VAERS 2021 Database www.vaers.hhs.gov

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







Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 0936365
Sex: M
Age:
State: AR

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

Lab Data:

Allergies:

Symptoms: Fever; aches; chills; headache; This is a spontaneous report from a contactable consumer (patient himself). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration at the left arm on 05Jan2021 13:30 at a single dose for COVID-19 immunization. The patient's medical history included COVID-19 from an unknown date. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jan2021, 07:00 PM, the patient experienced fever, aches, chills, and headache. No treatment was received for the events. Outcome of the events at the time of last observation was reported as recovering. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0936366
Sex: M
Age:
State:

Vax Date: 12/18/2020
Onset Date: 01/05/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Date: 20210105; Test Name: SARS-Cov-2; Test Result: Positive

Allergies:

Symptoms: He tested positive last Tuesday for SARS-Cov-2; He tested positive last Tuesday for SARS-Cov-2; This is a spontaneous report from a Pfizer Sponsored Program, Pfizer First Connect via a contactable other health professional (HCP) (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive last Tuesday (05Jan2021) for SARS-Cov-2 and the patient wanted to know if he could receive his second dose of vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.

Other Meds:

Current Illness:

ID: 0936367
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: The 'left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minutes and then went away'; she felt 'a wave of nausea; This is a spontaneous report from a contactable consumer for herself. This 66-year-old female patient received the first dose of BNT162B2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient stated 3 hours after having received the vaccine, she felt 'a wave of nausea that went away just as fast as it had hit' her. The left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minutes and then went away. This was on the same side that she got the vaccine. She had never experienced anything like that. The outcome of event face went numb was recovered. The outcome of other events was unknown. Information about Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 0936368
Sex: F
Age:
State: WA

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

Lab Data:

Allergies:

Symptoms: tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at 0.3 mL, single for COVID-19 immunization. The patient's medical history included ventricular tachycardia from 2010 and defibrillator in her chest. There were no concomitant medications. She was scared initially so she waited for her coworkers to get the vaccine. Now, she is scared for the second dose. The night after the injection, on 28Dec2020, she had soreness in her arm. It was really bad. After two days, on 30Dec2020, she developed muscle pain, diarrhea, nausea, and headache. On Saturday (02Jan2021), she had an issue with her left eye wherein the eye lid became sore, and it got worse and worse. Her left eyelid was swollen and hurts. Now it is all swollen up. Her eye is not red. The top of the eyelid is so sore. She was really tired initially on an unspecified date. Outcome of the pain in arm and tiredness was unknown, of the swollen eyelid and eyelid pain was not recovered, of the muscle pain was recovered on 31Dec2020, while of the remaining events was recovered on an unspecified date.

Other Meds:

Current Illness:

ID: 0936369
Sex: U
Age:
State: MT

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

Lab Data:

Allergies:

Symptoms: Sore left arm; This is a spontaneous report from a contactable other HCP. An adult patient of an unspecified gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular in left arm on 05Jan2021 20:00 at a single dose for COVID-19 Immunization. Medical history included Traumatic brain injury, pacemaker, A-Fib and allergy to amoxicillin, and had covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2, lot number EH9899 on 15Dec2020 at 16:15, intramuscular in right arm for COVID-19 immunization The patient experienced sore left arm on 05Jan2021 20:00 with outcome of recovering. there was no treatment required for the said event. The event was assessed as non-serious. Since the vaccination, the patent has the patient not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0936370
Sex: F
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: she was a lactating; she was a lactating; Have some side effects last night from Covid Vaccine, got hives right above my breast; she has really bad Asthma/because of that she has "shortness of breath"; Felt like itchy like tingling on my lip; Felt like itchy like tingling on my lip; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2 (lot#: EK5730, expiration date: 31Mar2021), via an unspecified route of administration at arm left, on 02Jan2021 04:00, at single dose, for COVID-19 immunization, and salbutamol (ALBUTEROL) via an unspecified route of administration, from an unspecified date, at unknown dose, for asthma. Medical history included ongoing asthma, and ongoing very unslept person, and she was a lactating for she has a baby about year like 13 months ago (2019) so she is still producing milk. Concomitant medication not provided. The patient thought she has some side effects last night from her Covid Vaccine, so she got it yesterday around 4 O'clock and around 10, 10:30 she got hives on her chest, right above her breast, and about an hour after she got the vaccine, she thought it was just her asthma, so she has really bad Asthma, her Asthma kept like, she kept Asthma and because of that she has "shortness of breath" (not clarified), so she was just taking her Inhaler (unspecified medication) but then like last night wherever after that her "bedtime" (not clarified) she got hives on her chest and it felt like itchy like tingling on her lip, she was very unslept person so she just took some Benadryl (treatment) today she woke up fine, she feel fine but she was just thinking it would be okay to take her second dosage (Covid vaccine). When probed if visited to any physician office/ emergency Room for the treatment, consumer stated she just at home, she just took Benadryl. The action taken in response to the events for salbutamol was unknown. The outcome of the events was recovered.

Other Meds:

Current Illness: Asthma; Lactation normal; Sleep deficit (unslept person)

ID: 0936371
Sex: F
Age:
State: ME

Vax Date: 12/23/2020
Onset Date: 01/03/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea; loose stools; This is a spontaneous report from a contactable other nurse. A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular in left arm on 23Dec2020 14:45 at a single dose for covid-19 immunization. The vaccination was done in a hospital. Medical history included Acid reflux, depression, and B12 deficiency. The patient was not diagnosed COVID-19 prior to vaccination. Concomitant medication included drospirenone, ethinylestradiol (SYEDA), cyanocobalamin (B12-VITAMIIN), and venlafaxine hydrochloride (EFFEXOR). The patient experienced nausea and loose stools on 03Jan2021 04:00. The outcome of the events was not recovered. The event was assessed as non-serious. The patient was not tested for COVID-19 post vaccination. There was no treatment for the said events. No follow-up attempts are possible. No further information is expected.

Other Meds: SYEDA; B12-VITAMIIN; EFFEXOR

Current Illness:

ID: 0936372
Sex: F
Age:
State: NC

Vax Date: 12/18/2020
Onset Date: 12/21/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Lymphadenopathy supraclavicular nodes, left side; This is a spontaneous report from a contactable physician. A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) via an unspecified route of administration in left arm on 18Dec2020 12:30 at single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history included Known allergies with Penicillin. The patient was not pregnant. The patient was not diagnosed with COVID-19prior to vaccination. There were no concomitant medications. On 21Dec2020, the patient experienced Lymphadenopathy supraclavicular nodes, left side starting day 3 post vaccine and persistent to current with outcome of recovering. There was no treatment reported for the event. The event was assessed as non-serious. The patient was not tested for COVID-19 post vaccination.

Other Meds:

Current Illness:

ID: 0936373
Sex: F
Age:
State: MA

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

Lab Data: Test Date: 202101; Test Name: Covid test; Result Unstructured Data: Test Result:positive

Allergies:

Symptoms: she received the COVID-19 vaccine and the next day she tested positive for the viral infection; she received the COVID-19 vaccine and the next day she tested positive for the viral infection; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient was tested on 02Jan2021, and did not get the results till 06Jan2021 and tested positive. The patient wanted to know if she could have any side effects if she received the COVID-19 vaccine and the next day she tested positive for the viral infection. She is unsure of when she contracted the infection. The outcome was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0936374
Sex: F
Age:
State: KS

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

Lab Data:

Allergies:

Symptoms: Severe fatigue; Headache; Body aches; Feel like my skin is crawling; Nauseous; Arm is very sore; I feel like I'm dying; This is a spontaneous report from a contactable healthcare professional. A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as COVID-19 vaccine), via an unspecified route of administration left arm on an unspecified date (unknown lot number and expiration date) at a single dose; and via an unspecified route of administration left arm on 04Jan2021 18:00 [06:00 PM] (lot number: Eh9899; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had known allergies to amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine administered in a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Jan2021 17:00 [05:00 PM], the patient experienced severe fatigue, headache and body aches- feel like her skin is crawling and was hit by a freight train. The patient has never had a reaction like this before. The patient was also nauseous, and her arm is very sore, but she doesn't even notice since she feeling like she's dying. The patient has not been tested for COVID-19 since the vaccination. The treatment received by the patient for the adverse event included paracetamol (TYLENOL)/ibuprofen around the clock (OTC medication). The patient reported that the events was non-serious. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the event was not resolved. The following information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 0936375
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Body aches; Head congestion; Fatigue; This is a spontaneous report from a non-contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had body aches; head congestion; and fatigue. The outcome of the events, body aches, head congestion and fatigue, was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0936376
Sex: F
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; Painful lump on arm that has turned red and itches when she pressed on it/as a site reaction; It seemed that it had persisted longer and he said it sounded like it was getting infected; it was painful almost immediately/as a site reaction; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), via an unspecified route of administration on 28Dec2020 injected in unknown arm at single dose for precaution as a front line healthcare worker in hospital. The patient's medical history and concomitant medications were not reported. In the last 9 months, she worked in the COVID unit. It was unknown if additional vaccines administered on same date of bnt162b2. Prior vaccinations within 4 weeks was unknown. Patient said she got the bnt162b2 through her hospital on 28Dec2020, and still had a painful lump on arm that had turned red and itches when she pressed it was reported as worsened on 28Dec2020, it was painful almost immediately, like you would normally get with any vaccination. It seemed that it had persisted longer and he (Sales Representative) said it sounded like it was getting infected. She said it was painful when she pressed on it and he told her not to press on it. Compared to when she had gotten other vaccines in the arm, this seemed out of the ordinary for how long it had been painful as a site reaction. No ER or physician's office required. The outcome of the events was not recovered. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0936377
Sex: M
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: Fever; Muscle aches; This is a spontaneous report from a contactable healthcare professional (patient). A 24-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686; Expiration date was not reported) on 30Dec2020 (08:45) at a single dose on the left arm, with route of administration and therapy date unspecified, for COVID-19 immunization at a public health clinic. Medical history included COVID-19 prior to vaccination. There were no concomitant medications. On 30Dec2020 (20:00), the patient had fever and muscle aches. The patient had not been tested for COVID-19 post-vaccination, and did not receive any treatment for the reported adverse events. The outcome of the events, fever and muscle aches, was recovered on 31Dec2020.

Other Meds:

Current Illness:

ID: 0936378
Sex: F
Age:
State: AZ

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

Lab Data:

Allergies:

Symptoms: ringing in the left ear; This is a spontaneous report from a contactable Other HCP. This Other HCP reported same events for himself and other two patients. This is first of three reports, reported for one of two patients. A female patient started to receive started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 at single dose for covid-19 immunisation. Medical history, concomitant medications or past drug history were not provided. She developed a ringing in her left ear in Jan2021. It was assessed as non serious. Outcome of the event was unknown. Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021009229 same reporter/drug/event, different patient;US-PFIZER INC-2021009439 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 0936379
Sex: F
Age:
State: CA

Vax Date: 12/31/2020
Onset Date: 01/02/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:elevated; Test Name: heart rate; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: chest tightness; palpitations; elevated heart rate; fatigue; This is a spontaneous report from a contactable Other HCP. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. Medical history included Dermatographia. The patient is allergic to Penicillin, lactose, Cephalosporins and Beepen-VK. There were no concomitant medications. Seventy two hours after the vaccine was given the patient had an elevated heart rate, chest tightness and fatigue. Are this consistent with the vaccine. She does not have a history of elevated heart rate or palpitations. She checked her heart rate with her Apple watch and sent in a strip to the doctor. The doctor is concerned and is asking if this is related. She went to the ER to make sure she was ok but was not admitted. Outcome of event heart rate increased as recovered on 05Jan2021, of fatigue was not recovered, of others was recovering. Information about 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 elevated heart rate, chest tightness, palpitations and fatigue due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including 12-lead EKG , 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: 0936380
Sex: F
Age:
State: CT

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

Lab Data: Test Name: Temperature; Result Unstructured Data: Test Result:normally 97.4; Test Date: 20210105; Test Name: Temperature; Result Unstructured Data: Test Result:temperature is 98.2

Allergies:

Symptoms: rash that started on her face and now it is going everywhere; temperature is 98.2/slight fever; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), intramuscularly on 05Jan2021 injection in left arm at single dose for preventative since she works in nursing home. The patient's medical history and concomitant medications reported as no. The patient was experiencing a rash that started on her face and now it was going everywhere on 05Jan2021. Rash was reported as worsened. She just took diphenhydramine hydrochloride (BENADRYL). Patient stated it was not serious at this point. She just took her temperature before she called and her temperature was 98.2 on 05Jan2021 and stated this was a slight fever since she was normally 97.4. The outcome of the event rash was not recovered, outcome of slight fever was unknown. The report was reported as non-serious. Information on the lot/batch number has been requested

Other Meds:

Current Illness:

ID: 0936381
Sex: F
Age:
State: MO

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

Lab Data:

Allergies:

Symptoms: Face redness; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient experienced face redness on an unspecified date. The outcome of the event was unknown. Information on batch number has been requested.

Other Meds:

Current Illness:

ID: 0936382
Sex: M
Age:
State: IL

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

Lab Data: Test Date: 20201230; Test Name: fever; Result Unstructured Data: Test Result:101/102

Allergies:

Symptoms: Body Aches; Chills; 101/102 fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm on 29Dec2020 13:30 at a single dose for COVID-19 immunization. The patient was diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. On 30Dec2020, the patient experienced body aches, chills, and 101/102 fever. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious.

Other Meds:

Current Illness:

ID: 0936383
Sex: F
Age:
State: NY

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she does not feel well; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EU9231), via an unspecified route of administration in the left arm on 05Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient does not feel well on 06Jan2021. Outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 0936384
Sex: F
Age:
State: DC

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Date: 20201230; Test Name: Nasal Swab; Test Result: Negative ; Test Name: tested; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptoms: hives; raised papular rash bilateral lower extremity; Pruritic rash; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 04Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Jan2021 14:00, the patient experienced pruritic rash then on 06Jan2021 10:00, the patient experienced hives and raised papular rash bilateral lower extremity. No angioedema. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included nasal swab was negative on 30Dec2020. It was reported that the patient has been tested for COVID-19 on an unspecified date since the vaccination. Outcome of the events was recovering. The events were considered non-serious. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0936385
Sex: F
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she was hot and cold; dry throat; nausea; a little stomach upset; left arm was sore for several days too; Headache; muscle ache; joint pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable a 50-year-old female Registered Nurse reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 11:40 on Deltoid Left at single dose for covid-19 immunisation. Medical history included was none. There were no concomitant medications. The patient experienced headache, muscle ache, joint pain, left arm was sore for several days too on 17Dec2020; not feeling well, sore, runny nose, sore throat, swollen glands, sweats, chills, feeling like she was hot and cold, dry throat, nausea, a little stomach upset on an unknown date. The detail clinical course was provided as following: the nurse reported side effects and want to verify if side effects that "keep coming and going back every couple days" are "normal". Received first dose last 17Dec2020 and felt side effects on the evening. Returned on Monday last week, lasted until Friday, and back on 06Jan2021. The patient had developed a runny nose, sore throat, and feeling like she was hot and cold. She said she had sweats and chills, but no fever. She said she kept getting a warm sensation, and checked her temperature several times, but did not have a fever. She said she had a super dry throat, and her throat felt like a desert. She said she had swollen neck glands, clarifying the swollen neck glands were underneath her mandible. She said she had nausea, and a little stomach upset with no diarrhea. She said she was still not feeling well in her stomach. Reported last week she had 3 days with a nonstop headache, swollen glands, and a sore throat. She said the headache, swollen glands, and sore throat went away, but are back again, 06Jan2021. She said she was thinking what she was experiencing was more a side effect of the COVID-19 Vaccine than being ill because her symptoms went away and now were back. She said when a person was ill, the person got through the illness, and that was it, but her symptoms kept going away and coming back. Clarified the night of 17Dec2020, she had a headache and some muscle aches and joint pain, specifically in her neck. She said her left arm was sore for several days too. She said everything went away. She said she started feeling sick again last Tuesday, 29Dec2020, and felt ill through Friday, 01Jan2021. She said over the weekend she felt fine, and then on 06Jan2021, she was feeling ill with the same symptoms of a headache, sore throat, runny nose, and swollen glands. She said she thought it was odd that the symptoms came back again. She said maybe what she was experiencing were not side effects from the COVID-19 Vaccine, and she was ill. She said it was odd that she felt bad and then felt better, and then the symptoms come back again. Reported she can work through her symptoms, clarifying she had mild symptoms. The event outcome was unknown. All events were reported as non-serious. The events did not require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None. Treatment: Declined any Reported she was scheduled to get her second COVID-19 Vaccine dose on 07Jan2021. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 0936386
Sex: F
Age:
State: MN

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

Lab Data:

Allergies:

Symptoms: Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; injection site soreness; shaking hands; This is a spontaneous report from a contactable other HCP reported for herself. A 50-year-old female patient received first dose of BNT162B2 (lot number: ej1686), via intramuscular in right arm, on 05Jan2021 06:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Medical history included Known allergies: sulfa antibiotics, avascular necrosis, multiple joint replacements, anticoagulation, chronic pain, multiple hospitalizations in 2020 for diverticulitis. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines was received within 4 weeks prior to the COVID vaccine. Concomitant medications which patient received within 2 weeks of vaccination included warfarin, oxycodone, linaclotide (LINZESS), cyanocobalamin (VIT B12), ergocalciferol (VIT D) and iron. The patient experienced severe nausea, headache, sore throat, sweating with chills, chest pain, injection site soreness, shaking hands on 05Jan2021 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering.

Other Meds: ; ; LINZESS; VIT B12; VIT D;

Current Illness:

ID: 0936387
Sex: M
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: He has irritation on his arms.; he got the first shot of the covid vaccine he started itching; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left upper arm on 31Dec2020 at single dose for COVID-19 immunisation, dexlansoprazole (DEXILANT) oral from 2019 (reported as 2 years ago as of 06Jan2021) to an unspecified date at 30 mg capsule once as needed for acid reflux, oxycodone oral from 2020 (reported as 3-4 months ago as of 06Jan2021) to an unspecified date at 10mg tablet once by mouth as needed for chronic pain from two back surgeries that did not go well, omeprazole oral from 2020 (reported as about a year ago as of 06Jan2021) to an unspecified date at 20 mg capsule once by mouth as needed for acid reflux. Medical history included ongoing low white blood cells has had for a couple of years, and two back surgeries. There were no concomitant medications. The patient previously received Flu shots. The patient took his first dose of the COVID Vaccine last Thursday (31Dec2020) and about 10 minutes after he started itching. That day he had previously taken a PPI medication for acid reflux, Dexilant, and some pain medication, Oxycodone. Since then he has been trying to rule out what is going on and what gave him the itching. Now, every time he takes his PPI medication, either Dexilant, or Omeprazole, he itches. This did not happen prior to getting the vaccine. He asks, how long does the COVID Vaccine stay in the system for? He is supposed to get the second dose in 3 weeks, but he does not want the same results. He was asking if it is normal for his to experiencing itching and how long will it occur. He has to take his medications. He does not want issues with his esophagus, but he also does not want to itch. The itching right after he got the vaccine lasted about a day or so and dissipated by Friday. Saturday he did not have it. Then he took a Dexilant that day, on Saturday, for acid reflux, and he itched until the Dexilant was out of his system. Then yesterday, he tried an Omeprazole and he had the same results. He can not even wear a pajama top or anything on his arms cause it makes him itch. He has irritation on his arms on Jan2021. He also has low white blood cells, which he had prior to getting the vaccine. He started Dexilant originally about 2 years ago. He takes it only when he needs it. Has taken it about 3-4 times prior to getting the COVID Vaccine. He started Omeprazole about a year ago. Only takes this as needed, PRN, even thought the doctor said he should not take it as needed. He does not like to take medicine so he tries not to take things. He has taken flu shots in the past, he gets one every year, and has never had an issue with that. He wants to get the second dose of the vaccine, he just does not want to itch. The action taken in response to the event for dexlansoprazole, oxycodone, omeprazole was unknown. Event outcome of itching was recovered on Jan2020, while for other event(s) was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness: White blood cell count low

ID: 0936388
Sex: M
Age:
State: NM

Vax Date: 12/18/2020
Onset Date: 12/21/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: if a patient experienced an allergic reaction to the first dose is there anything prophylactically needing to be done when administering the second dose of the Covid vaccine; delayed hyper sensitive reaction; Angioedema; Urticarial rash; This is a spontaneous report from a contactable other hcp. A 47-years-old male patient received first dose of bnt162b2 (BNT162B2), unknown on 18Dec2020 (lot number: EK5730) at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is a Physician Assistant. Caller states that she is calling about the Covid Vaccine. She had a patient received his first dose of the vaccine on Friday 18Dec2020, 3 days later on 21Dec2020 he had an urticarial rash that persisted, The urticarial rash was treated with prednisone and resolved by 27Dec2020, it has not reoccurred. The allergist said it was a delayed hyper sensitive reaction that was Prompted by the immune simulation from the vaccine. The Patient was treated for the urticaria. Caller would like to know if a patient experienced an allergic reaction to the first dose is there anything prophylactically needing to be done when administering the second dose of the Covid vaccine? Caller is very upset and frustrated and stating she wants to speak to someone that is a clinician with the clinical trial team who can give her recommendations for a specific patient. Caller asks if they should do Prophylaxis with antihistamines for the second dose. He did not have anaphylaxis but he had angioedema. Caller states that she did a Vaers report on 22Dec2020, but no one contacted her. He started taking Zyrtec and Vistaril. The Allergist said it was fine and he will still need the 2nd Booster Dose. The Angioedema started on 22Dec2020, it was also treated with prednisone, in addition to being administered Benadryl IM, and Vistaril. The outcome of the event urticarial rash was recovered on 27Dec2020 and Angioedema was recovered on 22Dec2020. No follow-up attempts are needed; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the angioedema and the other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase level and complement panel, 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: 0936389
Sex: F
Age:
State: ID

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

Lab Data:

Allergies:

Symptoms: little bit of back pain right where her kidney is; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284 ), via an unspecified route of administration on 05Jan2021 07:00 at single dose for covid-19 immunisation . Medical history included 50 percent of her kidney function. The patient's concomitant medications were not reported. The patient experienced little bit of back pain right where her kidney is on 05Jan2021 13:00. The outcome of event was unknown.

Other Meds:

Current Illness:

ID: 0936390
Sex: F
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: Local site pain immediately; headache; chills; fatigue; general body aches; BNT162B2 , 17Dec2020 Dose number 1, 05Jan2020 Dose number 2; Pregnant at the time of vaccination?: Yes/received BNT162B2; Pregnant at the time of vaccination?: Yes/Pregnant at the time of vaccination?: Yes/received BNT162B2; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable nurse. This is the mother report. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: El0140), intramuscular on 17Dec2020 18:30 (dose number 1, right arm) and on 05Jan2021 18:30 (dose number 2, right arm) at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included an unspecified prenatal drug, sertraline hydrochloride (ZOLOFT), and acetylcarnitine hydrochloride (NEUROTIN). The patient was pregnant at the time of vaccination. No other vaccines in four weeks was taken. Patient has no COVID-19 prior vaccination. Patient was not tested for COVID-19 post vaccination. The patient experienced Local site pain immediately, headache, chills, fatigue and general body aches next day on 06Jan2021. 09:00. No treatment was given. Event outcome was recovering. The reporter assessed the events as non-serious.

Other Meds: ZOLOFT; NEUROTIN [ACETYLCARNITINE HYDROCHLORIDE]

Current Illness:

ID: 0936391
Sex: M
Age:
State: NY

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:101 Fahrenheit; Comments: Fever (101 F)

Allergies:

Symptoms: Fever (101 F); myalgia; malaise; headache; This is a spontaneous report from a contactable physician (patient). A 36-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date not provided), via an unspecified route of administration (anatomical location: Arm right) on 05Jan2021 07:00 at SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient has no known allergies. It was reported that patient experienced fever (101 F), myalgia, malaise, and headache on 06Jan2021 at 07:00. It was reported that no treatment was provided for the events. It was also mentioned that prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 0936392
Sex: F
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: Angioedema; Tongue numb observer notified about 10 minutes after vaccine, then tongue and Lower lips numb; tachycardia with throat tightness; tachycardia with throat tightness.; This is a spontaneous report from a contactable nurse (patient). The 37-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), unknown on 05Jan2021 07:45 at SINGLE DOSE on left arm for COVID-19 immunisation. The patient is not pregnant. No covid tested post vaccination. Medical history included Idiopathic angioedema, HTN, PCOS, Allergies to medications, food, or other products: Latex, penicillin, coconut. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included spironolactone (ALDACTONE), fexofenadine hydrochloride (ALLEGRA), hydrochlorothiazide, amlodipine besilate (NORVASC). The patient did not take other vaccine in four weeks. The patient experienced Angioedema event occurred approximately 18 hrs later with repeat of treatment in ER on 06Jan2021, tongue numb observer notified about 10 minutes after vaccine, then tongue and lower lips numb on 05Jan2021 08:00, taken to ER became tachycardia with throat tightness on 05Jan2021 08:00. EPIPEN administered, benadryl and prednisone (steroids), and famotidine administered along with a saline bolus. The outcome of the events was recovered. No follow-up attempts are needed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the angioedema and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including complement levels, 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: ALDACTONE [SPIRONOLACTONE]; ALLEGRA; ; NORVASC

Current Illness:

ID: 0936393
Sex: F
Age:
State: ND

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

Lab Data:

Allergies:

Symptoms: Experienced hives and rashes all over body eight hours after the shot and lasted for the whole next day.; Experienced hives and rashes all over body eight hours after the shot and lasted for the whole next day.; This is a spontaneous report from a contactable healthcare professional (patient). A 19-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the right arm on 31Dec2020 15:30 at a single dose for COVID-19 immunization at workplace clinic. The patient had no known allergies. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included influenza vaccine (FLU) on 17Dec2020 at right arm, and prednisone received within 2 weeks of vaccination. The patient experienced hives and rashes all over body on 31Dec2020 23:45, eight hours after the shot and lasted for the whole next day. Events were reported as non-serious. The patient received diphenhydramine (BENADRYL) as treatment. The outcome of the events was recovered. Patient was not tested for COVID post vaccination.

Other Meds: FLU;

Current Illness:

ID: 0936394
Sex: F
Age:
State: OH

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

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable nurse. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular from 17Dec2020 07:00 at single dose at right arm for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 17Dec2020 18:00, it was reported that the patient experienced fever, chills, aches, HA, stomach pains for first two nights, and only at night. Woke up, fine by morning. The events were assessed as non-serious. The patient did not receive treatment for the events. The outcome of the events was recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0936395
Sex: M
Age:
State: WA

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: right arm weakness; loss of sensation intermittently; lightheaded, dizzy; briefly difficult to speak on one occasion; This is a spontaneous report from a contactable physician. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELO142, expiry date: unknown), intramuscular on the right arm on 04Jan2021 15:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient experienced right arm weakness/loss of sensation intermittently lasting <5 minutes on at least 5 occasions on 05Jan2021. Patient also experienced lightheaded, dizzy, and briefly difficult to speak on one occasion on 05Jan2021. The events resulted in an emergency room visit but no treatment was given. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. There were no other vaccine administered within 4 weeks prior to the COVID vaccine.

Other Meds:

Current Illness:

ID: 0936396
Sex: M
Age:
State: VA

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

Lab Data: Test Date: 20201221; Test Name: BP; Result Unstructured Data: Test Result:returned to normal; Test Date: 20201221; Test Name: BP; Result Unstructured Data: Test Result:180/110; Test Date: 20201221; Test Name: BP; Result Unstructured Data: Test Result:160/100

Allergies:

Symptoms: extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple line; BP was 180/110 / BP stayed around 160/100; felt an "amped" feeling; felt flush; uncomfortable; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, intramuscularly on 21Dec2020 14:00 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten allergy with causes dermatitis herpetiformis, osteoporosis, and fibromyalgia. The patient previously took Benadryl and experienced allergies. Concomitant medications were not reported. The patient reported that immediately after receiving vaccine on 21Dec2020, he felt an "amped" feeling and felt flush. It was uncomfortable but not alarming at first. About ten minutes after shot, he started to have extremely bad dry mouth. He went back to work, but he went back downstairs after feeling like he was getting seriously ill and his lips were going numb. His BP was 180/110. The facial numbness went away but his BP stayed around 160/100. He was asked to go to ER, but he refused because he would have to pay for it and he was feeling better. He also noticed after going back upstairs that he had a rash from his neck to his nipple line. The doctor asked for Benadryl, but he was not given due to possible Benadryl allergy. He went home and his BP returned to normal 2 hours later. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. The outcome of the events was recovered in 21Dec2020 for blood pressure increased and facial numbness, and recovered on an unspecified date for the other events. Information on the 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 BP increased and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG and chemistry panel, 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: 0936397
Sex: F
Age:
State: WA

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

Lab Data: Test Name: urine/urinalysis; Test Result: Negative ; Test Date: 20210104; Test Name: urine/urinalysis; Result Unstructured Data: Test Result:found crystals

Allergies:

Symptoms: crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; having no energy; feeling tired/Tiredness; kidney stone; pain in her back; did not feel good; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140) intramuscular on 31Dec2020 16:00 at a single dose on left arm for Covid-19 prophylaxis. Medical history included rheumatoid arthritis. There were no concomitant medications. The patient wanted to know if she could receive the second dose of the COVID-19 vaccine if she presented the following side effects with the first shot: feeling tired/tiredness on 02Jan2021; having no energy on 03Jan2021; muscle pain, joint pain, and flu like symptoms/feeling like she has the flu, on 04Jan2021. She went to work on Monday and has taken the last couple of days off because she did not feel good on Jan2021. She did have rheumatoid arthritis, but it was different and has not been like this. She went to the doctor on Monday after she got off of work and thought at first maybe she had a UTI; treated herself with AZO, but had a urinalysis that was negative on an unspecified date. She was told some of the pain in her back might have been a kidney stone on Jan2021 because they found crystals in her urine on 04Jan2021, but she did not know about that. She noticed having no energy on Sunday. She wanted to know if it was recommended that she get the second vaccine since she was having side effects. The events required a visit to physician office and did not require a visit to Emergency Room. Prior vaccinations within 4 weeks was noted as none. Family medical history relevant to the events (AE) was noted as none.The outcome of the events of feeling tired/tiredness was not recovered; of having no energy, muscle pain, joint pain, flu like symptoms/feeling like she has the flu was recovering; of the rest of events was unknown.

Other Meds:

Current Illness:

ID: 0936399
Sex: F
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: very bad joint pain; headache; chills; body pain/body aches; back pain; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was not reported, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 28Dec2020. On 01Jan2021, she had very bad joint pain, headache, body pain/ body aches and chills; but no fever, most have gone away but still have back pain. She doesn't have any shortness of breath or fever. She added that she was confused if this was from the vaccine or from Coronavirus and queried what she should I do. She confirmed that she did not get tested for corona virus. She did read that her symptoms could be from vaccine. She also asked that, since she received the vaccine, if it will affect the results of test for corona virus i.e. false positive. The outcome of the events very bad joint pain, headache, body pain/ body aches and chills was recovered on an unknown date in Jan2021 while not recovered for back pain. Information about Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 0936400
Sex: F
Age:
State: VA

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

Lab Data:

Allergies:

Symptoms: pain at the administration site; joint pain "everywhere", mainly on her hands, legs, arms and back; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient experienced joint pain and pain at the administration site, asked how long it was expected to last. Patient experienced joint pain "everywhere", mainly on her hands, legs, arms and back. Patient was taking acetaminophen for pain relief, but was not getting any better. Outcome of the events was unknown. The events were reported as non-serious. Information about Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 0936402
Sex: F
Age:
State: MO

Vax Date: 12/22/2020
Onset Date: 01/06/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Name: COVID 19; Result Unstructured Data: Test Result:not detected; Test Name: Influenza A; Result Unstructured Data: Test Result:negative; Test Date: 20210106; Test Name: influenza B; Result Unstructured Data: Test Result:positive

Allergies:

Symptoms: Patient tested positive today for influenza b; This is a spontaneous report from a contactable physician. A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EH9899), via an unspecified route of administration in the left arm on 22Dec2020 12:00 at single dose for covid-19 immunisation. Medical history included hypothyroidism, tobacco user to 2017. Patient did get the Influenza vaccine on 20Oct2020. Concomitant medication included levothyroxine. Physician calling regarding the Pfizer COVID 19 vaccine. Reports she has a patient who received the first dose of the vaccine two weeks ago. The patient is scheduled to receive the second dose on Tuesday but today she tested positive for Influenza B. The patient then tested positive for influenza B today 06Jan2021. She was tested using the Sofia test and states the Influenza A part was negative; and COVID 19 not detected. Relevant Tests Sofia -states the Influenza B was positive; Influenza A was negative; and COVID 19 not detected. Outcome of event was unknown.

Other Meds:

Current Illness:

ID: 0936403
Sex: M
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: sore arm the next day; cold sweats; Loss of smell /Last night he noticed very little aroma from food or candles; This is a spontaneous report from a contactable pharmacist. A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021at single dose for COVID-19 immunisation. Medical history included cough and laryngitis. He had symptoms that started prior to vaccine with cough and laryngitis, he was vaccinated on 04Jan2021. He had a sore arm the next day, woke up in cold sweats, he ate a cookie, orange flavor, it didn't taste the same, He thought it was because he kept the package open. He could still kinda smell the 3 drugs he sniffed yesterday, (when counting drugs some drugs have certain smells). Last night he noticed very little aroma from food or candles. He currently is still with Loss of smell and laryngitis. The outcome of Loss of smell was not recovered, of other events were unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0936404
Sex: F
Age:
State: MA

Vax Date: 12/16/2020
Onset Date: 12/30/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right ear feeling blocked 2 weeks post vaccine; This is a spontaneous report from a contactable nurse. A 26-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EH9899; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 at a single dose for covid-19 vaccination. Medical history included migraine. The patient has no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received her most recent COVID-19 vaccine in a hospital. The patient had right sided face numb/tingling with no drooping or asymmetry and right ear feeling blocked 2 weeks post vaccine (30Dec2020). The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the adverse event. The adverse event result in emergency room/department or urgent care. The event was considered as non-serious. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 0936406
Sex: M
Age:
State: MA

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

Lab Data:

Allergies:

Symptoms: Intermittent headaches for 48 hours; general malaise; chills without fever; Sore injection site; This is a spontaneous report from a contactable Physician reporting for himself. A 33-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular Right arm on 16Dec2020 10:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included allergy to Shellfish. The patient's concomitant medications were none (None medication the patient received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Intermittent headaches for 48 hours, general malaise and intermittent chills without fever, Sore injection site on 16Dec2020 13:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event Intermittent headaches was recovered on 18Dec2020 13:00, the outcome of the other events was recovered on an unknown date.

Other Meds:

Current Illness:

ID: 0936407
Sex: F
Age:
State: CA

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: injection site pain; Result Unstructured Data: Test Result:6/10; Comments: First dose side effect of moderate 6/10 injection site pain; Test Date: 202101; Test Name: injection site pain; Result Unstructured Data: Test Result:worse; Comments: injection site pain (worse than prior dose); Test Date: 202101; Test Name: severe myalgia; Result Unstructured Data: Test Result:10/10

Allergies:

Symptoms: severe myalgia 10/10 entire body affected; Hyperesthesia; violent chills/rigors; injection site pain (worse than prior dose); This is a spontaneous report from a contactable physician (patient herself). A 35-year-old female patient received second dose of PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left arm) on 05Jan2021 at 11:45 a.m., at a single dose, for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD) and allergic rhinitis. Concomitant medications included loratadine (CLARITIN), methylphenidate hydrochloride (CONCERTA), fluticasone propionate (FLONASE), and montelukast sodium (SINGULAIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 17Dec2020 for COVID-19 immunization and experienced injection site pain; and isoniazid and experienced rash. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 06Jan2021, at 12:00 a.m., the patient experienced severe myalgia 10/10 entire body affected, hyperesthesia, violent chills/rigors, and injection site pain (worse than prior dose), peaked approximately 12 hours after dose. Patient has no fever. It was reported that first dose side effect of moderate 6/10 injection site pain in Dec2020, responded well to naproxen. The patient did not receive treatment for the events. Patient did not seek medical care, because she and her husband are both intensive care unit (ICU) physicians. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination.

Other Meds: CLARITIN [LORATADINE]; CONCERTA; FLONASE [FLUTICASONE PROPIONATE]; SINGULAIR

Current Illness:

ID: 0936409
Sex: M
Age:
State: MD

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: shoulder turned black/Shoulder blade and whole shoulder turned black; blistered; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in deltoid left on 04Jan2021 at single dose for COVID-19 immunization. There were no medical history or concomitant medications. The patient experienced his whole shoulder turned black/ shoulder blade and whole shoulder turned black and is blistering on 05Jan2021 12:00. Caller also took the shingles shot 3 weeks prior to getting the COVID-19 vaccine. Confirmed no testing was done. When he went to the doctor they just peeled the scab off, placed ointment on, bandaged him up. He was also provided with a prescription. The outcome of the events was unknown. Information about Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 0936410
Sex: F
Age:
State: CA

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

Lab Data: Test Date: 20201221; Test Name: BP; Result Unstructured Data: Test Result:155/80; Comments: elevated; Test Date: 20201221; Test Name: BP; Result Unstructured Data: Test Result:115/60; Comments: BP came down and normalized again; Test Date: 20201221; Test Name: HR; Result Unstructured Data: Test Result:122; Comments: elevated; Test Date: 20201221; Test Name: HR; Result Unstructured Data: Test Result:70; Comments: came down and normalized again

Allergies:

Symptoms: Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; pulse and BP both were elevated (HR 122 BP 155/80); pulse and BP both were elevated (HR 122 BP 155/80); This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (lot number: EL0140), intramuscular on 21Dec2020 10:30 at single dose in the left arm for COVID-19 immunization. There were no medical history. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. On 21Dec2020 10:30, it was reported that shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby, the patient started to feel flushed in her face and very warm, and felt her heart racing. The nurse came and took her pulse and BP both were elevated (HR 122 BP 155/80), after three minutes her heart rate and BP came down and normalized again (HR 70 and BP 115/60). Stated that she has never had a similar experience. 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 with outcome of recovered on unspecified dates.

Other Meds:

Current Illness:

ID: 0936412
Sex: F
Age:
State: DE

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

Lab Data: Test Name: Chest x-ray; Result Unstructured Data: Test Result:inflammation on the lungs; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Negative; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Negative

Allergies:

Symptoms: A chest x-ray showed some inflammation on the lungs; Slight pain in her arms after taking the vaccine; Bad headache; She started to develop a cough after the injection that did not improve and had worsened by the end of the second week; This is a spontaneous report from a contactable Nurse (reporting for herself). A 62-year-old female patient started received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on 18Dec2020 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. As reported, patient asked, "should I get the second injection of the COVID-19 vaccine since I have this cough that will not go away?." This female nurse, who was also the patient, reported receiving her first injection of the PFIZER COVID-19 VACCINE on 18Dec2020. She started to develop a cough after the injection that did not improve and had worsened by the end of the second week. Treatment has included cetirizine (ZYRTEC), dextromethorphan (ROBITUSSIN),Guaifenesin (MUCINEX) and albuterol inhaler. A chest x-ray showed some inflammation on the lungs and she was given a steroid inhaler, which has helped. She has received two COVID-19 tests at different time intervals, and both were negative. She was scheduled to receive the second COVID-19 vaccination on Friday but was uncertain if she should receive it given her cough was not improving. She had a bad cough, and other symptoms just before her injection (pending clarification). But her general practitioner (GP) put her in a steroid inhaler. She talked to her GP but can't give her complete advice as to whether she can still take the 2nd dose or not due to her situation. She said she had very slight pain in her arms after taking the vaccine, and felt a really bad headache on 18Dec2020. She would like to know if she still needs to continue the 2nd dose of vaccine or not since she still has a cough. Patient asked if there was any guidance on getting a second dose and what if test was a false positive and she really did have COVID-19?. Outcome of the event "She started to develop a cough after the injection that did not improve and had worsened by the end of the second week" was not recovered while "A chest x-ray showed some inflammation on the lungs", Slight pain in her arms and Bad headache were unknown. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 0936413
Sex: F
Age:
State: MN

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

Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:typically in the 50's; Comments: Caller's heart rate is typically in the 50's, it went up to 65 and she "could feel it."; Test Name: Heart rate; Result Unstructured Data: Test Result:went up to 65; Comments: Caller's heart rate is typically in the 50's, it went up to 65 and she "could feel it."

Allergies:

Symptoms: racing heart/Caller's heart rate is typically in the 50's, it went up to 65 and she "could feel it."; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 who stated that after getting her first dose of the vaccine she experienced a racing heart. This was further clarified as a racing heart for her. The patient's heart rate was typically in the 50's, it went up to 65 and she "could feel it." The patient questioned if she should get the second dose scheduled for 19Jan2021. The outcome of the events was unknown. Information on Lot/Batch has been requested.

Other Meds:

Current Illness:

ID: 0936414
Sex: M
Age:
State: CA

Vax Date: 12/18/2020
Onset Date: 01/03/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Lymphadenopathy/Enlarged Lymph node; This is a spontaneous report from a contactable physician. A 40-year-old male patient received bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine and also reported as Covid Vaccine; unknown lot number and expiration date), via an unspecified route of administration left deltoid (reported as once by injection on the left deltoid) on 18Dec2020 at a single dose for covid-19 vaccination. The patient has no medical history and concomitant medications. The physician reported that he got the COVID Vaccine on 18Dec2020 and he got Lymphadenopathy as a possible side effect of the vaccine. It was recently (03Jan2021), he noticed an enlarged lymph node (Lymph node is on left supraclavicular, so above the clavicle on the left side). It could be unrelated, but he was told to call and report it. He would like to know were there patients in the clinical trial who got lymphadenopathy (which part of the body). He did not received treatment. He knows that lymphadenopathy was reported in the study. The reported considered the event as non-serious. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0936416
Sex: F
Age:
State: NY

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 22Dec2020 14:00 at a single dose on Arm Left for COVID-19 immunization. Medical history included none. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 23Dec2020 21:00, the patient experienced Rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear. Treatment was received for the adverse event which included Benadryl 50mg. The outcome of the events at the time of last observation was recovered/resolved on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered as non-serious. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0936417
Sex: F
Age:
State: AZ

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

Lab Data: Test Date: 20201231; Test Name: blood pressure; Result Unstructured Data: Test Result:Elevated

Allergies:

Symptoms: Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of tongue; numbness and paresthesia of tongue; pain in left upper arm between elbow and shoulder; tachycardia; elevated blood pressure; This is a spontaneous report from a contactable physician. A 35-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular at arm left on 31Dec2020 at single dose for covid-19 immunization. The vaccine was administered at other (as reported). Medical history included asthma (Allergy induced asthma). Concomitant medication within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) from Dec2020 at 10mg daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020, the patient experienced Left Bell's palsy, numbness and paresthesia of tongue, left side of face, inability to raise left eyebrow, pain in left upper arm between elbow and shoulder, tachycardia, elevated blood pressure. The adverse events result in emergency room/department or urgent care. The patient received treatment for the adverse events which included Prednisone 20mg daily, Valacyclovir 1000mg twice a day. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events 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 Bell's palsy and other reported events due to temporal relationship. However, the Bell's palsy may possibly represent a concurrent medical condition. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including viral serologies, 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: ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 0936419
Sex: F
Age:
State: AZ

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

Lab Data:

Allergies:

Symptoms: Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899), intramuscularly on 28Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. Medical history included migraine from an unknown date. Concomitant medication included erenumab aooe (AIMOVIG), estradiol, diphenhydramine hydrochloride (BENADRYL), trazodone hydrochloride (TRAZODON). No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site on 28Dec2020 15:00. Patient received Antibiotics, steroids epi as treatment for the adverse events. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event migraine was recovered in Jan2021, other events was recovered on an unknown date. The events were reported as non-serious.; 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 Vaccination site cellulitis, shortness of breath, stridor and migraine, 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, 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: AIMOVIG; ; BENADRYL; TRAZODON

Current Illness:

ID: 0936420
Sex: F
Age:
State: CA

Vax Date: 12/21/2020
Onset Date: 12/23/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; Numbness and tinging began in my lower extremities about 36 hours following injection. It started as intermittent and became more consistent and spread to my upper extremities. It is sometimes present; ng began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; discomfort in her extremities; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 21Dec2020 at 10:45 at a single dose, for COVID-19 immunization. Medical history included migraine and latex allergy. The patient's concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 23Dec2020, about 36 hours following injection, numbness and tingling began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips. She was also experiencing some discomfort in her extremities. These were accompanied by headaches and significant brain fog, difficulty concentration, and fatigue. She was working on being evaluated by allergy and neurology. The patient did not receive treatment for the events. Outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 0936422
Sex: M
Age:
State:

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

Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:No fever

Allergies:

Symptoms: his ear got bright red and really really itchy; his ear got bright red and really really itchy; This is a spontaneous report from a contactable Pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The facility type vaccine was clinic. The patient medical history and concomitant medications were not reported. Within 5-10 minutes administering dose, patient ear got bright red and really really itchy and noticeable compared to the other ear. No fever and breathing is fine. The outcome of events was unknown. The pharmacist asked if this a reaction to the vaccine. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm