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

Date Died: 02/08/2021

ID: 1035542
Sex: M
Age:
State: UT

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: passed away; This is a spontaneous report from a contactable consumer (patient's granddaughter). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN9581), via an unspecified route of administration on 08Feb2021 at 14:30 into right arm at single dose for COVID Prevention. Medical history included Heart valve replacement from 5 years before 09Feb2021 (2016), on Oxygen at night (reporter did not know the liter amount that the patient used at night). The patient's concomitant medications were not reported. Patient had no other vaccines on the same day as the COVID vaccine. It was reported that patient received his first dose of the Pfizer vaccine around 14:30 on 08Feb2021 and he was fine before that, and by 16:30, he had passed away on 08Feb2021. Reporter reported that the cause of death was unknown at this time and that the family would be having an autopsy performed but that it had not yet been performed. No investigation assessment could provide. The patient died on 08Feb2021 at 16:30. An autopsy was not performed.; Reported Cause(s) of Death: passed away

Other Meds:

Current Illness:

ID: 1035543
Sex: F
Age:
State: FL

Vax Date: 01/29/2021
Onset Date: 01/01/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck was numb/Numbness in leg/jaws are numb; I'm feeling my teeth are still and my jaws are numb; felt very odd sensation as she was swallowing; was closing up but much wasn't closing up/it was not full open; swelling on her throat; Muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side; it hurts my neck area across my back; it hurts my neck area across my back; Stumbling; face was swollen; eyes looks like little switch; thirsty; felt very sluggish; nose started to running; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first single dose BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (anatomical location: arm left) on 29Jan2021 15:00 for COVID-19 immunization. Medical history included insomnia and asthma. The patient's concomitant medications were not reported. Patient stated, "I got the vaccine yesterday about 3 pm and I came home and I had dinner and sat down to watch TV at 9 O' clock, I turn the program on and I was out like a 'light' and this stuff knock me out (onset date: 29Jan2021). My dog has to wake me up licking my face at 3:15 this morning. I normally don't sleep long 4 hours and that's it. I'm 68 years old and I have insomnia (History) but when I woke up I was stumbling around, still have to sleep (onset date Jan2021), I took the dog out to walk and came back and saw myself in mirror, my face was swollen and my eyes looks like little switch. I noticed, I was thirsty and I went to get and drank, some coke because I felt very sluggish and I drank some coke and when I was swallowing the coke I felt very odd sensation as I was swallowing, I noticed that after swallowing. I have asthma (History) to begin with so I'm anticipated on having some of the symptoms it start showing up a bit, my nose started to running and I noticed that my whole entire face my head, down my back my neck was numb along with swelling on my throat, I felt okay but I felt it wasn't being, it was closing up but much wasn't closing up you know what I mean it was not full open. I also had muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side. I also noticed I went to a lovely person and when I went to bathroom I pull my pants down I felt numbness on my legs. So, my whole body was kind of having that not tingling sensation but numb and when I ran my fingers across my leg you know how you feel numbness when you run your fingers across a part of your body when it's numb that's exactly how I felt and that was about 3:30 this morning that happened I woke up by but I also want to ask question because I got to go back to my second shot. I'm wondering if I go back to my second dose am I going to have even more intense reaction to the stuff that I get this time." Patient further added "I was still trying to eat something but I'm feeling my teeth are still and my jaws are numb and this I got since yesterday (29Jan2021)." The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1035544
Sex: F
Age:
State: IL

Vax Date: 02/01/2021
Onset Date: 02/07/2021
Rec V Date: 02/17/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day three of a coma on life support from a brain aneurysm; Mood swings; irate; Body aches; This is a spontaneous report from a Contactable Consumer, the patient. This 28-year-old non-pregnant female consumer (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 as a single dose, for COVID-19 vaccination. Historical vaccination includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1. The facility in which the second vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. No Medical history reported ('No health issues, At all'). The patient has no known allergies. There were no concomitant medications. On an unspecified The Patient Experienced became irate. Mood swings. Body aches for couple days; On 07Feb2021 at 13:45, The patient experienced Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm (hospitalization, disability, life threatening), Treatment was given for the events of stroke, a thunder clap headache, limbs stiffened up, eyes crossed, lost speech, and brain aneurysm. The Adverse Event resulted in an Emergency Room Visit. Treatment was given for the events. 'Patient on Life support still'. The Clinical Outcome of the events Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm not recovered, while Mood Swings, Anger and Pain was unknown. Information on Lot has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1035545
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Death; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received Covid 19 Vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunization.The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter was calling about the Covid 19 Vaccine. Reporter stated that she gets information every day from the nursing home. Reporter stated that she will provide the name of the Nursing home, she just forgot to put it down. The patient, within 2 days dead from it, he was perfectly healthy. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on Lot/batch number has been requested.; Reported Cause(s) of Death: Death

Other Meds:

Current Illness:

Date Died: 02/03/2021

ID: 1035546
Sex: F
Age:
State: FL

Vax Date: 01/16/2021
Onset Date: 01/31/2021
Rec V Date: 02/17/2021
Hospital: Y

Lab Data: Test Date: 2021; Test Name: Investigation; Result Unstructured Data: Test Result:Brain bleed and discovered she had a stroke; Test Date: 202102; Test Name: COVID-19 virus test; Test Result: Negative

Allergies:

Symptoms: Stroke; This is a spontaneous report from a contactable consumer. A 94-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 16Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing hypertension (took medication). Patient did not have COVID-19 prior to vaccination. Concomitant included unspecified medication for hypertension. The patient experienced stroke on 31Jan2021. The patient was brought to the emergency room and hospitalized due to the event on 31Jan2021. No therapeutic measures were taken as a result of the event. The patient underwent lab tests and procedures which included COVID-19 virus test: negative in Feb2021 (a week before report); investigation: brain bleed and discovered she had a stroke (on unknown date in 2021). The patient died on 03Feb2021 due to stroke and old age. An autopsy was not performed. Patient's family did not attribute her death to the vaccine at all. The information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: stroke; Old age

Other Meds:

Current Illness: Hypertension (Took medication)

ID: 1035547
Sex: M
Age:
State: FL

Vax Date: 01/22/2021
Onset Date: 01/26/2021
Rec V Date: 02/17/2021
Hospital: Y

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

Allergies:

Symptoms: left parietal CVA; left popliteal DVT; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= el 1284), via an unspecified route of administration on 22Jan2021 17:00 at single dose at left arm for covid-19 immunization. Medical history included cholesterol. Concomitant medications in two weeks included atorvastatin (LIPITOR), esomeprazole sodium (NEXIUM), triazolam and OTC vitamin. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 05:30 AM, the patient experienced left parietal CVA and left popliteal DVT (hospitalization, life threatening) with outcome of recovering. The patient was hospitalized for both events for 5 days. The patient underwent lab tests and procedures post vaccination which included nasal swab: unknown results. Patient received TPA (Tissue plasminogen activator), blood thinners as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event).

Other Meds: LIPITOR [ATORVASTATIN]; NEXIUM [ESOMEPRAZOLE SODIUM]; TRIAZOLAM

Current Illness:

ID: 1035548
Sex: M
Age:
State: FL

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 02/17/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Repetitive episodes of tingling; numbness occurring in left side of body including side of face; Possible TIA; This is a spontaneous report from a contactable consumer reporting for himself. A 73-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9262), via an unspecified route of administration in the left arm on 02Feb2021 16:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included amlodipine (unknown manufacturer). On 02Feb2021 16:00 the patient experienced repetitive episodes of tingling and numbness occurring in left side of body including side of face; possible TIA with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient was hospitalized for 3 days due to the events. The events were serious as life-threatening and due to hospitalization. It was unknown if the patient received treatments for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.

Other Meds: AMLODIPINE

Current Illness:

Date Died:

ID: 1035549
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Name: blood bilirubin; Result Unstructured Data: Test Result:1.50; Test Name: osmolality; Result Unstructured Data: Test Result:297; Test Name: blood pressure; Result Unstructured Data: Test Result:159/106; Test Name: Blood urea (BUN); Result Unstructured Data: Test Result:22.3; Test Name: monocytes; Test Result: 12.1 %; Test Name: platelet count; Result Unstructured Data: Test Result:Thrombocytopenia; Test Date: 20201221; Test Name: platelet count; Result Unstructured Data: Test Result:platelet count decreased again to 0

Allergies:

Symptoms: Thrombocytopenia; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thrombocytopenia on an unspecified date, the seriousness of the event reported as death. The patient died two weeks after receiving a COVID-19 vaccine. Patient's wife said that he died from a condition known as thrombocytopenia, marked by a shortage of the blood platelets that help stop bleeding, after he received BNT162B2. The patient underwent lab tests and procedures which included blood bilirubin: 1.50, blood osmolarity: 297, blood pressure measurement: 159/106, blood urea: 22.3, monocyte count: 12.1 %, platelet count: thrombocytopenia, platelet count: platelet count decreased again to 0 on 21Dec2020. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Thrombocytopenia

Other Meds:

Current Illness:

ID: 1035550
Sex: F
Age:
State: OH

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Blood blister; hands, feet, torso are covered and painful/soreness and tenderness of palms; has trouble with ambulation; torso are covered and painful; This is a spontaneous report from a contactable nurse (patient's daughter). An 86-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry: Mar2021), intramuscular in the left upper arm on 25Jan2021 13:30 at a single dose for protection against virus. Medical history included COVID from 18Nov2020 and ongoing (recovering/resolving). The patient's concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry: Mar2021) intramuscular in the left arm on 04Jan2021 for protection against virus with no problem. On 26Jan2021, patient had one tiny blood blister but now was covered in them. Her hands, feet, and torso are covered and are painful. The patient has trouble with ambulation and using her walker since. The palms of her hands are covered front and back too. The patient was also covered on her toes and areas of the abdomen around the umbilicus area. Had the first dose on 04Jan2021 and the second on 25Jan2021. Her mother has an appointment on 03Feb2021, and caller wanted to know if this is uncommon or a rare side effect. The reporter has found a couple of articles, but most of them refer to pediatrics and rashes and she didn't see any side effects about blood blisters for her mother's age group. Further stated that areas covered are progressively worse and disabling since her mother was using a walker to ambulate. Has not been able to really use the walker due to the soreness and tenderness of palms. Her mother had the disease (COVID) back on 18Nov2020 and was symptomatic and was mild. No other vaccines received the same time. No history of problems with vaccines in past. They can't think of nothing that was new, no new medications, lotions, creams, or detergents, nothing new. The events did not require a visit to emergency room nor a physician office. Onset date of events reported was on 26Jan2021 with outcome of not recovered. The reporter assessed the seriousness of events as disability. The events were assessed as related to vaccines.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness: COVID-19 (Recovering/Resolving)

ID: 1035551
Sex: F
Age:
State: OR

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown Results

Allergies:

Symptoms: vaccine is really taking a big toll on her brain function; feels just weird, like everything is in slow motion/feeling really weird; dizzy/lightheaded; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left deltoid on 02Feb2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient got the COVID vaccine a couple hours ago on 02Feb202 and was very lightheaded. When the patient was asked to provide her mailing address, she stated she was feeling really weird, the vaccine was really taking a big toll on her brain function, she was super dizzy and feels just weird, like everything is in slow motion. Lightheadedness started probably about 20 minutes after she had the shot, they made her wait for 15 minutes, now she just feels really weird. The patient was healthy, she just got blood tests back and everything said she is healthy. She thought they said to call if she was having a side effect of dizziness or weakness, as they are more serious, but she called her doctor and they said to call Pfizer. The outcome of the events was unknown. The patient underwent lab tests and procedures which included blood test: unknown results on unspecified date.

Other Meds:

Current Illness:

Date Died: 12/29/2020

ID: 1035552
Sex: F
Age:
State:

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:98 Fahrenheit

Allergies:

Symptoms: approxmately 1:30 Pm the resident passed away; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported that a female patient of an unspecified age (reported as 85 without unit) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular at left arm on 29Dec2020 11:29 at single dose for COVID-19 immunization. Medical history included dementia, aphasia, type 2 diabetes mellitus (DM), iron deficiency, asthenia, osteoporosis, polyneuropathy, anxiety, Major depressive disorder (MDD). Concomitant medication included gabapentin, memantine. The patient had allergies to codiene, phenobarbital, penicillin. The vaccine was administrated with no immediate adverse reaction at 11:29. Vaccine screening questions were completed and resident was not feeling sick and temperature was 98F. At approximately 13:30 on 29Dec2020, the resident passed away. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: approxmately 1:30 Pm the resident passed away

Other Meds: GABAPENTIN; MEMANTINE

Current Illness:

Date Died: 02/02/2021

ID: 1035553
Sex: F
Age:
State:

Vax Date: 01/19/2021
Onset Date: 01/25/2021
Rec V Date: 02/17/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Pt passed soon after; shortly after progressed with other covid symptoms and was admitted / acute resp failure, COVID pneumonia; acute resp failure, COVID pneumonia; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; This is a spontaneous report from a non-contactable Pharmacist. A 76-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EL3247), intramuscular on 19Jan2021 at single dose for COVID-19 immunisation. The patient medical history included COVID symptoms from 16Jan2021 and ongoing. Concomitant medications were not reported. The patient with acute resp failure, COVID pneumonia, that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior to a admit, then shortly after progressed with other covid symptoms and was admitted on 25Jan2021. She decompensated while intp and was transferred to ICU for rising O2 needs, ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed, hemodynamics deteriorated. The patient died on 02Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events death, COVID-19 pneumonia, acute respiratory failure, hypotension, abdominal wall haematoma and abdominal wall haemorrhage cannot be excluded. 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.; Reported Cause(s) of Death: Pt passed soon after

Other Meds:

Current Illness: Suspected COVID-19

ID: 1035555
Sex: M
Age:
State: CA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:high; Test Date: 20210128; Test Name: Blood pressure; Result Unstructured Data: Test Result:up; Test Date: 20210128; Test Name: Temperature; Result Unstructured Data: Test Result:100

Allergies:

Symptoms: When he went to the bathroom it was like diarrhea, watery, and had blood; He also had pains in his stomach; he could hardly move; Last night he sweated, the sheets were all wet; Pain on the right side of his back/ night before he had it on his left side/ he moved it hurt so bad; He only slept for 4 hours; Fever and chills; Fever, temperature was only 100; his blood pressure went up; Stomach problems; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL9265), via an unspecified route of administration at the left arm on 27Jan2021 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history included ongoing high blood pressure and ongoing cholesterol. Ongoing concomitant medications included lisinopril for high blood pressure, amlodipine for high blood pressure and atorvastatin for cholesterol. The patient previously took montelukast and dries up his sinuses. On 27Jan2021 he received the first dose in the afternoon about 5 o'clock or a little after. It started with stomach problems on 27Jan2021. He kept feeling like he had to go to the bathroom all throughout the night on 27Jan2021. He slept through the night and was okay. He had a little something going on in his stomach. The next day (28Jan2021), that evening, around 7pm he had fever and chills and his blood pressure went up. His temperature was only 100. It never went over that. And he was having to go to the bathroom. In the morning, it was fine but at night he was having to go. Normally he has a bowel movement in the morning. When he went to the bathroom it was like diarrhea, watery, and had blood. It was not dried blood, but blood. It happened twice. He then had to go again. The same thing happened again and then it stopped. He also had pains in his stomach. He went to sleep and the next day he went to the bathroom the first thing in the morning and it was normal. The reported also mention that stomach problems were worse on 28Jan2021. He only slept for 4 hours on 28Jan2021. The next day, 29Jan2021 he was fine. He only had a little bit of a fever and a little bit of chills. Then the chills and fever went away that day. He did not feel ill or weak at all when this was happened which is why he did not go to the doctor. He did not feel that the symptoms were bad enough. He felt okay once they were over. He had to get it out. On 31Jan2021, he also had fever and pain on the right side of his back. It was a really sharp pain and he could hardly move. The night before he had it on his left side. He made himself get out of bed. When he moved it hurt so bad. On 31Jan2021, he sweated, the sheets were all wet. He slept 4 hours. He has been using ice packs and icing it down. The pain on the right side has gone away but the pain on the left side is still there. It has improved and there is only a little pain. He iced it down first thing this morning. He walks everyday. The outcome of the event diarrhea bloody was recovered on an unspecified date, stomach problems and his blood pressure went up recovered on 28Jan2021; pain back was recovering; outcome for all other events was unknown.

Other Meds: LISINOPRIL; AMLODIPINE; ATORVASTATIN

Current Illness: Blood cholesterol abnormal; Blood pressure high

ID: 1035556
Sex: F
Age:
State: TX

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: stayed up all night, slept all day; Hallucinations/ just saw people but never heard voices; stayed up all night, slept all day; This is a spontaneous report from a contactable consumer (patient's daughter). An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EN5318, expiration date unknown) via an unspecified route of administration on the right arm on 01Feb2021 at a single dose as vaccine for COVID-19. The patient had no medical history and no concomitant medications. On 01Feb2021 23:00, the patient experienced hallucinations. It was reported that patient started hallucinating on 01Feb2021 23:00 and just saw people but never heard voices. The reporter stated that her mom never had hallucinations ever. The patient feared people were in the house and stayed up all night (from 01Feb2021 23:00), slept all day (on 02Feb2021). The reporter wanted to know if they have ever heard of this happening. She has made an appointment with the patient's doctor. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1035557
Sex: M
Age:
State: NY

Vax Date: 01/29/2021
Onset Date: 01/31/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Swollen lymph nodes; Developed Shingles on his face; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported for a 32-year-old male patient (her fiance). A 32-year-old male patient received second 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 at the right arm on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 on 08Jan2021 for COVID-19 immunization. The patient developed shingles on his face on 31Jan2021 and swollen lymph nodes on 01Feb2021. The events were reported as serious (medically significant) and worsened. There were no investigation assessment. The patient had not recovered from the events at the time of the report. Information on the batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the Company considers the event swollen lymph nodes is possibly related to suspect vaccine BNT162B2. Other than a temporal association, there is no evidence or argument to suggest a causal relationship between BNT162B2 and the event shingles, which is likely an intercurrent condition. 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: 1035558
Sex: F
Age:
State: MI

Vax Date: 01/19/2021
Onset Date: 01/01/2021
Rec V Date: 02/17/2021
Hospital: Y

Lab Data: Test Name: Platelet Count; Result Unstructured Data: Test Result:normal; Comments: His wife had blood work and platelets checked before the vaccine and they were normal; Test Date: 20210128; Test Name: Platelet Count; Result Unstructured Data: Test Result:were low at 10,000; Test Date: 20210128; Test Name: Platelet Count; Result Unstructured Data: Test Result:were down to 8,000; Comments: They got to the ER and they checked her platelets; Test Date: 20210128; Test Name: Platelet Count; Result Unstructured Data: Test Result:came back to 11,000; Comments: They decided to admit her after giving the treatment in the ER; Test Date: 20210129; Test Name: Platelet Count; Result Unstructured Data: Test Result:7,000; Test Date: 20210130; Test Name: Platelet Count; Result Unstructured Data: Test Result:26,000; Test Date: 20210131; Test Name: Platelet Count; Result Unstructured Data: Test Result:36,000; Comments: They continued the treatment during the night/they released her that day late on Sunday; Test Date: 20210201; Test Name: Platelet Count; Result Unstructured Data: Test Result:61,000 now

Allergies:

Symptoms: Low platelets; Rash on her body; Bruising; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3249), via an unspecified route of administration in the right arm on 19Jan2021 at a single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus since 2011 (reported diagnosed 10 years from this report, ongoing congenital heart defect which patient was born with but did not find out until she was in her 50s; does not bother her too much; one of the major arteries has a 90 degree angle vs. an S curve, mild multiple sclerosis; no longer has this as she has not had another relapse; she was diagnosed almost 30 years ago; she has never had another attack since she had 2 of them and was on medication that did damage to her liver, breast cancer; patient is a breast cancer survivor and issues with magnesium levels. There were no concomitant medications. On 28Jan2021 the patient had blood work done for her kidney doctor. They withdrew blood from her arm. They had a hard time stopping the bleeding afterwards. They finally got it to stop and put regular cotton balls and a band aid on it. By the time she was walking out she was bleeding out of her arm she felt in her coat. They were able to stop the bleeding again. This was at about 10 AM. Patient went home and afterwards was called back and instructed to go to the ER for critical care. Her platelets were low at 10,000 at that time. They got to the ER and they checked her platelets and they were down to 8,000. They administered some steroids; Prednisone. They decided to admit her after giving the treatment in the ER. After that her platelets came back to 11,000. The next morning on 29Jan2021 her platelet count was 7,000. They started administering the same drug through an IV. He thinks it was still a steroid. They did it in smaller amounts and overnight the next day her platelets were up to 26,000 on 30Jan2021. They continued the treatment during the night again and on Sunday they were 36,000 and they released her that day late on Sunday. They went back and did blood work yesterday on 01Feb2021. The local doctor said her platelets are up to 61,000. The patient was getting blood work every Monday and Thursday for 3 weeks. Th patient had blood work and platelets checked before the vaccine and they were normal. The patient was hospitalized from 28Jan2021 to 31Jan2021 due to the event. The patient also noticed rash on her body and bruising maybe on 21Jan2021 or 22Jan2021. The bruising was really bad on her left hand by her wrist. It was really dark. She was also bruised everywhere they poked her with an IV and bruises where they put the heart monitor on her and pressed down to stick it to her. The bruising is still all over her body. It has stayed about the same. The one on her hand is still severe. The other from where she has been poked are starting to clear up. Overall it was about the same. The outcome of event bruising was not recovered, low platelets was unknown while rash on her body recovered on unspecified date.

Other Meds:

Current Illness: Congenital heart valve disorder; Diabetic

ID: 1035559
Sex: M
Age:
State: NC

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Name: vision field test; Result Unstructured Data: Test Result:which is how the stroke was diagnosed; Comments: the eye doctor is the one that discovered the stroke; He had a vision field test which is how the stroke was diagnosed.

Allergies:

Symptoms: Stroke; like he had a film over his eye, it was cloudy, like a cloudy day; This is a spontaneous report from a contactable consumer (patient). A 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283 and expiry date: 30Apr2021) solution for injection, intramuscular in left arm on 18Jan2021 13:10 at a single dose for Covid-19 immunization. Medical history included chicken pox, measles, and mumps (had chicken pox vaccine, measles, and mumps when he was younger, and he got the flu shot for flu). The patient's concomitant medications were not reported. The next day (19Jan2021) after receiving the injection, patient reported it was like he had a film over his eye, it was cloudy, like a cloudy day. This went on for a couple of days before it improved. There was still a little bit in his left eye, but he can read and it has improved. He can see now and his eyes were improving. He found out that he had a stroke on 28Jan2021. He did not go to the hospital. He does not think the stroke affected anything else. He was supposed to have an MRI sometime this week. He went to the eye doctor and the eye doctor was the one that discovered the stroke and his eye doctor sent the report over to his primary office. He had a vision field test which was how the stroke was diagnosed. He was taking a baby aspirin and he will be put on a blood thinner called Plavix. He has not started Plavix yet, he has to go pick it up. Outcome of the event stroke was unknown while the other events was recovering. No follow-up activities are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1035566
Sex: U
Age:
State: WI

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE/PQC reported; an expired dose of M-M-R II was given to a patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JAN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # R035704, expiration date:09-DEC-2020 (dose, route of administration and anatomical location were not reported) for prophylaxis. There were no know temperature excursions. No adverse event was reported.

Other Meds:

Current Illness:

ID: 1035567
Sex: U
Age: 1
State: OH

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; Improperly stored dose was administered; This spontaneous report was received from a nurse and refers to a 13-month-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided. On 01-FEB-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) 0.5 mL, lot number: T013205, expiration date: 03-DEC-2021 (strength, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 48 (unit not reported) for 24 hours and 45 minutes. Digital data logger was involved. There was no previous temperature excursion noted. There was no additional adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013205; expirationdate: 03-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: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1035568
Sex: U
Age:
State: NJ

Vax Date: 12/12/2011
Onset Date:
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: autoimmune disorder; hypersensitivity; headaches; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 12-DEC-2011 (at approximately 67 years old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a health care provider (reported as provider) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: autoimmune disorder, hypersensitivity and headaches. The outcome of the events was unknown. Upon internal review, autoimmune disorder was determined to be medically significant.

Other Meds:

Current Illness:

ID: 1035569
Sex: F
Age:
State:

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Date: 20210212; Test Name: flu test; Test Result: Negative ; Test Date: 20210212; Test Name: Covid; Test Result: Negative ; Test Date: 20210212; Test Name: strep test; Test Result: Negative

Allergies:

Symptoms: she has a fever of 101.5; headache; nausea; This spontaneous report was received from a company employee (also reported as the patient's grandmother) and the patient's mother, referring to a 17 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown by reporter. On 11-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis. On 12-FEB-2021, the patient had a fever of 101.5 (units not provided), headache and nausea. The patient sought medical attention by seeing the administering physician in afternoon and was tested for flu, strep, and Covid, all of which were negative. The patient was diagnosed that her symptoms were an adverse reaction to the vaccine. The outcome of fever of 101.5 (units not provided), headache and nausea were unknown. It was reported that the patient would not be receiving the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The reporter considered the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was related.

Other Meds:

Current Illness:

ID: 1035570
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: shingles - like rash / Rash is painful; shingles - like rash; This case was reported by a other health professional via interactive and described the occurrence of painful rash 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 painful rash and vesicular rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the painful rash and vesicular rash were unknown. It was unknown if the reporter considered the painful rash and vesicular rash 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 it was selected as adult as per the vaccine indication. The patient received Shingrix and had shingles like rash. The rash was painful and patient received valacyclovir 1 g BID was helpful. The reporter asked was it possible to get shingles from the vaccine.

Other Meds:

Current Illness:

ID: 1035571
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Name: Body temperature; Result Unstructured Data: (Test Result:100,Unit:degree F,Normal Low:,Normal High:)

Allergies:

Symptoms: 100?temp; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient received 2nd dose of Shingrix and got 100 degree F body temperature. The patient was asking how long will the fever last.

Other Meds:

Current Illness:

ID: 1035572
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Got the first one and I now have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient him/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received the 1st dose of Shingles vaccine and he/she now had shingles. The patient stated that if you got the 1st vaccine out, you should get the newer one. The patient's physician said that he/she needed to get the newer vaccine.

Other Meds:

Current Illness:

ID: 1035573
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: shingles which were painful; painful; This case was reported by a nurse via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included viral infection. Concurrent medical conditions included disability (caused by unspecified virus). On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were not recovered/not resolved. It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient (nurse) him/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient had far too many viruses and was disabled from an unnamed virus that he/she caught from a patient in 1981. The patient received 1st dose of shingles vaccine and stated was only partially effective so he/she still had shingles which were painful. The patient stated that they do not had all of the complications and had no idea as to what the sequel of COVID would be, as he/she do not need another virus. If you ignore history, you would repeat it and if you develop COVID now you do know which complications you would have and have no idea as to which Sequel you would have in the long-distance future. The patient stated that this was why you who are young need the COVID vaccination, we who are old did not had vaccination for chicken pox.

Other Meds:

Current Illness: Disability (caused by unspecified virus)

ID: 1035574
Sex: M
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: chills; fever; This case was reported by a physician and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were recovered/resolved. It was unknown if the reporter considered the chills and fever to be related to Shingrix. Additional information was provided as follows: The age at vaccination was not reported. In 2020, the patient received 2nd dose of Shingrix and experienced chills and fever for 2 and a half days. The patient completed the series of vaccine last year. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1035575
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: flu like symptoms; chills; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and chills. On an unknown date, the outcome of the influenza-like symptoms and chills were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and chills to be related to Shingrix. Additional information was provided as follows: The case was reported by the wife of patient. The age at vaccination was not reported. In 2020, the patient received 1st dose of Shingrix on left arm. The patient experienced chills and flu like symptoms which were resolved in 1 day. The reporter mentioned that, her husband had received both the shots in 2020 but could not provide the specific dates. The reporter consented to follow up. For tolerance of 2nd dose, refer case- US2021AMR008973, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR008962:same reporter US-GLAXOSMITHKLINE-US2021008404:same reporter US-GLAXOSMITHKLINE-US2021AMR008973:same patient, 2nd dose

Other Meds:

Current Illness:

ID: 1035576
Sex: M
Age: 61
State: OK

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Welts on his face and chest; Welts on his face and chest / are sore; This case was reported by a consumer via call center representative and described the occurrence of welts in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingles. Concurrent medical conditions included kidney transplant. In December 2020, the patient received the 1st dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced welts and pain. On an unknown date, the outcome of the welts and pain were unknown. It was unknown if the reporter considered the welts and pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported but it could be 60 or 61 years. The patient received 1st dose of Shingrix in right arm. The patient experienced welts on his face and chest and the welts vary in size, were sore and appear intermittently. He had been to a dermatologist. All information was not available. The reporter consent to follow up.

Other Meds:

Current Illness: Kidney transplant

ID: 1035577
Sex: F
Age: 57
State: IL

Vax Date: 11/20/2020
Onset Date: 11/21/2020
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: swelling at the injection site; redness / at the injection site; bruising at the injection site; nausea; body aches; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th November 2020, the patient received the 1st dose of Shingrix. On 21st November 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site bruising, nausea, general body pain and chills. On an unknown date, the outcome of the injection site swelling, injection site erythema, nausea, general body pain and chills were recovered/resolved and the outcome of the injection site bruising was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site bruising, nausea, general body pain and chills to be related to Shingrix. Additional details were reported as follows: The patient received Shingrix and experienced redness and swelling at the injection site. The patient also reports bruising at the injection site, which had not fully resolved. The patient also experienced chills, body aches, and nausea. All events except for the bruising at the injection site have resolved. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1035578
Sex: M
Age: 70
State: PA

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The syringe separated from the needle and leaked out on my skin, it appears as i wasn't clear if i got the full dose; The syringe separated from the needle and leaked out on my skin; The pharmacist who administered the vaccine tried twice in giving the dose and same thing happen both times; don't know how much I got; I had a little tenderness, no pain; A spontaneous report was received from a physician, a 70-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "PT had a little tenderness, no pain," "the syringe separated from the needle and leaked out on my skin," and "the pharmacist who administered the vaccine tried twice in giving the dose and same thing happen both times; don't know how much I got." The patient's medical history was not provided. No relevant concomitant medications were reported. On 01 Feb 2021, at 13:30, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012MZ0A/012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 01 Feb 2021, during vaccine administration, the syringe separated from the needle and leaked onto the patient's skin. It wasn't clear if the full dose was given. The pharmacist administering the vaccine then tried to give a second dose and the same thing happened both times. The patient was not sure how much he received. No treatment was provided. Action taken with mRNA-1273 in response to the events was not reported. The events of "the syringe separated from the needle and leaked out on my skin", and "the pharmacist who administered the vaccine tried twice in giving the dose and same thing happen both times; don't know how much I got", were considered resolved on 01 Feb 2021. The event outcome of "I had a little tenderness, no pain" was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these event/s has been provided at this time

Other Meds:

Current Illness:

ID: 1035579
Sex: U
Age:
State:

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Systemic symptoms; Bruising after vaccination; Limited range of motion in arm and struggles to lift arm; Tender arm; Vaccine inadvertently injected into the bursa; A spontaneous report was received from a nurse concerning a unknown patient of an unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and vaccine inadvertently injected into the bursa/incorrect route of product administration, experienced tender arm/tenderness, systemic smptoms/general symptom, bruising after vaccination/vaccination site bruising, and limited range of motion and struggles to lift arm/injected limb mobility decreased. The patient's medical history was not provided. No concomitant medications were reported. On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), for prophylaxis of COVID-19 infection. On 06 Jan 2021, the patient reported that she received her first vaccine, and it was inadvertently injected into the bursa. The patient later reported that she experienced a tender arm, systemic symptoms, bruising after vaccination, limited range of motion and struggles to lift the injected arm. She stated she will seek medical attention. No treatment information was provided. Consent given for Safety to follow up. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of the event, vaccine inadvertently injected into the bursa, was recovered on 06 Jan 2021. The events, tender arm, systemic symptoms, bruising after vaccination, and limited range of motion and struggles to lift the injected arm, were not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1035580
Sex: M
Age: 63
State: NC

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: None

Allergies: Ampicillin, Glyburide, Niacin, eggs

Symptoms: Injection site pain, fever, chills, slight diarrhea, fatigue

Other Meds: Metformin, Ozempic, Lisinopril, Lipitor, Mag-Oxide, Drisdol, Vitamin B12 injections, Lantus, Allopurinol

Current Illness: None

ID: 1035581
Sex: F
Age: 54
State: FL

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: None

Allergies: Latex

Symptoms: 02/03/2020 16:00pm Pain developed in the left deltoid and arm, site of vaccine. Swelling of site was mild. No rash. Difficulty lifting arm, very painful to touch, difficulty removing clothing and difficulty sleeping due to arm pain. 02/04/2020 02:30am Pain worsened in left arm. Developed mouth ulcers which were unexpected and painful. Rigorous chills. Temp normal, 97.7 F. 02/05/2020 05:00am Extreme fatigue, continued pain in left arm and continued painful mouth ulcers. 02/06/2020 02:30am Woke up and symptoms resolved with the exception of arm pain which remained until 02/08/2020. 02/15/2020 05:00am Mild left arm pain at site returned for duration of the day and then resolved by bedtime. 02/17/2020 04:00am 2 inch x 3 inch non-raised rash/redness appeared left deltoid at vaccine site with no pain. Warm to touch.

Other Meds: Synthroid, Zoloft, Amlodipine, Vitamin D3, CoQ10, Rosuvastatin

Current Illness: None

ID: 1035582
Sex: F
Age: 38
State: MI

Vax Date: 02/09/2021
Onset Date: 02/16/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Week after shot my arm all the sudden starting itching and super sore again and skin is red n swollen.

Other Meds:

Current Illness:

ID: 1035583
Sex: F
Age: 72
State: IN

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies: Prednisone Sensitive to latex, cortisones

Symptoms: Started with sinus drainage, which became constant and intermingled with blood. Arm was sore, joint and muscular aches. Then progressed to persistent productive cough. No fever during this time. These symptoms lasted until 2/15/2021.

Other Meds: Alendronate sodium, multivitamin, fiber tablets, Viactiv, potassium, magnesium, Vitamin D

Current Illness:

ID: 1035584
Sex: F
Age: 73
State: AZ

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies: Demerol, penicillin

Symptoms: Dissiness for 5 days

Other Meds: Multi vitamin, 80mg aspirin, med for rls, B-complex, osteo-biflex

Current Illness: None

ID: 1035585
Sex: F
Age: 63
State: NJ

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: Refused transport to hospital for further evaluation.

Allergies: Penicillin

Symptoms: Experienced syncopal episode following vaccine. Epinephrine 0.3mL administered by EMS at site.

Other Meds: rosuvastatin (CRESTOR) 5 mg tablet

Current Illness:

ID: 1035586
Sex: M
Age: 60
State: GA

Vax Date: 02/09/2021
Onset Date: 02/12/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: Since 12 Feb to present I have had aching bones and joints alone constant fatigue and general weakness in my left arm.

Other Meds: Ultram EQ 500 mg Celebrex 200 mg Protein Shake supplement

Current Illness: none

ID: 1035587
Sex: M
Age: 61
State: PA

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: NA

Allergies: NA

Symptoms: Vaccination out of manufacturers specifications. Pt stated 2nd dose was within 4 day grace period when in fact after checking the patient was 7 days early. Discovery was after injection was given. Per CDC guidelines series not needed to restart.

Other Meds: NA

Current Illness: NA

ID: 1035588
Sex: F
Age: 71
State: NH

Vax Date: 02/04/2021
Onset Date: 02/14/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies: Sudafed

Symptoms: red, round rash at injection site. Itching and mild swelling, no pain

Other Meds: metformin, atorvastatin, famotadine, wellbutrin, locating, alendronate sodium, vitamin D, Omega-3

Current Illness: none

ID: 1035589
Sex: F
Age: 85
State: PA

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 02/17/2021
Hospital: Y

Lab Data: ER twice for fluids and extreme dehydration

Allergies: none

Symptoms: severe nausea, chills diarehha, throwing up

Other Meds: calcium

Current Illness: none

ID: 1035590
Sex: F
Age: 48
State: PA

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: None

Allergies: Anaprox and crab

Symptoms: 101.7 fever, chills, headache, muscle aches, joint aches, pain at injection site with hardness and swelling at site. Started with injection site pain and muscle aches at about 12 hours (12am), chills by 2am, and progressed to full detailed symptoms by the time I woke up at 615am (fever,

Other Meds: Multi vitamin and fish oil -regular daily doses

Current Illness: None

ID: 1035591
Sex: F
Age: 28
State: TN

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: None

Allergies: Cephlasporins, Sulfa, PCN

Symptoms: Received 1st dose COVID-19 Vaccine at 1705. Ambulated to restroom and noted hives developed on torso and legs with heaviness in chest; denies difficulty breathing. Received MD evaluation in ED. Benadryl 50mg IV and Decadron 10mg IV. Discharged home in stable condition. Instructed NOT to receive 2nd COVID-19 Vaccine. Home with Prednisone and Epi-pen PRN.

Other Meds: None

Current Illness: None

ID: 1035592
Sex: F
Age: 66
State: MI

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies: Penicillin

Symptoms: Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days Upper arm still sore after 12 days. Pain on movement and unable to sleep on that side, as the arm pain awakens me. Also, the injection seemed to be placed extremely high on the arm, about an inch from top of shoulder and in the center/front or arm where it more bone/less muscle

Other Meds: Lisinopril

Current Illness:

ID: 1035593
Sex: F
Age: 78
State: FL

Vax Date: 02/01/2021
Onset Date: 02/13/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies: Not many. Relatively healthy.

Symptoms: Wed Feb 17. Fatique feet seem discolored at times arm seems to feel like mild pins and needles

Other Meds: I am due for my six month Prolia shot. What to do? This survey should be extended. Adverse affects start later. The site is still hurting and a large hard area is there. It itching and hot. When touched sore.

Current Illness: None

ID: 1035594
Sex: F
Age: 50
State: NH

Vax Date: 01/21/2021
Onset Date: 01/25/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: nothing

Allergies: thimersol

Symptoms: Red rash and swelling at injection site. The red rash and swelling with pain to touch lasted until Feb 8. then the arm was still slightly swollen and currently black and blue

Other Meds: Tamoxifen Neurontin Synthroid Liothyronine Phentermine Zyrtec Singulair

Current Illness: none

ID: 1035595
Sex: F
Age: 72
State: FL

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: none

Allergies: Bee venom & venom wasp (prior anaphylaxis), Keflex, Penicillin

Symptoms: SEVERE muscle pain, burning sensation in chest cavity and espophagus, slight fever (1 degree), fatigue, headache. These were the most severe manifestations I have ever experienced. Since I have previously had anaphylaxis, I am more worried about the reactions. I was not able yo sleep at all due to the strong pain. I do feel better this morning, but nowhere near ok.

Other Meds: Atenolol 15 mg one half/day Atorvastatin 10 mg Latanaprost 0.005% in each eye Multivitamin Vit B12 1000 mg

Current Illness: none

ID: 1035596
Sex: F
Age: 57
State: OH

Vax Date: 01/27/2021
Onset Date: 01/29/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies: NKDA

Symptoms: ADR occurred covid vaccination clinic on 1/27/21. Employee received covid 2nd vaccination (Moderna Lot 013L20A, Exp 07/08/21) on 1/27/21. Reaction reported 1/29/21 documented left arm red, swelling warmth at covid vaccine site. Patient was recommended to be seen by physician following Monday for medical evaluation if symptoms continued. Per documentation in Athena, 1/29/21 patient received a one time diphenhydramine 50mg injection, with instruction to start ice pack.

Other Meds:

Current Illness:

Date Died: 01/17/2021

ID: 1035597
Sex: M
Age: 42
State: GA

Vax Date: 12/30/2020
Onset Date: 01/17/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies: NKA

Symptoms: Death on 1/17/2021. Found at home deceased.

Other Meds:

Current Illness: unknown

ID: 1035598
Sex: M
Age: 60
State: VA

Vax Date: 02/06/2021
Onset Date: 02/16/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Terrible rash on hands and feet

Other Meds: Ginko biloba; fish oil; daily vitamin; zinc supplement; vitamin C; vitamin D

Current Illness: Not applicable

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm