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**
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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: 1021998
Sex: F
Age:
State: OH

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: Blood sugar; Result Unstructured Data: Test Result:low

Allergies:

Symptoms: Numbness in face, legs; Slight headache; Whole chest froze up; It has been an effort to talk, she was really working hard to talk; Muscle tightness around her whole face; Legs weren't steady enough; Didn't feel well; She was very weak; Could only stay awake for very short amounts of time; She never had trouble with her stomach like this before; Lip has a slight droop on left side of her face; Felt like she was having a heart attack; Felt extreme exhaustion; Not able to eat; She thought she has low blood sugar; This is a spontaneous report from a contactable consumer (the patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiration date not reported), via an unspecified route of administration (left arm) on 21Jan2021 14:50 at a single dose for COVID-19 immunization. Medical history includes therapy on her back from the past, from an unknown date. Concomitant medication included melatonin to sleep and, paracetamol (TYLENOL) to sleep. The patient received the first dose of the vaccine on 21Jan2021 at around 2:50 PM, the next morning on 22Jan2021, she felt extreme exhaustion, she'd get up and have to get back to bed, not able to eat, and she thought she has low blood sugar. She got up and had a bowl of cereal. On an unspecified date, the patient also reported numbness in face, legs and slight headache, and need to eat all of a sudden or pass out, and these has gone on for five days now (at time of report). The patient also reported that her lip has a slight droop on left side of her face which was concerning her. The patient reported that after numbness and not eating, she had some ice cream and her whole chest froze up, and it felt like she was having a heart attack. Her chest felt like ice which never had happened before. It has been an effort to talk, she was really working hard to talk. The patient explained she got the vaccine 5 days ago (from the time of report) and reported she had muscle tightness around her whole face, she had a slight droop on the left lip, a slight headache right across the eye brows, her legs feel a little numb off and on, she got feeling of tiredness but that passes, she had the need to go eat suddenly or she will get very weak. The reason for the call was she was wondering if she should she go for the second vaccine when 5 days after having the vaccine she was experiencing numbness. Slight droop on the left lip started but never looked close until the time of report, not a lot but the lower lip on the left side it is slightly droopy, with slight headache right across the eye brows. Her legs felt a little numb off and on, and she stated that about 3 days after the vaccine, she was afraid to take a shower because her legs weren't steady enough. They are still that way at the time of report, but this did go away for a while on a day and she was able to take a shower. She also didn't feel well after the vaccine. On the day of the vaccine, she had a good dinner and felt good; but the next morning she was very weak and could only stay awake for very short amounts of time. She was in bed and couldn't stay up and this is not like her, she did not like to be in the bed. She got the feeling of tiredness but that passes and she can stay up for longer periods of time. She had to go eat or she gets very weak, she didn't feel like eating in the beginning. It was on the 4th day after the vaccine she would have to get a bowl of cereal all of a sudden or she would feel like she was going to pass out. She never had trouble with her stomach like this before where she felt the need to have to go and eat. She explained she never had trouble with stomach, she never had headaches, and never had a vaccine before. Muscle tightness around her whole face started 2 days after getting the vaccine and was getting worse. Her face felt really tight almost numb feeling. The outcome of the events was unknown.

Other Meds: MELATONIN; TYLENOL

Current Illness:

ID: 1021999
Sex: F
Age:
State:

Vax Date: 01/27/2021
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: nausea, diarrhea, and not feeling well; nausea, diarrhea, and not feeling well; nausea, diarrhea, and not feeling well; This is a spontaneous report from a contactable consumer (daughter of the patient). A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021at a single dose for Covid-19 immunisation. Medical history and concomitant medications were unknown. On 28Jan2021, the patient was experiencing, nausea, diarrhea, and not feeling well. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022000
Sex: F
Age:
State:

Vax Date: 01/24/2021
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fatigue; headache; arm pain from shoulder to elbow; This is a spontaneous report from a non-contactable consumer (patient). A 37-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (left arm) on 24Jan2021 at 09:30 at a single dose for COVID-19 immunization. Medical history was reported as 'none'. 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 medications received within 2 weeks of vaccination. The patient experienced fatigue, headache and arm pain from shoulder to elbow on 25Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment administered for the events. The events were resolving. No follow-up attempts are possible; information about batch/lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1022001
Sex: F
Age:
State: SC

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: today, the foot is swollen; unusual pain on her left foot that has been worsening; This is a spontaneous report from a contactable consumer (patient's daughter). A 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in the left arm, on 22Jan2021, at the age of 95 years, at a single dose for COVID-19 immunization. Medical history included congestive heart failure diagnosed a year and a half ago, reported as "October last year"; blood pressure abnormal (reported as blood pressure), pain and headaches. Patient had no prior vaccinations within 4 weeks. Concomitant medications included metoprolol 50 mg tablet for blood pressure; amlodipine for blood pressure; and tramadol 50 mg tablet for pain and headaches, patient has been on this about a year and a half. It was reported patient gets anxiety from her concomitant medications. The reporter stated that her mother, the patient, received the first dose of the COVID-19 vaccine on the left arm, last Friday, on 22Jan2021. She explained the next day, Saturday (23Jan2021), her mother experienced some unusual pain on her left foot that has been worsening and today, 26Jan2021, the foot was swollen. She asked if her mother's experience was a reported side effect to the vaccine. The reporter added that yesterday, 25Jan2021, the pain was not quite as bad, but today, 26Jan2021, it has worsened and was now swollen. The reporter clarified again it was just her left foot, not her whole leg, and stated it was just odd. The events were reported as non-serious, and did not require a visit to Emergency Room nor the Physician Office. The outcome of the events was not recovered, reported as worsened.

Other Meds: METOPROLOL; AMLODIPINE; TRAMADOL

Current Illness:

ID: 1022002
Sex: M
Age:
State: IL

Vax Date: 01/07/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: height; Result Unstructured Data: Test Result:either 5ft 8 inches or 5 ft 9 inches; Test Date: 20210121; Test Name: Covid; Test Result: Positive

Allergies:

Symptoms: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer reporting for self. This 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 about noon at left deltoid (reported as left shoulder) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received his first dose on 07Jan2021. On 21Jan2021 he tested positive for COVID. He was scheduled to receive his second dose of the vaccine today (26Jan2021), and he wanted to know if he can get the second dose as scheduled or did he have to wait since he was still in quarantine. After informing doctor he had tested positive for COVID, he spoke with his doctor and recommended he take diphenhydramine hydrochloride (BENADRYL), Zyterec-D, and Nasal Spray. There were no additional vaccines administered on same date of BNT162B2, and there were no other vaccinations within 4 weeks. The event did not require a visit to emergency room or physician office. Lab data included height: either 5ft 8 inches or 5 ft 9 inches on unspecified date. The outcome of event was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1022003
Sex: M
Age:
State: AZ

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Flu like symptoms; Body aches; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration (left arm) on 21Jan2021 at 00:15 at a single dose for COVID-19 immunization. Medical history included sleep apnea, and prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced flu like symptoms and body aches on 21Jan2021. Since the vaccination, the patient has not been tested for COVID-19. No treatment was administered for the events. The events resolved on an unspecified date in Jan2021.

Other Meds:

Current Illness:

ID: 1022004
Sex: F
Age:
State: SC

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: muscle aches; nausea; vomiting; weakness; chills; Diarrhea; Joint pain; It scared me that I was so sick.; Slight headache like a little pressure on her head / Horrible headache; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EL9262 (the patient was not sure of the second letter), via an unspecified route of administration in left arm on 23Jan2021 at 16:15 at single dose for COVID-19 immunization. Medical history included sinus infection. The patient was not pregnant at the time of vaccination. Facility where the COVID-19 vaccine was administered was Hospital. The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included amoxicillin, clavulanic acid (AUGMENTINE) for sinus infection and pravastatin. The patient stated that when she went home after vaccination, she had a slight headache, like a little pressure on her head when she went to bed but that was supposed to be normal. So, she went to sleep and the next morning she woke up and she had every single side effects: the nausea was horrible, she must have thrown up 15 times, she had diarrhea and joint pain. She did not think she had any fever but she did had chills and muscle pain, weakness and had horrible headache. The events onset date was reported as 24Jan2021 at 12:00 AM (except for headache which started on 23Jan2021). No treatment was administered for these events. The patient stated that it scared her that she was so sick. All the reported events were assessed as non-serious. The patient reported that 3 days later she was still feeling very weak. At the time of the report the events headache, muscle aches, nausea, vomiting and chills had recovered with sequelae, the event weakness had not yet resolved, whereas the outcome of the events diarrhea, joint pain and sickness was unknown.

Other Meds: AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]; PRAVASTATIN

Current Illness:

ID: 1022005
Sex: F
Age:
State: NC

Vax Date: 01/24/2021
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: dizziness; headache; tachycardia; chest pain; chills; fever; This is a spontaneous report from a contactable other healthcare professional (HCP). A 37-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982 and expiration date: unknown), intramuscular (right arm) on 24Jan2021 at 10:30 at a single dose for COVID-19 immunization. Medical history was not reported. Allergies to medications, food, or other products was unknown. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: unknown), on 03Jan2021 at 10:15AM, intramuscular (left arm) for COVID-19 immunization. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced dizziness, headache, tachycardia, chest pain, chills and fever on 25Jan2021. Treatment for the events included IV fluids, Benadryl, Antivert, Benadryl, Toradol and Reglan. The events required Emergency Room Visits and Physician Office Visit. The events were resolving at the time of the report.

Other Meds:

Current Illness:

ID: 1022006
Sex: M
Age:
State:

Vax Date: 01/24/2021
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: redness on the injection site; pain on the injection site; This is a spontaneous report from a contactable consumer (patient). An 84-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration on 24Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of the Pfizer Covid vaccine last Sunday (24Jan2021) and started to experience pain and redness on the injection site on 25Jan2021. On the day of the report (26Jan2021), the pain was completely gone but the redness is still there. The patient wanted to know if this is normal or if he should be concerned about this. The event redness at the injection site had not resolved while the pain on the injection site resolved on 26Jan2021. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1022007
Sex: M
Age:
State:

Vax Date: 01/08/2021
Onset Date: 01/14/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210114; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptoms: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer reporting for himself. This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date unknown) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant drugs were not reported. The patient received the first dose of the vaccine on 08Jan2021 and then tested positive for COVID-19 on 14Jan2021. The patient wanted to know what he should do regarding receiving the second dose of the vaccine. The outcome of the event was unknown. Information about Lot/Batch number is requested.

Other Meds:

Current Illness:

ID: 1022008
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: platelet counts; Result Unstructured Data: Test Result:low

Allergies:

Symptoms: a low platelet count; This is a spontaneous report from a contactable consumer reporting for her mother. A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced a low platelet count on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included platelet count: low. The reporter is wondering if it is safe for the patient to receive the second shot. Information about lot and batch number was requested

Other Meds:

Current Illness:

ID: 1022009
Sex: F
Age:
State:

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210108; Test Name: COVID-19; Result Unstructured Data: Test Result:Negative; Comments: testing negative on a rapid test prior to receiving her first dose of the Pfizer covid-19 vaccine on 08Jan2021; Test Date: 20210109; Test Name: COVID-19; Result Unstructured Data: Test Result:Positive; Comments: On 09Jan2021, she experienced symptoms of covid-19 and then tested positive for covid-19

Allergies:

Symptoms: tested positive for covid-19 after administration of a PCR test; tested positive for covid-19 after administration of a PCR test; scratchy throat; she was really sick for two weeks; cough; This is a spontaneous report from a contactable consumer (patient). The female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 08Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. This female diabetes educator, who is also the patient, reports testing negative on a rapid test prior to receiving her first dose of the Pfizer covid-19 vaccine on 08Jan2021. On 09Jan2021, she experienced symptoms of covid-19 and then tested positive for covid-19 after administration of a PCR test. She does not feel getting covid-19 is related to receiving the covid-19 vaccine. She reports her covid-19 symptoms included scratchy throat, cough, and she was really sick for two weeks but now just has a little scratchy throat and cough still continuing. She is scheduled to receive her second dose of Pfizer covid-19 vaccine on 29Jan2021.the patient queried if she could get the second injection of Pfizer covid-19 vaccine when it is due since she got COVID-19 disease after the first injection or is that a contraindication. The outcome of the events was unknown. No follow-up attempts are possible, information on batch number cannot be obtained.; 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. While reporter causality is noted and it is very likely that the vaccine may not provide protection yet, further clinical information is needed for meaningful medical assessment.

Other Meds:

Current Illness:

ID: 1022010
Sex: F
Age:
State: VA

Vax Date: 01/02/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210126; Test Name: Covid-19 Test; Result Unstructured Data: Test Result:Pending; Comments: Nasal swab

Allergies:

Symptoms: The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; improper technique; bruising after the first shot because of improper technique; felt hot at the injection site; swelling; tiredness/tired; arm pain; headache; chills; This is a spontaneous report from a contactable pharmacist (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686, expiry date not reported), intramuscular on 02Jan2021 17:00 at a single dose in the left arm for COVID-19 immunization. Medical history included hypertension, known allergies to latex and has covid-19, all from unknown dates and unknown if ongoing. The patient was not pregnant at the time of the vaccination. Concomitant medications included hydrochlorothiazide, potassium chloride, and calcium citrate (CITRACAL). The patient had no other vaccine in four weeks. Patient stated that a cooler used to transport the covid 19 vaccines had a temperature of 31 to 33 degrees F and she was concerned about the vaccines on the bottom of the shipper that were next to the dry ice in the shipper (date unspecified). Patient wanted temperature excursion data for the covid 19 vaccine and stated in Jan2021 she felt hot at the injection site, swelling, tired, arm pain and had bruising after the first shot because of improper technique (02Jan2021 17:00). Patient reported on the first dose having only arm pain, chills, and tiredness, and headache in Jan2021. Patient also stated that the first dose was much better tolerated. Patient stated some of her pharmacist friends have had the same effects from the vaccine. Patient wanted to verify that the vaccine in the syringe is good for 6 hours and that she read Moderna is effective for 1 year and Pfizer is good for 6 to 12 months. She does not think her vaccination of covid 19 was valid because she thinks the temperature that the pharmacist recorded was not correct. Patient wanted to know if she should get tested to see if the vaccine worked. Patient stated that Pfizer is too complex and has too many pieces and states they need to give more information about how to use the thermal shipper. The patient had Covid test post vaccination as nasal swab on (BioReference COVID-19 Nasopharynx) on 26Jan2021 with results as pending. No treatments received felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache. The patient did recover from the events felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache on an unspecified date in Jan2021.

Other Meds: HYDROCHLOROTHIAZIDE; POTASSIUM CHLORIDE; CITRACAL [CALCIUM CITRATE]

Current Illness:

ID: 1022011
Sex: F
Age:
State: AR

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: Covid; Test Result: Positive ; Test Date: 20210126; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: fatigue; chest congestion; chills; altered smell; This is a spontaneous report from a contactable health professional reporting for herself. A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), lot#EJ1686 via intramuscular route at the left arm on 20Jan2021 01:00 PM at single dose for COVID-19 immunization. Medical history included Hypothyroidism and allergy to codeine and sulfa. Concomitant medications were not reported. The patient had received the first dose of the same vaccine on 30Dec2020 01:00 PM from lot#EL1284, via intramuscular route at the left arm. On unknown date the patient experienced fatigue, chest congestion, chills and altered smell. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the events. Prior to vaccination, the patient was diagnosed with COVID-19 on unknown date. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 26Jan2021 and the result was negative. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1022013
Sex: F
Age:
State: NY

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 2021; Test Name: COVID-19; Test Result: Positive ; Comments: COVID-19 and tested positive

Allergies:

Symptoms: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscularly at left arm on 15Jan2021 at single dose for COVID-19 vaccination. Medical history included her son having Covid-19. Concomitant medications were unknown. The patient received the covid vaccine on 15Jan2021 and since then she developed COVID-19 and tested positive in 2021. She believed this was related to her son having Covid-19. The patient didn't think she got the COVID from her shot, she thought she got it from her son who had it. She called to ask if it was okay if she received her second dose on 05Feb2021. The patient stated she already spoke with her doctor and he said it was okay as long as she was feeling better. Outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: The patient received the covid vaccine on 15Jan2021 and since then she developed COVID-19 and tested positive in 2021. Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. However, no complete effect of the suspect vaccine could be reasonably achieved from the first dose to protect from the targeted infection. Further information like COVID infection date needed for meaningful medical assessment.

Other Meds:

Current Illness:

ID: 1022014
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: contract the virus; contract the virus; This is a spontaneous report from a contactable consumer reporting for herself via a Pfizer Sponsored Program. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date 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 drugs were not reported. The patient reported that she received the first dose and was scheduled to receive the second one in 3 weeks, and she usually got tested for the COVID-19 infection every 2 and a half weeks, and she stated "actually I contract the virus". The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022015
Sex: F
Age:
State: IL

Vax Date: 01/25/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: Height; Result Unstructured Data: Test Result:She is 5'8.5" or 5'9"; Test Date: 20210126; Test Name: Body temperature; Result Unstructured Data: Test Result:103 fever; Test Date: 202101; Test Name: Covid; Test Result: Negative ; Test Date: 202101; Test Name: Covid; Test Result: Negative

Allergies:

Symptoms: her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; fever; her right carotid on her neck felt swollen; right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt; tired and achy; tired and achy; feeling sick; muscle and joint pain; muscle and joint pain; cough; the back of her ribs hurt; Nausea; she is having shooting pains in different spots; This is a spontaneous report from a contactable nurse reporting for self. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number EL3249, via an unspecified route of administration from 25Jan2021 14:00 (at the age of 47 years old), Dose 2, as a single dose in the left arm for COVID-19 immunization. Medical history included she had her tonsils out on an unknown date. She was a nurse that works with COVID patients; she got tested twice last week (Jan2021), both were negative. She had no pre-existing medical conditions. She has never had a problem with vaccines. There were no concomitant medications. The patient previously received dose 1 of BNT162B2 on 04Jan2021 (Lot # EX9231) and experienced no reaction then. The patient had the second dose of the Pfizer vaccine around 2 PM yesterday (25Jan2021) and she kept moving around in bed and feeling sick last night. That night she was just tired and achy but she thought that could just be from working. She went to bed early and she woke up around 1:50 or 2 AM with chills so she went and got a thermometer. She woke up at about 2 AM (26Jan2021) with a 103 fever and chills and her right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt. Her skin just burns; she went to take a shower. With the skin burning she knew it was sore to touch but when she got in the shower, that was when she noticed it hurt. She was really achy; her legs were aching and she was having shooting pains in different spots. She commented that she called out today (26Jan2021), she never calls out; all she wanted to do was take a shower and she wondered if she needed to go to the doctor. Her skin burns even when she was showering; every part her skin burns. She was also having muscle and joint pain and cough and the back of her ribs hurt (Jan2021). The other thing was nausea (Jan2021). The fever and chills were persisting and were about the same. She was hoping for it to go down so she could go to work to tomorrow (27Jan2021). The clinical outcome of the fever, chills, and her right carotid on her neck felt swollen and hurt was not recovered. The clinical outcome of feeling sick, tired and achy, face feels swollen, skin burning, muscle and joint pain, cough, back of her ribs hurt, nausea, and shooting pains in different spots was unknown. The reporter states she thinks what she is reporting was directly related to the product.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1022016
Sex: F
Age:
State: KY

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: foot started bothering her a little bit and everyday it was getting worse; foot started bothering her a little bit and everyday it was getting worse; peroneal tendonitis; This is a spontaneous report from a contactable consumer for mother. An 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included the patient was having a foot issue that she has previously had in the past. The patient's concomitant medications were not reported. The patient had her first dose of the Covid-19 vaccine on 14Jan2021. She was due for the second injection 04Feb2021.She got her vaccine on 14Jan2021 and on 15Jan2021 her foot started hurting. She was having a foot issue that she has previously had in the past. A doctor injected her "today" with a steroid called Kenalog. She has problems with her feet already. She has had this problem with the other foot. Her foot started bothering her a little bit and everyday it was getting worse. She took her to a foot doctor and the doctor gave her a injection of the steroid Kenalog into her foot for peroneal tendonitis. The reporter wanted to find out if the shot her mother has received due to pain in the foot would affect the efficacy of the Covid vaccine. The outcome was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022017
Sex: M
Age:
State: GA

Vax Date: 12/18/2020
Onset Date: 01/03/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210104; Test Name: COVID; Test Result: Negative ; Test Date: 20210105; Test Name: COVID; Test Result: Positive

Allergies:

Symptoms: contracted COVID; contracted COVID; This is a spontaneous report received from a Pfizer sponsored program from a contactable Other-HCP (patient). A 34-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration in the left deltoid on 18Dec2020 at SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. He got the first dose of the COVID Vaccine on 18Dec2020. He then contracted COVID on 03Jan2021. The patient clarified that he started with symptoms on 03Jan2021. He tested negative for COVID on 04Jan2021 and then tested positive on 05Jan2021. He was supposed to get the second dose on 08Jan2021. He wanted to know how to proceed with receiving the second dose. Inquiring how long it will be effective. The outcome of the event was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.

Other Meds:

Current Illness:

ID: 1022018
Sex: M
Age:
State: MI

Vax Date: 01/16/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210121; Test Name: Fever; Result Unstructured Data: Test Result:100-101 Fahrenheit; Comments: 100-101 degrees F

Allergies:

Symptoms: Fever 100-101 degrees F; Severe chills at night; Irregular urination; Rusty colored urine; Fatigue; Kidneys felt sore; This is a spontaneous report from a contactable other healthcare professional reported for himself. A 32-year-old male patient received first dose BNT162B2 (reported as PFIZER BIONTECH COVID 19 VACCINE, Lot number: EL3249, Vaccine location: Left arm), via an unspecified route of administration on 16Jan2021 15:45 at single dose for covid-19 immunization. The patient had no medical history. The patient did not have allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Roughly four days after vaccination (21Jan2021 04:00 AM) the patient developed a fever 100-101 degrees F, severe chills at night, irregular urination (including rusty colored urine), fatigue, and his kidneys felt sore. These events did not result in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, was not congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient did not have been tested for COVID-19. The patient was not received treatment for the adverse events. Facility where the most recent COVID-19 vaccine was administered was other. The outcome of the events was resolving.

Other Meds:

Current Illness:

ID: 1022019
Sex: M
Age:
State: TX

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: O2 levels; Result Unstructured Data: Test Result:80; Comments: O2 levels are dropping down to 80

Allergies:

Symptoms: my O2 levels are dropping down to 80/ oxygen level is low; I am feeling blah; This is a spontaneous report from a contactable consumer. A 79 years-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration, on 20Jan2021, as a single dose, for Covid-10 immunization. Medical history and concomitant medications were not reported. It was reported that the patient reported that it has been a week since getting the firs dose of the vaccine had he experienced O2 levels dropping down to 80, he got his first COVID shot. He was wondering how long was this going to last. He was 79, and he just feels kind of blah. His oxygen level is low. The clinical outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1022020
Sex: F
Age:
State: MN

Vax Date: 01/18/2021
Onset Date: 01/22/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: dry and reddened rash; the rash is so itchy and swollen; the rash is so itchy and swollen; This is a spontaneous report from a contactable Nurse. A 54-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL9261) vaccine , via an unspecified route of administration in the left shoulder on 18Jan2021 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 vaccine on 28Dec2020. The patient experienced dry and reddened rash in the anterior side of her neck in the shape of her thyroid. on 22Jan2021 with outcome of not recovered , the rash is so itchy and swollen on 22Jan2021 with outcome of not recovered. The reported events were considered Important Medical Events. The patient used her son's eczema cream, clarified as "Elcom" or "Elecom" but the events worsened.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1022021
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:fever; Test Name: COVID; Test Result: Positive

Allergies:

Symptoms: the same symptoms of COVID all over again; the same symptoms of COVID all over again; bad fever; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. The consumer reported same events for 2 patients. This is a first of two reports. A patient of unspecified age and gender received 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 included COVID-19 (not ongoing). Concomitant medications were not reported. The patient experienced symptoms of COVID-19 all over again and bad fever all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107798 Same reporter/product/event, different patient

Other Meds:

Current Illness:

ID: 1022022
Sex: F
Age:
State: IL

Vax Date: 01/22/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: temperature; Result Unstructured Data: Test Result:101; Test Name: covid test; Test Result: Negative

Allergies:

Symptoms: terrible aches all over; headache; there is something wrong with her smell/she can smell but things do not smell right; She has chills really bad; felt really awful; nausea; She had a fever; dry cough; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date:31May2021), via an unspecified route of administration on the left arm, on 22Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation from Nov2019, heart attack 2016, stent placed from 2016, and cardiac ablation from Aug2020. There were no concomitant medications. Patient had her first dose on 22Jan2021 and she felt all the side effects like nausea, fever, chills, headache on 24Jan2021 and wanted to know if that is normal. She also experienced dry cough on Jan2021. Patient reported she was fine and did not even feel it. She was fine that day and the next day. By the third day she started getting every symptom in the world. The one that really bothered her, and she cannot find any information on it was the dry cough. She was asking if dry cough is a reported side effect. She further clarified that the dry cough started either the same day she received the vaccine or the next day and all her other symptoms started on Sunday afternoon (24Jan2021). She had a fever and still has fever at the time of report, and had improved slightly since she takes Tylenol every 6 hours which was keeping the fever at bay. But her temperature was still over 100. She had terrible aches all over which has slightly improved and a headache (she does not think she has one now), and stated it had improved. The nausea was off and on and there was something wrong with her smell. She can smell but things do not smell right. She smelled something like gasoline earlier but she knew it was not gasoline. She thought about food and she wanted to gag, and her taste seems ok. She has chills really bad and clarified all symptoms aside from the dry cough started Sunday around 4 in the afternoon. She felt really awful and took her temperature and it was 101 on Jan2021. The chills are off and on and when her fever goes up, then her chills go up. Outcome of the events of nausea, chills and felt awful was unknown, for events dry cough and something wrong with smell was not recovered, and for the remaining events was recovering. Patient was asking if she somehow contracted covid in between getting her vaccine and now. She had a negative covid test a long time ago when she was going to have procedures done. She confirmed she has not had a covid test recently and stated it was just seems weird since she felt fine right after getting the covid shot.

Other Meds:

Current Illness:

ID: 1022023
Sex: F
Age:
State: OR

Vax Date: 01/21/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Right sensory neural hearing loss; Bilateral increased auditory fullness; Tinnitus; This is a spontaneous report from a contactable physician (patient herself). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL8982 and expiry date unknown) intramuscular at the left arm on 21Jan2021 15:00PM at a single dose for COVID-19 immunization. The patient's medical history included osteoarthritis and exercise-induced asthma, both from an unknown date and unknown if ongoing. Concomitant medications included celecoxib, paracetamol (TYLENOL), and Vitamin D (NOS); the patient received these medications within 2 weeks of vaccination. The patient is not pregnant at the time of vaccination. She received the first dose of BNT162B2 (lot number: EK9231, expiry date unknown) intramuscular at the left arm on 30Dec2020, 8:30AM at a single dose for COVID-19 immunization. The patient previously took metronidazole from an unknown date and had allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Five days after the second vaccine, on 26Jan2021, 6:00AM, the patient had a sudden onset of right sensory neural hearing loss. Leading up to the sudden loss of hearing, bilateral increased auditory fullness and tinnitus began one to two days after vaccine. The patient received intratympanic steroid injection as treatment for the adverse events. Outcome of the events was not recovered. The case report was assessed as Serious since the events were reported as disabling/incapacitating.; Sender's Comments: A contributory role of BNT162B2 to reported events cannot be fully excluded based on the temporal relationship. Case will be reassessed if additional information is received. 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: CELECOXIB; TYLENOL; VITAMIN D NOS

Current Illness:

ID: 1022024
Sex: F
Age:
State:

Vax Date: 01/07/2021
Onset Date: 01/26/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210126; Test Name: covid; Test Result: Positive

Allergies:

Symptoms: received Pfizer vaccine on 07Jan2021 tested positive on 26Jan2021 for covid; received Pfizer vaccine on 07Jan2021 tested positive on 26Jan2021 for covid; This is a spontaneous report from a contactable other health care professional (reported as nurse and NP). A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 07Jan2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. The reporter reported that patient received Pfizer vaccine on 07Jan2021 tested positive on 26Jan2021 for COVID. The reporter inquired the recommendations to get their second shot. 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 (PFIZER-BIONTECH COVID-19 VACCINE) in this patient cannot be completely excluded. However, no complete effect of the suspect vaccine could be reasonably achieved from the first dose to protect from the targeted infection.

Other Meds:

Current Illness:

ID: 1022025
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: antigen test; Result Unstructured Data: Test Result:Positive; Comments: rapid antigen test kit

Allergies:

Symptoms: 4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; 4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 1st of 4 patient. A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101864 same reporter/drug/event, different patient;US-PFIZER INC-2021101866 same reporter/drug/event, different patient;US-PFIZER INC-2021101865 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1022026
Sex: F
Age:
State: OH

Vax Date: 08/09/2016
Onset Date: 08/09/2016
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: redness in the injection arm when she received the PREVNAR 13 vaccine and was diagnosed with cellulitis; redness in the injection arm/Redness around injection site; redness down her arm/big ring around where it got red and started going down her arm; allergic reaction; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 66-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in left arm on 09Aug2016 in the morning at single dose for immunization. Medical history included penicillin allergy and Sulfa drug allergy from an unknown date and unknown if ongoing. The patient previously had Tetanus shot on 23Apr2015 and Flu shot on unspecified date. The patient's concomitant medications were not reported. The patient experienced redness in the injection arm when she received the PREVNAR 13 vaccine and was diagnosed with cellulitis on 09Aug2016. The patient got a PREVNAR 13 shot back in 09Aug2016 and had a bad reaction. The patient wanted to know if it was the shot or not and wanted to be able to take the COVID shot. The patient has not had any shot since Aug2016. The patient had bad reaction to PREVNAR 13, redness around injection. The patient heard on commercials about redness at injection site. She went to the doctor three times in one week. The redness was growing and ended up with cellulitis in her arm. She wondered if it was the actual PREVNAR 13 shot she was allergic to or if something else happened. The patient was afraid to take the COVID shot because of her reaction with PREVNAR 13. The patient has not taken a Flu shot since then. The patient thought her doctor may have reported it. The patient was wondering if the PREVNAR 13 was actually given in the muscle or maybe bacteria entered at the time of injection. The patient noticed redness down her arm that night on 09Aug2016. The next morning, she noticed it was bigger and went to the doctor's office three times that week. The doctor kept marking it. She was asked if redness got close to her elbow she might need to go to the ER. The patient was prescribed an antibiotic and was allergic to the antibiotic. The patient had a big ring around where it, got red and started going down her arm. The redness continued and was told by her doctor she was having an allergic reaction. The patient was switched to another antibiotic after clindamycin, but doesn't remember which one and then it started working. The facility where the most recent COVID-19 vaccine was administered was in the physician office. No other vaccine was given to the patient on the same date of PREVNAR 13. The patient did not receive any other vaccines within 4 weeks prior. The doctor would just mark the redness on her arm and confirmed that the patient has not yet received the COVID-19 vaccine. The patient was prescribed Clindamycin and redness continued. The answer to the question, if a sample of the product was available to be returned, if requested; and if the packaging was sealed and intact was not provided. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1022027
Sex: M
Age:
State: FL

Vax Date: 01/15/2021
Onset Date: 01/22/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: felt weak; Dysentery; violently sick; throwing up; dehydrated; dry heaving; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E18982, expiration date was not reported), intramuscular on the left arm (also reported as left shoulder) on 15Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. It was reported that the patient was taking an unspecified blood thinner and other unspecified products. It was reported that patient got the first dose on 15Jan2021 and everything was fine. The following Friday, exactly a week later, on 22Jan2021 at 930am he got violently sick as far as throwing up and dysentery. He was asking if it could be from the shot. He got sick and was heaving for 7 hours, then he was dry heaving after throwing up so much, it was green bile. He knew he was getting dehydrated and drank a bottle of Pedialyte at 7pm that night. He had to stay a half hour after getting the vaccine since they wanted to monitor him a little longer since he takes blood thinners an other crap. He did not specify the other medications that he takes. On Saturday he felt fine but he felt weak. The patient recovered from dysentery and throwing up on 23Jan2021, while outcome of the remaining events was unknown.

Other Meds:

Current Illness:

ID: 1022028
Sex: M
Age:
State: HI

Vax Date: 01/16/2021
Onset Date: 01/23/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: COVID 19 (nasal test ); Test Result: Positive ; Comments: at 11: 40 AM

Allergies:

Symptoms: got positive with Covid Virus; he tested positive for the COVID; sore throat; stuffiness; fatigue; This is a spontaneous report received from a Pfizer-sponsored program from a contactable consumer reported for himself. A 51-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 16:00 at SINGLE DOSE for covid-19 immunization. Medical history included ongoing Ulcerative colitis, ongoing Allergy and "had close contact with someone who was positive". Concomitant medication included ongoing mesalazine (taking for over 20 years) for Ulcerative colitis and ongoing allergy medicine (taking for two years, thinks it is Claritin grocery brand) for Allergy. Caller received first Pfizer vaccine on 16Jan2021. He was performed the nasal test at 11: 40 AM yesterday (25Jan2021) and received positive results for Covid 19 today (26Jan2021). Adds he had no symptoms after the vaccine. But he has sore throat, stuffiness, fatigue that started the 23Jan2021 with the COVID 19. All of these are getting better as of today (26Jan2021). The event did not require a visit to physician or ER. The patient stated "I had close contact with someone who was positive." He was supposed to receive his second vaccine dose on 06Feb2021. The patient stated "they told me to quarantine for 10 days from the time I was exposed and that would be until 02Feb2021. Is there any reason I shouldn't get my 2nd dose?" The outcome of the event COVID 19 was unknown, of other events was recovering.

Other Meds: MESALAZINE

Current Illness: Allergy; Ulcerative colitis

ID: 1022029
Sex: F
Age:
State: PA

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210124; Test Name: BW; Result Unstructured Data: Test Result:Unknown; Test Date: 20210124; Test Name: Lyme Disease Test; Test Result: Negative ; Test Date: 202011; Test Name: Routine Physical Examination; Result Unstructured Data: Test Result:Unknown

Allergies:

Symptoms: Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EV1685, expiry date unknown) via an unspecified route of administration on the left deltoid, left arm, on 05Jan2021 08:15 AM at a single dose for COVID-19 immunization. The patient's medical history included allergies to Penicillin and Sulfa from an unknown date and unknown if ongoing. The patient had no current Illness and no family medical history. The patient is not pregnant. Concomitant medications included metoprolol tartrate, Vitamin C [ascorbic acid], Vitamin D3, and Multivitamins; patient received these medications within two weeks prior to the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Patient had a routine Physical Examination on Nov2020 and underwent lab tests and procedures on 24Jan2021 which included unknown BW and negative Lyme Disease Test. On 23Jan2021 18:30, the patient developed bell's palsy on left side which was reported as getting a little worse every day. The event required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care; the event resulted in Disability or permanent damage. Since 24Jan2021, patient received Prednisone 60 mg, daily for 7days and Valtrex 1g, 3x/day (TID) for 7days as treatment for the event. The patient did not recover from the event Bell's palsy on left side.' It was further reported that patient experienced soreness at the injection site on an unspecified date with outcome of unknown.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event Facial paralysis cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: METOPROLOL TARTRATE; VITAMIN C [ASCORBIC ACID]; VITAMIN D3

Current Illness:

ID: 1022030
Sex: M
Age:
State: FL

Vax Date: 01/07/2021
Onset Date: 01/12/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210122; Test Name: covid-19; Test Result: Positive ; Comments: at 10:20

Allergies:

Symptoms: tested positive for covid-19; tested positive for covid-19; he had a cold; Coughing; runny nose; congestion; This is a spontaneous report from a contactable consumer (Patient's wife). A 68-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246), intramuscular in Right arm on 07Jan2021 at 08:30-08:35 at single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient had symptoms and was tested positive for covid-19 on 22Jan2021 10:20. On 12Jan2021 04:00, the patient had coughing, runny nose, congestion and thought he had a cold. The patient was scheduled to have his second dose on 28Jan2021, and the reporter wanted to know if the patient should get it or not. The outcome of the event COVID-19 was unknown, of other events was recovering.

Other Meds:

Current Illness:

ID: 1022032
Sex: U
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Got sick after the first dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on an unspecified date at SINGLE DOSE (first dose) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced got sick after the first dose on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.

Other Meds:

Current Illness:

ID: 1022033
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:high

Allergies:

Symptoms: warm feelings; his blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient received his first dose of the Pfizer-BioNTech COVID-19 Vaccine and stated "right after I got the shot, hot flashes on chest and stomach which went to both of my arms, then went down to the legs and feet, and back to the arms". Patient mentioned that this lasted for 45 minutes and he was brought by an ambulance to a hospital. Patient was then observed but wasn't administered any medicine. Patient stated that he had a high blood pressure but was not sure if it was because he was afraid or because of the experience with the vaccine. Patient confirmed that he was not given any medication and eventually discharged after a few hours. Patient clarified regarding 'hot flashes' and mentioned that these were not rashes but warm feelings, "similar to when they prep you for a CAT scan". It was also reported that patient asked for any available reports on this. Patient also asked what to do about the second shot if he got the shot on the outside of the parking lot. Patient was also seeking guidance on local vaccination site and mentioned that he would want to be inside a facility when taking his 2nd shot (scheduled in 21 days). Outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022034
Sex: F
Age:
State:

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210122; Test Name: COVID; Test Result: Positive

Allergies:

Symptoms: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable nurse who reported for herself. A 25-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on 22Jan2021 for Covid-19 immunization. The patient's concomitant medications were not reported. The patient got her first dose on 22Jan2021 and was tested positive for Covid that night due to close contact with a friend that had had a positive test. Her next vaccination date was after the 14 days quarantine but she was wondering if someone kept testing positive after that 14 day period, she knew some people test positive for months. She would like to know was it still safe to get the second dose. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; 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. While the vaccine may not provide protection yet, further clinical information is needed for meaningful medical assessment.

Other Meds:

Current Illness:

ID: 1022035
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: had the "usual side effects", aches and pains; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (parent) reported that a female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that her daughter (patient) who is a nurse experienced the "usual side effects", aches and pains on an unspecified date after her second dose. The patient took ibuprofen as treatment. The reporter's healthcare professional (HCP) told her not to take any ibuprofen because it reduces effectiveness of the vaccine. The reporter wanted to know if it was true. Outcome of the event pain was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022036
Sex: F
Age:
State: OH

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: legs were not working after the Covid-19 vaccine shot; This is a spontaneous report from a contactable consumer. A 91-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261, expiration date 31May2021), intramuscular on her left arm on 23Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's legs were not working after the Covid-19 vaccine shot on 24Jan2021. She got the shot on Saturday afternoon. The patient seems to be ok today. The outcome of the event was recovered in 25Jan2021.

Other Meds:

Current Illness:

ID: 1022037
Sex: F
Age:
State: TN

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: BP; Result Unstructured Data: Test Result:160/100; Test Date: 20210125; Test Name: HR; Result Unstructured Data: Test Result:110; Test Date: 20210125; Test Name: HR; Result Unstructured Data: Test Result:69; Test Date: 20210125; Test Name: HR; Result Unstructured Data: Test Result:40; Test Date: 20210125; Test Name: HR; Result Unstructured Data: Test Result:80; Test Date: 20210125; Test Name: HR; Result Unstructured Data: Test Result:112

Allergies:

Symptoms: felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100; irregular HR with PVCs; HR 40; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1283) on 25Jan2021 08:15 given intramuscular (left arm) single dose for COVID-19 immunization. Medical history included was reported as none. The patient was not pregnant at the time of vaccination. Concomitant medication included estradiol, testosterone, lorazepam (ATIVAN). The patient previously received ultram/ Zofran ad experienced drug allergies, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 04Jan2021 08:15 intramuscular single dose for COVID-19 immunization. The patient was not diagnosed with covid prior vaccination and the patient was not tested for covid post vaccination. On 25Jan2021 at 08:45 AM, 30 minutes after injection,-the patient felt horrible described as her heart was pounding hard and felt tachycardic. BP was 160/100 and HR 110 and felt near syncopal. Then PVCs started/ very short of breath, and HR went from 112, 69, 40, then 80. The patient went to ER. The patient was monitored and given was IVFs and O2, and labs checked. The patient was discharged 7 hours later and continued having irregular HR with PVCs. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on the available information, a possible contribution of the drug to the event syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: ESTRADIOL; TESTOSTERONE; ATIVAN

Current Illness:

ID: 1022038
Sex: F
Age:
State:

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nightmares; Jumping nerves; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), via an unspecified route of administration on 18Jan2021 at single dose on Left arm for COVID-19 immunization. No Other vaccine in four weeks. No Covid prior vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced nightmares and jumping nerves on an unspecified date. Treatment AE: No. No covid tested post vaccination. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1022039
Sex: M
Age:
State: FL

Vax Date: 01/14/2021
Onset Date: 01/16/2021
Rec V Date: 02/11/2021
Hospital: Y

Lab Data: Test Date: 20210116; Test Name: CTA; Test Result: Negative ; Test Date: 20210116; Test Name: ECHO; Test Result: Negative ; Test Date: 20210116; Test Name: troponins; Result Unstructured Data: Test Result:elevated

Allergies:

Symptoms: Pericarditis after admit and negative ECHO, and CTA; Chest discomfort; initially thought it was heart burn lasted over 15 overs decided to visit ER.; Had elevated troponins was diagnosed with Pericarditis after admit and negative ECHO, and CTA; This is a spontaneous report from a contactable nurse (patient) reported that a 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 14Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received influenza vaccine (FLU) on 10Dec2020 for immunization; and received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 24Dec2020 15:30 for Covid-19 immunization. On 16Jan2021 15:30, the patient experienced chest discomfort, initially thought it was heart burn lasted over 15 "overs" decided to visit ER. The patient had elevated troponins, and was diagnosed with Pericarditis after admit and negative ECHO, and CTA. As treatment, patient received IV Toradol. The reported events resulted hospitalization for 1 day. The patient underwent lab tests and procedures which included angiogram (CTA): negative, echocardiogram (ECHO): negative, troponin: elevated; all on 16Jan2021. The outcome of the events was recovering.; Sender's Comments: Based on the vaccine's safety profile, the event pericarditis and the associated symptoms are more likely intercurrent condition, unrelated to suspect vaccine BNT162B2 administration. 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: 1022040
Sex: F
Age:
State: TN

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: back of neck at the spine began feeling odd and maybe the middle of my spine; When I got the shot, I felt something shoot into the arm and it felt a little startling or shocking to the body; feeling numb in my left pinky & a little in the ring finger plus a strange feeling (achy) in right arm/light numbness on outside of my left leg from the knee down to the ankle; feeling numb in my left pinky & a little in the ring finger plus a strange feeling (achy) in right arm/lighter soreness up the outside of my left forearm; The pinkies feel swollen when I bend them; soreness at the injection site; This is a spontaneous report from a contactable consumer (reported for herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9261; expiry date: not known), via an unspecified route of administration in the left arm on 26Jan2021 15:00 at single dose for COVID-19 immunization; and ibuprofen, via an unspecified route of administration from an unspecified date at 1 dosage form (DF) for an unspecified indication. Medical history included known allergies to some pesticides, herbicides, chlorox, or possibly the products mixed with them/permanent magic markers (mad her lips and face felt numb, could make it hard to breath, almost made her pass out once/made her feel sick in the past); and caused neuropathy up the back of her legs once. The patient is not pregnant. Concomitant medications included lactobacillus acidophilus (ACIDOPHILUS), melatonin, and ascorbic acid (SUPER C). The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 26Jan2021 20:00, after when she got the shot, she felt something shoot into the arm and it felt a little startling or shocking to the body. After 10 minutes, she did not feel it. The patient started feeling numb in her left pinky & a little in the ring finger plus a strange feeling (achy) in right arm. Eventually, she also felt a lighter soreness up the outside of her left forearm. The pinkies felt swollen when she bent them. She felt a normal soreness at the injection site. On 26Jan2021 23:50, she started feeling light numbness on outside of her left leg from the knee down to the ankle. The ankle on the outside felt a fairly pronounced numbness. Also, the back of neck at the spine began feeling odd and maybe the middle of her spine. Although she stated the spine spot had a twinge of pain the night before & in the morning so that might not be the vaccine. The right pinky also started feeling light numbness by 01:00 the next day. The patient took 2 Tylenol and before bed, she took 1 ibuprofen for back of neck at the spine began feeling odd and maybe the middle of her spine and soreness at the injection site. No treatment received for other events. The action taken in response to the events for ibuprofen was unknown. The outcome of the event "when I got the shot, I felt something shoot into the arm and it felt a little startling or shocking to the body" was recovered on 26Jan2021 20:10; while outcome was unknown for other events.

Other Meds: ACIDOPHILUS; MELATONIN; SUPER C [ASCORBIC ACID]

Current Illness:

ID: 1022041
Sex: F
Age:
State: CA

Vax Date: 01/22/2021
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sore; tired; getting this stabbing shock pain on the left side of my head; This is a spontaneous report from a contactable Other HCP (patient). A 24-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) via an unspecified route of administration on 22Jan2021 07:45 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. Patient age at vaccination was 24 years. The patient has no known allergies. Medical history was none. The patient's concomitant medications were not reported. The patient reported first days she was just sore, tired then by the 3rd day began getting this stabbing shock pain on the left side of her head that last about 3-5 seconds each time through out the whole day. It is not like a regular headache pain it is a sudden stabbing shocking pain only on the left side of the head. Over the counter migrane medicine does not take that pain away when it does come. Onset date of the events was reported as 25Jan2021 01:00 PM. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1022042
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: her arm was sore; This is a spontaneous report received by Pfizer from a contactable other healthcare professional (HCP) (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. It was stated that an NP at the clinic also reported her arm was sore following the vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1022043
Sex: F
Age:
State: NC

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210123; Test Name: Vitals; Result Unstructured Data: Test Result:unknown results; Test Date: 20210123; Test Name: monitor; Result Unstructured Data: Test Result:elevated BP noted with Afib; Test Date: 20210123; Test Name: monitor; Result Unstructured Data: Test Result:periods of Afib and normal sinus

Allergies:

Symptoms: Afib; Felt dizzy; heart racing; elevated BP; This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration at the right arm on 23Jan2021 at 13:30 (01:30 PM) at single dose for COVID-19 immunization, administered in workplace clinic. The patient is not pregnant. The patient's medical history included atrial fibrillation (Afib), hypertension, thyroid cancer, and lymphoma. It was unknown if the patient has known allergies. Concomitant medications (other medications in two weeks) included multiple prescription medications (unspecified). It was unknown if the patient had other vaccines in four weeks. It was unknown if the patient had COVID prior to vaccination. The patient felt dizzy, heart racing, elevated BP (blood pressure), and Afib on 23Jan2021 at 13:30 (01:30 PM), described as: Felt dizzy and "heart racing", elevated BP (blood pressure) noted with Afib on monitor. Patient felt symptoms at 15 minutes with periods of Afib and normal sinus on the monitor. Vitals and ongoing monitoring taken. The patient verbalized history of chronic Afib. No other symptoms and no distress noted otherwise. The patient and her family declined ER treatment or further medical evaluation. The patient did not receive treatment for the events. It was unknown if the patient was tested for COVID post vaccination. The outcome of the events was recovered on Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 1022044
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: A person gets the first dose of the COVID-19 vaccine and within 5-7 days gets COVID-19; A person gets the first dose of the COVID-19 vaccine and within 5-7 days gets COVID-19; This is a spontaneous report from a contactable physician. This physician reported for a patient of unspecified age and gender 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 immunization. The patient medical history and concomitant medications were not reported. The patient got the first dose of the covid-19 vaccine and within 5-7 days got covid-19 on an unspecified date with outcome of unknown. Information about batch/lot number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), and within 5-7 days got COVID-19. 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 COVID 19 likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.

Other Meds:

Current Illness:

ID: 1022045
Sex: F
Age:
State: FL

Vax Date: 01/05/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210121; Test Name: positive for Covid19; Test Result: Positive

Allergies:

Symptoms: She tested positive for Covid19; She tested positive for Covid19; This is a spontaneous report from a contactable consumer. A 32-year-old female patient (reporter's daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for covid19 on 21Jan2021. The patient wanted to know can the patient get a 2nd vaccine if they are positive or will she have to start with dose 1 again. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1022046
Sex: M
Age:
State:

Vax Date: 01/11/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: tested; Test Result: Positive

Allergies:

Symptoms: tested positive for Covid since the first dose; tested positive for Covid since the first dose; This is a spontaneous report from a contactable consumer. This consumer reported for himself that the male patient of unknown age who received first dose of bnt162b2 (Pfizer-Biontech covid-19 vaccine), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medications were unknown. States he is due to get his second dose on 02Feb2021 but he has tested positive for Covid since the first dose (Jan2021) and wants to know what to do. The outcome of the events was unknown. Information about Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1022047
Sex: F
Age:
State: WA

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and sweats; I turned white as a ghost and sweats; Got the chills after sweating; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself that she received 1st dose of bnt162b2 (BNT162B2; lot number EL9261) on 26Jan2021 04:30 PM at left arm for COVID-19 immunization in Public Health Clinic. Medical history and concomitant drugs was none. The patient woke up at midnight with severe leg cramps, tried walking it out, collapse and passed out (according to husband). He stated that the patient turned white as a ghost and sweats. After coming too, drank electrolytes and water. The patient got the chills after sweating. It took a while for her to warm up and go back to sleep. Event start time was reported as 27Jan2021. The outcome of the event was resolved.

Other Meds:

Current Illness:

ID: 1022048
Sex: F
Age:
State: MO

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Muscle soreness at injection site; Muscle soreness at injection site; left bicep muscle twitching for about 1-2 minutes at around midnight; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN5318, on 26Jan2021 07:00 at single dose in left arm for Covid-19 immunization. Medical history included high blood pressure, allergies to penicillin and amoxicillin. Concomitant medications included amlodipine besilate (NORVASC), atorvastatin (LIPITOR), pseudoephedrine hydrochloride (SUDAFED), VITAMIN D NOS, and cetirizine hydrochloride (WAL ZYR). The patient was not Pregnant at the time of vaccination. The patient had no any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Muscle soreness at injection site that was still occurring but lessened 24h later and left bicep muscle twitching for about 1-2 minutes at around midnight. No treatment was received for all events. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The outcome of all events was resolving.

Other Meds: NORVASC; LIPITOR [ATORVASTATIN]; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]; VITAMIN D NOS; WAL ZYR

Current Illness:

ID: 1022049
Sex: M
Age:
State: NY

Vax Date: 01/07/2021
Onset Date: 01/10/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210110; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptoms: diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer. This consumer reported for self that the male patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. On 10Jan2021 the patient developed symptoms and was diagnosed with COVID-19 (unrelated to vaccine obviously). He was fully recovered as of 26Jan2021. He was scheduled for the second doze of vaccine for 28Jan2021. The outcome of the events was recovered. Information on Lot/Batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm