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: 1051360
Sex: M
Age:
State: MN

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

Lab Data:

Allergies:

Symptoms: Headache; left arm and back pain; left arm and back pain; everything hurt; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK4176; dose 1) via an unspecified route of administration on 23Jan2021 at 16:00 (at the age of 72-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included a dental appointment in Jan2021; the patient had no other conditions. Concomitant medications were not reported. The patient previously took penicillin and had a reaction when he was younger. The patient had not had adverse events from prior vaccinations. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 24Jan2021 the patient experienced headache, left arm and back pain, everything hurt. The patient said that "it" didn't bother him at all that day (23Jan2021) but on 24Jan2021 he had headaches, left arm and back pain and everything hurt. It was worse "yesterday" but "today" (on an unknown date) his arm and back still hurt. The events did not require a visit to the emergency room or physicians office. The patient underwent lab tests and procedures which included a new dental crown put on on 25Jan2021. The clinical outcome of headache was recovering. The outcome of left arm and back pain and everything hurt was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1051361
Sex: F
Age:
State: WA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: hot flash sensation on right side body under her arms down side of her body; This is a spontaneous report from a contactable pharmacist (patient). This 45-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3302; dose 1) via an unspecified route of administration on 26Jan2021 (at the age of 45-years-old) as a single dose in the arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced hot flash sensation on the right side of her body. The patient stated she got the vaccine "today" (26Jan2021) and wanted to find out if the kind of side effect she was having would resolve or if she needed to contact her physician. She had been experiencing a hot flash sensation on the right side of her body under her arms and down the side of her body on 26Jan2021. The outcome of hot flash sensation on the right side of her body was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1051362
Sex: F
Age:
State: NY

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Date: 202005; Test Name: antibodies; Result Unstructured Data: Test Result:8.2; Test Date: 20210120; Test Name: fever; Result Unstructured Data: Test Result:100.2; Test Date: 20200326; Test Name: Covid; Test Result: Positive

Allergies:

Symptoms: Chills; Fever of 100.2; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old 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 the left arm, on 19Jan2021 13:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 26Mar2020, she tested positive for Covid. In the beginning of May2020, she went to get tested for antibodies, she did have them, that she received a report, number was 8.2 and knows that at 1.4 she would be considered to have antibodies so they told her it was good that her number was high, she asked them what it meant and they told her they did not know. Patient had chills, fever of 100.2, bad headache, and muscle aches on 20Jan2021. She took Tylenol to treat her symptoms and they went away, and states they would come back as Tylenol wore off. Her symptoms have completely resolved however she does not have the exact date. Outcome of the events was recovered on Jan2021. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1051363
Sex: F
Age:
State:

Vax Date: 01/16/2021
Onset Date: 01/01/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 10 days later arm got red; soreness to her arm; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has a question about the COVID-19 vaccine. She stated that she thought she had a simple question, and she called the COVID hotline, and the CDC and they just keep bouncing her around. She said she had her first dose of the vaccine on 16Jan2021, and wasn't bothered by it, she had just a bit of soreness when she touched her arm (unspecified date in Jan2021), but 10 days later, on 26Jan2021, her arm got red, so she is wondering if this could be a delayed reaction. She stated that she is not having bad effects, she is just wondering why it would pop up after so many days. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1051364
Sex: M
Age:
State: MN

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

Lab Data:

Allergies:

Symptoms: Lip swelling; Extreme tiredness; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231) via an unspecified route of administration on the left upper arm on 25Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history seafood allergy. There were no family medical history and concomitant medications. The patient previously received flu shots in Sep2020 (Has had 100's of vaccines while in the army and never had a reaction to any of them). The patient experienced extreme tiredness on 25Jan2021; was noticed at 6pm when he fell asleep on the phone. Right now, he is fine, stating later he was just a little tired. Lip swelling- this was noticed about 11pm on 25Jan2021 the day he received the shot, when he woke to go to the bathroom. Both lips were swollen but he wasn't worried as he knew this was a possible side effect. He reported that he was back to normal other than being a little tired. He just slept. Patient reported that he couldn't stay awake for a more than 5 minutes but he is still very glad he got it. The second dose is due 15Feb2021. The events did not require a visit to physician office or emergency room. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. Outcome of the event lip swelling was recovered on 26Jan2021 while the event extreme tiredness was recovering.

Other Meds:

Current Illness:

ID: 1051365
Sex: F
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Name: Body Temperature; Result Unstructured Data: Test Result:can't seem to regulate

Allergies:

Symptoms: Nausea; Fever; Diarrhea; Pain and stiffness in her chest; Pain and stiffness in her chest; can't seem to regulate her body temperature; Laboring to breathe; Immediate soreness in arm; couldn't really taste, things didn't really taste right; Muscle pain; Joint pain; Red rash; Hives; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. This consumer reported for a patient (other health professional). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. It was reported that the patient was having the same symptoms with the caller except that it was after receiving the second dose. On an unspecified date, the patient experienced immediate soreness in arm, stated that she couldn't really taste, things didn't really taste right, muscle pain, joint pain, red rash, hives, nausea, fever, diarrhea, and pain and stiffness in her chest. She also can't seem to regulate her body temperature and was laboring to breathe on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076108 same reporter/drug, similar events, different patient

Other Meds:

Current Illness:

ID: 1051366
Sex: F
Age:
State: SC

Vax Date: 01/22/2021
Onset Date: 01/25/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea/sick to her stomach; Headache; stomach is upset; not feeling great; dizziness; Vertigo; This is a spontaneous report from a contactable consumer. A 78-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) on her left arm, via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. It was reported that the patient got shot on Friday and last night she woke up with vertigo on 25Jan2021. This morning (26Jan2021), she could not eat breakfast because she was nauseous and sick to her stomach; stomach is upset. She is walking around now and just is not feeling great. She also has a headache and dizziness. The outcome of the event nausea was recovering while unknown for the other events.

Other Meds:

Current Illness:

ID: 1051368
Sex: F
Age:
State: MA

Vax Date: 01/15/2021
Onset Date: 01/01/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:fine

Allergies:

Symptoms: small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EL1284, expiry date: 31Apr2021), via an unspecified route of administration on the left arm, on 15Jan2021 09:30, at single dose, for covid-19 immunization. Medical history included heart issues from an unspecified date, cardiac ablation in 2020, total knee replacements on 2001 (approximately 20 years ago) and 2009 (approximately 12 years ago), spinal fusion surgery in 2017 (3 fused disc in her back approximately 4 years ago). Concomitant medication included cortisone which started on 21Jan2021 (as reported, pending clarification) for an unspecified indication. In Jan2021 (reported as "Saturday morning"), the patient experienced small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired. She was calling because she didn't know if it was possible if she could be having a reaction. She stated she had one other symptom, her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too. Treatment for the events small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired included Mucinex Night Shift Cold and Flu syrup, Halls Relief lozenges and Advil. The patient reported that her symptoms have stayed about the same. The patient took her temperature on an unspecified date and reported that it was fine. She reported she did not any lab tests done for the events. The outcome of the events was not recovered.

Other Meds: CORTISONE

Current Illness:

ID: 1051369
Sex: F
Age:
State: TX

Vax Date: 01/18/2021
Onset Date: 01/01/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she forgets her own address; This is a spontaneous report from a contactable consumer (patient). A female patient of an 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 18Jan2021 17:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she was fine and wanted to inform that she had her Covid vaccine shot on 18Jan2021 at 17:00. She has not been sick and does not have fever. She was now waiting on the date for the second dose. She then mentioned that she forgets her own address on Jan2021. The outcome of the event was unknown. Information about the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1051370
Sex: F
Age:
State: FL

Vax Date: 12/28/2020
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: Chest X-ray; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptoms: Sore arm; Pain in chest to her left upper sternal border area (under collar bone); Pain in the neck, its an aching pain, a nuisance type of pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the left deltoid on 28Dec2020 (07:15) at a single dose for COVID-19 immunization at the hospital. The had no relevant medical history and concomitant medications. On an unspecified date, after the first dose of vaccination, the patient had sore arm; pain in chest to her upper sternal border area (under the collar bone); and pain in the neck (further described as "an aching pain, a nuisance type of pain"). The patient had chest x-ray on 25Jan2021 (results were not provided). The patient had received paracetamol (TYLENOL), naproxen sodium (ALEVE) and ibuprofen as treatment for the reported events. The outcome of the events was not recovered for 'pain in chest to her upper sternal border area (under the collar bone)'; and was unknown for 'sore arm' and 'pain in the neck'. The patient had received the second dose of vaccination on 14Jan2021. The reporter believed that it was "highly coincidental" (pertaining to causality) considering the events happened with both vaccine doses. No further information was provided or obtained.

Other Meds:

Current Illness:

ID: 1051371
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Name: Temperature; Result Unstructured Data: Test Result:103

Allergies:

Symptoms: Temperature of 103; Had severe body aches; Weakness; This is a spontaneous report from a non-contactable consumer reporting for a patient. A female patient in her 60's received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on an unspecified date at SINGLE DOSE for preventative for Covid 19. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on an unspecified date for covid-19 immunisation. The patient experienced temperature of 103, had severe body aches, and weakness on an unspecified date which lasted for two days and then recovered on an unspecified date. No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1051372
Sex: F
Age:
State: NC

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

Lab Data:

Allergies:

Symptoms: after getting the vaccine, her taste and smell came back which has been gone since Oct2017 when she had shingles in her mouth and right side of face; This is a spontaneous report received from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 lot number: EK9231, expiry date: 30Apr2021), via an unspecified route of administration on the left arm, on 24Jan2021 15:30, at 0.3 mL, single, to protect her husband and her neighbor/COVID-19 immunization. Medical history included shingles in her mouth and right side of her face in Oct2017; and has not been able to taste or smell since 2017. There were no concomitant medications. The patient had shingles in her mouth and right side of her face on Oct2017 and she lost her taste and smell from it. She has not been able to taste or smell since 2017. The patient called to report a positive thing that happened after she got the COVID-19 vaccine on 24Jan2021 15:30. By the morning of 25Jan2021, the patient fixed her coffee and when she drank her coffee, she tasted it. She was like, 'wait a minute'. So, she took another sip. She can taste and smell. She smelled and tasted everything. After the coffee, she fixed an egg and put extra salt and pepper and she could taste it. After getting the vaccine, her taste and smell came back which has been gone since Oct2017 when she had shingles in her mouth and right side of face. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1051373
Sex: M
Age:
State: SD

Vax Date: 01/21/2021
Onset Date: 01/23/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: hives from his knee to his chest, and from his chest to his arm and to his neck area, hives had little red bumps and were itchy; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on the left arm, at the age of 75 years, on 21Jan2021 10:00 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient said he had red hives develop on Saturday, 23Jan2021. He went to an Urgent Care for treatment. He said the doctor at the Urgent Care looked at his hives, and told him the hives were likely related to the COVID-19 Vaccine, but the doctor was not positive of that. The patient said he hadn't had any recent changes in his health, or issues before he received the COVID-19 Vaccine, so that was why the doctor thought the hives were from the COVID-19 Vaccine. He clarified he has hives from his knee to his chest, and from his chest to his arm and to his neck area. He clarified the hives have been moving around his body. He said the hives had little red bumps, saying the hives were itchy. Therapeutic measures (Zyrtec and Hydrocortisone Cream) were taken as a result of hives from his knee to his chest, and from his chest to his arm and to his neck area, hives had little red bumps and were itchy (urticaria). The outcome of the event was recovering.

Other Meds:

Current Illness:

ID: 1051374
Sex: F
Age:
State: MN

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I'm currently 20 hours post administration of my 2nd dose and feel lousy; light nausea approx 2 hours after adminstration; dull headache and intense body aches approx 8 hours after administration; dull headache and intense body aches approx 8 hours after administration; This is a spontaneous report from a contactable other hcp. A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on the left arm at the age of 36 years, on 26Jan2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included anaphylactic reaction, drug hypersensitivity to penicillin, food allergy to pistachios. The patient's concomitant medications were not reported. The patient had the first dose on an unspecified date in Jan2021. On 26Jan2021, the patient experienced light nausea approx 2 hours after administration. Then developed a dull headache and intense body aches approx 8 hours after administration. The patient was currently 20 hours post administration of 2nd dose (27Jan2021) and feels lousy. There was no treatment received for the adverse events. The outcome of the event feel lousy was unknown while other events were recovered on an unspecified date in Jan2021.

Other Meds:

Current Illness:

ID: 1051375
Sex: M
Age:
State: NC

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for different patient. This is the first of two reports. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on his left arm, via an unspecified route of administration on 19Jan2021 at a single dose for covid-19 immunization. Medical history included egg allergy, bladder cancer and surgery. There were no concomitant medications. It was reported that the patient had a sore arm after getting the shot. The outcome of the event was recovered on an unspecified date in Jan2021. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106756 same drug, same event and different patient

Other Meds:

Current Illness:

ID: 1051376
Sex: F
Age:
State: FL

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area (under collar bone); fatigued; chills; fever; body aches, it was more like body cramping; body aches, it was more like body cramping; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), intramuscular on the left deltoid, on 14Jan2021 07:15 at a single dose for COVID-19 immunization. The first dose was received on 28Dec2020 (lot number: EK9231), intramuscular on the left deltoid and patient experienced sore arm, and left upper (under collar bone) pain in her chest. The patient medical history was not reported. There were no concomitant medications. She received the vaccine around 7:15 in the morning and by midnight on 15Jan2021 (she works nights), she started to feel the pain. By that point, she was like "ooh, my arm is sore". She also started to have the same pain in her chest as she had before (pain in chest to her left upper sternal border area (under collar bone). Her doctor ordered a chest x-ray on 25Jan2021. Patient stated it was not cardiac. It's just there. The pain was annoying and she can feel it when she moves or when she goes to get up, it's an ache. Its a pain in the neck. On Friday, 15Jan2021, she was real fatigued, had chills, a little bit of a fever, and body aches. She clarified it was more like body cramping and her body hurt so bad. She over that by Sunday.All of her symptoms resolved by Sunday 17Jan2021, except for the pain she was experiencing in her chest which was still ongoing and persisting. She had taken Tylenol, Aleve, and Ibuprofen, but it doesn't resolve the pain at all. Outcome of the event of sore arm was unknown, for pain in chest was not recovered while for the remaining events was recovered on 17Jan2021.

Other Meds:

Current Illness:

ID: 1051377
Sex: F
Age:
State: WI

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

Lab Data:

Allergies:

Symptoms: Monday-second day after=started to feel more sick, scratchy/sore throat; scratchy/sore throat; Monday-second day after=started to feel more sick, scratchy/sore throat/scratchy throat; Chest heaviness/tightness-slightly short of breath/chest tightness; Chest heaviness/tightness-slightly short of breath; Muscle aches; Minor chills; Headache; Sunday-first day after=just felt lousy, fatigue/fatigue; General malaise/ just felt lousy; Saturday night= extremely sore arm (lasted for first 24-48 hrs after); This is a spontaneous report from a contactable nurse. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1284), intramuscular on the left arm at the age of 32 years, on 23Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included eczema and allergy to metals from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient received the first dose on 02Jan2021. On Saturday night (23Jan2021), the patient's had extremely sore arm (lasted for first 24-48 hrs. Then on Sunday( 24Jan2021), patient just felt lousy and fatigue. On Monday (25Jan2021), patient started to feel more sick, scratchy/sore throat, fatigue, chest heaviness/tightness lightly short of breath, muscle aches, minor chills, headache. On Tuesday, third day after, muscle aches, headache, fatigue, general malaise, scratchy throat, chest tightness. No treatment was received for the events. The outcome of the events was recovering.

Other Meds: ZOLOFT

Current Illness:

ID: 1051378
Sex: M
Age:
State: MI

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

Lab Data: Test Date: 20210201; Test Name: Body temperature; Result Unstructured Data: Test Result:102.8

Allergies:

Symptoms: Fever of 102.8; Chills; fatigue; head and body aches; body aches; This is a spontaneous report from a contactable consumer (patient). A 29- year-old male patient received first dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3248) via unknown route of administration on left arm, at 05:45 on 01Feb2021, at single dose for COVID-19 immunization. The patient medical history included Coeliac disease and gluten allergy. The concomitant medication included finesteride, iron, biotin, niacin and zinc. The patient experienced fever 102.8 centigrade, chills, fatigue, head and body aches at 18.30 on 01Feb2021. The patient didn't receive any treatment. The patient was not diagnosed with COVID-19 prior to vaccination and after vaccination. The patient received COVID-19 vaccine at workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The events was reported as non-serious by the reporter. The outcome of the events was reported as recovered on an unknown date in Feb2021.

Other Meds: FINASTERIDE; IRON; BIOTIN; NIACIN; ZINC

Current Illness:

ID: 1051379
Sex: M
Age:
State:

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: soreness at injection site; Splitting headache for 48 hours after injection; nausea; body aches; fatigue; This is a spontaneous report from non-contactable consumer (patient). An adult male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunisation. Medical history included asthma. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown and expiration date unknown) on 09Jan2021 for COVID-19 immunisation. The patient's concomitant medications were not reported. It was not known if the patient received other vaccines within 4 weeks prior to the COVID vaccine. It was not known if the patient was diagnosed with COVID-19 prior to vaccination. The patient experienced splitting headache for 48 hours after injection, nausea, body aches, fatigue and soreness at injection site all on 30Jan2021. The patient recovered from splitting headache on 01Feb2021 while the patient recovered from the other events on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1051380
Sex: F
Age:
State: MN

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

Lab Data:

Allergies:

Symptoms: breakout rash on her chest, neck, and under her chin; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date: May2021), via intramuscular route of administration on 23Jan2021 at 16:25 at 0.3 mL, single for COVID-19 immunization. Medical history included allergy, penicillin allergy, allergic to bee stings, and allergic to baby powder. The patient's concomitant medications were not reported. On 23Jan2021 at 23:30, the patient had breakout rash on her chest, neck, and under her chin. She says she took Benadryl, which puts her right to sleep, and she slept 12 hours. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1051381
Sex: F
Age:
State: CO

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fever; body aches; mild vertigo; The first dose was received on 02Dec2020 and the second dose was received on 16Jan2021; This is a spontaneous report from a contactable Other Health Professional reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration (left arm) from 16Jan2021 17:30 (05:30 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Keflex and sulfa from unspecified date. Patient is not pregnant. No other vaccine was given in four weeks. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. Concomitant medication included botulinum toxin type a (BOTOX), and ibuprofen (MOTRIN) from an unspecified date for an unspecified indication (medications in two weeks). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on 02Dec2020 07:45 AM, Left arm. The first dose was received on 02Dec2020 and the second dose was received on 16Jan2021. The patient experienced fever, body aches, mild vertigo on 17Jan2021 12:00. Treatment was not given. Outcome of the events was recovered in 2021. Information about lot/batch number has been requested.

Other Meds: BOTOX; MOTRIN [IBUPROFEN]

Current Illness:

ID: 1051382
Sex: F
Age:
State: NY

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: metallic taste in mouth; itchy throat that felt constricted; itchy throat that felt constricted; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142) intramuscular on the left arm on 30Dec2020 10:30 at a single dose for COVID-19 immunization. Medical history included pre-diabetes and known allergies: Penicillin. Concomitant medication included escitalopram oxalate (LEXAPRO). Immediately after the 1st dose on 30Dec2020, the patient experienced metallic taste in mouth followed by itchy throat that felt constricted. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. 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. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.

Other Meds: LEXAPRO

Current Illness:

ID: 1051383
Sex: F
Age:
State: NY

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: tongue numbness; weird taste; persistent allergies; itchy face; This is a spontaneous report from a contactable health care professional (patient). A 39-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8982, expiry date unknown), via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included pre-diabetes and allergies to penicillin both from an unknown date and unknown if ongoing. The patient concomitantly received cetirizine hydrochloride (ZYRTEC) as pre-medication and Lexi pro (as reported). The patient received the first dose of BNT162B2 (lot number: EL0142, expiry date unknown), intramuscular on 30Dec2020 at 10:30 AM on the left arm for COVID-19 immunization where the patient immediately after experienced metallic taste in mouth followed by itchy throat that felt constricted. Prior to vaccination, the patient has not had COVID-19. The patient has not been tested for COVID-19 post vaccination. The patient was premedicated with Zyrtec and 15 minutes after second dose had tongue numbness and weird tast on 20Jan2021 at 16:15 and itchy face started hours later and then continued with persistent allergies every day since the second dose until present was placed on oral steroid. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient received oral steroid and Benadryl as treatment for the events. The outcome of the events was recovering.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1051384
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Site swelling and high pain for 3 days; Site swelling and high pain for 3 days; Global Migraines; Irritated; This is a spontaneous report from a non-contactable nurse (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9262) via an unspecified route of administration on the left arm on 21Jan2021 22:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Dec2020 for COVID-19 immunization. On 22Jan2021 03:00 AM, the patient experienced site swelling and high pain for 3 days. Global Migraines that I have never hard before 2 days after vaccination and irritated. Events treatment included paracetamol (TYLENOL), cetirizine (ZYRTEC) and diphenhydramine (BENADRYL). Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1051385
Sex: F
Age:
State: MO

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

Lab Data: Test Date: 20210124; Test Name: Body temperature; Result Unstructured Data: Test Result:101; Comments: fever; Test Date: 20210125; Test Name: Body temperature; Result Unstructured Data: Test Result:100; Comments: fever

Allergies:

Symptoms: Soreness at injection site; sore throat; cough; fever for two nights (101 [unit unspecified]/100 [unit unspecified]); This is a spontaneous report from a contactable consumer (patient). An elderly non-pregnant female patient (reported as 65 [unit unspecified]) received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9263; expiration date: unknown) unknown age of vaccination via an unspecified route of administration left arm on 23Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included had covid-19 prior vaccination (if covid prior vaccination: yes). Concomitant medication includes unspecified medications. The patient did not received vaccination in four weeks. The patient received the vaccine in a hospital. On 24Jan2021 09:00 AM, the patient had soreness at injection site, sore throat, fever for two nights (101 [unit unspecified] on 24Jan2021 and 100 [unit unspecified] on 25Jan2021) and cough. The patient did not received treatment for the adverse events. The patient has not been covid tested post vaccination. The outcome of the event was recovering.

Other Meds:

Current Illness:

ID: 1051386
Sex: F
Age:
State: AR

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (09:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included anemia and allergies. Concomitant medications included an unspecified allergy shot. The patient was not pregnant at the time of vaccination. On 26Jan2021 (12:15), the patient had felt pains; lymph nodes had swelled; had pain on tongue; extreme dehydration; fatigue; and difficulty swallowing. The patient had received diphenhydramine (BENADRYL) as treatment for the events, and drank lots of water. The outcome of the events, 'felt pains', 'lymph nodes swelled', 'pain on tongue', 'extreme dehydration', 'fatigue' and 'difficulty swallowing', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1051387
Sex: M
Age:
State: VA

Vax Date: 01/13/2021
Onset Date: 01/15/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Rash and swelling in hands; Rash and swelling in hands; Blisters; This is a spontaneous report from a contactable healthcare professional (patient). An adult male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176; Expiration date was not reported) on 13Jan2021 (12:00) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient did not have relevant medical history and concomitant medications. On 15Jan2021, the patient had rash and swelling in hands; and blisters. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had received valacyclovir as treatment for the reported events. The outcome of the events, 'rash and swelling in hands' and 'blisters', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1051388
Sex: F
Age:
State: NC

Vax Date: 01/21/2021
Onset Date: 01/25/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: fever; Result Unstructured Data: Test Result:low grade

Allergies:

Symptoms: swollen neck lymph nodes five days after shot; My left arm was swollen; low grade fever; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1283), via an unspecified route of administration (left arm) on 21Jan2021 15:00 at SINGLE DOSE for covid-19 immunisation. Medical history included cholesterol (abnormal) from an unknown date. Patient is not pregnant. No other vaccines were given in four weeks. Patient did not have COVID prior vaccination and patient was not tested for COVID post vaccination. Concomitant medications (medications in two weeks) included pravastatin from unspecified date for cholesterol (abnormal); estrogens conjugated (PREMARIN), allopurinol (ELAVIL), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10), aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX) from an unspecified date for an unspecified indication. The patient experienced low grade fever on 25Jan2021 that went away but the following morning on 26Jan2021, the patient also experienced swollen neck lymph nodes five days (five days as reported) after shot. Patient stated she does not know if it was going away. Patient's left arm was also swollen on 26Jan2021. Left arm was described as swollen just little bit, not much but that's gone down. The patient stated there was no fever as of reporting, but the swollen lymph node was being reported and since she has been up, it's gone down considerably but she can just feel them a little bit on her neck. Treatment was not given. She mentioned she has a person coming to do a work at the house and wanted to know if it is okay if she still comes. She asked if she should be alarmed about the side effect. She mentioned she was just concerned about if she needs to be concerned about this or if she can be around people. She mentioned she wear masks anyways but just need to know if it is okay if people come into her home. Outcome of the events low grade fever and left arm was swollen was recovered on Jan2021, while unknown for swollen neck lymph nodes five days after shot.

Other Meds: PRAVASTATIN; PREMARIN; ELAVIL [ALLOPURINOL]; COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECA; B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FO

Current Illness:

ID: 1051389
Sex: F
Age:
State: NY

Vax Date: 01/04/2021
Onset Date: 01/01/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Date: 2021; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: joint pain; muscle ache; fatigue; This is a spontaneous report received from a contactable consumer. A 51-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration, on 04Jan2021 (lot number and expiry date unknown), at single dose; then received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration, on 25Jan2021 (lot number and expiry date unknown), at single dose, for COVID-19 immunization. Medical history included type 2 diabetes mellitus (reported as "t2dm"). The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccines in four weeks. The patient experienced joint pain, muscle ache and fatigue in Jan2021. Treatment for the events included APAP. The patient was tested for COVID-19 post vaccination in Jan2021 thru nasal swab with unknown results. The patient was recovering from the events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1051390
Sex: U
Age:
State: NJ

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Heart palpitations for three days after injection; Cold symptoms for three days after injection; This is a spontaneous report from a non-contactable consumer. A 26-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm on 08Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart palpitations and cold symptoms for three days after injection on 08Jan2021. No treatment was received for the events. The outcome of the event was recovered on an unspecified date. No follow up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1051391
Sex: F
Age:
State: OH

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Date: 20210121; Test Name: Nasal Swab (Rapid and PCR); Test Result: Negative

Allergies:

Symptoms: Hives that itched and burned on my head; Hives that itched and burned on my head; Hives that itched and burned on my head; Rash to my face; Body aches; weakness; fatigue and woozy feeling xs 4 days; fatigue and woozy feeling xs 4 days; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ1686) via an unspecified route of administration on the left arm on 20Jan2021 23:15 at a single dose for COVID-19 immunization. Medical history included Raynaud's, hypotension, known allergies: barley, oatmeal, pork, tomatoes. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient previously took doxycycline and experienced allergies. Benadryl prior to administration. On 20Jan2021 03:00 PM, the patient experienced hives that itched and burned on her head - still remain after 6 days but improved. Rash to her face, body aches, weakness, fatigue and woozy feeling for 4 days. Events treatment included diphenhydramine (BENADRYL). The facility where the vaccine was administered was in a nursing home/senior living facility. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID test post vaccination included Nasal Swab (Rapid and PCR) on 21Jan2021: negative. Outcome of the events was recovering.

Other Meds: BENADRYL

Current Illness:

ID: 1051392
Sex: M
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: Muscle aches; overnight chills; This is a spontaneous report from a non-contactable pharmacist. A 41-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient describes muscle aches and overnight chills after receiving the 2nd COVID19 vaccine injection on 25Jan2021. No treatment was received for the events. The outcome of the events was recovered in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1051393
Sex: F
Age:
State: WA

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today; pain and pressure in head through today; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 20Jan2021 07:45 AM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines weeks prior to receiving bnt162b2. The patient was not pregnant. Prior vaccination, the patient was not diagnosed with covid. Medical history included prone to headaches. She had no known allergies. Concomitant medications included clarithromycin (CLARITIN), dextroamphetamine [dexamfetamine], fish oil, and "Olly multivit". On 20Jan2021 02:00 PM, the patient experienced very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today, Day 6 after vaccine, and counting. No corrective treatment was received. Outcome of the events was not recovered. The patient was not tested for covid post vaccination. Information on the lot/batch number has been requested.

Other Meds: CLARITIN [CLARITHROMYCIN]; DEXTROAMPHETAMINE [DEXAMFETAMINE]; FISH OIL

Current Illness:

ID: 1051394
Sex: F
Age:
State: TN

Vax Date: 01/21/2021
Onset Date: 01/24/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: red rash over her torso including her back and lower stomach and a slight rash on her arms and legs; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318) in a Public Health Clinic, via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose on the left arm for COVID-19 immunization. Medical history included diabetes and high blood pressure both from an unknown date and unknown if ongoing. The patient had COVID-19 prior to vaccination on an unspecified date. The patient had no known allergies. The patient has not been tested for COVID-19 post vaccination. Concomitant medication included metformin hydrochloride, pioglitazone hydrochloride (ACTOPLUS MET), olmesartan medoxomil (BENICAR), loratadine (CLARITIN) and montelukast sodium (SINGULAIR). The patient had red rash over her torso including her back and lower stomach and a slight rash on her arms and legs on 24Jan2021 at 12:00. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient was administered a steroid shot by her primary physician as treatment for the event. The outcome of the event was not recovered.

Other Meds: ACTOPLUS MET; BENICAR; CLARITIN [LORATADINE]; SINGULAIR

Current Illness:

ID: 1051395
Sex: F
Age:
State: KY

Vax Date: 01/05/2021
Onset Date: 01/08/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Date: 20210111; Test Name: nasal swab for Covid; Test Result: Negative

Allergies:

Symptoms: chills; headache; sore throat; nausea; Loss of smell; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscularly on the right arm, on 05Jan2021 10:00, at single dose, for covid-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications included omeprazole; metoprolol; methocarbamol; vitamin d3; pregabalin; and levothyroxine. The patient did not have Covid prior vaccination. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. With the first shot the patient experienced chills, headache, sore throat, nausea and, loss of smell - all on 08Jan2021. These adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for these adverse events. At the time of the report, the patient was recovering from the events. The patient had a nasal swab for Covid on 11Jan2021 with results of negative.

Other Meds: OMEPRAZOLE; METOPROLOL; METHOCARBAMOL; VITAMIN D3; PREGABALIN; LEVOTHYROXINE

Current Illness:

ID: 1051396
Sex: M
Age:
State: FL

Vax Date: 01/09/2021
Onset Date: 01/11/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: synovitis bilateral hands; This is a spontaneous report from a contactable other health professional. A 65-year-old male 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 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had unspecified concomitant medications. 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 11Jan2021, the patient had synovitis bilateral hands. The patient received an unspecified steroids as treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered. No follow-up attempts are possible; Information about lot/batch could not be obtained.

Other Meds:

Current Illness:

ID: 1051397
Sex: M
Age:
State:

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

Lab Data: Test Date: 20210202; Test Name: Body temperature; Result Unstructured Data: Test Result:100; Comments: Low grade fever (100 degrees)

Allergies:

Symptoms: Low grade fever (100 degrees); Chills; aches; fatigue; This is a spontaneous report from a contactable consumer reported for himself. A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EL3248), on right arm via an unspecified route of administration on 01Feb2021 13:15 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2, (Lot no: EL3248) on 13Jan2021 01:15 pm for covid-19 immunisation. On 02Feb2021 12:00 AM patient experienced low grade fever (100 degrees), chills, aches and fatigue. Outcome of the events was recovered on unspecified date in 2021.

Other Meds:

Current Illness:

ID: 1051398
Sex: F
Age:
State: MA

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

Lab Data:

Allergies:

Symptoms: A slight fever on the day after injection.; Pain in left arm at injection site as well as soreness in left arm as a whole; Pain in left arm at injection site as well as soreness in left arm as a whole.; A Migraine on day of injection as well as the following day; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date unknown), via an unspecified route of administration on left arm on 01Feb2021, at 09:15 AM at the age of 24 years old at a single dose for Covid-19 immunization in the hospital. Patient was not pregnant at the time of vaccination. The patient's medical history included complex aphthosis. Concomitant medications included probiotics. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received probiotics within 2 weeks of vaccination. On 01Feb2021 at 11:00, the patient experienced pain in left arm at injection site as well as soreness in left arm as a whole. A Migraine on day of injection (01Feb201 at 11:00) as well as the following day. On 02Feb2021, on the day after injection a slight fever. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Feb2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1051399
Sex: F
Age:
State: PA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Name: COVID test; Test Result: Negative

Allergies:

Symptoms: Little shortness of breath; Dizzy; very tired; Chills; Stiff neck/ head and neck are very stiff; Felt crummy; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 21Jan2021 at a single dose on the left arm to be prevented from COVID 19. The patient's medical history included COVID from 04Dec2020 and after that, on unspecified date, COVID test was negative. Concomitant medication was reported as none. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 on the right arm at 28- years of age to be prevented from COVID 19. On 21Jan2021, the patient had what everyone was talking about, the chills and stiff neck, she felt crummy, muscle aches, thought it was the normal. The next day (22Jan2021), she had a little shortness of breath, she felt dizzy on and off and her head and neck are very stiff, and she is very tired. The outcome of the events stiff neck/ head and neck are very stiff, felt crummy, and dizzy was not recovered while the other events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1051400
Sex: M
Age:
State: MI

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 24 hours of flu like body aches; extreme tiredness; Sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date unknown), via an unspecified route of administration on left arm at the age of 56 years old on 02Feb2021 at 14:30 at a single dose for COVID-19 immunisation at workplace clinic. The patient's medical history was not reported. Allergies to medications, food, or other products was none. Concomitant medications included atorvastatin calcium (LIPITOR), hydrochlorothiazide, irbesartan (AVALIDE), famotidine and amlodipine besilate (NORVASC). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date unknown) on left arm on 12Jan2021 at 07:00 AM for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced sore shoulder, 24 hours of flu like body aches and extreme tiredness all on 02Feb2021 at 04:30 AM. The patient assessed the events as non-serious. No treatment was received in response to the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has recovered from flu like body aches on 03Feb2021 while the patient recovered from the sore shoulder and extreme tiredness on an unspecified date in Feb2021. The information on the Batch/Lot number has been requested.

Other Meds: LIPITOR [ATORVASTATIN CALCIUM]; AVALIDE; FAMOTIDINE; NORVASC

Current Illness:

ID: 1051401
Sex: M
Age:
State: MI

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

Lab Data:

Allergies:

Symptoms: Soreness at injection site; Following morning experienced headache and fatigue throughout day; Following morning experienced headache and fatigue throughout day; queasiness; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248, Expiry date: unknown) at 28 years of age via an unspecified route of administration on the right arm on 01Feb2021 at 09:15 am at a single dose for COVID-19 immunisation. Medical history and some surgeries were none. The patient has no allergies to medications, food, or other products. Concomitant medications included fluticasone propionate (50mcg) nasal spray and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took the first dose of BNT162B2 (lot number: EL3248, expiry date: unknown) on 12Jan2021 at 08:30 am on left arm for COVID-19 immunisation. The patient experienced soreness at injection site. Following morning experienced headache and fatigue throughout day. Some queasiness possibly related to vaccine. Following day, it was reported that the only remaining symptom is a slight headache. The events were assessed as non-serious by the reporter. 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. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events. The patient was recovering from the events.

Other Meds: FLUTICASONE PROPRIONATE; VITAM

Current Illness:

ID: 1051402
Sex: F
Age:
State: PA

Vax Date: 01/22/2021
Onset Date: 01/01/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she woke up and noticed everything was spinning; Dizzy; sore arm after the shot.; Swollen arm; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on his right arm, via an unspecified route of administration on 22Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included blood pressure high and surgery. There were no concomitant medications. Historical vaccine included a flu shot for flu immunization and experienced arm is sore and pain. The patient reported she got the COVID shot last Friday at 3pm. That night she woke up at 2am and everything was spinning. She is better now but not completely. If she lies down and gets up or turns her head a certain way, she gets dizzy. She had a swollen arm and sore arm after the shot. No treatment was received for the events. The outcome of the events swollen arm and sore arm was unknown while recovering for the other events.

Other Meds:

Current Illness: Blood pressure high

ID: 1051403
Sex: F
Age:
State: NC

Vax Date: 01/22/2021
Onset Date: 01/25/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she just does not feel good; Feeling like she is getting a cold; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283 and expiry date: 30Apr2021), via an unspecified route of administration on the right arm, on 22Jan2021 at 0.3 mL, single for COVID-19 immunization. There were no medical history and concomitant medications. Patient stated she was feeling like she was getting a cold. She clarified that she started feeling this way starting last night on 25Jan2021, and today on 26Jan2021, she just does not feel good. Outcome of the events was not recovered. The reporter considered the events non-serious.

Other Meds:

Current Illness:

ID: 1051404
Sex: F
Age:
State: NV

Vax Date: 12/19/2020
Onset Date: 12/29/2020
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Name: autoimmune disease; Test Result: Negative

Allergies:

Symptoms: dyspnea; rash; severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: Ek5760, via an unspecified route of administration in the right arm, on 19Dec2020 17:00 at SINGLE DOSE for covid-19 immunization. The patient's medical history included urticaria and folliculitis: patient was under successful treatment for urticaria and folliculitis with near resolution. Concomitant medication included cefalexin (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC) and triamcinolone. The patient received BNT162B2 on 19Dec2020. Then on 29Dec2020, 12:00, severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); experienced rash and dyspnea requiring steroids and epipen. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. The patient was recovering from all events. Treatment for the events included Prednisone course, epipen, and H2 blockers. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on the temporal relationship and known safety profile of BNT162B2, the reasonable possibility of an association between rash, dyspnea and suspect product cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: KEFLEX [CEFALEXIN]; CEFDINIR; ALLEGRA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TRIAMCINOLONE

Current Illness:

ID: 1051405
Sex: F
Age:
State: TX

Vax Date: 01/10/2021
Onset Date: 01/01/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: temperature; Result Unstructured Data: Test Result:100.5; Comments: degrees; Test Date: 202101; Test Name: temperature; Result Unstructured Data: Test Result:101; Comments: degrees; Test Date: 20210121; Test Name: flu test; Test Result: Negative ; Test Date: 202101; Test Name: pulse ox; Result Unstructured Data: Test Result:92; Test Date: 20210121; Test Name: Covid testing; Test Result: Positive

Allergies:

Symptoms: soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest level); tightness in chest (no productive cough); 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, solution for injection) via unspecified route of administration at the left arm on 10Jan2021 09:00 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital and not in a military facility. Medical history included asthma. Concomitant medications included albuterol [salbutamol] from unspecified date for unspecified indication. Historical vaccine included flu shot in Oct2020 for immunization and experienced some soreness in arm and achy. The patient was not given other vaccines given the same day or 4 weeks prior. In Jan2021, the patient had some soreness in arm and achiness (Jan2021) after the Pfizer BioNTech Covid-19 vaccine it didn't last long and she went to work afterwards. The patient was scheduled for work the next day and could tell something was not right. The patient was flushed and thought it was from the Albuterol since it can cause a racing heart beat and checked for a fever and didn't' have one. The patient checked temperature before bed and it was 100.5 degrees and she went straight to (redacted). The patient informed that she went for Covid testing; she went to physician office for Covid testing. The patient was praying for the flu so she could take Tamiflu and the flu test was negative (21Jan2021) and the Covid testing was positive (21Jan2021). The patient was tested positive after first Covid vaccine and ran fever 8 to 9 days and highest temperature was 101 degrees, had a little bit of asthma and kept a close watch, congestion, pulse ox 92 (lowest level), tightness in chest (no productive cough), felt beat up, fatigued and tiredness. The patient was diagnosed with Covid-19. She was told as well not to take pain relievers (ibuprofen, Advil and Aleve) and was advised to take Tylenol instead. The patient informed that she was to get her second dose tomorrow. The patient wanted to know if she can get the second dose if she was tested positive. The patient was supposedly scheduled to have the second dose on 27Jan2021 however it was moved to 04Feb2021 due to tested positive of Covid and was put on quarantined. The outcome of the events was recovering. The patient was unable to provide seriousness criteria when queried and said that this was her luck of the draw. The patient thought the shot actually helped.

Other Meds: ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1051406
Sex: F
Age:
State: WI

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Got nervous feeling; Allergic reaction to bee sting; rash of heat from her neck up to her head; noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow/still having the swallowing; Congested head, head felt congested, not like pressure; Fingertips a little numb and tingling; Fingertips a little numb and tingling; This is a spontaneous report from a contactable consumers (one is the patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269), via an unspecified route of administration on 03Feb2021 at 10:40 at a single dose on the right arm for COVID-19 immunization, ibuprofen (manufactured by other company, strength: 200 mg, lot number: 7AE1784B, expiry date: Nov2018), oral from an unspecified date and ongoing at 400 mg, as needed for an unspecified indication, hydrochlorothiazide (strength: 25 mg), oral from an unspecified date and ongoing at 25 mg, once a day (about 8am) for high blood pressure, and valsartan (strength: 160 mg, expiration date: 11Nov2021), oral from an unspecified date and ongoing at 160 mg, once a day (about 8am) for high blood pressure. Medical history included ongoing high blood pressure. The patient's concomitant medications were not reported. The patient previously took flu shot about 15-20 years ago for immunization and experienced swelling. On 03Feb2021, patient received the vaccine. When going home, she noticed all of a sudden a rash of heat from her neck up to her head. Figured it was not a problem to have a little reaction and thought nothing of it. She had a cup of coffee this morning and not a lot of water, so she started drinking water and had 3 bottles. After the heat passed she noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow. She is still having the swallowing and is continuing to drink water even at home. She also congested head, head felt congested, but not like pressure. She does not get headaches so she guesses she is getting this instead of a headache. She noticed her fingertips feel a little numb and tingling, but overall feels okay. She mentioned that on an unspecified date, she just got this nervous feeling and had allergic reaction to bee sting. Mentioned that her husband and brother in law got the shot and were feeling fine. No further details provided. The action taken in response to the events for ibuprofen was dose not changed , for hydrochlorothiazide was dose not changed, and for valsartan was dose not changed. The outcome of the event rash of heat from her neck up to her head was recovering; event got nervous feeling was unknown, while the other events was not recovered.

Other Meds: HYDROCHLOROTHIAZIDE; HYDROCHLOROTHIAZIDE; IBUPROFEN

Current Illness: Blood pressure high

ID: 1051407
Sex: F
Age:
State: HI

Vax Date: 01/30/2021
Onset Date: 02/01/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: terrible headache/Her head was pounding; fatigue; injection site soreness; soreness; Her head was pounding, and she was having a hard time concentrating; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable female consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took sumatriptan succinate for migraine. She had the first shot of the Pfizer covid vaccine on Saturday since then, she's had soreness. She of course had injection site soreness and fatigue 48 hours after the shot. Today (01Feb2021) she also has a terrible, terrible headache. She was asking if she can take her previous migraine medication called Sumatriptan Succinate tablet. Her head was pounding, and she was having a hard time concentrating. The outcome of events was unknown. Follow-up attempts are completed. The following information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 1051408
Sex: M
Age:
State: CT

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Name: Blood sugar; Result Unstructured Data: Test Result:Fine; Test Date: 20210129; Test Name: blood pressure; Result Unstructured Data: Test Result:130/76; Test Name: Blood work; Result Unstructured Data: Test Result:Fine; Test Name: Temperature; Result Unstructured Data: Test Result:97.6; Test Name: pulse; Result Unstructured Data: Test Result:Fine; Test Name: labs; Result Unstructured Data: Test Result:always off, but normal; Comments: for having Multiple Myeloma

Allergies:

Symptoms: rash worsened; compromised immune system with the Multiple Myeloma/ getting the COVID-19 Vaccine; compromised immune system with the Multiple Myeloma/ getting the COVID-19 Vaccine; This is a spontaneous report from a contactable nurse for her husband. A 79-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration at left arm on 26Jan2021 06:00 at single dose for covid-19 immunisation. Medical history included plasma cell myeloma from Oct2018, a compromised immune system with the Multiple Myeloma, rash from Dec2020 and ongoing. The patient had a diagnosis of multiple myeloma and had developed a slight rash on his left arm to lenalidomide (REVLIMID) before receiving the COVID vaccine, Benadryl was taken and after 3 days, it was gone. It was only on his upper arms. She said a rash was a known side effect of the lenalidomide. The nurse giving his vaccine shot noticed his slight rash on his left arm. Concomitant medication included lenalidomide (REVLIMID) for 2.5 years for multiple myeloma in remission. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The past drug included bortezomib (VELCADE), the patient was administered a chemo agent (bortezomib) at the oncology center every 2 weeks and the oncology center held off giving his chemo shot 2 weeks before he received his first COVID-19 Vaccine on 26Jan2021. The reporter said her husband would not restart the chemo shot until he sees his oncologist again. She clarified her husband has now been off the bortezomib for a month, as of 01Feb2021. The patient experienced rash worsened on 28Jan2021. By 28Jan2021 the rash had spread to his trunk and by 29Jan2021 to his back. She clarified his rash was a dry rash, with no blisters or oozing. Her first thought was to get an ointment or a spray. He has now been given prednisone instead of a dose pack and the rash was gone/ the rash cleared up almost immediately and will stop lenalidomide for a couple weeks and continue the round of prednisone. The doctor could alter his therapy as needed. On 04Feb2021, the rash was gone but her husband's doctor wants him to finish his prescribed course of Prednisone. She clarified the Prednisone (manufacturer: Actavis) 40 mg was started on 01Feb2021, the rash started fading fast. By the next day (Tuesday, 02Feb2021) the rash was really fading, and now (04Feb2021) the rash was totally not there. The doctor told her husband to take one Benadryl, and to continue taking the Benadryl if his rash itches. She said her husband's latest blood work didn't indicate anything. She said her husband's labs were always off, but were normal for having Multiple Myeloma. Both doctors want to keep her husband off of the lenalidomide. Reporter seriousness was reported as medically significant . The patient was treated for Multiple Myeloma for the past 2-1/2 years. He had been doing well, and his cancer doctors approved of him getting the COVID-19 Vaccine. The oncologist wanted her to call Pfizer to see if she can find anything about the COVID-19 Vaccine and how it pertains to the lenalidomide and her husband's Multiple Myeloma. She said her husband was almost 80 years old and very active. She said her husband had been in remission Multiple Myeloma for a year and his blood work was fine. By the time her husband starts taking lenalidomide again, he would be off of lenalidomide for almost 4 weeks. She said her husband's oncologist said he was going to cut back her husband's lenalidomide milligram dose and change his lenalidomide frequency to every other day when he resumes the lenalidomide. The reporter checked her husband's blood pressure (130/76) on 29Jan2021, after his rash worsened. She saidnot require a visit to emergency room or physician office. The rash event outcome his pulse was fine, and she tested his blood sugar and it was fine. She said he had no temperature, clarifying his temperature was 97.6. The event did was recovering. The drug result was reported as unrelated. The reporter and her husband's doctors don't think his rash has anything to do with the COVID-19 Vaccine. The patient asked if Pfizer can point her in any direction with regard to her husband's situation. She said she read the COVID-19 Vaccine is a dead virus, but wants to know if her husband should be cautious in getting the second COVID-19 Vaccine dose. She said her husband's doctors know that the rash was not precipitated by the COVID-19 Vaccine, but his rash did get worse after he got the first COVID-19 Vaccine dose. His second dose was due 16Feb2021. The reporter was wondering if she should delay the second dose of the vaccine, the vaccine would make the rash worse.; Sender's Comments: Based on the information currently provided, the rash worsened after 2 days following the vaccine use thus a contributory role of BNT162B2 might not be fully excluded towards the event onset. Severe allergic reaction is the known risk for the product and Rash faded soon under Prednisone. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate

Other Meds: REVLIMID

Current Illness: Rash

ID: 1051409
Sex: F
Age:
State: PA

Vax Date: 07/28/2015
Onset Date: 07/29/2015
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: her arm was red; arm swelling; arm warm; he put her on antibiotics just in case because her arm was warm; allergic reaction; she broke out with a rash a little the next day after the vaccination; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received pneumococcal 13-valent conjugate vacccine (dipht crm197 protein) (PREVNAR 13 Solution for injection in pre-filled syringe, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 28Jul2015 14:00, at single dose, for immunization, at the physician's office. There were no medical history, family history and concomitant medications. The patient did not receive other vaccines within 4 weeks. On 29Jul2015, next day after the vaccination, the patient broke out with rash which faded in a few days. Then the rash came back on 03Aug2015. The patient went to the doctor because her rash came back. The patient reported that she had an allergic reaction, nothing serious only rash and on 03Aug2015, her arm was red, warm and swelling. The patient went to the doctor because her rash came back, and her doctor put her on antibiotics just in case because her arm was warm. The events all went away in a few days. The patient reported there was no hospitalization, she only visited the doctor. The outcome of the events was resolved on an unspecified date in 2015. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1051410
Sex: F
Age:
State: NC

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: uncomfortable all night; itching; hives all over my body/developed giant hives all over her body/the giant hives were like fire ant bites/developed little hives on the inside of her arms, behind her knees, and on the tops of her feet; This is a spontaneous report from a contactable health care professional nurse, the patient. A 74-years-old female patient (retired nurse) received the first dose of bnt162b2 (BNT162B2, Lot Number EL9262) , via an unspecified route of administration in the right deltoid on 29Jan2021 at 11:00 (at 74 years of age) as a Single dose for Covid-19 Vaccination. The Vaccination Facility was 'movie theater'. No other vaccines were given within 4 weeks. Medical history included hypertension from 2020 ( doctor considered taking her off of blood pressure medicine because her blood pressure is very normal now), Prediabetes (diagnosed with Prediabetes about 3 years ago) and Allergic reaction to bee sting (numerous yellow jacket stings throat felt like it was starting to close, and tongue felt funny. Went to ER and Treated with Zantac and Epinephrine) and lost 55 lbs. (borderline high blood pressure was related to her weight). Concomitant medication included ongoing generic losartan (LOSARTAN) 50 mg, 1x/day for borderline high blood pressure, metformin (METFORMIN) 500 mg, 1x/day for glucose tolerance impaired. On 29Jan2021at 5 PM the patient started having some itching 'felt like she had a mosquito bite but on further investigation she noticed "giant hives all over my body'. She said she took some Benadryl Lot Number: P119923 Expiration Date: Apr2023 and 1 expired Zantac (Lot Number: NL4604, Expiration Date: Nov2019) on 29Jan2021 to help treat giant hives and itching. The giant hives 'kind of subsided' after she took the Benadryl and the Zantac, though she did remain itchy and uncomfortable all night. She said by the morning (30Jan2021) the giant hives were gone. She said that evening (30Jan2021) the giant hives came back again, and the giant hives were all over her body. She said the giant hives were like fire ant bites, she said the giant hives were just awful. She said she had a previously scheduled appointment with her doctor on Monday, 01Feb2021 (prior to developing the giant hives after her first COVID-19 Vaccine dose) but probably would have gone to see her doctor anyway, if she didn't have a prior appointment. She said she had taken pictures of her giant hives, her doctor believes the giant hives she experienced was a reaction the COVID-19 Vaccine's preservatives. She said her doctor still wants her to get the second COVID-19 Vaccine dose. Consumer stated Reported her giant hives were gone by Monday morning (01Feb2021), when she woke up. She stated during Monday (01Feb2021) into Tuesday (02Feb2021) she developed little hives on the inside of her arms, behind her knees, and on the tops of her feet. She said she has a residual itching that is lingering, but not continual. She said she has been taking one generic Zyrtec 10mg tablet per day, Lot Number: NL4604, Expiration Date: Nov2019. The events Hives and Itching was medically significant and uncomfortable was non serious. Treatment was given for itching and hives. Her doctor still wants her to get the second COVID-19 Vaccine dose. Patient second COVID-19 Vaccine dose is scheduled for 19Feb2021. The patient reported her doctor told her it would be a good idea for her to take one Zyrtec, each day, for 3 days before her next COVID-19 Vaccine dose. She said her doctor told her to pre-medicate with Benadryl on the day of her second COVID-19 Vaccine dose. The clinical outcome of Pruritus was recovering while Hives was recovered on 02Feb2021 and the outcome of uncomfortable was unknown. The events Giant hive, hives and itching were considered related to the suspect product.

Other Meds: LOSARTAN; METFORMIN

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm