on daily basis). Medical history included hypertension, hip replacement from an accident four years before 07Jan2021 in December (Dec2016). The patient was not overweight, exercises, was older, but considered in good health. The patient's concomitant medications were not reported. The past vaccine event included weak after the Flu shot. Couple weeks after first vaccine, before new year (Dec2020), dental implants came out. The patient clarified she was referring to dental implants had no pain, had a bridge in her mouth on the left lower side. Felt something was bothering her. Noticed her bridge lifted up and her implants fell out. Had to go to doctor's and had it removed. Everything was moving. She was very uncomfortable. Surgery cost her almost $3,000. Surgery was 3 days before 07Jan2021 (04Jan2021) for her implants and bridge. Had to use bone graft. Her bones were hurting her. After COVID-19 Vaccine, her hip was hurting more. She stated the pain in hip beginning up to one week as of 07Jan2021. The had labs in Dec2020 and everything was ok. The event outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021011233 same reporter/drug, similar event with different patients

Other Meds:

Current Illness:

ID: 0942681
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Dental implant fell out; This is a spontaneous report from a contactable nurse. This nurse reported similar event for two patients. This is the 2nd of two reports. A male patient of an unspecified age received bnt162b2 (also reported as COVID-19 Vaccine, lot no. and expiry date were unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced dental implant fell out on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021011228 same reporter/drug, similar event with different patients

Other Meds:

Current Illness:

ID: 0942682
Sex: F
Age:
State: NY

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; This is a spontaneous report from a contactable nurse (patient). This 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020 09:00 at single dose in Arm Right for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Migraines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included nortriptyline, bupropion, magnesium sulfate, fish oil , ca. The patient experienced By 2am extreme headache, by 4 am vomiting, chills, to sleep till 5p, headache, chills and muscle aches on 24Dec2020 02:00 AM, Back to normal in 72 hours. The outcome was recovered. No treatment received for the adverse events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0942683
Sex: F
Age:
State: VA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; This is a spontaneous report from a contactable Nurse (patient). This 40-year-old female Nurse reported for herself received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Elt9899/expiration date: unknown), via unknown route of administration, on 17Dec2020 at 07:45 PM (at the age of 40 years old) as a single dose in the left arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Eh9899/expiration date: unknown), via unknown route of administration, on 07Jan2021at 06:30 AM (at the age of 40 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included asthma. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Albuterol inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 03:00 PM, the patient experienced body chills, extreme fatigue, arm soreness at injection site. No treatment was received for the events body chills, extreme fatigue, arm soreness at injection site. The outcome of the events body chills, extreme fatigue, arm soreness at injection site was unknown. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds: ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 0942684
Sex: F
Age:
State:

Vax Date: 12/31/2020
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: arm pain from the injection site up to her shoulder; "penny-sized lump" above her collarbone (on the same side she was vaccinated on) which is painful to the touch and "feels like it is full of fluid"; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first Pfizer covid vaccine on 31Dec2020; and 7 days later (07Jan2021), the patient experienced arm pain from the injection site up to her shoulder and also reported "penny-sized lump" above her collarbone (on the same side she was vaccinated on) which was painful to the touch and "feels like it is full of fluid". The patient asked if these effects were normal and if she should receive the second dose of the vaccine. The outcome of the events was unknown. Information of lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0942685
Sex: F
Age:
State: NY

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210107; Test Name: Nasal Swab-PCR; Result Unstructured Data: Test Result:Pending

Allergies:

Symptoms: Rash; This is a spontaneous report from a contactable physician (patient herself). A 38-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on left arm on 05Jan2021 08:15 at single dose for covid-19 immunization, administered at hospital. Medical history included asthma. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced rash within 12 hours on 05Jan2021. The reported event was non-serious. The patient underwent lab tests and procedures which included nasal swab-PCR on 07Jan2021 with pending result. Therapeutic measures were taken as a result of rash with steroid cream and antihistamine. The outcome of the event was not recovered. No follow-up attempts are possible; Information on the lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0942686
Sex: F
Age:
State: IN

Vax Date: 12/29/2020
Onset Date: 12/31/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Name: temperature; Result Unstructured Data: Test Result:99.5

Allergies:

Symptoms: temperature of 99.5; Excessive/Severe itching from head to toe/itching has progressively gotten worse; experiencing slight headaches; low blood pressure; This is a spontaneous report from a contactable other-HCP (patient). A 25-years-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot: EL1284) via an unspecified route of administration on 29Dec2020 12:30 at single dose for COVID-19 immunisation. The patient was allegic to Sulfa products and Nickel products. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020 08:00 AM, the patient experienced excessive/severe itching from head to toe that started 2 days after the vaccine was administered. The itching has progressively gotten worse. She had also been experiencing slight headaches, low blood pressure, and temperature of 99.5 on 31Dec2020 08:00. Events resulted in doctor or other healthcare professional office/clinic visit. The patient received Medrol Dose pack as treatment. Events outcome was not recovered.

Other Meds: WELLBUTRIN

Current Illness:

ID: 0942687
Sex: M
Age:
State: NY

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210106; Test Name: temperature; Result Unstructured Data: Test Result:97.5; Test Date: 20210107; Test Name: temperature; Result Unstructured Data: Test Result:99; Comments: degrees; Test Date: 20210107; Test Name: temperature; Result Unstructured Data: Test Result:went up 1.5; Comments: degrees; Test Date: 20210105; Test Name: feels; Result Unstructured Data: Test Result:feels like a 3 or 4 out of 10

Allergies:

Symptoms: 99 degrees; felt really bad/feels like a 3 or 4 out of 10; muscle aches and pains; tired and fatigue; felt like he was going to throw up; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PFI302), via an unspecified route of administration in left arm on 05Jan2021 11:00 at single dose for ''front line worker''. Medical history included Crohn's disease from 2012. Concomitant medications included adalimumab (HUMIRA, injection, Lot: R22-03-A-01, Expiry: Feb2021) from Feb2019 and ongoing at 40 ml twice monthly for Crohn's disease (When providing weight he adds that he has had some weight gain due to medication side effects with Humira), ibuprofen (He took Ibuprofen on Tuesday night and 1 last night. He has not taken any today). Caller received the Pfizer covid-19 vaccine two days ago (05Jan2021). He has mild side effects to report. He is a Clinic Social Worker. Following the vaccine he experienced muscle aches and pains on 05Jan2021. He was tired and fatigued on 05Jan2021. His temperature was 97.5 yesterday (06Jan2021). It now 99 degrees (07Jan2021). His temperature went up 1.5 degrees. He felt like he was going to throw up in Jan2021. He received the vaccine at 11:00 am. At 05Jan2021 4:00 pm he felt really bad. He feels like a 3 or 4 out of 10. He is scheduled to get his second dose on 26Jan2021. The outcome of the events muscle aches and pains and tired and fatigue was recovering. The outcome of other events was unknown.

Other Meds: HUMIRA;

Current Illness:

ID: 0942688
Sex: F
Age:
State: IN

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Name: counts; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201113; Test Name: Chest x-ray; Result Unstructured Data: Test Result:Unknown results; Test Name: weight; Result Unstructured Data: Test Result:gained 10lbs lbs

Allergies:

Symptoms: Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to her elbow; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; Nausea; total loss of appetite; stated that she gained 10lbs, but she is very physically active.; either not making blood or there was an interference; she was freezing/she woke up cold and could not get warm/ felt cold; she had a little headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: Mar2021), intramuscular at left arm on 31Dec2020 at single dose for covid-19 prophylaxis. Medical history included low sodium, Covid-19 in Nov2020 (She had felt sick for a week and on 13Nov2020 she went to the ER and they did blood tests and she could not eat or drink for 3 days. She stated that she had 4 different IV fluids going and one of them was sodium and the other was for nausea), blood did not clot properly, broke her back. There were no concomitant medications.The patient had a unique reaction after receiving the Covid-19mRNA Vaccine. She clarified that she never had a reaction to a shot before. She received the vaccine on 31Dec2020 and was fine for the first 20 hours. She said that the next morning on 01Jan2021 at 0600 she woke up cold and could not get warm. She said that she spent the next 24 hours to where she kept adding clothes and blankets to keep warm. She stated that she was freezing and the she felt like the interior of her body was freezing even down to her toes felt cold. She also had injection site pain and the arm felt heavy and stated that the pain extended from her shoulder down to her elbow. She stated that the injection site pain was kind of delayed. She had aches and pains. She said that some of the pain went from the injection shoulder and spread to the middle of her spine. She had nausea and total loss of appetite and could not even eat. Her aches and pains after the vaccine were similar aches like she had with the Covid. She said that she had a terrible headache when she had Covid though. She stated that after the 24 hours of receiving the vaccine she had a little headache, but she took a migraine pill for it. She said that she was able to shed clothes, but she could not take a shower, but within 24-36 hours she was back to normal like it all never happened. She said that was when she figured out it was like her hemorrhaging with one of her childbirths. She explained that she had 3 children and hemorrhaged with each of her child births and was going into shock with one of them and felt this freezing sensation due to blood loss. She thought that her reaction to the vaccine was so bad that she was either not making blood or there was an interference. There was some kind of weird interruption. She said that her blood clots break down from minutes to hours after her child birth or with dental procedures. She had a PAI-1 deficiency or Plasminogen Activator Inhibitor-1 deficiency. She said that there was also something deeper that her doctors had not figured out yet too. She said that her blood did not clot properly. She said that she did not bruise or anything, but she was not allowed to have internal surgery without a transfusion. She said that her doctor's started to figure this all out after she broke her back before. She went to a hematologist and had her counts checked regularly. She said that she was being studied by 127 different clinics. She gained 10lbs, but she was very physically active. This was her first dose of teh vaccine. She said that her doctors told her that she needs to be under 48 hours of observation if she gets the second vaccine. Her primary care physician recommended that she did not take another mRNA vaccine. She said that she was taking their advice and canceled her second dose appointment. She said that when she had Covid-19 they did a Chest x-ray on 13Nov2020 and she had low sodium. She said that they gave her tramadol at the hospital for her headache, but she had already taken 3 migraine pills that day. She had already had her flu shot and read somewhere on a website, that mRNA vaccines might cause unstable anticoagulation. She wondered if it could be possible that Covid-19 antibodies interfered with her injection? The outcome of events was unknown.

Other Meds:

Current Illness:

ID: 0942689
Sex: M
Age:
State: WI

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I'm feeling like I have motion sickness.; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received bnt162b2, lot El0143, via an unspecified route of administration in the right arm on 06Jan2021 14:00 at single dose for covid-19 immunisation. The patient's medical has no relevant medical history. Patient has allergies to medications, food, or other products. The patient's concomitant medications were not reported. On an 07Jan2021 05:00, the patient felt like he has a motion sickness. The outcome of the event was recovering. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm