VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 0929046
Sex: M
Age:
State: CA

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: he dust that landed on his face caused hives; feeling flushed; started feeling itchy about 2 hours post vaccine; This is a spontaneous report from a contactable nurse. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, intramuscular from 23Dec2020 11:00 at a single dose for COVID-19 immunization. Medical history included patient's known allergies: Only grass, pollen, dust mites; and hives all from unspecified dates. Concomitant medication included naproxen sodium (ALEVE) for " itchy", ibuprofen (MOTRIN) and paracetamol (TYLENOL 8 HOUR). The patient got the COVID vaccine on 23Dec2020 at 11:00. He stayed at vaccination location for 30 minutes and then drove to his destination. Upon arrival at 12:00, he started feeling flushed. No shortness of breath or breathing difficulties. He then started feeling itchy about 2 hours post vaccine. He took an Aleve. At home in the evening, took Benadryl with improvement of symptoms. The following day he also took Benadryl. On 25Dec2020 & 26Dec2020, he still had some itching, but not bothersome enough to take medications. On 27Dec2020 he was working cutting tile and wearing protective eye wear, but the dust that landed on his face caused hives. He has been taking Benadryl since. He said that this has occurred in the past when his body was hypersensitive, the hives. He has seasonal allergies but no allergies to food/medications/vaccines. Patient was not diagnosed with COVID-19 and since the vaccination, he has not been tested for COVID-19.

Other Meds: ALEVE; MOTRIN [IBUPROFEN]; TYLENOL 8 HOUR

Current Illness:

ID: 0929047
Sex: M
Age:
State: CA

Vax Date: 12/17/2020
Onset Date: 12/20/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: pain in the right maxillary sinus, and upper right molars; pain in the right maxillary sinus, and upper right molars; right fronto-parietal scalp tenderness; numbness of right canines; possible sinus infection; headache; This is a spontaneous report from a contactable physician (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730) , intramuscular into the left arm on 17Dec2020,at 17:00 as first single dose for covid-19 immunization. Medical history included known allergy to dairy from an unknown date. There were no concomitant medications. The patient experienced pain in the right maxillary sinus, and upper right molars on 20Dec2020, at 06:00 with outcome of recovering; right fronto-parietal scalp tenderness on 20Dec2020, at 06:00 with outcome of recovering; numbness of right canines on 20Dec2020, at 06:00 with outcome of recovering; possible sinus infection on 20Dec2020, at 06:00 with outcome of recovering; headache on 20Dec2020, at 06:00 with outcome of recovering. Details were as follows: described as possible trigeminal neuralgia, awoke on 20Dec2020, and noted right eye appeared smaller than the left. Also noted, was pain in the right maxillary sinus, and upper right molars. The patient was afebrile. On 21Dec2020, noted onset of right fronto-parietal scalp tenderness along with numbness of right canines. Patient did not have any skin lesions. Therapeutic measures were taken as a result of the events; began azithromycin and sinus rinse for a possible sinus. Despite treatment, right scalp pain/tenderness, tooth pain numbness of canines persisted and peaked on 26Dec2020. Symptoms subsided but were still present. Acetylsalicylic acid (ASPIRIN) for headache infection was given with improvement. Symptoms appear to be in the right trigeminal dermatome. Patient had never had chicken pox and had been vaccinated. For varicella, the patient did not have a rash in the affected dermatome; valacyclovir (MANUFACTURER UNKNOWN), has been started. The events were reported as non-serious. The patient was recovering from the events.

Other Meds:

Current Illness:

ID: 0929048
Sex: M
Age:
State: CA

Vax Date: 12/18/2020
Onset Date: 12/25/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201225; Test Name: Covid-19 test; Test Result: Positive

Allergies:

Symptoms: infection of SARS-COV-2; infection of SARS-COV-2; This is a spontaneous report from a contactable healthcare professional. A 31-year-old male patient started to receive received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0140), intramuscular into the left arm on 18Dec2020, at 10:30 as single dose for covid-19 immunization. There was no medical history and no concomitant medications. The patient experienced infection of SARS-COV-2 on 25Dec2020. Details were as follows: The patient received the first dose of the two dose series. On 20Dec2020, he was exposed to COVID-19. Official positive diagnosis of COVID-19 was made on 25Dec2020. Patient had symptoms of fatigue, joint pain and a small fever on an unspecified date, and had been exposed to SARS-COV-2 on 20Dec2020, and the infection on 25Dec2020. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on 25Dec2020. The patient was scheduled to receive second dose of the vaccine; he will be out of quarantine around five to six days before that dose. The outcome of infection of SARS-COV-2 was recovering.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.

Other Meds:

Current Illness:

ID: 0929049
Sex: F
Age:
State: WA

Vax Date: 12/21/2020
Onset Date:
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201225; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative

Allergies:

Symptoms: Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; This is a spontaneous report from a contactable Health Care Professional (patient). A 63-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK572) in the left arm, on 21Dec2020 at 11:30 AM, at single dose, for COVID-19 immunisation. COVID-19 vaccine was administered at hospital. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks and 2 weeks prior to the BNT162B2 vaccine. The patient experienced in the past an allergy due to amoxicillin. On an unspecified date, the patient experienced hives from her head to her toes, intense itching, painful, swollen ears, swollen lip. Emergency room/department or urgent care required. Treatment was received: prednisone 60 mg for 5 days. The patient recovered from the events on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid test post vaccination (nasal swab) was performed on 25Dec2020 and the result was negative. The case was assessed as non-serious.

Other Meds:

Current Illness:

ID: 0929050
Sex: F
Age:
State: NJ

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

Lab Data: Test Name: antigen test; Test Result: Positive

Allergies:

Symptoms: recipient of the covid 19 vaccine received a positive antigen test within 10 days of getting the vaccine; recipient of the covid 19 vaccine received a positive antigen test within 10 days of getting the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the second of 2 reports. A female patient of an unspecified age (Age: 30, Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received a positive antigen test within 10 days of the vaccine and wanted to know if the vaccine could cause a positive antigen test. There was no mention of exposure to a positive person. Outcome of the events was unknown. Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 antigen test positive and LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020519946 same reporter, drug, and events; different patients

Other Meds:

Current Illness:

ID: 0929051
Sex: F
Age:
State: CA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: left sided mild case of trigeminal neuritis that persisted beyond 48 hrs after vaccination given (symptom-numbness); headache; gritty/sandy sensation in mouth; borderline intermittent scratchy/sore throat, gritty/sandy sensation in mouth; borderline intermittent scratchy/sore throat; lost taste; burning/tingling on tongue; burning/tingling on tongue; This is a spontaneous report from a contactable physician, the patient. A 38-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK5730), intramuscular in the left arm on 28Dec2020 at 12:30 (at the age of 38-years-old) as a single dose for Covid-19 vaccination. edical history included trigeminal neuritis in the past twice, first from herpes simplex virus (HSV1) and second from flu shot a few years ago; acne and recurrent oral HSV 1, all from an unknown date and unknown if ongoing. The patient was allergic to sulfa. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications included drospirenone, ethinylestradiol (LORYNA) for OCP; prednisone (MANUFACTURER UNKNOWN), short course completed prior to vaccination; beclometasone dipropionate (QNASL); xylometazonline hychrochloride (SUDAFED) which was stopped before vaccination; valaciclovir hydrochloride (VALTREX); ascorbic acid (VITAMIN C) which was stopped before vaccination and multivitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020 at 12:45, the patient experienced left sided mild case of trigeminal neuritis that persisted beyond 48 hours with symptoms of numbness with decreased sensation on lateral part of V2 trigeminal nerve which started 10-15 mins after vaccination with small spot corner of mouth on left and involved lateral part of entire left side of face from corner of left eye down within 1-2 hours after received vaccine. The patient also experienced headache, borderline intermittent scratchy/sore throat, gritty/sandy sensation in mouth, at 12-14 hours after getting vaccine on 28Dec2020; got burning/tingling on tongue and then lost taste 100% for about 1 hour then started to slightly come back-and waxed and waned until later that evening and most was back to normal except sweet taste still gone. The events resulted in a doctor or other healthcare professional office visit. Therapeutic measures were taken for all of the events which included antihistamines and valaciclovir; and for the trigeminal neuritis only, methylprednisolone pack. The clinical outcome of the event trigeminal neuritis was recovering (lasted longer than 48 hours after vaccination); for headache, stomatitis, throat irritation, oropharyngeal pain, ageusia, tongue discomfort and paraesthesia oral was recovered (at 48 hours after vaccination).

Other Meds: LORYNA; ; QNASL; SUDAFED; VALTREX; VITAMIN C

Current Illness:

ID: 0929052
Sex: F
Age:
State: WA

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; This is a spontaneous report from a contactable nurse. A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number= ELO140, via an unspecified route of administration, in the right arm, on 31Dec2020 at 13:45 (at the age of 28 years-old) as a single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included polycystic ovarian syndrome. There were no concomitant medications. The patient had not received other vaccines in 4 weeks nor taken any other medications in 2 weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. On 01Jan2021 at 0700 the patient experienced hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The clinical course was as follows: Sudden development of hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The vision blurring and hot flashes resolved within 15-20 minutes but the fatigue, headache and nausea persisted throughout the day. The patient was not hospitalized for the event nor was treatment administered. The clinical outcome of the hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0929053
Sex: F
Age:
State: CA

Vax Date: 12/18/2020
Onset Date: 12/25/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, claritin, and loratidine; Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, claritin, and loratidine; This is a spontaneous report from a contactable nurse. A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in right arm, on 18Dec2020 at 09:00 ( at the age of 40 years-old) as a single dose for COVID-19 immunization. The patient was administered the vaccine at a hospital. Medical history was not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were also no other medications taken in the last two weeks. On approximately 25Dec2020 (reported as one week after vaccination on 18Dec2020), the patient experienced hives and itchy rash. The patient was not hospitalized for the events but received treatment with diphenhydramine (BENADRYL), loratadine (CLARITIN) and generic loratadine. clinical outcome of hives and itchy rash was not recovered: the patient reported that the hives and itchy rash continued despite multiple doses of BENADRYL, CLARITIN, and loratadine. Since the vaccination, the patient has not been tested for COVID-19. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0929054
Sex: F
Age:
State: TN

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201231; Test Name: fevers; Result Unstructured Data: Test Result:102.8

Allergies:

Symptoms: dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; cold-clammy skin; headache; exhaustion; nausea; Redness and swelling at injection site that is still getting more severe after 48 hours; Redness and swelling at injection site that is still getting more severe after 48 hours; This is a spontaneous report from a contactable nurse reporting for self. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899, intramuscularly from 30Dec2020 13:00 (age at vaccination: 54 years old) at single dose in left arm (dose 1) for COVID-19 immunization. There was no other vaccine administered in the 4 weeks prior to COVID vaccination. The patient was not pregnant. Medical history included hypertension, arthritis, degenerative disc, CRPS/RSD, thyroid cancer, thyroidectomy during 2007, and Crohn's disease. Known allergiesincluded insect stings and environmental allergies. The patient had COVID prior to vaccination. Concomitant medication included thyroid (THYROID); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN); hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ); meloxicam (MOBIC); vitamin D; alpha lipoic acid (ALPHA LIPOIC ACID); duloxetine hydrochloride (CYMBALTA); and pantoprazole sodium sesquihydrate (PROTONIX). Within 24 hours of receiving COVID vaccine, the patient experienced dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, and nausea, from 31Dec2020 at 08:00. These continued to worsen over the next 24 hours. Redness and swelling at injection site that was still getting more severe after 48 hours. The patient was unable to drive home from work the day after injection due to adverse reactions getting worse throughout the day. The patient self-treated at home with medications (not further specified). The outcome of the events dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, nausea, and redness and swelling at injection site were not recovered. The events were reported as non-serious. The patient was not COVID-tested post-vaccination.

Other Meds: ; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYR; LISINOPRIL HCTZ; MOBIC; VITAMIN D [VITAMIN D NOS]; ALPHA LIPOIC ACID; CYMBALTA; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]

Current Illness:

ID: 0929055
Sex: F
Age:
State: MI

Vax Date: 12/26/2020
Onset Date: 12/26/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: neuropathy/ started acutely in feet bilaterally / persist intermittently in left extremities; One-time episode of upper extremity (UE) numbness; This is a spontaneous report from a contactable health care professional (patient). A 40-year-old female patient (not pregnant) received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot unknown) at single dose via an unknown route at left arm on 26Dec2020 for Covid-19 immunization. COVID-19 vaccine was administered in Pharmacy or Drug Store. Medical history was reported as "none". Patient had no COVID prior vaccination, further reported as patient was not diagnosed with COVID-19 prior to vaccination. No known medications, food, or other products allergies. Concomitant drugs (Other-medications-in-two weeks) included levocabastine hydrochloride (ZYRTEC), diphenhydramine hydrochloride (BENADRYL) as needed, ibuprofen (MOTRIN), and multivitamin. No other-vaccine-in-four weeks received. Patient experienced adverse-event of neuropathy, which started acutely in feet bilaterally and now (as of 02Jan2021) persist intermittently in left extremities (LEs). One-time episode of upper extremity (UE) numbness. No weakness. Patient inquired if 2nd dose should be held. Adverse-event-start-date was 26Dec2020. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment received. The event was reported as non-serious. Since the vaccination, patient had not been tested for COVID-19. Outcome of the event was not resolved. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of peripheral neuropathy and upper extremity (UE) numbness due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and nerve conduction tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]; BENADRYL; MOTRIN [IBUPROFEN]

Current Illness:

ID: 0929056
Sex: F
Age:
State: CA

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Right supraclavicular lymphadenopathy; This is a spontaneous report from a contactable physician reporting for herself. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284/expiration date: not provided), via intramuscular route of administration in the right arm, on 30-DEC-2020 at 11:30 AM (at the age of 29 years old) as a single dose for COVID-19 vaccination. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced right supraclavicular lymphadenopathy - five freely mobile lymph nodes, tender to palpation, roughly 1 cm in size. The patient did not receive treatment for the event right supraclavicular lymphadenopathy. The outcome of the event right supraclavicular lymphadenopathy was not recovered. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0929057
Sex: M
Age:
State: CA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Became extremely flushed; tingling in hands and feet; disorientation; This is a spontaneous report from a non-contactable nurse (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0140/expiration date unknown), via intramuscular route of administration, on 28Dec2020 (at the age of 34 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included Gastrooesophageal reflux disease (GERD), Attention deficit hyperactivity disorder (ADD), Generalised anxiety disorder (GAD). The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included esomeprazole sodium (NEXIUM), venlafaxine hydrochloride (EFFEXOR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, at 09:00 PM, the patient became extremely flushed, tingling in hands and feet, disorientation. Treatment was received for the events became extremely flushed, tingling in hands and feet, disorientation included Diphenhydramine 50mg @2200 and again at 0200. The outcome of the events became extremely flushed, tingling in hands and feet, disorientation was recovered on unknown date. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of extremely flushed, tingling in hands and feet and disorientation due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chemistry panel and Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: NEXIUM [ESOMEPRAZOLE SODIUM]; EFFEXOR; ADDERALL

Current Illness:

ID: 0929058
Sex: F
Age:
State: NY

Vax Date: 12/19/2020
Onset Date: 12/23/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201225; Test Name: ct of my chest; Test Result: Negative ; Test Date: 20201225; Test Name: influenza type A/b combo; Test Result: Negative ; Test Date: 20201225; Test Name: influenza type A/b combo; Test Result: Negative ; Test Date: 20201225; Test Name: Covid 19; Test Result: Negative ; Test Date: 20201225; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Around 10:30pm I felt like my throat was closing and I was choking; Around 10:30pm I felt like my throat was closing and I was choking; I had chest pain, chest tightness; I had chest pain, chest tightness; Very SOB at rest; Throughout the day I was cough and my face started flushing so I tool Benadryl/severe facial flushing; On 23Dec I got nerve blocks for my migraines.; Throughout the day I was cough and my face started flushing so I tool Benadryl.; This is a spontaneous report from a contactable nurse who reported for herself. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730) dose number 1, via an unspecified route of administration on 19Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included von willebrand's disease, narcolepsy with cataplexy, IIH (Idiopathic intracranial hypertension), HTN (hypertension), GERD (gastrooesophageal reflux disease), migraines. Patient also had known allergies: PCN (penicillin), shellfish, IV contrast, cefdinir and bees. On 23Dec2020, patient got nerve blocks for her migraines. Throughout the day patient was cough and her face started flushing so she tooled diphenhydramine hydrochloride (BENADRYL). Around 22:30, patient felt like her throat was closing and she was choking. She had chest pain, chest tightness. EMS (emergency medical services) was called and patient was brought to the hospital. On 25Dec2020, patient felt like her throat was closing, like someone was sitting on her chest and chest tightness still with chest pain. Very SOB (shortness of breath) at rest. Patient went to the ER (emergency room) and received IV dexamethasone (DECADRON) and diphenhydramine hydrochloride. On 26Dec2020, patient had the same symptoms but with severe facial flushing and patient went back to the ER and was given IV dexamethasone. Patient was sent home on a maximum amount of medications. I had seen her primary care, ENT (ear nose throat centre), Allergy, ID (infectious disease), and pulmonology. Her CT (computerised tomogram) of chest on 25Dec2020 was negative along with her COVID test. Patient SOB on rest and exertion still. Onset date of the adverse events was reported as 23Dec2020, 22:30. Patient received treatment for the events included multiple medications and high dose prednisone. Lab data on 25Dec2020 included CT of chest: negative, influenza type A/B combo: negative, Covid 19: negative and nasal swab: negative. Action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. The clinical presentation of the events is suggestive of possible allergic reactions. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0929059
Sex: F
Age:
State: MA

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20210102; Test Name: Nasal Swab; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptoms: raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; baseball size red warm to touch welt; baseball size red warm to touch welt; temp; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; This is a spontaneous report from a contactable nurse, , the patient. A 31 -year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot_number: unknown), via an unspecified route of administration on 29Dec2020 at 11:30 AM, (at the age of 31 years-old) for COVID-19 vaccination. Medical history included Crohn's. The patient was allergic to adalimumab (HUMIRA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020 at 08:00 PM, the patient had a baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills. On 30Dec2020 (reported as day 2), the patient experienced headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The patient was not treated for baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The clinical outcome of baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site was recovering. It was also reported that since the vaccination, the patient was been tested for COVID-19 (nasal swab) on 02Jan2021. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.

Other Meds:

Current Illness:

ID: 0929060
Sex: F
Age:
State: GA

Vax Date: 12/29/2020
Onset Date: 01/02/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; This is a spontaneous report from a contactable consumer, the patient. A 68 -year-old elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration in the left arm on 29Dec2020 at 02:30 PM, (at the age of 68 -years-old) as a single dose, dose number=1 for COVID-19 vaccination. Medical history included hypothyroidism and osteopenia. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxin and citalopram within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 02Jan2021, the patient woke up with a red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea. The patient was treated for red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea with diphenhydramine (BENADRYL) 50 mg x 1. The clinical outcome of red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: LEVOTHYROXIN;

Current Illness:

ID: 0929061
Sex: F
Age:
State:

Vax Date: 12/24/2020
Onset Date: 01/01/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20210101; Test Name: Covid; Result Unstructured Data: Test Result:positive

Allergies:

Symptoms: I tested positive for COVID today; I tested positive for COVID today; This is a spontaneous report from a contactable other Health Care Professional (HCP). A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown) via an unspecified route of administration on 24Dec2020 (at an unknown age) at an unknown dose for COVID-19 vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for COVID on 01Jan2021. The patient was inquiring as to if she can still get the second dose since she has tested positive in between. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 01Jan2021. The clinical outcome of COVID-19 virus test positive was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0929062
Sex: F
Age:
State: PA

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201231; Test Name: EKG; Result Unstructured Data: Test Result:Unknown results; Comments: placed on a monitor / EKG was obtained.; Test Date: 20201231; Test Name: Heart rate; Result Unstructured Data: Test Result:110-120; Comments: My heart rate became elevated 110-120; Test Date: 20201231; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative; Test Date: 202012; Test Name: Body vitals; Result Unstructured Data: Test Result:Normal; Comments: all my vitals were within normal limits

Allergies:

Symptoms: 48 hours after the vaccine , I awoke from a sleep with chills; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; I still felt a little weak in my legs; This is a spontaneous report from a contactable nurses. A 56-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EK9231, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at 13:00 at single dose at right arm for COVID-19 immunization. Medical history included hypertension, cholesterol (abnormal) and hypothyroid which were well managed. The patient was not pregnant at the time of vaccination and had no allergies to medications, food or other products. Concomitant medications were not reported. On 31Dec2020 at 13:30, approximately 5-10 minutes after receiving the Pfizer covid-19 vaccine, patient's heart rate became elevated at 110-120, chest was irritated, head felt full and started to cough. Patient was taken to the emergency room (ER) and was placed on a monitor/EKG was obtained. Patient was released to home that same day, however she still felt a little weak in her legs. It was reported that 48 hours after the vaccine, the patient awoke from a sleep with chills, all her vitals were within normal limits, but the dry cough had returned. The patient was treated with fluids, vitals, EKG closely monitored and rapid cov (as reported). The events resulted to a doctor or healthcare professional office/ clinic visit. The patient was vaccinated at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and there were other medications the patient received within 2 weeks of vaccination. The patient underwent lab tests and procedures which included a nasal swab was negative on 31Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was unknown.

Other Meds:

Current Illness:

ID: 0929063
Sex: F
Age:
State: MI

Vax Date: 12/29/2020
Onset Date: 12/31/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201223; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Diarrhea; Nausea; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 29Dec2020 at 17:00 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none, and the patient had no known allergies. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 31Dec2020 at 12:30, the patient experienced diarrhea and nausea. The patient did not receive any treatment for the events. Since the vaccination, the patient had been tested for COVID-19 on 23Dec2020 (as reported) via nasal swab and the result was negative. The clinical outcome of the diarrhea and nausea was not resolved. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0929064
Sex: F
Age:
State: IA

Vax Date: 12/14/2020
Onset Date: 12/01/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: covid; Result Unstructured Data: Test Result:positive

Allergies:

Symptoms: experienced loss of smell, taste and a headache/she came down with signs and symptoms/she got tested and got the results on Thursday that she was positive for covid 19 virus; experienced loss of smell, taste and a headache/she came down with signs and symptoms/she got tested and got the results on Thursday that she was positive for covid 19 virus; 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) Solution for injection, lot number, via an unspecified route of administration from 14Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of COVID vaccine on 14Dec2020. Eleven days following first dose, she experienced loss of smell, taste and a headache. She stated that she came down with signs and symptoms on 25Dec2020 and she got tested and got the results on Thursday that she was positive for Covid 19 virus. She was due for the 2nd dose of the COVID vaccine on the 6th of January. She asked what she should do about the second dose. She mentioned that her symptoms and positive test results were reported where she works in (State name). She wanted to know information as to whether she should get the second dose. Her second dose's scheduled was 6Jan2021. The event outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of suspected LOE and COVID 19 infection due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0929065
Sex: M
Age:
State:

Vax Date: 12/17/2020
Onset Date: 12/22/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201226; Test Name: Covid test; Result Unstructured Data: Test Result:positive

Allergies:

Symptoms: had a positive covid test results; had a positive covid test results; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization.On 22Dec2020 he started to experience COVID like symptoms. On 26Dec2020, he had a positive COVID test results. On 28Dec2020, he received the Regeneron antibody infusion. Patient wants to know more about receiving the 2nd dose based on his positive diagnosis/antibody treatment. Outcome of the event was unknown. Information on batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of SARS-CoV-2 test positive and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0929066
Sex: F
Age:
State: CA

Vax Date: 12/20/2020
Onset Date: 12/20/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201220; Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Comments: 14:30; Test Date: 20201220; Test Name: tachycardia, arrhythmia; Result Unstructured Data: Test Result:tachycardia, arrhythmia; Comments: 14:30

Allergies:

Symptoms: diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness on chest; Chest tightness; Lightheaded; possible tongue swelling; possible tongue swelling (felt heavy after vaccine); dry mouth; sore throat; This is a spontaneous report from a contactable nurse (patient) who reported for herself that a 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration, on 20Dec2020 14:15 at left arm/arm right (pending clarification), single dose for COVID-19 immunization. Medical history included factor II, history of melanoma. She has no known allergies. She was not pregnant at the time of the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), ibuprofen (MOTRIN), multivitamin. Nurse reported administering COVID-19 vaccine at hospital, experiencing tachycardia, high blood pressure, redness on chest, chest tightness, lightheaded, possible tongue swelling (felt heavy after vaccine), arrhythmia, dry mouth, sore throat (after leaving emergency department) at 14:30 on 20Dec2020; After one day, she experienced diarrhea, headache, lower back pain and fatigue since 21Dec2020. Fatigue lasting for several days. Adverse events resulted in emergency room/department or urgent care (pending clarification). Nurse received intravenous diphenhydramine hydrochloride (BENADRYL) and fluids as treatments. Nurse assessed the events as non-serious. Nurse also reported that, prior to vaccination, she was not diagnosed with COVID-19; since the vaccination, she has not been tested for COVID-19. She did not receive other vaccine in four weeks. Outcome of fatigue was not recovered, outcome of the rest of the events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the tachycardia, high blood pressure, arrhythmia and the other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: WELLBUTRIN; MOTRIN [IBUPROFEN]; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 0929067
Sex: F
Age:
State: TX

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: BP; Result Unstructured Data: Test Result:high BP 140's; Test Name: HR; Result Unstructured Data: Test Result:110's to 120s; Test Name: flu; Result Unstructured Data: Test Result:negative; Test Name: covid; Result Unstructured Data: Test Result:negative; Test Name: strep; Result Unstructured Data: Test Result:negative

Allergies:

Symptoms: Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0929068
Sex: F
Age:
State: CA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: Blood Pressure; Result Unstructured Data: Test Result:high; Test Name: STAT EKG; Result Unstructured Data: Test Result:105 bpm, sinus tachycardia; Test Name: Heart rate; Result Unstructured Data: Test Result:racing

Allergies:

Symptoms: diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair to the ED; my heart started racing; high blood pressure; Sinus tachycardia at 105 bpm; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EJ1685), via an unspecified route of administration on 28Dec2020 09:00 at a single dose for covid-19 immunization. The patient's medical history included allergy to fish but patient had a type of fish she was not allergic to on 01Jan2021. Concomitant medications were not reported. The patient received first vaccine on 28Dec2020 at 9:00 am. After about 5-15 minutes her heart started racing, she felt light headed when she went to stand up and patient was taken by wheelchair to the emergency department (ED). The procedures done in ED included Stat EKG which showed sinus tachycardia at 105 bpm and high blood pressure. Patient was normotensive normally. ED gave her Benedryl and pepcid. It took about 3 hours for my heartrate and BP to go back to normal in ED for 3 1/2 hours. Patient takes allergy meds everyday, allegra. The patient stated she went to bed and woke with headache (HA), (tylenol and ibuprofen were taken) lasted for 2 hours and returned the next day and patient took more ibuprofen and then it went away. The patient was allergic to fish, but she had a type of fish she was not allergic to on 01Jan2021 and had diarrhea within 30 minutes (one time occurrence). It was reported that the patient wishes to take the 2nd vaccine and has had no further adverse events. The outcome of the event was Headache (HA), heart rate increased and high blood pressure was recovered on an unknown date and unknown outcome for the remaining events.

Other Meds:

Current Illness:

ID: 0929069
Sex: F
Age:
State: MI

Vax Date: 12/30/2020
Onset Date: 01/02/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20210102; Test Name: Heart rate; Result Unstructured Data: Test Result:124; Comments: Increased heart rate of 124

Allergies:

Symptoms: Increased heart rate of 124; clammy hands; nausea; calf pain; extreme muscle and joint pain; extreme muscle and joint pain; shortness of breath; coughing; chest pain; This is a spontaneous report from a contactable Other Health Professional (patient). A 24-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number was unknown, via an unspecified route of administration in the left arm, on 30Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included asthma and drug hypersensitivity to sulfa. The patient was not pregnant. The patient had not received any other vaccines in four weeks prior to Covid vaccine. The patient's concomitant medications included birth control and multivitamin, both unspecified. The patient experienced increased heart rate of 124, clammy hands, nausea, calf pain, extreme muscle and joint pain, shortness of breath, coughing and chest pain, all on 02Jan2021 12:00 PM with outcome of recovering. The events are reported as non-serious with no treatment received. The patient had no covid prior vaccination. She was not tested for covid post vaccination. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0929070
Sex: F
Age:
State:

Vax Date: 12/23/2020
Onset Date: 12/26/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: bloodwork; Test Result: Negative ; Test Name: EKG; Test Result: Negative ; Test Name: other testing; Test Result: Negative

Allergies:

Symptoms: becoming incoherent and talking nonsense; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age 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 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Physician calling about whether or not she should receive the second dose of vaccine. She received dose on 23Dec2020. On 26Dec2020 she started experiencing several side effects including becoming incoherent and talking nonsense. Her daughter who is an EMT suggested that she go to the ER. While in the ER she received TPA but it was later decided she did not have a stroke. Her EKG, bloodwork and other testing came back negative. She otherwise healthy and has no comorbidities. She already spoke with agency. She has also already spoken with an infectious disease doctor and her neurologist. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the event incoherent is conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agencys, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0929071
Sex: F
Age: 44
State: MT

Vax Date: 12/29/2020
Onset Date: 01/06/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: CBC, CMP, brain CT and MRI

Allergies: Morphine

Symptoms: Chills and body aches approximately 8 hours vision changes approximately 30 minutes, headache ongoing for several days now, fatigue

Other Meds: Levothyroxine 50mcg daily Lexapro 10mg daily Bariatric fusion one a day capsule with iron Viactiv calcium soft chews 2x day Gabapentin 200mg 2x day Ativan 1mg daily Estrogen 0.1% topical cream

Current Illness: Head cold

ID: 0929072
Sex: F
Age: 37
State: IL

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies: Vicodin

Symptoms: My arm hurt severely and the muscles in my arm would not contract to allow for motion until 11:00am on 1/8/21, but the pain was so severe that I could not sleep. I have also had severe chills, nausea, vomited twice, generalized weakness and shakiness. It is currently 12:10pm on 1/8/21 and these symptoms continue. Two of my other co-workers were at this same facility at the same time on 1/7 and have had very similar symptoms as well as severe headache which prevented them to work today. We are all physical therapists, healthy young individuals, no co-comorbidities and were very surprised by these negative reactions and concerned.

Other Meds: Women's Mult-vitamin once/day

Current Illness: None

ID: 0929073
Sex: F
Age:
State: CA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: tingly feeling to my lips; some lip swelling; tightness in my throat.; This is a spontaneous report from a contactable Other HCP. A 35-years-old female patient started to receive BNT162B2, via an unspecified route of administration from 30Dec2020 12:00 to 30Dec2020 12:00 at SINGLE DOSE for covid-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing, gastritis from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. Concomitant medication included lorazepam (ATIVAN), ivermectin (IVERMECTIN), escitalopram oxalate (LEXAPRO), esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), levocetirizine dihydrochloride (XYZAL). The patient previously took tamiflu and experienced drug hypersensitivity. The patient experienced tingly feeling to my lips (paraesthesia oral) (non-serious) on 30Dec2020 15:30 with outcome of recovered, some lip swelling (lip swelling) (non-serious) on 30Dec2020 15:30 with outcome of recovered, tightness in my throat. (throat tightness) (non-serious) on 30Dec2020 15:30 with outcome of recovered. The action taken in response to the event(s) for BNT162B2 was not applicable. Therapeutic measures were taken as a result of tingly feeling to my lips (paraesthesia oral), some lip swelling (lip swelling), tightness in my throat. (throat tightness). This is a spontaneous report from a contactable other HCP. This 35-year-old female other HCP reported that: Report about covid vaccine: Yes Reporter type: Patient Age group: Adult (18-64 Years) Is pregnant: No Race: (race provided) Ethnicity: (ethnicity provided) Patient occupation: Other Health Professional Covid vaccine details: product-COVID 19, Lot number-EL1284, Lot unknown-False, Administration date-30Dec2020, Administration time-12:00 PM, Vaccine location-Left arm, Dose number-1 Facility type vaccine: Hospital If other vaccine in four weeks: Yes Other vaccine 4weeks details: other vaccine 4weeks product -Allergy Immunotherapy injections , Other vaccine 4weeks vaccine date -07Dec2020, Other vaccine 4weeks dose number -2 , Other vaccine 4weeks vaccine location-Left and right arm. Other medications in two weeks: Nexium, xyzal, Ativan, Lexapro, Ivermectin Adverse event: At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I ended up taking 25mg of Benadryl, then 50 mg of Benadryl 5 hrs later. The following morning my lips where feeling tingly again so I took 25mg of Benadryl again and continued for the next 48 hrs at the advice of my doctor. Adverse event start date: 30Dec2020 Adverse event start time: 3:30PM AE resulted in: None of the above If patient recovered: Recovered If treatment AE: Yes AE treatment: Benadryl for 48 hrs If covid prior vaccination: No If covid tested post vaccination: No Known allergies: Tamiflu Other medical history: Chronic allergies, gastritis, anxiety, Depression Identification of the case safety report Serious: No Seriousness criteria-Results in death: No Seriousness criteria-Life threatening: No Seriousness criteria-Caused/prolonged hospitalization: No Seriousness criteria-Disabling/Incapacitating: No Seriousness criteria-Congenital anomaly/birth defect: No VAERS Primary Reporter Addl Qualification: Patient Relevant medical history and concurrent conditions: Structured information (Patient episode name): Chronic allergies, gastritis, anxiety, depression Reaction(s)/Event(s): Reaction/event as reported by primary source: At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I Reaction/event in terminology (LLT) : At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I ended up taking 25mg of Benadryl, then 50 mg of B Date of start of reaction/event: 30Dec2020 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED Drug(s) Information: Characterization of drug role: Suspect Batch/lot number: EL1284 Date of start of drug:30Dec2020 Anatomical location: Arm left Dose number:1 Active drug substance information: Active drug substances name: COVID 19 Drug(s) Information: Characterization of drug role: CONCOMITANT Proprietary medicinal product name: Allergy Immunotherapy injections Date of start of drug:07Dec2020 Dose number:2 Narrative case summary and further information: Case narrative Age at vaccination: 35 Pregnant at the time of vaccination?: No Start Date/Time:30Dec2020 12:00 PM Facility where the most recent COVID-19 vaccine was administered: Hospital Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Yes List of any other medications the patient received within 2 weeks of vaccination: Nexium, xyzal, Ativan, Lexapro, Ivermectin Reported Event: At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I ended up taking 25mg of Benadryl, then 50 mg of Benadryl 5 hrs later. The following morning my lips where feeling tingly again so I took 25mg of Benadryl again and continued for the next 48 hrs at the advice of my doctor. Was treatment received for the adverse event?: Yes: Benadryl for 48 hrs Prior to vaccination, was the patient diagnosed with COVID-19?:No Since the vaccination, has the patient been tested for COVID-19?:No Allergies to medications, food, or other products: Tamiflu Vaccine Facility information available. Ethnicity information is available. Race information is available. Location of injection information is available for other vaccines within 4 weeks PRIOR.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: ATIVAN; ; LEXAPRO; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; XYZAL

Current Illness:

ID: 0929074
Sex: F
Age: 31
State: CA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital: Y

Lab Data: Tachycardic with HR 120s, all other vital signs stable.

Allergies: phenazopyridine--hallucinations

Symptoms: About 15 minutes after receiving the vaccine she felt palpitations. She was monitored for another 15 minutes and while she was walking to her car se started noticing sore throat associated with inability to talk, unable to swallow secretions, and swelling the lips. Patient presented to the emergency room where she received EpiPen dose. Received diphenhydramine, famotidine, and prednisone. Lip swelling and sore throat began improving in ED.

Other Meds: ascorbic acid Vitamin D Vitamin E zinc sulfate

Current Illness: none

ID: 0929075
Sex: F
Age:
State: FL

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: mild flu-like symptoms; Diffuse myalgias, more severe on both right and left arm; Numbness in lower legs evening of vaccine; Felt mild headache; foggy feeling this night; This is a spontaneous report from a contactable healthcare professional, reporting for a patient. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK9231), intramuscular in the right arm on 30Dec2020 at 09:45 (at the age of 26-years-old) as a single dose for Covid-19 vaccination. Medical history included Covid-19 prior to the vaccination on an unknown date. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. On 30Dec2020 at 19:30, the patient experienced diffuse myalgias, more severe on both right and left arm and numbness in lower legs the evening of the vaccine; felt mild headache and foggy feeling that night as well. The second day on 31Dec2020, the patient experienced mild flu-like symptoms such as weakness, fatigue, and myalgias. Therapeutic measures were taken for the myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness which included Tylenol. The clinical outcome of the events myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness was recovered on an unknown date.

Other Meds:

Current Illness:

ID: 0929076
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: headache; arm soreness for 3 days; fever and back pain that began Thursday; fever and back pain that began Thursday; nausea; body aches for 2 weeks; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 (at the age of 36-years-old) as a single dose for COVID-19 vaccination. Medical history was not reported. The patient's concomitant medications were not reported. On an unknown date the patient experienced headache, arm soreness, body aches for 2 weeks, fever, back pain and nausea. The patient reported feeling absolutely horrible, which felt like it is escalating sometimes per patient. The patient stated that it was initially just arm soreness for 3 days then all other symptoms including fever and back pain that began Thursday (date unknown), and now a headache, per the patient "before it was just soreness, body aches for 2 weeks, nausea". The patient is completing daily check-ins on the website name. She has a copy of the Fact Sheet for Recipients and Caregivers. The clinical outcome of the headache, arm soreness for 3 days, fever, back pain, nausea and body aches for 2 weeks was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0929077
Sex: U
Age:
State: VA

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

Lab Data:

Allergies:

Symptoms: red splotches on tongue and bumps around edge of tongue day after injection; mild-moderate headache; moderate tiredness; Dizziness the first 30 minutes; swollen lymph nodes starting 1-2 hours after injection, lasting approx. 6 hours; red splotches on tongue and bumps around edge of tongue day after injection; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old patient of unknown gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284), via an unspecified route of administration in the right arm on 02Jan2021 at 11:00 (at the age of 74-years-old) as a single dose for COVID-19 vaccination. Medical history included fibromyalgia, bronchiectasis, Degen. Scoliosis, spinal stenosis, peptic esophogitus grade II, osteoarthritis and benign nodules in both upper lobes of lungs (Pulmonary scarring-bilateral lower lobes). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had allergies (unspecified) to medications, food, or other products. The patient's concomitant medications were not reported; however it was reported the patient did receive other medications (unspecified) within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient experienced dizziness the first 30 minutes on 02Jan2021; swollen lymph nodes starting 1-2 hours after injection, lasting approx. 6 hours on 02Jan2021; red splotches on tongue on 02Jan2021 and bumps around edge of tongue day after injection on 03Jan2021; mild-moderate headache on 02Jan2021 and on 02Jan2021 moderate tiredness lasting 2 days+. The patient did not receive any treatment for the events. The clinical outcome of the dizziness the first 30 minutes, swollen lymph nodes starting 1-2 hours after injection, lasting approx. 6 hours, red splotches on tongue and bumps around edge of tongue day after injection, mild-moderate headache and moderate tiredness was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0929078
Sex: F
Age: 26
State: MT

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fever 100.4, chills, joint pain, fatigue, Diarrhea

Other Meds:

Current Illness:

ID: 0929079
Sex: F
Age:
State:

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache; nausea; tiredness; site injection swelling; site injection pain; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 28Dec2020 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 28Dec2020, the patient experienced headache, nausea, tiredness, injection site swelling and injection site pain. Treatment was not received for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events headache, nausea, tiredness, injection site swelling, and injection site pain were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0929080
Sex: F
Age:
State:

Vax Date: 12/17/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201221; Test Name: Covid 19; Result Unstructured Data: Test Result:Positive

Allergies:

Symptoms: I was given a vaccine on Dec17th, on Dec21st I tested positive for Covid; I was given a vaccine on Dec17th, on Dec21st I tested positive for Covid; This is a spontaneous report from a contactable nurse. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. There was no relevant medical history. The patient's concomitant medications were not reported. The patient was given a vaccine on 17Dec2020, the on 21Dec2020, the patient tested positive for COVID. The outcome of the event was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information

Other Meds:

Current Illness:

ID: 0929081
Sex: F
Age: 40
State: CA

Vax Date: 12/26/2020
Onset Date: 12/26/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: no

Allergies: GI intolerance to codeine that causes nausea

Symptoms: About 5 min after the vax I was at the recovery/triage at the vaccine place and I started to get tingling and numbness on the right side of my tongue, so I did not actually reported as a concern but after my 15 min observation I left but then the numbness and tingliness got worse in my tongue and now lower lip and then I decided to return to the vaccine area to report my symptoms and they brought me over and took my vitals and they were stable BP/HR were normal and the numbness and tingling did not get any worse but because of the reaction they gave me 25mg of oral Benadryl probably around 40 min after the vaccine they kept monitoring me for abot 2 hours but my vitals remained very stable and the numbness and tingling have resolved. My tongue was still numb but not getting any worse so i felt it was ok to leave. I decided to go home after those 2 hours and i took 10 min of zyrtec and about 5 hours later i still had a little numbness and tingling on the right side of the tongue but the rest of the tongue and lip had resolvedf. Had fatigue and myalgia for the rest of the day.

Other Meds: No

Current Illness: No

ID: 0929082
Sex: F
Age:
State:

Vax Date: 12/31/2020
Onset Date:
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: could not breath; had a "warm liquid running through her body" feeling/same sensation stated again today, 04Jan; dryness in the throat; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she received the Pfizer covid vaccine on 31Dec2020 and she could not breath and had a "warm liquid running through her body" feeling that went away after some time. She said she has the same sensation stated again today, 04Jan2021 and this time it's not going away. She said it's been 10-15 minutes with this and also have dryness in the throat. She wanted to know if this was normal. The patient said she was going to the emergency room. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0929083
Sex: F
Age:
State: MI

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:Elevated; Test Name: blood pressure; Result Unstructured Data: Test Result:155/95; Test Name: blood pressure; Result Unstructured Data: Test Result:110/60; Comments: normal blood pressure; Test Name: heart rate; Result Unstructured Data: Test Result:decrease; Test Name: heart rate; Result Unstructured Data: Test Result:55

Allergies:

Symptoms: Elevated blood pressure (155/95); decrease in heart rate (55); Face & tongue went numb; Face & tongue went numb; Residual ringing in left ear; This is a spontaneous report from a contactable physician, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 22Dec2020 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included seasonal allergies and allergies/asthma, from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 22Dec2020 at 16:00, the patient experienced elevated blood pressure of 155/95 (normal was 110/60), a decrease in heart rate which was 55, face and tongue went numb and residual ringing in the left ear. The patient was treated for the events with diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events elevated blood pressure of 155/95 (normal was 110/60), a decrease in heart rate which was 55, face and tongue went numb and residual ringing in the left ear was resolved with sequel. Information on lot/batch number has been requested.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SINGULAIR

Current Illness:

ID: 0929084
Sex: F
Age: 51
State: TX

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

Lab Data:

Allergies:

Symptoms: Symptoms - ? Patient reports itchiness to bilateral hands approximately 25 mins after vaccination, denies rash. Patient reports she struggles with allergies and prophylactically medicated prior to first dose with 50 mg of Benadryl and Xytal. Patient reports no adverse reaction after 1st vaccine. Patient reports she prophylactically medicated last night as well but only took 25 mg and no Xytal, patient endorses she believes that is the difference in her symptoms between the first and second dose. Patient endorses allergies to high dose Vitamin D (50,000 units). Patient denies difficulty breath or SOB at this time. Patient reports she is able to move freely at this time. Last day of work and shift - ? currently working at home today Home remedies? - 50 mg Benadryl at 08:00 and Pepcid and Xytal at 11:20 (did not disclose dosage) Any improvement? ? Patient reports mild improvement Recommendation? Patient encouraged to take allergy medication as directed and to call vaccine support if symptoms worsen. Patient educated to call 911 or seek immediate care if any airway issues or difficulty breathing.

Other Meds:

Current Illness:

ID: 0929085
Sex: F
Age: 27
State: MD

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies: NA

Symptoms: Tip of tongue was burning, weird metallic taste in mouth, entire tongue numb and tingly , throat closing, hard to swallow. received 50 mg Benadryl po

Other Meds: NA

Current Illness: NA

ID: 0929086
Sex: F
Age:
State: NC

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination. On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'. The patient did not received treatment as a result of the event. The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date, 'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date. Information on the lot/batch number has been requested.

Other Meds: ASA; VIT D; VIT C; ; ;

Current Illness:

ID: 0929087
Sex: F
Age:
State: NC

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20210103; Test Name: PCR; Result Unstructured Data: Test Result:Pending; Test Date: 20210103; Test Name: strep; Result Unstructured Data: Test Result:negative for strep

Allergies:

Symptoms: low back ache; sore throat; low grade fever; body aches; severe headache; hot flashes; sweating heavily; felt flushed; This is a spontaneous report from a contactable Nurse. This 22-year-old female patient received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 16:30 (at the age of 22-years) as single dose, intramuscular in left arm for COVID-19 immunization. Medical history included the patient had no known allergies. The patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID virus in Oct2020. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was given first dose of the COVID vaccine on 31Dec2020. The patient was monitored 15 minutes after receiving the vaccine. When she went back to work on 31Dec2020 she felt flushed, having hot flashes and she started sweating heavily. The patient was taken to the nearest Emergency room (ER) for evaluation and states that the (ER) doctor told her it could have been a reaction to the vaccine. On 01Jan2021, the patient started having low grade fever, body aches and severe headache. On 02Jan2021, the patient was having a sore throat and low grade fever still, but no body aches or headache. On 03Jan2021, the patient was still having the sore throat and a low back ache, the patient was told to go to an Urgent Care to be evaluated. The patient states that she was given antibiotics and was negative for Strep. The patient was also swabbed for COVID again. The patient was given treatment for sore throat but it was unknown if patient received treatment for other events. Lab data included SARS-CoV-2 test (PCR nasal swab) on 03Jan2021 which is pending. The patient did not received treatment as a result of the event. The outcome of event felt flushed was recovering, hot flashes was recovering, sweating heavily was recovering, low grade fever was not recovered, body aches was recovered Jan2021, severe headache was recovered on Jan2021, sore throat was not recovered and low back ache was not recovered.

Other Meds:

Current Illness:

ID: 0929088
Sex: F
Age: 56
State: PR

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: NO

Allergies: ASPIRIN

Symptoms: HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARGEMENT OF LYMPH NODE

Other Meds: SYNTHROID

Current Illness:

ID: 0929089
Sex: F
Age:
State: MI

Vax Date: 12/30/2020
Onset Date: 01/01/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: dry cough; felt feverish; body aches; This is a spontaneous report from a contactable consumer. A 22-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first vaccine on 30Dec2020. Around 4 days, in Jan2021, after getting the first vaccine, she started getting body aches, she felt feverish but didn't have a fever, and also a dry cough. She knows from reading the fact sheet that symptoms should resolve after a couple of days. She states her symptoms happened after a couple of days. Caller's question is if the symptoms are from the vaccine or should she get tested for something else. The outcome of the events was unknown. Information about Lot/Batch has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003818 pfizer

Other Meds:

Current Illness:

ID: 0929090
Sex: F
Age:
State: LA

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

Lab Data: Test Name: TSH; Result Unstructured Data: Test Result:borderline hypothyroidism; Test Name: lipid panel liver; Result Unstructured Data: Test Result:Unknown Result

Allergies:

Symptoms: TSH level has been borderline hypothyroidism; Almost feel like somebody is gently holding my throat, so I could still breathe, talk, eat but I had the feeling that my throat was being kind of squished; This is a spontaneous report from a contactable nurse. A 64-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), via an unspecified route of administration in right deltoid on an unspecified date at a single dose for covid-19 immunization. Medical history included hypertension and high cholesterol. Concomitant medication included evolocumab (REPATHA) for high cholesterol and two unspecified medications for hypertension. The got the first dose of Pfizer Vaccine for COVID, and for about 3 or 4 almost 5 days afterwards, she felt like somebody, it almost feel like somebody was gently holding her throat, so she could still breathe, talk, eat but had the feeling that throat was being kind of squished. The patient had her lipid panel liver and TSH level done because of the Repatha and TSH level has been borderline hypothyroidism, so she haven't really been on medicine for it but it might be. The patient added that the events had certainly correlated with the vaccine. She didn't have the events until she got the vaccine, so she feel like it was and then her concern was it wouldn't be safe to take the second one. The patient did not visit emergency room and physician office because of the issue 'feel like somebody was gently holding her throat' and all she did was take Benadryl at night. The outcome of the events was unknown.; Sender's Comments: The causal relationship between bnt162b2 and the event hypothyroidism cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: REPATHA

Current Illness:

ID: 0929091
Sex: F
Age: 52
State: KS

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: none

Allergies: Lisinopril, latex

Symptoms: site pain, Joint pain, hives, fever, lymph node swelling and painful.

Other Meds: Bystolic, Zyrtec, Prilosec, Lipitor, Xarelto, Metformin, Vitamin D3 2000 units,

Current Illness:

ID: 0929092
Sex: F
Age:
State: MI

Vax Date: 12/15/2020
Onset Date: 12/26/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201227; Test Name: Influenza; Test Result: Negative ; Comments: I initially tested negative for COVID and influenza.; Test Date: 20201227; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20201229; Test Name: Nasal Swab; Test Result: Positive

Allergies:

Symptoms: test positive for COVID-19/fever, chills, body aches, joint pain; test positive for COVID-19/fever, chills, body aches, joint pain; This is a spontaneous report from a contactable other HCP. A 35-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5703), via an unspecified route of administration in left arm on 15Dec2020 17:30 at a single dose for covid-19 immunization. Administration was done in the hospital. Medical history included seronegative rheumatoid arthritis and allergies to latex and actemra. Concomitant medication included tofacitinib citrate (XELJANZ), and ibuprofen. Eight days after vaccination, on 23Dec2020 at 13:30, the patient came down with fever, chills, body aches, joint pain. The patient was initially tested negative for COVID (nasal swab) and influenza on 27Dec2020 but did test positive for COVID-19 on 29Dec2020 (nasal swab). The patient stated that she knew that the vaccine did not cause COVID however as she was on immunosuppressants (Xeljanz), she wanted to record this information. There was no treatment included for the events. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19.; 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 events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.

Other Meds: XELJANZ;

Current Illness:

ID: 0929093
Sex: M
Age:
State: NJ

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

Lab Data:

Allergies:

Symptoms: sore at injection site; This is a spontaneous report from a non-contactable consumer reporting for a patient. This 53-year-old male received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on an unknown date (at the age of 53-years) as single dose, at unspecified route of administration for immunization. Medical history was unknown. Allergies were unknown. Concomitant drugs were unknown. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to BNT162B2. On an unspecified date, the patient experienced 'sore at injection site'. It was unknown if the patient received treatment as a result of the event. The outcome of event 'sore at injection site' was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 0929094
Sex: F
Age:
State:

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:extremely low

Allergies:

Symptoms: severe dizziness; aches; chest pain; palpitations; extremely low blood pressure; fever; shortness of breath; This is a spontaneous report from a non-contactable nurse, the patient. A 38-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK9231; Expiration date was not reported), via an unspecified route of administration in the left arm on 29Dec2020 at 09:15 (at the age of 38-years) as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to the 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 vaccination. The patient previously took cefzil and experienced allergies. On an unspecified date, the patient experienced severe dizziness, shortness of breath, chest pain, palpitations, extremely low blood pressure, fever, and aches. The patient was seen in the emergency department for the events. Therapeutic measures for the events included medications and IV fluids; both not further specified. The outcome of the event severe dizziness, shortness of breath, chest pain, palpitations, extremely low blood pressure, fever, and aches was recovered. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0929095
Sex: F
Age:
State:

Vax Date: 12/17/2020
Onset Date: 12/17/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: COVID-19 rapid POC test; Test Result: Positive

Allergies:

Symptoms: COVID-19 rapid POC test positive; COVID-19 rapid POC test positive; the amount of vaccine given as 1 cc; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A contactable nurse (patient) reported that a 52-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EH9899), via an unspecified route of administration on 17Dec2020 at 1 mL, single dose for COVID-19 immunization. Medical history included ongoing hypertension diagnosed when she was 33 years old. There were no concomitant medications. The patient got the vaccine on 17Dec2020. The patient stated that the amount of vaccine given was 1 cc. She took a COVID-19 rapid POC test on the 28Dec2020 and tested positive. She wanted to know if she should have the second dose of the vaccine. The outcome of the events was unknown.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness: Hypertension (diagnosed when she was 33 years old.)

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm