VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1057396
Sex: M
Age: 73
State: MI

Vax Date: 02/04/2021
Onset Date: 02/08/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Stool culture ordered today.

Allergies: None

Symptoms: Four days after the vaccine, episodes of explosive diarrhea began. They are ongoing.

Other Meds: Lutein and zeaxanthin supplement, melatonin

Current Illness: None

ID: 1057397
Sex: F
Age: 26
State: VA

Vax Date: 02/24/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Vomiting, fever, chills, diarrhea, body aches, cough, shortness of breath, fatigue,

Other Meds: Pantoprazole

Current Illness: None

Date Died:

ID: 1057547
Sex: M
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: 86 year old manager received the two doses of the Moderna vaccine and died; A spontaneous report was received from a consumer, concerning an 86-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received their doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. On an unspecified date, it was reported that the patient passed away after receiving both doses. The cause of death was unknown. It was unknown if an autopsy was performed. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the events is not applicable. The outcome of event "86 year old manager received the two doses of the Moderna vaccine and died" was fatal.; Reporter's Comments: Very limited information regarding this event has been provided at this time. No autopsy report provided. Further information has been requested.; Reported Cause(s) of Death: 86 year old manager received the two doses of the Moderna vaccine and died

Other Meds:

Current Illness:

ID: 1057548
Sex: M
Age: 55
State:

Vax Date: 01/02/2021
Onset Date: 01/30/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data: Test Date: 20210205; Test Name: CT scan; Result Unstructured Data: Bilateral pulmonary embolism and multiple areas of infarct along with atelectasis; Test Date: 202102; Test Name: CT scan; Result Unstructured Data: pulmonary embolism not progressing; positive for pulmonary effusions (second CT completed 2 days s/p hospital discharge); Test Date: 20210205; Test Name: D-dimer; Result Unstructured Data: 4800; Test Date: 202102; Test Name: PTT; Result Unstructured Data: increased after coagulation; Test Date: 20210205; Test Name: Covid-19; Result Unstructured Data: negative; Test Date: 202102; Test Name: Covid-19; Result Unstructured Data: negative; Test Date: 20210205; Test Name: ultrasound of the legs; Result Unstructured Data: Ultrasound of legs negative for deep vein thrombosis; Test Date: 202102; Test Name: ultrasound of the legs; Result Unstructured Data: Utrasound of legs positive for deep vein thrombosis

Allergies:

Symptoms: bilateral pulmonary embolism; multiple areas of infarct; back pain; ateltheisis; chest pain; left leg pain; deep vein thrombosis; pulmonary effusions; fever; Chills; myalgia; A spontaneous report was received from a physician who was also a 55-year-old, previously healthy male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/pyrexia, chills, myalgia, chest and back pains, bilateral pulmonary embolism/pulmonary embolism, multiple areas of infarct/pulmonary infarct, ateltheisis/atelectasis, left leg pain, and deep vein thrombosis. The patient's medical history included daily exercise and no personal or family history of clotting issues and no trauma. Products known to have been used by the patient were not provided. On 02 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039k20-2a) intramuscularly for prophylaxis of COVID-19 infection. On 30 Jan 2021, approximately 28 days after the first dose, and prior to the onset of symptoms, the patient received the second of two planned doses of mRNA-1273 (Lot number: 012m20a) intramuscularly for the prophylaxis of COVID-19 infection. On 30 Jan 2021, the patient reports that for the first 18 hours, he experienced fever, chills and myalgia. On 01 Feb 2021, the patient reports that he thought the myalgia was continuing, as he had pain in his chest and back. The chest pains gradually worsened. On 05 Feb 20221, the patient went to the emergency room and was admitted. He was diagnosed with a pulmonary embolism. He was started on enoxaparin sodium but switched to apixaban. A computerized tomography study of the lungs showed that he had bilateral pulmonary embolism, multiple areas of infarct and atelectasis. His dimer was 4800. COVID-19 test was negative. An echocardiograph was performed, no results were reported. An ultrasound of the legs was performed and ruled out deep vein thrombosis. Date of discharge was not specified. On an unknown date two days after discharge, the patient experienced left leg pain and returned to the emergency department. Patient was diagnosed with deep vein thrombosis that ran the entire length of the femoral artery. Patient was switched back to enoxaparin sodium and taken off the apixaban. A repeat computerized tomography study was done to see if the pulmonary embolism was progressing and it was not, however, it showed pulmonary effusions. All current lab work was reported as normal, except for an increased prothrombin time. COVID-19 test was negative. Patient continues to be followed by a pulmonologist and hematologist. Consent to contact patient, pulmonologist and hematologist was obtained. Action taken with mRNA-1273 was not applicable. The outcome of the events, fever/pyrexia, chills, myalgia, chest and back pains, bilateral pulmonary embolism/pulmonary embolism, multiple areas of infarct/pulmonary infarct, ateltheisis/atelectasis, left leg pain, and deep vein thrombosis, was considered not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1057549
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: My first vaccine I received it gluteal; A spontaneous report was received from a consumer regarding themselves, a patient of unreported age and sex regarding receiving the fist dose of Moderna's mRNA-1273 vaccine via the gluteus muscle/inappropriate route of administration. The patient's medical history was not included. Products known to have been used by the patient were not provided. On an unspecified date, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the gluteus for prophylaxis of COVID-19 infection. Patient was given the injection into the gluteus muscle and not the deltoid muscle. Consent to contact was obtained. Treatment information was not provided. Action taken with mRNA-1273 was not reported. The outcome of the events, dose being administered in the gluteus and not the deltoid muscle, was considered resolved.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected event of Incorrect route of product administration with mRNA-1273 (Lot # unknown), with no associated adverse events. Reporter stated that the injection was given into the gluteus muscle and not the deltoid muscle. The event occurred the same day as the first dose of mRNA-1273. Very limited information has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1057550
Sex: F
Age:
State: TN

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:high 150s; Test Name: Blood pressure; Result Unstructured Data: Test Result:never lower than 187; Test Date: 20210206; Test Name: Blood pressure; Result Unstructured Data: Test Result:220/97; Test Date: 20210209; Test Name: Blood pressure; Result Unstructured Data: Test Result:180; Comments: Systolic blood pressure 180; Test Date: 20210210; Test Name: Blood pressure; Result Unstructured Data: Test Result:gone down

Allergies:

Symptoms: has sporadic a-fib (at baseline); She stated she was in real bad stroke territory; she felt like she was going to faint; Her blood pressure was 220/97; tingling in her hands and feet; felt like brain sizzling like it was frying/going to faint; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, first dose) solution for injection intramuscular in the left arm on 06Feb2021 at 09:30 (at the age of 79-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing sporadic A fib (atrial fibrillation) for 6 years know about; allergy to polyethylene glycol in 1985 (she had difficulty taking birth, control pills and they found out it was the coating PEG in); cerebrovascular accident prophylaxis; in 1985 She had difficulty taking birth control pills and they found out it was the coating PEG in it. She had an allergy to this where she broke out in bumps on her fingers and mouth and had itchy eyes, a full blown allergy; and when she was 45 going through menopause. Concomitant medication included apixaban (ELIQUIS) for A fib and cerebrovascular accident prophylaxis. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021, the patient had sporadic a-fib (at baseline) then put in a medical van requiring emergency room visit. The patient stated, She stated she was in real bad stroke territory, felt like she was going to faint (6 minutes after vaccination), blood pressure was 220/97, tingling in her hands (6 minutes after vaccination) and feet and felt like brain sizzling like it was frying/going to faint (6 minutes after vaccination) on 06Feb2021. Lab tests included blood pressure on an unknown date high 150s and never lower than 187, then on 06Feb2021 was 220/97, on 09Feb2021 was systolic blood pressure 180, then on 10Feb2021 had gone down. The outcome of the events atrial fibrillation and feeling unwell was recovered on 06Feb2021, after 3 hours. The outcome of the events stroke, faint and tingling of extremity was unknown. The outcome of the event blood pressure was 220/97 was recovered on 10Feb2021.

Other Meds: ELIQUIS

Current Illness: AFib (6 years know about)

ID: 1057551
Sex: F
Age:
State: FL

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Arm pain; arm with shot is swollen getting red; arm with shot is swollen getting red; Injection site is swelling and the pain is worse; Injection site is swelling and the pain is worse/Injection site pain; Arm was stiff; Crohn's disease went crazy/worse Crohn's flare; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age (reported as '75', units unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the arm on 06Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease. The patient's concomitant medications were not reported. The patient previous had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), on an unspecified date for COVID-19 immunization. The patient had her Pfizer second shot received on Saturday (06Feb2021) and after the shot she had arm pain (same as after the first shot) and Crohn's disease went crazy and she keep wanted to run to bathroom. Arm hurt a few days then it went away. Injection site pain started again last night and her arm with shot is swollen and getting red, she put ice on it and it's hurting. Today, it was slightly more red and swollen. The injection site is swelling, and the pain is worse than the 1st dose. The patient has Crohn's disease and was having a whole problem with that at the moment. She had gotten the second Covid shot on Saturday and on Sunday (07Feb2021), had the worse Crohn's flare she's actually ever had in 35 years. The day after the shot (07Feb2021), her arm was stiff and that is what happened after the first shot also. It cleared up on Monday and Tuesday. Last evening, Wednesday, her upper arm on the injections site arm started to hurt and get swollen. Since it was last night, she had no one to call and called the pharmacy and was told to put ice on it and she did. It's getting worse and worse and angry like and getting more swollen. The patient wanted to know what she should do in this situation. The outcome of the event "arm was stiff" was recovered on Feb2021 while the other events were unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness: Crohn's disease

ID: 1057552
Sex: F
Age:
State:

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

Lab Data: Test Date: 202102; Test Name: audiology test; Result Unstructured Data: Test Result:hearing was almost completely gone; Test Date: 202102; Test Name: MRI; Result Unstructured Data: Test Result:no abnormalities

Allergies:

Symptoms: lost complete hearing in her left ear/hearing was almost completely gone based on the audiology test; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EN5318 and expiry date unknown, via unspecified route of administration at the left arm on 02Feb2021 15:30 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no covid prior vaccination. On 02Feb2021 16:00 (30 minutes after receiving the vaccination), The patient lost complete hearing in her left ear. The patient informed that it came on very suddenly and did not improve by the next morning. The patient contacted her doctor at the clinic and was scheduled for a hearing test on Thursday at 9:30 and an appointment with an ENT afterwards. The hearing was almost completely gone based on the audiology test (Feb2021). The patient began very high levels of steroids for a 14-day program and her hearing has started to return. The patient also had an MRI done on Monday (Feb2021) showing no abnormalities. The patient was not covid tested post vaccination. The patient informed that this seemed to be a very real coincidence that the vaccine triggered this response to her hearing. The outcome of the event was recovering. The event was considered serious (disability).

Other Meds:

Current Illness:

ID: 1057553
Sex: F
Age:
State: IL

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210127; Test Name: covid test (saliva); Test Result: Negative ; Test Date: 20210210; Test Name: covid test (saliva); Test Result: Negative

Allergies:

Symptoms: hallucination; severe confusion; dizziness/light headedness; disorientation; fatigue; tachycardia; anxiety; full body weakness; full body muscle aches; chills; headache; This is a spontaneous report from a contactable healthcare professional (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3247), intramuscular in left arm on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included generalised anxiety and allergies: Sulfa sensitive. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. On 22Jan2021, 45-60 minutes after vaccination, patient experienced hallucination, severe confusion, dizziness/light headedness, disorientation, fatigue, tachycardia, anxiety, full body weakness, then on 22Jan2021, 8 hours after, patient had full body muscle aches, headache, chills, fatigue, confusion, hallucination, anxiety, tachycardia, 16 hours after, experienced confusion, full body muscle aches, headache, chills, fatigue, confusion, hallucination, tachycardia, anxiety, then 48 hours after, had confusion, full body muscle aches (TYLENOL helped), headache, fatigue, confusion, hallucination, tachycardia, anxiety, then 1 week after vaccination, patient was experiencing confusion, anxiety, and hallucinations throughout the entire week. Patient was unsure if she ever had a fever, as she did not check her temperature. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID saliva test: negative on 27Jan2021 and negative on 10Feb2021. Therapeutic measures were taken as a result of full body muscle aches. No treatment was received for the other adverse events. The outcome of the events was recovered with sequelae.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported event hallucination cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1057554
Sex: F
Age:
State: OH

Vax Date: 01/16/2021
Onset Date: 01/24/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data: Test Date: 20210128; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: cellulitus around left eye which spread down left cheek, across chin and started up the right cheek; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on the left arm, on 16Jan2021 at 12:00, at a single dose for Covid-19 immunization. The patient has no medical history and no known allergies. Concomitant medication included amoxicillin. On 24Jan2021, the patient experienced cellulitis around left eye which spread down left cheek, across chin and started up the right cheek. The adverse event resulted in doctor or other healthcare professional office/clinic visit, hospitalization. The patient was hospitalized for 6 days. The patient has no Covid prior vaccination and was Covid tested post vaccination. The patient had a nasal swab on 28Jan2021 and result was negative. The patient was recovering from the event. Information on lot/batch number has been requested.

Other Meds: AMOXICILLIN

Current Illness:

ID: 1057555
Sex: F
Age:
State: WA

Vax Date: 01/29/2021
Onset Date: 02/11/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Name: height; Result Unstructured Data: Test Result:Under 5 feet

Allergies:

Symptoms: injection site area was red; injection site was swollen; injection site area was painful; injection site area was warm to touch; This is a spontaneous report from a contactable nurse and consumer. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL9265, intramuscular on 29Jan2021 11:30 at a single dose in the left arm for COVID-19 immunization. Medical history included asthma from 2010, hypothyroidism diagnosed in 2000, obesity from 1995, hypertension from 2000. She has allergies to medications and environmental, allergic to Gadolinium dye. She had an anaphylactic reaction in a hospital, mostly due to food and environmental. No additional vaccines administered on the same date and no prior vaccinations within 4 weeks. Concomitant medication included benralizumab (FASENRA PEN) for asthma (taking for a couple of years). The patient previously took hydrochlorothiazide and experienced allergy. The patient received the first covid vaccine dose on 29Jan2021 and was fine until this morning (11Feb2021 at 9:00) when she woke up and the left arm injection site area was red, swollen, painful and warm to touch. Her height was under 5 feet. The outcome of the events was not recovered. The events Left arm injection site area is red, swollen, painful and warm to touch were assessed as serious-medically significant. Causality of the events to the suspect drug was related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "the left arm injection site area was red, swollen, painful and warm to touch" and the administration of the COVID-19vaccine, BNT162B2, based on the reasonable temporal association. 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 RA, IEC, as appropriate.

Other Meds: FASENRA PEN

Current Illness:

ID: 1057556
Sex: F
Age:
State: CA

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: slight soreness on head; Knees extremely sore; passed out; fuzzy feeling; This is a spontaneous report from a contactable consumer(patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 10Feb2021 at 16:30 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included type 2 diabetes mellitus, hypertension and allergy to Victoza. Concomitant medications included metformin, dulaglutide (TRULICITY), atorvastatin and fluoxetine. On 10Feb2021 at 21:00 about the patient five hours after vaccine in kitchen washing dishes, passed out. No symptoms or light headedness leading up to this event. Patient woke up on floor hit head minor and knees. On 11Feb2021 the patient complained slight soreness on head, fuzzy feeling. Knees extremely sore, small cut on ankle. Her doctor adviced to report this due to the time event happened in relation to vaccine (as reported). No treatment reported for events. At the time of the reporting the patient was recovering from the events. .

Other Meds: METFORMIN; TRULICITY; ATORVASTATIN; FLUOXETINE

Current Illness:

ID: 1057557
Sex: F
Age:
State: PA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration in the left arm on 28Jan2021 08:30 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 07Jan2021 at 09:00 AM for COVID-19 immunization. Patient was pregnant. Patient has no other vaccines in four weeks and no other medications in two weeks. Patient has no COVID prior vaccination and no known allergies. On 05Feb2021 at 06:00 PM, patient experienced miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant. No treatment received for the event miscarriage. The event resulted in doctor's office/clinic visit. The patient was not tested for COVID post vaccination. The outcome of the event miscarriage was recovering. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the compatible temporal association, a possible contributory role of the vaccination with BNT162B2 in triggering the onset of miscarriage in this patient at 6 weeks pregnant cannot be excluded. Additional information regarding relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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: 1057558
Sex: F
Age:
State: OH

Vax Date: 01/28/2021
Onset Date: 02/06/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data: Test Date: 202102; Test Name: Blood work; Result Unstructured Data: Test Result:Everything was fine

Allergies:

Symptoms: trouble breathing; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that she is a 26-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization at a hospital. Patient has a history of breathing problems (unspecified). On 06Feb2021, patient went into hospital due to trouble breathing. Treatment included antibiotics (unspecified) and prednisone 125 mg intravenous (IV) in the hospital and then took oral prednisone 40 mg for 4 days after being discharged on 10Feb2021. Patient further stated that she was in emergency for 4 days, and was given 125 mgs of prednisone, and that she was there in the emergency, but didn't want to stay, and was sent with prednisone and antibiotics, she was off the antibiotics not the prednisone after discharge. As of 11Feb2021, patient was off of prednisone. The patient had an unspecified blood work in the hospital and was reported to be everything was fine in Feb2021 had blood work. Outcome of the event was unknown. The patient does not feel like her breathing problems were related to the COVID-19 vaccine since she has a history of breathing problems that were aggravated in cold weather. The patient was to receive the second dose on 18Feb2021 and has inquired if she can take the shot given her problem. Information on batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1057559
Sex: F
Age:
State: CA

Vax Date: 02/03/2021
Onset Date: 02/01/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data: Test Date: 202102; Test Name: Lab test; Result Unstructured Data: Test Result:unknown result

Allergies:

Symptoms: anaphylactic reaction; having issues breathing/didn't have normal respiratory support; swallowing, weakness, unable to take anything by mouth/had lost ability to swallow; swallowing, weakness, unable to take anything by mouth; affected my lungs, gut, muscles, everything.; still having lung issues; This is a spontaneous report from a contactable consumer(patient). A 65-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number RM9809), via an unspecified route of administration on 03Feb2021 at the 65 years old at single dose for COVID-19 immunization. The medical history included Muscular dystrophy. The concomitant medications included unspecified multiple medications. The patient received the first dose on 03Feb2021. Immediately after the vaccine on 03Feb2021 she had an anaphylactic reaction, received an Epipen, went to the ER was given steroids and sent home. Next day, still having symptoms, received second Epipen administration, went to Urgent Care, was admitted to hospital 04Feb2021. The patient stated she had a history of muscular dystrophy. She stated she was having issues breathing, swallowing, weakness, unable to take anything by mouth, didn't have normal respiratory support in Feb2021. It had affected her lungs, gut, muscles, everything. She may leave here on hospice. She wanted to know if there were others who had reported side effects such as hers. She had anaphylactic reaction to the mineral. She was still in the hospital. She had lost ability to swallow and she was still having lung issues in Feb2021. She was a disabled rehab healthcare worker. She did not have an address right now in the hospital but if sent her something later once she get out she will be able to do that but she did not have it now. She takes multiple medications. Right now she cannot take medications she need orally. She had gone to hospital getting meds via primarily IV. She had acute anaphylactic reaction immediately after the vaccine and went by ambulance to hospital and was given steroids, care basically and sent home and she still had issues the next day and it kept going from home to urgent care to admission at the hospital. She had done lot of lab tests in Feb2021. She was very concerned that this was not going to be a temporary issue. She had form of muscular dystrophy and now what was happening was the week before she got the vaccine totally independent in her home, feeling ok, medications okay and now she was at IV medications not being able to swallow. She talked to someone yesterday and they told she should be calling and reporting what happened and that was why she had been on the phone all day. She just want make sure she did not feel like the healthcare was reaching out to their own vaccination department and she want to make absolutely sure that not only does Pfizer know that have a horrid reaction but she want the healthcare firm that she had a horrid reaction and she want the CDC to know that she had a horrid reaction because right now she would tell all her friends with the severe form of muscle dystrophy she had not going to be vaccinated even though the researchers were telling her to get vaccinated. It was going to take a while to stop the efficacy again and having to be on the phone everyday when she was barely breathing. The patient underwent lab tests and procedures, which included Lab test unknown result in Feb2021. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1057560
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: she is legally blind; felt a little tired; a little anxious; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself, a female patient of an unspecified age (reported as 63, no units) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had the first dose of the vaccine and felt a little tired and a little anxious one day but she felt it was because she was nervous about getting it. The patient stated she was legally blind and it was hard for her to read some things. The patient asked how long side effects will last, if she would get any, and if how long do the symptoms last after the second dose. She also asked if one did not have any side effects after the first vaccine, could they still get side effects after the second. The patient asked if people can take their medications as usual after receiving the vaccine, and if she could take Tylenol after the vaccine if she get symptoms. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1057561
Sex: F
Age:
State: NH

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: mental fog; Headache; fatigue; pain in armpit; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 05Feb2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and patient's concomitant medications were not reported. Patient is not pregnant. Patient has no covid prior vaccination. It was unknown if patient got tested post vaccination. It was unknown if patient had vaccine in four weeks and unknown if other medications in two weeks. The patient experienced mental fog (medically significant); headache, fatigue, and pain in armpit. All the events occurred on 06Feb2021. It was reported that the events were continuing after 6 days. No treatment was provided for the events. Facility type vaccine was nursing home. Outcome of the events was not recovered. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1057562
Sex: F
Age:
State: NC

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data: Test Date: 20210124; Test Name: oxygen saturation; Result Unstructured Data: Test Result:low; Test Date: 20210125; Test Name: nasal swab covid test; Test Result: Negative

Allergies:

Symptoms: disoriented/disorientation; low oxygen saturation; acute CHF; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El3247, expiry date: unknown), via an unspecified route of administration on 23Jan2021 15:15 (at the age 69 years old) at a single dose, in the right arm for covid-19 immunisation. Medical history included fibromyalgia and polymyalgia. The patient's concomitant medications included other medications both prescribed and over the counter. The patient had no other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination. On 24Jan2021 at 0900, the patient experienced disorientation that was present then went away and the patient seemed to be okay; low oxygen saturation and acute congestive heart failure (CHF). On Monday, she was disoriented again and went to emergency room (ER). All the events resulted in emergency room visit and hospitalization for seven days. The patient underwent lab test and procedures which included nasal swab covid test on 25Jan2021 which showed negative. Outcome of all the events was recovered on unspecified date.

Other Meds:

Current Illness:

ID: 1057563
Sex: F
Age:
State: NJ

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fainted; Nausea; Headache; Slight fever; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 06Feb2021 17:00 at a single dose for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. The patient is not pregnant. On 07Feb2021 09:15, the patient fainted 16 hours after getting the shot. The patient also experienced nausea, headache and slight fever. The events were assessed as serious (medically significant). No treatment was received for the events. The outcome of the events was recovered on an unspecified date. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1057564
Sex: F
Age:
State: FL

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

Lab Data: Test Date: 20210126; Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Comments: sustained high blood pressure

Allergies:

Symptoms: sustained high blood pressure; Have 2 aneurysms; Continuous headache; some dizziness; This is a spontaneous report from a contactable 68-year-old female consumer reported for herself. A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9262), via an unspecified route of administration (right arm) on 26Jan2021, 17:15 at SINGLE DOSE for covid-19 immunisation, at 68 years old. Medical history included allergies: Penicillin from an unspecified date. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is taking unspecified concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH 9899, at 68 years old), on 05Jan2021, 16:30, right arm for COVID-19 immunization. The patient experienced sustained high blood pressure, have 2 aneurysms, continuous headache, and some dizziness on 26Jan2021. Therapeutic measures were taken as a result of the events which include 3 different blood pressure medications, still not under control; medications and monitoring of pressure. She mentioned she has 2 aneurysms so she needs to keep her pressure normal. Outcome of the events was not recovered. The event was considered non-serious by the reporter.

Other Meds:

Current Illness:

ID: 1057565
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: He had an infection, a UTI, Sepsis; He had an infection, a UTI, Sepsis; walking to the car when he started shaking; he felt freezing; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's husband). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Report's husband who got his first vaccine at the same time (unknown date reported as two and a half weeks ago) as the reporter, she was walking to the car when the patient started shaking and said he felt freezing on unknown date. Later that night reporter had to call an ambulance. He was rushed to ER (emergency room) and hospitalized for 5 days. The patient had an infection, a UTI, Sepsis. He did not know had a UTI and the doctors believe that between the COVID vaccine and infection the two went crazy and beat up on each other. The patient was in the hospital for five days after his COVID shot. It was a combination of an infection and he didn't know and didn't have any symptoms. The two just clashed. He was very sensitive about it. He was feeling better and clean and clear. He was getting the second one. The outcome of events was recovering. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1057566
Sex: M
Age:
State: SC

Vax Date: 01/21/2021
Onset Date: 01/27/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210127; Test Name: Covid-19 test; Test Result: Positive

Allergies:

Symptoms: pneumonia; Diagnosed with COVID after getting the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program, via a contactable consumer (reporting for himself). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on his right arm on 21Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Jan2021, the patient was diagnosed with COVID after getting the first dose of the vaccine and experienced pneumonia. The outcome of the event was unknown. Information about batch/lot number requested.

Other Meds:

Current Illness:

ID: 1057567
Sex: F
Age:
State: CO

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

Lab Data:

Allergies:

Symptoms: felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient) A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room. The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.

Other Meds: WELLBUTRIN; PREDNISONE; EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]

Current Illness:

ID: 1057568
Sex: M
Age:
State: OH

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210205; Test Name: sugar; Result Unstructured Data: Test Result:38; Comments: sudden severe sugar drop to 38

Allergies:

Symptoms: had a sudden severe sugar drop to 38; close to passing out; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: 59267-1000-01), via unknown route of administration on left arm on 05Feb2021, at 17:00 at the age of 73 years old at a single dose for COVID-19 immunization administered at Pharmacy or drug Store. Medical history included hypoglycemia. Concomitant medications included diltiazem, lansoprazole, cimetidine, acarbose and omeprazole (ZOL). Past drug event included allergy to doxycyclene. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient stated, "I have hypoglycaemia", "On 05Feb2021, about 4 hrs after vaccine I had a sudden severe sugar drop to 38. No warning signs like I usually have. Followed normal process of bringing sugar back up with Glucose tablets, boost and protein bar. Was close to passing out and just wanted to make someone aware that this could happen. I did call and talk to the pharmacist about it". The patient assessed the events as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Feb2021.

Other Meds: DILTIAZEM; LANSOPRAZOLE; CIMETIDINE; ACARBOSE; ZOL

Current Illness:

ID: 1057569
Sex: M
Age:
State: FL

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: A-Fib recurred with a vengeance; A-Fib recurred with a vengeance; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9262), via an unspecified route of administration on 10Feb2021 13:00 at single dose (arm left) for Covid-19 immunization. Medical history included atrial fibrillation (AFib) treated well with Diltiazem. The patient had no allergies to medications, food and other products. Concomitant medication included diltiazem for Afib. On 11Feb2021 11:00, 22 hours after vaccine, A-Fib recurred with a vengeance, requiring an emergency room (ER) visit and overnight stay in hospital in order to stabilize. The patient was hospitalized on 11Feb2021 to 12Feb2021. The patient was treated with diltiazem I.V. for 12 hours. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received diltiazem within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19. Outcome of event was recovered on an unspecified date.

Other Meds: DILTIAZEM

Current Illness:

ID: 1057570
Sex: F
Age:
State: CA

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

Lab Data: Test Name: Blood electrolytes; Result Unstructured Data: Test Result:Unknown results; Test Name: Full blood count; Result Unstructured Data: Test Result:Unknown results; Test Name: hormone; Result Unstructured Data: Test Result:Unknown results; Test Name: Monocyte count; Result Unstructured Data: Test Result:Normal

Allergies:

Symptoms: Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflammation); Lymph gland infection; Tooth disorder (rancid); Swelling in upper cheeks and ears; Swelling in upper cheeks and ears; Eyes are burning and a little bit dry; Eyes are burning and a little bit dry; Mouth really hurt to me; Flu; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# CL3302), via an unspecified route of administration, on 01Feb2021, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from Apr2020 to an unknown date, Sjogren's syndrome from 2015 and ongoing (was under control), fibromyalgia, autoimmune disorder, ongoing hormone level abnormal (taking estrogen), ongoing eye disorder. Concomitant medications included ongoing ciclosporin (RESTASIS) for eye disorder, famotidine (PEPCID), albuterol [salbutamol] (unknown manufacturer), ongoing estradiol (ESTROGEN) for hormone level abnormal. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced pain, asthma and nasal irritation. The patient experienced salivary gland infection (medically significant) in Feb2021 with outcome of unknown, Sjogren's syndrome (mouth inflammation) (medically significant) in Feb2021 with outcome of unknown, lymph gland infection in Feb2021 with outcome of unknown, tooth disorder (rancid) in Feb2021 with outcome of unknown, swelling in upper cheeks and ears in Feb2021 with outcome of unknown, eyes are burning and a little bit dry in Feb2021 with outcome of unknown, mouth really hurt to me in Feb2021 with outcome of unknown, flu in Feb2021 with outcome of unknown. The patient went to the emergency room for Sjogren's syndrome (mouth inflammation) and tooth disorder (rancid). On unknown date the patient underwent lab tests and procedures which included blood electrolytes: unknown results, full blood count: unknown results, investigation: unknown results, monocyte count: normal. Therapeutic measures were taken as a result of the events and included treatment with Salagen and Tylenol. The reporter stated she believed to have a reaction from the vaccine shot.

Other Meds: RESTASIS; PEPCID [FAMOTIDINE]; ALBUTEROL [SALBUTAMOL]; ESTROGEN

Current Illness: Eye disorder; Hormone level abnormal (taking estrogen); Sjogren's syndrome (Was under control)

ID: 1057571
Sex: U
Age:
State: MI

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

Lab Data:

Allergies:

Symptoms: received quadracel in error at age of 2 year (age range for Quadracel was 4-6yrs of age)/no AE; Initial information received on 16-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 year old patient who received quadracel in error at age of 2 year (age range for Quadracel was 4-6yrs of age), while he/she received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot number not reported via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day). A health office received a Quadracel vaccine. The age range for Quadracel was 4-6yrs of age, which means this child received Quadracel in error. At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1057675
Sex: U
Age:
State: FL

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patients received improperly stored vaccines; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-FEB-2021, the patient (also reported as an unknown number of patients) was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 dose, lot # T032761, expiration date 30-MAY-2022 (exact dose and route of administration were not reported) for prophylaxis. The administered vaccine experienced temperature excursion of 46.9 degrees Fahrenheit for 15 min. Previous temperature excursion included 48.7 degrees Fahrenheit for 3 h 15 min. The digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T032761; expirationdate: 30-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness:

ID: 1057676
Sex: F
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: lymphangitis; serum sickness; hypocomplementemic vasculitis; This spontaneous report was received from a currently 83-year-old female patient who reported on herself. The patient's medical history included reaction / allergy for tetanus vaccine and for sulfites. No information regarding the patient's concurrent conditions or concomitant medications was not provided. On an unspecified date in 1990, the patient was vaccinated wit the first and the second doses of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, lot #, expiration date, route of administration were not reported) injection in arm for prophylaxis (reported as "she was working in the intensive care unit (ICU) in Critical Care and 3 physicians were diagnosed with Hepatitis B so the employees were advised to get the vaccine"). On an unspecified date in 1990, reported as after the first two doses, she experienced malaise and "vaccination reaction". On an unspecified date, she received the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). On an unknown date, after the third dose, she developed a red streak from elbow to shoulder area, lymphangitis, and serum sickness. The patient was eventually diagnosed with hypocomplementemic vasculitis. She was on "cortisone/steroids" for approximately 1 year after the reaction to the vaccine (conflicting information, it was also reported that the patient was not given any treatment for adverse event). It was reported that the patient sought medical attention and spoke to several physician. She also had unspecified testing by dermatologist (result not reported). The outcome of the events was reported as recovering. The causality assessment between the aforementioned events and the suspect vaccine was not provided, however upon internal review, it was considered related to the suspect vaccine. Upon internal review, the events of lymphangitis and hypocomplementemic vasculitis were determined to be medically significant.

Other Meds:

Current Illness: Allergy to vaccine; Reaction to sulphite

ID: 1057677
Sex: U
Age:
State: TX

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no other adverse event; Improperly stored product administered; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided. On 20-FEB-2021, the improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 1 dose, lot # s011532 with expiration date 01-DEC-2021 (route of administration, exact dose and frequency were unknown) was administered to a patient (product storage error). The vaccine was stored at -2.7 Celsius degrees for 11 hours and 52 minutes. There was no previous temperature excursions. Digital data logger was involved. No other adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: s011532; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1057679
Sex: M
Age: 14
State: NY

Vax Date: 02/12/2021
Onset Date: 02/14/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: some skin discoloration; Injection site swelling; injection site pain; This spontaneous report as received from a physician refers to a 15-year-old male patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 12-FEB-2021,the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number:16211931 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9); Lot number:16211931 does not match any Company product as confirmed by Lot Verification team, expiration date reported as: 26-JAN-2022) for prophylaxis (dose, and route were not reported). It was reported that 2-3 days later, on approximately on 14-FEB-2021 (also reported as on 20-FEB-2021 by the same reporter), he had injection site swelling (Vaccination site swelling) and pain (Vaccination site pain). On 20-FEB-2021, the patient was seen in the office to evaluate injection site swelling. The reporter stated that the site was swollen about 1 cm in diameter, very painful with some skin discoloration, on 20-FEB-2021 (Vaccination site discolouration). No additional adverse event or PQC reported. The patient seek medical attention by office visit. No treatment was given for the events. The outcome of vaccination site swelling, vaccination site pain and vaccination site discolouration was not recovered. The causal relationship between the aforementioned event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.

Other Meds:

Current Illness:

ID: 1057680
Sex: U
Age:
State: CA

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no adverse event; 9 month old patient was administered VAQTA; This spontaneous report was received from a physician via company representative, referring to a 9-month-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported. On 18-FEB-2021, a 9-month-old patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) (product administered to patient of inappropriate age). No additional adverse event reported.

Other Meds:

Current Illness:

ID: 1057681
Sex: F
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: arm swollen; arm was warm; didn't feel well for a long time; This spontaneous report as received from a consumer refers to a 71-year-old female patient.There was no information about the patient's medical history, concurrent conditions or concomitant medication. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient stated her arm was warm (feeling hot) and swollen and she "did not feel well for a long time (malaise)." The patient reported she was taking diphenhydramine hydrochloride (BENADRYL) after reaction. No clarifying details were provided. The outcome of peripheral swelling, malaise and feeling hot is unknown. The causality assessment for the events was not reported. This is one of several reports received from the same reporter; Sender's Comments: US-009507513-2102USA008670:

Other Meds:

Current Illness:

ID: 1057682
Sex: U
Age:
State: VA

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no other AE's reported; temperature - 7.4 C / the VARIVAX was administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-FEB-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live VARIVAX 0.5 ml, lot # T021821, expiration date 25-JUN-2022 (route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of -7.4 degrees Celsius (C) for 3 hours and 54 minutes. No previous temperature excursion was reported. Digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2102USA008721: US-009507513-2102USA008814:

Other Meds:

Current Illness:

ID: 1057683
Sex: U
Age:
State: TX

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no additional adverse event; three doses of ROTATEQ were administered following a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml once, orally, lot # 1691308, expiration date 28-NOV-2021 for prophylaxis. The vaccine experienced a temperature excursion, however, at the time of reporting, the reporter was waiting for multiple excursion form to be returned so no details were provided. Digital data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2102USA008565:

Other Meds:

Current Illness:

ID: 1057684
Sex: M
Age:
State: SC

Vax Date: 01/22/2021
Onset Date: 02/04/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Two nosebleeds; Heart skipped all day long; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EU9231, unknown expiration), via an unspecified route of administration in left arm on 22Jan2021 at a single dose for prevention; apixaban (ELIQUIS), oral from an unspecified date at 2.5 mg twice daily for thromboembolism prophylaxis; and ranolazine (RANEXA), oral from an unspecified date at 500 mg twice daily for an unspecified indication. Medical history included bypass surgery in 2007, stent placement (5 stents), and 3 blocked arteries, diagnosed several years ago, he guesses he is living on half of them. There were no concomitant medications. The patient received his first shot of COVID vaccine on 22Jan2021. The patient then experienced two nosebleeds, they did not ask if he had been on a blood thinner, he takes Eliquis, 2.5mg and Ranexa, so his question is a couple days, his heart skips beats anyway, but on the 13th day, it skipped all day long, so he was concerned about the other shot, he was supposed to get it today, he was concerned because he had bypass surgery, had 5 stents, 3 blocked arteries now that they can't do anything about. He was calling about COVID vaccine. He took it 3 weeks ago today and was supposed to get second shot. Concerned as to whether or not he should take it. He was supposed to get the second shot today (12Feb2021), doesn't know, but was really concerned about whether he should take or not. Nosebleeds were the 13th day after the shot (on 04Feb2021). He has recovered completely from nosebleeds. He stated he only bled for a couple seconds. Heart skipped all day long the 13th day after taking the shot (on 04Feb2021), states it is doing fine at this time, comes and goes, may skip one day, next day maybe 3 times and skip, then 4 times and skip, he guesses he has a crazy heart. The patient recovered from the event two nosebleeds on unspecified date, while unknown outcome for the remaining event. The action taken in response to the events for apixaban and ranolazine was unknown. Additional information was also received by Pfizer from Bristol-Myers Squibb Company (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-016064), license party for Apixaban. This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Two nosebleeds) and EXTRASYSTOLES (Heart skipped all day long) in 86-year-old male patient who received apixaban (Eliquis) tablet for Thromboembolism prophylaxis. CO-SUSPECT PRODUCTS included ranolazine (Ranexa) tablet for an unknown indication and Covid-19 Vaccine injection for Prevention. The patient's past medical history included Bypass surgery in 2007, Stent placement and Arterial occlusion. On an unknown date, the patient started Eliquis (Oral), 2.5 milligram twice a day and Ranexa (Oral), 500 milligram twice a day. On 22-Jan-2021, the patient started Covid-19 Vaccine (unknown route) by injection once to left shoulder. On 04-Feb-2021, an unknown time after starting Eliquis, the patient experienced EPISTAXIS (Two nosebleeds) and EXTRASYSTOLES (Heart skipped all day long). The action taken with Eliquis(Oral) was unknown. At the time of the report, EPISTAXIS resolved and EXTRASYSTOLES outcome was unknown. For Eliquis(Oral), the reporter did not provide any causality assessments. Nosebleeds were the 13th day after the shot. He took shot on 22Jan2021. Has recovered completely from nosebleeds. States he only bled for a couple seconds. Heart skipped all day long the 13th day after taking the shot, states it is doing fine at this time, comes and goes, may skip one day, next day maybe 3 times and skip, then 4 times and skip, he guesses he has a crazy heart.

Other Meds: ELIQUIS; RANEXA

Current Illness:

ID: 1057685
Sex: U
Age:
State:

Vax Date: 12/31/2020
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: soreness at injection; little swelling; little pain; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date for tolerance see case US2021AMR000320). On 31st December 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced injection site pain, swelling and pain. On an unknown date, the outcome of the injection site pain, swelling and pain were unknown. It was unknown if the reporter considered the injection site pain, swelling and pain to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient experienced side effect of soreness at injection, the little swelling and the little pain. The reporter inquired that What should be done to calm these reaction. The information regarding consent to follow up was not reported.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR000320:1st dose

Other Meds:

Current Illness:

ID: 1057686
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: had a severe allergies to something in the second dose of Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of multiple allergies in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced multiple allergies. On an unknown date, the outcome of the multiple allergies was unknown. It was unknown if the reporter considered the multiple allergies to be related to Shingrix. Additional details were provided as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient stated that he/she had severe allergies to something in the 2nd dose of Shingrix, The patient wanted to know if he/she should get COVID vaccine.

Other Meds:

Current Illness:

ID: 1057687
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: I have an allergic reaction to the first dose; This case was reported by a consumer via media and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Shingrix. Additional details were provided as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received 1st dose of Shingrix and had allergic reaction.

Other Meds:

Current Illness:

ID: 1057688
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Large patch of redness at Shingrix injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported however captured as adult as per vaccine indication. The patient experienced large patch of redness at Shingrix injection site.

Other Meds:

Current Illness:

ID: 1057689
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Developed muscular aches; Pain; Headaches; When to bed and slept for ~12 hours; This case was reported by a physician and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, pain, headache and sleep excessive. On an unknown date, the outcome of the muscle pain, pain, headache and sleep excessive were recovered/resolved. The reporter considered the muscle pain, pain, headache and sleep excessive to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The physician stated that upon receiving the 2nd dose of Shingrix, the patient developed muscular aches and pain and headache and when to bed and slept for approximately 12 hours and this resolved the next day. The patient was not hospitalized. The physician believed that this was related to the vaccine. The reporter consented to follow-up.

Other Meds:

Current Illness:

ID: 1057690
Sex: M
Age:
State:

Vax Date: 09/30/2020
Onset Date: 09/30/2020
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: range of motion is limited; has a hard time sleeping at night due to the pain; immediately experienced a sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 30th September 2020, the patient received the 1st dose of Shingrix. On 30th September 2020, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced mobility decreased and difficulty sleeping. On an unknown date, the outcome of the pain in arm, mobility decreased and difficulty sleeping were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, mobility decreased and difficulty sleeping to be related to Shingrix. Additional details were provided as follows: The patient had his first dose and immediately experienced a sore arm. The soreness had not resolved and his range of motion was limited. He said he had a hard time sleeping at night due to the pain. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1057691
Sex: F
Age: 75
State: TX

Vax Date: 10/01/2020
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Itching for several days; Experienced an allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included multiple allergies. In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pruritus and allergic reaction. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the pruritus and allergic reaction were recovered/resolved. It was unknown if the reporter considered the pruritus and allergic reaction to be related to Shingrix. Additional details were provided as follows: The reporter reported for herself. The age at vaccination was not reported but it could be 74 or 75 years. The reporter stated that, after vaccination with 1st dose, experienced an allergic reaction, had itching for several days. The patient took steroid medication for few days.; Sender's Comments: US-GLAXOSMITHKLINE-US2021008415:Same reporter. Duplicate case - deleted.

Other Meds:

Current Illness: Multiple allergies

ID: 1057692
Sex: F
Age: 62
State: TX

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Felt like she had anemia; Was out of breath; Felt really bad / did not feel better after eating yesterday or after eating breakfast this morning/ have not resolved; Flu-like symptoms; Fever; Chills; Achiness; A lot of fatigue; Headache; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 62-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication. Concurrent medical conditions included hashimoto's disease. On 15th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 16th January 2021, 1 days after receiving Shingrix, the patient experienced feeling bad, influenza-like symptoms, fever, chills, pain, fatigue and headache. On 19th January 2021, the patient experienced anemia and shortness of breath. The action taken with Shingrix was unknown. On 17th January 2021, the outcome of the influenza-like symptoms, fever, chills, pain and headache were recovered/resolved. On an unknown date, the outcome of the feeling bad, fatigue, anemia and shortness of breath were not recovered/not resolved. It was unknown if the reporter considered the feeling bad, influenza-like symptoms, fever, chills, pain, fatigue, headache, anemia and shortness of breath to be related to Shingrix. Additional details were reported as follows: The patient received shingrix vaccine on in the upper left arm at . She stated that the next she felt really bad with flu-like symptoms, including fever, chills, achiness, a lot of fatigue and headache. She reported that, they all were gone by on 17th January 2021 and that she felt fine on On 18th January 2021. She also reported on 19th January 2021, she felt like she had anemia, was out of breath and had fatigue. She did not feel better after eating day before reporting or after eating breakfast on the day of reporting. These had not resolved. The patient consented to follow up.

Other Meds:

Current Illness: Hashimoto's disease

ID: 1057693
Sex: F
Age: 63
State: NC

Vax Date: 10/03/2018
Onset Date: 01/24/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: middle area of her back started to itch; sensation of little stabbing needles / in the middle of her back; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received in 2018.). On 3rd October 2018, the patient received Shingrix. On 24th January 2021, 844 days after receiving Shingrix, the patient experienced pruritus and pins and needles. On an unknown date, the outcome of the pruritus and pins and needles were not recovered/not resolved. It was unknown if the reporter considered the pruritus and pins and needles to be related to Shingrix. Additional details were provided as follows: The patient had both doses in 2018. After searching paperwork, the date 3rd October 2018 was found as vaccination date but the reporter was not sure if that was the first dose or second dose date. After receiving Shingrix, the patient experienced the middle area of her back started to itch and the sensation of little stabbing needles presented, and it was under her bra area in the middle of her back. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1057694
Sex: F
Age:
State: FL

Vax Date: 11/01/2020
Onset Date: 11/01/2020
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Dr. diagnosed it as an allergic reaction; RASH ON THE ARM / covered her entire left arm; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis. In November 2020, the patient received the 1st dose of Shingrix. In November 2020, 2 days after receiving Shingrix and an unknown time after starting Zyrtec, the patient experienced allergic reaction and rash. The patient was treated with cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the allergic reaction and rash to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix in unknown arm. After receiving 1st dose of Shingrix, the patient experienced rash covered her entire left arm. The doctor diagnosed it as an allergic reaction. The rash disappeared after one week. The patient reported all possible side effects. The patient became frustrated with the collection of demographics and hung up the phone before transfer to the product team. The patient did not give permission to contact their doctor. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1057695
Sex: F
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: Soreness at injection site; left arm was Sore to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix. Additional details were provided as follows: After receiving 1st dose of Shingrix, the patient experienced soreness at injection site and left arm was sore to the touch. All information was not available. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1057696
Sex: F
Age:
State:

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: experiencing "all of the listed side effects." / not feeling well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 27th January 2021, the patient received the 2nd dose of Shingrix. On 28th January 2021, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved. It was unknown if the reporter considered the feeling unwell to be related to Shingrix. Additional information was provided as follows: The age at vaccination was not reported. On 27th January 2021, the patient received 2nd dose of Shingrix. The reporter stated that, she experienced all of the listed side effects and refused to answer any questions as she was not feeling well enough to do so. Limited information was provided. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1057697
Sex: M
Age: 53
State: MA

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

Lab Data:

Allergies:

Symptoms: Rash on his arm; Sweating; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 11th January 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th January 2021, 12 hrs after receiving Shingrix, the patient experienced sweating and vomiting. On 26th January 2021, the patient experienced rash. On an unknown date, the outcome of the sweating and vomiting were recovered/resolved and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the sweating, vomiting and rash to be related to Shingrix. Additional details were provided as follows: The patient reported for himself. The patient stated that, about 12 hours after vaccination, the patient had sweating and vomiting and were resolved. The patient stated that 3 days ago, the patient developed a rash on his arm and was not recovered. The patient did not consent to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021022953:same reporter US-GLAXOSMITHKLINE-US2021022954:same reporter

Other Meds:

Current Illness:

ID: 1057698
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: A skin issue; This case was reported by a consumer via call center representative and described the occurrence of skin disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin disorder. The patient was treated with antibiotics nos (Anti-Biotic (Drug Name Unknown)). On an unknown date, the outcome of the skin disorder was not recovered/not resolved. It was unknown if the reporter considered the skin disorder to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. Patient received the dose of Shingrix and experienced skin issue. The reporter stated that, he/she was due for the 2nd dose of Shingrix. The patient took anitbiotics for the skin disorder.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm